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MS210300 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS To investigate the efficacy and safety of linagliptin , a dipeptidyl peptidase-4 inhibitor , in type 2 diabetes mellitus ( T2DM ) patients for whom metformin was inappropriate . METHODS This 1-year double-blind study ( Clinical Trials.gov , NCT00740051 ) enrolled T2DM patients with inadequate glycaemic control , treatment-naïve [ glycated haemoglobin ( HbA1c ) 7.0 - 10.0 % ] or previously treated with one oral antidiabetes drug ( HbA1c 6.5 - 9.0 % before washout ) , ineligible for metformin because of contraindications ( e.g. renal impairment ) or previous intolerable side effects . Patients were r and omized to monotherapy with linagliptin 5 mg once daily ( n = 151 ) or placebo ( n = 76 ) for 18 weeks , after which placebo patients switched to glimepiride 1 - 4 mg once daily and treatments continued for another 34 weeks . The primary endpoint was change from baseline in HbA1c after 18 weeks ( full- analysis set , last observation carried forward ) . RESULTS At week 18 , adjusted mean difference in change from baseline HbA1c ( 8.1 % ) was -0.60 % ( 95 % confidence interval -0.88 , -0.32 ; p < 0.0001 ) ( -0.39 % with linagliptin , + 0.21 % with placebo ) . At week 52 , mean HbA1c was decreased from baseline in both groups [ linagliptin : -0.44 % ; placebo/glimepiride : -0.72 % ( observed cases ) ] . Adverse events occurred in 40.4 and 48.7 % of linagliptin and placebo patients , respectively , during the initial 18 weeks . During the 34-week extension , patients receiving linagliptin experienced less hypoglycaemia ( 2.2 % vs. 7.8 % ) and no weight gain ( mean change from baseline of -0.2 and + 1.3 kg , respectively ) compared with glimepiride patients . CONCLUSIONS In T2DM patients for whom metformin was inappropriate , linagliptin improved glycaemic control and was well tolerated , with less hypoglycaemia and relative weight loss compared with glimepiride OBJECTIVE To evaluate the effects of canagliflozin , a sodium-glucose cotransporter 2 inhibitor , in type 2 diabetes mellitus inadequately controlled with metformin monotherapy . RESEARCH DESIGN AND METHODS This was a double-blind , placebo-controlled , parallel-group , multicenter , dose-ranging study in 451 subjects r and omized to canagliflozin 50 , 100 , 200 , or 300 mg once daily ( QD ) or 300 mg twice daily ( BID ) , sitagliptin 100 mg QD , or placebo . Primary end point was change in A1C from baseline through week 12 . Secondary end points included change in fasting plasma glucose ( FPG ) , body weight , and overnight urinary glucose-to-creatinine ratio . Safety and tolerability were also assessed . RESULTS Canagliflozin was associated with significant reductions in A1C from baseline ( 7.6–8.0 % ) to week 12 : −0.79 , −0.76 , −0.70 , −0.92 , and −0.95 % for canagliflozin 50 , 100 , 200 , 300 mg QD and 300 mg BID , respectively , versus −0.22 % for placebo ( all P < 0.001 ) and −0.74 % for sitagliptin . FPG was reduced by −16 to −27 mg/dL , and body weight was reduced by −2.3 to −3.4 % , with significant increases in urinary glucose-to-creatinine ratio . Adverse events were transient , mild to moderate , and balanced across arms except for a non – dose-dependent increase in symptomatic genital infections with canagliflozin ( 3–8 % ) versus placebo and sitagliptin ( 2 % ) . Urinary tract infections were reported without dose dependency in 3–9 % of canagliflozin , 6 % of placebo , and 2 % of sitagliptin arms . Overall incidence of hypoglycemia was low . CONCLUSIONS Canagliflozin added onto metformin significantly improved glycemic control in type 2 diabetes and was associated with low incidence of hypoglycemia and significant weight loss . The safety/tolerability profile of canagliflozin was favorable except for increased frequency of genital infections in females CONTEXT Dapagliflozin , a selective sodium-glucose cotransporter 2 ( SGLT2 ) inhibitor , reduces hyperglycemia in patients with type 2 diabetes mellitus ( T2DM ) by increasing urinary glucose excretion , and weight loss is a consistent associated finding . OBJECTIVES Our objectives were to confirm weight loss with dapagliflozin and establish through body composition measurements whether weight loss is accounted for by changes in fat or fluid components . DESIGN AND SETTING This was a 24-wk , international , multicenter , r and omized , parallel-group , double-blind , placebo-controlled study with ongoing 78-wk site- and patient-blinded extension period at 40 sites in five countries . PATIENTS Included were 182 patients with T2DM ( mean values : women 63.3 and men 58.6 yr of age ; hemoglobin A1c 7.17 % , body mass index 31.9 kg/m2 , and body weight 91.5 kg ) inadequately controlled on metformin . INTERVENTION Dapagliflozin 10 mg/d or placebo was added to open-label metformin for 24 wk . MAIN OUTCOME MEASURES Primary endpoint was total body weight ( TBW ) change from baseline at wk 24 . Key secondary endpoints were waist circumference and dual-energy x-ray absorptiometry total-body fat mass ( FM ) changes from baseline at wk 24 , and patient proportion achieving body weight reduction of at least 5 % at wk 24 . In a subset of patients , magnetic resonance assessment of visceral adipose tissue ( VAT ) and sc adipose tissue ( SAT ) volume and hepatic lipid content were also evaluated . RESULTS At wk 24 , placebo-corrected changes with dapagliflozin were as follows : TBW , -2.08 kg [ 95 % confidence interval (CI)=-2.84 to -1.31 ; P<0.0001 ] ; waist circumference , -1.52 cm ( 95 % CI=-2.74 to -0.31 ; P=0.0143 ) ; FM , -1.48 kg ( 95 % CI=-2.22 to -0.74 ; P=0.0001 ) ; proportion of patients achieving weight reduction of at least 5 % , + 26.2 % ( 95 % CI=15.5 to 36.7 ; P<0.0001 ) ; VAT , -258.4 cm3 ( 95 % CI=-448.1 to -68.6 ; nominal P=0.0084 ) ; SAT , -184.9 cm3 ( 95 % CI=-359.7 to -10.1 ; nominal P=0.0385 ) . In the dapagliflozin vs. placebo groups , respectively , serious adverse events were reported in 6.6 vs. 1.1 % ; events suggestive of vulvovaginitis , balanitis , and related genital infection in 3.3 vs. 0 % ; and lower urinary tract infections in 6.6 vs. 2.2 % . CONCLUSIONS Dapagliflozin reduces TBW , predominantly by reducing FM , VAT and SAT in T2DM inadequately controlled with metformin OBJECTIVE To examine the efficacy and safety of lixisenatide ( 20 μg once daily , administered before the morning or evening meal ) as add-on therapy in patients with type 2 diabetes insufficiently controlled with metformin alone . RESEARCH DESIGN AND METHODS This was a 24-week , r and omized , double-blind , placebo-controlled study in 680 patients with inadequately controlled type 2 diabetes ( HbA1c 7–10 % [ 53−86 mmol/mol ] ) . Patients were r and omized to lixisenatide morning ( n = 255 ) , lixisenatide evening ( n = 255 ) , placebo morning ( n = 85 ) , or placebo evening ( n = 85 ) injections . RESULTS Lixisenatide morning injection significantly reduced mean HbA1c versus combined placebo ( mean change −0.9 % [ 9.8 mmol/mol ] vs. −0.4 % [ 4.4 mmol/mol ] ; least squares [ LS ] mean difference vs. placebo −0.5 % [ 5.5 mmol/mol ] , P < 0.0001 ) . HbA1c was significantly reduced by lixisenatide evening injection ( mean change –0.8 % [ 8.7 mmol/mol ] vs. –0.4 % [ 4.4 mmol/mol ] ; LS mean difference –0.4 % [ 4.4 mmol/mol ] , P < 0.0001 ) . Lixisenatide morning injection significantly reduced 2-h postpr and ial glucose versus morning placebo ( mean change −5.9 vs. −1.4 mmol/L ; LS mean difference −4.5 mmol/L , P < 0.0001 ) . LS mean difference in fasting plasma glucose was significant in both morning ( –0.9 mmol/L , P < 0.0001 ) and evening ( –0.6 mmol/L , P = 0.0046 ) groups versus placebo . Mean body weight decreased to a similar extent in all groups . Rates of adverse events were 69.4 % in both lixisenatide groups and 60.0 % in the placebo group . Rates for nausea and vomiting were 22.7 and 9.4 % for lixisenatide morning and 21.2 and 13.3 % for lixisenatide evening versus 7.6 and 2.9 % for placebo , respectively . Symptomatic hypoglycemia occurred in 6 , 13 , and 1 patient for lixisenatide morning , evening , and placebo , respectively , with no severe episodes . CONCLUSIONS In patients with type 2 diabetes inadequately controlled on metformin , lixisenatide 20 μg once daily administered in the morning or evening significantly improved glycemic control , with a pronounced postpr and ial effect , and was well tolerated UNLABELLED Inhibition of dipeptidyl peptidase-4 enhances the activity of incretin hormones , improving glycemic control in subjects with type 2 diabetes . This twelve-week r and omized , double-masked , placebo-controlled study assessed the efficacy and tolerability of the specific and potent oral dipeptidyl peptidase-4 inhibitor , vildagliptin ( 25 mg , bid , n=70 ) VS . placebo ( bid , n=28 ) in previously diet-treated subjects with type 2 diabetes . St and ardized meal tests were performed at baseline and endpoint . The between-group difference in adjusted mean change in HbA1c from baseline to endpoint was - 0.6 + /- 0.2 % ( p=0.0012 ) for the whole cohort ( baseline 8.0 % ) and -1.2 % for subjects with baseline HbA1c 8.0 - 9.5 % . Fasting glucose and mean pr and ial glucose were reduced by 1.1 + /- 0.4 ( p=0.0043 ) and 1.9 + /- 0.5 mmol/l ( p < 0.0001 ) , respectively . The between-group differences in corrected insulin response at peak glucose and mean pr and ial C-peptide were + 0.06 + /- 0.02 ( p=0.0258 ) and + 0.10 + /- 0.03 nmol/l ( p=0.0031 ) , respectively . Vildagliptin had no effect on fasting lipid levels or body weight . The incidence of adverse events was similar in subjects receiving placebo ( 71.4 % ) and vildagliptin ( 55.7 % ) . CONCLUSION monotherapy with vildagliptin is well tolerated and improves glycemic control in diet-treated subjects with type 2 diabetes . Concomitant improvements in beta-cell function were also observed . Subjects with higher baseline HbA1c levels showed greater response OBJECTIVE Dapagliflozin , a highly selective inhibitor of the renal sodium-glucose cotransporter-2 , increases urinary excretion of glucose and lowers plasma glucose levels in an insulin-independent manner . We evaluated the efficacy and safety of dapagliflozin in treatment-naive patients with type 2 diabetes . RESEARCH
Output:
| Severe hypoglycaemia was rare not increased for any comparisons .
Conclusions Metformin and the simultaneous initiation of dual therapy , but not AHA used alone or as single add-on combination therapy , was associated with an increased risk of any hypoglycaemia relative to placebo |
MS210301 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Non-steroid anti-inflammatory drugs ( NSAIDs ) have been proposed as part of a multimodal postoperative analgesia in patients operated for colorectal cancer . However , whether these drugs are prescribed and taken by the patients have not been evaluated . The aim of this study was to quantify the postoperative use of NSAIDs in these patients . Methods Data from patients operated for colorectal cancer between January 1 , 2006 and December 31 , 2009 were collected from the Danish Colorectal Cancer Group ’s ( DCCG ) prospect i ve data base . From the electronically registered medical records , data for the use of the two NSAIDs diclofenac and ibuprofen were recorded . The data from six colorectal departments in eastern Denmark were compared . Results Of the 2,754 patients analyzed overall , 40.6 % received NSAIDs as part of their analgesic treatment . The percentage of the patients receiving NSAIDs , receiving a pre-defined dosage as a minimum and receiving NSAIDs as p.r.n . medication , and the type of NSAID were significantly different both between department and within departments . The median dose of ibuprofen and diclofenac were 1200 mg ( 400–2,400 mg ) and 100 mg ( 50–200 mg ) , respectively . Conclusions The large variation between and within the departments points to an inconsistency in the use of multimodal post-operative pain treatments . This may be a result of insufficient evidence on procedure specific pain treatments and possibly a lack of compliance to existing guidelines . High- quality large-scale studies are warranted to form the basis for guidelines for postoperative analgesic treatment We hypothesize that perinatal exposures , in particular the human microbiome and maternal nutrition during pregnancy , interact with the genetic predisposition to cause an abnormal immune modulation in early life towards a trajectory to chronic inflammatory diseases such as asthma and others Background : The Western Denmark Heart Registry ( WDHR ) has not previously been described as a research tool in clinical epidemiology . Objectives : We examined the setting , organization , content , data quality , and research potential of the WDHR . Method : We collected information from members of the WDHR organization , including the committee of representatives , the board , the data management group , and physicians reporting to the data base . We retrieved 2008 data from the WDHR to illustrate data base variables . Results : The WDHR is a clinical data base within a population -based health care system . It was launched on 1 January 1999 to monitor and improve the quality of cardiac intervention in Western Denmark ( population : 3.3 million ) and to allow for clinical and health-service research . More than 200,000 interventions , with 50–150 variables each , have been registered . The data quality is ensured by automatic validation rules at data entry combined with systematic validation procedures and r and om spot-checks after entry . Conclusions : The WDHR is a valuable research tool because it provides ongoing longitudinal registration of detailed patient and procedural data . The Danish national health care system enables this research because it allows complete follow-up for medical events after cardiac intervention by linkage with multiple medical data bases Background Glycaemia control ( GC ) remains an important therapeutic goal in critically ill patients . The enhanced Model Predictive Control ( eMPC ) algorithm , which models the behaviour of blood glucose ( BG ) and insulin sensitivity in individual ICU patients with variable blood sample s , is an effective , clinical ly proven computer based protocol successfully tested at multiple institutions on medical and surgical patients with different nutritional protocol s. eMPC has been integrated into the B.Braun Space GlucoseControl system ( SGC ) , which allows direct data communication between pumps and microprocessor . The present study was undertaken to assess the clinical performance and safety of the SGC for glycaemia control in critically ill patients under routine conditions in different ICU setting s and with various nutritional protocol s. Methods The study endpoints were the percentage of time the BG was within the target range 4.4 – 8.3 mmol.l−1 , the frequency of hypoglycaemic episodes , adherence to the advice of the SGC and BG measurement intervals . BG was monitored , and insulin was given as a continuous infusion according to the advice of the SGC . Nutritional management ( enteral , parenteral or both ) was carried out at the discretion of each centre . Results 17 centres from 9 European countries included a total of 508 patients , the median study time was 2.9 ( 1.9 - 6.1 ) days . The median ( IQR ) time – in – target was 83.0 ( 68.7 - 93.1 ) % of time with the mean proposed measurement interval 2.0 ± 0.5 hours . 99.6 % of the SGC advices on insulin infusion rate were accepted by the user . Only 4 episodes ( 0.01 % of all BG measurements ) of severe hypoglycaemia < 2.2 mmol.l−1 in 4 patients occurred ( 0.8 % ; 95 % CI 0.02 - 1.6 % ) . Conclusion Under routine conditions and under different nutritional protocol s the Space GlucoseControl system with integrated eMPC algorithm has exhibited its suitability for glycaemia control in critically ill patients .Trial registration Clinical Trials.gov Background Percutaneous mitral valve repair ( MVR ) using the MitraClip system has become a valid alternative for patients with severe mitral regurgitation ( MR ) and high operative risk . Objective To identify clinical and periprocedural factors that may have an impact on clinical outcome . Design Multi-centre longitudinal cohort study . Setting Tertiary referral centres . Patients Here we report on the first 100 consecutive patients treated with percutaneous MVR in Switzerl and between March 2009 and April 2011 . All of them had moderate – severe ( 3 + ) or severe ( 4 + ) MR , and 62 % had functional MR . 82 % of the patients were in New York Heart Association ( NYHA ) class III/IV , mean left ventricular ejection fraction was 48 % and the median European System for Cardiac Operative Risk Evaluation was 16.9 % . Interventions MitraClip implantation performed under echocardiographic and fluoroscopic guidance in general anaesthesia . Main outcome measures Clinical , echocardiographic and procedural data were prospect ively collected . Results Acute procedural success ( APS , defined as successful clip implantation with residual MR grade ≤2 + ) was achieved in 85 % of patients . Overall survival at 6 and 12 months was 89.9 % ( 95 % CI 81.8 to 94.6 ) and 84.6 % ( 95 % CI 74.7 to 91.0 ) , respectively . Univariate Cox regression analysis identified APS ( p=0.0069 ) and discharge MR grade ( p=0.03 ) as significant predictors of survival . Conclusions In our consecutive cohort of patients , APS was achieved in 85 % . APS and residual discharge MR grade are important predictors of mid-term survival after percutaneous MVR Background Long-term mortality and causes of death in patients with pulmonary tuberculosis ( PTB ) and extrapulmonary tuberculosis ( EPTB ) are poorly documented . In this study , long-term mortality and causes of death in PTB and EPTB patients were compared with the background population and it was investigated whether mortality was associated with family-related risk factors . Methods A nationwide cohort study was conducted including : all adult Danes notified with PTB or EPTB from 1977 to 2008 and alive 1 year after diagnosis ; a r and omly selected comparison cohort matched on birth date and sex ; adult siblings of PTB patients ; and population controls . Data were extracted from national registries . All-cause and cause-specific mortality rate ratios were calculated for patients and siblings and compared with their respective control cohorts . A total of 8,291 patients ( 6,402 PTB and 1,889 EPTB ) , 24,873 population controls , 1,990 siblings of PTB patients and 11,679 siblings of PTB population controls were included . Results Overall , the mortality rate ratio was 1.86 ( 95 % confidence interval [ CI ] 1.77–1.96 ) for PTB patients and 1.24 ( 95 % CI 1.12–1.37 ) for EPTB patients . Both patient cohorts had significantly increased risk of death due to infectious diseases and diabetes . Further , the PTB patients had increased mortality due to cancers ( mainly respiratory and gastrointestinal tract ) , liver and respiratory system diseases , and alcohol and drug abuse . The PTB patients had increased mortality compared with their siblings ( mortality rate ratio 3.55 ; 95 % CI 2.57–4.91 ) as did the siblings of the PTB patients compared with the siblings of population controls ( mortality rate ratio 2.16 ; 95 % CI 1.62–2.87 ) . Conclusion We conclude that adult PTB patients have an almost two-fold increased long-term mortality whereas EPTB patients have a slightly increased long-term mortality compared with the background population . The increased long-term mortality in PTB patients stems from diseases associated with alcohol , tobacco , and drug abuse as well as immune suppression , and family-related factors Background Patient-self-management ( PSM ) of oral anticoagulant therapy with vitamin K antagonists has demonstrated efficacy in r and omized , controlled trials . However , the effectiveness and efficacy of PSM in clinical practice and whether outcomes are different for females and males has been sparsely investigated . The objective is to evaluate the sex-dependent effectiveness of PSM of oral anticoagulant therapy in everyday clinical practice . Methods All patients performing PSM affiliated to Aarhus University Hospital and Aalborg University Hospital , Denmark in the period 1996–2012 were included in a case-series study . The effectiveness was estimated using the following parameters : stroke , systemic embolism , major bleeding , intracranial bleeding , gastrointestinal bleeding , death and time spent in the therapeutic international normalized ratio ( INR ) target range . Prospect ively registered patient data were obtained from two data bases in the two hospitals . Cross-linkage between the data bases and national registries provided detailed information on the incidence of death , bleeding and thromboembolism on an individual level . Results A total of 2068 patients were included , representing 6,900 patient-years in total . Males achieved a significantly better therapeutic INR control than females ; females spent 71.1 % of the time within therapeutic INR target range , whereas males spent 76.4 % ( p<0.0001 ) . Importantly , death , bleeding and thromboembolism were not significantly different between females and males . Conclusions Among patients treated with self-managed oral anticoagulant therapy , males achieve a higher effectiveness than females in terms of time spent in therapeutic INR range , but the incidence of major complications is low and similar in both sexes Background and Purpose — Although secondary medical prevention strategies in patients with stroke are well established , only sparse data exist regarding their effectiveness in routine care . We examined the effectiveness in a nationwide , population -based follow-up study . Methods — Using data from the Danish National Indicator Project ( DNIP ) , 28 612 patients hospitalized for ischemic stroke in 2003 to 2006 were identified . Information on drug use and outcomes was by individual-level record linkage with national medical data bases . Hazard ratios were computed for death , myocardial infa rct ion , and recurrent stroke according to drug use after hospital discharge . Results — Treatment with antiplatelets , oral anticoagulants , antihypertensives , or statins was associated with a lower risk of the combined end point of death , myocardial infa rct ion , or recurrent stroke during a mean follow-up period of 2.7 years ( adjusted hazard ratios [ HRs ] from 0.44 [ 95 % CI , 0.39–0.49 ] to 0.94 [ 95 % CI , 0.89–0.99 ] ) . All drug classes were associated with lower risk of death ( adjusted HRs from 0.36 [ 95 % CI , 0.32–0.41 ] to 0.85 [ 95 % CI , 0.80–0.90 ] ) , with oral anticoagulant treatment in patients with atrial fibrillation being particularly effective in elderly women ( > 80 years ; adjusted HR , 0.35 ; 95 % CI , 0.28–0.45 ) . Oral anticoagulant treatment was associated with a lower risk of recurrent stroke ( adjusted HR , 0.58 ; 95 % CI , 0.47–0.73 ) , and statins were associated with a lower risk of myocardial infa rct ion ( adjusted HR , 0.84 ; 95 % CI , 0.73–0.97 ) and recurrent stroke ( adjusted HR , 0.86 ; 95 % CI , 0.79–0.92 ) . Conclusions — Secondary medical prophylaxis after ischemic stroke was associated with improved outcome in routine setting s. Although these findings are of an observational nature , they tend to support the results from previous r and omized trials Objective Patient ’s language , tradition , conventions , and customs may all determine integration into a society and are also part of the doctor – patient relationship that influences diagnostic and therapeutic outcome . Language barrier and sociocultural disparity of Eastern and Southern European patients may hamper recovery from pain and depression compared to Middle European patients in Switzerl and . Methods In a
Output:
| This systematic review gathered evidence from Denmark and Switzerl and on barriers and facilitators concerning data harmonization , sharing and linkage .
Barriers and facilitators were strictly interrelated with the national context where projects were carried out .
Structural changes , such as legislation implemented at the national level , were mirrored in the projects .
This underlines the impact of national strategies in the field of health data . |
MS210302 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Pre clinical data indicate EGFR signals through both kinase-dependent and independent pathways and that combining a small-molecule EGFR inhibitor , EGFR antibody , and /or anti-angiogenic agent is synergistic in animal models . METHODS We conducted a dose-escalation , phase I study combining erlotinib , cetuximab , and bevacizumab . The subset of patients with non-small cell lung cancer ( NSCLC ) was analyzed for safety and response . RESULTS Thirty-four patients with NSCLC ( median four prior therapies ) received treatment on a range of dose levels . The most common treatment-related grade ≥2 adverse events were rash ( n=14 , 41 % ) , hypomagnesemia ( n=9 , 27 % ) , and fatigue ( n=5 , 15 % ) . Seven patients ( 21 % ) achieved stable disease ( SD ) ≥6 months , two achieved a partial response ( PR ) ( 6 % ) , and two achieved an unconfirmed partial response ( uPR ) ( 6 % ) ( total=32 % ) . We observed SD≥6 months/PR/uPR in patients who had received prior erlotinib and /or bevacizumab , those with brain metastases , smokers , and patients treated at lower dose levels . Five of 16 patients ( 31 % ) with wild-type EGFR experienced SD≥6 months or uPR . Correlation between grade of rash and rate of SD≥6 months/PR was observed ( p<0.01 ) . CONCLUSION The combination of erlotinib , cetuximab , and bevacizumab was well-tolerated and demonstrated antitumor activity in heavily pretreated patients with NSCLC PURPOSE To evaluate the efficacy and safety of cetuximab , a monoclonal antibody that inhibits the epidermal growth factor receptor ( EGFR ) , as a first-line monotherapy in patients with unresectable squamous cell carcinoma of the skin ( SCCS ) . PATIENTS AND METHODS Thirty-six patients received cetuximab ( initial dose of 400 mg/m(2 ) followed by subsequent weekly doses of 250 mg/m(2 ) ) for at least 6 weeks with a 48-week follow-up . The primary end point was the disease control rate ( DCR ) at 6 weeks ( according to Response Evaluation Criteria in Solid Tumors [ RECIST ] criteria ) . Secondary end points included best response rate , overall survival , progression-free survival ( PFS ) , and toxicity assessment . Association of treatment efficacy with RAS mutations or FcγR genotypes was investigated . RESULTS Median age of the study population was 79 years . DCR at 6 weeks was obtained in 25 of 36 patients ( 69 % ; 95 % CI , 52 % to 84 % ) of the intention-to-treat population . The best responses were eight partial responses and two complete responses . There were no cetuximab-related deaths . There were three related serious adverse events : two grade 4 infusion reactions and one grade 3 interstitial pneumopathy . Grade 1 to 2 acne-like rash occurred in 78 % of patients and was associated with prolonged PFS . One HRAS mutation was identified . Combined FcγRIIa-131H/H and /or FcγRIIIa-158V/V polymorphisms were not associated with the clinical outcomes . CONCLUSION As a first-line treatment in patients with unresectable SCCS , cetuximab achieved 69 % DCR . A r and omized phase III trial is warranted to confirm that cetuximab may be considered as a therapeutic option especially in elderly patients . The low frequency of RAS mutations in SCCS makes SCCS tumors attractive for EGFR inhibition BACKGROUND According to the results of a number of phase 3 r and omized studies , sorafenib is the only approved systemic therapy for advanced HCC ; however the issue of high economic cost remains challenging ; thus we have conducted this retrospective analysis of our HCC patients treated with sorafenib . METHODS HCC patients treated at Ain Shams University Hospitals , in the period between 2010 and 2012 were review ed . Eligible patients were those who had received sorafenib for advanced HCC not eligible for or progressed after surgery or locoregional therapy . We investigated the impact of baseline clinicopathological factors ( age , gender , child status , performance score , BCLC tumor stage , cause of chronic liver disease , median baseline alpha fetoprotein level and previous treatment received for HCC ) on overall survival ( OS ) in an adjusted Cox regression model . RESULTS 41 patients were included in the analysis fulfilling the inclusion criteria . At a median follow up period of 13 months , the median PFS for the whole group was 4 months ; the median OS for the whole group is 6.25 months . Multivariate analysis identified three baseline characteristics that were prognostic indicators for overall survival : ECOG performance status ( median OS for ECOG 1=7.01 months and for ECOG 2=3.03 months ) , Child-Pugh status ( median OS for child A=12.04 months and for child B=5.23 months ) , and median baseline levels of alpha-fetoprotein . CONCLUSIONS In limited re source countries like Egypt , we suggest that the use of sorafenib for the treatment of advanced HCC cases should be restricted to a highly selected subgroup of patients with good performance and child BACKGROUND The purpose of this phase II trial was to evaluate the efficacy and safety of cetuximab and irinotecan as second-line treatment in patients with gastro-oesophageal adenocarcinoma . PATIENTS AND METHODS Patients with failure to first-line platinum-based chemotherapy received cetuximab 500 mg/m(2 ) and irinotecan 180 mg/m(2 ) every second week until disease progression . Toxicity was evaluated according to The Cancer Institute Common Terminology Criteria for Adverse Events ( NCI-CTCAE ) v. 3.0 . Antitumour activity was assessed according to Response Evaluation Criteria in Solid Tumours ( RECIST ) v. 1.0 . RESULTS Sixty-three patients were enrolled , median age was 60 years , median performance status was 1 ( 0 - 1 ) , 35 patients had two or more organs involved . The median number of courses was 5 ( range 1 - 25 ) . Response rate was 11 % ( 6 partial response ( PR ) ) and 37 % had stable disease . Median progression free survival was 2.8 months and overall survival ( OS ) was 6.1 months . Grade 3 - 4 toxicity included : diarrhoea ( 6 % ) , fatigue ( 5 % ) , vomiting ( 5 % ) and neutropenia ( 16 % ) . Two patients developed febrile neutropenia . Forty-six patients ( 73 % ) had developed grade 1 - 2 skin rash . Patients developing skin rash had a prolonged survival with an OS at 7.1 months . CONCLUSIONS The combination of cetuximab and irinotecan is active as second-line therapy in patients with gastro-oesophageal cancer . Cetuximab induced skin rash was associated with prolonged survival The only approved systemic therapy for patients with advanced hepatocellular carcinoma ( HCC ) till now is sorafenib . A preliminary study suggested that capecitabine , an oral fluoropyrimidine , may be effective in advanced HCC . We have tested this hypothesis in this phase 2 study . In this single-center , phase 2 , open-label trial , we r and omly assigned 52 patients with advanced HCC who had not received previous systemic treatment to receive either sorafenib ( at a dose of 400 mg twice daily ) or capecitabine ( 1,000 mg/m2 twice daily ) ( day 1–day 14 ) . Primary outcome was progression-free survival . Secondary outcomes included the overall survival and safety . Median overall survival was 7.05 months in the sorafenib group and 5.07 months in the capecitabine group ( hazard ratio in the capecitabine group 2.36 ; 95 % confidence interval 1.174–4.74 ; P < 0.016 ) . The median progression-free survival was 6 months in the sorafenib group and 4 months in the capecitabine group ( P < 0.005 ) . Three patients in the sorafenib group ( 11.5 % ) and one patient in the capecitabine group ( 3 % ) had a partial response ; one patient ( 3 % ) had a complete response in the sorafenib group . H and –foot skin reaction was more frequent in the sorafenib group , hyperbilirubinemia was more common in the capecitabine group , and diarrhea was equivalent between both groups . In patients with advanced HCC , capecitabine is inferior to sorafenib in terms of median progression-free survival and overall survival , and it should not be used alone for the treatment of advanced HCC , but rather , combination therapy with sorafenib should be considered BACKGROUND Previous results from our phase 3 r and omised trial showed that adding cetuximab to primary radiotherapy increased overall survival in patients with locoregionally advanced squamous-cell carcinoma of the head and neck ( LASCCHN ) at 3 years . Here we report the 5-year survival data , and investigate the relation between cetuximab-induced rash and survival . METHODS Patients with LASCCHN of the oropharynx , hypopharynx , or larynx with measurable disease were r and omly allocated in a 1:1 ratio to receive either comprehensive head and neck radiotherapy alone for 6 - 7 weeks or radiotherapy plus weekly doses of cetuximab : 400 mg/m(2 ) initial dose , followed by seven weekly doses at 250 mg/m(2 ) . R and omisation was done with an adaptive minimisation technique to balance assignments across stratification factors of Karnofsky performance score , T stage , N stage , and radiation fractionation . The trial was un-blinded . The primary endpoint was locoregional control , with a secondary endpoint of survival . Following discussion s with the US Food and Drug Administration , the data set was locked , except for queries to the sites about overall survival , before our previous report in 2006 , so that an independent review could be done . Analyses were done on an intention-to-treat basis . Following completion of treatment , patients underwent physical examination and radiographic imaging every 4 months for 2 years , and then every 6 months thereafter . The trial is registered at www . Clinical Trials.gov , number NCT00004227 . FINDINGS Patients were r and omly assigned to receive radiotherapy with ( n=211 ) or without ( n=213 ) cetuximab , and all patients were followed for survival . Up date d median overall survival for patients treated with cetuximab and radiotherapy was 49.0 months ( 95 % CI 32.8 - 69.5 ) versus 29.3 months ( 20.6 - 41.4 ) in the radiotherapy-alone group ( hazard ratio [ HR ] 0.73 , 95 % CI 0.56 - 0.95 ; p=0.018 ) . 5-year overall survival was 45.6 % in the cetuximab-plus-radiotherapy group and 36.4 % in the radiotherapy-alone group . Additionally , for the patients treated with cetuximab , overall survival was significantly improved in those who experienced an acneiform rash of at least grade 2 severity compared with patients with no rash or grade 1 rash ( HR 0.49 , 0.34 - 0.72 ; p=0.002 ) . INTERPRETATION For patients with LASCCHN , cetuximab plus radiotherapy significantly improves overall survival at 5 years compared with radiotherapy alone , confirming cetuximab plus radiotherapy as an important treatment option in this group of patients . Cetuximab-treated patients with prominent cetuximab-induced rash ( grade 2 or above ) have better survival than patients with no or grade 1 rash . FUNDING ImClone Systems , Merck KGaA , and Bristol-Myers Squibb BACKGROUND The r and omised phase 3 First-Line Erbitux in Lung Cancer ( FLEX ) study showed that the addition of cetuximab to cisplatin and vinorelbine significantly improved overall survival compared with chemotherapy alone in the first-line treatment of advanced non-small-cell lung cancer ( NSCLC ) . The main cetuximab-related side-effect was acne-like rash . Here , we assessed the association of this acne-like rash with clinical benefit . METHODS We did a subgroup analysis of patients in the FLEX study , which enrolled patients with advanced NSCLC whose tumours expressed epidermal growth factor receptor . Our l and mark analysis assessed if the development of acne-like rash in the first 21 days of treatment ( first-cycle rash ) was associated with clinical outcome , on the basis of patients in the intention-to-treat population alive on day 21 . The FLEX study is registered with Clinical Trials.gov , number NCT00148798 . FINDINGS 518 patients in the chemotherapy plus cetuximab group-290 of whom had first-cycle rash- and 540 patients in the chemotherapy alone group were alive on day 21 . Patients in the chemotherapy plus cetuximab group with first-cycle rash had significantly prolonged overall survival compared with patients in the same treatment group without first-cycle rash ( median 15·0 months [ 95 % CI 12·8 - 16·4 ]
Output:
| Exploratory subgroup analysis showed no effect of tumor types on the RR of ORR .
Our meta- analysis has demonstrated that cetuximab-induced rash is associated with a significantly improved OS , PFS and ORR .
Cetuximab-induced skin rash may represent a prognostic factor in patients with advanced solid tumors |
MS210303 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Objective : To determine the effectiveness of a brief cognitive behavioural intervention in reducing the incidence of sexually transmitted infections among gay men . Design : R and omised controlled trial with 12 months ' follow up . Setting : Sexual health clinic in London . Participants : 343 gay men with an acute sexually transmitted infection or who reported having had unprotected anal intercourse in the past year . Main outcome measures : Number of new sexually transmitted infections diagnosed during follow up and self reported incidence of unprotected anal intercourse . Results : 72 % ( 361/499 ) of men invited to enter the study did so . 90 % ( 308/343 ) of participants returned at least one follow up question naire or re-attended the clinic and requested a check up for sexually transmitted infections during follow up . At baseline , 37 % ( 63/172 ) of the intervention group and 30 % ( 50/166 ) of the control group reported having had unprotected anal intercourse in the past month . At 12 months , the proportions were 27 % ( 31/114 ) and 32 % ( 39/124 ) respectively ( P=0.56 ) . However , 31 % ( 38/123 ) of the intervention group and 21 % ( 35/168 ) of controls had had at least one new infection diagnosed at the clinic ( adjusted odds ratio 1.66 , 95 % confidence interval 1.00 to 2.74 ) . Considering only men who requested a check up for sexually transmitted infections , the proportion diagnosed with a new infection was 58 % ( 53/91 ) for men in the intervention group and 43 % ( 35/81 ) for men in the control group ( adjusted odds ratio 1.84 , 0.99 to 3.40 ) . Using a regional data base that includes information from 23 sexual health clinics in London , we determined that few participants had attended other sexual health clinics . Conclusions : This behavioural intervention was acceptable and feasible to deliver , but it did not reduce the risk of acquiring a new sexually transmitted infection among these gay men at high risk . Even carefully design ed interventions should not be assumed to bring benefit . It is important to evaluate their effects in r and omised trials with objective clinical end points . What is already known on this topic The need for effective HIV prevention strategies based on reducing sexual risk behaviour remains important Few interventions to reduce sexual risk behaviour have been rigorously evaluated using r and omised controlled trials What this study adds This is the first r and omised controlled trial of an intervention addressing sexual behaviour in homosexual men that uses sexually transmitted infections and self reported behaviour as end points The intervention was brief and feasible to use in a busy clinic , but it did not reduce the risk of participants acquiring new infections The potential for behavioural interventions to do more harm than good needs to be taken BACKGROUND Effective interventions are needed to prevent acquisition of HIV infection in men who have sex with men . To date , no behavioural interventions specifically for this risk group have been tested with HIV infection as the primary outcome . METHODS This multisite two-group r and omised controlled phase IIb trial tested the efficacy of a behavioural intervention in preventing HIV infection among 4295 men who have sex with men . The experimental intervention consisted of ten one-on-one counselling sessions followed by maintenance sessions every 3 months . The st and ard condition was twice-yearly Project RESPECT individual counselling . Twice-yearly follow-up visits included testing for HIV antibody and assessment of behavioural outcomes . FINDINGS The rate of acquisition of HIV infection was 18.2 % ( 95 % CI -4.7 to 36.0 ) lower in the intervention group than the st and ard group . Adjustment for baseline covariates attenuated the intervention effect to 15.7 % ( -8.4 to 34.4 ) . The effect was more favourable in the first 12 - 18 months of follow-up . The occurrence of unprotected receptive anal intercourse with HIV-positive and unknown-status partners was 20.5 % ( 10.9 to 29.0 ) lower in the intervention than in the st and ard group . INTERPRETATION The results from the primary analyses allow us to rule out that the experimental intervention is associated with a 35 % lower rate of HIV acquisition than in the st and ard group . The overall estimate of a difference of 18.2 % , more favourable estimates of effect in the first 12 - 18 months , and similar effects on risk behaviours suggest that prevention of HIV infection among men who have sex with men by a behavioural intervention is feasible . Further work should be done to develop more effective interventions At the time of this writing , no r and omized controlled trial ( RCT ) of an intervention to reduce unsafe sex among Latino gay and bisexual men ( LGBM ) had been published . We report the results of an RCT conducted in New York City in which 180 LGBM were assigned either to an intervention developed specifically for this population or to a wait-list control group . The intervention was based on empowerment theory and used factors identified in prior research as determinants of unsafe sex . By eligibility criteria , all men had engaged in unprotected anal intercourse ( UAI ) within two months of the baseline assessment . At first ( two months ) and second ( six months later ) follow-up assessment s , approximately half of the men in the experimental group reported no UAI . Yet , a similar proportion of the control group also reported no UAI . Baseline data indicate that although the men had been the subject of social oppression and sexual prejudice ( homophobia ) , they did not feel disempowered , externally controlled or fatalistic , and they reported self-efficacy and intentionality to enact safer sex . Lessons learned are discussed , as well as notes of caution for future research employing a similar conceptual framework Objectives : To evaluate the effects of an enhanced peer-led intervention on transmission risk behavior and serostatus disclosure of HIV-seropositive gay and bisexual men . Design : A r and omized intervention trial . Methods : HIV-seropositive gay and bisexual men were recruited from New York City and San Francisco and were r and omly assigned to either a st and ard or an enhanced intervention . The st and ard intervention consisted of one session that provided safer sex information . The enhanced intervention consisted of six sessions and included safer sex information , interactive learning activities , and discussion groups that were facilitated by HIV-seropositive peers . Participants completed audio computer-assisted self interview ( A-CASI ) assessment s at baseline and 3 and 6-month follow-ups . Optional testing for sexually transmitted infections was offered at baseline and the 6-month follow-up . Results : A total of 811 participants met the inclusion criteria for outcome analyses . Of these , 85 and 90 % were retained for the 3 and 6-month follow-ups , respectively . Compared with the st and ard intervention , fewer men assigned to the enhanced intervention reported unprotected receptive anal intercourse with a negative or unknown-serostatus partner at 3 months ( 21 versus 26 % , P < 0.05 ) . However , there were no other significant differences in transmission risk or serostatus disclosure at 3 or 6 months . Conclusion : The enhanced intervention was associated with only a limited reduction in transmission risk at 3 months relative to the st and ard intervention . The characteristics of the intervention that may have reduced its efficacy are identified and directions for future research are suggested Behavior change can curtail the spread of acquired immune deficiency syndrome ( AIDS ) . In this study , 104 gay men with a history of frequent AIDS high-risk behavior completed self-report , self-monitoring , and behavioral measures related to AIDS risk . The sample was r and omly divided into experimental and waiting-list control groups . The experimental intervention provided AIDS risk education , cognitive-behavioral self-management training , sexual assertion training , and attention to the development of steady and self-affirming social supports . Experimental group participants greatly reduced their frequency of high-risk sexual practice s and increased behavioral skills for refusing sexual coercions , AIDS risk knowledge , and adoption of " safer sex " practice s. Change was maintained at the 8-month follow-up Objectives The incidence of AIDS is increasing at a higher rate among homosexual Asian and Pacific Isl and ers ( API ) than white homosexual men in the United States . The number of homosexual API men engaging in unsafe sex is increasing at an alarming rate . HIV risk reduction is urgently needed in this population . Subjects and methods We developed and evaluated culturally appropriate brief group counseling with 329 self-identified homosexual API recruited in San Francisco between 1992 and 1994 . Participants were r and omized into a single , 3-h skills training group or a wait-list control group . The intervention consisted of four components : ( 1 ) development of positive self-identity and social support , ( 2 ) safer sex education , ( 3 ) eroticizing safer sex , and ( 4 ) negotiating safer sex . Data were collected at baseline and 3 months after the intervention . Results Significant reductions in number of sexual partners were observed among all treatment subjects , regardless of ethnicity ( P= 0.003 ) . Treatment decreased the number of partners reported at 3-month follow-up by 46 % [ 95 % confidence interval ( CI ) , 28–77 ] . Chinese and Filipino men further benefited from the intervention : treatment subjects from these two ethnic groups reduced unprotected anal intercourse at follow-up by more than half when compared to their counterparts ( odds ratio = 0.41 ; 95 % CI , 0.19–0.89 ; P= 0.024 ) . Conclusions We demonstrated the efficacy of brief group counseling in reducing HIV risk among homosexual API . Cities with significant API population s should adopt culturally tailored skills training as part of HIV prevention strategies for this group of homosexual men This controlled prospect i ve study assessed the effectiveness of a sexual health approach to HIV prevention for men who have sex with men ( MSM ) . Participants ( N = 422 Midwestern MSM ) were r and omly assigned to the intervention group , who participated in a 2-day comprehensive human sexuality seminar design ed to context ually address long-term risk factors and cofactors , or to the control group , who watched 3 hours of HIV prevention videos . Risk behavior during the preceding 3 months was measured at baseline , 3-month follow-up , and 12-month follow-up . Any unprotected anal intercourse outside a long-term seroconcordant relationship was the dependent variable . Of the total , 14%-24 % of the participants were considered at risk of acquiring or transmitting HIV . At the 12-month follow-up , the control reported a 29 % decrease in the use of condoms during anal intercourse ; the intervention group reported an 8 % increase ( t = 2.546 ; p = .015 ) . The sexual health seminars appear a promising new intervention at significantly reducing unprotected anal intercourse between men HIV prevention , by intervening within social networks , is potentially important but highly understudied . Approaches that systematic ally identify , train , and enlist known social influence leaders to advise members of their own networks in risk reduction constitute ways to reach hidden population segments , persons who are distrustful of authorities but trust their peers , and those who can not be reached through traditional professionally delivered counseling . This article illustrates and provides evaluation data on a program that recruited 14 intact social networks of young men who have sex with men ( YMSM ) in St. Petersburg , Russia , and Sofia , Bulgaria . Sociometric measures were used to identify the social leader of each network , and baseline risk assessment measures were administered to all members of each social network . The sociometrically determined leaders then attended a six-session group program that provided training and guidance in how to carry out theory-based and tailored HIV prevention conversations with members of their own social networks . Four months after leaders completed the program , all network members were readministered risk assessment measures . Pre- to postintervention data revealed that the program produced : ( 1 ) increases in the level and comfort with which network members talked about AIDS prevention topics in their daily conversations ; ( 2 ) increased network-level AIDS risk reduction knowledge and improved risk reduction norm perceptions , attitudes , behavioral intentions , and self-efficacy ; and ( 3 ) increased condom use levels among network members . Although not a controlled , r and omized trial , these program evaluation findings strongly support the feasibility of social network-level HIV prevention approaches CONTEXT High-risk sexual behavior is increasingly prevalent among men who have sex with men ( MSM ) and among men with a history of repeat testing for HIV . OBJECTIVES The study assessed whether one counseling intervention session focusing on self-justifications ( thoughts , attitudes , or beliefs that allow the participant to engage in high-risk sexual behaviors ) at most recent unprotected anal intercourse ( UAI ) is effective in reducing future high-risk behaviors among HIV-negative men . DESIGN , SETTING , AND PARTICIPANTS A r and omized , controlled , counseling intervention trial was conducted at an anonymous testing site in San Francisco , California , between May 1997 and January 2000 . Participants were 248 MSM with a history of at least one previous negative HIV test result and self-reported UAI ( receptive or insertive ) in the previous 12 months with partners of unknown or discordant HIV status . Two intervention groups received st and ard HIV test counseling plus a cognitive-behavioral intervention , and two control groups received only st and ard HIV test counseling . Follow-up evaluation was at 6 and 12 months . MAIN OUTCOME MEASURE Number of episodes of UAI with non primary partners ( of unknown or discordant HIV status ) in the 90 days preceding the interview was measured via self-report during face-to-face interview . RESULTS A novel counseling intervention focusing on self-justifications significantly
Output:
| The Task Force concluded that the findings are applicable to MSM aged 20 years or older , across a range of setting s and population s , assuming that interventions are appropriately adapted to the needs and characteristics of the MSM population of interest .
Based on findings from economic evaluation studies , the Task Force also concluded that group- and community-level HIV behavioral interventions for adult MSM are not only cost effective but also result in actual cost savings . |
MS210304 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES No longitudinal studies have concurrently evaluated predictors of anxiety , depression , and fatigue in people with multiple sclerosis ( PwMS ) . This study determined factors that best predicted anxiety , depression , and fatigue in MS patients from a large pool of disease , cognitive , life-event stressor ( LES ) , psychosocial , life-style , and demographic factors . DESIGN A 2-year prospect i ve longitudinal study evaluated predictors of psychological distress and fatigue in PwMS . METHODS One hundred and one consecutive participants with MS were recruited from two MS clinics in Sydney , Australia . LES , anxiety , depression , and fatigue were assessed at baseline and at 3-monthly intervals for 2-years . Disease , cognitive , demographic , psychosocial , and life-style factors were assessed at baseline . Patient-reported relapses were recorded and corroborated by neurologists or evaluated against accepted relapse criteria . RESULTS Depression strongly predicted anxiety and fatigue , and anxiety and fatigue strongly predicted later depression . Psychological distress ( i.e. anxiety , depression ) was also predicted by a combination of unhealthy behaviours ( e.g. drug use , smoking , no exercise , or relaxation ) and psychological factors ( e.g. low optimism , avoidance coping ) , similar to the results of community-based studies . However , state-anxiety and fatigue were also predicted by immunotherapy status , and fatigue was also predicted by LES and demographics . CONCLUSIONS These results suggest that similar factors might underpin psychological distress and fatigue in MS patients and community-well sample s , although MS treatment factors may also be important . These results might assist clinicians in determining which MS patients are at greatest risk of developing anxiety , depression , or fatigue OBJECTIVE The aim of this study was to design a trial that could evaluate the effect of acceptance and commitment therapy as a group-intervention for multiple sclerosis patients with psychological distress . DESIGN R and omized controlled trial with assessment at pretreatment , end of treatment , and at 3-month follow-up . SUBJECTS Multiple sclerosis out patients with elevated symptoms of anxiety and /or depression ( n = 21 ) . METHODS Patients were r and omly assigned to acceptance and commitment therapy or relaxation training . Both treatments consisted of 5 sessions over 15 weeks containing didactic sessions , group discussion s , and exercises . Outcome was assessed by self-rated symptoms of anxiety , depression , and a measure of acceptance . RESULTS At 3-month follow-up , the relaxation training group had a significant decline in anxiety symptoms whereas the acceptance and commitment therapy group showed a maintained improvement in rated acceptance at follow-up . CONCLUSION The results reflect the different emphases of the therapies . Acceptance and commitment therapy is aim ed at living an active , valued life and increasing acceptance , while relaxation training focuses directly on coping strategies to h and le emotional symptoms . The results are preliminary , but supportive of further study of brief group interventions for reducing psychological distress in patients with multiple sclerosis Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Disability status , depression and anxiety are important determinants of quality of life ( Q oL ) in patients with multiple sclerosis ( MS ) . We investigated whether anxiety and depression influence the relation between disability status and Q oL in our cohort of recently diagnosed patients . Disability status [ Exp and ed Disability Status Scale ( EDSS ) ] , anxiety and depression [ Hospital A nxiety and Depression Scale ( HADS ) ] , and Q oL ( SF-36 ) were prospect ively obtained in 101 MS patients . The relation between EDSS and SF-36 scales was examined using regression analyses , without and with adjustment for anxiety and depression . Interaction effects were investigated by comparing the relation between EDSS and Q oL in patients with high and low anxiety and depression . In the unadjusted analyses , EDSS was significantly related to all SF-36 physical and mental health scales . A fter adjustment for anxiety and depression , EDSS was significantly related only to the SF-36 physical functioning , role-physical functioning and bodily pain scales . The relation between EDSS and these SF-36 scales was consistently higher in patients with more symptoms of anxiety or depression , suggesting that anxiety and depression strengthened the association of EDSS in these SF-36 physical health scales . A fter adjustment for anxiety and depression , EDSS was not significantly related to the SF-36 mental health scales and the general health scale . This finding is compatible with the hypothesis that anxiety and depression are intermediate factors in the association of EDSS with these SF-36 scales . Screening for symptoms of anxiety and depression is recommended in studies that use Q oL as an outcome measure of treatment or intervention efficacy Objective : To evaluate the cost effectiveness of a psychological adjustment group shown to be clinical ly effective in comparison with usual care for people with multiple sclerosis . Design : R and omized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio . Setting : Community . Participants : People with multiple sclerosis were screened on the General Health Question naire 12 and Hospital Anxiety and Depression Scale , and those with low mood were recruited . Interventions : Participants r and omly allocated to the adjustment group received six group treatment sessions . The control group received usual care , which did not include psychological interventions . Main measures : Outcomes were assessed four and eight months after r and omization , blind to group allocation . The costs were assessed from a service use question naire and information provided on medication . Quality of life was assessed using the EQ-5D . Results : Of the 311 patients identified , 221 ( 71 % ) met the criteria for having low mood . Of these , 72 were r and omly allocated to receive treatment and 79 to usual care . Over eight months follow-up there was a decrease in the combined average costs of £ 378 per intervention respondent and an increase in the costs of £ 297 per patient in the control group , which was a significant difference ( p=0.03 ) . The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory – II was £ 118 . Conclusion : In the short term , the adjustment group programme was cost effective when compared with usual care , for people with multiple sclerosis presenting with low mood . The longer-term costs need to be assessed Anxiety and phobia frequently prevent patients with multiple sclerosis ( MS ) from self-injecting their injectable disease-modifying medications . This small , r and omized , controlled trial tested the efficacy of a six-session nurse-administered programme to teach self-injection to patients with MS , who , due to anxiety or phobia , were unable to self-inject their injectable medications . Participants were 30 patients with MS who were prescribed interferon beta-1a ( IFNβ-1a ) administered via weekly intramuscular injection . All patients were unable to self-inject due to anxiety or phobia . Patients were r and omized to either the six-session Self-Injection Anxiety Therapy ( SIAT ) or a control telephone support condition modelled on the support programme offered by the manufacturer of IFNβ-1a . Four patients dropped out of SIATwhile three dropped out of the control condition . Eight patients receiving SIAT , compared to three control patients , were able to self-inject after six weeks of treatment . SIAT patients were significantly more likely to achieve self-injection at treatment cessation , compared to telephone control patients , in completer analyses ( p=0.022 ) , however , this only reached a trend in intent-to-treat analyses ( p=0.058 ) . These findings suggest that SIAT is a potentially valuable intervention to teach self-injection skills to injection phobic and anxious patients , and should be investigated more thoroughly in a larger clinical trial Objective : There has long been a belief that depression contributes to fatigue in multiple sclerosis ( MS ) although supporting data are minimal at best . Clinical guidelines for the treatment of fatigue include recommendations for the treatment of depression in the absence of clear empirical support . The goal of this study was to examine the effects of treatment for depression on fatigue in MS . Methods : Sixty patients with a relapsing form of MS and moderate to severe depression were r and omly assigned to one of three vali date d 16‐week treatments for depression : individual cognitive behavioral therapy , group psychotherapy , or sertraline . Assessment s at baseline and treatment cessation included the primary outcome measure , fatigue assessment instrument ( FAI ) , and Beck depression inventory ( BDI ) . Results : The total FAI and the global fatigue severity subscale were significantly reduced over the course of treatment ( p values < .02 ) . Other subscales did not change significantly . Secondary analyses showed change in global fatigue severity was associated with change in BDI ( p = .03 ) but change in total FAI was only marginally related to change in BDI ( p = .05 ) . These relationships were due entirely to change in mood ( p values < .02 ) and not to change in cognitive or vegetative symptoms ( p values > .17 ) . Conclusions : These findings suggest that treatment for depression is associated with reductions in the severity of fatigue symptoms , and that this relationship is due primarily to treatment related changes in mood Background People with multiple sclerosis ( MS ) are at high risk of depression . We undertook a pilot trial of computerised cognitive behavioural therapy ( CCBT ) for the treatment of depression in people with MS to test the feasibility of undertaking a full trial . Methods Participants with a diagnosis of MS and clinical levels of depression were recruited through out-patient clinics and postal screening question naires at two UK centres and r and omised to CCBT or usual care . Clinical outcomes included the Beck Depression Inventory ( BDI-II ) and Multiple Sclerosis Impact Scale ( MSIS-29 ) at baseline , 8 and 21 weeks . Feasibility outcomes included : recruitment rate ; reasons for refusal , withdrawal and dropout ; feasibility and acceptability of the proposed outcome measures ; sample size estimation and variation in and preferences for service delivery . Results Twenty-four participants were recruited . The recruitment rate , calculated as the proportion of those invited to fill in a screening question naire who were consented into the trial , was 4.1 % . Recruitment through out-patient clinics was somewhat slower than through screening question naire mail-out but the overall recruitment yield was similar . Of the 12 patients in the CCBT arm , 9 ( 75 % ) completed at least four , and 6 completed all 8 CCBT sessions . For completers , the median time ( IQR ) to complete all eight CCBT sessions was 15 ( 13 to 20 ) weeks . Participants expressed concern about the face validity of the Beck Depression Inventory II for the measurement of self-reported depression in people with MS . The MSIS-29 was the patient-reported outcome measure which participants felt best reflected their concerns . The estimated sample size for a full trial is between 180 and 390 participants . NHS partners were not delivering CCBT in community facilities and participants preferred to access CCBT at home , with no one expressing a preference for use of CCBT in an alternative location . Conclusions A definitive trial , with a recruitment window of one year , would require the participation of around 13 MS centres . This number of centres could be reduced by exp and ing the eligibility criteria to include either other neurological conditions or people with more severe depression . The MSIS-29 should be used as a patient-important outcome measurement . Trial registration IS RCT N : IS RCT In a double-blind clinical trial involving 28 patients with multiple sclerosis and major depressive disorder , 14 patients were r and omly assigned to a 5-week trial of desipramine and individual psychotherapy and 14 to placebo plus psychotherapy . Clinical judgments indicated that patients treated with desipramine improved significantly more than the placebo group . This was confirmed by scores on the Hamilton Rating Scale for Depression but not by Beck Depression Inventory scores . Side effects limited desipramine dosage in half of the treated patients . The authors conclude that desipramine has a modest beneficial effect in serious depression associated with multiple sclerosis but that side effects may be more of a limiting factor than in patients without medical or neurologic disease BACKGROUND Several studies have shown that telephone-administered cognitive-behavioral therapy ( T-CBT ) is superior to forms of no treatment controls . No study has examined if the skills-training component to T-CBT provides any benefit beyond that provided by nonspecific factors . OBJECTIVE To test the efficacy of a 16-week T-CBT against a strong control for attention and nonspecific therapy effects . DESIGN R and omized controlled trial including 12-month follow-up . SETTING Telephone administration of psychotherapy with patients in their homes . PARTICIPANTS Participants had depression and functional impairments due to multiple sclerosis . INTERVENTIONS A 16-week T-CBT program was compared with 16 weeks of telephone-administered supportive emotion-focused therapy . MAIN OUTCOME MEASURES Hamilton Depression Rating Scale score , Structured Clinical Interview for DSM-IV diagnosis of major depressive disorder , Beck Depression Inventory score , and Positive Affect scale score of the Positive and Negative Affect Scale . RESULTS Of the 127 participants r and omized , 7 ( 5.5 % ) dropped out of treatment . There were significant improvement during treatment on all outcome measures ( P<.01 for all ) and an increase in Positive Affect Scale score . Improvements over 16 weeks of treatment were significantly greater for T-CBT , compared with telephone-administered supportive emotion-focused therapy , for major depressive disorder frequency ( P =
Output:
| Pharmacological and psychological treatments for depression were effective in reducing depressive symptoms in MS .
The data are insufficient to determine the effectiveness of treatments for anxiety |
MS210305 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: STUDY OBJECTIVE To evaluate the feasibility of lung cancer screening using low-dose spiral CT as a part of annual health examinations . DESIGN Nonr and omized , screening practice . METHODS From April 1998 to August 2000 , CT screening was performed as a part of annual health examinations on a total of 7,956 individuals who belonged to the Hitachi Employee 's Health Insurance Group . Of those participants , 5,568 were rescreened 1 year later . When a noncalcified solitary pulmonary nodule ( SPN ) > or= 8 mm was detected on CT screening , a detailed CT scan was carried out approximately 1 month later . RESULTS During the baseline screening , a total of 2,865 noncalcified SPNs were detected among the 7,956 participants . Primary lung cancer was histologically confirmed in 40 patients ( 41 lesions ) . The prevalence was 0.44 % of all participants from the baseline , and 0.07 % from the repeated screening . Thirty-five of 41 tumors were stage I. Current or former smokers represented only 17 of 40 cases . The detection rate was rather high in female participants . CONCLUSION Low-dose spiral CT seems to be a promising method for screening early lung cancer as a part of annual health examinations . Female and nonsmoking subjects should be included in the baseline screening . However , for yearly repeat screening , the participants may be selected on the basis of gender , smoking history , and results at the baseline screening STUDY OBJECTIVE To assess the ability of endobronchial ultrasonography ( EBUS ) using a guide sheath ( EBUS-GS ) to diagnose peripheral pulmonary lesions . METHOD We devised a technique for EBUS-GS covering a miniature probe , and 150 lesions were evaluated in a prospect i ve open study . In this procedure , the probe covered by a guide sheath is introduced into the lesion via the working channel of a bronchoscope . The probe is withdrawn , while the guide sheath is left in situ . A brush or biopsy forceps is introduced through the guide sheath into the lesion . RESULTS One hundred sixteen of 150 EBUS-GS procedures ( 77 % ) were diagnostic . Cases in which the probe was located within the lesion had a significantly higher diagnostic yield ( 105 of 121 cases , 87 % ) than when the probe was located adjacent to it ( 8 of 19 cases , 42 % ) [ p < 0.0001 , chi(2 ) ] . The diagnostic yield from EBUS-GS in lesions < /= 10 mm ( 16 of 21 lesions , 76 % ) , > 10 to < /= 15 mm ( 19 of 25 lesions , 76 % ; p = 0.99 , chi(2 ) ) , > 15 to < /= 20 mm ( 23 of 35 lesions , 66 % ; p = 0.41 , chi(2 ) ) , and > 20 to < /= 30 mm ( 33 of 43 lesions , 77 % ; p = 0.96 , chi(2 ) ) were similar , demonstrating the efficacy of EBUS-GS even in lesions < /= 10 mm in diameter . In 54 of 81 lesions < /= 20 mm , fluoroscopy was not able to confirm whether the forceps reached the lesion . However , the yield was the same with ( 67 % , 18 of 27 lesions ) and without ( 74 % , 40 of 54 lesions ) successful fluoroscopy ( p = 0.96 , chi(2 ) ) . Moderate bleeding occurred in two patients ( 1 % ) ; there were no other complications . CONCLUSIONS EBUS-GS is a useful method for collecting sample s from peripheral pulmonary lesions , even those too small to be visualized under fluoroscopy PURPOSE To report results of a 5-year prospect i ve low-dose helical chest computed tomographic ( CT ) study of a cohort at high risk for lung cancer . MATERIAL S AND METHODS After informed written consent was obtained , 1520 individuals were enrolled . Protocol was approved by institutional review board and National Cancer Institute and was compliant with Health Insurance Portability and Accountability Act , or HIPAA . Participants were aged 50 years and older and had smoked for more than 20 pack-years . Participants underwent five annual ( one initial and four subsequent ) CT examinations . A significant downward shift was evaluated in non-small cell lung cancers detected initially from advanced stage down to stage I by using a one-sided binomial test of proportions . Poisson regression and Fisher exact tests were used for comparisons with Mayo Lung Project . RESULTS In 788 ( 52 % ) men and 732 ( 48 % ) women , 61 % ( 927 of 1520 ) were current smokers , and 39 % were former smokers . After five annual CT examinations , 3356 uncalcified lung nodules were identified in 1118 ( 74 % ) participants . Sixty-eight lung cancers were diagnosed ( 31 initial , 34 subsequent , three interval cancers ) in 66 participants . Twenty-eight subsequent cases of non-small cell cancers were detected , of which 17 ( 61 % ; 95 % confidence interval : 41 % , 79 % ) were stage I tumors . Diameter of cancers detected subsequently was 5 - 50 mm ( mean , 14.4 mm ; median , 10.0 mm ) . Analysis for a more than 50 % shift in proportion of stage I non-small cell cancer detection did not show statistical significance . Forty-eight participants died of various causes since enrollment . Lung cancer mortality rate for incidence portion of trial was 1.6 per 1000 person-years . There was no significant difference in lung cancer mortality rates of cancers detected in subsequent examinations between this trial and Mayo Lung Project after separation of participants into subsets ( 2.8 vs 2.0 per 1000 person-years , P = .43 ) . CONCLUSION CT allows detection of early-stage lung cancers . Benign nodule detection rate is high . Results suggest no stage shift To evaluate the individual and additive diagnostic yield(s ) of several bronchoscopic sampling techniques for the diagnosis of lung lesions with no corresponding airway abnormalities , consecutive patients with lung nodules or masses were prospect ively evaluated between December 1989 and November 1994 . A CT of the chest was done in all patients before flexible bronchoscopy ( FB ) . Size , location , and character of the border of the lesion were determined . During FB , using biplane fluoroscopic guidance , the lesion was localized and following sampling techniques were done : brushing , transbronchial lung biopsy ( TBLB ) , and Sofcor transbronchial needle aspiration ( STBNA ) . Bronchial washings ( BWs ) were collected throughout the procedure . Problems associated with each sampling technique were noted . Forty-nine patients underwent 51 FB . A diagnosis was established by FB in 36 ( 73 % ) . After a nondiagnostic FB , histologic diagnosis was established in 9 of 13 patients by other methods . A benign or malignant nature of lesion was established in other four patients by clinical follow-up . FB was diagnostic in 32 of 40 ( 80 % ) patients with primary lung cancer , in 3 of 6 ( 50 % ) patients with benign disease , and in 1 of 3 ( 33 % ) patients with metastatic disease to lung . All sampling procedures could be done in 33 of 51 ( 65 % ) FBs . Overall diagnostic yields were as follows : BW , 18 of 51 ( 35 % ) ; brush , 25 of 48 ( 52 % ) ; TBLB , 23 of 40 ( 57 % ) ; and STBNA , 19 of 37 ( 51 % ) . In 12 of 51 ( 24 % ) FBs , only one sample was diagnostic . Lesions with sharp borders had a lower combined diagnostic yield , 13 of 24 ( 54 % ) compared to lesions with fuzzy borders , 20 of 24 ( 83 % ) ( p=0.03 ) . Yield of TBLB in lesions with fuzzy borders , 14 of 18 ( 78 % ) , was higher than the yield for lesions with sharp borders , 6 of 19 ( 32 % ) ( p=0.005 ) . Size of the lesion in centimeters in patients with a positive FB ( 4.55+/- 2.35 ; mean + /-SD ) was significantly larger than in patients with a nondiagnostic FB ( 3.14+/-1.31 ; mean+/-SD ) ( p=0.009 , t test ) . Diagnostic yield was directly related to the size of the lesion . For lesions less than 2 cm , yield was 6 of 11 ( 54 % ) ( p=0.19 ) ; for lesions less than 3 cm , yield was 12 of 21 ( 57 % ) ( p=0.07 ) ; and for lesions greater than 3 cm , yield was 24 of 30 ( 80 % ) . Yield from lesions located in the lower lobe basal segments or the apical segment of upper lobes was lower ( 11/19 , 58 % ) than that from lesions in other parts of the lung ( 25/30 , 83 % ) ( p=0.05 ) . FB was terminated prior to collecting all sample s because of severe bleeding after brushing ( n=3 ) or instability of the patient ( n=4 ) . None of the patients required intubation . There were no pneumothoraces . Diagnostic yield of FB depends on the location , size , character of the border of the lesion , and the ability to perform all sampling methods . Brushing , TBLB , and STBNA should be performed in all patients to give the best diagnostic yield . Routine cytologic examination of BW is unnecessary . Methods other than FB should be considered for lesions 2 cm or less in size , especially when they have a sharp border and /or are located in the basal segment of a lower lobe/apical segment of an upper lobe BACKGROUND Low-dose spiral CT of the chest effectively detects early-stage lung cancer in high-risk individuals . The high rate of benign nodules and issues of making a differential diagnosis are critical factors that currently hamper introduction of large-scale screening programmes . We investigated the efficacy of repeated yearly spiral CT and selective use of positron emission tomography ( PET ) in a large cohort of high-risk volunteers . METHODS We enrolled 1035 individuals aged 50 years or older who had smoked for 20 pack-years or more . All patients underwent annual low-dose CT , with or without PET , for 5 years . Lesions up to 5 mm were deemed non-suspicious and low-dose CT was repeated after 12 months ( year 2 ) . FINDINGS By year 2 , 22 cases of lung cancer had been diagnosed ( 11 at baseline , 11 at year 2 ) . 440 lung lesions were identified in 298 ( 29 % ) participants , and 95 were recalled for high-resolution contrast CT . PET scans were positive in 18 of 20 of the identified cancer cases . Six patients underwent surgical biopsy for benign disease because of false-positive results ( 6 % of recalls , 22 % of invasive procedures ) . Complete resection was achieved in 21 ( 95 % ) lung cancers , 17 ( 77 % ) were pathological stage I ( 100 % at year 2 ) , and the mean tumour size was 18 mm . There were no interval lung cancers in the 2.5 years of follow-up ( average time on study from r and omisation to last contact ) , although 19 individuals were diagnosed with another form of cancer ( two deaths and 17 non-fatal admissions ) . INTERPRETATION Combined use of low-dose spiral CT and selective PET effectively detects early lung cancer . Lesions up to 5 mm can be checked again at 12 months without major risks of progression STUDY OBJECTIVES We evaluated the feasibility and efficacy of transbronchial biopsy ( TBB ) and bronchial brushing by endobronchial ultrasonography ( EBUS ) with a guide sheath ( GS ) as a guide for diagnosing peripheral pulmonary lesions ( PPLs ) without radiographic fluoroscopy . PATIENTS One hundred twenty-one patients with 123 PPLs ( mean diameter , 31.0 mm ) whose bronchoscopic findings were normal . METHODS An EBUS-GS was inserted and advanced to the PPL without fluoroscopy . Once we obtained the EBUS image , the probe was withdrawn and the GS was left in place . TBB and /or bronchial brushing were performed via the GS . When an EBUS image could not be obtained , we changed to the bronchoscopic examination under fluoroscopy . RESULTS Seventy-six of 123 PPLs ( 61.8 % ) were diagnosed by EBUS-GS guidance without fluoroscopy . The diagnostic yield for PPLs > 20 mm in diameter ( 75.6 % ) was significantly higher than that for those < or= 20 mm in diameter ( 29.7 % ; p < 0.01 ) . The PPLs located in the middle lobe and the lingular segment had significantly higher diagnostic yields ( p < 0.05 ) . When the bronchus leading to the PPL was identified on the CT scan , the yield was 79.2 % . Moreover , the solid lesions had a higher diagnostic yield ( 67.0 % ) compared with
Output:
| EBUS is a safe and relatively accurate tool in the investigation of PPLs .
Diagnostic sensitivity of EBUS may be influenced by the prevalence of malignancy in the patient cohort being examined and lesion size . |
MS210306 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Soy sauce ( Shoyu ) is a traditional fermented seasoning of East Asian countries and is available throughout the world . We obtained polysaccharides from raw soy sauce , and showed the anti-allergic activities of these Shoyu polysaccharides ( SPS ) in vitro and in vivo . The present study determined whether oral supplementation of SPS is an effective intervention for patients with seasonal allergic rhinitis . In an 8-week r and omized , double-blind , placebo-controlled parallel group study , patients with mild seasonal allergic rhinitis were treated with 600 mg of SPS ( n=25 ) or placebo ( n=26 ) each day . After 4 weeks of treatment with SPS , symptom scores such as sneezing , nasal stuffiness , and hindrance of daily life were significantly different ( P<0.05 ) from those in placebo-treated groups . The total symptom score , calculated from the sum of individual scores , showed a significant difference ( P<0.05 ) between the 2 groups after 4 - 8 weeks . On nasal examination by the investigator , the color of the inferior turbinate in SPS-treated patients was significantly different ( P<0.05 ) from that in placebo-treated patients between weeks 4 and 8 , and the nasal symptom scores for color of inferior turbinate , watery discharge , and state of sniffles were also significantly different ( P<0.05 ) from those in the placebo-treated group after 8 weeks . In conclusion , SPS of soy sauce improved the quality of life of patients with seasonal allergic rhinitis , and soy sauce would be useful in an anti-allergic therapy utilizing daily foods Abstract Objectives : To compare the efficacy and tolerability of butterbur ( Petasites hybridus ) with cetirizine in patients with seasonal allergic rhinitis ( hay fever ) . Design : R and omised , double blind , parallel group comparison . Setting : Four outpatient general medicine and allergy clinics in Switzerl and and Germany . Participants : 131 patients were screened for seasonal allergic rhinitis and 125 patients were r and omised ( butterbur 61 ; cetirizine 64 ) . Interventions : Butterbur ( carbon dioxide extract tablets , ZE 339 ) one tablet , four times daily , or cetirizine , one tablet in the evening , both given for two consecutive weeks . Main outcome measures : Scores on SF-36 question naire and clinical global impression scale . Results : Improvement in SF-36 score was similar in the two treatment groups for all items tested hierarchically . Butterbur and cetirizine were also similarly effective with regard to global improvement scores on the clinical global impression scale ( median score 3 in both groups ) . Both treatments were well tolerated . In the cetirizine group , two thirds ( 8/12 ) of reported adverse events were associated with sedative effects ( drowsiness and fatigue ) despite the drug being considered a non-sedating antihistamine . Conclusions : The effects of butterbur are similar to those of cetirizine in patients with seasonal allergic rhinitis when evaluated blindly by patients and doctors . Butterbur should be considered for treating seasonal allergic rhinitis when the sedative effects of antihistamines need to be avoided . What is already known on this topic Seasonal allergic rhinitis ( hay fever ) is common in countries with temperate climates . Most patients have their symptoms treated for short periods , particularly during peaks in atmospheric pollen count What this study adds After two weeks , the effects of butterbur and cetirizine were comparable in patients with hay fever Butterbur produced fewer sedating effects than cetirizine Butterbur should be considered when the sedating effects of antihistamines must be 1 The seed of Butyrospermum parkii yields shea butter which according to local traditional healers relieves inflammation of the nostrils . 2 Since there is as yet no absolutely satisfactory nasal decongestant in clinical use , it was decided to investigate the effects of shea butter in nasal congestion . The substance was prepared in the laboratory . 3 The human subjects used were those suffering from rhinitis with moderate to severe nasal congestion . They were divided into the test group which received shea butter , the control group which was treated with xylometazoline and the ' placebo ' group which received white petroleum jelly B.P. 4 The results showed that nasal congestion was relieved more satisfactorily in the test group than in the other two groups . 5 It is concluded that shea butter may prove more efficacious in nasal congestion than conventional nasal drops The present study was undertaken to determine whether oral supplementation with rosmarinic acid ( RA ) is an effective intervention for patients with SAR . In addition , the anti‐inflammatory mechanism of RA also estimated in the ear edema models . Clinical trial : Patients were treated daily with RA ( 200 mg or 50 mg ) or placebo for 21 days . Patients recorded symptoms daily and profiles of infiltrating cells and concentration of cytokines were measured in nasal lavage fluid . Compared to placebo , supplementation with RA result ed in a significant decrease in responder rates for each symptom . RA also significantly decreased the numbers of neutrophils and eosinophils in nasal lavage fluid . Animal Study : Topical application RA showed anti‐inflammatory activity 5‐hours after 12‐tetradecanoylphorbol 13‐acetate ( TPA ) treatment with marked inhibition of neutrophil infiltration . Up regulation of ICAM‐1 , VCAM‐1 cyclooxygenase‐2 ( COX‐2 ) , KC and MIP‐2 by TPA were markedly reduced by pre‐treatment with extract of perilla ( PE ) or RA . Reactive oxygen radical production detected as thiobarbituric acid reactive substance ( TBARS ) , lipid peroxide ( LPO ) and 8‐hydroxy‐2'deoxyguanosine ( 8OH‐dG ) , by double treatment of TPA was reduced by pretreatment with PE or RA . RA is an effective intervention for SAR that is mediated by inhibition of PMNL infiltration . This effect of RA is due to two independent mechanisms : inhibition of the inflammatory response and scavenging of ROS OBJECTIVES To investigate whether the efficacy and safety of Butterbur extract Ze339 are related to dosage when administered to patients with intermittent allergic rhinitis . DESIGN Prospect i ve , r and omized , double-blind , placebo-controlled , parallel-group comparison . SETTING Multicenter , including 6 outpatient general medicine and allergy clinics . PATIENTS One hundred eighty-six patients were r and omized ( Butterbur Ze339 high dose , 60 ; low dose , 65 ; and placebo , 61 patients ) . Established diagnostic criteria for intermittent allergic rhinitis were confirmed by skin allergy tests in all patients . INTERVENTIONS High-dose group , 1 tablet 3 times daily ; low-dose group , 1 tablet twice daily ; or matching placebo . All groups were treated for 2 consecutive weeks . MAIN OUTCOME MEASURES The main efficacy variable was change in symptoms from baseline to end point during the daytime . The secondary efficacy variables were Clinical Global Impression score , change in symptoms from baseline to treatment day 7 , and responder rates . Statistical analysis was prospect i ve , on an intention-to-treat basis . RESULTS Improvement in the main efficacy variable was significantly superior in the Butterbur Ze339 groups , relative to placebo , and a significant dose relationship was observed between the 2 Butterbur doses . The clinicians ' assessment of efficacy and the overall responder rates were significantly superior for the active groups compared with placebo . The incidence and type of adverse events were indistinguishable across the herbal treatment and placebo groups . CONCLUSIONS Butterbur Ze339 is an effective treatment for intermittent allergic rhinitis symptoms and is well tolerated . The effects of this herbal medicine are clear to patients and physicians in a double-blind evaluation against placebo Background There are presently no placebo‐controlled data regarding the effects of butterbur ( BB ) on subjective and objective outcomes in patients with perennial allergic rhinitis OBJECTIVE To observe the therapeutic effect of Kebimin decoction ( KD ) on allergic rhinitis ( AR ) and its effect on blood levels of nitric oxide ( NO ) and superoxide dismutase ( SOD ) activity . METHODS Eighty-two AR patients were r and omly divided into two groups , the treated group and the control group , 41 in each group . To the treated group , KD was given one dose per day for 10 days as one therapeutic course and 1 - 3 courses were given successively . The control group was treated with Xinfang Rhinitis capsule for 30 days . Blood levels were determined and compared before and after treatment . RESULTS The total effective rate in the treated group was 93 % , which was better than that in the control group ( 51 % ) , the difference was significant ( chi 2 = 17.704 , P < 0.01 ) . Serum level of NO was higher and that of SOD activity was lower in the AR patients than that in healthy persons ( P < 0.01 ) , KD could significantly lower the former and increase the latter ( P < 0.01 ) . CONCLUSION The therapeutic effect of KD in treating AR was significant , its mechanism might be related with the lowering of NO and increasing of SOD activity in serum , as well as the scavenging of oxygen free radical BACKGROUND Butterbur ( Petasites hybridus ) contains the active ingredient petasin , which exhibits antileukotriene and antihistamine activity . Previous studies of intermittent allergic rhinitis ( IAR ) have demonstrated a comparable response to butterbur compared with a histamine H1-receptor antagonist on the 36-Item Short-Form Health Survey quality -of-life score . However , there has been no placebo-controlled study of the effects of butterbur use on objective and subjective outcomes in IAR . OBJECTIVE To evaluate the effects of treatment with butterbur vs placebo on objective and subjective outcomes in IAR . METHODS A double-blind , placebo-controlled , crossover study was carried out during the grass pollen season in Tayside , Scotl and . Thirty-five patients ( 14 men and 21 women ) with IAR received butterbur , 50 mg twice daily , or placebo for 2 weeks . Domiciliary measurements were taken in the morning and evening for peak nasal inspiratory flow ( PNIF ) ( the primary outcome variable ) , nasal and eye symptoms , and rhinoconjunctivitis-specific quality -of-life score . RESULTS Butterbur treatment had no significant effect on PNIF , total nasal symptom score , eye symptom score , or quality of life compared with placebo use . Mean ( SEM ) morning and evening PNIF values were 107 ( 6 ) and 114 ( 6 ) L/min , respectively , for butterbur vs 105 ( 6 ) and 117 ( 6 ) L/min for placebo . Mean ( SEM ) morning and evening total nasal symptom scores ( maximum total score , 12 ) were 3.4 ( 0.4 ) and 3.5 ( 0.4 ) , respectively , for butterbur vs 3.7 ( 0.3 ) and 3.8 ( 0.4 ) for placebo . CONCLUSIONS There was no significant clinical efficacy of butterbur use vs placebo use on objective and subjective outcomes in IAR . Further studies are now indicated to investigate the use of butterbur in persistent allergic rhinitis BACKGROUND Butterbur or Petasites hybridus is an herbal remedy that exhibits antihistamine and antileukotriene activity and has been shown to attenuate the response to adenosine monophosphate challenge in patients with allergic rhinitis and asthma . However , no data are available regarding its effects on the histamine and allergen cutaneous response . OBJECTIVE To evaluate the effects of butterbur compared with fexofenadine and montelukast on the histamine and allergen wheal and flare cutaneous responses . METHODS Atopic patients were r and omized into a double-blind , double-dummy , crossover study to receive for 1 week butterbur , 50 mg twice daily ( 8 AM and 10 PM ) ; fexofenadine , 180 mg once daily ( 10 PM ) , and placebo once daily ( 8 AM ) ; montelukast , 10 mg once daily ( 10 PM ) , and placebo once daily ( 8 AM ) ; or placebo twice daily ( 8 AM and 10 PM ) . Patients attended the department at 10 AM and had measurements of the cutaneous wheal and flare responses to histamine , allergen , and saline control at 10-minute intervals for 60 minutes . RESULTS Twenty patients completed the study . The mean + /- SE histamine wheal and flare responses , respectively , were significantly attenuated ( P < .05 ) by fexofenadine ( 9.4 + /- 1.8 mm2 and 13.5 + /- 3.2 mm2 ) compared with placebo ( 15.5 + /- 3.3 mm2 and 179.8 + /- 74.3 mm2 ) but not by butterbur ( 16.4 + /- 2.1 mm2 and 297.7 + /- 121.2 mm2 ) or montelukast ( 19 + /- 1.9 mm2 and 240.2 + /- 66.6 mm2 ) . The allergen wheal and flare responses , respectively , were also significantly attenuated ( P < .05 ) by fexofenadine ( 31.1 + /- 6.3 mm2 and 25
Output:
| There is encouraging evidence suggesting that P hybridus may be an effective herbal treatment for seasonal ( intermittent ) AR .
There are also promising results generated for other herbal products , particularly Aller-7 , Tinospora cordifolia , Perilla frutescens , and several Chinese herbal medicines . |
MS210307 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Half of all cases of cerebral palsy ( CP ) occur in term infants , for whom risk factors have not been clearly defined . Recent studies suggest a possible role of chorioamnionitis . OBJECTIVE To determine whether clinical chorioamnionitis increases the risk of CP in term and near-term infants . DESIGN , SETTING , AND PATIENTS Case-control study nested within a cohort of 231 582 singleton infants born at 36 or more weeks ' gestation between January 1 , 1991 , and December 31 , 1998 , in the Kaiser Permanente Medical Care Program , a managed care organization providing care for more than 3 million residents of northern California . Case patients were identified from electronic records and confirmed by chart review by a child neurologist , and comprised all children with moderate to severe spastic or dyskinetic CP not due to postnatal brain injury or developmental abnormalities ( n = 109 ) . Controls ( n = 218 ) were r and omly selected from the study population . MAIN OUTCOME MEASURE Association between clinical chorioamnionitis and increased risk of CP in term and near-term infants . RESULTS Most CP cases had hemiparesis ( 40 % ) or quadriparesis ( 38 % ) ; 87 % had been diagnosed by a neurologist and 83 % had undergone neuroimaging . Chorioamnionitis , considered present if a treating physician made a diagnosis of chorioamnionitis or endometritis clinical ly , was noted in 14 % of cases and 4 % of controls ( odds ratio [ OR ] , 3.8 ; 95 % confidence interval [ CI ] , 1.5 - 10.1 ; P = .001 ) . Independent risk factors identified in multiple logistic regression included chorioamnionitis ( OR , 4.1 ; 95 % CI , 1.6 - 10.1 ) , intrauterine growth restriction ( OR , 4.0 ; 95 % CI , 1.3 - 12.0 ) , maternal black ethnicity ( OR , 3.6 ; 95 % CI , 1.4 - 9.3 ) , maternal age older than 25 years ( OR , 2.6 ; 95 % CI , 1.3 - 5.2 ) , and nulliparity ( OR , 1.8 ; 95 % CI , 1.0 - 3.0 ) . The population -attributable fraction of chorioamnionitis for CP is 11 % . CONCLUSION Our data suggest that chorioamnionitis is an independent risk factor for CP among term and near-term infants BACKGROUND As the interval between rupture of the fetal membranes at term and delivery increases , so may the risk of fetal and maternal infection . It is not known whether inducing labor will reduce this risk or whether one method of induction is better then another . METHODS We studied 5041 women with prelabor rupture of the membranes at term . The women were r and omly assigned to induction of labor with intravenous oxytocin ; induction of labor with vaginal prostagl and in E2 gel ; or expectant management for up to four days , with labor induced with either intravenous oxytocin or vaginal prostagl and in E2 gel if complications developed . The primary outcome was neonatal infection . Secondary outcomes were the need for cesarean section and women 's evaluations of their treatment . RESULTS The rates of neonatal infection and cesarean section were not significantly different among the study groups . The rates of neonatal infection were 2.0 percent for the induction-with-oxytocin group , 3.0 percent for the induction-with-prostagl and in group , 2.8 percent for the expectant-management ( oxytocin ) group , and 2.7 percent for the expectant-management ( prostagl and in ) group . The rates of cesarean section ranged from 9.6 to 10.9 percent . Clinical chorioamnionitis was less likely to develop in the women in the induction-with-oxytocin group than in those in the expectant-management ( oxytocin ) group ( 4.0 percent vs. 8.6 percent , P<0.001 ) , as was postpartum fever ( 1.9 percent vs. 3.6 percent , P=0.008 ) . Women in the induction groups were less likely to say they liked " nothing " about their treatment than those in the expectant-management groups . CONCLUSIONS In women with prelabor rupture of the membranes at term , induction of labor with oxytocin or prostagl and in E2 and expectant management result in similar rates of neonatal infection and cesarean section . Induction of labor with intravenous oxytocin results in a lower risk of maternal infection than does expectant management . Women view induction of labor more positively than expectant management We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11 Objective To compare 12-hour and 72-hour expectant management of premature rupture of membranes ( PROM ) in singleton term pregnancies . Methods In a prospect i ve , nonr and omized study , 566 low-risk women with singleton term pregnancies presenting with PROM were assigned to either 12-hour or 72-hour expectant management . Patients who had not entered labor at the end of the assigned period were induced with oxytocin . The pregnancy outcome of both methods was compared with regard to infectious complications and method of delivery . Results There was no statistical difference in the rate of chorioamnionitis between the 12-hour and 72-hour expectant management groups ( 11.7 versus 12.7 % ; relative risk [ RR ] 0.9 , 95 % confidence interval [ CI ] 0.6 - 1.5 ; P = .83 ) . Cesareans were performed to a similar degree in both groups ( 4.7 versus 6.7 % ; RR 0.7 , 95 % CI 0.3 - 1.4 ; P = .39 ) . Fifty-five percent of the 12-hour group underwent oxytocin induction , compared with 17.5 % of those in the 72-hour group ( RR 5.8 , 95 % CI 3.9 - 8.5 ; P < .001 ) . Women undergoing induction after 72-hour expectant management had an increased risk of cesarean delivery compared with those after a 12-hour wait ( RR 5.9 , 95 % CI 2.3 - 15.1 ; P < .001 ) . Overall , women in the 12-hour group had shorter admission-to-discharge times than the 72-hour group ( 5 versus 6 days , 95 % CI of the difference 0.6 - 1.3 ; P < .01 ) . Conclusion Regimens of 12-hour and 72-hour expectant management of PROM are comparable regarding infectious complications and pregnancy outcome . However , the longer wait prolongs the interval to delivery and increases hospitalization costs OBJECTIVE We hypothesize that expectant management in the presence of premature rupture of membranes at term would result in a lower cesarean birth rate with no increase in maternal , fetal , or neonatal infection . STUDY DESIGN Term patients who consented to the study were r and omly allocated either to expectant management for 48 hours or to induction of labor 8 hours after premature rupture of membranes . Premature rupture of membranes was confirmed by sterile speculum examination of the vagina . Patients r and omized to expectant management were transferred to antenatal care and were not examined vaginally until they went into labor . Patients r and omized to induction of labor had induction with oxytocin 8 hours after premature rupture of membranes . RESULTS Two hundred sixty-two patients were r and omized to the expectant management and induction of labor groups . The cesarean birth rate and the clinical diagnosis of postpartum endometritis was not significantly different in the two groups . Pathologic diagnosis of chorioamnionitis and funisitis , however , was significantly greater in the expectant management group ( p < 0.05 ) . Eight of the 15 babies with funisitis were admitted to the neonatal intensive care unit for therapy ( two in the induction of labor group and six in the expectant management group , p < 0.05 ) . CONCLUSION Expectant management did not reduce the incidence of cesarean birth and increased the pathologic diagnosis of funisitis and newborn requirements for neonatal intensive care A prospect i ve , r and omized study was conducted comparing the use of betamethasone and early delivery , early delivery alone , and expectant management in patients in the 28th to 34th week of pregnancy with premature rupture of the membranes ( PROM ) . Tocolytic drugs were used to delay delivery until 24 hours had elapsed after the first dose of steroid or 24 to 48 hours of latent period had elapsed in the second group . There were ho significant differences in maternal age , gestation at PROM , maximum maternal temperature , birth weights , maternal hospital days , respiratory distress , maternal sepsis , or delivery routes in the three groups . Comparisons with one other similar prospect i ve , r and omized study support the concept that expectant management offers less risk from tocolytic side effects OBJECTIVE Our purpose was to compare induction of labor with preterm rupture of membranes between 34 and 37 weeks ' gestation with expectant management . STUDY DESIGN In this prospect i ve investigation 120 gravid women at > or = 34 weeks 0 days and < 36 weeks 6 days of gestation were r and omized to receive oxytocin induction ( n = 57 ) or observation ( n = 63 ) . RESULTS Estimated gestational age at rupture of membranes ( 34.3 + /- 1.4 weeks vs 34.5 + /- 1.4 weeks ) and ultrasonographically estimated fetal weight ( 2230 + /- 321 gm vs 2297 + /- 365 gm ) were equivalent between groups ( not significant ) . Chorioamnionitis occurred more often ( 16 % vs 2 % , p = 0.007 ) , and maternal hospital stay ( 5.2 + /- 6.8 days vs 2.6 + /- 1.6 days , p = 0.006 ) was significantly longer in the control group . Neonatal sepsis was also more common in the observation group ( n = 3 ) than among induction patients ( n = 0 ) , but the difference was not statistically significant . CONCLUSION Aggressive management of preterm premature rupture of the membranes at > or = 34 weeks 0 days of gestation by induction of labor is safe for the infant in our population and avoids maternal-neonatal infectious complications OBJECTIVE This study was undertaken to determine the effect of antenatal betamethasone administration on the incidences of respiratory distress syndrome , intraventricular hemorrhage , and perinatal infectious morbidity in the setting of preterm premature rupture of membranes . STUDY DESIGN We performed a nonconcurrent prospect i ve analysis of women with singleton pregnancies who were delivered between 24 and 32 weeks ' gestation after preterm premature rupture of membranes . Patients were subdivided into 2 groups according to betamethasone exposure : ( 1 ) none ( control group ) and ( 2 ) two 12-mg doses in a 24-hour interval on admission ( single-course group ) . Patients who received > 2 doses of betamethasone were excluded . All patients received broad-spectrum prophylactic antibiotics . Data were analyzed with the Student t test , the chi(2 ) test , and the Fisher exact test . Multiple logistic regression analyses incorporated multiple variables considered risk factors for respiratory distress syndrome and intraventricular hemorrhage . P < .05 for all 2-tailed tests was considered significant . RESULTS A total of 362 patients were included , with 203 in the control group and 159 in the single-course group . Patients in these groups were delivered at 31.0 + /- 3.0 and 30.2 + /- 2.7 ( mean + /- SD ) weeks ' gestation , respectively . The groups were similar with respect to selected demographic characteristics , latency until delivery , mode of delivery , birth weight , and maternal group B streptococcal colonization status . Univariate analysis demonstrated significant decreases in the frequencies of both respiratory distress syndrome ( odds ratio , 0.31 ; 95 % confidence interval , 0.2 - 0.5 ) and grade III/IV intraventricular hemorrhage (
Output:
| Maternal infection as well as respiratory distress syndrome ( RDS ) & neonatal sepsis ( NS ) were not different between the two groups .
Based on the available evidence , ID in pregnancies complicated with PPROM between 28 and 34 weeks carries some maternal and neonatal risks with no added benefits . |
MS210308 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Although inflammatory activity is known to play a role in depression , no work has examined whether experimentally induced systemic inflammation alters neural activity that is associated with anhedonia , a key diagnostic symptom of depression . To investigate this , we examined the effect of an experimental inflammatory challenge on the neural correlates of anhedonia-namely , reduced ventral striatum ( VS ) activity to reward cues . We also examined whether this altered neural activity related to inflammatory-induced increases in depressed mood . METHODS Participants ( n = 39 ) were r and omly assigned to receive either placebo or low-dose endotoxin , which increases proinflammatory cytokine levels in a safe manner . Cytokine levels were repeatedly assessed through hourly blood draws ; self-reported and observer-rated depressed mood were assessed regularly as well . Two hours after drug administration , neural activity was recorded as participants completed a task in which they anticipated monetary rewards . RESULTS Results demonstrated that subjects exposed to endotoxin , compared with placebo , showed greater increases in self-reported and observer-rated depressed mood over time , as well as significant reductions in VS activity to monetary reward cues . Moreover , the relationship between exposure to inflammatory challenge and increases in observer-rated depressed mood was mediated by between-group differences in VS activity to anticipated reward . CONCLUSIONS The data reported here show , for the first time , that inflammation alters reward-related neural responding in humans and that these reward-related neural responses mediate the effects of inflammation on depressed mood . As such , these findings have implication s for underst and ing risk of depression in persons with underlying inflammation Although social withdrawal is a prominent symptom of sickness , the mechanisms associated with this behavioral change remain unclear . In animals , the amygdala is a key neural region involved in sickness-induced social withdrawal . Consistent with this , in humans , heightened amygdala activity to negative social cues is associated with social avoidance tendencies . Based on these findings , we investigated whether an experimental inflammatory challenge selectively increased amygdala activity to socially threatening images as well as whether this activity related to feelings of social disconnection . Thirty-nine participants were r and omly assigned to receive either placebo or low-dose endotoxin , which increases inflammatory activity . Pro-inflammatory cytokines were assessed at 7 hourly time points via blood draws ; self-reported feelings of social disconnection and physical sickness symptoms were assessed hourly as well . Two hours post-injection , participants underwent an fMRI procedure to assess amygdala reactivity during the presentation of socially threatening images ( fear faces ) as well as non-socially threatening images ( guns ) , socially non-threatening images ( happy faces ) , and non-social , non-threatening images ( household objects ) . Endotoxin led to greater amygdala activity in response to socially threatening vs. all other types of images . No such differences were found for placebo participants . Additionally , increased amygdala activity in endotoxin participants during the viewing of socially vs. non-socially threatening images was associated with increased feelings of social disconnection . These findings highlight the amygdala as a neural region that may be important for sickness-induced social withdrawal . The implication s of amygdalar involvement in sickness-induced social withdrawal are discussed Background We tested the hypothesis that endothelial dysfunction underlies the association between an acute inflammatory episode and the transiently increased risk of a cardiovascular event by examining the effects of an experimental inflammatory stimulus on endothelium-dependent vasodilation . Methods and Results Salmonella typhi vaccine was used to generate a systemic inflammatory response in healthy volunteers . In 12 subjects , dilatation of the brachial artery to flow and to sublingual nitroglycerin ( NTG ) was recorded ( conduit vessel response ) , and in 6 subjects , venous occlusion plethysmography was used to measure forearm blood flow during intrabrachial infusion of the endothelium-dependent dilators acetylcholine ( ACh ) and bradykinin ( BK ) and the endothelium-independent dilators NTG and verapamil ( resistance vessel response ) . Responses were assessed 16 hours before and 8 and 32 hours after vaccination . Vaccination result ed in elevations in white cell count and serum levels of interleukin-6 and interleukin-1 receptor antagonist . Eight hours after vaccination , resistance vessel responses to BK ( P = 0.0099 ) and ACh ( P = 0.0414 ) were markedly attenuated , and brachial artery flow-mediated dilatation was depressed . Resistance vessel responses to verapamil and NTG were unchanged , as was the conduit vessel response to NTG . Thirty-two hours after vaccination , resistance vessel responses to BK and ACh had returned to normal . Conclusions S typhi vaccine generates a mild inflammatory reaction associated with temporary but profound dysfunction of the arterial endothelium in both resistance and conduit vessels to both physical and pharmacological dilator stimuli . This finding might explain the association between infection and inflammation and the enhanced risk of an acute cardiovascular event Significance Functional MRI ( fMRI ) is 25 years old , yet surprisingly its most common statistical methods have not been vali date d using real data . Here , we used resting-state fMRI data from 499 healthy controls to conduct 3 million task group analyses . Using this null data with different experimental design s , we estimate the incidence of significant results . In theory , we should find 5 % false positives ( for a significance threshold of 5 % ) , but instead we found that the most common software packages for fMRI analysis ( SPM , FSL , AFNI ) can result in false-positive rates of up to 70 % . These results question the validity of a number of fMRI studies and may have a large impact on the interpretation of weakly significant neuroimaging results . The most widely used task functional magnetic resonance imaging ( fMRI ) analyses use parametric statistical methods that depend on a variety of assumptions . In this work , we use real resting-state data and a total of 3 million r and om task group analyses to compute empirical familywise error rates for the fMRI software packages SPM , FSL , and AFNI , as well as a nonparametric permutation method . For a nominal familywise error rate of 5 % , the parametric statistical methods are shown to be conservative for voxelwise inference and invalid for clusterwise inference . Our results suggest that the principal cause of the invalid cluster inferences is spatial autocorrelation functions that do not follow the assumed Gaussian shape . By comparison , the nonparametric permutation test is found to produce nominal results for voxelwise as well as clusterwise inference . These findings speak to the need of validating the statistical methods being used in the field of neuroimaging Background Systemic infections commonly cause sickness symptoms including psychomotor retardation . Inflammatory cytokines released during the innate immune response are implicated in the communication of peripheral inflammatory signals to the brain . Methods We used functional magnetic resonance brain imaging ( fMRI ) to investigate neural effects of peripheral inflammation following typhoid vaccination in 16 healthy men , using a double-blind , r and omized , crossover-controlled design . Results Vaccination had no global effect on neurovascular coupling but markedly perturbed neural reactivity within substantia nigra during low-level visual stimulation . During a cognitive task , individuals in whom typhoid vaccination engendered higher levels of circulating interleukin-6 had significantly slower reaction time responses . Prolonged reaction times and larger interleukin-6 responses were associated with evoked neural activity within substantia nigra . Conclusions Our findings provide mechanistic insights into the interaction between inflammation and neurocognitive performance , specifically implicating circulating cytokines and midbrain dopaminergic nuclei in mediating the psychomotor consequences of systemic infection BACKGROUND Infectious , autoimmune , and neurodegenerative diseases are associated with profound psychological disturbances . Studies in animals clearly demonstrate that cytokines mediate illness-associated behavioral changes . However , the mechanisms underlying the respective psychological alterations in humans have not been established yet . Therefore , we investigated the effects of low-dose endotoxemia , a well-established and safe model of host-defense activation , on emotional , cognitive , immunological , and endocrine parameters . METHODS In a double-blind , crossover study , 20 healthy male volunteers completed psychological question naires and neuropsychological tests 1 , 3 , and 9 hours after intravenous injection of Salmonella abortus equi endotoxin ( 0.8 ng/kg ) or saline in 2 experimental sessions . Blood sample s were collected hourly , and rectal temperature and heart rate were monitored continuously . RESULTS Endotoxin had no effects on physical sickness symptoms , blood pressure , or heart rate . Endotoxin caused a mild increase in rectal temperature ( 0.5 degrees C ) , and increased the circulating levels of tumor necrosis factor alpha ( TNF-alpha ) , soluble TNF receptors , interleukin (IL)-6 , IL-1 receptor antagonist , and cortisol . After endotoxin administration , the subjects showed a transient significant increase in the levels of anxiety ( effect size [ ES ] = 0.55 ) and depressed mood ( ES = 0.66 ) . Verbal and nonverbal memory functions were significantly decreased ( ES = 0.55 to 0.64 ) . Significant positive correlations were found between cytokine secretion and endotoxin-induced anxiety ( r = 0.49 to r = 0.60 ) , depressed mood ( r = 0.40 to r = 0.75 ) , and decreases in memory performance ( r = 0.46 to r = 0.68 ) . CONCLUSIONS In humans , a mild stimulation of the primary host defense has negative effects on emotional and memory functions , which are probably caused by cytokine release . Hence , cytokines represent a novel target for neuropsychopharmacological research Increases in peripheral cytokines during acute inflammation may affect various neuropsychological functions . The aim of this functional magnetic resonance imaging ( fMRI ) study was to investigate the effects of acute endotoxemia on mood and the neural response to emotionally aversive visual stimuli in healthy human subjects . In a double-blind , r and omized crossover study , 18 healthy males received a bolus injection of bacterial lipopolysaccharide ( LPS ; 0.4 ng/kg ) or saline . Plasma levels of pro- and anti-inflammatory cytokines and cortisol as well as mood ratings were analyzed together with the blood-oxygen-level dependent ( BOLD ) response during the presentation of aversive versus neutral pictures . Endotoxin administration induced pronounced transient increases in plasma levels of TNF-α , IL-1ra , IL-6 , IL-10 , and cortisol . Positive mood was decreased and state anxiety increased . In addition , activation of right inferior orbitofrontal cortex ( OFC ) in response to emotional visual stimuli was significantly increased in the LPS condition . Increased prefrontal activation during the presentation of emotional material may reflect enhanced cognitive regulation of emotions as an adaptive response during an acute inflammation . These findings may have implication s for the putative role of inflammatory processes in the pathophysiology of depression Significance The periaqueductal gray is a brainstem region that is critical for autonomic regulation and for defensive responses ( e.g. , “ fight , ” “ flight , ” “ freeze ” ) . It has been studied extensively in rodents and cats , but less is known about the human periaqueductal gray . The small size and shape of the periaqueductal gray makes it challenging to study using st and ard noninvasive MRI techniques . We used a high-field strength magnet to examine this region at high resolution while participants viewed emotionally aversive or neutral images . Emotion-related functional activity was concentrated in particular subregions and in ways that are consistent with neurobiological observations in nonhuman animals . This study establishes a technique to uncover the functional architecture of the periaqueductal gray in humans . The midbrain periaqueductal gray ( PAG ) region is organized into distinct subregions that coordinate survival-related responses during threat and stress [ B and ler R , Keay KA , Floyd N , Price J ( 2000 ) Brain Res 53 (1):95–104 ] . To examine PAG function in humans , research ers have relied primarily on functional MRI ( fMRI ) , but technological and method ological limitations have prevented research ers from localizing responses to different PAG subregions . We used high-field strength ( 7-T ) fMRI techniques to image the PAG at high resolution ( 0.75 mm isotropic ) , which was critical for dissociating the PAG from the greater signal variability in the aqueduct . Activation while participants were exposed to emotionally aversive images segregated into subregions of the PAG along both dorsal/ventral and rostral/caudal axes . In the rostral PAG , activity was localized to lateral and dorsomedial subregions . In caudal PAG , activity was localized to the ventrolateral region . This shifting pattern of activity from dorsal to ventral PAG along the rostrocaudal axis mirrors structural and functional neurobiological observations in nonhuman animals . Activity in lateral and ventrolateral subregions also grouped with distinct emotional experiences ( e.g. , anger and sadness ) in a factor analysis , suggesting that each subregion participates in distinct functional circuitry . This study establishes the use of high-field strength fMRI as a promising technique for revealing the functional architecture of the PAG . The techniques developed here also may be extended to investigate the functional roles of other brainstem nuclei Objective To investigate whether plasma interleukin-
Output:
| Meta‐ analysis of 24 neuroimaging studies revealed consistently reported regions .
Some regions were specific to study design and task .
Patterns of regions resembled intrinsic brain networks and corticostriatal loops .
Co‐activated regions formed prefrontal‐brainstem and insula‐brainstem ensembles .
Multilevel kernel density analysis of 24 studies ( 37 statistical maps ; 264 coordinates ; 457 participants ) revealed consistent effects in the amygdala , hippocampus , hypothalamus , striatum , insula , midbrain , and brainstem , as well as prefrontal and temporal cortices .
Effects in some regions were specific to particular study design s and tasks .
Spatial pattern analysis revealed significant overlap of reported effects with limbic , default mode , ventral attention , and corticostriatal networks , and co‐activation analyses revealed functional ensembles encompassing the prefrontal cortex , insula , and midbrain/brainstem . |
MS210309 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objective . Gastroesophageal reflux disease has been reported to be a common burden on health-care re sources in the Western world , but its manifestations in the general population are as yet unclear . The aim of this study was to estimate the prevalence of , and to identify the risk factors for gastroesophageal reflux symptoms ( GERS ) and erosive esophagitis ( EE ) in the adult population of two Swedish municipalities . Material and methods . A r and om sample ( n=3000 ) of the adult population ( 20–81 years of age ) of two Swedish municipalities ( n=21,610 ) was surveyed using a vali date d postal question naire assessing gastrointestinal symptoms . The response rate was 74 % . A sub sample ( n=1000 ) of the responders was subsequently invited , in r and om order , for esophago-gastro-duodenoscopy with evaluation of GERS , risk factors and tests for Helicobacter pylori . Results . GERS were reported by 40.0 % and EE was found in 15.5 % of the population that had undergone endoscopy . Of those with GERS , 24.5 % had EE while 36.8 % of those with EE reported no GERS . Hiatus hernia and obesity remained significant risk factors for GERS and /or EE , with or without symptoms in a main effect model ( OR up to 14 at EE ) . Those with active H. pylori infection had a higher risk of GERS without EE than those without H. pylori infection ( OR=1.71 ( 1.23–2.38 ) ) . Conclusions . GERS and EE ( of which one-third is asymptomatic ) are highly prevalent in the Swedish adult population . H. pylori infection seems to play a role in the manifestations of gastroesophageal reflux BACKGROUND & AIMS Gastroesophageal reflux is considered a common condition , but detailed population -based data on reflux in the United States are lacking . The aim of this study was to determine the prevalence and clinical spectrum of gastroesophageal reflux in Olmsted County , Minnesota . METHODS A reliable and valid self-report question naire was mailed to an age- and sex-stratified r and om sample of 2200 Olmsted County residents aged 25 - 74 years . RESULTS The prevalence per 100 of heartburn and /or acid regurgitation experienced at least weekly was 19.8 ( 95 % confidence interval [ 95 % CI ] , 17.7 - 21.9 ) . Heartburn and acid regurgitation were associated with noncardiac chest pain ( odds ratio [ OR ] , 4.2 ; 95 % CI , 2.9 - 6.0 ) , dysphagia ( OR , 4.7 ; 95 % CI , 2.9 - 7.4 ) , dyspepsia ( OR , 3.1 ; 95 % CI , 1.9 - 5.0 ) , and globus sensation ( OR , 1.9 ; 95 % CI , 1.0 - 3.6 ) but not with asthma , hoarseness , bronchitis , or a history of pneumonia . Among subjects with reflux symptoms , 1.0 % reported an episode of hematemesis and 1.3 % had a past esophageal dilatation . CONCLUSIONS Symptoms of reflux are common among white men and women who are 25 - 74 years of age . Heartburn and acid regurgitation are significantly associated with chest pain , dysphagia , dyspepsia , and globus sensation . The percentage of patients reporting complications is low , but the absolute number is probably considerable given the high prevalence of the condition in the community AIM To clarify the association between physical activity and gastroesophageal reflux disease ( GERD ) in non-obese and obese people . METHODS A Swedish population -based cross-sectional survey was conducted . Participants aged 40 - 79 years were r and omly selected from the Swedish Registry of the Total Population . Data on physical activity , GERD , body mass index ( BMI ) and the covariates age , gender , comorbidity , education , sleeping problems , and tobacco smoking were obtained using vali date d question naires . GERD was self-reported and defined as heartburn or regurgitation at least once weekly , and having at least moderate problems from such symptoms . Frequency of physical activity was categorized into three groups : ( 1 ) " high " ( several times/week ) ; ( 2 ) " intermediate " ( approximately once weekly ) ; and ( 3 ) " low " ( 1 - 3 times/mo or less ) . Analyses were stratified for participants with " normal weight " ( BMI < 25 kg/m² ) , " overweight " ( BMI 25 to ≤ 30 kg/m² ) and " obese " ( BMI > 30 kg/m² ) . Multivariate logistic regression was used to calculate odds ratios ( ORs ) with 95 % confidence intervals ( CIs ) , adjusted for potential confounding by covariates . RESULTS Of 6969 eligible and r and omly selected individuals , 4910 ( 70.5 % ) participated . High frequency of physical activity was reported by 2463 ( 50 % ) participants , GERD was identified in 472 ( 10 % ) participants , and obesity was found in 680 ( 14 % ) . There were 226 ( 5 % ) individuals with missing information about BMI . Normal weight , overweight and obese participants were similar regarding distribution of gender and tobacco smoking status , while obese participants were on average slightly older , had fewer years of education , more comorbidity , slightly more sleeping problems , lower frequency of physical activity , and higher occurrence of GERD . Among the 2146 normal-weight participants , crude point estimates indicated a decreased risk of GERD among individuals with high frequency of physical activity ( OR : 0.59 , 95 % CI : 0.39 - 0.89 ) , compared to low frequency of physical activity . However , after adjustment for potential confounding factors , neither intermediate ( OR : 1.30 , 95 % CI : 0.75 - 2.26 ) nor high ( OR : 0.99 , 95 % CI : 0.62 - 1.60 ) frequency of physical activity was followed by decreased risk of GERD . Sleeping problems and high comorbidity were identified as potential confounders . Among the 1859 overweight participants , crude point estimates indicated no increased or decreased risk of GERD among individuals with intermediate or high frequency of physical activity , compared to low frequency . After adjustment for confounding , neither intermediate ( OR : 0.75 , 95 % CI : 0.46 - 1.22 ) nor high frequency of physical activity were followed by increased or decreased risk of GERD compared to low frequency among nonobese participants . Sleeping problems and high comorbidity were identified as potential confounders for overweight participants . In obese individuals , crude ORs were similar to the adjusted ORs and no particular confounding factors were identified . Intermediate frequency of physical activity was associated with a decreased occurrence of GERD compared to low frequency of physical activity ( adjusted OR : 0.41 , 95 % CI : 0.22 - 0.77 ) . CONCLUSION Intermediate frequency of physical activity might decrease the risk of GERD among obese individuals , while no influence of physical activity on GERD was found in non-obese people Objective : Prostagl and ins regulate gastric motor function . Inhibition of prostagl and ins by nonsteroidal antiinflammatory drugs ( NSAIDs ) may alter gastric emptying . To study gastric emptying of solids and its relation to endoscopic findings and Helicobacter pylori in patients receiving long-term NSAIDs , we undertook this study . Methods : Ninety-five patients with arthritis , 65 taking long-term NSAIDs ( Group I ) and 30 not taking NSAIDs ( Group II ) were studied . Presence of dyspeptic symptoms was determined using a question naire . Mucosal damage was determined by endoscopy . H. pylori was detected by antral biopsies for rapid urease test and histology . Gastric emptying for solids was evaluated using a scintigraphic method . Thirty healthy volunteers were used as controls for gastric emptying ( Group III ) . Patients with peptic ulcer were excluded from the analysis of gastric emptying . Logistic regression analysis was performed to identify predictive factors for gastric emptying . Results : Nineteen patients from Group I with peptic ulcers were excluded . Dyspeptic symptoms were seen in 24 ( 52 % ) Group I and seven ( 23 % ) Group II patients . Gastroduodenal erosions were seen in 10 ( 21.7 % ) Group I patients and four ( 13.3 % ) Group II patients . H. pylori was detected in 17 patients in Group I ( 36.9 % ) and Group II ( 56.6 % ) . Gastric emptying was delayed in 24 ( 52 % ) Group I patients , six ( 20 % ) Group II patients ( p < 0.001 ) , and in none of the Group III controls . The mean gastric emptying times were 99.5 ( 15.6 ) min and 89 ( 17.7 ) min for Groups I and II , respectively ( p < 0.05 ) . Endoscopic damage was found with similar frequency in Group I patients with delayed or normal gastric emptying . H. pylori infection was present in 37.5 % Group I patients with delayed gastric emptying and in 36.3 % with normal gastric emptying ( p= ns ) . Logistic regression analysis identified NSAID therapy as the single factor most predictive of delayed gastric emptying . Conclusion : Delayed gastric emptying was seen in 52 % of patients on long-term NSAID therapy Background : Although the ingestion of chilli has been associated with gastroesophageal reflux ( GER ) symptoms , there are no studies that have explored the effect of a chronic ingestion of different kinds of chilli with a variable content of capsaicin as a cause of GER . Methods : The effect of chilli on esophageal 24-hour pH monitoring was studied in 12 healthy subjects without GER symptoms before and after of ingestion one of two kinds of chilli . Patients were r and omized to ingest 3 g daily of cascabel chilli ( Capsicum annum coraciforme containing 880 ppmof capsaicin ) or ancho chilli ( Capsicum annum grossum containing 488 ppm of capsaicin ) . Results : After chilli ingestion , the Johnson De Meester Index ( JDI ) increased significantly [ basal : 7 ( 1–14 ) , after chilli : 13 ( 2–69 ) , p = 0.0047 ] . When considering both kinds of chilli separately , the JDI varied , although nonsignificantly , with the ancho chilli [ basal : 3 ( 1–8 ) , after chilli : 10 ( 2–69 ) , p = 0.11 ] , and significantly with the cascabel chilli [ basal : 10 ( 5–14 ) , after chilli : 18 ( 2–44 ) , p = 0.028 ] . Conclusion : Our results suggest that the chronic ingestion of chilli induces GER , and that the magnitude of the induced reflux seems to be related to the kind of chilli BACKGROUND Two types of reflux episodes have been identified : upright or daytime and supine or nocturnal . The population -based prevalence of symptoms of nocturnal gastroesophageal reflux disease ( GERD ) and the impact of those symptoms on health-related quality of life ( HRQL ) have not been established . METHODS A national r and om- sample telephone survey was conducted to estimate the prevalence of frequent GERD and nocturnal GERD-like symptoms and to assess the relationship between HRQL , GERD , and nocturnal GERD symptoms . Respondents were classified as controls , subjects with symptomatic nonnocturnal GERD , and subjects with symptomatic nocturnal GERD . The HRQL was assessed using the Medical Outcomes Study Short-Form 36 Health Survey ( SF-36 ) . RESULTS The prevalence of frequent GERD was 14 % , with an overall prevalence of nocturnal GERD of 10 % . Seventy-four percent of those with frequent GERD symptoms reported nocturnal GERD symptoms . Subjects with nonnocturnal GERD had significant decrements on the SF-36 physical and mental component summary scores compared with the US general population . Subjects reporting nocturnal GERD symptoms were significantly more impaired than subjects reporting nonnocturnal GERD symptoms on both the physical component summary ( 38.94 vs 41 . 52 ; P<.001 ) and mental component summary ( 46.78 vs 49.51 ; P<.001 ) and all 8 subscales of the SF-36 ( P<.001 ) . Subjects with nocturnal GERD demonstrated considerable impairment compared with the US general population and chronic disease population s. Subjects with nocturnal GERD had significantly more pain than those with hypertension and diabetes ( P<.001 ) and similar pain compared with those with angina and congestive heart failure . CONCLUSIONS Nocturnal symptoms are commonly experienced by individuals who report frequent GERD symptoms . In addition , HRQL is significantly impaired in those persons who report frequent GERD symptoms , and HRQL impairment is exacerbated in those who report nocturnal GERD symptoms Symptoms suggestive of gastro-oesophageal re
Output:
| Risk factors for GORD were also identified which may allow clinicians to recognise individuals most at risk |
MS210310 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Atezolizumab is a humanised antiprogrammed death-lig and 1 ( PD-L1 ) monoclonal antibody that inhibits PD-L1 and programmed death-1 ( PD-1 ) and PD-L1 and B7 - 1 interactions , reinvigorating anticancer immunity . We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer . METHODS We did a r and omised , open-label , phase 3 trial ( OAK ) in 194 academic or community oncology centres in 31 countries . We enrolled patients who had squamous or non-squamous non-small-cell lung cancer , were 18 years or older , had measurable disease per Response Evaluation Criteria in Solid Tumors , and had an Eastern Cooperative Oncology Group performance status of 0 or 1 . Patients had received one to two previous cytotoxic chemotherapy regimens ( one or more platinum based combination therapies ) for stage IIIB or IV non-small-cell lung cancer . Patients with a history of autoimmune disease and those who had received previous treatments with docetaxel , CD137 agonists , anti-CTLA4 , or therapies targeting the PD-L1 and PD-1 pathway were excluded . Patients were r and omly assigned ( 1:1 ) to intravenously receive either atezolizumab 1200 mg or docetaxel 75 mg/m2 every 3 weeks by permuted block r and omisation ( block size of eight ) via an interactive voice or web response system . Co primary endpoints were overall survival in the intention-to-treat ( ITT ) and PD-L1-expression population TC1/2/3 or IC1/2/3 ( ≥1 % PD-L1 on tumour cells or tumour-infiltrating immune cells ) . The primary efficacy analysis was done in the first 850 of 1225 enrolled patients . This study is registered with Clinical Trials.gov , number NCT02008227 . FINDINGS Between March 11 , 2014 , and April 29 , 2015 , 1225 patients were recruited . In the primary population , 425 patients were r and omly assigned to receive atezolizumab and 425 patients were assigned to receive docetaxel . Overall survival was significantly longer with atezolizumab in the ITT and PD-L1-expression population s. In the ITT population , overall survival was improved with atezolizumab compared with docetaxel ( median overall survival was 13·8 months [ 95 % CI 11·8 - 15·7 ] vs 9·6 months [ 8·6 - 11·2 ] ; hazard ratio [ HR ] 0·73 [ 95 % CI 0·62 - 0·87 ] , p=0·0003 ) . Overall survival in the TC1/2/3 or IC1/2/3 population was improved with atezolizumab ( n=241 ) compared with docetaxel ( n=222 ; median overall survival was 15·7 months [ 95 % CI 12·6 - 18·0 ] with atezolizumab vs 10·3 months [ 8·8 - 12·0 ] with docetaxel ; HR 0·74 [ 95 % CI 0·58 - 0·93 ] ; p=0·0102 ) . Patients in the PD-L1 low or undetectable subgroup ( TC0 and IC0 ) also had improved survival with atezolizumab ( median overall survival 12·6 months vs 8·9 months ; HR 0·75 [ 95 % CI 0·59 - 0·96 ] ) . Overall survival improvement was similar in patients with squamous ( HR 0·73 [ 95 % CI 0·54 - 0·98 ] ; n=112 in the atezolizumab group and n=110 in the docetaxel group ) or non-squamous ( 0·73 [ 0·60 - 0·89 ] ; n=313 and n=315 ) histology . Fewer patients had treatment-related grade 3 or 4 adverse events with atezolizumab ( 90 [ 15 % ] of 609 patients ) versus docetaxel ( 247 [ 43 % ] of 578 patients ) . One treatment-related death from a respiratory tract infection was reported in the docetaxel group . INTERPRETATION To our knowledge , OAK is the first r and omised phase 3 study to report results of a PD-L1-targeted therapy , with atezolizumab treatment result ing in a clinical ly relevant improvement of overall survival versus docetaxel in previously treated non-small-cell lung cancer , regardless of PD-L1 expression or histology , with a favourable safety profile . FUNDING F. Hoffmann-La Roche Ltd , Genentech , Background Kidney and renal pelvis cancers account for 4 % of all new cancer cases in the United States , among which 85 % are renal cell carcinomas ( RCC ) . While cigarette smoking is an established risk factor for RCC , little is known about the contribution of environmental tobacco smoke ( ETS ) to RCC incidence . This study assesses the role of smoking and ETS on RCC incidence using a population -based case-control design in Florida and Georgia . Methods Incident cases ( n = 335 ) were identified from hospital records and the Florida cancer registry , and population controls ( n = 337 ) frequency-matched by age ( + /- 5 years ) , gender , and race were identified through r and om-digit dialing . In-person interviews assessed smoking history and lifetime exposure to ETS at home , work , and public spaces . Home ETS was measured in both years and hours of exposure . Odds ratios and 95 % confidence intervals were calculated using logistic regression , controlled for age , gender , race , and BMI . Results Cases were more likely to have smoked 20 or more pack-years , compared with never-smokers ( OR : 1.35 , 95 % CI : 0.93 – 1.95 ) . A protective effect was found for smoking cessation , beginning with 11–20 years of cessation ( OR : 0.39 , 95 % CI : 0.18–0.85 ) and ending with 51 or more years of cessation ( OR : 0.11 , 95 % CI : 0.03–0.39 ) in comparison with those having quit for 1–10 years . Among never-smokers , cases were more likely to report home ETS exposure of greater than 20 years , compared with those never exposed to home ETS ( OR : 2.18 ; 95 % CI : 1.14–4.18 ) . Home ETS associations were comparable when measured in lifetime hours of exposure , with cases more likely to report 30,000 or more hours of home ETS exposure ( OR : 2.37 ; 95 % CI : 1.20–4.69 ) . Highest quartiles of combined home/work ETS exposure among never-smokers , especially with public ETS exposure , increased RCC risk by 2 to 4 times . Conclusion These findings confirm known associations between smoking and RCC and establish a potential etiologic role for ETS , particularly in the home . Differences in methods of retrospective measurement of lifetime smoking and ETS exposure may contribute to discrepancies in measures of associations across studies , and should be addressed in future research Purpose Nivolumab , a programmed death-1 inhibitor , prolonged overall survival compared with docetaxel in two independent phase III studies in previously treated patients with advanced squamous ( CheckMate 017 ; Clinical Trials.gov identifier : NCT01642004 ) or nonsquamous ( CheckMate 057 ; Clinical Trials.gov identifier : NCT01673867 ) non-small-cell lung cancer ( NSCLC ) . We report up date d results , including a pooled analysis of the two studies . Methods Patients with stage IIIB/IV squamous ( N = 272 ) or nonsquamous ( N = 582 ) NSCLC and disease progression during or after prior platinum-based chemotherapy were r and omly assigned 1:1 to nivolumab ( 3 mg/kg every 2 weeks ) or docetaxel ( 75 mg/m2 every 3 weeks ) . Minimum follow-up for survival was 24.2 months . Results Two-year overall survival rates with nivolumab versus docetaxel were 23 % ( 95 % CI , 16 % to 30 % ) versus 8 % ( 95 % CI , 4 % to 13 % ) in squamous NSCLC and 29 % ( 95 % CI , 24 % to 34 % ) versus 16 % ( 95 % CI , 12 % to 20 % ) in nonsquamous NSCLC ; relative reductions in the risk of death with nivolumab versus docetaxel remained similar to those reported in the primary analyses . Durable responses were observed with nivolumab ; 10 ( 37 % ) of 27 confirmed responders with squamous NSCLC and 19 ( 34 % ) of 56 with nonsquamous NSCLC had ongoing responses after 2 years ' minimum follow-up . No patient in either docetaxel group had an ongoing response . In the pooled analysis , the relative reduction in the risk of death with nivolumab versus docetaxel was 28 % ( hazard ratio , 0.72 ; 95 % CI , 0.62 to 0.84 ) , and rates of treatment-related adverse events were lower with nivolumab than with docetaxel ( any grade , 68 % v 88 % ; grade 3 to 4 , 10 % v 55 % ) . Conclusion Nivolumab provides long-term clinical benefit and a favorable tolerability profile compared with docetaxel in previously treated patients with advanced NSCLC
Output:
| Conclusions Higher PD-L1 expression is more closely associated with poor prognosis and more advanced clinicopathological features in RCC patients than PD-L2 , especially in women and Caucasian patients .
PD-L2 was a weak negative predictor of poor CSS of RCC and was not a prompt for the metastasis of RCC |
MS210311 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The mechanisms of paraneoplastic thrombocytosis in ovarian cancer and the role that platelets play in abetting cancer growth are unclear . METHODS We analyzed clinical data on 619 patients with epithelial ovarian cancer to test associations between platelet counts and disease outcome . Human sample s and mouse models of epithelial ovarian cancer were used to explore the underlying mechanisms of paraneoplastic thrombocytosis . The effects of platelets on tumor growth and angiogenesis were ascertained . RESULTS Thrombocytosis was significantly associated with advanced disease and shortened survival . Plasma levels of thrombopoietin and interleukin-6 were significantly elevated in patients who had thrombocytosis as compared with those who did not . In mouse models , increased hepatic thrombopoietin synthesis in response to tumor-derived interleukin-6 was an underlying mechanism of paraneoplastic thrombocytosis . Tumor-derived interleukin-6 and hepatic thrombopoietin were also linked to thrombocytosis in patients . Silencing thrombopoietin and interleukin-6 abrogated thrombocytosis in tumor-bearing mice . Anti-interleukin-6 antibody treatment significantly reduced platelet counts in tumor-bearing mice and in patients with epithelial ovarian cancer . In addition , neutralizing interleukin-6 significantly enhanced the therapeutic efficacy of paclitaxel in mouse models of epithelial ovarian cancer . The use of an antiplatelet antibody to halve platelet counts in tumor-bearing mice significantly reduced tumor growth and angiogenesis . CONCLUSIONS These findings support the existence of a paracrine circuit wherein increased production of thrombopoietic cytokines in tumor and host tissue leads to paraneoplastic thrombocytosis , which fuels tumor growth . We speculate that countering paraneoplastic thrombocytosis either directly or indirectly by targeting these cytokines may have therapeutic potential . ( Funded by the National Cancer Institute and others . ) PURPOSE This study attempted to determine the prognostic value for survival of various pretreatment characteristics in patients with nonresectable non-small-cell lung cancer in the context of more than 10 years of experience of a European Cooperative Group . PATIENTS AND METHODS We included in the analysis all eligible patients ( N = 1,052 ) with advanced non-small-cell lung cancer registered onto one of seven trials conducted by the European Lung Cancer Working Party ( ELCWP ) during one decade . The patients were treated by chemotherapy regimens based on platinum derivatives . We prospect ively collected 23 variables and analyzed them by univariate and multivariate methods . RESULTS The global estimated median survival time was 29 weeks , with a 95 % confidence interval of 27 to 30 weeks . After univariate analysis , we applied two multivariate statistical techniques . In a Cox regression model , the selected explanatory variables were disease extent , Karnofsky performance status , WBC and neutrophil counts , metastatic involvement of skin , serum calcium level , age , and sex . These results were confirmed by application of recursive partitioning and amalgamation algorithms ( RECPAM ) , which led to classification of the patients into four homogeneous subgroups . CONCLUSION We confirmed by our analysis the role of well-known independent prognostic factors for survival , but also identified the effect of the neutrophil count , rarely studied , with the use of two methods : a classical Cox regression model and a RECPAM analysis . The classification of patients into the four subgroups we obtained needs to be vali date d in other series We have evaluated the prognostic value of 22 pretreatment attributes in 436 small cell lung cancer ( SCLC ) patients included in a prospect i ve multicenter study with a minimum 5-year follow-up . Pretreatment clinical and laboratory parameters were registered . Possible prognostic factors were evaluated by univariate analysis ( log rank test ) and by the Cox multivariate regression model . In the univariate analysis of all patients , only age , nodal metastasis , and skin metastasis were not associated with survival . The multivariate Cox model identified gender , extent of disease , performance status ( PS ) , weight loss , platelet count , LDH , and NSE as independent prognostic factors . In subset multivariate analyses according to extent of disease , we found haemoglobin level , PS , NSE , and total WBC as significant prognostic indicators for survival in limited-stage disease ( LD-SCLC ) , while PS , weight loss , LDH , number of metastases , liver metastases , and brain metastases were identified as independent prognostic factors in extensive-stage disease ( ED-SCLC ) . There was a significant correlation between serum LDH and NSE levels . In conclusion , gender , extent of disease , PS , weight loss , haemoglobin , WBC count , platelet count , LDH , and NSE were all found to be independent prognostic factors for SCLC survival . However , the prognostic value of these factors depends highly on whether all or subsets of SCLC patients are studied There is a sub clinical activation of coagulation and fibrinolysis system in lung cancer . Alterations in hemostatic system are seen frequently in lung cancer correlated with the prognosis of disease . In this prospect i ve study , our purpose was to investigate the prognostic significance of hemostatic markers in patients with lung cancer . The study comprised 58 patients ( 22 squamous cell carcinoma , 16 adenocarcinoma , 20 small cell carcinoma ) . There were 55 men ( 95 % ) and 3 women ( 5 % ) with a mean age of 61 years range ( 36 - 74 ) . Plasma level of platelets ( PLT ) , prothrombin time ( PT ) , active partial thromboplastin time ( aPTT ) , antithrombin III ( AT III ) , fibrinogen ( F ) and D-dimer level were measured before the initiation of any therapy . Patients were followed up for 17 ( 12 - 20 ) months . The median survival was determined as 6.4 months . Three histopathologic groups ; squamous cell carcinoma , adenocarcinoma and small cell carcinoma were compared for the hemostatic parameters . There were no statistically significant differences among the histopathologic types for any of the parameters ( P > 0.05 ) . Patients were divided into two groups as patients without distant metastasis ( stages I , II , III ) and with distant metastasis ( stage IV ) . The group with distant metastasis had higher level of D-dimer than the other group ( P < 0.05 ) . However , there were no statistically significant differences for D-dimer level between stages IIIB and IV ( P > 0.05 ) . Patients having high D-dimer and low AT III level had poor survival in our study . Thus , high level of D-dimer and low AT III level were determined as correlated with short survival ( P < 0.05 ) . These results suggest that elevated plasma level of D-dimer and low AT III level might be a sign of poor prognosis in patients with lung cancer INTRODUCTION FRAME was a prospect i ve observational study that captured real-world data on patients with advanced or metastatic non-small cell lung cancer ( NSCLC ) receiving platinum-based chemotherapies as first-line treatment ( FLT ) across Europe . As previously reported , most patients observed in the study had initiated FLT with either pemetrexed , gemcitabine , vinorelbine or taxanes in combination with a platinum . Baseline patient and disease characteristics including age , performance status , and histology varied ( all p<0.01 ) across cohorts . METHODS Consenting adult patients initiating FLT for advanced or metastatic NSCLC with platinum-based chemotherapy , with or without a targeted agent , entered the study between April 2009 and February 2011 . The choice of FLT was left to physicians ' discretion per routine clinical practice . The primary objective was to evaluate overall survival ( OS ) across platinum-based doublet chemotherapy cohorts and key secondary objectives included the evaluation of OS in patients with different histological subtypes of NSCLC . Survival outcomes were assessed using Kaplan-Meier analysis , and unadjusted estimates are presented . RESULTS Median OS in months was 10.3 across cohorts ( n=1524 ) , 10.7 for pemetrexed ( n=569 ) , 10.0 for gemcitabine ( n=360 ) , 9.1 for taxanes ( n=295 ) , and 10.7 for vinorelbine ( n=300 ) . For patients with non-squamous NSCLC who received cisplatin ( n=616 , 40 % of total ) , median OS in months was 10.6 across the cohorts , 11.6 for pemetrexed , 8.4 for gemcitabine , 9.6 for taxanes , and 9.9 for vinorelbine . CONCLUSIONS FRAME describes real-world treatment patterns and survival for patients initiating FLT for advanced or metastatic NSCLC between 2009 and 2011 across Europe Background : The aim of the present study was to investigate any prognostic value of pre-treatment anemia , leukocytosis and thrombocytosis in patients with advanced pretreated NSCLC . Methods : A r and omized , multicenter phase II study comparing the IGF-1R modulator AXL with st and ard docetaxel in the treatment of previously treated stage IIIB or IV NSCLC patients was conducted in 2011 - 2013 . Clinical and laboratory data were collected , including serum values for hemoglobin ( Hgb ) , white blood cells ( WBC ) and platelets ( Plt ) at baseline . These hematological parameters were studied in relation to overall survival using Kaplan – Meier product-limit estimates and multivariate Cox proportional hazards regression models . Results : The median overall survival for all patients was 8.9 months . Patients with leukocytosis ( WBC > 9 x 109/L ) had a significantly shorter median overall survival ( 4.2 months ) as compared with those with a WBC ≤ 9 x 109/L at baseline ( 12.3 months ) with a corresponding of HR 2.10 ( 95 % CI : 1.29 - 3.43 ) . Patients with anemia ( Hgb < 110 g/L ) had a non-significant ( p = 0.097 ) shorter median overall survival ( 6.1 months ) as compared with their counterparts with Hgb ≥ 110 g/L at baseline ( 9.4 months ) . As for thrombocytosis ( Plt > 350 x 109/L ) , there was no statistically significant impact on overall survival . Leukocytosis retained its prognostic significance in a multivariate model where other clinical factors such as age , sex and WHO performance status were taken into consideration ( HR : 1.83 , 95 % CI : 1.06 - 3.13 , p = 0.029 ) . Conclusion : Pre-treatment leukocytosis is a strong and independent prognostic marker for shorter overall survival in previously treated stage IIIB or IV NSCLC patients receiving docetaxel or AXL1717 . Combined use of pre-treatment leukocytosis assessment s together with established prognostic factors such as performance status could be of help when making treatment decisions in this clinical setting AIMS An elevated plasma D-dimer level indicates the activation of coagulation and fibrinolysis . In the present study , we investigated the association of pre-treatment haemostatic parameters ( D-dimer , fibrinogen and prothrombin fragment 1 + 2 ) with clinicopathological parameters and outcome in patients with lung cancer . MATERIAL S AND METHODS Plasma levels of D-dimer and other parameters were measured in 78 evaluable patients with lung cancer ( 60 non-small cell lung cancers , 18 small cell lung cancers ) . At diagnosis , 35 patients ( 44.9 % ) were locally advanced stage ( IIIA/B ) and 43 patients ( 55.1 % ) had metastatic disease ( IV ) . Multivariate statistical analysis was carried out using Cox 's proportional hazards model . The receiver operating characteristic curve was used to determine the cut-off values for D-dimer , fibrinogen and prothrombin fragment 1 + 2 . RESULTS The median survival for all patients was 264 days ( 95 % confidence interval 200 - 328 days ) . A significant association between the plasma levels of D-dimer and the response to chemotherapy was observed ( P=0.03 ) . With the univariate analysis , tumour stage , pre-treatment plasma levels of D-dimer , fibrinogen , platelet count , lactate dehydrogenase concentration and Karnofsky performance status were predictive for survival . With the multivariate analysis ( P < or = 0.1 ) , the plasma level of D-dimer ( P<0.001 ) , tumour stage ( P=0.01 ) and Karnofsky performance status ( P=0.02 ) were identified as independent predictive factors . The median survival times were 405 days ( 95 % confidence interval 165 - 644 days ) and 207 days ( 95 % confidence interval 146 - 267 days , P<0.001 ) , respectively , for patients with a low D-dimer level ( < or = 0.65 microg/ml ) and a high D-dimer level ( > 0.65 microg/ml ) . CONCLUSIONS Elevated plasma levels of D-dimer in patients with lung cancer are associated with decreased survival and a poor response to treatment . Pre-treatment for the D-dimer level may be useful in the prediction of survival
Output:
| In subgroup analyses , elevated pretreatment platelet counts were also associated with poorer OS and DFS/PFS/TTP in most subgroups .
This meta- analysis revealed that elevated pretreatment platelet counts were an independent predictor of OS and DFS/PFS/TTP in lung cancer patients . |
MS210312 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVES : To study factors affecting the occurrence of exercise induced bronchospasm ( EIB ) in elite runners . METHODS : Fifty eight elite runners , 79 % of them belonging to Finnish national teams , volunteered . The athletes answered a question naire on respiratory symptoms . Skin prick tests were used to investigate atopy , and spirometry to examine lung function at rest and after an exercise challenge test ( ECT ) at subzero temperature in the winter and after a similar ECT in the summer at the end of the birch pollen season . RESULTS : Definitive EIB ( a post-exercise reduction of 10 % or more in forced expiratory volume in one second ( FEV1 ) was observed in five ( 9 % ) of the 58 runners . A subgroup consisting of 19 non-atopic symptom-free runners with no family history of asthma was used to establish a normal range for post-exercise reduction in FEV1 . When this group 's mean exercise induced change in FEV1 minus 2 SDs ( a reduction of 6.5 % or more in FEV1 ) was taken as the lower limit of the reference range , 15 ( 26 % ) of the runners had probable EIB in either the winter or the pollen season . The occurrence of probable EIB depended on atopy ( odds ratio increased with number of positive skin prick test reactions , p < 0.05 ) . Nine ( 22 % ) of the 41 runners , challenged in both the winter and the pollen season , had probable EIB only in the winter , and three ( 7 % ) had it only in the pollen season . Only one runner ( 2 % ) had EIB in both tests . CONCLUSIONS : Mild EIB is common in Finnish elite runners and is strongly associated with atopy . Seasonal variability affects the occurrence of EIB , and thus exercise testing should be performed in both cold winter air and the pollen season to detect EIB in elite runners To determine the effect of two forms of warm-up on postexercise bronchoconstriction in athletes with exercise-induced asthma , 12 moderately trained persons with asthma ( age = 26.5 + /- 2.2 yr ; height = 169.2 + /- 2.6 cm ; weight = 64.3 + /- 2.6 kg ; VO2max = 52.7 + /- 1.3 ml.kg-1.min-1 ) were tested under three experimental conditions ; continuous warm-up ( CW ) , interval warm-up ( IW ) , and control ( C ) . CW consisted of 15 min of treadmill running at a velocity corresponding to 60 % VO2max followed by an exercise challenge test ( ET = 6 min at 90 % VO2max ) . IW involved 8 x 30-s runs ( 1.5 min rest between bouts of exercise ) , at an intensity equivalent to 100 % VO2max , followed by an ET . C consisted of only the ET . FEV1 , FVC , and MMEFR were measured prior to the experimental conditions , repeated before the ET , and every 2 min during a 25-min passive recovery period , using a Breon spirometer . Postexercise changes in pulmonary function were recorded as the largest decrese in FEV1 , FVC , and MMEFR during the recovery period , and expressed as a percentage of baseline values . Significant differences were detected in % FEV1 ( 34 . 6,16.7,29.7 : P = 0.009 ) , % FVC ( 30.0,10.7,21.0 : P = 0.03 ) , and % MMEFR ( 50.0,30.2,43.4 : P = 0.05 ) , in comparing C , CW , and IW , respectively . Scheffe 's test detected significance ( P < 0.05 ) between C and CW for all three dependent variables ; no statistical significance between C and IW or IW and CW occurred . These data indicate that a continuous warm-up of 15 min at 60 % VO2max can significantly decrease postexercise bronchoconstriction in moderately trained athletes The effect of a prolonged warm-up period of exercise on subjects with exercise-induced asthma ( EIA ) has been studied . Seven asthmatic subjects with known EIA were exercised according to two different protocol s on two separate days , which were r and omized . On Day A , subjects performed a st and ard 6-min treadmill run ( S1A ) , which increased heart rate to 98 % predicted maximum , followed 45 min later by an identical run ( S2A ) . Refractoriness was demonstrated on the second exercise test , with a mean maximal fall in FEV1 of 29 + /- 3.1 % and a PEFR of 32 + /- 2.8 % after S2A , compared with a mean maximal fall in FEV1 of 46 + /- 2.6 % and a PEFR of 51 + /- 4.0 % after S1A . On Day B , subjects performed a 30-min treadmill run at a lower gradient ( W1B ) , followed 21 min later by another st and ard 6-min treadmill test ( S2B ) . W1B was followed by significantly less EIA ( mean maximal fall in FEV1 of 17 + /- 5.4 % and a PEFR of 21 + /- 6.3 % ) than followed S1A . Nevertheless , when subjects subsequently performed a st and ard 6-min run ( S2B ) , significant refractoriness to bronchoconstriction , comparable to that observed after S2A , developed , with a mean maximal fall in FEV1 of 26 + /- 3.6 % and a PEFR of 27 + /- 2.3 % ( p less than 0.05 ) . We conclude that a warm-up period of exercise can induce refractoriness to EIA without itself inducing marked bronchoconstriction There are two apparently conflicting theories on the pathogenesis of exercise-induced asthma . One view is that exercise-induced asthma is directly related to respiratory heat exchange and that mast cells are not involved . The other theory explains exercise-induced asthma on the basis of a temperature-independent release of mast-cell mediators . A theory is put forward here that airway cooling in asthmatic subjects during exercise leads directly to mast-cell degranulation and that this explains the association between exercise , respiratory heat exchange , and mediator release
Output:
| CONCLUSIONS The most consistent and effective attenuation of EIB was observed with high-intensity interval and variable intensity preexercise warm-ups .
These findings indicate that an appropriate warm-up strategy that includes at least some high-intensity exercise may be a short-term nonpharmacological strategy to reducing EIB |
MS210313 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery , and triclosan-coated sutures were developed to reduce their occurrence . The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure , compared with non-coated PDS II sutures , in the prevention of surgical site infections . METHODS This multicentre , r and omised controlled group-sequential superiority trial was done in 24 German hospitals . Adult patients ( aged ≥18 years ) who underwent elective midline abdominal laparotomy for any reason were eligible for inclusion . Exclusion criteria were impaired mental state , language problems , and participation in another intervention trial that interfered with the intervention or outcome of this trial . A central web-based r and omisation tool was used to r and omly assign eligible participants by permuted block r and omisation with a 1:1 allocation ratio and block size 4 before mass closure to either triclosan-coated sutures ( PDS Plus ) or uncoated sutures ( PDS II ) for abdominal fascia closure . The primary endpoint was the occurrence of superficial or deep surgical site infection according to the Centers for Disease Control and Prevention criteria within 30 days after the operation . Patients , surgeons , and the outcome assessors were masked to group assignment . Interim and final analyses were by modified intention to treat . This trial is registered with the German Clinical Trials Register , number DRKS00000390 . FINDINGS Between April 7 , 2010 , and Oct 19 , 2012 , 1224 patients were r and omly assigned to intervention groups ( 607 to PDS Plus , and 617 to PDS II ) , of whom 1185 ( 587 PDS Plus and 598 PDS II ) were analysed by intention to treat . The study groups were well balanced in terms of patient and procedure characteristics . The occurrence of surgical site infections did not differ between the PDS Plus group ( 87 [ 14·8 % ] of 587 ) and the PDS II group ( 96 [ 16·1 % ] of 598 ; OR 0·91 , 95 % CI 0·66 - 1·25 ; p=0·64 ) . Serious adverse events also did not differ between the groups-146 of 583 ( 25·0 % ) patients treated with PDS Plus had at least one serious adverse event , compared with 138 of 602 ( 22·9 % ) patients treated with PDS II ; p=0·39 ) . INTERPRETATION Triclosan-coated PDS Plus did not reduce the occurrence of surgical site infection after elective midline laparotomy . Innovative , multifactorial strategies need to be developed and assessed in future trials to reduce surgical site infections . FUNDING Johnson & Johnson Medical Limited OBJECTIVES The incidence of surgical site infection ( SSI ) after open vein harvesting in coronary artery bypass grafting ( CABG ) patients ranges in different studies between 2 and 20 % . Triclosan is an antibacterial substance that reduces the growth of bacteria by inhibiting fatty acid synthesis . We hypothesized that wound closure with triclosan-coated sutures would reduce SSI after open vein harvesting . METHODS An investigator-initiated prospect i ve r and omized double-blind single-centre study was performed with 374 patients , r and omized to subcutaneous and intracutaneous leg-wound closure with either triclosan-coated sutures ( Vicryl Plus ® and Monocryl Plus ® , Ethicon , Somerville , NJ , USA ) ( n = 184 ) or identical sutures without triclosan ( n = 190 ) from the same manufacturer . All patients were followed up after 30 days ( clinical visit ) and 60 days ( telephone interview ) . Primary endpoint was SSI within 60 days after surgery according to the definition of Center for Disease Control . Predefined secondary endpoints included culture-proven and antibiotic-treated SSI . RESULTS The primary endpoint occurred in 23 patients ( 12.5 % ) with triclosan-coated sutures and in 38 patients ( 20.0 % ) in the group without triclosan ( P = 0.0497 , risk ratio 0.63 , ( 95 % confidence interval 0.39–1.00 ) . Corresponding figures for culture-proven infections were 7.6 vs 12.1 % , ( P = 0.15 ) , and for antibiotic-treated infections , 10.9 vs 18.4 % , ( P = 0.039 ) . Staphylococcus aureus and coagulase-negative staphylococci were the most common pathogens in both groups . Insulin-treated diabetes and vein-harvesting time were associated with SSI after vein harvesting . CONCLUSIONS Leg-wound closure with triclosan-coated sutures in CABG patients reduces SSIs after open vein harvesting . ( Clinical Trials.gov number NCT01212315 ) OBJECT Implantation of cerebrospinal fluid ( CSF ) shunting devices is associated with a 5 - 15 % risk of infection as cited in contemporary pediatric neurosurgical literature . Shunt infections typically require complete removal of the device and prolonged antibiotic treatment followed by shunt replacement . Moreover , shunt infections are commonly associated with prolonged hospital stays , potential comorbidity , and the increased risk of neurological compromise due to ventriculitis or surgical complications . The authors prospect ively evaluated the incidence of CSF shunt infection following shunt procedures performed using either antimicrobial suture ( AMS ) or conventional suture . METHODS In a single-center , prospect i ve , double-blinded , r and omized controlled trial , the authors enrolled 61 patients , among whom 84 CSF shunt procedures were performed over 21 months . R and omization to the study ( AMS ) or control ( placebo ) group was stratified to minimize the effect of known shunt infection risk factors on the findings . Antibacterial shunt components were not used . The primary outcome measure was the incidence of shunt infection within 6 months of surgery . RESULTS The shunt infection rate in the study group was 2 ( 4.3 % ) of 46 procedures and 8 ( 21 % ) of 38 procedures in the control group ( p = 0.038 ) . There were no statistically significant differences in shunt infection risk factors between the groups ( procedure type and time , age < 6 months , weight < 4 kg , recent history of shunt infection ) . No suture-related adverse events were reported in either group . CONCLUSIONS These results support the suggestion that the use of AMS for CSF shunt surgery wound closure is safe , effective , and may be associated with a reduced risk of postoperative shunt infection . A larger r and omized controlled trial is needed to confirm this association BACKGROUND Surgical site infection ( SSI ) is the fourth commonest healthcare-associated infection and complicates at least 5 % of open operations . In a r and omized clinical trial , antimicrobial-coated sutures were compared with their conventional counterparts , polyglactin and poliglecaprone , for skin closure after breast cancer surgery to assess their role in reducing the rate of SSI . METHODS Between November 2008 and February 2011 , 150 female patients presenting with breast cancer to a single center were r and omized to skin closure with antimicrobial-coated or plain sutures . Postoperatively , SSI was defined using the U.S. Centers for Disease Control and Prevention ( CDC ) definitions and scored using the ASEPSIS or Southampton systems by trained , blinded observers with close post-discharge surveillance and patient diaries . Surgeons and patients were blinded to the type of suture used . RESULTS Using CDC criteria , the overall rate of SSI was 18.9 % at six weeks . Six patients ( 4.7 % ) needed intervention or readmission for SSI . Skin closure with antimicrobial sutures showed a non-statistically significant reduction in the SSI rate , to 15.2 % , compared with conventional sutures ( 22.9 % ) . A uniform tendency for fewer SSIs in the antimicrobial-coated suture group was found using ASEPSIS and Southampton scores , but again , the difference was not statistically significant . CONCLUSION The previously reported high rate of SSI related to breast surgery was confirmed . Using statistical modeling and earlier reports , the study was powered to show a difference using ASEPSIS scores , but the modification used in this trial failed to find a difference . Finding a statistically significant difference would have needed two to three times the number of patients recruited . Further evaluation of antimicrobial-coated sutures is merited , particularly if used as part of a care bundle to reduce SSI after breast cancer surgery Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND The primary objective of this multicenter post-market study was to compare the cosmetic outcome of triclosan-coated VICRYL Plus sutures with Chinese silk sutures for skin closure of modified radical mastectomy . A secondary objective was to assess the incidence of surgical site infection ( SSI ) . METHODS Patients undergoing modified radical mastectomy were r and omly assigned to coated VICRYL Plus antibacterial ( Polyglactin 910 ) suture or Chinese silk suture . Cosmetic outcomes were evaluated postoperatively at days 12 ( ± 2 ) and 30 ( ± 5 ) , and the evidence of SSI was assessed at days 3 , 5 , 7 , 12 ( ± 2 ) , 30 ( ± 5 ) , and 90 ( ± 7 ) . Cosmetic outcomes were independently assessed via visual analogue scale ( VAS ) score evaluations of blinded incision photographs ( primary endpoint ) and surgeon-assessed modified Holl and er Scale ( mHCS ) scores ( secondary endpoint ) . SSI assessment s used both CDC criteria and ASEPSIS scores . RESULTS Six Chinese hospitals r and omized 101 women undergoing modified radical mastectomy to closure with coated VICRYL Plus suture ( n = 51 ) or Chinese silk suture ( n = 50 ) . Mean VAS cosmetic outcome scores for antibacterial suture ( 67.2 ) were better than for Chinese silk ( 45.4 ) at day 30 ( P < 0.0001 ) ) . Mean mHCS cosmetic outcome total scores , were also higher for antibacterial suture ( 5.7 ) than for Chinese silk ( 5.0 ) at day 30 ( P = 0.002 ) . CONCLUSIONS Patients using coated VICRYL Plus suture had significantly better cosmetic outcomes than those with Chinese silk sutures . Patients using coated VICRYL Plus suture had a lower SSI incidence compared to the Chinese silk sutures , although the difference did not reach statistical significance OBJECTIVE To evaluate the efficacy and safety of new antibacterial suture ( Vicryl Plus ) compared with a traditional braided suture ( Vicryl ) in a clinical study . The primary goal was to study effectiveness on reduced surgical site infection in an appendectomy operation . The authors ' secondary goal was to analyze the safety and physical properties of Vicryl plus . MATERIAL AND METHOD This was a prospect i ve , r and omized , controlled , double blind , comparative , single-center study . After appendectomy was done , the patients were r and omized in two groups : Vicryl Plus and Vicryl to selected suture for suturing the abdominal sheath . The surgical site infection was evaluated for 30 days , 6 months , and 1 year . The surgeons and attending doctor were blind to the type of suture . This is the primary report of the first 100 patients . RESULTS There was no difference in demographic and preoperative clinical in both groups . Although there was no statistical difference in the surgical site infection of Vicryl and Vicryl Plus ( 8 and 10 % , p = 0.05 ) , one case of deep surgical site infection was detected in the Vicryl group . No complications and no difference in related suture material s were detected . CONCLUSION Coated polyglactin 910 with tricosan ( Vicryl Plus ) is safe and satisfactory in surgical practice . Surgical site infection of appendectomy seemed too to be comparable between coated polyglactin 910 with tricosan ( Vicryl Plus ) and traditional polyglactin 910 ( Vicryl ) group BACKGROUND Surgical wound infection is a common complication , which increases the hospital stay and costs after surgery for head and neck cancer . In this study , we evaluated the effect of Triclosan-coated sutures on surgical wounds and analyzed the risk factors for wound infections in head and neck cancer surgery . PATIENTS AND METHODS From January 2007 to December 2009 , 253 consecutive patients underwent wide excision of a head or neck cancer and reconstructive procedures . All patient data were collected prospect ively . Of these , 241 patients were included in this study , divided into two groups . The Triclosan group contained 112 patients , whose surgical wounds were closed with Triclosan-coated sutures ( Vicryl Plus ) . The control group included the remaining 129 patients
Output:
| The effect of antimicrobial coating was similar between different suture , wound , and procedure types .
Triclosan-coated sutures may reduce SSI risk . |
MS210314 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The unique dosimetric features of proton radiotherapy make it an attractive modality for normal tissue sparing . We present our initial experience with protons for three-dimensional , conformal , external-beam accelerated partial breast irradiation ( 3D-CPBI ) . METHODS AND MATERIAL S From March 2004 to June 2005 , 25 patients with tumors < or = 2 cm and negative axillary nodes were treated with proton 3D-CPBI . The prescribed dose was 32 Cobalt Gray Equivalents ( CGE ) in 4 CGE fractions given twice daily . One to three fields were used to provide adequate planning target volume ( PTV ) coverage and dose homogeneity . RESULTS Excellent PTV coverage and dose homogeneity were obtained in all patients with one to three proton beams . The median PTV receiving 95 % of the prescribed dose was 100 % . Dose inhomogeneity exceeded 10 % in only 1 patient ( 4 % ) . The median volume of nontarget breast tissue receiving 50 % of the prescribed dose was 23 % . Median volumes of ipsilateral lung receiving 20 CGE , 10 CGE , and 5 CGE were 0 % , 1 % , and 2 % , respectively . The contralateral lung and heart received essentially no radiation dose . Cost analysis suggests that proton 3D-CPBI is only modestly more expensive ( 25 % ) than traditional whole-breast irradiation ( WBI ) . CONCLUSION Proton 3D-CPBI is technically feasible , providing both excellent PTV coverage and normal tissue sparing . It markedly reduces the volume of nontarget breast tissue irradiated compared with photon-based 3D-CPBI , addressing a principle disadvantage of external-beam approaches to PBI . As proton therapy becomes more widely available , it may prove an attractive tool for 3D-CPBI BACKGROUND Radiotherapy can impair Health Related Quality of Life ( HRQoL ) in survivors of childhood brain tumors , but proton radiotherapy ( PRT ) may mitigate this effect . This study compares HRQoL in PRT and photon ( XRT ) pediatric brain tumor survivors . METHODS HRQoL data were prospect ively collected on PRT-treated patients aged 2 - 18 treated at Massachusetts General Hospital ( MGH ) . Cross-sectional PedsQL data from XRT treated Lucile Packard Children 's Hospital ( LPCH ) patients provided the comparison data . RESULTS Parent proxy HRQoL scores were reported at 3 years for the PRT cohort ( PRT-C ) and 2.9 years ( median ) for the XRT cohort ( XRT-C ) . The total core HRQoL score for the PRT-C , XRT-C , and normative population differed from one another and was 75.9 , 65.4 and 80.9 respectively ( p=0.002 ; p=0.024 ; p<0.001 ) . The PRT-C scored 10.3 and 10.5 points higher than the XRT-C in the physical ( PhSD ) and psychosocial ( PsSD ) summary domains of the total core score ( TCS , p=0.015 ; p=0.001 ) . The PRT-C showed no difference in PhSD compared with the normative population , but scored 6.1 points less in the PsSD ( p=0.003 ) . Compared to healthy controls , the XRT-C scored lower in all domains ( p<0.001 ) . CONCLUSIONS The HRQoL of pediatric brain tumor survivors treated with PRT compare favorably to those treated with XRT and similar to healthy controls in the PhSD OBJECTIVE To evaluate late ( more than 5 years ) radiation failures after uveal melanoma treatment . DESIGN Comparison of three retrospective , interventional , partially r and omized case series . PARTICIPANTS Nine hundred ninety-six patients who were treated in several phase I , II , and III trials of uveal melanoma radiation . MAIN OUTCOME MEASURES Follow-up period , treatment history , recurrence rates , type of recurrence , and mortality associated with late local recurrences . RESULTS Eleven of 996 irradiated uveal melanoma patients experienced intraocular recurrence more than 5 years after radiation . All 11 of these patients were treated with iodine 125 ( (125)I ) brachytherapy . Late recurrences were detected between 5.5 to 15.3 years after treatment . These patients did not have either high-risk clinical parameters ( thin , posterior tumors in proximity to the optic nerve ) or radiation dosimetry characteristics ( low dose-delivery radiation ) associated with a known increased risk for tumor recurrence after radioactive plaques . The annualized incidence rate for regrowth was 1.9 % per year between 5 and 15 years after (125)I brachytherapy . In contrast to charged particles , the risk of late recurrence after (125)I brachytherapy continued with increased follow-up . CONCLUSIONS There was a significantly higher late recurrence rate with (125)I brachytherapy as compared with charged particle radiation . Although tumor enlargement 5 or more years after radiation can be the result of intratumor hemorrhage , in a patient treated with radioactive plaque , a late failure is a distinct possibility PURPOSE Relevant clinical data are needed given the increasing national interest in charged particle radiation therapy ( CPT ) programs . Here we report long-term outcomes from the only r and omized , stratified trial comparing CPT with iodine-125 plaque therapy for choroidal and ciliary body melanoma . METHODS AND MATERIAL S From 1985 to 1991 , 184 patients met eligibility criteria and were r and omized to receive particle ( 86 patients ) or plaque therapy ( 98 patients ) . Patients were stratified by tumor diameter , thickness , distance to disc/fovea , anterior extension , and visual acuity . Tumors close to the optic disc were included . Local tumor control , as well as eye preservation , metastases due to melanoma , and survival were evaluated . RESULTS Median follow-up times for particle and plaque arm patients were 14.6 years and 12.3 years , respectively ( P=.22 ) , and for those alive at last follow-up , 18.5 and 16.5 years , respectively ( P=.81 ) . Local control ( LC ) for particle versus plaque treatment was 100 % versus 84 % at 5 years , and 98 % versus 79 % at 12 years , respectively ( log rank : P=.0006 ) . If patients with tumors close to the disc ( < 2 mm ) were excluded , CPT still result ed in significantly improved LC : 100 % versus 90 % at 5 years and 98 % versus 86 % at 12 years , respectively ( log rank : P=.048 ) . Enucleation rate was lower after CPT : 11 % versus 22 % at 5 years and 17 % versus 37 % at 12 years , respectively ( log rank : P=.01 ) . Using Cox regression model , likelihood ratio test , treatment was the most important predictor of LC ( P=.0002 ) and eye preservation ( P=.01 ) . CPT was a significant predictor of prolonged disease-free survival ( log rank : P=.001 ) . CONCLUSIONS Particle therapy result ed in significantly improved local control , eye preservation , and disease-free survival as confirmed by long-term outcomes from the only r and omized study available to date comparing radiation modalities in choroidal and ciliary body melanoma BACKGROUND We aim ed to compare overall survival after st and ard-dose versus high-dose conformal radiotherapy with concurrent chemotherapy and the addition of cetuximab to concurrent chemoradiation for patients with inoperable stage III non-small-cell lung cancer . METHODS In this open-label r and omised , two-by-two factorial phase 3 study in 185 institutions in the USA and Canada , we enrolled patients ( aged ≥ 18 years ) with unresectable stage III non-small-cell lung cancer , a Zubrod performance status of 0 - 1 , adequate pulmonary function , and no evidence of supraclavicular or contralateral hilar adenopathy . We r and omly assigned ( 1:1:1:1 ) patients to receive either 60 Gy ( st and ard dose ) , 74 Gy ( high dose ) , 60 Gy plus cetuximab , or 74 Gy plus cetuximab . All patients also received concurrent chemotherapy with 45 mg/m(2 ) paclitaxel and carboplatin once a week ( AUC 2 ) ; 2 weeks after chemoradiation , two cycles of consolidation chemotherapy separated by 3 weeks were given consisting of paclitaxel ( 200 mg/m(2 ) ) and carboplatin ( AUC 6 ) . R and omisation was done with permuted block r and omisation methods , stratified by radiotherapy technique , Zubrod performance status , use of PET during staging , and histology ; treatment group assignments were not masked . Radiation dose was prescribed to the planning target volume and was given in 2 Gy daily fractions with either intensity-modulated radiation therapy or three-dimensional conformal radiation therapy . The use of four-dimensional CT and image-guided radiation therapy were encouraged but not necessary . For patients assigned to receive cetuximab , 400 mg/m(2 ) cetuximab was given on day 1 followed by weekly doses of 250 mg/m(2 ) , and was continued through consolidation therapy . The primary endpoint was overall survival . All analyses were done by modified intention-to-treat . The study is registered with Clinical Trials.gov , number NCT00533949 . FINDINGS Between Nov 27 , 2007 , and Nov 22 , 2011 , 166 patients were r and omly assigned to receive st and ard-dose chemoradiotherapy , 121 to high-dose chemoradiotherapy , 147 to st and ard-dose chemoradiotherapy and cetuximab , and 110 to high-dose chemoradiotherapy and cetuximab . Median follow-up for the radiotherapy comparison was 22.9 months ( IQR 27.5 - 33.3 ) . Median overall survival was 28.7 months ( 95 % CI 24.1 - 36.9 ) for patients who received st and ard-dose radiotherapy and 20.3 months ( 17.7 - 25.0 ) for those who received high-dose radiotherapy ( hazard ratio [ HR ] 1.38 , 95 % CI 1.09 - 1.76 ; p=0.004 ) . Median follow-up for the cetuximab comparison was 21.3 months ( IQR 23.5 - 29.8 ) . Median overall survival in patients who received cetuximab was 25.0 months ( 95 % CI 20.2 - 30.5 ) compared with 24.0 months ( 19.8 - 28.6 ) in those who did not ( HR 1.07 , 95 % CI 0.84 - 1.35 ; p=0.29 ) . Both the radiation-dose and cetuximab results crossed protocol -specified futility boundaries . We recorded no statistical differences in grade 3 or worse toxic effects between radiotherapy groups . By contrast , the use of cetuximab was associated with a higher rate of grade 3 or worse toxic effects ( 205 [ 86 % ] of 237 vs 160 [ 70 % ] of 228 patients ; p<0.0001 ) . There were more treatment-related deaths in the high-dose chemoradiotherapy and cetuximab groups ( radiotherapy comparison : eight vs three patients ; cetuximab comparison : ten vs five patients ) . There were no differences in severe pulmonary events between treatment groups . Severe oesophagitis was more common in patients who received high-dose chemoradiotherapy than in those who received st and ard-dose treatment ( 43 [ 21 % ] of 207 patients vs 16 [ 7 % ] of 217 patients ; p<0.0001 ) . INTERPRETATION 74 Gy radiation given in 2 Gy fractions with concurrent chemotherapy was not better than 60 Gy plus concurrent chemotherapy for patients with stage III non-small-cell lung cancer , and might be potentially harmful . Addition of cetuximab to concurrent chemoradiation and consolidation treatment provided no benefit in overall survival for these patients . FUNDING National Cancer Institute and Bristol-Myers Squibb COMMENTARY Recently , mature data were published from the MA.20 and European Organization for the Research and Treatment of Cancer ( EORTC ) 22922 trials , providing clinicians with increasing data supporting the value of regional nodal irradiation ( RNI ) . The MA.20 r and omized 1832 women with highrisk node-negative ( T3 , T2 with < 10 nodes removed and grade 3/estrogen receptor-negative/lymphovascular space invasion ) or node-positive disease to receive whole breast irradiation with or without RNI ( axillary apex , internal mammary , supraclavicular ) with > 80 % of patients having 1 to 3 nodes positive . Ten-year outcomes demonstrated an improvement in disease-free survival ( 82 % vs. 77 % ) with reductions in distant metastases and locoregional recurrences with the addition of RNI with modest increases in pneumonitis ( 1.2 % vs. 0.2 % ) and lymphedema
Output:
| RESULTS The cost-effectiveness for prostate cancer-the single most common diagnosis currently treated with PBT-was suboptimal .
PBT was the most cost-effective option for several pediatric brain tumors .
PBT costs for breast cancer were increased but were favorable for appropriately selected patients with left-sided cancers at high risk of cardiac toxicity and compared with brachytherapy for accelerated partial breast irradiation .
For non-small cell lung cancer ( NSCLC ) , the greatest cost-effectiveness benefits using PBT were observed for locoregionally advanced-but not early stage-tumors .
PBT offered superior cost-effectiveness in selected head/neck cancer patients at higher risk of acute mucosal toxicities .
Similar cost-effectiveness was observed for PBT , enucleation , and plaque brachytherapy in patients with uveal melanoma .
With greatly limited amounts of data , PBT offers promising cost-effectiveness for pediatric brain tumors , well-selected breast cancers , locoregionally advanced NSCLC , and high-risk head/neck cancers .
Heretofore , it has not been demonstrated that PBT is cost-effective for prostate cancer or early stage NSCLC . |
MS210315 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE : Low-level laser therapy ( LLLT ) has been promoted for its beneficial effects on tissue healing and pain relief . However , according to the results of in vivo studies , the effectiveness of this modality varies . Our purpose was to assess the putative effects of LLLT on healing using an experimental wound model . DESIGN AND SETTING : We used a r and omized , triple-blind , placebo-controlled design with 2 within-subjects factors ( wound and time ) and 1 between-subjects factor ( group ) . Data were collected in the laboratory setting . SUBJECTS : Twenty-two healthy subjects ( age = 21 + /- 1 years , height = 175.6 + /- 9.8 cm , mass = 76.2 + /- 14.2 kg ) . MEASUREMENTS : Two st and ardized 1.27-cm(2 ) abrasions were induced on the anterior forearm . After wound cleaning , st and ardized digital photos were recorded . Each subject then received LLLT ( 8 J/cm(2 ) ; treatment time = 2 minutes , 5 seconds ; pulse rate = 700 Hz ) to 1 of the 2 r and omly chosen wounds from either a laser or a sham 46-diode cluster head . Subjects reported back to the laboratory on days 2 to 10 to be photographed and receive LLLT and on day 20 to be photographed . Data were analyzed for wound contraction ( area ) , color changes ( chromatic red ) , and luminance . RESULTS : A group x wound x time interaction was detected for area measurements . At days 6 , 8 , and 10 , follow-up testing revealed that the laser group had smaller wounds than the sham group for both the treated and the untreated wounds ( P < .05 ) . No group x wound x time differences were detected for chromatic red or luminance . CONCLUSIONS : The LLLT result ed in enhanced healing as measured by wound contraction . The untreated wounds in subjects treated with LLLT contracted more than the wounds in the sham group , so LLLT may produce an indirect healing effect on surrounding tissues . These data indicate that LLLT is an effective modality to facilitate wound contraction of partial-thickness wounds The split-mouth design is a popular design in oral health research . In the most common split-mouth study , each of two treatments are r and omly assigned to either the right or left halves of the dentition . The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect . However , already about 20 years ago the pitfalls of the design have been reported in the oral health literature . Yet , many clinicians are not aware of the potential problems with the split-mouth design . Further , it is our experience that most statisticians are not even aware of the existence of this design . Since most of the critical remarks appeared in the oral health literature , we argue that it is necessary to introduce the split-mouth design to a statistical audience , so that both clinicians and statisticians clearly underst and the advantages , limitations , statistical considerations , and implication s of its use in clinical trials and advise them on its use in practice OBJECTIVE The aim of this study was to investigate the effect of low-level laser therapy ( LLLT ) on reducing post-adjustment orthodontic pain via evaluation of gingival crevicular fluid ( GCF ) composition changes at the level of prostagl and in-E(2 ) ( PGE(2 ) ) and visual analogue scale ( VAS ) . BACKGROUND DATA LLLT has been found to be effective in pain relief . PGE(2 ) has the greatest impact on the process of pain signals and can be detected in GCF in order to investigate the response of dental and periodontal tissues in a biochemical manner . MATERIAL S AND METHODS Nineteen patients ( 11 females and 8 males ; mean age 13.9 years ) were included in this study . Maxillary first molars were b and ed and then a r and omly selected first molar at one side was irradiated ( λ820 nm ; continuous wave ; output power : 50 mW ; focal spot : 0.0314 cm(2 ) ; exposure duration : 5 sec ; power density : 1.59 W/cm(2 ) ; energy dose : 0.25 J ; energy density : 7.96 J/cm(2 ) for each shot ) , while the molar at the other side was served as placebo control . The GCF was collected from the gingival crevice of each molar to evaluate PGE(2 ) levels , before b and placement , 1 and 24 h after laser irradiation . Pain intensity was analyzed at 5 min , 1 h , and 24 h after b and placement by using VAS . RESULTS Although no difference was found in pain perception at 5 min and 1 h , significant reduction was observed with laser treatment 24 h after application ( p<0.05 ) . The mean PGE(2 ) levels were significantly elevated in control group , whereas a gradual decrease occurred in laser group . The difference in PGE(2 ) levels at both 1 and 24 h were statistically significant between two groups ( p<0.05 ) . CONCLUSIONS The significant reductions in both pain intensity and PGE(2 ) levels revealed that LLLT was efficient in reducing orthodontic post-adjustment pain INTRODUCTION Pain control during orthodontics is an important aspect of patient compliance . The aim of this prospect i ve , r and omized , double-blind clinical trial was to compare the pain control effectiveness of acetaminophen ( 650 mg ) with ibuprofen ( 400 mg ) taken 1 hour before separator placement in adolescents . METHODS The patients recorded their discomfort on a 100-mm visual analog scale during several activities ( teeth not touching , chewing , and fitting back teeth together ) and by selecting words adapted from the McGill Pain Question naire at 5 time intervals : immediately before separator placement , immediately after separator placement , 2 to 3 hours later , at bedtime , and on awakening the next morning . The patients ( n = 33 ) were r and omly assigned to the ibuprofen group or the acetaminophen group . A repeated- measures ANOVA was performed as a function of time and treatment group . RESULTS Pain increased immediately after separator placement , lessened , and then increased to a peak the next morning . The most commonly selected words to describe pain were " annoying , " " sore , " and " tight . " There was no significant difference in pain at any time after separator placement regardless of the medication taken . CONCLUSIONS Acetaminophen and ibuprofen produced no significant differences in pain after separator placement patients undergoing any form of dental treatment , to the extent that 77 % of a patient population reported some degree of pain from a visit to the dentist.1 Pain following orthodontic adjustments appears to be equally prevalent.2 - 10 Jones and Chan showed that compliance with orthodontic treatment may be predicated on the amount of initial pain and discomfort experienced.5 Other studies indicate that plaque control may suffer as a result of the pain associated with orthodontics.7,11 Although analgesics have been found to reduce such discomfort , in most cases they do not totally eliminate it.12 - 15 Moreover , some patients may be allergic to these agents , and one report suggested that nonsteroidal anti-inflammatory drugs may adversely affect the rate of tooth movement.14 Patients who do not respond to or elect not to use pharmacological therapy have had few practical alternatives . Some orthodontists recommend chewing on gum or a plastic wafer immediately after adjustments.16 Proffit suggested that lower force levels could reduce pain,17 but Lim and colleagues showed that pain or discomfort was still experienced by most patients even when “ physiologic and light forces ” were used.18 Recently , there have been major developments in the underst and ing of pain mechanisms and of new approaches to the management of pain.19 Low-level laser therapy has been shown to produce analgesic effects in many clinical applications , including orthodontics.18 Transcutaneous electrical nerve stimulation ( TENS ) is another non-pharmacological , non-invasive method of reducing post-orthodontic adjustment pain.20,21 Vibratory stimulation , a classic noninvasive and non-medicinal method of reducing pain , could also be effective in orthodontic patients .21 - 26 The orthodontic application of this method was first investigated by Dr. Powers on a patient with a history of painful post-adjustment episodes during closure of a wide maxillary midline diastema with elastic chain . After placing a new elastic chain , Dr. Powers observed that gentle vibration of the maxillary central incisors produced two effects : the blanching of the tissue between and above the incisors was quickly reversed , and the previous level of pain did not occur OBJECTIVE To analyze the effect of low-level laser therapy ( LLLT ) on perception of pain after separator placement and compare it with perceptions of control and placebo groups using a frequent irradiation protocol . MATERIAL S AND METHODS Eighty-eight patients were r and omly allocated to a laser group , a light-emitting diode ( LED ) placebo group , or a control group . Elastomeric separators were placed on the first molars . In the laser and LED groups , first molars were irradiated for 30 seconds every 12 hours for 1 week using a portable device . Pain was marked on a visual analog scale at predetermined intervals . Repeated measure analysis of variance was performed for statistical analysis . RESULTS The pain scores of the laser group were significantly lower than those of the control group up to 1 day . The pain scores in the LED group were not significantly different from those of the laser group during the first 6 hours . After that point , the pain scores of the LED group were not significantly different from those of the control . CONCLUSIONS Frequent LLLT decreased the perception of pain to a nonsignificant level throughout the week after separator placement , compared with pain perception in the placebo and control groups . Therefore , LLLT might be an effective method of reducing orthodontic pain INTRODUCTION The purpose of this study was to clinical ly evaluate the effect of low-level laser therapy ( LLLT ) as a method of reducing pain reported by patients after placement of their first orthodontic archwires . METHODS The sample comprised 60 orthodontic patients ( ages , 12 - 18 years ; mean , 15.9 years ) . All patients had fixed orthodontic appliances placed in 1 dental arch ( maxillary or m and ibular ) , received the first archwire , and were then r and omly assigned to the experimental ( laser ) , placebo , or control group . This was a double-blind study . LLLT was started in the experimental group immediately after placement of the first archwire . Each tooth received a dose of 2.5 J per square centimeter on each side ( buccal and lingual ) . The placebo group had the laser probe positioned into the mouth at the same areas overlying the dental root and could hear a sound every 10 seconds . The control group had no laser intervention . All patients received a survey to be filled out at home describing their pain during the next 7 days . RESULTS The patients in the LLLT group had lower mean scores for oral pain and intensity of pain on the most painful day . Also , their pain ended sooner . LLLT did not affect the start of pain perception or alter the most painful day . There was no significant difference in pain symptomatology in the maxillary or m and ibular arches in an evaluated parameter . CONCLUSIONS Based on these findings , we concluded that LLLT efficiently controls pain caused by the first archwire OBJECTIVE To test the hypothesis that there is no difference in the pain associated with orthodontic force application after the application of local CO(2 ) laser irradiation to the teeth involved . MATERIAL S AND METHODS Separation modules were placed at the distal contacts of the maxillary first molars in 90 patients in this single-blinded study . In 60 of these patients ( 42 females and 18 males ; mean age = 19.22 years ) this was immediately followed by laser therapy . The other 30 patients ( 18 females and 12 males ; mean age = 18.8 years ) did not receive active laser irradiation . Patients were then instructed to rate their levels of pain on a visual analog scale over time , and the amount of tooth movement was analyzed . RESULTS Significant pain reductions were observed with laser treatment from immediately after insertion of separators through day 4 , but no differences from the nonirradiated control side were noted thereafter . No significant difference was noted in the amount of tooth movement between the irradiated and nonirradiated group . CONCLUSIONS The hypothesis was rejected . The results suggest that local CO(2 ) laser irradiation will reduce pain associated with orthodontic force application without interfering with the tooth movement The aim of this study was to evaluate the efficacy of diode superpulsed low-level laser therapy ( SLLLT ) in reducing experimentally induced orthodontic pain . Overall , 120 subjects ( 23.01 ± 1.39 years ) were enrolled for a clinical trial . Subjects were r and omly assigned to upper ( U , N = 60 ) or lower ( L , N = 60 ) jaw groups . All subjects received 4 elastomeric separators mesial and distal to the upper ( U group ) or lower ( L group ) right first molar and bicuspids . Each subject of the U and L groups was r and omly assigned to laser ( Ul , N = 20 and Ll , N = 20 ) , placebo ( Up , N = 20 and Lp , N = 20 ) or control ( Uc , N = 20 and Lc , N = 20 ) sub-groups . Subjects in laser groups received a single GaAs diode SLLLT application ( 910 nm , 160 mW , beam diameter of 8 mm , applied for 340 s ) immediately after placing orthodontic separators . Placebo groups received a simulated SLLLT and controls did not receive any ther
Output:
| It was concluded that the use of diode LLLT for orthodontic pain appears promising .
However , due to method ological weaknesses , there was insufficient evidence to support or refute LLLT ’s effectiveness . |
MS210316 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Angiogenesis plays a role in the biology of ovarian cancer . We examined the effect of bevacizumab , the vascular endothelial growth factor inhibitor , on survival in women with this disease . METHODS We r and omly assigned women with ovarian cancer to carboplatin ( area under the curve , 5 or 6 ) and paclitaxel ( 175 mg per square meter of body-surface area ) , given every 3 weeks for 6 cycles , or to this regimen plus bevacizumab ( 7.5 mg per kilogram of body weight ) , given concurrently every 3 weeks for 5 or 6 cycles and continued for 12 additional cycles or until progression of disease . Outcome measures included progression-free survival , first analyzed per protocol and then up date d , and interim overall survival . RESULTS A total of 1528 women from 11 countries were r and omly assigned to one of the two treatment regimens . Their median age was 57 years ; 90 % had epithelial ovarian cancer , 69 % had a serous histologic type , 9 % had high-risk early-stage disease , 30 % were at high risk for progression , and 70 % had stage IIIC or IV ovarian cancer . Progression-free survival ( restricted mean ) at 36 months was 20.3 months with st and ard therapy , as compared with 21.8 months with st and ard therapy plus bevacizumab ( hazard ratio for progression or death with bevacizumab added , 0.81 ; 95 % confidence interval , 0.70 to 0.94 ; P=0.004 by the log-rank test ) . Nonproportional hazards were detected ( i.e. , the treatment effect was not consistent over time on the hazard function scale ) ( P<0.001 ) , with a maximum effect at 12 months , coinciding with the end of planned bevacizumab treatment and diminishing by 24 months . Bevacizumab was associated with more toxic effects ( most often hypertension of grade 2 or higher ) ( 18 % , vs. 2 % with chemotherapy alone ) . In the up date d analyses , progression-free survival ( restricted mean ) at 42 months was 22.4 months without bevacizumab versus 24.1 months with bevacizumab ( P=0.04 by log-rank test ) ; in patients at high risk for progression , the benefit was greater with bevacizumab than without it , with progression-free survival ( restricted mean ) at 42 months of 14.5 months with st and ard therapy alone and 18.1 months with bevacizumab added , with respective median overall survival of 28.8 and 36.6 months . CONCLUSIONS Bevacizumab improved progression-free survival in women with ovarian cancer . The benefits with respect to both progression-free and overall survival were greater among those at high risk for disease progression . ( Funded by Roche and others ; ICON7 Controlled-Trials.com number , IS RCT N91273375 . ) BACKGROUND Targeting of VEGF is a potential therapeutic option in patients with malignant ovarian ascites . We present the final results of a multicentre study of the efficacy and safety of aflibercept , a potent inhibitor of both VEGF and placental growth factor , in the treatment of malignant ascites . METHODS In this double-blind , placebo-controlled , parallel-group , phase 2 study , patients with advanced chemoresistant ovarian cancer and recurrent symptomatic malignant ascites were r and omly assigned ( 1:1 ) via an interactive voice response system to either intravenous aflibercept ( 4 mg/kg every 2 weeks ) or placebo , stratified by interval of time ( ≤ 2 weeks vs > 2 weeks ) between the two most recent paracenteses before r and omisation . Patients participated in the double-blind period ( during which patients , investigators , and sponsor personnel were masked to treatment assignment ) until they had a repeat paracentesis and for at least 60 days , and could also participate in an optional open-label period during which all patients received aflibercept . The primary efficacy endpoint was time to repeat paracentesis based on response during the double-blind period alone , and was analysed in the intention-to-treat population with censoring of patients who did not have a repeat paracentesis as of the last day of the double-blind period . Safety analyses included both double-blind and open-label periods . This study is registered at Clinical Trials.gov , number NCT00327444 . FINDINGS 55 patients with a median of four ( range two to 11 ) previous lines of chemotherapy were r and omly assigned to receive placebo ( n=26 ) or aflibercept ( n=29 ) . Mean time to repeat paracentesis was significantly longer with aflibercept than with placebo ( 55·1 [ SE 7·3 ] vs 23·3 [ 7·7 ] days ; difference 31·8 days , 95 % CI 10·6 - 53·1 ; p=0·0019 ) . In the aflibercept group , two patients did not need a repeat paracentesis during 6 months of double-blind treatment . The most common grade 3 or 4 treatment-emergent adverse events were dyspnoea ( six [ 20 % ] aflibercept vs two [ 8 % ] placebo ) , fatigue or asthenia ( four [ 13 % ] vs 11 [ 44 % ] ) , and dehydration ( three [ 10 % ] vs three [ 12 % ] ) . The frequency of fatal gastrointestinal events was higher with aflibercept ( three intestinal perforations ) than with placebo ( one intestinal fistula leading to sepsis ) . INTERPRETATION This study shows the effectiveness of VEGF blockade in the reduction of malignant ascites , but confirms the significant clinical risk of fatal bowel perforation in this population of patients with very advanced cancer . VEGF blockade should be used with caution in advanced ovarian cancer with abdominal carcinomatosis , and the benefit-risk balance should be thoroughly discussed for each patient . FUNDING Sanofi Oncology PURPOSE This r and omized , multicenter , blinded , placebo-controlled phase III trial tested the efficacy and safety of bevacizumab ( BV ) with gemcitabine and carboplatin ( GC ) compared with GC in platinum-sensitive recurrent ovarian , primary peritoneal , or fallopian tube cancer ( ROC ) . PATIENTS AND METHODS Patients with platinum-sensitive ROC ( recurrence ≥ 6 months after front-line platinum-based therapy ) and measurable disease were r and omly assigned to GC plus either BV or placebo ( PL ) for six to 10 cycles . BV or PL , respectively , was then continued until disease progression . The primary end point was progression-free survival ( PFS ) by RECIST ; secondary end points were objective response rate , duration of response ( DOR ) , overall survival , and safety . RESULTS Overall , 484 patients were r and omly assigned . PFS for the BV arm was superior to that for the PL arm ( hazard ratio [ HR ] , 0.484 ; 95 % CI , 0.388 to 0.605 ; log-rank P < .0001 ) ; median PFS was 12.4 v 8.4 months , respectively . The objective response rate ( 78.5 % v 57.4 % ; P < .0001 ) and DOR ( 10.4 v 7.4 months ; HR , 0.534 ; 95 % CI , 0.408 to 0.698 ) were significantly improved with the addition of BV . No new safety concerns were noted . Grade 3 or higher hypertension ( 17.4 % v < 1 % ) and proteinuria ( 8.5 % v < 1 % ) occurred more frequently in the BV arm . The rates of neutropenia and febrile neutropenia were similar in both arms . Two patients in the BV arm experienced GI perforation after study treatment discontinuation . CONCLUSION GC plus BV followed by BV until progression result ed in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC PURPOSE Inhibiting angiogenesis is one of the most promising avenues for new therapies for ovarian cancer . We investigated the efficacy and safety of a novel agent , BIBF 1120 , a triple angiokinase inhibitor , after chemotherapy for relapsed disease . PATIENTS AND METHODS We conducted a r and omized , double-blind , controlled phase II trial in 83 patients who had just completed chemotherapy for relapsed ovarian cancer , with evidence of response , but at high risk of further early recurrence . The patients were r and omly assigned to receive maintenance therapy using BIBF 1120 250 mg or placebo , twice per day , continuously for 36 weeks . End points were progression-free survival ( PFS ) , toxicity , and overall survival . RESULTS Thirty-six-week PFS rates were 16.3 % and 5.0 % in the BIBF 1120 and placebo groups , respectively ( hazard ratio , 0.65 ; 95 % CI , 0.42 to 1.02 ; P = .06 ) . Four patients continued on BIBF 1120 , including two patients for another year or more . The proportion of patients with any grade 3 or 4 adverse events was similar between the groups ( 34.9 % for BIBF 1120 v 27.5 % for placebo ; P = .49 ; mostly grade 3 ) . However , more patients on BIBF 1120 experienced diarrhea , nausea , or vomiting ( mainly grade 1 or 2 and no grade 4 ) . There was a higher rate of grade 3 or 4 hepatotoxicity in patients on BIBF 1120 ( 51.2 % ) compared with patients on placebo ( 7.5 % ; P < .001 ) , but this was rarely of clinical significance , and patients continued with the trial treatment . A single-level dose reduction to 150 mg was made in 15 patients , all on active drug . CONCLUSION BIBF 1120 is well tolerated and associated with a potential improvement in PFS . The observed treatment effect is sufficient to justify further study within a large phase III trial Purpose : This phase II trial evaluated bevacizumab plus erlotinib in platinum-resistant ovarian cancer ; exploratory biomarker analyses , including that of tumor vascular endothelial growth factor A ( VEGF-A ) , were also done . Experimental Design : Forty heavily pretreated patients received erlotinib ( 150 mg/d orally ) and bevacizumab ( 10 mg/kg i.v . ) every 2 weeks until disease progression . Primary end points were objective response rate and response duration ; secondary end points included progression-free survival ( PFS ) , toxicity , and correlations between angiogenic protein levels , toxicity , and efficacy . Results : Grade 3 toxicities included skin rash ( n = 6 ) , diarrhea ( n = 5 ) , fatigue ( n = 4 ) , and hypertension ( n = 3 ) . Grade 4 toxicities were myocardial infa rct ion ( n = 1 ) and nasal septal perforation ( n = 1 ) . Only one grade 3 fistula and one grade 2 bowel perforation were observed . Nine ( 23.1 % ) of 39 evaluable patients had a response ( median duration , 36.1 + weeks ; one complete response ) , and 10 ( 25.6 % ) patients achieved stable disease , for a disease control rate of 49 % . Median PFS was 4 months , and 6-month PFS was 30.8 % . Biomarker analyses identified an association between tumor cell VEGF-A expression and progression ( P = 0.03 ) ; for every 100-unit increase in the VEGF-A score , there was a 3.7-fold increase in the odds of progression ( 95 % confidence interval , 1.1 - 16.6 ) . Conclusions : Bevacizumab plus erlotinib in heavily pretreated ovarian cancer patients was clinical ly active and well tolerated . Erlotinib did not seem to contribute to efficacy . Our study raises the intriguing possibility that high levels of tumor cell VEGF-A , capable of both autocrine and paracrine interactions , are associated with resistance to bevacizumab , emphasizing the complexity of the tumor microenvironment . Clin Cancer Res ; 16(21 ) ; 5320–8 . © 2010 AACR BACKGROUND Recurrent platinum-resistant ovarian cancer usually has a poor outcome with conventional chemotherapeutic therapy and new treatment modalities are warranted . This phase II study was conducted to evaluate sunitinib , an oral antiangiogenic multitargeted tyrosin kinase inhibitor , in this setting . MATERIAL AND METHODS The primary end point of this r and omized phase II trial was the objective response rate according to RECIST criteria and /or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies . A selection design was employed to compare two schedules of sunitinib ( arm 1 : 50 mg sunitinib daily orally for 28 days followed by 14 days off drug ; and arm 2 : 37.5 mg
Output:
| The type and frequency of bevacizumab-related adverse events was as expected in these studies based on published data .
Promising efficacy data have been published for a number of emerging anti-angiogenic agents in phase III development for advanced ovarian cancer . |
MS210317 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Obstructive airways disease in older patients is reported to be not only common , but frequently overlooked and untreated by general practitioners . This study examines the value of screening elderly patients in a large semi-rural general practice for potentially treatable asthma and chronic obstructive pulmonary disease ( COPD ) . METHODS A r and om sample of 353 patients aged 60–75 years attended a nurse run screening clinic for pulmonary function testing , serial peak flow recording , and completion of a symptom question naire . Patients with a low forced expiratory volume in one second ( below the fifth centile of their predicted value ) or > 15 % mean diurnal variation in peak flow were referred to a doctor ’s clinic for further diagnostic assessment and /or to discuss possible treatment where appropriate . RESULTS Fifty eight patients ( 16.4 % ) had obstructive airways disease , the prevalence of asthma being 6.5 % and that of COPD 9.9 % . Of these , 30 had no previous diagnosis of airways disease and were not on treatment ; eight of them had significant airways reversibility and 10 were current smokers . No newly diagnosed patients had severe disease as measured by pulmonary function or quality of life assessment , and six patients accepted treatment . CONCLUSION Few older patients benefited from a screening programme for obstructive airways disease in a semi-rural general practice OBJECTIVES The prevalence of COPD in Greece is unknown . The aim of this study was to determine the prevalence and trends of COPD among adults in Greece . METHODS This study involved 888 r and omly identified adults ( 475 men and 413 women ) aged > 35 years , and smokers of at least 100 cigarettes , in a population -based , multiregional , cross-sectional descriptive design . The selected individuals reflected the urban/rural population distribution in Greece and , within each study region , the age group and gender of the community setting . The diagnosis of COPD was based on clinical and spirometric data including reversibility test ( DeltaFEV(1 ) < 15 % ) . RESULTS The overall prevalence of COPD in the population aged > 35 years with a smoking history of > 100 cigarettes per lifetime was 8.4 % . The gender-st and ardized COPD prevalence was 11.6 % for men and 4.8 % for women . The COPD prevalence by community setting was as follows : Athens , 6 % ; other urban areas , 10.1 % ; semiurban areas , 8.5 % ; and rural areas , 9.1 % . Smoking intensity and age were significantly associated with higher COPD prevalence in both men and women . CONCLUSIONS COPD is a substantial health problem in Greece , although prevalence rates are lower than expected when the high smoking rates are taken into account . The high proportion of the patients with mild COPD who were unaware of their illness highlights the need to increase public awareness of COPD BACKGROUND Previous studies showing that tiotropium improves multiple end points in patients with chronic obstructive pulmonary disease ( COPD ) led us to examine the long-term effects of tiotropium therapy . METHODS In this r and omized , double-blind trial , we compared 4 years of therapy with either tiotropium or placebo in patients with COPD who were permitted to use all respiratory medications except inhaled anticholinergic drugs . The patients were at least 40 years of age , with a forced expiratory volume in 1 second ( FEV(1 ) ) of 70 % or less after bronchodilation and a ratio of FEV(1 ) to forced vital capacity ( FVC ) of 70 % or less . Co primary end points were the rate of decline in the mean FEV(1 ) before and after bronchodilation beginning on day 30 . Secondary end points included measures of FVC , changes in response on St. George 's Respiratory Question naire ( SGRQ ) , exacerbations of COPD , and mortality . RESULTS Of a total of 5993 patients ( mean age , 65+/-8 years ) with a mean FEV(1 ) of 1.32+/-0.44 liters after bronchodilation ( 48 % of predicted value ) , we r and omly assigned 2987 to the tiotropium group and 3006 to the placebo group . Mean absolute improvements in FEV(1 ) in the tiotropium group were maintained throughout the trial ( ranging from 87 to 103 ml before bronchodilation and from 47 to 65 ml after bronchodilation ) , as compared with the placebo group ( P<0.001 ) . After day 30 , the differences between the two groups in the rate of decline in the mean FEV(1 ) before and after bronchodilation were not significant . The mean absolute total score on the SGRQ was improved ( lower ) in the tiotropium group , as compared with the placebo group , at each time point throughout the 4-year period ( ranging from 2.3 to 3.3 units , P<0.001 ) . At 4 years and 30 days , tiotropium was associated with a reduction in the risks of exacerbations , related hospitalizations , and respiratory failure . CONCLUSIONS In patients with COPD , therapy with tiotropium was associated with improvements in lung function , quality of life , and exacerbations during a 4-year period but did not significantly reduce the rate of decline in FEV(1 ) . ( Clinical Trials.gov number , NCT00144339 . Background The clinical effects of mucolytics in patients with chronic obstructive pulmonary disease ( COPD ) are discussed controversially . Cineole is the main constituent of eucalyptus oil and mainly used in inflammatory airway diseases as a mucolytic agent . We hypothesised that its known mucolytic , bronchodilating and anti-inflammatory effects as concomitant therapy would reduce the exacerbation rate and show benefits on pulmonary function tests as well as quality of life in patients with COPD . Methods In this double-blind , placebo-controlled multi-center- study we r and omly assigned 242 patients with stable COPD to receive 200 mg of cineole or placebo 3 times daily as concomitant therapy for 6 months during winter-time . The frequency , duration and severity of exacerbations were combined as primary outcome measures for testing as multiple criteria . Secondary outcome measures included changes of lung function , respiratory symptoms and quality of life as well as the single parameters of the exacerbations . Results Baseline demographics , lung function and st and ard medication of both groups were comparable . During the treatment period of 6 months the multiple criteria frequency , severity and duration of exacerbations were significantly lower in the group treated with cineole in comparison to placebo . Secondary outcome measures vali date d these findings . Improvement of lung function , dyspnea and quality of life as multiple criteria were statistically significant relative to placebo . Adverse events were comparable in both groups . Conclusion Concomitant therapy with cineole reduces exacerbations as well as dyspnea and improves lung function and health status . This study further suggests cineole as an active controller of airway inflammation in COPD by intervening in the pathophysiology of airway inflammation of the mucus membrane . Trial registration IS RCT The present work aims to assess the international variation in the prevalence of chronic bronchitis and its main risk factor , smoking habits , in young adults of 35 centres from 16 countries . Respiratory symptoms and pulmonary function were assessed in 17,966 subjects ( 20 - 44 yrs ) , r and omly selected from the general population , in the frame of the European Community Respiratory Health Survey . The median prevalence of chronic bronchitis was 2.6 % , with wide variations across countries ( p<0.001 ; 0.7 - 9.7 % ) . The prevalence of current smokers ranged 20.1 - 56.9 % , ( p<0.001 ) with a median value of 40 % . Current smoking was the major risk factor for chronic bronchitis , especially in males . Its effect increased according to number of pack-yrs : in males , the odds ratio of chronic bronchitis was 3.51 ( 95 % confidence interval ( CI ) 2.31 - 5.32 ) in 1 - 14 pack-yrs smokers and increased to 17.32 ( 9.97 - 30.11 ) in > or = 45 pack-yrs smokers with respect to nonsmokers . Only 30 % of the geographical variability in prevalence could be explained by differences in smoking habits , suggesting that other environmental and /or genetic factors may play an important role . In conclusion , chronic bronchitis is a substantial health problem even in young adults . The impressive prevalence in current smokers in most countries highlights the need to improve the quality of prevention RATIONALE Exacerbations are key drivers of morbidity and mortality in chronic obstructive pulmonary disease ( COPD ) . OBJECTIVES We compared the relative efficacy of the long-acting inhaled bronchodilator/antiinflammatory combination ( salmeterol/fluticasone propionate ) 50/500 microg twice daily and the long-acting bronchodilator ( tiotropium ) 18 microg once daily in preventing exacerbations and related outcomes in severe and very severe COPD . METHODS A total of 1,323 patients ( mean age , 64 yr , post-bronchodilator FEV1 , 39 % predicted ) were r and omized in this 2-year , double-blind , double-dummy parallel study . MEASUREMENTS AND MAIN RESULTS Primary endpoint was health care utilization exacerbation rate . Other endpoints included health status measured by St. George 's Respiratory Question naire ( SGRQ ) , mortality , adverse events , and study withdrawal . Probability of withdrawing from the study was 29 % greater with tiotropium than salmeterol/fluticasone propionate ( P = 0.005 ) . The modeled annual exacerbation rate was 1.28 in the salmeterol/fluticasone propionate group and 1.32 in the tiotropium group ( rate ratio , 0.967 ; 95 % confidence interval [ CI ] , 0.836 - 1.119 ] ; P = 0.656 ) . The SGRQ total score was statistically significantly lower at 2 years on salmeterol/fluticasone propionate versus tiotropium ( difference 2.1 units ; 95 % CI , 0.1 - 4.0 ; P = 0.038 ) . Mortality was significantly lower in the salmeterol/fluticasone propionate group ; 21 ( 3 % ) of patients in this group died compared with 38 ( 6 % ) in the tiotropium group ( P = 0.032 ) . More pneumonias were reported in the salmeterol/fluticasone propionate group relative to tiotropium ( P = 0.008 ) . CONCLUSIONS We found no difference in exacerbation rate between salmeterol/fluticasone propionate and tiotropium . More patients failed to complete the study while receiving tiotropium . A small statistically significant beneficial effect was found on health status , with an unexpected finding of lower deaths in salmeterol/fluticasone propionate-treated patients . Clinical trial registered with www . clinical trials.gov ( NCT 00361959 ) BACKGROUND Patients with chronic obstructive pulmonary disease ( COPD ) often present with severe acute exacerbations requiring hospital treatment . However , little is known about the prognostic consequences of these exacerbations . A study was undertaken to investigate whether severe acute exacerbations of COPD exert a direct effect on mortality . METHODS Multivariate techniques were used to analyse the prognostic influence of acute exacerbations of COPD treated in hospital ( visits to the emergency service and admissions ) , patient age , smoking , body mass index , co-morbidity , long term oxygen therapy , forced spirometric parameters , and arterial blood gas tensions in a prospect i ve cohort of 304 men with COPD followed up for 5 years . The mean ( SD ) age of the patients was 71 ( 9 ) years and forced expiratory volume in 1 second was 46 (17)% . RESULTS Only older age ( hazard ratio ( HR ) 5.28 , 95 % CI 1.75 to 15.93 ) , arterial carbon dioxide tension ( HR 1.07 , 95 % CI 1.02 to 1.12 ) , and acute exacerbations of COPD were found to be independent indicators of a poor prognosis . The patients with the greatest mortality risk were those with three or more acute COPD exacerbations ( HR 4.13 , 95 % CI 1.80 to 9.41 ) . CONCLUSIONS This study shows for the first time that severe acute exacerbations of COPD have an independent negative impact on patient prognosis . Mortality increases with the frequency of severe exacerbations , particularly if these require admission to hospital This r and omised , double-blind , parallel-group , 1-yr study compared the effect of tiotropium 18 microg once daily ( n=500 ) and placebo ( n=510 ) on exacerbations , associated health re source use ( HRU ) and airflow limitation in chronic obstructive pulmonary disease ( COPD ) patients . The mean+/-sd number of exacerbations during the past year was 2.14+/-1.40 , the mean weekly morning peak expiratory flow ( PEF ) was 259.6+/-96.1 L.min-1 and the mean forced expir
Output:
| The methods used to estimate these epidemiological parameters were highly variable in terms of the definition of COPD , severity scales , methods of investigation and target population s. Nevertheless , to a large extent , several recent international guidelines or research initiatives , such as GOLD , BOLD or PLATINO , have boosted a substantial st and ardization of methodology in data collection and have result ed in the availability of more comparable epidemiological estimates across countries .
On the basis of such st and ardization , severity estimates as well as prevalence estimates present much less variation across countries .
Conclusions The accuracy of COPD epidemiological parameters is important for guiding decision making with regard to preventive measures , interventions and patient management in various health care systems . |
MS210318 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The presence of renal noninflammatory necrotizing vasculopathy ( NNV ) is often associated with a severe form of lupus nephritis ( LN ) , which is unresponsive to st and ard therapy . We conducted a 6-month r and omized , prospect i ve , open-label trial comparing mycophenolate mofetil ( MMF ) ( 1.5—2.0 g/day ) with monthly i.v . cyclophosphamide ( CTX ) ( 0.75—1.0 g/m2 ) as induction therapy for class IV LN with NNV . The primary and second end points were complete remission ( CR ) and partial remission ( PR ) , respectively . Of 20 patients recruited , nine were r and omly assigned to MMF and 11 to CTX . The baseline characteristics between groups were not significant . CR was achieved in four patients ( 44.4 % ) receiving MMF and in none of the patients receiving CTX ( P = 0.026 ) . PR was achieved in two patients ( 22.2 % ) in the MMF group and three patients ( 27.2 % ) in the CTX group . The total remission rate ( CR + PR ) in the MMF and CTX group was 66.6 and 27.2 % , respectively ( P = 0.17 ) . MMF was more effective than i.v . CTX in reducing proteinuria and haematuria . Adverse events were significantly less frequent with MMF than with CTX ( P = 0.028 ) . MMF was superior to i.v . CTX in inducing CR of LN with NNV and had a more favourable safety profile . Lupus ( 2007 ) 16 , 707—712 Class V lupus nephritis ( LN ) occurs in one-fifth of biopsy-proven cases of systemic lupus erythematosus . To study the effectiveness of treatments in this group of patients , we pooled analysis of two large r and omized controlled multicenter trials of patients with diverse ethnic and racial background who had pure class V disease . These patients received mycophenolate mofetil ( MMF ) or intravenous cyclophosphamide ( IVC ) as induction therapy for 24 weeks , with percentage change in proteinuria and serum creatinine as end points . Weighted mean differences , pooled odds ratios , and confidence intervals were calculated by using a r and om-effects model . A total of 84 patients with class V disease were divided into equal groups , each group had comparable entry variables but one received MMF and one received IVC . Within these groups , 33 patients on MMF and 32 patients on IVC completed 24 weeks of treatment . There were no differences between the groups in mean values for the measured end points . Similarly , no difference was found regarding the number of patients who did not complete the study or who died . In patients with nephrotic syndrome , no difference was noted between those treated with MMF and IVC regarding partial remission or change in urine protein . Hence we found that the response to MMF as induction treatment of patients with class V LN appears to be no different from that to IVC BACKGROUND Although mycophenolate mofetil ( MMF ) is being increasingly used to manage lupus nephritis ( LN ) , long-term experience is limited . Despite treatment , a significant proportion of patients will be refractory to this regime . METHODS We report , in this observational study , our long-term experience treating 70 patients with biopsy-proven LN , with MMF as continuous induction-maintenance therapy , who were followed up prospect ively over a 5-year period . As rescue therapy for MMF-resistant cases , tacrolimus ( 0.075 mg/kg/day ) was added . The study primary end point was complete response ( CR ) . Secondary end points included partial response ( PR ) , treatment failure , relapse and side effects . Predictor factors associated to renal outcome were analysed by Cox regression analysis . RESULTS Thirty-six MMF-treated patients ( 51 % ) remained in CR , and 23 ( 33 % ) failed treatment at last follow-up . Time to treatment failure was associated with persistent hypoalbuminaemia ( hazard ratio ( HR ) = 0.87 ; 95%CI , 0.81 - 0.95 ; P = 0.001 ) , higher proteinuria ( HR = 1.29 ; 95%CI , 1.03 - 1.62 ; P = 0.030 ) and fewer early responses ( HR 0.28 ; 95%CI , 0.10 - 0.77 ; P = 0.014 ) . Renal relapse occurred in 24 ( 34 % ) patients . Time to flare was associated with persistent anti-dsDNA titres ( HR = 1.001 ; 95%CI , 1.001 - 1.003 ; P = 0.005 ) and younger age at inclusion ( HR = 0.36 ; 95%CI , 0.14 - 0.90 ; P = 0.029 ) . Tacrolimus was added to 17 ( 24 % ) patients . A significant reduction of proteinuria was already observed at 3 months ( P = 0.002 ) . After 2 years follow-up , 12 ( 70 % ) of them achieved clinical response ( six CR and six PR ) . Conclusions . MMF is an effective treatment for LN . Combination therapy with tacrolimus is an effective and safe alternative for MMF-resistant patients Background Current method ological guidelines provide advice about the assessment of sub-group analysis within RCTs , but do not specify explicit criteria for assessment . Our objective was to provide research ers with a set of criteria that will facilitate the grading of evidence for moderators , in systematic review s. Method We developed a set of criteria from method ological manuscripts ( n = 18 ) using snowballing technique , and electronic data base search es . Criteria were review ed by an international Delphi panel ( n = 21 ) , comprising authors who have published method ological papers in this area , and research ers who have been active in the study of sub-group analysis in RCTs . We used the Research ANd Development/University of California Los Angeles appropriateness method to assess consensus on the quantitative data . Free responses were coded for consensus and disagreement . In a subsequent round additional criteria were extracted from the Cochrane Review ers ' H and book , and the process was repeated . Results The recommendations are that meta-analysts report both confirmatory and exploratory findings for sub-groups analysis . Confirmatory findings must only come from studies in which a specific theory/ evidence based a-priori statement is made . Exploratory findings may be used to inform future/subsequent trials . However , for inclusion in the meta- analysis of moderators , the following additional criteria should be applied to each study : Baseline factors should be measured prior to r and omisation , measurement of baseline factors should be of adequate reliability and validity , and a specific test of the interaction between baseline factors and interventions must be presented . Conclusions There is consensus from a group of 21 international experts that method ological criteria to assess moderators within systematic review s of RCTs is both timely and necessary . The consensus from the experts result ed in five criteria divided into two groups when synthesis ing evidence : confirmatory findings to support hypotheses about moderators and exploratory findings to inform future research . These recommendations are discussed in reference to previous recommendations for evaluating and reporting moderator studies Background Long-term immunosuppressive treatment does not efficiently prevent relapses of lupus nephritis ( LN ) . This investigator-initiated r and omised trial tested whether mycophenolate mofetil ( MMF ) was superior to azathioprine ( AZA ) as maintenance treatment . Methods A total of 105 patients with lupus with proliferative LN were included . All received three daily intravenous pulses of 750 mg methylprednisolone , followed by oral glucocorticoids and six fortnightly cyclophosphamide intravenous pulses of 500 mg . Based on r and omisation performed at baseline , AZA ( target dose : 2 mg/kg/day ) or MMF ( target dose : 2 g/day ) was given at week 12 . Analyses were by intent to treat . Time to renal flare was the primary end point . Mean ( SD ) follow-up of the intent-to-treat population was 48 ( 14 ) months . Results The baseline clinical , biological and pathological characteristics of patients allocated to AZA or MMF did not differ . Renal flares were observed in 13 ( 25 % ) AZA-treated and 10 ( 19 % ) MMF-treated patients . Time to renal flare , to severe systemic flare , to benign flare and to renal remission did not statistically differ . Over a 3-year period , 24 h proteinuria , serum creatinine , serum albumin , serum C3 , haemoglobin and global disease activity scores improved similarly in both groups . Doubling of serum creatinine occurred in four AZA-treated and three MMF-treated patients . Adverse events did not differ between the groups except for haematological cytopenias , which were statistically more frequent in the AZA group ( p=0.03 ) but led only one patient to drop out . Conclusions Fewer renal flares were observed in patients receiving MMF but the difference did not reach statistical significance Recent studies have suggested that mycophenolate mofetil ( MMF ) may offer advantages over intravenous cyclophosphamide ( IVC ) for the treatment of lupus nephritis , but these therapies have not been compared in an international r and omized , controlled trial . Here , we report the comparison of MMF and IVC as induction treatment for active lupus nephritis in a multinational , two-phase ( induction and maintenance ) study . We r and omly assigned 370 patients with classes III through V lupus nephritis to open-label MMF ( target dosage 3 g/d ) or IVC ( 0.5 to 1.0 g/m(2 ) in monthly pulses ) in a 24-wk induction study . Both groups received prednisone , tapered from a maximum starting dosage of 60 mg/d . The primary end point was a prespecified decrease in urine protein/creatinine ratio and stabilization or improvement in serum creatinine . Secondary end points included complete renal remission , systemic disease activity and damage , and safety . Overall , we did not detect a significantly different response rate between the two groups : 104 ( 56.2 % ) of 185 patients responded to MMF compared with 98 ( 53.0 % ) of 185 to IVC . Secondary end points were also similar between treatment groups . There were nine deaths in the MMF group and five in the IVC group . We did not detect significant differences between the MMF and IVC groups with regard to rates of adverse events , serious adverse events , or infections . Although most patients in both treatment groups experienced clinical improvement , the study did not meet its primary objective of showing that MMF was superior to IVC as induction treatment for lupus nephritis Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more In the United States , approximately 35 % of adults with Systemic Lupus Erythematosus ( SLE ) have clinical evidence of nephritis at the time of diagnosis ; with an estimated total of 50–60 % developing nephritis during the first 10 years of disease [ 1–4 ] . The prevalence of nephritis is significantly higher in African Americans and Hispanics than in Caucasians , and is higher in men than in women . Renal damage is more likely to develop in non-Caucasian groups [ 2–4 ] . Overall survival in patients with SLE is approximately 95 % at 5 years after diagnosis and 92 % at 10 years [ 5 , 6 ] . The presence of lupus nephritis significantly reduces survival , to approximately 88 % at 10 years , with even lower survival in African Americans [ 5 , 6 ] . The American College of Rheumatology ( ACR ) last published guidelines for management of systemic lupus erythematosus ( SLE ) in 1999 [ 7 ] . That publication was design ed primarily for education of primary care physicians and recommended therapeutic and management approaches for many manifestations of SLE . Recommendations for management of lupus nephritis ( LN ) consisted of pulse glucocorticoids followed by high dose daily glucocorticoids in addition to an immunosuppressive medication , with cyclophosphamide viewed as the most effective immunosuppressive medication for diffuse proliferative glomerulonephritis . Mycophenolate mofetil was not yet in use for lupus nephritis and was not mentioned . Since that time , many clinical trials of glucocorticoids-plus-immunosuppressive interventions have been published , some of which are high quality prospect i ve trials , and some not only prospect i ve but also r and omized . Thus , the ACR determined that a new set of management recommendations was in order . A combination of extensive literature review and the opinions of highly qualified experts , including rheumatologists , nephrologists and pathologists , has been used to reach the recommendations . The management strategies discussed here apply to lupus nephritis in adults , particularly to those receiving care in the United States of America , and include interventions that were available in the United States as of April 2011 . While these recommendations were developed using rigorous methodology , guidelines do have inherent limitations in informing individual patient care ; hence the selection of the term “ recommendations . ” While they should not supplant clinical judgment or limit clinical judgment , they do provide expert advice to the practicing physician managing
Output:
| There was very low QoE for other moderators or prognostic factors associated with MMF treatment outcomes . |
MS210319 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Purpose In addition to structural transformations , deeper changes are needed to enhance physicians ’ sense of meaning and satisfaction with their work and their ability to respond creatively to a dynamically changing practice environment . The purpose of this research was to underst and what aspects of a successful continuing education program in mindful communication contributed to physicians ’ well-being and the care they provide . Method In 2008 , the authors conducted in-depth , semistructured interviews with primary care physicians who had recently completed a 52-hour mindful communication program demonstrated to reduce psychological distress and burnout while improving empathy . Interviews with a r and om sample of 20 of the 46 physicians in the Rochester , New York , area who attended at least four of eight weekly sessions and four of eight monthly sessions were audio-recorded , transcribed , and analyzed qualitatively . The authors identified salient themes from the interviews . Results Participants reported three main themes : ( 1 ) sharing personal experiences from medical practice with colleagues reduced professional isolation , ( 2 ) mindfulness skills improved the participants ’ ability to be attentive and listen deeply to patients ’ concerns , respond to patients more effectively , and develop adaptive reserve , and ( 3 ) developing greater self-awareness was positive and transformative , yet participants struggled to give themselves permission to attend to their own personal growth . Conclusions Interventions to improve the quality of primary care practice and practitioner well-being should promote a sense of community , specific mindfulness skills , and permission and time devoted to personal growth UNLABELLED RATIONALE , AIMS & OBJECTIVE : Tools for the assessment of the quality of research studies tend to be specific to a particular research design ( e.g. r and omized controlled trials , or qualitative interviews ) . This makes it difficult to assess the quality of a body of research that addresses the same or a similar research question but using different approaches . The aim of this paper is to describe the development and preliminary evaluation of a quality assessment tool that can be applied to a method ologically diverse set of research articles . METHODS The 16-item quality assessment tool ( QATSDD ) was assessed to determine its reliability and validity when used by health services research ers in the disciplines of psychology , sociology and nursing . Qualitative feedback was also gathered from mixed- methods health research ers regarding the comprehension , content , perceived value and usability of the tool . RESULTS Reference to existing widely used quality assessment tools and experts in systematic review confirmed that the components of the tool represented the construct of ' good research technique ' being assessed . Face validity was subsequently established through feedback from a sample of nine health research ers . Inter-rater reliability was established through substantial agreement between three review ers when applying the tool to a set of three research papers ( κ = 71.5 % ) , and good to substantial agreement between their scores at time 1 and after a 6-week interval at time 2 confirmed test-retest reliability . CONCLUSIONS The QATSDD shows good reliability and validity for use in the quality assessment of a diversity of studies , and may be an extremely useful tool for review ers to st and ardize and increase the rigour of their assessment s in review s of the published papers which include qualitative and quantitative work Positive psychology has flourished in the last 5 years . The authors review recent developments in the field , including books , meetings , courses , and conferences . They also discuss the newly created classification of character strengths and virtues , a positive complement to the various editions of the Diagnostic and Statistical Manual of Mental Disorders ( e. g. , American Psychiatric Association , 1994 ) , and present some cross-cultural findings that suggest a surprising ubiquity of strengths and virtues . Finally , the authors focus on psychological interventions that increase individual happiness . In a 6-group , r and om-assignment , placebo-controlled Internet study , the authors tested 5 purported happiness interventions and 1 plausible control exercise . They found that 3 of the interventions lastingly increased happiness and decreased depressive symptoms . Positive interventions can supplement traditional interventions that relieve suffering and may someday be the practical legacy of positive psychology We investigated the impact of mindfulness training ( MT ) on working memory capacity ( WMC ) and affective experience . WMC is used in managing cognitive dem and s and regulating emotions . Yet , persistent and intensive dem and s , such as those experienced during high-stress intervals , may deplete WMC and lead to cognitive failures and emotional disturbances . We hypothesized that MT may mitigate these deleterious effects by bolstering WMC . We recruited 2 military cohorts during the high-stress predeployment interval and provided MT to 1 ( MT , n = 31 ) but not the other group ( military control group , MC , n = 17 ) . The MT group attended an 8-week MT course and logged the amount of out-of-class time spent practicing formal MT exercises . The operation span task was used to index WMC at 2 testing sessions before and after the MT course . Although WMC remained stable over time in civilians ( n = 12 ) , it de grade d in the MC group . In the MT group , WMC decreased over time in those with low MT practice time , but increased in those with high practice time . Higher MT practice time also corresponded to lower levels of negative affect and higher levels of positive affect ( indexed by the Positive and Negative Affect Schedule ) . The relationship between practice time and negative , but not positive , affect was mediated by WMC , indicating that MT-related improvements in WMC may support some but not all of MT 's salutary effects . Nonetheless , these findings suggest that sufficient MT practice may protect against functional impairments associated with high-stress context CONTEXT Primary care physicians report high levels of distress , which is linked to burnout , attrition , and poorer quality of care . Programs to reduce burnout before it results in impairment are rare ; data on these programs are scarce . OBJECTIVE To determine whether an intensive educational program in mindfulness , communication , and self-awareness is associated with improvement in primary care physicians ' well-being , psychological distress , burnout , and capacity for relating to patients . DESIGN , SETTING , AND PARTICIPANTS Before- and -after study of 70 primary care physicians in Rochester , New York , in a continuing medical education ( CME ) course in 2007 - 2008 . The course included mindfulness meditation , self-awareness exercises , narratives about meaningful clinical experiences , appreciative interviews , didactic material , and discussion . An 8-week intensive phase ( 2.5 h/wk , 7-hour retreat ) was followed by a 10-month maintenance phase ( 2.5 h/mo ) . MAIN OUTCOME MEASURES Mindfulness ( 2 subscales ) , burnout ( 3 subscales ) , empathy ( 3 subscales ) , psychosocial orientation , personality ( 5 factors ) , and mood ( 6 subscales ) measured at baseline and at 2 , 12 , and 15 months . RESULTS Over the course of the program and follow-up , participants demonstrated improvements in mindfulness ( raw score , 45.2 to 54.1 ; raw score change [ Delta ] , 8.9 ; 95 % confidence interval [ CI ] , 7.0 to 10.8 ) ; burnout ( emotional exhaustion , 26.8 to 20.0 ; Delta = -6.8 ; 95 % CI , -4.8 to -8.8 ; depersonalization , 8.4 to 5.9 ; Delta = -2.5 ; 95 % CI , -1.4 to -3.6 ; and personal accomplishment , 40.2 to 42.6 ; Delta = 2.4 ; 95 % CI , 1.2 to 3.6 ) ; empathy ( 116.6 to 121.2 ; Delta = 4.6 ; 95 % CI , 2.2 to 7.0 ) ; physician belief scale ( 76.7 to 72.6 ; Delta = -4.1 ; 95 % CI , -1.8 to -6.4 ) ; total mood disturbance ( 33.2 to 16.1 ; Delta = -17.1 ; 95 % CI , -11 to -23.2 ) , and personality ( conscientiousness , 6.5 to 6.8 ; Delta = 0.3 ; 95 % CI , 0.1 to 5 and emotional stability , 6.1 to 6.6 ; Delta = 0.5 ; 95 % CI , 0.3 to 0.7 ) . Improvements in mindfulness were correlated with improvements in total mood disturbance ( r = -0.39 , P < .001 ) , perspective taking subscale of physician empathy ( r = 0.31 , P < .001 ) , burnout ( emotional exhaustion and personal accomplishment subscales , r = -0.32 and 0.33 , respectively ; P < .001 ) , and personality factors ( conscientiousness and emotional stability , r = 0.29 and 0.25 , respectively ; P < .001 ) . CONCLUSIONS Participation in a mindful communication program was associated with short-term and sustained improvements in well-being and attitudes associated with patient-centered care . Because before- and -after design s limit inferences about intervention effects , these findings warrant r and omized trials involving a variety of practicing physicians Mindfulness-based stress reduction ( MBSR ) has produced behavioral , psychological , and physiological benefits , but these programs typically require a substantial time commitment from the participants . This study assessed the effects of a shortened ( low-dose [ ld ] ) work-site MBSR intervention ( MBSR-ld ) on indicators of stress in healthy working adults to determine if results similar to those obtained in traditional MBSR could be demonstrated . Participants were r and omized into MBSR-ld and wait-list control groups . Self-reported perceived stress , sleep quality , and mindfulness were measured at the beginning and end of the 6-week intervention . Salivary cortisol was assessed weekly . Significant reductions in perceived stress ( p = .0025 ) and increases in mindfulness ( p = .0149 ) were obtained for only the MBSR-ld group ( n = 22 ) . Scores on the global measure of sleep improved for the MBSR-ld group ( p = .0018 ) as well as for the control group ( p = .0072 ; n = 20 ) . Implication s and future research are discussed This article is the second in a series reporting on research exploring the effects of Mindfulness-based Stress Reduction on nurses and describes the quantitative data . The third article describes qualitative data . Treatment group participants reduced scores on 2 of 3 subscales of the Maslach Burnout Inventory significantly more than wait-list controls ; within-group comparisons for both groups pretreatment and posttreatment revealed similar findings . Changes were maintained as long as 3-month posttreatment . Implication s of these findings are discussed Cultivating Awareness and Resilience in Education ( CARE for Teachers ) is a mindfulness-based professional development program design ed to reduce stress and improve teachers ' performance and classroom learning environments . A r and omized controlled trial examined program efficacy and acceptability among a sample of 50 teachers r and omly assigned to CARE or waitlist control condition . Participants completed a battery of self-report measures at pre- and postintervention to assess the impact of the CARE program on general well-being , efficacy , burnout/time pressure , and mindfulness . Participants in the CARE group completed an evaluation of the program after completing the intervention . ANCOVAs were computed between the CARE group and control group for each outcome , and the pretest scores served as a covariate . Participation in the CARE program result ed in significant improvements in teacher well-being , efficacy , burnout/time-related stress , and mindfulness compared with controls . Evaluation data showed that teachers viewed CARE as a feasible , acceptable , and effective method for reducing stress and improving performance . Results suggest that the CARE program has promise to support teachers working in challenging setting s and consequently improve classroom environments This study implemented an innovative new model of delivering a Mindfulness-Based Stress Reduction ( MBSR ) program that replaces six of the eight traditional in-person sessions with group telephonic sessions ( tMBSR ) and measured the program 's impact on the health and well-being of nurses employed within a large health care organization . As part of a nonr and omized pre – post intervention study , 36 nurses completed measures of health , stress , burnout , self-compassion , serenity , and empathy at three points in time . Between baseline ( Time 1 ) and the end of the 8-week tMBSR intervention ( Time 2 ) , participants showed improvement in general health , t(37 ) = 2.8 , p < .01 , decreased stress , t(37 ) = 6.8 , p < .001 , decreased work burnout , t(37 ) = 4.0 , p < .001 , and improvement in several other areas . Improvements were sustained 4 months later ( Time 3 ) , and individuals who continued their MBSR practice after the program demonstrated better outcomes than those that did not . Findings suggest that the tMBSR program can be a low cost , feasible , and scalable intervention that shows positive impact on health and well-being , and could allow MBSR to be delivered to employees who are otherwise unable to access traditional , on-site programs Evidence -based medicine is crucial to contemporary healthcare . It is dependent on systematic review methodology modelled on an arguably inadequate hierarchy of evidence . There has been a significant increase in medical and health research using qualitative and mixed method design s. The perspective taken in this article is that we need to broaden our evidence base if we are to fully take account of issues of context , acceptability and feasibility in the development and implementation of healthcare interventions . One way of doing this is to use a range of methods that better fit the different aspects of intervention development and implementation . Methods for the systematic review of evidence , other than r and omised-controlled trials , are available
Output:
| The quality of the studies was high in relation to the clarity of aims , data collection and analysis , but weaker in terms of sample size and the use of theoretical frameworks . |
MS210320 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Schizophrenia is a disruptive and distressing illness , not only for the person affected but also for family members . Family intervention , particularly in a group format using a diverse range of modalities , is thought to effectively satisfy the informational needs of families and enhance their coping abilities when caring for a relative with schizophrenia , and thus reduce a patient ’s relapse from illness . This study tested the hypothesis that participants in a family psychoeducation and mutual support group would demonstrate significant improvements in levels of patient and family functioning and shorter duration of re-hospitalization than families in routine care . A r and omized controlled trial was conducted with a sample of 68 Chinese families of schizophrenia sufferers in Hong Kong , who were r and omly assigned to either a family psychoeducation and support group ( n = 34 ) , or a routine care group ( n = 34 ) . The interventions were delivered at two psychiatric outpatient clinics over a nine-month period . Results of multivariate analyses of variance test indicated that the psychoeducation and support group reported greater improvements on family and patient functioning and shorter lengths of patient hospitalizations at the two post-tests ( one month and one year after completion of the intervention ) , compared with the routine care group . The findings substantiate that within a Chinese context , psychoeducation and mutual support group intervention can effectively help families care for a mentally ill relative OBJECTIVE The present study aims to assess the efficacy of a structured psychoeducational group intervention for adolescents with early-onset psychosis and their families . The intervention was implemented in parallel in 2 separate groups by focusing specifically on problem-solving strategies and structured psychosis-related information to manage daily life difficulties associated with the disease , to mitigate crises , and to prevent relapses . METHOD We performed a 9-month , r and omized , rater-blinded clinical trial involving 55 adolescent patients with early-onset psychosis and either or both of their parents . A psychoeducational problem-solving group intervention ( n = 27 ) was compared with a nonstructured group intervention ( n = 28 ) . The primary outcomes were number of hospitalizations , days of hospitalization , and visits to the emergency department . The secondary outcome measures were clinical variables and family environment . RESULTS Assessment s were performed before and after the intervention . At the end of the group intervention , 15 % of patients in the psychoeducational group and 39 % patients in the nonstructured group had visited the emergency department ( χ² = 3.62 , df = 1 , p = .039 ) . The improvement in negative symptoms was more pronounced in the psychoeducational group ( 12.84 [ 7.87 ] ) than in the nonstructured group ( 15.81 [ 6.37 ] ) ( p = .039 ) . CONCLUSION A parallel psychoeducational group intervention providing written instructions in a structured manner could help adolescents with early-onset psychosis and their parents to manage crises by implementing problem-solving strategies within the family , thus reducing the number of visits to the emergency department . Negative symptoms improved in adolescents in the psychoeducational group . Clinical trial registration information -- Intervention Module AGES ( AGES-CM ) ; http:// clinical trials.gov/ ; NCT02101372 . [ corrected ] BACKGROUND Family intervention reduces relapse rates in psychosis . Cognitive-behavioural therapy ( CBT ) improves positive symptoms but effects on relapse rates are not established . AIMS To test the effectiveness of CBT and family intervention in reducing relapse , and in improving symptoms and functioning in patients who had recently relapsed with non-affective psychosis . METHOD A multicentre r and omised controlled trial ( IS RCT N83557988 ) with two pathways : those without carers were allocated to treatment as usual or CBT plus treatment as usual , those with carers to treatment as usual , CBT plus treatment as usual or family intervention plus treatment as usual . The CBT and family intervention were focused on relapse prevention for 20 sessions over 9 months . RESULTS A total of 301 patients and 83 carers participated . Primary outcome data were available on 96 % of the total sample . The CBT and family intervention had no effects on rates of remission and relapse or on days in hospital at 12 or 24 months . For secondary outcomes , CBT showed a beneficial effect on depression at 24 months and there were no effects for family intervention . In people with carers , CBT significantly improved delusional distress and social functioning . Therapy did not change key psychological processes . CONCLUSIONS Generic CBT for psychosis is not indicated for routine relapse prevention in people recovering from a recent relapse of psychosis and should currently be reserved for those with distressing medication-unresponsive positive symptoms . Any CBT targeted at this acute population requires development . The lack of effect of family intervention on relapse may be attributable to the low overall relapse rate in those with carers BACKGROUND Family intervention in schizophrenia can reduce patient relapse and improve medication adherence , but few studies on this have involved a Chinese population . AIMS To examine the effects of a mutual support group for Chinese families of people with schizophrenia , compared with psychoeducation and st and ard care . METHOD R and omised controlled trial in Hong Kong with 96 families of out- patients with schizophrenia , of whom 32 received mutual support , 33 psychoeducation and 31 st and ard care . The psychoeducation group included patients in all the sessions , the mutual support group did not . Intervention was provided over 6 months , and patient- and family-related psychosocial outcomes were compared over an 18-month follow-up . RESULTS Mutual support consistently produced greater improvement in patient and family functioning and caregiver burden over the intervention and follow-up periods , compared with the other two conditions . The number of readmissions did not decrease significantly , but their duration did . CONCLUSIONS Mutual support for families of Chinese people with schizophrenia can substantially benefit family and patient functioning and caregiver burden Background Caring for a young person experiencing first-episode psychosis is challenging and can affect carers ’ well-being adversely . While some face-to-face approaches have achieved promising outcomes , they are costly and re source -intensive to provide , restricting their reach and penetration . Guided self-help in book-form ( or bibliotherapy ) is an alternative but untested approach in these circumstances . In this study , we aim ed to evaluate carers ’ beliefs about the usefulness of problem-solving guided self-help manual for primary carers of young people with first-episode psychosis . Methods A qualitative process evaluation nested in a r and omised controlled trial , conducted across two early intervention psychosis services in Melbourne , Australia . 124 carers were r and omised to problem-solving guided self-help intervention or treatment as usual . We also undertook a qualitative process evaluation , using individual interviews , with a r and om sample of 24 of the intervention group . A thematic analysis of the qualitative data was undertaken , which is the subject of this paper . Interviews were conducted between January 2009 and September 2010 . Results Three themes were abstract ed from the data , reflecting carers ’ beliefs about the usefulness of the manual : promoting carers ’ well-being , increasing carers ’ underst and ing of and support for the young person with first-episode psychosis , and accessibility and delivery modes of the programme . Conclusion This process evaluation highlights that guided self-help is useful in informing and supporting carers of affected young people . While there is scope for broadening the delivery modes , the approach is easy to use and accessible , and can be used as a cost-effective adjunct to st and ard support provided to carers , by community mental health nurses and other clinicians . Trial registration Abstract Aim Caring for young people with first‐episode psychosis is difficult and dem and ing , and has detrimental effects on carers ' well‐being , with few evidence ‐based re sources available to assist carers to deal with the problems they are confronted with in this situation . We aim ed to examine if completion of a self‐directed problem‐solving bibliotherapy by first‐time carers of young people with first‐episode psychosis improved their social problem solving compared with carers who only received treatment as usual . Methods A r and omized controlled trial was carried out through two early intervention psychosis services in Melbourne , Australia . A sample of 124 carers were r and omized to problem‐solving bibliotherapy or treatment as usual . Participants were assessed at baseline , 6‐ and 16‐week follow‐up . Results Intent‐to‐treat analyses were used and showed that recipients of bibliotherapy had greater social problem‐solving abilities than those receiving treatment as usual , and these effects were maintained at both follow‐up time points . Conclusions Our findings affirm that bibliotherapy , as a low‐cost complement to treatment as usual for carers , had some effects in improving their problem‐solving skills when addressing problems related to the care and support of young people with first‐episode psychosis Family interventions for first-episode psychosis ( FEP ) are an integral component of treatment , with positive effects mainly on patients ’ mental state and relapse rate . However , comparatively little attention has been paid to the effects of family interventions on caregivers ’ stress coping and well-being , especially in non-Western countries . We aim ed to test the effects of a 5-month clinician-supported problem-solving bibliotherapy ( CSPSB ) for Chinese family caregivers of people with FEP in improving family burden and carers ’ problem-solving and caregiving experience , and in reducing psychotic symptoms and duration of re-hospitalizations , compared with those only received usual outpatient family support ( UOFS ) . A r and omized controlled trial was conducted across 2 early psychosis clinics in Hong Kong , where there might be inadequate usual family support services for FEP patients . A total of 116 caregivers were r and omly selected , and after baseline measurement , r and omly assigned to the CSPSB or UOFS . They were also assessed at 1-week and 6- and 12-month post-intervention . Intention-to-treat analyses were applied and indicated that the CSPSB group reported significantly greater improvements in family burden and caregiving experience , and reductions in severity of psychotic symptoms and duration of re-hospitalizations , than the UOFS group at 6- and 12-month follow-up . CSPSB produces moderate long-term benefits to caregivers and FEP patients , and is a low-cost adjunct to UOFS This r and omized controlled trial examined the effectiveness of a 12-session mutual support group conducted over 3-months for Chinese family caregivers of a relative with schizophrenia compared with routine family support services in Hong Kong . Forty-eight family caregivers from two psychiatric outpatient clinics were allocated r and omly to an experimental ( mutual support and usual outpatient care ) group ( n = 24 ) or a control ( usual outpatient care only ) group ( n = 24 ) . Data were collected prior to , 1 week and 3 months after the intervention . Families allocated to the mutual support group experienced decreased levels of family burden and increased family functioning and these changes were significantly greater than those of the controls at both post-intervention time points . The experimental group also showed a significant decrease in the duration of patient re-hospitalization ( the total number of days of psychiatric hospitalization ) at 3 months compared with the control group . This suggests that the mutual support group provided a more responsive service for patients than st and ard care . However , there was no significant difference in family service utilization between the two groups . The findings indicate that a mutual support group can provide benefits for family caregivers of people with schizophrenia that go beyond those provided by routine family support OBJECTIVE To investigate whether the beneficial effects of a structured , psychoeducational , parallel-group program for adolescents with early-onset psychosis and their families observed immediately after the intervention were maintained 2 years later . METHOD The present study examines the longitudinal efficacy of a r and omized controlled trial based on a psychoeducational , problem-solving , structured group intervention for adolescents with early-onset psychosis and their families ( PE ) and compares it with that of a nonstructured group intervention ( NS ) after a 2-year follow-up . We analyzed whether the differences between PE and NS found after the intervention persisted 2 years later . Intergroup differences in number and duration of hospitalizations , symptoms , and functioning were also assessed . RESULTS After 2 years of follow-up , we were able to reassess 89 % of patients . In the PE group , 13 % of patients had visited the emergency department , compared with 50 % in the NS group ( p = .019 ) . However , no statistically significant differences were found between the groups for negative symptoms or number and duration of hospitalizations . A significant improvement in Positive and Negative Syndrome Scale ( PANSS ) general symptoms was observed in the PE group . CONCLUSION Our psychoeducational group intervention showed sustained effects by diminishing the number of visits to emergency departments 2 years after the intervention . Our findings indicate that this psychoeducational intervention could provide patients with long-lasting re sources to manage crises more effectively . Clinical trial registration information-Intervention Module AGES ( AGES-CM ) ; http:// clinical trials.gov/ ; NCT02101372 OBJECTIVE This study was conducted to test the effects of a nine-month family-led peer support group for Chinese people with schizophrenia in Hong Kong over a three-year follow-up and to compare outcomes with those of psychoeducation and st and ard psychiatric outpatient care . METHODS A r and omized controlled trial of 106 Chinese families of patients with schizophrenia was conducted between August 2007 and January 2011 in three psychiatric outpatient clinics
Output:
| Compared with usual psychiatric care , family intervention was more effective in reducing care burden over all follow-up periods .
Family intervention was also superior to usual care with regards to caregiving experience in the short term and improved utilization of formal support and family functioning over longer-term follow up .
Mutual support is more effective than psychoeducation in improving family functioning when measured 1 to 2 years after the intervention but had equivalent effects on utilization of formal support services .
CONCLUSIONS This review provides evidence that family intervention is effective for caregivers of recent-onset psychosis , especially for care burden where the positive effects are enhanced over time |
MS210321 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background . No rehabilitation intervention has effectively improved functional use of the arm and h and in patients with severe upper limb paresis after stroke . Pilot studies suggest the potential for transcranial direct current stimulation and bilateral robotic training to enhance gains . Objective . In a double-blind , r and omized trial the combination of these interventions was tested . Methods . This study r and omized 96 patients with an ischemic supratentorial lesion of 3 to 8 weeks ’ duration with severe impairment of motor control with a Fugl-Meyer score ( FMS ) for the upper limb < 18 into 3 groups . For 6 weeks , group A received anodal stimulation of the lesioned hemisphere , group B received cathodal stimulation of the nonlesioned side for 20 minutes at 2.0 mA , and group C received sham stimulation . The electrodes were placed over the h and area and above the contralateral orbit . Contemporaneously , the subjects practice d 400 repetitions each of 2 different bilateral movements on a robotic assistive device . Results . The groups were matched at onset . The FMS improved in all patients at 6 weeks ( P < .001 ) . No between-group differences were found ; initial versus finish FMS scores were 7.8 ± 3.8 versus 19.1 ± 14.4 in group A , 7.9 ± 3.4 versus 18.8 ± 10.5 in group B , and 8.2 ± 4.4 versus 19.2 ± 15.0 in group C. No significant changes between groups were present at 3 months . Conclusions . Neither anodal nor cathodal transcranial direct current stimulation enhanced the effect of bilateral arm training in this exploratory trial of patients with cortical involvement and severe weakness . Unilateral h and training and upregulation of the nonlesioned hemisphere might also be tried in this population Objective : Motor recovery after stroke depends on the integrity of ipsilesional motor circuits and interactions between the ipsilesional and contralesional hemispheres . In this sham-controlled r and omized trial , we investigated whether noninvasive modulation of regional excitability of bilateral motor cortices in combination with physical and occupational therapy improves motor outcome after stroke . Methods : Twenty chronic stroke patients were r and omly assigned to receive 5 consecutive sessions of either 1 ) bihemispheric transcranial direct current stimulation ( tDCS ) ( anodal tDCS to upregulate excitability of ipsilesional motor cortex and cathodal tDCS to downregulate excitability of contralesional motor cortex ) with simultaneous physical/occupational therapy or 2 ) sham stimulation with simultaneous physical/occupational therapy . Changes in motor impairment ( Upper Extremity Fugl-Meyer ) and motor activity ( Wolf Motor Function Test ) assessment s were outcome measures while functional imaging parameters were used to identify neural correlates of motor improvement . Results : The improvement of motor function was significantly greater in the real stimulation group ( 20.7 % in Fugl-Meyer and 19.1 % in Wolf Motor Function Test scores ) when compared to the sham group ( 3.2 % in Fugl-Meyer and 6.0 % in Wolf Motor Function Test scores ) . The effects outlasted the stimulation by at least 1 week . In the real-stimulation group , stronger activation of intact ipsilesional motor regions during paced movements of the affected limb were found postintervention whereas no significant activation changes were seen in the control group . Conclusions : The combination of bihemispheric tDCS and peripheral sensorimotor activities improved motor functions in chronic stroke patients that outlasted the intervention period . This novel approach may potentiate cerebral adaptive processes that facilitate motor recovery after stroke . Classification of evidence : This study provides Class I evidence that for adult patients with ischemic stroke treated at least 5 months after their first and only stroke , bihemispheric tDCS and simultaneous physical/occupational therapy given over 5 consecutive sessions significantly improves motor function as measured by the Upper Extremity Fugl-Meyer assessment ( raw change treated 6.1 ± 3.4 , sham 1.2 ± 1.0 ) PURPOSE It is thought that following a stroke the contralesional motor region exerts an undue inhibitory influence on the lesional motor region which might limit recovery . Pilot studies have shown that suppressing the contralesional motor region with cathodal transcranial Direct Current Stimulation ( tDCS ) can induce a short lasting functional benefit ; greater and longer lasting effects might be achieved with combining tDCS with simultaneous occupational therapy ( OT ) and applying this intervention for multiple sessions . METHODS We carried out a r and omized , double blind , sham controlled study of chronic stroke patients receiving either 5 consecutive days of cathodal tDCS ( for 30 minutes ) applied to the contralesional motor region and simultaneous OT , or sham tDCS+OT . RESULTS we showed that cathodal tDCS+OT result ed in significantly more improvement in Range-Of-Motion in multiple joints of the paretic upper extremity and in the Upper-Extremity Fugl-Meyer scores than sham tDCS+OT , and that the effects lasted at least one week post-stimulation . Improvement in motor outcome scores was correlated with decrease in fMRI activation in the contralesional motor region exposed to cathodal stimulation . CONCLUSIONS This suggests that cathodal tDCS combined with OT leads to significant motor improvement after stroke due to a decrease in the inhibitory effect that the contralesional hemisphere exerts onto the lesional hemisphere We set out to answer two questions with this study : 1 . Can stroke patients improve voluntary control of their paretic ankle by practising a visuo-motor ankle-tracking task ? 2 . Are practice effects enhanced with non-invasive brain stimulation ? A carefully selected sample of chronic stroke patients able to perform the experimental task attended three data collection sessions . Facilitatory transcranial direct current stimulation ( tDCS ) was applied in a r and om order over the lower limb primary motor cortex of the lesioned hemisphere or the non-lesioned hemisphere or sham stimulation was delivered over the lesioned hemisphere . In each session , tDCS was applied as patients practice d tracking a sinusoidal waveform for 15 min using dorsiflexion – plantarflexion movements of their paretic ankle . The difference in tracking error prior to , and after , the 15 min of practice was calculated . A practice effect was revealed following sham stimulation , and this effect was enhanced with tDCS applied over the lesioned hemisphere . The practice effect observed following sham stimulation was eliminated by tDCS applied over the non-lesioned hemisphere . The study provides the first evidence that non-invasive brain stimulation applied to the lesioned motor cortex of moderate- to well-recovered stroke patients enhances voluntary control of the paretic ankle . The results provide a basis for examining whether this enhanced ankle control can be induced in patients with greater impairments and whether enhanced control of a single or multiple lower limb joints improves hemiparetic gait patterns Recovery of function after a stroke is determined by a balance of activity in the neural network involving both the affected and the unaffected brain hemispheres . Increased activity in the affected hemisphere can promote recovery , while excessive activity in the unaffected hemisphere may represent a maladaptive strategy . We therefore investigated whether reduction of the excitability in the unaffected hemisphere by cathodal transcranial direct current stimulation could result in motor performance improvement in stroke patients . We compared these results with excitability-enhancing anodal transcranial direct current stimulation of the affected hemisphere and sham transcranial direct current stimulation . Both cathodal stimulation of the unaffected hemisphere and anodal stimulation of the affected hemisphere ( but not sham transcranial direct current stimulation ) improved motor performance significantly . These results suggest that the appropriate modulation of bihemispheric brain structures can promote motor function recovery Kim DY , Ohn SH , Yang EJ , Park C-I , Jung KJ : Enhancing Motor Performance by Anodal Transcranial Direct Current Stimulation in Subacute Stroke Patients . Objective : To investigate whether anodal transcranial direct current stimulation enhances motor performance in the paretic h and of subacute poststroke patients and how long the improvement persisted after the session . Design : Ten subacute poststroke patients who suffered stoke within 12 wks were recruited for this single-blinded , sham-controlled , crossover study . Anodal transcranial direct current stimulation or sham stimulation was r and omly delivered on the hot spot of the first dorsal interosseous in the affected hemisphere . The duration of transcranial direct current stimulation was 20 mins and sham was 30 secs. The Box and Block test and finger acceleration measurement were performed before , during , immediately after , and 30 and 60 mins after anodal or sham stimulation to assess time-dependent changes in motor performance . Results : Finger acceleration measurement and Box and Block test were significantly improved after anodal transcranial direct current stimulation compared with sham stimulation ( P < 0.05 ) . Anodal transcranial direct current stimulation significantly improved Box and Block test for at least 60 mins and finger acceleration until 30 mins after stimulation ( P < 0.05 ) without significant differences in attention and fatigue . Conclusions : Anodal transcranial direct current stimulation on the affected hemisphere can enhance motor performance of the hemiparetic h and transiently , outlasting the stimulation session OBJECTIVE Brain polarization in the form of transcranial direct current stimulation ( tDCS ) , which influences motor function and learning processes , has been proposed as an adjuvant strategy to enhance training effects in Neurorehabilitation . Proper testing in Neurorehabilitation requires double-blind sham-controlled study design s. Here , we evaluated the effects of tDCS and sham stimulation ( SHAM ) on healthy subjects and stroke patients ' self-report measures of attention , fatigue , duration of elicited sensations and discomfort . METHODS tDCS or SHAM was in all cases applied over the motor cortex . Attention , fatigue , and discomfort were self rated by study participants using visual analog scales . Duration of perceived sensations and the ability to distinguish tDCS from Sham sessions were determined . Investigators question ing the patients were blind to the intervention type . RESULTS tDCS and SHAM elicited comparably minimal discomfort and duration of sensations in the absence of differences in attention or fatigue , and could not be distinguished from SHAM by study participants nor investigators . CONCLUSIONS Successful blinding of subjects and investigators and ease of application simultaneously with training protocol s supports the feasibility of using tDCS in double-blind , sham-controlled r and omized trials in clinical Neurorehabilitation . SIGNIFICANCE tDCS could evolve into a useful tool , in addition to TMS , to modulate cortical activity in Neurorehabilitation Objective : To evaluate whether robot-assisted gait training combined with transcranial direct current stimulation is more effective than robot-assisted gait training alone or conventional walking rehabilitation for improving walking ability in stroke patients . Design : Pilot r and omized clinical trial . Setting : Rehabilitation unit of a university hospital . Subjects : Thirty patients with chronic stroke . Interventions : All patients received ten 50-minute treatment sessions , five days a week , for two consecutive weeks . Group 1 ( n = 10 ) underwent a robot-assisted gait training combined with transcranial direct current stimulation ; group 2 ( n = 10 ) underwent a robot-assisted gait training combined with sham transcranial direct current stimulation ; group 3 ( n = 10 ) performed overground walking exercises . Main measures : Patients were evaluated before , immediately after and two weeks post treatment . Primary outcomes : six-minute walking test , 10-m walking test . Results : No differences were found between groups 1 and 2 for all primary outcome measures at the after treatment and follow-up evaluations . A statistically significant improvement was found after treatment in performance on the six-minute walking test and the 10-m walking test in favour of group 1 ( six-minute walking test : 205.20 ± 61.16 m ; 10-m walking test : 16.20 ± 7.65 s ) and group 2 ( six-minute walking test : 182.5 ± 69.30 m ; 10-m walking test : 17.71 ± 8.20 s ) compared with group 3 ( six-minute walking test : 116.30 ± 75.40 m ; 10-m walking test : 26.30 ± 14.10 s ) . All improvements were maintained at the follow-up evaluation . Conclusions : In the present pilot study transcranial direct current stimulation had no additional effect on robot-assisted gait training in patients with chronic stroke . Larger studies are required to confirm these preliminary findings Kim DY , Lim JY , Kang EK , You DS , Oh MK , Oh BM , Paik NJ : Effect of transcranial direct current stimulation on motor recovery in patients with subacute stroke . Objective : To test the hypothesis that 10 sessions of transcranial direct current stimulation combined with occupational therapy elicit more improvement in motor function of the paretic upper limb than sham stimulation in patients with subacute stroke . Design : Eighteen patients with subacute stroke with h and motor impairment were r and omly assigned to one of the three 10-day sessions of ( a ) anodal transcranial direct current stimulation over the affected motor cortex , ( b ) cathodal transcranial direct current stimulation over the unaffected motor cortex , or ( c ) sham stimulation . Blinded evaluators assessed upper limb motor impairment and global functional state with the Fugl-Meyer Assessment score and the Modified Barthel Index at baseline , 1 day after stimulation , and 6 mos after stim
Output:
| Transcranial direct current stimulation is likely to be effective in enhancing motor performance in the short term when applied selectively to patients with stroke . |
MS210322 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting . Methods Twenty facilities took part in a r and omized controlled trial with a seven month follow-up period . Two outreach visits were delivered by a pharmacist . At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates , psychotropic drug prescribing and stroke risk reduction practice s ( BP monitoring , aspirin and warfarin use ) for the facility relevant to the physician . The effect of the interventions was determined via pre- and post-intervention case note audit . Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications . Chi-square tests , independent sample s t-test , and logistic regression were used in the analysis . Results Data were available from case notes at baseline ( n = 897 ) and seven months follow-up ( n = 902 ) , 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits . Pre- and post-intervention data were available for 715 participants . There were no differences between the intervention and control groups for the three month fall rate . We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention . The exception was significantly greater use of " as required " antipsychotics in the intervention group compared with the control group after the pharmacy intervention ( RR = 4.95 ; 95%CI 1.69–14.50 ) . There was no statistically significant difference between groups for the numbers of patients " at risk of stroke " on aspirin at follow-up . Conclusions While the strategy was well received by the physicians involved , there was no change in prescribing patterns . Patient care in residential setting s is complex and involves contributions from the patient 's physician , family and residential care staff . The project highlights challenges of delivering evidence based care in a setting in which there is a paucity of well controlled trial evidence but where significant health outcomes can be attained OBJECTIVE To test the effect of a complex guideline -based intervention on agitation and psychotropic prescriptions . DESIGN , SETTING , PARTICIPANTS Cluster r and omized controlled trial ( VIDEANT ) with blinded assessment of outcome in 18 nursing homes in Berlin , Germany , comprising 304 dementia patients . INTERVENTION Training , support , and activity therapy intervention , delivered at the level of each nursing home , focusing on the management of agitation in dementia . Control group nursing homes received treatment as usual . MEASUREMENTS Levels of agitated and disruptive behavior ( Cohen-Mansfield agitation inventory [ CMAI ] ) as the primary outcome . Number of neuroleptics , antidepressants , and cholinesterase inhibitors ( ChEIs ) prescribed in defined daily dosages ( DDDs ) . RESULTS Of 326 patients screened , 304 ( 93.3 % ) were eligible and cluster-r and omized to 9 intervention ( n = 163 ) and 9 control ( n = 141 ) nursing homes . Data were collected from 287 ( 94.4 % ) patients at 10 months . At 10 months , compared with controls , nursing home residents with dementia in the intervention group exhibited significantly less agitation as measured with the CMAI ( adjusted mean difference , 6.24 ; 95 % CI 2.03 - 14.14 ; P = .009 ; Cohen 's d = 0.43 ) , received fewer neuroleptics ( P < .05 ) , more ChEIs ( P < .05 ) , and more antidepressants ( P < .05 ) . CONCLUSION Complex guideline -based interventions are effective in reducing agitated and disruptive behavior in nursing home residents with dementia . At the same time , increased prescription of ChEIs and antidepressants together with decreased neuroleptic prescription suggests an effect toward guideline -based pharmacotherapy OBJECTIVES To evaluate the effectiveness of efforts to translate and disseminate evidence -based guidelines about atypical antipsychotic use to nursing homes ( NHs ) . DESIGN Three-arm , cluster r and omized trial . SETTING NHs . PARTICIPANTS NHs in the state of Connecticut . MEASUREMENTS Evidence -based guidelines for atypical antipsychotic prescribing were translated into a toolkit targeting NH stakeholders , and 42 NHs were recruited and r and omized to one of three toolkit dissemination strategies : mailed toolkit delivery ( minimal intensity ) ; mailed toolkit delivery with quarterly audit and feedback reports about facility-level antipsychotic prescribing ( moderate intensity ) ; and in-person toolkit delivery with academic detailing , on-site behavioral management training , and quarterly audit and feedback reports ( high intensity ) . Outcomes were evaluated using the Reach , Effectiveness , Adoption , Implementation , Maintenance ( RE- AIM ) framework . RESULTS Toolkit awareness of 30 % ( 7/23 ) of leadership of low-intensity NHs , 54 % ( 19/35 ) of moderate-intensity NHs , and 82 % ( 18/22 ) of high-intensity NHs reflected adoption and implementation of the intervention . Highest levels of use and knowledge among direct care staff were reported in high-intensity NHs . Antipsychotic prescribing levels declined during the study period , but there were no statistically significant differences between study arms or from secular trends . CONCLUSION RE- AIM indicators suggest some success in disseminating the toolkit and differences in reach , adoption , and implementation according to dissemination strategy but no measurable effect on antipsychotic prescribing trends . Further dissemination to external stakeholders such as psychiatry consultants and hospitals may be needed to influence antipsychotic prescribing for NH residents OBJECTIVES To assess the feasibility of a multifaceted strategy to translate evidence -based guidelines for treating nursing home-acquired pneumonia ( NHAP ) into practice using a small intervention trial . DESIGN Pre-posttest with untreated control group . SETTING Two Colorado State Veterans Homes ( SVHs ) during two influenza seasons . PARTICIPANTS Eighty-six residents with two or more signs of lower respiratory tract infection . INTERVENTION Multifaceted , including a formative phase to modify the intervention , institutional-level change emphasizing immunization , and availability of appropriate antibiotics ; interactive educational sessions for nurses ; and academic detailing . MEASUREMENTS Subjects ' SVH medical records were review ed for guideline compliance retrospectively for the influenza season before the intervention and prospect ively during the intervention . Bivariate comparisons-of-care processes between the intervention and control facility before and after the intervention were made using the Fischer exact test . RESULTS At the intervention facility , compliance with five of the guidelines improved : influenza vaccination , timely physician response to illness onset , x-ray for patients not being hospitalized , use of appropriate antibiotics , and timely antibiotic initiation for unstable patients . Chest x-ray and appropriate and timely antibiotics were significantly better at the intervention than at the control facility during the intervention year but not during the control year . CONCLUSION Multifaceted , evidence -based , NHAP guideline implementation improved care processes in a SVH . Guideline implementation should be studied in a national sample of nursing homes to determine whether it improves quality of life and functional outcomes of this debilitating illness for long-term care residents OBJECTIVE To test the effectiveness of using a full-time project nurse to assist residential aged care facilities in using evidence -based approaches to falls injury prevention . DESIGN , SETTING AND PARTICIPANTS Cluster r and omised controlled trial involving 5391 residents in 88 aged care facilities in the Hunter and Lower Mid North Coast areas of New South Wales . Residents were followed for 545 days or until death or discharge . Data were collected from July 2005 to June 2007 . INTERVENTION Employment of a project nurse to encourage best- practice falls injury prevention strategies during the 17-month intervention period . MAIN OUTCOME MEASURES Monthly data about falls , falls injury and falls injury prevention programs ; audit of hospitalisation for fractured neck of femur . RESULTS Despite significant increases in the provision of hip protectors and use of vitamin D supplementation in both intervention and control facilities , there was no difference in the number of falls or falls injuries between the intervention and control groups , nor a reduction in falls overall . There was also no difference between the 7-month pre-intervention period and the intervention period in the number of falls or falls injuries . Factors related to residents having an increased risk of falls with fractured neck of femur included being ambulant , having dementia , increasing age , and having a high falls risk assessment score . CONCLUSION It is difficult to change falls risk among high-risk population s , including people with dementia . The use of important strategies such as hip protectors and vitamin D and calcium supplementation increased during the study , probably with contamination of control facilities . Longer follow-up may be required to measure the impact on falls outcomes of the strategy of using a facilitating nurse . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry ACTRN12605000540617 In this prospect i ve cluster r and omized controlled trial we evaluated the impact of short-term provision of enhanced infection control support on infection control practice in nursing homes in South London . Twelve nursing homes were recruited , six each in intervention ( 300 residents ) and control ( 265 residents ) groups . Baseline observations of h and hygiene facilities , environmental cleanliness and safe disposal of clinical waste showed poor compliance in both groups . Post-intervention observations showed improvement in both groups . There was no statistical difference between the two groups in the compliance for h and hygiene facilities ( P=0.69 ) ; environmental cleanliness ( P=0.43 ) and safe disposal of clinical waste ( P=0.96 ) . In both groups , greatest improvement was in compliance with safe disposal of clinical waste and the least improvement was in h and hygiene facilities . Since infection control practice improved in intervention and control groups , we could not demonstrate that provision of short-term , enhanced , infection control support in nursing homes had a significant impact in infection control practice BACKGROUND Pain prevalence in nursing homes remains high , with multiple resident , staff , and physician barriers presenting serious challenges to its improvement . AIMS The study aims were to ( 1 ) develop and test a multifaceted , culturally competent intervention to improve nursing home pain practice s ; ( 2 ) improve staff , resident , and physician knowledge and attitudes about pain and its management ; ( 3 ) improve actual pain practice s in nursing homes ; and ( 4 ) improve nursing home policies and procedures related to pain . METHODS A multifaceted , culturally competent intervention was developed and tested in six Colorado nursing homes , with another six nursing homes serving as control sites . Both educational and behavioral change strategies were employed . FINDINGS The intervention was successful in improving the percentage of residents reporting constant pain in the treatment homes . Context ual factors ( implementation of Medicare 's Nursing Home Compare report card ) appeared to exert a positive influence on pain documentation . There was no reduction in the percentage of residents reporting pain or reporting moderate/severe pain . DISCUSSION Multiple challenges to quality improvement exist in nursing homes . Turnover of nursing staff reduced actual exposure to the intervention , and turnover of directors of nursing influenced constancy of message and overall facility stability . Residents often failed to report their pain , and physicians were reluctant to alter their prescribing practice s. IMPLICATION S Any intervention to improve pain management in nursing homes must target explicitly the residents , nursing home staff , and primary care physicians . Implementation strategies need to accommo date the high turnover rates among staff , as well as the changes among the nursing home leadership . CONCLUSIONS Pain is a complex problem in the nursing home setting . Multiple factors must be considered in both the design and implementation of interventions to improve pain practice s and reduce pain prevalence in nursing homes BACKGROUND Frail older people admitted to nursing homes are at risk of a range of adverse outcomes , including pressure ulcers . Clinical decision support systems are believed to have the potential to improve care and to change the behaviour of healthcare professionals . OBJECTIVES To determine whether a multi-faceted tailored strategy to implement an electronic clinical decision support system for pressure ulcer prevention improves adherence to recommendations for pressure ulcer prevention in nursing homes . DESIGN Two-armed r and omized controlled trial in a nursing home setting in Belgium . The trial consisted of a 16-week implementation intervention between February and June 2010 , including one baseline , four intermediate , and one post-testing measurement . Primary outcome was the adherence to guideline -based care recommendations ( in terms of allocating adequate pressure ulcer prevention in residents at risk ) . Secondary outcomes were the change in resident outcomes ( pressure ulcer prevalence ) and intermediate outcomes ( knowledge and attitudes of healthcare professionals ) . SETTING R and om sample of 11 wards ( 6 experimental ; 5 control ) in a convenience sample of 4 nursing homes in Belgium . PARTICIPANTS In total , 464 nursing home residents and 118 healthcare professionals participated . METHODS The experimental arm was involved in a multi-faceted tailored implementation intervention of a clinical decision support system , including interactive education , reminders , monitoring , feedback and leadership . The control arm received a hard-copy of the pressure ulcer prevention protocol , supported by st and ardized 30 min group lecture . RESULTS Patients in the intervention arm were significantly more likely to receive fully
Output:
| Conclusions Little is known about how to improve the implementation of guidelines in nursing homes , and the evidence to support or discourage particular interventions is inconclusive . |
MS210323 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: We previously demonstrated that local massage for one minute can enhance immunogenicity of diphtheria , tetanus , and whole-cell pertussis ( DTPw ) vaccination . This study further analyzes the effects of more intense local manipulation on infants after DTPw and DTPa ( diphtheria , tetanus , and acellular pertussis ) vaccination . A total of 808 infants aged two months were recruited to be vaccinated with either DTPw or DTPa . Vaccinees in both groups were further divided into two groups ; those receiving local manipulation ( massage and hot packing after vaccinations ) and those receiving only vaccinations . Results showed that safety profiles were largely similar between those who had local manipulation following vaccination and those without . The only significant difference was more frequent local reactions including pain and swelling following the first two doses in both the DTPa and DTPw groups receiving manipulation compared with the groups not receiving manipulation . Serologic tests revealed that local manipulation had no significant effect on antibody response to pertussis toxin and filamentous hemagglutinin , and diphtheria and tetanus toxins . The effect of local massage on DTPw was related to the intensity of local massage . Too vigorous a local manipulation caused adverse local reactions and no beneficial effect on antibody response . As for the infants receiving DTPa and local massages for two minutes with hot packing , no significant effect on either the reactogenicity or immunogenicity was found AIMS This study examined the effectiveness of non-nutritive sucking on preterm infant pain , changes in infant behaviour and frequency of abnormal physiological signals during heel stick procedures in Taiwan . BACKGROUND Preterm infants ' repetitive exposure to painful procedures may result in changes to brain organisation . Pain management should be a priority in neonatal care . DESIGN R and omised control trial . METHODS Preterm infants ( gestational age 28.9 - 37 weeks ) were r and omised to two groups : those receiving ( experimental , n = 52 ) or not receiving non-nutritive sucking ( control , n = 52 ) during heel stick procedures . Pain was measured before ( for three minutes ) , during and after ( during 10-minute recovery ) heel stick procedures by the Premature Infant Pain Profile , changes in infant behaviour and abnormal physiological parameters . Results . Infants in both groups had similar odds ratios for pain and moderate-to-severe pain ( 0.57 and 0.58 , respectively ) , after adjusting for time effects , postconceptional age , heel stick duration , painful experiences and baseline Premature Infant Pain Profile score . The pain scores of infants with non-nutritive sucking were significantly lower than those of non-nutritive sucking infants at all eight phases of the heel stick procedures . Infants undergoing heel stick procedures in the experimental group had lower rates ratios for ' grimace ' and ' h and to mouth or face ' behaviours than control infants ( 0.73 and 0.78 , respectively ) . CONCLUSION Non-nutritive sucking effectively reduced pain , particularly mild to moderate pain and behavioural responses to pain in infants receiving heel stick procedures , suggesting that nurses can offer this intervention to relieve pain in preterm infants undergoing invasive procedures . RELEVANCE TO CLINICAL PRACTICE Infants should be given an appropriate-sized pacifier for comfort during painful procedures . Nurses need to be informed about the effectiveness of non-nutritive sucking , its analgesic mechanisms and how to use and incorporate it into practice OBJECTIVE To test the efficacy of maternal skin-to-skin contact , or kangaroo care ( KC ) , on diminishing the pain response of preterm neonates to heel lancing . DESIGN A crossover design was used , in which the neonates served as their own controls . Subjects Preterm neonates ( n = 74 ) , between 32 and 36 weeks ' postmenstrual age and within 10 days of birth , who were breathing without assistance and who were not receiving sedatives or analgesics in 3 level II to III neonatal intensive care units in Canada . INTERVENTIONS In the experimental condition , the neonate was held in KC for 30 minutes before the heel-lancing procedure and remained in KC for the duration of the procedure . In the control condition , the neonate was in the prone position in the isolette . The ordering of conditions was r and om . MAIN OUTCOME MEASURES The primary outcome was the Premature Infant Pain Profile , which is composed of 3 facial actions , maximum heart rate , and minimum oxygen saturation changes from baseline in 30-second blocks . Videotapes , taken with the camera positioned on the neonate 's face so that an observer could not tell whether the neonate was being held or was in the isolette , were coded by research assistants who were naïve to the purpose of the study . Heart rate and oxygen levels were continuously monitored into a computer for later analysis . A repeated- measures analysis of covariance was used , with order of condition and site as factors and severity of illness as a covariate . RESULTS Premature Infant Pain Profile scores across the first 90 seconds from the heel-lancing procedure were significantly ( .002<P<.04 ) lower by 2 points in the KC condition . CONCLUSIONS For preterm neonates who are 32 weeks ' postmenstrual age or older , KC seems to effectively decrease pain from heel lancing . Further study is needed to determine if younger neonates or those requiring assistance in breathing , or older infants or toddlers , would benefit from KC , or if it would remain effective over several procedures . Given its effectiveness , and that parents of neonates in critical care units want to participate more in comforting their children , KC is a potentially beneficial strategy for promoting family health This experiment had three goals : 1 . To identify the basis of sucking-induced analgesia in healthy , term , newborn humans undergoing the painful , routine , procedure of heel lance and blood collection . 2 . To evaluate how taste-induced and sucking-induced analgesias combine to combat pain . 3 . To determine whether facial grimacing was an accurate index of diminished pain , or whether it was linked to tissue trauma . We report that : 1 . Sucking an unflavored pacifier was analgesic when and only when suck rate exceeded 30 sucks/min . 2 . The combination of sucrose and nonnutritive sucking was remarkably analgesic ; we saw no behavioral indication in nine of the ten infants that the heel lance had even occurred . 3 . Grimacing was reduced to almost naught by procedures that essentially eliminated crying and markedly reduced heart rate during the blood harvesting procedure Background Co-bedding , a developmental care strategy , is the practice of caring for diaper clad twins in one incubator ( versus separating and caring for each infant in separate incubators ) , thus creating the opportunity for skin-to-skin contact and touch between the twins . In studies of mothers and their infants , maternal skin-to-skin contact has been shown to decrease procedural pain response according to both behavioral and physiological indicators in very preterm neonates . It is uncertain if this comfort is derived solely from maternal presence or from stabilization of regulatory processes from direct skin contact . The intent of this study is to compare the comfort effect of co-bedding ( between twin infants who are co-bedding and those who are not ) on infant pain response and physiologic stability during a tissue breaking procedure ( heelstick ) . Methods / Design Medically stable preterm twin infants admitted to the Neonatal Intensive Care Unit will be r and omly assigned to a co-bedding group or a st and ard care group . Pain response will be measured by physiological and videotaped facial reaction using the Premature Infant Pain Profile scale ( PIPP ) . Recovery from the tissue breaking procedure will be determined by the length of time for heart rate and oxygen saturation to return to baseline . Sixty four sets of twins ( n = 128 ) will be recruited into the study . Analysis and inference will be based on the intention-to-treat principle . Discussion If twin contact while co-bedding is determined to have a comforting effect for painful procedures , then changes in current neonatal care practice s to include co-bedding may be an inexpensive , non invasive method to help maintain physiologic stability and decrease the long term psychological impact of procedural pain in this high risk population . Knowledge obtained from this study will also add to existing theoretical models with respect to the exact mechanism of comfort through touch . Trial registration OBJECTIVE . The role of laparoscopic surgery in pediatric inguinal hernia repair is unclear . We aim ed to compare day-case laparoscopic hernia repair with open repair . METHODS . A prospect i ve , single-blinded r and omized study in children aged 4 months to 16 years with unilateral inguinal hernia was performed . The primary outcome measure was the time to normal daily activities after surgery . Secondary outcome measures included postoperative pain , time in the operation room , results , and complications . RESULTS . Eighty-nine patients were enrolled ( laparoscopic hernia repair : 47 , open repair : 42 ) . The mean number of days to normal activity after laparoscopic hernia repair and open repair was 2.4 and 2.5 , respectively . Thirty-seven ( 79 % ) patients with laparoscopic hernia repair and 20 ( 42 % ) with open repair required rescue analgesia postoperatively . The median pain score in the second postoperative morning was significantly higher after laparoscopic hernia repair . The median times in the operation room for laparoscopic hernia repair and open repair were 63 and 38 minutes , respectively . Surgical and cosmetic results were similar at up to 2 years ' follow-up . CONCLUSIONS . Recovery and outcome were similar after open repair and laparoscopic hernia repair in children . Laparoscopic hernia repair was associated with increased theater time and postoperative pain BACKGROUND : Suprapubic aspiration ( SPA ) and urine catheterization ( UC ) are performed frequently in preterm neonates to rule out urinary tract infection ; however , a comparison of the pain caused by both procedures has not been made previously . OBJECTIVE : To compare pain responses in preterm infants who are undergoing urine collection by using SPA versus UC . METHODS : Prospect i ve , single-blind , r and omized clinical trial was conducted in 2 NICUs . Preterm infants who required urine sample s for microbiologic analysis were r and omly assigned to undergo either SPA or UC . The infants ' facial and physiologic responses were videotaped during the procedure and later scored by a research assistant who was blind to the method of urine collection . The primary outcome measure was facial-grimacing during the procedure , which was assessed by measuring the percentage of time the infants displayed brow-bulging . Secondary outcomes included changes in heart rate ( beats per minute ) , oxygen saturation ( % ) , and procedural success rate . RESULTS : Forty-eight preterm infants participated . Characteristics did not differ ( P > .05 ) between groups . The mean ( SD ) percent brow-bulging score was higher in the SPA group than in the UC group ( 67 % [ 34 ] vs 42 % [ 38 ] ; P = .02 ) . Heart rate and oxygen saturation did not differ ( P = .50 and .74 , respectively ) . The procedure-success rate , although lower in the SPA group , was not statistically different ( 60 % vs 78 % ; P = .17 ) . CONCLUSIONS : SPA was more painful than UC , as assessed by brow-bulging , and had a tendency to be associated with a higher rate of procedure failure . These findings should be taken into consideration when choosing between these 2 procedures for preterm infants who undergo urine sampling OBJECTIVES : Cobedding of preterm twin infants provides tactile , olfactory , and auditory stimulation and may affect pain reactivity . We carried out a r and omized trial to assess the effect of cobedding on pain reactivity and recovery in preterm twin neonates . METHODS : Stable preterm twins ( n = 67 sets ) between 28 and 36 weeks of gestational age were r and omly assigned to a cobedding group ( cared for in the same incubator or crib ) or a st and ard care group ( cared for in separate incubators or cribs ) . Pain response ( determined by the Premature Infant Pain Profile [ PIPP ] ) and time to return to physiologic baseline parameters were compared between groups with adjustment for the nonindependence of twin infants . RESULTS : Maternal and infant characteristics were not significantly different between twin infants in the cobedding and st and ard care groups except for 5-minute Apgar < 7 and postnatal age and corrected gestational age on the day of the heel lance . Mean PIPP scores were not different between groups at 30 , 60 , or 120 seconds . At 90 seconds , mean PIPP scores were higher in the cobedding group ( 6.0 vs 5.0 , P = .04 ) . Recovery time was shorter in the cobedding group compared with the st and ard care group , ( mean = 75.6 seconds versus 142.1 seconds , P = .001 ) . No significant adverse events were associated with cobedding . Adjustment for nonindependence between twins and differences in baseline characteristics did not change the results . CONCLUSIONS : Cobedding enhanced the physiologic recovery of preterm twins undergoing heel lance , but did not lead to lower pain scores The objective of this study was to compare the effects of containment and swaddling on premature infants ' heart rates ( HR ) , oxygen saturation ( SpO(2 ) , and the Premature Infant Pain Profile ( PIPP ) scores after heelstick . The study used a cross-over experimental design , 32 premature infants with gestational age < 3
Output:
| There is evidence that different non-pharmacological interventions can be used with preterms , neonates , and older infants to significantly manage pain behaviors associated with acutely painful procedures .
The most established evidence was for non-nutritive sucking , swaddling/facilitated tucking , and rocking/holding .
There are significant gaps in the existing literature on non-pharmacological management of acute pain in infancy |
MS210324 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Occupational sedentary behaviour is an important contributor to overall sedentary risk . There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours . The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time , sustained sedentary time ( bouts > 30 minutes ) , increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity ( MVPA ) during work hours . Methods A r and omised controlled trial ( ANZCTR number : ACTN12612000743864 ) was conducted using clerical , call centre and data processing workers ( n = 62 , aged 25–59 years ) in 3 large government organisations in Perth , Australia . Three groups developed interventions with a participatory approach : ‘ Active office ’ ( n = 19 ) , ‘ Active Workstation ’ and promotion of incidental office activity ; ‘ Traditional physical activity ’ ( n = 14 ) , pedometer challenge to increase activity between productive work time and ‘ Office ergonomics ’ ( n = 29 ) , computer workstation design and breaking up computer tasks . Accelerometer ( ActiGraph GT3X , 7 days ) determined sedentary time , sustained sedentary time , breaks in sedentary time , light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period . Results For all participants there was a significant reduction in sedentary time on work days ( −1.6 % , p = 0.006 ) and during work hours ( −1.7 % , p = 0.014 ) and a significant increase in number of breaks/sedentary hour on work days ( 0.64 , p = 0.005 ) and during work hours ( 0.72 , p = 0.015 ) ; there was a concurrent significant increase in light activity during work hours ( 1.5 % , p = 0.012 ) and MVPA on work days ( 0.6 % , p = 0.012 ) . Conclusions This study explored novel ways to modify work practice s to reduce occupational sedentary behaviour . Participatory workplace interventions can reduce sedentary time , increase the frequency of breaks and improve light activity and MVPA of office workers by using a variety of interventions . Trial Registration Australian New Zeal and Clinical Trials Registry ACTN12612000743864 PURPOSE Although moderate-to-vigorous physical activity is related to premature mortality , the relationship between sedentary behaviors and mortality has not been fully explored and may represent a different paradigm than that associated with lack of exercise . We prospect ively examined sitting time and mortality in a representative sample of 17,013 Canadians 18 - 90 yr of age . METHODS Evaluation of daily sitting time ( almost none of the time , one fourth of the time , half of the time , three fourths of the time , almost all of the time ) , leisure time physical activity , smoking status , and alcohol consumption was conducted at baseline . Participants were followed prospect ively for an average of 12.0 yr for the ascertainment of mortality status . RESULTS There were 1832 deaths ( 759 of cardiovascular disease ( CVD ) and 547 of cancer ) during 204,732 person-yr of follow-up . After adjustment for potential confounders , there was a progressively higher risk of mortality across higher levels of sitting time from all causes ( hazard ratios ( HR ) : 1.00 , 1.00 , 1.11 , 1.36 , 1.54 ; P for trend < 0.0001 ) and CVD ( HR:1.00 , 1.01 , 1.22 , 1.47 , 1.54 ; P for trend < 0.0001 ) but not cancer . Similar results were obtained when stratified by sex , age , smoking status , and body mass index . Age-adjusted all-cause mortality rates per 10,000 person-yr of follow-up were 87 , 86 , 105 , 130 , and 161 ( P for trend < 0.0001 ) in physically inactive participants and 75 , 69 , 76 , 98 , 105 ( P for trend = 0.008 ) in active participants across sitting time categories . CONCLUSIONS These data demonstrate a dose-response association between sitting time and mortality from all causes and CVD , independent of leisure time physical activity . In addition to the promotion of moderate-to-vigorous physical activity and a healthy weight , physicians should discourage sitting for extended periods Even when adults meet physical activity guidelines , sitting for prolonged periods can compromise metabolic health . Television ( TV ) time and objective measurement studies show deleterious associations , and breaking up sedentary time is beneficial . Sitting time , TV time , and time sitting in automobiles increase premature mortality risk . Further evidence from prospect i ve studies , intervention trials , and population -based behavioral studies is required Objective : To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers . Methods : A r and omized controlled trial was conducted among overweight/obese office workers ( n = 41 ; mean age = 40.1 ± 10.1 years ) at a private workplace . Participants were r and omly assigned to a shared-treadmill desk intervention ( n = 21 ) or a usual working condition control group ( n = 20 ) . Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention . Results : Compared with the control group , the intervention group increased daily steps ( 1622 steps/day ; P = 0.013 ) and light physical activity ( 1.6 minutes/hour ; P = 0.008 ) , and decreased sedentary time ( −3.6 minutes/hour ; P = 0.047 ) during working hours . Conclusions : Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity ( specifically 40 to 99 steps/minute ) and sedentary behavior among overweight/obese office workers Background Prolonged sitting time is detrimental for health . Individuals with desk-based occupations tend to sit a great deal and sit-st and workstations have been identified as a potential strategy to reduce sitting time . Hence , the objective of the current study was to examine the effects of using sit-st and workstations on office workers ’ sitting time at work and over the whole day . Methods We conducted a r and omized controlled trial pilot with crossover design and waiting list control in Sydney , Australia from September 2011 to July 2012 ( n = 42 ; 86 % female ; mean age 38 ± 11 years ) . Participants used a sit-st and workstation for four weeks in the intervention condition . In the time-matched control condition , participants received nothing and crossed over to the intervention condition after four weeks . The primary outcomes , sitting , st and ing and walking time at work , were assessed before and after using the workstations with ActivPALs and self-report question naires . Secondary outcomes , domain-specific sitting over the whole day , were assessed by self-report . Linear mixed models estimated changes in outcomes adjusting for measurement time , study grouping and covariates . Results Intervention participants significantly reduced objective ly assessed time spent sitting at work by 73 min/workday ( 95 % CI : -106,-39 ) and increased st and ing time at work by 65 min/workday ( 95 % CI : 47 , 83 ) ; these changes were significant relative to controls ( p = 0.004 and p < 0.001 , respectively ) . Total sitting time significantly declined in intervention participants ( -80 min/workday ; 95 % CI : -155 , -4 ) . Conclusions This study shows that introducing sit-st and workstations in the office can reduce desk-based workers ’ sitting time at work in the short term . Larger scale studies on more representative sample s are needed to determine the public health impact of sit-st and workstations . Trial registration Objectives To test the efficacy of a multicomponent technology intervention for reducing daily sedentary time and improving cardiometabolic disease risk among sedentary , overweight university employees . Design Blinded , r and omised controlled trial . Setting A large south-eastern university in the USA . Participants 49 middle-aged , primarily female , sedentary and overweight adults working in sedentary jobs enrolled in the study . A total of 40 participants completed the study . Interventions Participants were r and omised to either : ( 1 ) an intervention group ( N=23 ; 47.6 + 9.9 years ; 94.1 % female ; 33.2 + 4.5 kg/m2 ) ; ( 2 ) or wait-list control group ( N=17 ; 42.6 + 8.9 years ; 86.9 % female ; 31.7 + 4.9 kg/m2 ) . The intervention group received a theory-based , internet-delivered programme , a portable pedal machine at work and a pedometer for 12 weeks . The wait-list control group maintained their behaviours for 12 weeks . Outcome measures Primary ( sedentary and physical activity behaviour measured objective ly through StepWatch ) and secondary ( heart rate , blood pressure , height , weight , waist circumference , per cent body fat , cardiorespiratory fitness , fasting lipids ) outcomes were measured at baseline and postintervention ( 12 weeks ) . Exploratory outcomes including intervention compliance and process evaluation measures were also assessed postintervention . Results Compared to controls , the intervention group reduced daily sedentary time ( mean change ( 95%CI ) : −58.7 min/day ( −118.4 to 0.99 ; p<0.01 ) ) after adjusting for baseline values and monitor wear time . Intervention participants logged on to the website 71.3 % of all intervention days , used the pedal machine 37.7 % of all working intervention days and pedalled an average of 31.1 min/day . Conclusions These findings suggest that the intervention was engaging and result ed in reductions in daily sedentary time among full-time sedentary employees . These findings hold public health significance due to the growing number of sedentary jobs and the potential of these technologies in large-scale worksite programmes . Trial Registration Clinical Trials.gov # NCT01371084 Introduction The objective of this study was to assess change in sitting and physical activity behavior in response to a workplace intervention to disrupt prolonged sitting time . Methods Sixty office workers were r and omized to either a St and group ( n = 29 ) , which received hourly prompts ( computer-based and wrist-worn ) to st and up , or a Step group ( n = 31 ) , which received the same hourly prompts and an additional prompt to walk 100 steps or more upon st and ing . An ActivPAL monitor was used to assess sitting and physical activity behavior on the same 3 consecutive workdays during baseline and intervention periods . Mixed-effect models with r and om intercepts and r and om slopes for time were performed to assess change between groups and across time . Results Both groups significantly reduced duration of average sitting bouts ( St and group , by 16 % ; Step group , by 19 % ) and the number of sitting bouts of 60 minutes or more ( Step group , by 36 % ; St and group , by 54 % ) . The St and group significantly reduced total sitting time ( by 6.6 % ) , duration of the longest sitting bout ( by 29 % ) , and number of sitting bouts of 30 minutes or more ( by 13 % ) and increased the number of sit-to-st and transitions ( by 15 % ) and st and ing time ( by 23 % ) . Stepping time significantly increased in the St and ( by 14 % ) and Step ( by 29 % ) groups , but only the Step group significantly increased ( by 35 % ) the number of steps per workday . Differences in changes from baseline to intervention between groups were not significant for any outcome . Conclusion Interventions that focus on disrupting sitting time only in the workplace may result in less sitting . When sitting time disruptions are paired with a physical activity prompt , people may be more likely to increase their workday physical activity , but the effect on sitting time may be attenuated Objective : This study was conducted to determine whether installation of sit-st and desks ( SSDs ) could lead to decreased sitting time during the workday among sedentary office workers . Methods : A r and omized cross-over trial was conducted from January to April , 2012 at a business in Minneapolis . 28 ( nine men , 26 full-time ) sedentary office workers took part in a 4 week intervention period which included the use of SSDs to gradually replace 50 % of sitting time with st and ing during the workday . Physical activity was the primary outcome . Mood , energy level , fatigue , appetite , dietary intake , and productivity were explored as secondary outcomes . Results : The intervention reduced sitting time at work by 21 % ( 95 % CI 18%–25 % ) and sedentary time by 4.8 min/work-hr ( 95 % CI 4.1–5.4 min/work-hr ) . For a 40 h work-week , this translates into replacement of 8 h of sitting time with st and ing and sedentary time being reduced by 3.2 h. Activity level during non-work hours did not change . The intervention also increased overall sense of well-being , energy , decreased fatigue , had no impact on productivity , and reduced appetite and dietary intake . The workstations were popular with the participants . Conclusion : The SSD intervention was successful in increasing work-time activity level , without changing activity level during non-work hours BACKGROUND Prolonged sitting is prevalent in the workplace and is associated with adverse health markers . PURPOSE Investigate the
Output:
| Conclusion : Environmental work site interventions to reduce sedentary behavior show promise because work sites often have more control over environmental factors . |
MS210325 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIM Despite the lateral epicondylitis or tennis elbow is a common cause of pain in orthopaedic and sports medicine , the results of the different modalities of conservative treatment are still contradictory . The pourpose of this study was to evaluate the efficacy of radial shock wave therapy ( RSWT ) in the treatment of tennis elbow . METHODS In a prospect i ve r and omized controlled single-blind study , of 75 eligible patients , 62 with tennis elbow were r and omly assigned to study group and control group . There were 31 patients in the study group and 31 patients in the control group . Both groups had received a treatment a week for 4 weeks ; the study group had received 2000 impulses of RSWT and the control group 20 impulses of RSWT . All patients were evaluated 3 times : before treatment , at the end of treatment and to 6 months follow-up . The evaluation consisted of assessment s of pain , pain-free grip strength test , and functional impairment . RESULTS Statistical analysis of visual analogue scale ( VAS ) , disabilities of the arm , shoulder , and h and ( DASH ) question naire and pain-free grip strength test scores has shown , both after treatment and to the follow-up at 6 months , significant difference comparing study group versus control group ( P < 0.001 ) . Statistical analysis within the groups , showed always statistically significant values for the study group . Also the control group showed statistically significant differences for some analyzed parameters . Nevertheless such differences result ed to be more statistics that not clinics as it showed the percentage of satisfied patients in the study group ( 87 % post-treatment ; 84 % follow-up ) in comparison with that of the control group ( 10 % post-treatment ; 3 % follow-up ) , and the number needed to treat ( NNT ) that is of 1.15 at post-treatment and of 1.25 to the 6 months follow-up . CONCLUSION The use of RSWT allowed a decrease of pain , and functional impairment , and an increase of the pain-free grip strength test , in patients with tennis elbow . The RSWT is safe and effective and must be considered as possible therapy for the treatment of patients with tennis elbow AIM Prognosis and treatment of Achilles tendon pain ( achillodynia ) has been insufficiently studied . The purpose of the present study was to examine the long-term effect of eccentric exercises compared with stretching exercises on patients with achillodynia . METHODS Patients with achillodynia for at least 3 months were r and omly allocated to one of two exercise regimens . Exercise was performed daily for a 3-month period . Symptom severity was evaluated by tendon tenderness , ultrasonography , a question naire on pain and other symptoms , and a global assessment of improvement . Follow-up was performed at time points 3 , 6 , 9 , 12 weeks and 1 year . RESULTS Of 53 patients with achillodynia 45 patients were r and omized to either eccentric exercises or stretching exercises . Symptoms gradually improved during the 1-year follow-up period and were significantly better assessed by pain and symptoms after 3 weeks and all later visits . However , no significant differences could be observed between the two groups . Women and patients with symptoms from the distal part of the tendon had significantly less improvement . CONCLUSIONS Marked improvement in symptoms and findings could be gradually observed in both groups during the 1-year follow-up period . To that extent this is due to effect of both regimens or the spontaneous improvement is unsettled Injuries involving the Achilles tendon and manifested as chronic tendon pain are common , especially among recreational athletes . In a pilot study on a small group of patients with chronic painful mid-portion Achilles tendinosis , eccentric calf-muscle training was shown to give good clinical results . The aim of this prospect i ve study was to investigate if the previously achieved good clinical results could be reproduced in a larger group of patients , and also to investigate the effects of eccentric calf-muscle training in patients with chronic insertional Achilles tendon pain . Seventy-eight consecutive patients , having chronic painful Achilles tendinosis at the mid-portion ( 2–6 cm level ) in a total of 101 tendons ( 55 unilateral and 23 bilateral ) , and thirty consecutive patients with chronic insertional Achilles tendon pain in 31 tendons ( 29 unilateral and one bilateral ) were treated with eccentric calf-muscle training for 12 weeks . Most patients were recreational athletes . Evaluation of the amount of tendon pain during activity was recorded on a visual analogue scale ( VAS ) , before and after treatment . In 90 of the 101 Achilles tendons ( 89 % ) with chronic painful mid-portion Achilles tendinosis , treatment was satisfactory and the patients were back on their pre-injury activity level after the 12-week training regimen . In these patients , the amount of pain during activity , registered on the VAS-scale ( mean±SD ) , decreased significantly from 66.8±19.4 to 10.2±13.7 . On the contrary , in only ten of the tendons ( 32 % ) with chronic insertional Achilles tendon pain was treatment satisfactory , with a significant decrease on the VAS-scale ( mean±SD ) , from 68.3±7.0 to 13.3±13.2 . Our conclusion is that treatment with eccentric calf-muscle training produced good clinical results in patients with chronic painful mid-portion Achilles tendinosis , but not in patients with chronic insertional Achilles tendon pain 70 consecutive adult , nonrheumatic patients with a painful achilles tendinopathy were r and omized to treatment with either a nonsteroid antiinflammatory drug ( piroxicam ) or placebo . Both groups received adjunct treatment with a period of rest combined with stretching and strengthening exercises . 52/70 cases were engaged in various sports , notably running . All subjects were evaluated on days 3 , 7 , 14 , and 28 with respect to pain , tenderness , swelling , ankle joint movement and muscle strength . Results were judged from residual symptoms and an overall assessment of the efficacy . No differences were seen between the groups at any time during the study . The overall result was identical with a rate of success slightly better than 50 percent which corresponds to the placebo response reported in other studies Achilles tendinopathy is common and treatment with eccentric exercises seems promising . We design ed a prospect i ve r and omized clinical trial to test the hypothesis that eccentric calf muscle exercises reduce pain and improve function in patients with Achilles tendinopathy . Forty-four patients were recruited from primary care ( mean age : 45 years ; 23 women ; 65 % active in sports ) and r and omized to three treatment groups for 12 weeks : eccentric exercises , a night splint or a combination of both treatments . Pain and function were evaluated at 6 , 12 , 26 and 52 weeks by the Foot and Ankle Outcome Score . At 6 weeks , the eccentric group reported a significant pain reduction ( 27 % compared with baseline , P = 0.007 ) which lasted for 1 year ( 42 % , P = 0.001 ) . The two groups treated with a night splint also reported significant but less pain reduction than the eccentric group . Differences between all the three groups were not significant . At 12 weeks , the eccentric group reported significantly less pain than the splint-only group ( P = 0.04 ) . More patients in the eccentric group than in the splint group returned to sport after 12 weeks . We conclude that eccentric exercises seem to reduce pain and improve function in patients with Achilles tendinopathy . Our results are in line with previous studies and strengthen the recommendation that patients should undergo an eccentric exercise program prior to considering other treatments such as surgery A double-blind , controlled study is presented on the effect of low-dosage heparin on acute calcaneal peritendinitis crepitans in young men . Treatment consisted in exemption from physical work and subcutaneous injection of heparin . 5000 I.U. , or placebo , once a day for 5 consecutive weekdays . During the first week the mean total symptom score showed a gradual fall to 32 and 34 % of the baseline values in the heparin ( n = 10 ) and the placebo group ( n = 10 ) , respectively . On day 15 the value was unchanged in the heparin group , whereas it had increased again to 45 % in the placebo group . However , the symptoms and signs recorded never differed significantly between the two groups . No adverse reactions were observed . Consequently , further studies are needed to show whether a treatment of acute peritendinitis can be obtained with heparin in a dosage with less risk of bleeding than that involved in the previously reported regimen A retrospective study is presented of 83 athletes with tendo Achillis pain ( TAP ) treated conservatively over a 12-year period from 1976 to 1988 . Local steroid injections did not contribute to an earlier return to sport , though many individuals were improved symptomatically . Local steroids were not found to have a deleterious effect on outcome . Steroids were used most frequently in the chronic cases that presented late and had been treated previously : this group had most recurrences and surgical intervention . One case of Achilles rupture ( 3 % ) occurred in the group treated with steroids . Early presentation for treatment led to an earlier return to sport and avoidance of recurrences . Recurrences were most frequent in athletes with bilateral Achilles tendinopathy . The tendo Achillis lesion may range from peritendinitis through a mixed lesion of the tendon and paratenon , to complete rupture . The management depends upon accurate diagnosis , its chronicity and the age and aspirations of the patient . Steroids are safe to use and further prospect i ve trials should note presentation time and disease staging accurately BACKGROUND Extracorporeal shock wave therapy ( ESWT ) is an increasingly popular therapeutic approach in the management of a number of tendinopathies . Benefit has been shown in calcific tendinitis of the rotator cuff , but evidence for its use in non-calcific disorders is limited . AIMS To perform a double blind r and omised controlled trial of moderate dose shock wave therapy in plantar fasciitis . METHODS Adults with plantar fasciitis for at least 3 months were r and omised to receive either active treatment ( 0.12 mJ/mm(2 ) ) or sham therapy , monthly for 3 months . Pain in the day , nocturnal pain and morning start-up pain were assessed at baseline , before each treatment and 1 and 3 months after completion of therapy . RESULTS Eighty-eight subjects participated and no differences existed between the groups at baseline . At 3 months , 37 % of the subjects in the ESWT group and 24 % in the sham group showed a positive response ( 50 % improvement from baseline ) with respect to pain . Positive responses in night pain occurred in 41 % and 31 % in the ESWT and sham groups , respectively . Positive responses in start-up pain occurred in 37 % and 36 % in the ESWT and sham groups , respectively . Both groups showed significant improvement over the course of the study , but no statistically significant difference existed between the groups with respect to the changes were seen in any of the outcome measures over the 6-month period . CONCLUSIONS There appears to be no treatment effect of moderate dose ESWT in subjects with plantar fasciitis . Efficacy may be highly dependent upon machine types and treatment protocol s. Further research is needed to develop evidence based recommendation for the use ESWT in musculoskeletal complaints Background : Low level laser therapy ( LLLT ) has gained increasing popularity in the management of tendinopathy and arthritis . Results from in vitro and in vivo studies have suggested that inflammatory modulation is one of several possible biological mechanisms of LLLT action . Objective : To investigate in situ if LLLT has an anti-inflammatory effect on activated tendinitis of the human Achilles tendon . Subjects : Seven patients with bilateral Achilles tendinitis ( 14 tendons ) who had aggravated symptoms produced by pain inducing activity immediately before the study . Method : Infrared ( 904 nm wavelength ) LLLT ( 5.4 J per point , power density 20 mW/cm2 ) and placebo LLLT ( 0 J ) were administered to both Achilles tendons in r and om blinded order . Results : Ultrasonography Doppler measurements at baseline showed minor inflammation through increased intratendinous blood flow in all 14 tendons and measurable resistive index in eight tendons of 0.91 ( 95 % confidence interval 0.87 to 0.95 ) . Prostagl and in E2 concentrations were significantly reduced 75 , 90 , and 105 minutes after active LLLT compared with concentrations before treatment ( p = 0.026 ) and after placebo LLLT ( p = 0.009 ) . Pressure pain threshold had increased significantly ( p = 0.012 ) after active LLLT compared with placebo LLLT : the mean difference in the change between the groups was 0.40 kg/cm2 ( 95 % confidence interval 0.10 to 0.70 ) . Conclusion : LLLT at a dose of 5.4 J per point can reduce inflammation and pain in activated Achilles tendinitis . LLLT may therefore have potential in the management of diseases with an inflammatory component In a previous uncontrolled pilot study we demonstrated very good clinical results with eccentric calf muscle training on patients with painful chronic Achilles tendinosis located at the 2–6 cm level in the tendon . In the present prospect i ve multicenter study ( Sundsvall and Umeå ) patients with painful chronic Achilles tendinosis at the 2–6 cm level in the tendon were r and omized to treatment with either an eccentric or a concentric training regimen for the calf muscles . The study
Output:
| Eccentric exercises have the most evidence of effectiveness in treatment of midportion Achilles tendinopathy . |
MS210326 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: Background Patients at increased risk of sexually transmitted infections (STIs)/HIV acquisition are advised to reattend for retesting . A previous study showed that ‘ generic ’ text reminders did not improve reattendance . Aim To assess if a personalised text message with increased contact information would increase reattendance rates of at-risk patients . Methods Patients who are at risk of future STIs , defined by having a current acute STI , attending for emergency contraception , commercial sex workers ( CSWs ) or men who have sex with men ( MSM ) , were sent a text reminder to reattend for retesting 6 weeks after initial visit . Reattendance rates were measured for September to December 2012 ( control group who received a generic text message ) and February to May 2014 ( intervention ‘ personalised message ’ group who received a text message containing their first name and ways to contact the clinic ) . Reattendance was counted within 4 months of the end of the initial episode of care . Results The reattendance rate was significantly higher for the intervention group : 149/266 ( 56 % ) than the control group : 90/273 ( 33 % ) ( p=0.0001 ) and was also significantly higher in the intervention group than the control group in patients with the following risks : recent chlamydia ( 64/123 ( 52 % ) vs 43/121 ( 36 % ) ) ( p=0.03 ) , recent gonorrhoea ( 41/64 ( 64 % ) vs 4/21 ( 19 % ) ) ( p=0.0003 ) and MSM ( 26/45 ( 58 % ) vs 3/18 ( 16 % ) ) ( p=0.006 ) . New STI rates in the reattending intervention group and controls were 26/ 149 ( 17 % ) and 13/90 ( 14 % ) ( n.s ) , respectively . Conclusions Sending a personalised text message with increased contact information as a reminder for retesting increased reattendance rates by 23 % in patients who are at higher risk of STIs BACKGROUND Frequent testing of individuals at high risk of HIV is central to current prevention strategies . We aim ed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men , with a particular focus on men who delayed testing or had never been tested before . METHODS In this r and omised trial , HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia . Enrolled participants were r and omly assigned ( 1:1 ) to the intervention ( free HIV self-testing plus facility-based testing ) or st and ard care ( facility-based testing only ) . Participants completed a brief online question naire every 3 months , which collected the number of self-tests used and the number and location of facility-based tests , and HIV testing was subsequently source d from clinical records . The primary outcome of number of HIV tests over 12 months was assessed overall and in two strata : recent ( last test ≤2 years ago ) and non-recent ( > 2 years ago or never tested ) testers . A statistician who was masked to group allocation analysed the data ; analyses included all participants who completed at least one follow-up question naire . After the 12 month follow-up , men in the st and ard care group were offered free self-testing kits for a year . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12613001236785 . FINDINGS Between Dec 1 , 2013 , and Feb 5 , 2015 , 182 men were r and omly assigned to self-testing , and 180 to st and ard care . The analysis population included 178 ( 98 % ) men in the self-testing group ( 174 person-years ) and 165 ( 92 % ) in the st and ard care group ( 162 person-years ) . Overall , men in the self-testing group had 701 HIV tests ( 410 self-tests ; mean 4·0 tests per year ) , and men in the st and ard care group had 313 HIV tests ( mean 1·9 tests per year ) ; rate ratio ( RR ) 2·08 ( 95 % CI 1·82 - 2·38 ; p<0·0001 ) . Among recent testers , men in the self-testing group had 627 tests ( 356 self-tests ; mean 4·2 per year ) , and men in the st and ard care group had 297 tests ( mean 2·1 per year ) ; RR 1·99 ( 1·73 - 2·29 ; p<0·0001 ) . Among non-recent testers , men in the self-testing group had 74 tests ( 54 self-tests ; mean 2·8 per year ) , and men in the st and ard care group had 16 tests ( mean 0·7 per year ) ; RR 3·95 ( 2·30 - 6·78 ; p<0·0001 ) . The mean number of facility-based HIV tests per year was similar in the self-testing and st and ard care groups ( mean 1·7 vs 1·9 per year , respectively ; RR 0·86 , 0·74 - 1·01 ; p=0·074 ) . No serious adverse events were reported during follow-up . INTERPRETATION HIV self-testing result ed in a two times increase in frequency of testing in gay and bisexual men at high risk of infection , and a nearly four times increase in non-recent testers , compared with st and ard care , without reducing the frequency of facility-based HIV testing . HIV self-testing should be made more widely available to help increase testing and earlier diagnosis . FUNDING The National Health and Medical Research Council , Australia Background : Changing community norms to increase awareness of HIV status and reduce HIV-related stigma has the potential to reduce the incidence of HIV-1 infection in the developing world . Methods : We developed and implemented a multilevel intervention providing community-based HIV mobile voluntary counseling and testing , community mobilization , and posttest support services . Forty-eight communities in Tanzania , Zimbabwe , South Africa , and Thail and were r and omized to receive the intervention or clinic-based st and ard voluntary counseling and testing ( VCT ) , the comparison condition . We monitored utilization of community-based HIV mobile voluntary counseling and testing and clinic-based st and ard VCT by community of residence at 3 sites , which was used to assess differential uptake . We also developed quality assurance procedures to evaluate staff fidelity to the intervention . Findings : In the first year of the study , a 4-fold increase in testing was observed in the intervention versus comparison communities . We also found an overall 95 % adherence to intervention components . Study outcomes , including prevalence of recent HIV infection and community-level HIV stigma , will be assessed after 3 years of intervention . Conclusions : The provision of mobile services , combined with appropriate support activities , may have significant effects on utilization of voluntary counseling and testing . These findings also provide early support for community mobilization as a strategy for increasing testing rates Background Following HIV-1 acquisition , many individuals develop an acute retroviral syndrome and a majority seek care . Available antibody testing can not detect an acute HIV infection , but repeat testing after 2–4 weeks may detect seroconversion . We assessed the effect of appointment reminders on attendance for repeat HIV testing . Methods We enrolled , in a r and omized controlled trial , 18–29 year old patients evaluated for acute HIV infection at five sites in Coastal Kenya ( Clinical Trials.gov NCT01876199 ) . Participants were allocated 1:1 to either st and ard appointment ( a date d appointment card ) or enhanced appointment ( a date d appointment card plus SMS and phone call reminders , or in-person reminders for participants without a phone ) . The primary outcome was visit attendance , i.e. , the proportion of participants attending the repeat test visit . Factors associated with attendance were examined by bivariable and multivariable logistic regression . Principal Findings Between April and July 2013 , 410 participants were r and omized . Attendance was 41 % ( 85/207 ) for the st and ard group and 59 % ( 117/199 ) for the enhanced group , for a relative risk of 1.4 [ 95 % Confidence Interval , CI , 1.2–1.7].Higher attendance was independently associated with older age , study site , and report of transactional sex in past month . Lower attendance was associated with reporting multiple partners in the past two months . Conclusions Appointment reminders through SMS , phone calls and in-person reminders increased the uptake of repeat HIV test by forty percent . This low-cost intervention could facilitate detection of acute HIV infections and uptake of recommended repeat testing . Trial Registration Clinical trials.gov Objective To determine if the provision of rapid HIV testing to men who have sex with men attending a health service would increase their frequency of HIV testing over time . Design Non-blinded r and omised controlled trial . Setting Public sexual health service in Australia . Participants Men who reported having a male sexual partner within the previous year and an HIV test within the previous two years . Of 400 men entered , 370 ( 92.5 % ) completed the study . Interventions Men attending the service between September 2010 and March 2011 were r and omised 1:1 to either ongoing access to rapid HIV testing obtained with finger prick or to conventional HIV serology with venepuncture , over 18 months . Main outcome measure The incidence of all HIV testing after enrolment , including testing outside the study clinic , analysed by intention to treat . Results Of 200 men r and omised to the rapid testing arm , 196 were followed for 288 person years . Of 200 men r and omised to the conventional testing arm , 194 were followed for 278 person years . Median time since the last HIV test was six months for both arms . Men in the rapid test arm had 469 tests ( mean 1.63 tests a year ) , and men in the conventional test arm had 396 tests ( mean 1.42 tests a year ) ; incidence rate ratio 1.15 , 95 % confidence interval 0.96 to 1.38 ; P=0.12 . In a post hoc analysis , rates of initial HIV testing during follow-up were 1.32 and 1.01 tests a year , respectively ( 1.32 , 1.05 to 1.65 ; P=0.02 ) . Conclusions Provision of access to rapid HIV testing in a health service did not result in a sustained increase over time in HIV testing by men who have sex with men ; however , the rate of initial HIV testing did increase by a third . Further research is required to determine how to achieve sustained increases in the frequency of HIV testing by population s at risk . Trial registration ACTR No 12610000430033 We conducted an in-person survey of New York City ( NYC ) pharmacies to assess the availability , accessibility , and price of the over-the-counter , rapid HIV self-test kit . NYC pharmacies were stratified into high , moderate and low morbidity neighborhoods by the HIV diagnosis rate of the neighborhood in which the pharmacy was located . A r and om sample of 500 pharmacies was taken [ 250 from high morbidity neighborhoods ( HighMN ) and 250 from low morbidity neighborhoods ( LowMN ) ] . Pharmacies were excluded if : closed during survey , non-retail , or > 10 min walk from subway . Project staff visited pharmacies to determine kit availability ( in pharmacy on day of survey ) , accessibility ( not locked/behind counter ) , and price ( marked on shelf/product ) . Of 361 pharmacies ( 161 LowMN ; 200 HighMN ) , kits were available in 27 % and accessible in 10 % ; there was no difference by neighborhood . Kits were most often kept behind the pharmacy counter ; this was more common in HighMN than in LowMN . Kits were kept solely behind the pharmacy counter in 52 % . Median price was US $ 42.99 without variability across neighborhoods . The rapid HIV self-test had limited availability and access in retail pharmacies . The high median price measured suggests that cost remained a barrier . ResumenLlevamos a cabo una encuesta a farmacias en la ciudad de Nueva York para evaluar la disponibilidad , acceso y precio del autoexamen rápido para el VIH ( prueba casera de VIH ) . Clasificamos los barrios de la ciudad de acuerdo a si tienen una taza de diagnósticos de VIH alta , moderada o baja , y tomamos una muestra aleatoria de 500 farmacias [ 250 en áreas con una taza de diagnósticos de VIH alta ( HighMN , por sus siglas en inglés ) y 250 en áreas con una taza de diagnósticos de VIH baja ( LowMN , por sus siglas en inglés ) ] . Se excluyeron las farmacias que : estaban cerradas durante el sondeo ; las que no atienden al público ; o las que se ubican más de 10 minutos camin and o de una parada del metro . El personal del estudio visitó las farmacias para determinar la disponibilidad ( de venta el día de la encuesta ) , el acceso ( en áreas libres o detrás del mostrador ) , y el precio de venta ( marcado en el estante o en el producto ) . De 361 farmacias visitadas ( 161 LowMN ; 200 High
Output:
| Text message reminder interventions were most successful in increasing rates of frequent HIV testing .
Las intervenciones us and o recordatorios por mensajes de texto fueron más exitosas en incrementar las tasas de realizarse pruebas frecuentes . |
MS210327 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS The purpose of this r and omized controlled clinical trial was to examine the effects of three couples-focused interventions and a control condition on women and men 's resolution of depression and grief during the first year after miscarriage . METHODS Three hundred forty-one couples were r and omly assigned to nurse caring ( NC ) ( three counseling sessions ) , self-caring ( SC ) ( three video and workbook modules ) , combined caring ( CC ) ( one counseling session plus three SC modules ) , or control ( no treatment ) . Interventions , based on Swanson 's Caring Theory and Meaning of Miscarriage Model , were offered 1 , 5 , and 11 weeks after enrollment . Outcomes included depression ( CES-D ) and grief , pure grief ( PG ) and grief-related emotions ( GRE ) . Differences in rates of recovery were estimated via multilevel modeling conducted in a Bayesian framework . RESULTS Bayesian odds ( BO ) ranging from 3.0 to 7.9 favored NC over all other conditions for accelerating women 's resolution of depression . BO of 3.2 - 6.6 favored NC and no treatment over SC and CC for resolving men 's depression . BO of 3.1 - 7.0 favored all three interventions over no treatment for accelerating women 's PG resolution , and BO of 18.7 - 22.6 favored NC and CC over SC or no treatment for resolving men 's PG . BO ranging from 2.4 to 6.1 favored NC and SC over CC or no treatment for hastening women 's resolution of GRE . BO from 3.5 to 17.9 favored NC , CC , and control over SC for resolving men 's GRE . CONCLUSIONS NC had the overall broadest positive impact on couples ' resolution of grief and depression . In addition , grief resolution ( PG and GRE ) was accelerated by SC for women and CC for men OBJECTIVE To compare the efficacy of intramuscular methotrexate plus vaginal misoprostol to vaginal misoprostol alone in completing abortion in women with non-viable early first trimester pregnancy . METHOD Twenty-one women with non-viable pregnancy up to 49 days gestation were r and omized to receive intramuscular methotrexate , followed 2 days later by vaginal misoprostol or misoprostol alone . We also collected patient satisfaction information . RESULT Complete abortion occurred in all 12 ( 100 % ) women in the combined group and eight of nine ( 89 % , RR = 1.13 , CI 0.89 - 1.42 ) women in the misoprostol only group . Of the women , 75 % rated their experience as good and would choose medical management again . CONCLUSION Either methotrexate plus misoprostol or misoprostol alone effectively completed abortion in women with non-viable early pregnancy and represent acceptable medical alternatives to surgery or expectant management Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more This study was design ed to investigate the use of oral mifepristone ( RU 486 ) for the induction of natural expulsion of concepti in women with spontaneously interrupted pregnancy in the first trimester . It consisted of a double-blind placebo-controlled study of mifepristone ( 600 mg ) against placebo . A total of 46 women consulting for interrupted pregnancy were diagnosed at ultrasound with no clinical sign of miscarriage . Measurements were made of the occurrence of natural expulsion , the frequency of complete expulsion , the need for subsequent surgical evacuation , analgesia and the need for transfusion . Natural expulsion occurred within 5 days in 82 % of patients receiving mifepristone treatment versus 8 % of placebo-treated patients ( P < 0.001 ) . All patients experienced bleeding after RU 486 and two needed emergency aspiration for haemorrhagic expulsion . The treatment failed in four patients , who underwent evacuation under local anaesthesia . In the control group , 19 patients underwent evacuation under local ( n = 10 ) or general ( n = 9 ) anaesthesia . It was concluded that a st and ard oral pilot dose of 600 mg of mifepristone induces natural expulsion in 82 % of women with non-developing first trimester intrauterine pregnancies BACKGROUND Misoprostol is effective for cervical priming prior to suction evacuation in first trimester pregnancy termination . This is the first r and omized study to compare vaginal misoprostol versus expectant treatment in women presenting with spontaneous miscarriage . METHODS Sixty women presenting with spontaneous miscarriage were recruited to the study at the Queen Mary Hospital between 1998 and 1999 . They were r and omized to group 1 : misoprostol ; and group 2 : expectant management . Women in the misoprostol group received vaginal misoprostol 400 microg on days 1 , 3 and 5 . The expectant group was followed up according to the same schedule . Suction evacuation was performed if there was excessive bleeding or abdominal pain ; or if a gestational sac was detected by transvaginal scan on day 15 . RESULTS Fifty-nine women completed the trial . Those who did not require suction evacuation up to the time of return of normal menstruation were considered to be successful . The incidence of side-effects was comparable between the two groups . Three women in the expectant group and one in the misoprostol group underwent emergency suction evacuation because of excessive bleeding . The mean duration of vaginal bleeding was similar for both groups ( 14.6 days in the misoprostol group versus 15.0 days in the expectant group ) . The successful rate in the misoprostol group was significantly higher than that of the expectant group ( 83.3 versus 48.3 % , P < 0.05 ) . CONCLUSION We recommend repeated vaginal misoprostol 400 microg given on days 1 , 3 and 5 as a treatment option for women with first trimester spontaneous miscarriage OBJECTIVE To examine rates of conception and pregnancy loss and their relations with time to clinical pregnancy and reproductive outcomes . DESIGN A prospect i ve observational study . SETTING Population -based cohort in China . PATIENT(S ) Five hundred eighteen healthy newly married women who intended to conceive . Upon stopping contraception , daily records of vaginal bleeding and daily first-morning urine specimens were obtained for < or = 1 year or until a clinical pregnancy was achieved . Daily urinary hCG was assayed to detect early pregnancy loss ( EPL ) . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Conception , pregnancy loss , and time to clinical pregnancy . RESULT ( S ) The conception rate per cycle was 40 % over the first 12 months . Of the 618 detectable conceptions , 49 ( 7.9 % ) ended in clinical spontaneous abortion , and 152 ( 24.6 % ) in EPL . Early pregnancy loss was detected in 14 % of all the cycles without clinical ly recognized pregnancy , but the frequencies were lower among women with delayed time to clinical pregnancy . Early pregnancy loss in the preceding cycle was associated with increased odds of conception ( odds ratio [ OR ] , 2.6 ; 95 % confidence interval [ CI ] , 1.8 - 3.9 ) , clinical pregnancy ( OR , 2.0 ; 95 % CI , 1.3 - 3.0 ) , and EPL ( OR , 2.4 ; 95 % CI , 1.4 - 4.2 ) but was not associated with spontaneous abortion , low birth weight , or preterm birth in the subsequent cycle . CONCLUSION ( S ) We demonstrated substantial EPL in the non- clinical ly pregnant cycles and a positive relation between EPL and subsequent fertility Abstract Objective To ascertain whether a clinical ly important difference exists in the incidence of gynaecological infection between surgical management and expectant or medical management of miscarriage . Design R and omised controlled trial comparing medical and expectant management with surgical management of first trimester miscarriage . Setting Early pregnancy assessment units of seven hospitals in the United Kingdom . Participants Women of less than 13 weeks ' gestation , with a diagnosis of early fetal demise or incomplete miscarriage . Interventions Expectant management ( no specific intervention ) ; medical management ( vaginal dose of misoprostol preceded , for women with early fetal demise , by oral mifepristone 24 - 48 hours earlier ) ; surgical management ( surgical evacuation ) . Main outcome measures Confirmed gynaecological infection at 14 days and eight weeks ; need for unplanned admission or surgical intervention . Results 1200 women were recruited : 399 to expectant management , 398 to medical management , and 403 to surgical management . No differences were found in the incidence of confirmed infection within 14 days between the expectant group ( 3 % ) and the surgical group ( 3 % ) ( risk difference 0.2 % , 95 % confidence interval − 2.2 % to 2.7 % ) or between the medical group ( 2 % ) and the surgical group ( 0.7 % , − 1.6 % to 3.1 % ) . Compared with the surgical group , the number of unplanned hospital admissions was significantly higher in both the expectant group ( risk difference − 41 % , − 47 % to − 36 % ) and the medical group ( − 10 % , − 15 % to − 6 % ) . Similarly , when compared with the surgical group , the number of women who had an unplanned surgical curettage was significantly higher in the expectant group ( risk difference − 39 % , − 44 % to − 34 % ) and the medical group ( − 30 % , − 35 % to − 25 % ) . Conclusions The incidence of gynaecological infection after surgical , expectant , and medical management of first trimester miscarriage is low ( 2 - 3 % ) , and no evidence exists of a difference by the method of management . However , significantly more unplanned admissions and unplanned surgical curettage occurred after expectant management and medical management than after surgical management . Trial registration National Research Register : N0467011677/N0467073587 Abstract Objective To compare the efficacy and safety of mifepristone followed by misoprostol with misoprostol alone in the management of early pregnancy failure ( EPF ) . Study Design A r and omized double-blind placebo-controlled clinical trial . Methods Ninety-two women with EPF ≤12 weeks were recruited and r and omly allocated to receive either mifepristone 200 mg ( n = 46 ) or placebo ( n = 46 ) . Forty-eight hours later , patients in both the groups were given 800 µg misoprostol per-vaginum . If no expulsion occurred within 4 h , repeat doses of 400 µg misoprostol were given orally at 3-hourly interval to a maximum of 2 doses in women ≤9 weeks by scan and 4 doses in women > 9 weeks by scan . Results Pre-treatment of misoprostol with mifepristone significantly increased the complete abortion rate ( 86.7 vs. 57.8 % , p = 0.009 ) and , hence , reduced the need for surgical evacuation ( 13.3 vs. 42.2 % , p = 0.002 ) , induction to expulsion interval ( 4.74 ± 2.24 vs. 8.03 ± 2.77 h , p = 0.000 ) , mean number of additional doses of misoprostol required ( 0.68 vs. 1.91 , p = 0.000 ) , and side effects . Conclusion Use of mifepristone prior to misoprostol in EPF significantly improves the efficacy and reduces the side effects of misoprostol alone OBJECTIVE To compare the effect of vaginal misoprostol with that of placebo when used prior to dilation and aspiration in women with a missed abortion . METHOD Eighty-four pregnant women with a missed abortion were r and omized to receive either vaginal misoprostol ( 200 micrograms ) or placebo the day before the planned dilatation and aspiration under inhalation anesthesia . RESULT Thirty-five women ( 83.33 % ) in the misoprostol group and 6 women ( 17.14 % ) in the placebo group aborted spontaneously prior to the scheduled dilatation and aspiration , P < 0.0001 . The mean insertion to spontaneous expulsion time was 11.63 + /- 6.14 h in the misoprostol group compared to 11.95 + /- 5.43 h in placebo . In the misoprostol group two women required intramuscular pethidine for analgesia . In the placebo group there were two cases of blood loss in excess of 500 ml and one woman with a uterine perforation . CONCLUSION Vaginal administration of misoprostol to women with a missed abortion produced spontaneous expulsion of the pregnancy and reduced the need for surgical treatment BACKGROUND Mifepristone and a prostagl and in have been used successfully to terminate pregnancy in Europe and China . We report the results of a large U.S. study of mifepristone and misoprostol in women with pregnancies of up to nine weeks ' duration . METHODS We administered 600 m
Output:
| We detected unexplained inconsistency in evidence loops involving MIFE+MISO and adjusted for it .
EXP had lower effectiveness compared to other treatment options .
The effectiveness of medical treatments was similar compared to surgery .
WIDER IMPLICATION S Medical treatments for first-trimester miscarriage have similar effectiveness and side effects compared to surgery .
The addition of MIFE could increase the effectiveness of MISO and reduce side effects , although evidence is limited due to inconsistency .
EXP has lower effectiveness compared to other treatment options . |
MS210328 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE Adjuvant chemotherapy for breast cancer can have adverse effects on cognition shortly after administration . Whether chemotherapy has any long-term effects on cognition is largely unknown , yet it becomes increasingly relevant because of the widespread use of chemotherapy for early-stage breast cancer and the improved survival . We investigated whether cyclophosphamide , methotrexate , and fluorouracil ( CMF ) chemotherapy for breast cancer is associated with worse cognitive performance more than 20 years after treatment . PATIENTS AND METHODS This case-cohort study compared the cognitive performance of patients with breast cancer who had a history of adjuvant CMF chemotherapy treatment ( six cycles ; average time since treatment , 21 years ; n = 196 ) to that of a population -based sample of women never diagnosed with cancer ( n = 1,509 ) . Participants were between 50 and 80 years of age . Exclusion criteria were ever use of adjuvant endocrine therapy , secondary malignancy , recurrence , and /or metastasis . RESULTS The women exposed to chemotherapy performed significantly worse than the reference group on cognitive tests of immediate ( P = .015 ) and delayed verbal memory ( P = .002 ) , processing speed ( P < .001 ) , executive functioning ( P = .013 ) , and psychomotor speed ( P = .001 ) . They experienced fewer symptoms of depression ( P < .001 ) , yet had significantly more memory complaints on two of three measures that could not be explained by cognitive test performance . CONCLUSION Survivors of breast cancer treated with adjuvant CMF chemotherapy more than 20 years ago perform worse , on average , than r and om population controls on neuropsychological tests . The pattern of cognitive problems is largely similar to that observed in patients shortly after cessation of chemotherapy . This study suggests that cognitive deficits following breast cancer diagnosis and subsequent CMF chemotherapy can be long lasting Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem , there are few published studies that have investigated psychological interventions to address this issue . A waitlist r and omized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention ( “ ReCog ” ) that successfully targeted cancer-related cognitive decline in previously published pilot research . Participants were 29 cancer survivors who were r and omly allocated to either the intervention group or a waitlist group who received the intervention at a later date , and 16 demographically matched community volunteers with no history of cancer ( trial registration ACTRN12615000009516 , available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx ) . The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy ( CSE ) in people who have experienced cancer . Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning . Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE . There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention . Overall , the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline OBJECTIVE This research aim ed to address the gap in evidence -based treatment available for cancer survivors who are experiencing cognitive dysfunction , through piloting a novel treatment intervention . The overall research question was whether a group cognitive rehabilitation intervention would be feasible for improving cognitive function and quality of life for people who have completed cancer treatment . METHODS Three groups of adults were recruited as follows : an intervention group of 23 cancer survivors who completed a 4-week group cognitive rehabilitation treatment , a comparison group of nine cancer survivors , and a community sample of 23 adults who had never experienced cancer . Measures of objective and subjective cognitive function , quality of life , psychosocial distress , and illness perceptions were used . The research design was non-r and omised . RESULTS The results indicated that the intervention was effective in improving overall cognitive function , visuospatial/constructional performance , immediate memory , and delayed memory beyond practice effects alone . It was helpful in reducing participants ' perceptions of cognitive impairment and psychosocial distress , as well as promoting social functioning and underst and ing of cognition . The improvements were maintained at 3 months after the intervention . Participants reported a high level of satisfaction with the treatment . CONCLUSIONS The results provided evidence for the feasibility of a brief group-based cognitive rehabilitation intervention to treat cognitive problems experienced by cancer survivors Purpose / Objectives : To test combining a group intervention to build self‐efficacy for using compensatory strategies and lifestyle adjustments with brain‐training practice to improve cognition . Design : A quasiexperimental design . Setting : Texas Oncology , a community oncology practice in Austin . Sample : 20 women aged 35‐65 years , who had finished chemotherapy at least three months before the study , were within five years of completing all treatment , and had self‐reported cognitive concerns . Methods : Six group sessions to build self‐efficacy for using compensatory strategies , along with other health behaviors that affect cognitive performance , were combined with practice on a computer‐based training program . Female breast cancer survivors were recruited through flyers , mailings , and personal contacts . Main Research Variables : Cognitive performance , cognitive concerns , cognitive/memory strategies , fatigue , emotional distress , sleep disorders , and quality of life . Findings : Participants reported that the intervention was useful in building cognitive abilities . Although scores on performance tests did not increase , ratings of cognitive concerns , fatigue , emotional distress , and sleep disturbance decreased significantly . Use of cognitive/memory strategies increased significantly . Conclusions : This pilot study demonstrated the feasibility of combining a group intervention with brain‐training practice . A larger r and omized trial would afford a more rigorous test of efficacy . Implication s for Nursing : A growing body of evidence regarding potential interventions to address survivors ’ cognitive problems exists . Nurses should counsel breast cancer survivors about fatigue , sleep deprivation , and emotional distress , as well as the effects of cancer treatment on cognition Background Cancer-related cognitive dysfunction has mostly been attributed to chemotherapy ; this explanation , however , fails to account for cognitive dysfunction observed in chemotherapy-naïve patients . In a controlled , longitudinal , multisite study , we tested the hypothesis that cognitive function in breast cancer patients is affected by cancer-related post-traumatic stress . Methods Newly diagnosed breast cancer patients and healthy control subjects , age 65 or younger , underwent three assessment s within one year , including paper- and -pencil and computerized neuropsychological tests , clinical diagnostics of post-traumatic stress disorder ( PTSD ) , and self-reported cognitive function . Analysis of variance was used to compare three groups of participants - patients who did or did not receive chemotherapy and healthy control subjects-on age- and education-corrected cognitive performance and cognitive change . Differences that were statistically significant after correction for false discovery rate were investigated with linear mixed-effects models and mediation models . All statistical tests were two-sided . Results Of 226 participants ( 166 patients and 60 control subjects ) , 206 completed all assessment sessions ( attrition : 8.8 % ) . Patients demonstrated overall cognitive decline ( group*time effect on composite z -score : -0.13 , P = .04 ) and scored consistently worse on Go/Nogo errors . The latter effect was mediated by PTSD symptoms ( mediation effect : B = 0.15 , 95 % confidence interval = 0.02 to 0.38 ) . Only chemotherapy patients showed declined reaction time on a computerized alertness test . Overall cognitive performance correlated with self-reported cognitive problems at one year ( T = -0.11 , P = .02 ) . Conclusions Largely irrespective of chemotherapy , breast cancer patients may encounter very subtle cognitive dysfunction , part of which is mediated by cancer-related post-traumatic stress . Further factors other than treatment side effects remain to be investigated Importance Neurocognitive deficits ( NCD ) have been observed in non central nervous system cancers , yet short- and long-term neurocognitive data on patients treated for head and neck cancer ( HNC ) are lacking . Objective To assess objective neurocognitive function before and after definitive radiation therapy for HNC . Design , Setting , and Participants In a prospect i ve , longitudinal study , neurocognitive function and self-reported symptoms were assessed in 80 patients with histologically proven HNC requiring definitive chemoradiotherapy or radiotherapy and in 40 healthy controls 4 times ( baseline , 6 , 12 , and 24 months after baseline ) prior to commencing treatment at Princess Margaret Cancer Centre , Toronto , Canada . Main Outcomes and Measures Neurocognitive test scores were converted to age-corrected z scores ( mean , 0 ; st and ard deviation , 1 ) and reported as mean scores , st and ardized regression-based scores , and frequencies of impairments in intellectual capacity , concentration , memory , executive function , processing speed , and motor dexterity . Multivariable analysis was used to identify factors associated with NCD 2 years after treatment . Results Eighty patients and 40 healthy controls enrolled . Analyses revealed significant differences between patient and control mean performance in some domains , with patient deficits increasing over time : intellectual capacity ( Cohen d , effect sizes [ 95 % CIs ] of −0.46 [ −0.64 to 0.30 ] , −0.51 [ −0.72 to −0.30 ] , and −0.70 [ −0.92 to −0.49 ] for time points 6 , 12 , and 24 months , respectively ) ; concentration/short-term attention span ( −0.19 [ −0.37 to 0.00 ] , −0.38 [ −0.55 to −0.21 ] , −0.54 [ −0.71 to −0.37 ] ) ; verbal memory ( −0.16 [ −0.33 to 0.02 ] , −0.38 [ −0.64 to −0.12 ] , −0.53 [ −0.74 to −0.32 ] ) ; executive function ( −0.14 [ −0.27 to 0.00 ] , −0.34 [ −0.52 to −0.16 ] , −0.43 [ −0.64 to −0.22 ] ) , and global cognitive function composite ( −0.38 [ −0.55 to −0.22 ] , −0.75 [ −0.92 to −0.58 ] , −1.06 [ −1.26 to −0.86 ] ) . There was an increased rate of impaired global neurocognitive functioning among patients ( 38 % ) at 24 months compared with controls ( 0 % ) . Neurocognitive deficits were not associated with baseline cytokines . Conclusions and Relevance Head and neck cancer survivors have neurocognitive sequelae up to 2 years after definitive chemoradiotherapy or radiation treatment . Patients and health care teams should know about such potential risks . Further research is warranted in search of strategies to avoid , reduce , and compensate for declines OBJECTIVE Although chemotherapy-induced cognitive impairment is common among breast cancer patients , evidence for effective interventions addressing cognitive deficits is limited . This r and omized controlled trial examined the feasibility and preliminary efficacy of a Tibetan Sound Meditation ( TSM ) program to improve cognitive function and quality of life in breast cancer patients . METHODS Forty-seven breast cancer patients ( mean age 56.3 years ) , who were staged I-III at diagnosis , 6 - 60 months post-chemotherapy , and reported cognitive impairment at study entry were recruited . Participants were r and omized to either two weekly TSM sessions for 6 weeks or a wait list control group . Neuropsychological assessment s were completed at baseline and 1 month post-treatment . Self-report measures of cognitive function ( Functional Assessment of Cancer Therapy (FACT)-Cog ) , quality of life ( SF-36 ) , depressive symptoms ( Center for Epidemiologic Studies Depression Scale ) , sleep disturbance ( Pittsburgh Sleep Quality Index ) , fatigue ( Brief Fatigue Inventory ) , and spirituality ( FACT-Sp ) were completed at baseline , the end of treatment , and 1 month later . RESULTS Relative to the control group , women in the TSM group performed better on the verbal memory test ( Rey Auditory Verbal Learning Test trial 1 ) ( p = 0.06 ) and the short-term memory and processing speed task ( Digit Symbol ) ( p = 0.09 ) and reported improved cognitive function ( p = 0.06 ) , cognitive abilities ( p = 0.08 ) , mental health ( p = 0.04 ) , and spirituality ( p = 0.05 ) at the end of treatment but not 1 month later . CONCLUSIONS This r and omized controlled trial revealed that TSM program appears to be a feasible and acceptable intervention and may be associated with short-term improvements in objective and subjective cognitive function as well as mental health and spirituality in breast cancer patients The purpose of this study was to evaluate the preliminary efficacy and satisfaction/acceptability of training in memory or speed of processing versus wait-list control for improving cognitive function in breast cancer survivors . 82 breast cancer survivors completed a three-group r and omized , controlled trial . Primary outcomes were objective neuropsychological tests of memory and speed of processing . Secondary outcomes were perceived cognitive functioning , symptom distress ( mood disturbance , anxiety , and fatigue ) , quality of life , and intervention satisfaction/acceptability . Data were collected at baseline , post-intervention , and 2
Output:
| By cognitive domain , objective improvements in memory were most commonly reported , followed by executive functions and processing speed . |
MS210329 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Objectives Laparoscopic ovarian drilling ( LOD ) has been put forward as the treatment of choice in women with clomiphene citrate (CC)-resistant polycystic ovary syndrome ( PCOS ) , with tubo-ovarian adhesion formation as the major disadvantage . Our study proposed to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in terms of ovulation and pregnancy rate with the expected advantage of decreasing postoperative adhesion rate and change in fimbiro ovarian relationship with unilateral drilling . Methods This prospect i ve r and omized study included 44 patients with anovulatory infertility due to PCOS . Twenty-two patients underwent unilateral ovarian drilling in group-I and 22 patients underwent bilateral ovarian drilling in group-II between June 2005 and June 2007 . The number of drilling site in each ovary was limited to five . The clinical and biochemical response , ovulation and pregnancy rates over a follow-up period of 1 year were compared . Tubo-ovarian adhesion rate was compared during cesarean section or during repeat laparoscopy . Results There was no statistical difference between the two groups in terms of clinical and biochemical response , ovulation rate and pregnancy rate . Postoperatively , tubo-ovarian adhesions could be assessed in 36.3 % of the patients and no adhesions were found in a single case in either group . Conclusion Unilateral drilling cauterization of ovary is equally efficacious as bilateral drilling in inducing ovulation and achieving pregnancy . Unilateral ovarian drilling may be a suitable option in clomiphene citrate resistant infertility patient of PCOS which can replace bilateral ovarian drilling with the potential advantage of decreasing the chances of adhesion formation OBJECTIVE To compare the hormonal-metabolic profiles and reproductive outcomes in clomiphene-resistant patients with polycystic ovary syndrome and insulin resistance between women receiving metformin and those undergoing laparoscopic ovarian drilling . METHODS A total of 110 eligible participants were r and omly allocated to diagnostic laparoscopy plus metformin therapy ( group 1 , n=55 ) or laparoscopic ovarian drilling ( group 2 , n=55 ) . The t test was used for mean comparisons of hormonal-metabolic parameters and OGTT values before and after treatment . The chi(2 ) test was used for comparisons of ovulation , pregnancy , and abortion rates . RESULTS Groups 1 and 2 showed a significant decline in testosterone , insulin-like growth factor-1 ( P<0.001 vs P<0.001 ) , and luteinizing hormone ( P<0.05 vs P<0.001 ) , while the glucose to insulin ratio was significantly increased ( P<0.001 vs P<0.05 ) compared with baseline . Group 2 patients had more regular cycles and higher rates of ovulation and pregnancy compared with group 1 : 76.4 % [ 42/55 ] vs 58.2 % [ 32/55 ] , P<0.04 ; 50.8 % [ 131/258 ] vs 33.5 % [ 94/281 ] , P<0.001 ; and 38.2 % [ 21/55 ] vs 20.0 % [ 11/55 ] , P<0.03 , respectively . The difference in the early abortion rate between the groups was not statistically significant . CONCLUSION Although metformin results in a better attenuation of insulin resistance , laparoscopic ovarian drilling is associated with higher rates of ovulation and pregnancy The aim of the present study was to compare the reproductive outcomes of letrozole and laparoscopic ovarian drilling ( LOD ) in women with clomiphene citrate (CC)-resistant polycystic ovary syndrome ( PCOS ) . A total of 141 women with CC-resistant PCOS were enrolled and r and omly allocated into groups A and B. Group A ( n=71 ) received 2.5 mg letrozole from days 5 to 10 of menses for up to six cycles , and group B ( n=70 ) underwent LOD . A 6-month follow-up was performed . No statistically significant difference was found in the baseline clinical characteristics and the major serum hormone profiles , including luteinizing hormone , follicle-stimulating hormone , estradiol and free testosterone , between the two groups . Women receiving letrozole had a lower rate of spontaneous abortion ( 6.9 vs. 15.8 % ) and higher clinical pregnancy ( 40.8 vs. 27.1 % ) and live birth ( 38.0 vs. 22.9 % ) rates ; however , the differences were not statistically significant . Letrozole had superior reproductive outcomes compared with LOD in women with CC-resistant PCOS ; therefore , letrozole could be used as the first-line treatment for women with CC-resistant PCOS Objectives Rosiglitazone , an insulin sensitizing agent is used currently in women with clomiphene citrate ( CC ) resistant polycystic ovarian syndrome ( PCOS ) . Our study proposed to compare the efficacy of rosiglitazone and CC with laparoscopic ovarian drilling ( LOD ) and CC in terms of biochemical effects , ovulation rate and pregnancy rate in patients of PCOS resistant to CC . Methods This prospect i ve r and omised trial included 43 patients of PCOS resistant to CC . Twenty-two women were assigned to the rosiglitazone ( 4 mg twice daily ) and CC group and other 21 patients underwent unilateral LOD and then received CC and multivitamins . The treatment continued for six cycles in both the groups . The biochemical response , ovulation rate and pregnancy rate over a follow up period of 6 months were compared . Results Treatment with rosiglitazone and CC or LOD and CC result ed in increased ovulation ( 80.8 vs. 81.5 % ) and pregnancy ( 50 vs. 42.8 % ) , respectively . There was no statistical difference between the two groups in terms of biochemical response , ovulation rate and pregnancy rate . Conclusion To avoid the risk of adverse effects of LOD preference may be given to the use of rosiglitazone and CC therapy in patients of PCOS resistant to CC BACKGROUND Laparoscopic ovarian diathermy ( LOD ) is currently accepted as a successful second-line treatment for ovulation induction ( OI ) in clomiphene citrate (CC)-resistant women with polycystic ovary syndrome ( PCOS ) . The aim of this study was to test the hypothesis that LOD may be superior to CC as a first-line treatment . METHODS The study included 72 anovulatory women with PCOS who were r and omized to LOD ( n = 36 ) or CC ( n = 36 ) . Women who remained anovulatory after LOD were offered CC . Similarly , women receiving CC who failed to ovulate or conceive were offered LOD . Pregnancy rates were compared between the two groups using chi(2 ) and odds ratio with 95 % confidence interval ( OR , 95 % CI ) . RESULTS After r and omization , six women conceived before starting treatment and another patient postponed treatment . The remaining 65 women received the treatment ( 33 underwent LOD and 32 received CC ) . After the primary treatment , more pregnancies ( 44 % ) occurred in women receiving CC than in those undergoing LOD ( 27 % ) , although the difference did not reach statistical significance [ P = 0.13 , OR 2.1 ( 0.7 - 5.8 ) ] . After adding the second treatment , the pregnancy rate was still higher , but to a less extent , in the CC group [ 63 % versus 52 % , P = 0.2 , OR 1.6 ( 0.6 - 4.2 ) ] . CONCLUSIONS LOD is not superior to CC as a first-line method of OI in women with PCOS . The trial is registered with Clinical Trials.gov with an identifier number NCT00220545 OBJECTIVE To assess pain control in patients with polycystic ovary syndrome ( PCOS ) who are undergoing ovarian drilling during minilaparoscopy under local anesthesia and conscious sedation and to evaluate the efficacy of this protocol compared with the traditional approach in terms of operative and discharge times , subsequent ovulation , and pregnancy . DESIGN Prospect i ve r and omized study . SETTING University hospitals and private day-surgery unit . PATIENT(S ) Sixty-two infertile women with PCOS . INTERVENTION(S ) Group A underwent minilaparoscopic ovarian drilling under local anesthesia and conscious sedation . Group B ( control group ) was treated with traditional ovarian drilling by laparoscopy under general anesthesia . MAIN OUTCOME MEASURE(S ) Intraoperative pain score in group A. Hormonal profile before and after surgery , operative and discharge times , postoperative analgesic requirements , and reproductive follow-up in both groups . RESULT ( S ) Group A showed a good intraoperative pain score . The hormonal profile after surgery did not differ between groups A and B. Operative times were also similar for both groups . The number of patients discharged within 2 hours after surgery was significantly higher in group A. The need for postoperative analgesics was significantly higher in group B. No statistically significant differences were noted between the groups in terms of pregnancy and ovulation rates . CONCLUSION ( S ) Intraoperative and postoperative local anesthesia plus conscious sedation allows outpatient bilateral ovarian drilling by minilaparoscopy to be performed without general anesthesia . The high pregnancy rates , the simplicity of the method , and the faster discharge time offer a new option for patients with PCOS who are resistant to clomiphene citrate . Moreover , ovarian cauterization can be performed simultaneously with a diagnostic minilaparoscopy and integrated into the infertility workup of these patients This study was conducted to evaluate the efficacy of metformin compared with ovarian drilling in the treatment of clomiphene citrate ( CC ) resistant women with polycystic ovary syndrome . A total of 161 infertile , CC-resistant women with PCOS aged 22 - 34 years ( mean 25.5 ± 4.4 ) were evaluated prospect ively during the period between January 2000 and December 2001 . Patients were allocated into two groups ; group 1 includes 64 women who received metformin , 850 mg twice daily throughout the cycle , and group 2 which includes 97 women who underwent laparoscopic ovarian drilling . If spontaneous ovulation or pregnancy was not achieved within 3 months after treatment , CC was added with increments of 50 mg ( up to 150 mg/day ) for both groups . Clinical and menstrual characteristics in addition to the hormonal profile were evaluated before and after the treatment . There were no significant differences between the two groups in terms of age , body weight , BMI , duration of infertility and serum hormone levels ( and rogens , gonadotrophins , insulin ) before starting the treatment . A significant improvement in the regularity of menstrual cycles ( P<0.05 ) and a significant reduction in the serum levels of testosterone ( P<0.01 ) , and rostenedione ( P<0.01 ) , DHEAS ( P<0.05 ) , LH ( P<0.01 ) and LH : FSH ratio ( P<0.05 ) were noted after the treatment . There were no significant differences between the metformin group compared with the drilling group in the rates of ovulation ( 79.7 % vs. 83.5 % ) and pregnancy ( 64.1 % vs. 59.8 % ) . It is concluded that CC-resistant patients with polycystic ovary syndrome can be treated effectively either by metformin or by laparoscopic ovarian drilling . Menstrual cycle pattern and the rates of ovulation and pregnancy are improved significantly , due most probably to the significant decrease in the levels of and rogens and luteinising hormone Purpose To compare the effect of letrozole with laparoscopic ovarian diathermy ( LOD ) for ovulation induction in clomiphene citrate ( CC ) resistant women with polycystic ovary syndrome ( PCOS ) . Methods Two hundred and sixty anovulatory women with CC-resistant PCOS were selected in this r and omized controlled trial . Group A ( n = 128 ) received 2.5 mg letrozole daily for 5 days for up to six cycles . Group B ( n = 132 ) underwent LOD with 6 months follow-up . Outcome measures were ovulation rate , midcycle endometrial thickness , pregnancy , miscarriage and live birth rates . Results Ovulation occurred in 335/512 cycles ( 65.4 % ) in letrozole group and 364/525 cycles ( 69.3 % ) in LOD group without significant difference between both groups . Resumption of regular menstruation was similar in both treatment groups . A significant increase in midcycle endometrial thickness was observed in letrozole group ( 8.8 ± 1.1 mm vs. 7.9 ± 1.2 mm ) ( P < 0.05 ) . Pregnancy rate was similar in both groups ( 15.6 vs. 17.5 % ) . There were no statistical significant differences as regards miscarriage and live birth rates between both groups . No multiple pregnancy or ovarian hyperstimulation occurred in either group . Conclusion Letrozole and LOD are equally effective for inducing ovulation and achieving pregnancy in CC-resistant P
Output:
| AUTHORS ' CONCLUSIONS There was no clear evidence that LOD improves menstrual regularity or the and rogenic symptoms of PCOS , compared to most of the medical treatments used in the included studies .
LOD was associated with fewer gastrointestinal side effects compared to metformin and clomiphene .
There was also no clear evidence of different effectiveness between types of LOD , except that LOD with four to five punctures per ovary may be more effective than two or fewer punctures .
However , gonadotrophins are seldom used for this indication |
MS210330 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background —Delay from onset of acute coronary syndrome ( ACS ) symptoms to hospital admission continues to be prolonged . To date , community education campaigns on the topic have had disappointing results . Therefore , we conducted a clinical r and omized trial to test whether an intervention tailored specifically for patients with ACS and delivered one-on-one would reduce prehospital delay time . Methods and Results — Participants ( n=3522 ) with documented coronary heart disease were r and omized to experimental ( n=1777 ) or control ( n=1745 ) groups . Experimental patients received education and counseling about ACS symptoms and actions required . Patients had a mean age of 67±11 years , and 68 % were male . Over the 2 years of follow-up , 565 patients ( 16.0 % ) were admitted to an emergency department with ACS symptoms a total of 842 times . Neither median prehospital delay time ( experimental , 2.20 versus control , 2.25 hours ) nor emergency medical system use ( experimental , 63.6 % versus control , 66.9 % ) was different between groups , although experimental patients were more likely than control to call the emergency medical system if the symptoms occurred within the first 6 months following the intervention ( P=0.036 ) . Experimental patients were significantly more likely to take aspirin after symptom onset than control patients ( experimental , 22.3 % versus control , 10.1 % , P=0.02 ) . The intervention did not result in an increase in emergency department use ( experimental , 14.6 % versus control , 17.5 % ) . Conclusions —The education and counseling intervention did not lead to reduced prehospital delay or increased ambulance use . Reducing the time from onset of ACS symptoms to arrival at the hospital continues to be a significant public health challenge . Clinical Trial Registration — clinical trials.gov . Identifier NCT00734760 Background There has been increasing interest in the ability of the internet to produce behaviour change . The focus of this study was to describe program exposure across three intervention groups from a r and omised trial ( RT ) comparing traditional face-to-face , internet-mediated ( combined internet plus face-to-face ) , and internet-only program delivery . Methods Baseline and immediately post-intervention survey data , and exposure rates from participants that commenced the RT were included ( n = 192 ) . Exposure was defined as either face-to-face attendance , website usage , or a combination of both for the internet-mediated group . Characteristics of participants who were exposed to at least 75 % of the program material were explored . Descriptive analysis and logistical regression were used to examine differences between groups for program exposure . Results All groups showed decrease in program exposure over time . Differences were also observed ( χ2 = 10.37 , p < 0.05 ) , between intervention groups . The internet-mediated ( OR = 2.4 , 95 % CI 1.13–5.1 ) and internet-only ( OR = 2.96 , 95 % CI 1.38–6.3 ) groups were more likely to have been exposed to at least 75 % of the program compared to the face-to-face group . Participants with high physical activity self-efficacy were 1.82 ( 95 % CI 1.15–2.88 ) times more likely to have been exposed to 75 % of the program , and those allocated to the face-to-face group were less likely to have attended 75 % of the face-to-face sessions if they were classified as obese ( OR = 0.21 95 % CI 0.04–0.96 ) . Conclusion These results suggest that the internet groups were as effective as the face-to-face delivery mode in engaging participants in the program material . However , different delivery methods may be more useful to different sub- population s. It is important to explore which target groups that internet-based programs are best suited , in order to increase their impact The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice BACKGROUND The literature suggests that people delay too long prior to attending emergency departments with acute coronary syndrome ( ACS ) symptoms . This delay is referred to as prehospital delay . Patient decision delay contributes most significantly to prehospital delay . OBJECTIVES Using a r and omized controlled trial , we tested an educational intervention to reduce patient prehospital delay in ACS and promote appropriate responses to symptoms . METHODS Eligible patients who were admitted across five emergency departments ( EDs ) in Dublin were recruited to the study ( n = 1944 ; control : 972 , intervention : 972 ) . RESULTS Median baseline prehospital delay times did not differ significantly between the groups at baseline ( Mann-Whitney U , p = 0.34 ) ( CONTROL : 4.28 h , 25(th ) percentile = 1.71 , 75(th ) percentile = 17.37 ; Intervention 3.96 h , 25(th ) percentile = 1.53 , 75(th ) percentile = 18.51 ) . Both groups received usual in-hospital care . In addition , patients r and omized to the intervention group received a 40-min individualized education session using motivational techniques . This was reinforced 1 month later by telephone . Of the 1944 , 314 ( 16.2 % ) were readmitted with ACS symptoms : 177 ( 18.2 % ) and 137 ( 14.1 % ) of the intervention and control groups , respectively . Prehospital delay times were again measured . Median delay time was significantly lower in the intervention compared to the control group ( 1.7 h vs. 7.1 h ; p ≤ 0.001 ) . Appropriately , those in the intervention group reported their symptoms more promptly to another person ( p = 0.01 ) and fewer consulted a general practitioner ( p = 0.02 ) . There was no significant difference in ambulance use ( p = 0.51 ) or nitrate use ( p = 0.06 ) between the groups . CONCLUSION It is possible to reduce prehospital delay time in ACS , but the need for renewed emphasis on ambulance use is important Loss to follow-up is often hard to avoid in r and omised trials . This article suggests a framework for intention to treat analysis that depends on making plausible assumptions about the missing data and including all participants in sensitivity We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a r and omised controlled trial . To develop the framework , we undertook a Delphi survey ; ran an open meeting at a trial methodology conference ; conducted a review of definitions outside the health research context ; consulted experts at an international consensus meeting ; and review ed 27 empirical pilot or feasibility studies . We initially adopted mutually exclusive definitions of pilot and feasibility studies . However , some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions . Their viewpoint was supported by definitions outside the health research context , the use of the terms ‘ pilot ’ and ‘ feasibility ’ in the literature , and participants at the international consensus meeting . In our framework , pilot studies are a subset of feasibility studies , rather than the two being mutually exclusive . A feasibility study asks whether something can be done , should we proceed with it , and if so , how . A pilot study asks the same questions but also has a specific design feature : in a pilot study a future study , or part of a future study , is conducted on a smaller scale . We suggest that to facilitate their identification , these studies should be clearly identified using the terms ‘ feasibility ’ or ‘ pilot ’ as appropriate . This should include feasibility studies that are largely qualitative ; we found these difficult to identify in electronic search es because research ers rarely used the term ‘ feasibility ’ in the title or abstract of such studies . Investigators should also report appropriate objectives and methods related to feasibility ; and give clear confirmation that their study is in preparation for a future r and omised controlled trial design ed to assess the effect of an intervention PURPOSE To compare delay and circumstances of decisions to seek care in patients with acute myocardial infa rct ion ( AMI ) in the United States ( US ) , Engl and , Australia , South Korea , and Japan . DESIGN Comparative prospect i ve design . METHODS Patients diagnosed with AMI ( N = 913 ) were interviewed within 72 hours of hospital admission for confirmed AMI using the Response to Symptoms Question naire . Delay times were calculated from review of emergency room records and patients ' interviews . Analysis of variance was used to test differences in delay time among countries . FINDINGS Median delay ranged from 2.5 hours in Engl and to 6.4 hours in Australia , with the three Pacific Rim countries reporting median delay times > 4 hours . The majority of patients experienced initial symptoms at home ( range : 56 % in Japan to 73 % in the US ) with the most common witness being a family member ( 32 % in South Korea to 48 % in Engl and ) . Ambulance use was widely divergent with the highest use in Engl and ( 85 % ) and the lowest use in the US ( 42 % ) . CONCLUSIONS In all countries , median delay was too long to obtain maximum benefit from AMI therapies , particularly thrombolysis . Education and counseling of patients and families to reduce prehospital delay in AMI episodes might be more effective if the various factors influencing patients ' first responses to symptoms are considered , as well as differences in health care systems A consistent finding in health services research is the report of uneven uptake of research findings . Implementation trials have a variable record of success in effectively influencing clinicians ' behaviour . A more systematic approach may be to conduct Intervention Modelling Experiments before service-level trials , examining intervention effects on ' interim endpoints ' representing clinical behaviour , derived from empirically supported psychological theories . The objectives were to : ( 1 ) Design Intervention Modelling Experiments by backward engineering a ' real-world ' r and omised controlled trial ( NEXUS ) ; ( 2 ) examine the applicability of psychological theories to clinical decision-making ; ( 3 ) explore whether psychological theories can illuminate how interventions achieve their effects . A 2 x 2 factorial r and omised controlled trial was design ed with pre- and post-intervention data collection by postal question naire surveys . The first survey was used to generate feedback data and the interventions were delivered in the second survey . General medical practitioners ( GPs ) in Engl and and Scotl and participated . First survey respondents were r and omised twice to receive or not audit and feedback and educational reminder messages . The main outcome measures included behavioural intention ( general plan to refer for lumbar X-rays ) and simulated behaviour ( specific , scenario-based , decisions to refer for lumbar X-ray ) . Predictors were attitude , subjective norm , perceived behavioural control ( theory of planned behaviour ) , self-efficacy ( social cognitive theory ) and decision difficulty . Both interventions significantly influenced simulated behaviour , but neither influenced behavioural intention . There were no interaction effects . All theoretically derived cognitions significantly predicted simulated behaviour . Only subjective norm was not predictive of behavioural intention . The effect of audit and feedback on simulated behaviour was mediated through perceived behavioural control . The results of this study suggest that Intervention Modelling Experiments , using psychological models to help isolate mediators of clinical decision-making , may be a means of developing more potent interventions , and selecting implementation interventions with a greater likelihood of success in a service-level r and omised controlled trial CONTEXT Delayed access to medical care in patients with acute myocardial infa rct ion ( AMI ) is common and increases myocardial damage and mortality . OBJECTIVE To evaluate a community intervention to reduce patient delay from symptom onset to hospital presentation and increase emergency medical service ( EMS ) use . DESIGN AND SETTING The Rapid Early Action for Coronary Treatment Trial , a r and omized trial conducted from 1995 to 1997 in 20 US cities ( 10 matched pairs ; population range , 55,777 - 238,912 ) in 10 states . PARTICIPANTS A total of 59,944 adults aged 30 years or older presenting to hospital emergency departments ( EDs ) with chest pain , of whom 20,364 met the primary population criteria of suspected acute coronary heart disease on admission and were discharged with a coronary heart disease-related diagnosis . INTERVENTION One city in each pair was r and omly assigned to an 18-month intervention that targeted mass media , community organizations , and professional , public , and patient education to increase appropriate patient actions for AMI symptoms ( primary population , n=10,563 ) . The other city in each pair was r and omly assigned to reference status ( primary population , n=9801 ) . MAIN OUTCOME MEASURES Time from symptom onset to ED arrival and EMS use , compared between intervention and reference city pairs . RESULTS General population surveys provided evidence of increased public awareness and knowledge of program messages . Patient delay from symptom onset to hospital arrival at baseline ( median , 140 minutes ) was identical in the intervention and reference communities . Delay time decreased in intervention communities by -4.7 % per year ( 95 % confidence interval [ CI ] , -8.6 % to -0.6 % ) , but the change did not
Output:
| DISCUSSION Positive results changing intentions would lead to a r and omized controlled trial of the behaviour change intervention in clinical practice , assessing patient delay in the event of actual symptoms . |
MS210331 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Local treatment of burn injuries with conventional anti-infective preparations does not provide the moist environment that promotes fast wound healing . In a r and omized controlled trial the effects of liposome polyvinyl-pyrrolidone-iodine ( PVP-I ) hydrogel , a novel formulation of PVP-I in a liposome hydrogel with high water-binding capacity , were investigated in 43 patients with partial-thickness burn wounds in an intraindividual comparison with a conventional silver-sulfadiazine cream . Treatment with liposome PVP-I hydrogel result ed in significantly faster complete healing of the burn wounds compared with silver-sulfadiazine cream ( 9.9 ± 4.5 days versus 11.3 ± 4.9 ; P < 0.015 ) . The cosmetic result ( smoothness , elasticity , appearance ) was rated as excellent for 37.0 % of study wounds with liposome PVP-I hydrogel compared with 13.0 % of wounds treated with silver-sulfadiazine cream . Local tolerability was good ; h and ling and change of dressing were rated as easy . Local treatment with liposome PVP-I hydrogel thus provides fast wound healing with a favorable cosmetic result St and ard treatment for extensive partial-thickness burns in the United States and in much of the world involves the application of topical antimicrobial agents and repetitive wound débridements and dressing changes . We evaluated a new biologic wound covering , TransCyte ( Advanced Tissue Sciences , La Jolla , Calif , formerly marketed as Dermagraft-Transitional Covering ) , for the treatment of partial-thickness burns . This material is composed of human newborn fibroblasts which are then cultured on the nylon mesh of Biobrane ( Dow B. Hickam , Inc , Sugarl and , Tex ) ; the thin silicone membrane bonded to the mesh provides a moisture vapor barrier for the wound . A prospect i ve , r and omized , comparison study of silver sulfadiazine and TransCyte was performed with the use of paired wound sites on 14 patients . Wounds treated with TransCyte healed more quickly ( mean 11.14 days to 90 % epithelialization vs 18.14 days , P = .002 ) . A noncomparison evaluation was then done for an additional 18 patients , and it confirmed excellent wound healing and an absence of infections . There were no infections in the 32 wound sites treated with TransCyte . In the first study group , late wound evaluations ( 3 , 6 , and 12 months postburn ) were performed with use of the Vancouver Scar Scale . The results indicated that wound sites treated with TransCyte healed with less hypertrophic scarring than sites treated with silver sulfadiazine ( P < .001 at 3 and 6 months , P = .006 at 12 months ) Histological and clinical studies of wound healing have been made on comparable fresh partial thickness burns with honey dressing or silver sulfadiazine ( SSD ) in two groups of 25 r and omly allocated patients . Of the wounds treated with honey 84 per cent showed satisfactory epithelialization by the 7th day , and in 100 per cent of the patients by the 21st day . In wounds treated with silver sulfadiazine , epithelialization occurred by the 7th day in 72 per cent of the patients and in 84 per cent of patients by 21 days . Histological evidence of reparative activity was seen in 80 per cent of wounds treated with the honey dressing by the 7th day with minimal inflammation . Fifty two per cent of the silver sulfadiazine treated wounds showed reparative activity with inflammatory changes by the 7th day . Reparative activity reached 100 per cent by 21 days with the honey dressing and 84 per cent with SSD . Thus in honey dressed wounds , early subsidence of acute inflammatory changes , better control of infection and quicker wound healing was observed while in the SSD treated wounds sustained inflammatory reaction was noted even on epithelialization To compare the effect of honey dressing and silver-sulfadiazene ( SSD ) dressing on wound healing in burn patients . Patients ( n=78 ) of both sexes , with age group between 10 and 50 years and with first and second degree of burn of less than 50 % of TBSA ( Total body surface area ) were included in the study , over a period of 2 years ( 2006 - 08 ) . After stabilization , patients were r and omly attributed into two groups : ‘ honey group ’ and ‘ SSD group ’ . Time elapsed since burn was recorded . After washing with normal saline , undiluted pure honey was applied over the wounds of patients in the honey group ( n=37 ) and SSD cream over the wounds of patients in SSD group ( n=41 ) , everyday . Wound was dressed with sterile gauze , cotton pads and b and aged . Status of the wound was assessed every third and seventh day and on the day of completion of study . Patients were followed up every fortnight till epithelialization . The bacteriological examination of the wound was done every seventh day . The mean age for case ( honey group ) and control ( SSD group ) was 34.5 years and 28.5 years , respectively . Wound swab culture was positive in 29 out of 36 patients who came within 8 hours of burn and in all patients who came after 24 hours . The average duration of healing in patients treated with honey and SSD dressing at any time of admission was 18.16 and 32.68 days , respectively . Wound of all those patients ( 100 % ) who reported within 1 hour became sterile with honey dressing in less than 7 days while none with SSD . All of the wounds became sterile in less than 21 days with honey , while tthis was so in only 36.5 % with SSD treated wounds . The honey group included 33 patients reported within 24 hour of injury , and 26 out of them had complete outcome at 2 months of follow-up , while numbers for the SSD group were 32 and 12 . Complete outcome for any admission point of time after 2 months was noted in 81 % and 37 % of patients in the honey group and the SSD group . Honey dressing improves wound healing , makes the wound sterile in lesser time , has a better outcome in terms of prevention of hypertrophic scarring and post-burn contractures , and decreases the need of debridement irrespective of time of admission , when compared to SSD dressing Background R and omized trials are essential in assessing the effects of healthcare interventions and are a key component in systematic review s of effectiveness . Search ing for reports of r and omized trials in data bases is problematic due to the absence of appropriate indexing terms until the 1990s and inconsistent application of these indexing terms thereafter . Objectives The objectives of this study are to devise a search strategy for identifying reports of r and omized trials in EMBASE which are not already indexed as trials in MEDLINE and to make these reports easily accessible by including them in the Cochrane Central Register of Controlled Trials ( CENTRAL ) in The Cochrane Library , with the permission of Elsevier , the publishers of EMBASE . Methods A highly sensitive search strategy was design ed for EMBASE based on free-text and thesaurus terms which occurred frequently in the titles , abstract s , EMTREE terms ( or some combination of these ) of reports of trials indexed in EMBASE . This search strategy was run against EMBASE from 1980 to 2005 ( 1974 to 2005 for four of the terms ) and records retrieved by the search , which were not already indexed as r and omized trials in MEDLINE , were downloaded from EMBASE , printed and read . An analysis of the language of publication was conducted for the reports of trials published in 2005 ( the most recent year completed at the time of this study ) . Results Twenty-two search terms were used ( including nine which were later rejected due to poor cumulative precision ) . More than a third of a million records were downloaded and scanned and approximately 80,000 reports of trials were identified which were not already indexed as r and omized trials in MEDLINE . These are now easily identifiable in CENTRAL , in The Cochrane Library . Cumulative sensitivity ranged from 0.1 % to 60 % and cumulative precision ranged from 8 % to 61 % . The truncated term ' r and om$ ' identified 60 % of the total number of reports of trials but only 35 % of the more than 130,000 records retrieved by this term were reports of trials . The language analysis for the sample year 2005 indicated that of the 18,427 reports indexed as r and omized trials in MEDLINE , 959 ( 5 % ) were in language s other than English . The EMBASE search identified an additional 658 reports in language s other than English , of which the highest number were in Chinese ( 320 ) . Conclusion The results of the search to date have greatly increased access to reports of trials in EMBASE , especially in some language s other than English . The search strategy used was subjectively derived from a small ' gold st and ard ' set of test records and was not vali date d in an independent test set . We intend to design an objective ly-derived vali date d search strategy using logistic regression based on the frequency of occurrence of terms in the approximately 80,000 reports of r and omized trials identified compared with the frequency of these terms across the entire EMBASE data base Acticoat , a new silver-coated dressing , produces a moist healing environment along with the sustained release of ionic silver for improved microbial control . These properties suggest that Acticoat might be a useful donor site dressing . However , there are no human studies which assess Acticoat for this use . The purpose of this study was to compare the healing of human skin graft donor sites dressed with Acticoat , to the healing of those dressed with Allevyn , an occlusive moist-healing environment material , which is our st and ard donor site dressing . In burn patients who had undergone burn excision and grafting , identical side-by-side split thickness donor site wound pairs were dressed with Allevyn and Acticoat . Re-epithelialization was directly assessed daily by a single observer from post-operative day 6 onward , and by four independent observers who rated the extent of re-epithelialization by viewing st and ardized digital images of the wounds that had been obtained on post-operative days 6 , 8 , 10 , and 12 . Donor sites were swabbed for bacterial culture on days 3 , 6 , and 9 . Subsequently , each study donor site scar was rated by a blinded observer using the Vancouver Scar Scale at 1 , 2 , and 3 months . Sixteen paired sites in 15 patients ( 3 female , 12 male ) were studied . Donor sites dressed with Allevyn were > 90 % re-epithelialized at a mean of 9.1+/-1.6 days while donor sites dressed with Acticoat required a mean of 14.5+/-6.7 days to achieve > 90 % re-epithelialization ( P=0.004 ) . The Allevyn sites had significantly greater estimated re-epithelialization at days 6 , 8 , 10 and 12 than the Acticoat sites based on the observations of the digital images . There were no significant differences in the incidence of positive bacterial cultures with either dressing at days 3 , 6 , and 9 . Donor sites dressed with Acticoat had significantly worse scars at 1 and 2 months but this difference resolved by 3 months . Our findings do not support the use of Acticoat as a skin graft donor site dressing OBJECTIVE To explore the influence of silver nanoparticle dressing on prevention of infection and healing of the second degree burn wound . METHODS One hundred and ninety-one burn patients with second degree including superficial and deep burn wound were r and omly divided into three groups . Group A including 65 cases was treated by silver nanoparticle dressing on wounds , and group B ( 63 cases ) and group C ( 63 cases ) were treated by 1 % silver sulfadiazine cream and vaseline gauze on their wounds , respectively . Dressing was changed daily , and wound swab bacterial cultures were performed before and after dressing change , and also wound healing times were recorded in each patient . RESULTS Group A and B were similar in their bacterium colonizations on wound after treatment with the silver nanoparticle dressing and 1 % silver sulfadiazine cream , and they had a similar effect on reducing bacterium colonization on wound after treatment , while in vaseline gauze group bacterium colonization on wound increased after treatment . In group A the wound healing time of superficial second degree was significantly shorter than those in group B and group C ( P < 0.01 ) . In deep second degree wounds the healing time in group A was much shorter than that in group C ( P < 0.01 ) , but had no significant difference when compared with group B ( P > 0.05 ) . CONCLUSION Silver nanoparticle dressing can be used on second degree burn wound and can decrease the risk of wound infection and accelerate wound healing Mepitel is a new grid like silicone coated nylon dressing containing no additional biological compounds . We describe a prospect i ve r and omized pilot study comparing Mepitel to the st and ard silver sulfadiazine cream ( Flamazine ) dressing for the topical treatment of paediatric burns . Seventy-six children presenting within 24 h of injury with a non previously treated burn were r and omly assigned to Mepitel treatment ( group M ) or Flamazine treatment ( group F ) . Age , sex , surface area of burn and causal agent were noted at admission . The depth of the burn , cumulative number of dressings , presence or absence of a complete epithelial cover , infection , bleeding and allergy were
Output:
| Our review suggests that silver-containing dressings and topical silver were either no better or worse than control dressings in preventing wound infection and promoting healing of burn wounds |
MS210332 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The photopigment in the human eye that transduces light for circadian and neuroendocrine regulation , is unknown . The aim of this study was to establish an action spectrum for light-induced melatonin suppression that could help eluci date the ocular photoreceptor system for regulating the human pineal gl and . Subjects ( 37 females , 35 males , mean age of 24.5 ± 0.3 years ) were healthy and had normal color vision . Full-field , monochromatic light exposures took place between 2:00 and 3:30 A.M. while subjects ' pupils were dilated . Blood sample s collected before and after light exposures were quantified for melatonin . Each subject was tested with at least seven different irradiances of one wavelength with a minimum of 1 week between each nighttime exposure . Nighttime melatonin suppression tests ( n = 627 ) were completed with wavelengths from 420 to 600 nm . The data were fit to eight univariant , sigmoidal fluence – response curves ( R2 = 0.81–0.95 ) . The action spectrum constructed from these data fit an opsin template ( R2 = 0.91 ) , which identifies 446–477 nm as the most potent wavelength region providing circadian input for regulating melatonin secretion . The results suggest that , in humans , a single photopigment may be primarily responsible for melatonin suppression , and its peak absorbance appears to be distinct from that of rod and cone cell photopigments for vision . The data also suggest that this new photopigment is retinaldehyde based . These findings suggest that there is a novel opsin photopigment in the human eye that mediates circadian photoreception STUDY OBJECTIVES Sleep pattern and circadian rhythms are regulated via the retinohypothalamic tract in response to stimulation of a subset of retinal ganglion cells , predominantly by blue light ( 450 - 490 nm ) . With age , the transmission of blue light to the retina is reduced because of the aging process of the human lens , and this may impair the photoentrainment of circadian rhythm leading to sleep disorders . The aim of the study was to examine the association between lens aging and sleep disorders . DESIGN Cross-sectional population based study . SETTING The study was performed at the Research Center for Prevention and Health , Glostrup Hospital , Denmark and at the Department of Ophthalmology , Herlev Hospital , Denmark . PARTICIPANTS An age- and sex-stratified sample of 970 persons aged 30 to 60 years of age drawn from a sample r and omly selected from the background population . INTERVENTIONS Not applicable . MEASUREMENTS AND RESULTS Sleep disturbances were evaluated by a combination of question naire and the use of prescription sleeping medication . Lens aging ( transmission and yellowing ) was measured objective ly by lens autofluorometry . The risk of sleep disturbances was significantly increased when the transmission of blue light to the retina was low , even after correction for the effect of age and other confounding factors such as smoking habits , diabetes mellitus , gender , and the risk of ischemic heart disease ( P < 0.0001 ) . CONCLUSIONS Filtration of blue light by the aging lens was significantly associated with an increased risk of sleep disturbances . We propose that this is a result of disturbance of photoentrainment of circadian rhythms ABSTRACT This secondary analysis examined whether the benefits of bright light therapy on depression are greater in persons with mild/moderate or severe dementia . Exploratory analyses were also conducted to determine if bright light treatment targets different depressive symptom clusters based on dementia severity . Analyses using total scores from the instruments , Depressive Symptom Assessment for Older Adults and the Cornell Scale for Depression in Dementia , showed that bright light exposure is an equally effective intervention for depression in persons with both mild/moderate and severe dementia . Analyses of individual depressive subscales revealed that for disagreeable behavior and sleep impairment , bright light therapy appears to have greater benefits in persons with severe dementia than for those with mild/moderate dementia . Overall , this investigation supports the use of bright light therapy to treat depression regardless of dementia severity This study examined the effects of bright light exposure on three measures of depression and four measures of agitation in persons with dementia residing in long-term care . Using a r and omized controlled design , participants were r and omly assigned to receive either bright light ( n = 30 ) or low intensity light ( n = 30 ) for eight weeks . Bright light exposure was associated with significant improvement in depression and agitation , while participants receiving low intensity light displayed higher levels of depression and agitation or no significant change . Findings support the use of bright light exposure to reduce depression and agitation in this population Ten elderly subjects with severe dementia were given bright light ( 5000 - 8000 lux ) for 45 min each morning for 4 weeks . Two rating scales of behavioral symptoms in dementia were used as outcome measures : Cohen-Mansfield Agitation Inventory ( CMAI ) and Behavior Pathology In Alzheimer 's Disease Rating Scale ( BEHAVE-AD ) , a scale for sleep-wake disturbances , and actigraphy to monitor activity rhythm . Behavioral symptoms improved with treatment . No changes in sleep-wake measures were found . There was an advance of the activity rhythm acrophase during treatment . These results suggest that short-time bright light improves behavioral symptoms and aspects of activity rhythm disturbances even in severely demented subjects Two hundred ten community-dwelling patients with Alzheimer 's disease were examined prospect ively by psychiatrists as part of a longitudinal study . Twenty-five of these patients who were institutionalized during the next 3 years were then matched to 25 patients who were not institutionalized , and the groups were compared . The patients who had been institutionalized had higher scores on st and ardized psychiatric rating scales but not on formal neuropsychological tests of cognition . These results suggest that potentially treatable ( noncognitive ) behavioral and psychiatric symptoms are risk factors for institutionalization , and that treating these symptoms might delay or prevent institutionalization of some patients We investigated whether low intensity dawn-dusk simulation ( DDS ) , a ' naturalistic ' form of light therapy design ed to embed sleep in its accustomed phase , could improve the disturbed circadian rest-activity cycle , nocturnal sleep and and /or cognitive functions in dementia . A protocol of 3 weeks each of baseline , treatment and follow-up was completed by 13 patients ( 85yr old+/-5yr , MMSE 14+/-5 ; n=9 DDS versus n=4 ' placebo ' dim red light ) who wore an activity/lux monitor throughout . There were no significant changes in clinical or cognitive status , nor modification of circadian stability or amplitude characteristics of the rest-activity cycle . However , two aspects of sleep responded to DDS but not to dim red light . The main sleep episode was 1:14h earlier during treatment ( p=0.03 ) compared with before and after DDS . With respect to actimetry-determined sleep variables , the DDS group tended to have shortened ' sleep latency ' , longer ' sleep duration ' , more nocturnal immobility and less nocturnal activity than the dim red group ( p<0.1 ) . In parallel , nighttime light exposure tended to be reduced ( p=0.07 ) . These promising findings -after only 3 weeks of light treatment in elderly patients with advanced dementia-suggest that the circadian timing system remains functionally responsive even to low intensity DDS light . Increasing zeitgeber strength is an important strategy for improving sleep quality and timing in dementia , and DDS light therapy may provide one of the appropriate means to do so Background The ' Hawthorne Effect ' may be an important factor affecting the generalisability of clinical research to routine practice , but has been little studied . Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge , no attempt has been made to quantify them . Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia . Methods Participants in a dementia trial were r and omised to intensive follow-up ( with comprehensive assessment visits at baseline and two , four and six months post r and omisation ) or minimal follow-up ( with an abbreviated assessment at baseline and a full assessment at six months ) . Our primary outcomes were cognitive functioning ( ADAS-Cog ) and participant and carer-rated quality of life ( QOL-AD ) . Results We recruited 176 participants , mainly through general practice s. The main analysis was based on Intention to treat ( ITT ) , with available data . In the ANCOVA model with baseline score as a co-variate , follow-up group had a significant effect on outcome at six months on the ADAS-Cog score ( n = 140 ; mean difference = -2.018 ; 95%CI -3.914 , -0.121 ; p = 0.037 favouring the intensive follow-up group ) , and on participant-rated quality of life score ( n = 142 ; mean difference = -1.382 ; 95%CI -2.642 , -0.122 ; p = 0.032 favouring minimal follow-up group ) . There was no significant difference on carer quality of life . Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia result ed in a better outcome than minimal follow-up , as measured by their cognitive functioning . Trial registration Current controlled trials : IS RCT OBJECTIVE Preliminary data suggest that morning bright light might improve symptoms of agitation , a serious problem in patients with dementia . The authors exp and on an earlier pilot study by evaluating the effect of bright light therapy on agitated behavior in a large sample of patients with severe dementia . METHODS Ninety-two patients were r and omly assigned to morning bright light , morning dim red light , or evening bright light . Agitation was rated by research staff who observed the patients every 15 minutes throughout the treatment period and by caregivers at one time-point before and one time-point after treatment . RESULTS Morning bright light delayed the acrophase of the agitation rhythm by over 1.5 hours . Bright light was associated with improved caregivers ' ratings but had little effect on observational ratings of agitation . CONCLUSION Although the result that light shifted the peak of the agitated behavior might be generalizable to patients with milder forms of AD , the fact that agitation was not ameliorated might not be . Because the suprachiasmatic nucleus ( SCN ) of patients with severe AD is likely to be more degenerated , and the circadian activity rhythms deteriorate as the disease progresses , it is still possible that patients with more intact SCNs , that is , patients with mild or moderate AD , might benefit from light treatment even more than those with severe AD OBJECTIVES To compare the effects of physical resistance strength training and walking ( E ) , individualized social activity ( SA ) , and E and SA ( ESA ) with a usual care control group on total nocturnal sleep time in nursing home and assisted living residents . DESIGN Pretest-posttest experimental design with assignment to one of four groups for 7 weeks : E ( n=55 ) , SA ( n=50 ) , ESA ( n=41 ) , and usual care control ( n=47 ) . SETTING Ten nursing homes and three assisted living facilities . PARTICIPANTS One hundred ninety-three residents were r and omly assigned ; 165 completed the study . INTERVENTION The E group participated in high-intensity physical resistance strength training 3 days a week and on 2 days walked for up to 45 minutes , the SA group received social activity 1 hour daily 5 days a week , the ESA group received both E and SA , and the control group participated in usual activities provided in the homes . MEASUREMENT Total nocturnal sleep time was measured using 2 nights of polysomnography before and 2 nights of polysomnography after the intervention . Sleep efficiency ( SE ) , non-rapid eye movement ( NREM ) sleep , rapid eye movement sleep , and sleep onset latency were also analyzed . RESULTS Total nocturnal sleep time was significantly greater in the ESA group than in the control group ( adjusted means 364.2 minutes vs 328.9 minutes ) , as was SE and NREM sleep . CONCLUSION High-intensity physical resistance strength training and walking combined with social activity significantly improved sleep in nursing home and assisted living residents . The interventions by themselves did not have significant effects on sleep in this population OBJECTIVES To test the effects of walking , light exposure , and a combination intervention ( walking , light , and sleep education ) on the sleep of persons with Alzheimer 's disease ( AD ) . DESIGN R and omized , controlled trial with blinded assessors . SETTING Independent community living . PARTICIPANTS One hundred thirty-two people with AD and their in-home caregivers . INTERVENTIONS Participants were r and omly assigned to one of three active treatments ( walking , light , combination treatment ) or contact control and received three or six in-home visits . MEASUREMENTS Primary outcomes were participant total wake time based on wrist actigraphy and caregiver ratings of participant sleep quality on the Sleep Disorders Inventory ( SDI ) . Secondary sleep outcomes included additional actigraphic measurements of sleep percentage , number of awakenings , and total sleep time . RESULTS Participants in walking ( P=.05 ) , light ( P=.04 ) , and combination treatment ( P=.01 ) had significantly greater improvements in total wake time at posttest ( effect size 0.51 - 0.63 ) than controls but no significant improvement on the SDI . Moderate effect size improvements in actigraphic sleep percentage were also observed in active treatment participants . There were no significant differences between the active treatment groups and no group differences for any sleep outcomes at 6 months . Part
Output:
| The use of crossover design s and too high illumination as placebo lights might have nullified positive effects of BLT . |
MS210333 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The dexamethasone suppression test ( DST ) and the depressive attributional style question naire ( ASQ ) were administered to 105 depressed patients prior to participation in a double-blind outpatient study and to 29 normal controls . The depressed patients were classified into three groups ( 1 ) met criteria for both research diagnostic criteria for definite endogenous depression and DSM III melancholia ; ( 2 ) met criteria for neither , and ( 3 ) met criteria for one but not both . The group that met criteria for both RDC endogenous depression and DSM-III melancholia had a statistically greater frequency of abnormal DST versus the group that met neither criteria and the normal controls . With regard to ASQ , patients who met both criteria had statistically higher bad event internality scores but statistically lower bad event stability and globality scores as opposed to the group that met neither criteria . In general , normal controls had significantly lower bad event ASQ scores than the three depressive groups . There was no correlation between ASQ and DST , as both DST suppressors and nonsuppressors had similar ASQ scores and there was no correlation between ASQ bad event attributions and initial severity of depression BACKGROUND People with severe depressive illness have raised levels of cortisol and reduced glucocorticoid receptor function . AIMS To obtain a physiological assessment of hypothalamic-pituitary-adrenal ( HPA ) axis feedback status in an in-patient sample with depression and to relate this to prospect ively determined severe treatment resistance . METHOD The prednisolone suppression test was administered to 45 in- patients with depression assessed as resistant to two or more antidepressants and to 46 controls , prior to intensive multimodal in-patient treatment . RESULTS The patient group had higher cortisol levels than controls , although the percentage suppression of cortisol output after prednisolone in comparison with placebo did not differ . Non-response to in-patient treatment was predicted by a more dysfunctional HPA axis ( higher cortisol levels post-prednisolone and lower percentage suppression ) . CONCLUSIONS In patients with severe depression , HPA axis activity is reset at a higher level , although feedback remains intact . However , prospect ively determined severe treatment resistance is associated with an impaired feedback response to combined glucocorticoid and mineralocorticoid receptor activation by prednisolone Depressed patients have reduced glucocorticoid receptor ( GR ) function , as demonstrated by resistance to the suppressive effects of the synthetic glucocorticoid hormone , and GR agonist , dexamethasone . We have developed a suppressive test with prednisolone , a synthetic glucocorticoid that is similar to cortisol in its pharmacodynamics and pharmacokinetics , and binds to both the GR and the mineralocorticoid receptor ( MR ) . We have found that depressed patients suppress normally to prednisolone , unless they are particularly non-responsive to treatment . In the present study , we evaluated 28 in patients with treatment-resistant depression ( TRD ) , and compared salivary cortisol secretion ( at 0900 h , 1200 h and 1700 h ) after placebo or after prednisolone ( 5 mg ) , before and after an inpatient treatment admission . Half of the patients ( n=14 ) reached treatment response . When comparing the assessment between admission and discharge , cortisol output after placebo fell ( -26 % of area under the curve ; p=0.024 ) while the output after prednisolone did not change . Moreover , there was no change in the response to prednisolone ( percentage suppression ) between admission at discharge , and this was not influenced by treatment response . Finally , we could confirm and extend our previously published data with prednisolone ( 5 mg ) , showing that depressed patients ( n=12 ) and controls ( n=12 ) suppressed equally to both 5 and 10 mg doses of prednisolone . This study suggests that the response to prednisolone is similar in depressed patients and controls at different doses of prednisolone , and does not change with symptomatic improvement . This is in contrast with findings , from us and others , using other measures of hypothalamic-pituitary-adrenal axis function , such as basal cortisol levels or the response to dexamethasone . Thus , we propose that the prednisolone suppression test may offer specific biological and clinical information , related to its action at both the GR and the MR INTRODUCTION The serotonin-1A ( 5-HT1A ) receptor subtypes are considered as targets of a variety of antidepressant drugs . Previous studies have suggested different adaptive changes in pre- and post-synaptic 5-HT receptors in the brain after treatment with non-selective tricyclic antidepressants ( TCA ) and selective 5-HT re-uptake inhibitors ( SSRIs ) . The present study aim ed to investigate the adaptive effect of the TCA imipramine on the post-synaptic 5-HT1A receptor function in the hypothalamus . METHODS A longitudinal design was used in 14 patients with major depressive disorder ( DSM-IV ) with endogenous features ( Newcastle Scale ) in order to assess the functional status of post-synaptic 5-HT1A receptors before and after successful antidepressant treatment with imipramine . The effect of the 5-HT1A receptor agonist , buspirone , on ACTH , cortisol , and prolactine ( PRL ) plasma levels was used to assess the functional status of hypothalamic 5-HT1A receptors . A group of 15 concurrent normal subjects were used as control . RESULTS Endogenous depressed patients in remission and currently receiving treatment with imipramine ( mean length of treatment 145 days , SD=27 ) presented significantly lower buspirone responses to ACTH and cortisol than in the pre-treatment condition ( Deltamax p < or = .05 ; AUC p<.001 ) and to ACTH in comparison with healthy controls ( Deltamax p<.01 ; AUC p<.05 ) . No significant differences were found between the post-treatment and pre-treatment PRL responses , or between patients in both conditions and controls ; nevertheless , the PRL response in patients in remission and receiving treatment almost reached the values seen in controls . CONCLUSIONS This study extends previous findings from our group using the SSRI citalopram as an antidepressant . Imipramine and citalopram induce similar changes in the endocrine response to buspirone in depressed patients . As the direction of change in ACTH-cortisol and PRL responses after treatment is the opposite , we can not substantiate increases or decreases in the sensitivity of post-synaptic 5-HT1A receptors in the hypothalamus by long-term imipramine treatment and /or resolution of illness . Therefore , the hormonal changes may result from different or multiples unknown mechanisms Both stress-system activation and melancholic depression are characterized by fear , constricted affect , stereotyped thinking , and similar changes in autonomic and neuroendocrine function . Because norepinephrine ( NE ) and corticotropin-releasing hormone ( CRH ) can produce these physiological and behavioral changes , we measured the cerebrospinal fluid ( CSF ) levels each hour for 30 consecutive hours in controls and in patients with melancholic depression . Plasma adrenocorticotropic hormone ( ACTH ) and cortisol levels were obtained every 30 min . Depressed patients had significantly higher CSF NE and plasma cortisol levels that were increased around the clock . Diurnal variations in CSF NE and plasma cortisol levels were virtually superimposable and positively correlated with each other in both patients and controls . Despite their hypercortisolism , depressed patients had normal levels of plasma ACTH and CSF CRH . However , plasma ACTH and CSF CRH levels in depressed patients were inappropriately high , considering the degree of their hypercortisolism . In contrast to the significant negative correlation between plasma cortisol and CSF CRH levels seen in controls , patients with depression showed no statistical relationship between these parameters . These data indicate that persistent stress-system dysfunction in melancholic depression is independent of the conscious stress of the disorder . These data also suggest mutually reinforcing bidirectional links between a central hypernoradrenergic state and the hyperfunctioning of specific central CRH pathways that each are driven and sustained by hypercortisolism . We postulate that alpha-noradrenergic blockade , CRH antagonists , and treatment with antiglucocorticoids may act at different loci , alone or in combination , in the treatment of major depression with melancholic features Rationale Patients with major depression show hypothalamic – pituitary – adrenal ( HPA ) axis hyperactivity , but the mechanisms underlying this abnormality are still unclear . Objectives We have compared two synthetic glucorticoids , dexamethasone and prednisolone , in their ability to suppress the hypothalamic – pituitary – adrenal ( HPA ) axis in depressed patients . Dexamethasone probes glucocorticoid receptor ( GR ) function , while prednisolone probes both GR and mineralocorticoid receptor ( MR ) function . Material s and methods We used a single-blind , repeated-measure design . We administered placebo , prednisolone ( 5 mg ) or dexamethasone ( 0.5 mg ) , at 22:00 , to 18 severe , treatment-resistant depressed in patients ( 15 of them with a history of childhood trauma ) and 14 healthy volunteers . On the following days , we collected salivary cortisol from 9:00 to 22:00 . Results Depressed patients had higher salivary cortisol levels compared with controls , at baseline and after both prednisolone and dexamethasone ( p<0.001 ) . Consistent with previous studies , depressed in patients showed impaired suppression by dexamethasone : based on the analysis of the areas under the curve ( AUCs ) , suppression by dexamethasone ( 0.5 mg ) was −85 % in controls vs −46 % in depressed patients ( p=0.018 ) . However , the same depressed patients showed normal suppression by prednisolone ( 5 mg ) : suppression was −41 % in controls and −36 % in depressed patients ( p=0.6 ) . Conclusions We suggest that the additional effects of prednisolone on the MR explain the different responses to these glucocorticoids in the same depressed patients BACKGROUND Depression , a clinical ly heterogeneous syndrome , may also be etiologically heterogeneous . Using a prospect i ve , epidemiologic , and genetically informative sample of adult female twins , we identify and vali date a typology of depressive syndromes . METHODS Latent class analysis was applied to 14 disaggregated DSM-III-R symptoms for major depression reported over the last year by members of 1029 female-female twin pairs . RESULTS Seven classes were identified , of which 3 represented clinical ly significant depressive syndromes : ( 1 ) mild typical depression , ( 2 ) atypical depression , and ( 3 ) severe typical depression . Severe typical depression was characterized by comorbid anxiety and panic , long episodes , impairment , and help seeking . Atypical depression was similar in severity to mild typical depression , but was characterized by increased eating , hypersomnia , frequent , relatively short episodes , and a proclivity to obesity . Individuals with recurrent episodes tended to have the same syndrome on each occasion . The members of twin pairs concordant for depression had the same depressive syndrome more often than expected by chance and this resemblance was greater in monozygotic than in dizygotic pairs . CONCLUSION In an epidemiologic sample of female twins , depression is not etiologically homogeneous , but is instead made up of several syndromes that are at least partially distinct from a clinical , longitudinal , and familial/genetic perspective We summarise a series of studies using a MAOI to help establish the validity of a subgroup of depressives referred to as atypical depressives . Patients with reactive mood meeting DSM-III criteria for depressive illness who had associated atypical features ( which include hyperphagia , hypersomnolence , leaden paralysis , and rejection sensitivity ) were r and omised to imipramine , phenelzine and placebo . Non-responders were crossed over , and in all there were over 400 patient trials . Phenelzine consistently was found to be superior to imipramine . Only in trials which included patients lacking atypical , vegetative symptoms was imipramine found to equal phenelzine . We conclude that the research er and the clinician should consider the relevance of the atypical depressive syndrome Depression may be associated with a hypofunction of central serotonergic systems . The prolactin response to fenfluramine , an indicator of serotonergic activity , has been reported to be blunted in depressed patients compared to controls . It has also been suggested that blunting is more likely in melancholic depression . Baseline cortisol , prolactin and tryptophan availability have also been suggested to affect this response . Forty-eight men and 61 women with a major depressive episode , and who were drug free , and 20 healthy control men underwent clinical evaluation and fenfluramine challenge with dl-fenfluramine 1 mg/kg . When baseline variables were covaried , there was no difference in prolactin response to fenfluramine between males with depression and age-matched controls . Amongst all the depressed patients , body mass index showed a significant association with prolactin response to fenfluramine . There was an interaction between baseline cortisol and DSM-III-R melancholic subtype of depression whereby non-melancholic patients appeared more likely to increase prolactin response to fenfl
Output:
| Detailed analysis of the method ologies used in the studies revealed significant variability especially regarding the sample s ' definition comparing the HPA axis activity of melancholic patients to atypical depression , including healthy controls .
While the majority of studies did confirm the association between melancholic depression and increased post-challenge cortisol levels , the association with increases in basal cortisol and basal ACTH were less consistent .
In conclusion , our findings indicate that there is a difference in the activity of the HPA-axis between melancholic and atypical depressive subtypes .
However , these are more likely explained by hypercortisolism in melancholia ; and most often normal than decreased function in atypical depression . |
MS210334 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objectives : To determine whether writing clinical guideline recommendations in behaviourally specified “ plain English ” language increases the likelihood of their implementation by service users ( patients ) . Design : R and omised controlled trial in which participants received either the original text of the National Institute for Clinical Excellence ( NICE ) public guidelines for the management of schizophrenia or a behaviourally specified text with the same content . Setting : Mental health service user networks and voluntary sector organisations within two inner London boroughs . Participants : Eighty four mental health service users recruited by post or face to face contact at service user meetings . Intervention : The section of the NICE public guidelines for schizophrenia concerning psychological and pharmacological treatments was rewritten to improve style and behavioural specificity by applying evidence -based and psychologically informed principles of good written communication . Outcome measures : Cognitive predictors of behaviour , as specified by the evidence based theory of planned behaviour , constituted the primary outcome as it was not possible to measure the actual behaviour of guideline implementation . The predictors were behavioural intentions to implement the guidelines , attitudes towards implementation , and perceived behavioural control over implementation . Satisfaction with the guidelines and perceived comprehension were also measured . Results : Behaviourally specified “ plain English ” guidelines led to stronger intentions to implement the guidelines , more positive attitudes towards them , and greater perceived behavioural control over using them . There was no difference in satisfaction or perceived comprehension . Conclusions : Writing guidelines with high behavioural specificity in conjunction with the use of “ plain English ” may be a simple and effective method of increasing their implementation . Evaluation with a behavioural outcome is now needed Background : The effect of regular and expected printed educational material s on physician prescribing behaviour has not been studied . We sought to measure the impact of a series of evidence -based drug therapy letters mailed to physicians in British Columbia on prescribing to newly treated patients . Methods : A paired , cluster r and omized community design was used . The study population included 499 physicians from 24 local health areas in British Columbia . Local health areas were paired by number of physicians , and 1 of each pair was r and omly selected and its physicians assigned to an intervention group or a control group . The intervention was 12 issues of an evidence -based series called Therapeutics Letter . Physicians in the control group ( n = 241 ) received the letters 3–8 months after physicians in the intervention group ( n = 258 ) . The impact on prescribing to newly treated patients ( defined as patients who had not previously made a cl aim for any medication from the class of drugs profiled in the letter ) was analyzed using the drug cl aims data base of BC Pharmacare , a publicly funded drug benefits program that covered all seniors and people receiving social assistance . Results : The probability of prescribing a drug recommended in the Therapeutics Letter rather than another drug in the same class increased by 30 % in the 3 months after the mailing of the letter relative to the preceding 3 months , adjusted for any before – after changes in the control group ( relative risk 1.30 ; 95 % confidence interval 1.13–1.52 ) . No letter achieved statistical significance on its own . However , 11 of the 12 letters produced prescribing changes in the predicted direction such that the overall result was significant when their effect was combined . Interpretation : The combined effect of an ongoing series of printed letters distributed from a credible and trusted source can have a clinical ly significant effect on prescribing to newly treated patients Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials This paper describes a model , derived from subjective expected utility ( SEU ) theory , which attempts to explain the effects of a fear-arousing communication about smoking and lung cancer on smokers ' decisions to try to stop smoking . According to the model , the strength of the smoker 's intention to try to stop smoking will depend on three factors : ( 1 ) the utility of lung cancer ; ( 2 ) the perceived reduction in the risk of getting lung cancer that follows from successfully stopping smoking ( probability difference ) ; and ( 3 ) the subjective probability of successfully stopping smoking , or confidence . The usefulness of this model vis-à-vis one based on the amount of fear aroused by the communication was investigated in two experimental studies conducted in the field in which smokers watched either a videotape about smoking or one on a different health topic . The smoking videotape influenced not only attitudes and beliefs measured immediately after exposure but also subsequent self-reports of behavior ( whether or not the subject tried to stop smoking or to cut down in the 3-month period following exposure to the videotape ) . In accordance with predictions , the three variables specified by the model together affected intention to try to stop smoking , which in turn affected behavior . The effect of confidence on intention was relatively large . There was no evidence for the multiplicative combination of utilities and subjective probabilities predicted by a strict SEU model . Contrary to the predictions of the model , but consistent with previous research , the amount of fear aroused by the videotape had an independent effect on intention , suggesting that explanations of the effects of fear-arousing communications will have to incorporate both cognitive and emotional mediation processes Background Efficacious strategies for the primary prevention of coronary heart disease ( CHD ) are underused , and , when used , have low adherence . Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice . Methods We conducted a r and omized trial of a CHD prevention intervention ( including a computerized decision aid and automated tailored adherence messages ) at one university general internal medicine practice . After obtaining informed consent and collecting baseline data , we r and omized patients ( men and women age 40 - 79 with no prior history of cardiovascular disease ) to either the intervention or usual care . We then saw them for two additional study visits over 3 months . For intervention participants , we administered the decision aid at the primary study visit ( 1 week after baseline visit ) and then mailed 3 tailored adherence reminders at 2 , 4 , and 6 weeks . We assessed our outcomes ( including the predicted likelihood of angina , myocardial infa rct ion , and CHD death over 10 years ( CHD risk ) and self-reported adherence ) between groups at 3 month follow-up . Data collection occurred from June 2007 through December 2009 . All study procedures were IRB approved . Results We r and omized 160 eligible patients ( 81 intervention ; 79 control ) and followed 96 % to study conclusion . Mean predicted CHD risk at baseline was 11.3 % . The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points ( 95 % CI 8 % to 42 % ) , with the biggest effect for aspirin . It also changed predicted CHD risk by -1.1 % ( 95 % CI -0.16 % to -2 % ) , with a larger effect in a pre-specified subgroup of high risk patients . Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk . Clinical trials registration number Clinical Trials.gov : BACKGROUND : Providing antidepressant information to patients may foster greater adherence to therapy . OBJECTIVE : To assess physician information-giving while prescribing antidepressants , and to identify factors that influence the provision of information . DESIGN : R and omized experiment using st and ardized patients ( SPs ) . St and ardized patients roles were generated by crossing 2 clinical conditions ( major depression or adjustment disorder ) with 3 medication request types ( br and -specific , general , or none ) . PARTICIPANTS : One hundred and fifty-two general internists and family physicians recruited from solo and group practice s and health maintenance organizations ; cooperation rates ranged from 53 % to 61 % . MEASUREMENTS : We assessed physician information-giving by analyzing audio-recordings of interactions between physicians and SPs , and collected physician background information by survey . Generalized estimating equations were used to examine the influence of patient and physician factors on physicians ’ provision of information . RESULTS : One hundred and one physicians prescribed antidepressants , accounting for 131 interactions . The mean age of physicians was 46.3 years : 69 % were males . Physicians mentioned an average of 5.7 specific topics of anti-depressant-related information ( of a possible maximum of 11 ) . The most frequently mentioned topic was purpose ( 96.1 % ) . Physicians infrequently provided information about the duration of therapy ( 34.9 % ) and costs ( 21.4 % ) . St and ardized patients who presented with major depression received less information than those with adjustment disorder , and older and solo/private practice physicians provided significantly less information to SPs . CONCLUSIONS : Physicians provide limited information to patients while prescribing antidepressants , often omitting critical information that may promote adherence . Mechanisms are needed to ensure that patients receive pertinent antidepressant information Printed health education material s ( HEMs ) are widely used to increase awareness and knowledge , change attitudes and beliefs , and help individuals adopt and maintain healthy lifestyle behaviors . While much of the contemporary research and development of persuasive communication is based on McGuire 's input/output model , to date few studies have compared the impact of a large set of inputs across a comprehensive set of the 12 outputs . We examined the effects of printed HEMs on weight loss on the cognitive , affective , and behavioral responses of 198 overweight adults . Participants were recruited via a newspaper advertisement and were r and omly assigned to review one of three HEMs . Participants were interviewed and asked to complete a series of question naires both before and after viewing the HEMs . Regression analyses were conducted to identify the input characteristics associated with success at each of the output steps . The results revealed attractiveness , encouragement , level of information , and application to one 's life were significantly associated with early steps ( attention , liking , and underst and ing ) as well as some of the mediating steps ( recalling , keeping , and rereading HEMs ) . Later steps , such as intention to change behavior and show others , were associated with readiness to change , self-efficacy , and perceived application to one 's life . Behavior change was more likely for those who received tailored material s and those who had higher self-efficacy . These results provide useful direction for the use of computers in tailoring the content of HEMs and the development of effective communication of health information on weight loss BACKGROUND Physicians often search for information to improve patient care . We evaluated how nephrologists use online information sources for this purpose . METHODS In this cross-sectional study ( 2008 to 2010 ) , a r and om sample of Canadian nephrologists completed a survey of their online search practice s. We queried respondents on their search ing preferences , practice s and use of 9 online information sources . RESULTS Respondents ( n=115 ; 75 % response rate ) comprised both academic ( 59 % ) and community-based ( 41 % ) nephrologists . Respondents were an average of 48 years old and were in practice for an average of 15 years . Nephrologists used a variety of online sources to retrieve information on patient treatment including UpTo Date ( 92 % ) , PubMed ( 89 % ) , Google ( 76 % ) and Ovid MEDLINE ( 55 % ) . Community-based nephrologists were more likely to consult UpTo Date first ( 91 % ) , while academic nephrologists were divided between UpTo Date ( 58 % ) and PubMed ( 41 % ) . When search ing bibliographic re sources such as PubMed , 80 % of nephrologists scan a maximum of 40 citations ( the equivalent of 2 search pages in PubMed ) . Search ing practice s did not differ by age , sex or years in practice . CONCLUSIONS Nephrologists routinely use a variety of online re sources to search for information for patient care . These include bibliographic data bases , general search engines and specialized medical re sources The seven articles in this issue , and the accompanying meta- analysis in Health Psychology Review [ McEachan , R.R.C. ,
Output:
| DISCUSSION With CATCH it is possible to categorize and underst and the mechanisms that can trigger a change in behavior in health care providers . |
MS210335 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES We sought to determine the association between school- and neighborhood-level characteristics and physical activity among young people . METHODS We collected the data as part of Youth'07 , a nationally representative survey of the health and well-being of high school students in New Zeal and . In total , 9107 students from 96 schools participated ( 63 % response rate ) . Students answered questions about their schools ( e.g. , support for physical activity ) and neighborhoods ( e.g. , community cohesion , disintegration , safety , and recreational facilities ) . We created school-level measures by aggregating the students ' reports within their schools and we created neighborhood-level measures by aggregating the students ' reports of their neighborhoods to the census area unit of their residential address . We conducted analyses by using cross-classified r and om-effects models controlling for individual variables , with school and neighborhoods treated as r and om effects . RESULTS Schools characterized by high sports team participation and neighborhoods characterized by high social connections were positively associated with student physical activity . We observed few other significant characteristics of school and neighborhood environments . CONCLUSIONS Our findings highlight that opportunity for sports participation and strong social connections in neighborhoods are particularly important for youths ' physical activity BACKGROUND Our objective was to evaluate the effects of environmental , policy , and social marketing interventions on physical activity and fat intake of middle school students on campus . DESIGN Twenty-four middle schools were r and omly assigned to intervention or control conditions . Baseline measures were collected in spring 1997 , and interventions were conducted during the 1997 - 1998 and 1998 - 1999 school years SETTING /PARTICIPATION : The schools had mean enrollments of 1109 , with 44.5 % nonwhite students . Over 2 years , physical activity interventions were design ed to increase physical activity in physical education classes and throughout the school day . Nutrition interventions were design ed to provide and market low-fat foods at all school food sources , including cafeteria breakfasts and lunches , a la carte sources , school stores , and bag lunches . School staff and students were engaged in policy change efforts , but there was no classroom health education . MAIN OUTCOMES MEASURES Primary outcomes were measured by direct observation and existing records . RESULTS R and omized regression models ( N = 24 schools ) revealed a significant intervention effect for physical activity for the total group ( p < 0.009 ) and boys ( p < 0.001 ) , but not girls ( p < 0.40 ) . The intervention was not effective for total fat ( p < 0.91 ) or saturated fat ( p < 0.79 ) . Survey data indicated that the interventions reduced reported body mass index for boys ( p < 0.05 ) . CONCLUSIONS Environmental and policy interventions were effective in increasing physical activity at school among boys but not girls . The interventions were not effective in reducing fat intake at school . School environmental and policy interventions have the potential to improve health behavior of the student population , but barriers to full implementation need to be better understood and overcome Background Regular physical activity is associated with a range of physical and psychological health benefits . In North America the majority of adolescents are insufficiently active . Purpose The purpose of this study was to examine the prospect i ve relationship between adolescents ' perceptions of transformational leadership displayed by their school physical education teachers and their own physical activity behaviors , both with respect to within-class physical activity ( WCPA ) and also leisure time physical activity ( LTPA ) . Method The study used a prospect i ve observational design . Using multilevel structural equation modeling ( MSEM ) , we examined the extent to which adolescents ' affective attitudes mediated the effects of teachers ' behaviors on adolescents ' physical activity responses . Two thous and nine hundred and forty-eight adolescents ( Mage = 14.33 , SD = 1.00 , Nfemale = 1,641 , 55.7 % ) from 133 Grade 8–10 classes in British Columbia ( Canada ) provided ratings of their physical education teachers ' behaviors midway through the school year . Two months later , students completed measures of affective attitudes , WCPA , and LTPA . Results The results indicated that adolescents ' perceptions of transformational teaching explained significant variance in both WCPA and LTPA , and these effects were fully mediated by adolescents ' affective attitudes ( total indirect effect : b = 0.581 , p < 0.001 ) . Conclusion The findings suggest that transformational leadership behaviors displayed by physical education teachers may be an important source of adolescent enjoyment of physical education as well as health-enhancing physical activity involvement within school and outside of school PURPOSE To examine the relationship between role model presence , type of role model , and various health-risk and health-protective behaviors among California adolescents . METHODS We used cross-sectional data on 4,010 multiethnic adolescents aged 12 - 17 years from the 2003 California Health Interview Survey , a population -based r and om-digit dial telephone survey of more than 40,000 California households . The survey , conducted every other year since 2001 , collects extensive demographic , health , and health-related information . RESULTS Fifty-nine percent of adolescents identified a role model . Affluent teens were more likely to have a role model than lower income teens . Role models were generally of the same ethnicity and gender as the teens ; ethnic congruence was higher among African Americans and whites than Latinos and Asians ; gender congruence was higher among males . Type of role model was significantly associated with health-related behaviors . Identification of a teacher was strongly associated with positive health behaviors . Correlations with health-promoting behaviors were generally smaller in magnitude but consistently positive among family member and athlete role models . Peer or entertainer role models were associated with health-risk behaviors . CONCLUSION Not only role model presence but also the type of role model is an important predictor of adolescent health-related behaviors . Our findings have implication s for design ing youth targeted interventions and policies involving role models Within instructional setting s , individuals form relational efficacy appraisal s that complement their self-efficacy beliefs . In high school physical education ( PE ) , for instance , students develop a level of confidence in their teacher 's capabilities , as well as estimating how confident they think their teacher is in their ( i.e. , the students ' ) ability . Grounded in existing trans context ual work , we examined the motivational pathways through which students ' relational efficacy and self-efficacy beliefs in PE were predictive of their leisure-time physical activity . Singaporean students ( N = 990 ; age M = 13.95 , SD = 1.02 ) completed instruments assessing efficacy beliefs , perceptions of teacher relatedness support , and autonomous motivation toward PE , and 2 weeks later they reported their motivation toward , and engagement in , leisure-time physical activity . Structural equation modeling revealed that students reported stronger other-efficacy and RISE beliefs when they felt that their teacher created a highly relatedness-supportive environment . In turn , their relational efficacy beliefs ( a ) supported their confidence in their own ability , ( b ) directly and indirectly predicted more autonomous motives for participation in PE , and ( c ) displayed prospect i ve trans context ual effects in relation to leisure-time variables . By emphasizing the adaptive motivational effects associated with the tripartite constructs , these findings highlight novel pathways linking students ' efficacy perceptions with leisure-time outcomes Objective To examine associations between students ’ time spent in moderate to vigorous physical activity ( MVPA ) and the school built environment while also considering features of the schools ’ social environment and student-level characteristics . Methods Using surveys and GIS measures , multilevel linear regression analysis was applied to examine the environment- and student-level characteristics associated with time spent in MVPA among grade 9–12 students ( n = 22,117 ) attending 76 secondary schools in Ontario , Canada as part of the SHAPES-Ontario study . Results Statistically significant between-school r and om variation in student MVPA was identified [ $ $ \sigma^{2}_{\mu 0 } $ $ = 9,065.22 ( 250.64 ) ] ; school-level differences accounted for 3.0 % of the variability in student MVPA . Students attending a school that offered daily physical education or provided an alternate room for physical activity spent more time in MVPA than students attending a school without these re sources . Moreover , as l and -use mix diversity and walkability of the school neighbourhood increased , students ’ time spent in MVPA decreased . Conclusion Developing a better underst and ing of the environment- and student-level characteristics associated with students ’ time spent in MVPA is critical for informing school-based physical activity intervention programmes and policies PURPOSE School physical education ( PE ) is highly recommended as a means of promoting physical activity , and r and omized studies of health-related PE interventions in middle schools have not been reported . We developed , implemented , and assessed an intervention to increase physical activity during middle-school PE classes . METHODS Twenty-four middle schools ( approximately 25,000 students , 45 % nonwhite ) in Southern California participated in a r and omized trial . Schools were assigned to intervention ( N = 12 ) or control ( N = 12 ) conditions , and school was the unit of analysis . A major component of the intervention was a 2-yr PE program , which consisted of curricular material s , staff development , and on-site follow-up . Control schools continued usual programs . Student activity and lesson context were observed in 1849 PE lessons using a vali date d instrument during baseline and intervention years 1 and 2 . RESULTS The intervention significantly ( P = 0.02 ) improved student moderate to vigorous physical activity ( MVPA ) in PE , by approximately 3 min per lesson . Effects were cumulative ; by year 2 intervention schools increased MVPA by 18 % . Effect sizes were greater for boys ( d = 0.98 ; large ) than girls ( d = 0.68 ; medium ) . CONCLUSIONS A st and ardized program increased MVPA in middle schools without requiring an increase in frequency or duration of PE lessons . Program components were well received by teachers and have the potential for generalization to other schools . Additional strategies may be needed for girls Based on self-determination theory , the present study developed and evaluated the utility a school-based intervention to change pupils ’ physical activity intentions and self-reported leisure-time physical activity behaviour . The study evaluated utility of the intervention to promote physical activity participation over a 5-week interval of time . A cluster r and omised design targeting 215 pupils from 10 schools with schools as the unit of r and omisation was adopted ( Male = 106 , Female = 109 , Age = 14.84 , SD = 0.48 ) . Results indicated that pupils who were taught by autonomy-supportive teachers reported stronger intentions to exercise during leisure time and participated more frequently in leisure-time physical activities than pupils in the control condition . Autonomous motivation and intentions mediated the effects of the intervention on self-reported physical activity behaviour . It is concluded that self-determination theory provides a useful framework for the development of school-based interventions that ultimately affect leisure-time physical activity participation The Healthy Youth Places ( HYP ) intervention targeted increased fruit and vegetable consumption ( FV ) and physical activity ( PA ) through building the environmental change skills and efficacy of adults and youth . HYP included group training for adult school site leaders , environmental change skill curriculum , and youth-led FV and PA environment change teams . Sixteen schools were r and omized to either implement the HYP program or not . Participants ( N = 1,582 ) were assessed on FV and PA and hypothesized HYP program mediators ( e.g. , proxy efficacy ) at the end of sixth grade ( baseline ) , seventh grade ( Postintervention Year 1 ) , and eighth grade ( Postintervention Year 2 ) . After intervention , HYP schools did not change in FV but did significantly change in PA compared to control schools . Proxy efficacy to influence school PA environments mediated the program effects . Building the skills and efficacy of adults and youth to lead school environmental change may be an effective method to promote youth PA The relationship between the school environment and health has infrequently been examined . This study sought to examine the association between school students ' perceptions of their school environment , teachers ' and peers ' support and their health behaviours . A cross sectional descriptive survey by supervised self-administration was conducted in 1996 based on the international WHO collaborative survey of school children 's health and lifestyle ( the HBSC Study ) and extended in an Australian setting . R and omly sample d primary and secondary schools from Catholic , Independent and Government education sectors throughout New South Wales ( NSW ) , Australia , were invited to participate . The final sample included 3918 school students attending Year 6 ( primary school ) , Year 8 and Year 10 ( high school ) from 115 schools . The main outcome measures were self-reported health status and 7 health behaviours ( tobacco use , alcohol use , physical activity , dental hygiene , nutritional intake , seat belt and bicycle helmet use ) . Independent variables included student perceptions of the school environment , perceptions of teachers ' and peers ' support . Girls , Year 6 students and students who have less than $ 19 a week to spend were significantly more likely to have positive perceptions towards their school environment , teacher(s ) and peers . Students who had positive perceptions regarding their school environment and perceived their teachers as supportive were significantly more likely to engage in health promoting behaviours adjusting for age , sex and average weekly pocket money . A supportive peer environment was not associated with positive health behaviour . Health promotion practitioners need to consider the impact of the school environment on health behaviours of school students . In particular , practitioners should consider intervention models that improve the school environment as a key strategy within a health promoting school Objective : To assess developmental trends in physical activity and sedentary behaviour in British adolescents in relation to sex , ethnicity and socioeconomic status ( SES ) . Design : A 5-year longitudinal study of a diverse cohort of students aged 11
Output:
| A range of school-based policy ( e.g. break time length ) , physical ( e.g. facilities ) and social-environmental ( e.g. teacher behaviours ) factors were associated with adolescent physical activity , with limited research on sedentary behaviour .
The mixed- studies synthesis revealed the importance of specific activity setting s ( type and location ) and intramural sport opportunities for all students .
Important physical education-related factors were a mastery-oriented motivational climate and autonomy supportive teaching behaviours .
Qualitative evidence highlighted the influence of the wider school climate and shed light on complexities of the associations observed in the quantitative literature . |
MS210336 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background and Purpose — Pneumonia is a major cause of mortality and morbidity in patients with stroke fed via nasogastric tubes and may be because of vomiting and gastro-oesophageal regurgitation . The aim of the study was to assess whether regular treatment with metoclopramide , a D2-receptor antagonist with antiemetic and gastric prokinetic actions , could reduce the rate of aspiration and pneumonia . Methods — Patients with no signs of pneumonia within 7 days of stroke onset and 48 hours of insertion of a nasogastric tube were recruited into a double-blind r and omized placebo-controlled trial . Participants received metoclopramide 10 mg or placebo 3 × daily via the nasogastric tube for 21 days or until nasogastric feeds were discontinued . Clinical signs of pneumonia were recorded daily . Pneumonia was diagnosed if the patient had relevant clinical signs , high inflammatory markers , and new infiltrates on the chest radiograph . Results — Sixty patients ( mean age , 78 years ; 38 women ; mean National Institutes for Health Stroke Scale score , 19.25 ) were r and omized in a 1:1 ratio . There were significantly more episodes of pneumonia in the placebo group than in the metoclopramide group ( rate ratio , 5.24 ; P<0.001 ) . There were also significant differences in favor of metoclopramide in the rate of aspiration , oxygen saturation , highest inflammatory markers , and National Institutes for Health Stroke Scale . There was no significant difference in mortality between the groups . Conclusions — This study suggests that metoclopramide may reduce the rate of pneumonia and may improve other clinical outcomes in patients with subacute stroke fed via nasogastric tube . These findings need to be confirmed in larger r and omized and blinded trials . Clinical Trial Registration — URL : https://www . clinical trialsregister.eu . EudraCT no : 2006 - 002570 - 22 , URL : http://www.controlled-trials.com/IS RCT N18034911/18034911 Purpose This study aim ed to determine if preoperative oral administration of metoclopramide , chlorpromazine , gabapentin , or dexamethasone would effectively reduce postoperative nausea and vomiting ( PONV ) in the first 24 hours after surgery in patients undergoing maxillofacial trauma surgery . Methods One hundred fifty patients with maxillofacial skeletal trauma that need open reduction and internal fixation were r and omly assigned to receive one of the fallowing drugs orally , 1 hour preoperative : 10 mg metoclopramide ( group A ) , 300 mg gabapentin ( group B ) , 100 mg chlorpromazine ( group C ) , 5 mg dexamethasone ( group D ) , and placebo ( group E ) . All patients were observed in the first 24 hours for PONV . Data analysis was done with the SPSS software ( version 19 ) , using chi-square test , Fisher exact test , and multiple logistic regression methods . Results The incidence of vomiting was significantly lower in groups A ( 2/30 ) , B ( 3/30 ) , and C ( 2/30 ) compared with the placebo group ( 9/30 ) ( P < 0.05 ) . Also , the incidence of postoperative nausea was significantly high in the placebo group ( 11/30 ) as compared to treatment groups A ( 2/30 ) , B ( 3/30 ) , and C ( 3/30 ) ( P < 0.05 ) . No significant differences in the incidence of PONV were found between groups D ( 7/30 ) and E ( P > 0.05 ) . Of all demographic variables , anesthesia time ( P = 0.034 ) and surgery time ( P = 0.047 ) were predictors of PONV . Conclusion Our results demonstrated that premedication with oral metoclopramide , gabapentin , or chlorpromazine can significantly decrease the incidence of PONV in patients undergoing maxillofacial trauma surgery Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND Ventilator associated pneumonia is a major cause of morbidity in the intensive care unit . Difficulties in identification of the risk factors , in diagnosing and in prevention , have intensified the problem . OBJECTIVES To measure the incidence of ventilator associated pneumonia in intensive care unit and to identify the risk factors associated . METHODS A prospect i ve observational cohort study was done in which we evaluated 69 patients who were mechanically ventilated for more than 48 hours to find out the development of nosocomial pneumonia and presence or absence of risk factors . Data were subjected to univariate analysis using chi-square and t-test . Level of significance was set at 0.05 . RESULTS Twenty two ( 31.88 % ) out of 69 patients developed ventilator associated pneumonia , majority of them between four days to 14 days . Reintubation , invasive lines , H2 blockers and low PaO2/FiO2 were identified as major risk factors in our study . Enteral feeding via nasogastric tube and use of steroids was not associated with development of ventilator associated pneumonia . The patients with ventilator associated pneumonia had significantly longer duration of mechanical ventilation ( 18.88+/-7.7 days vs 7.36+/-4.19 days ) and stay ( 29+/-17.8 days vs 9.22+/-5.14 days ) . The morality was similar for both the groups with or without ventilator associated pneumonia . CONCLUSION The incidence of ventilator pneumonia is high . Patients requiring prolonged ventilation , re-intubation , more invasive lines and H2 blockers , are at high risk and need special attention towards prevention BACKGROUND AND OBJECTIVE Unguided nasojejunal feeding tube insertion success rates are low . Controversy persists about how to safely and efficiently perform enteral nutrition ( EN ) in critically ill patients . This study explores an innovative blind nasointestinal tube ( NIT ) insertion method and compares nasogastric and nasointestinal feeding . METHODS Seventy critically ill patients admitted to the intensive care unit ( ICU ) were divided r and omly into a nasogastric tube group ( NGT ; n=35 ) and an NIT group ( NIT ; n=35 ) . After bedside NGT and blind-type NIT insertion , tube position was assessed and EN was started on day 1 . Patients ' nutritional status parameters , mechanical ventilation duration , average ICU stay , nutritional support costs , and feeding complications were compared . RESULTS Pre-albumin and transferrin levels on days 7 and 14 were significantly higher in the NIT group than in the NGT group ( p<0.01 , p<0.05 ) . Bloating , diarrhea , upper gastrointestinal bleeding , and liver damage did not differ significantly between groups ( p>0.05 ) . Interleukin-6 and tumor necrosis factor-α levels and APACHE II score were significantly lower in the NIT group than in the NGT group ( p<0.01 , p<0.05 ) . Reflux and pneumonia incidences , mechanical ventilation duration , average ICU stay length , and nutritional support costs were significantly lower in the NIT group than in the NGT group ( p<0.01 ) . CONCLUSION Blind bedside NIT insertion is convenient and its use can effectively improve nutritional status , reduce feeding complications , and decrease nutritional support costs of critically ill patients Background There are numerous challenges in providing nutrition to the mechanically ventilated critically ill ICU patient . Underst and ing the level of nutritional support and the barriers to enteral feeding interruption in mechanically ventilated patients are important to maximise the nutritional benefits to the critically ill patients . Thus , this study aims to evaluate enteral nutrition delivery and identify the reasons for interruptions in mechanically ventilated Malaysian patients receiving enteral feeding . Methods A cross sectional prospect i ve study of 77 consecutive patients who required mechanical ventilation and were receiving enteral nutrition was done in an open 14-bed intensive care unit of a tertiary hospital . Data were collected prospect ively over a 3 month period . Descriptive statistical analysis were made with respect to demographical data , time taken to initiate feeds , type of feeds , quantification of feeds attainment , and reasons for feed interruptions . There are no set feeding protocol s in the ICU . The usual initial rate of enteral nutrition observed in ICU was 20 ml/hour , assessed every 6 hours and the decision was made thereafter to increase feeds . The target calorie for each patient was determined by the clinician alongside the dietitian . The use of prokinetic agents was also prescribed at the discretion of the attending clinician and is commonly IV metoclopramide 10 mg three times a day . Results About 66 % of patients achieved 80 % of caloric requirements within 3 days of which 46.8 % achieved full feeds in less than 12 hours . The time to initiate feeds for patients admitted into the ICU ranged from 0 – 110 hours with a median time to start feeds of 15 hours and the interquartile range ( IQR ) of 6–59 hours . The mean time to achieve at least 80 % of nutritional target was 1.8 days ± 1.5 days . About 79 % of patients experienced multiple feeding interruptions . The most prevalent reason for interruption was for procedures ( 45.1 % ) followed by high gastric residual volume ( 38.0 % ) , diarrhoea ( 8.4 % ) , difficulty in nasogastric tube placement ( 5.6 % ) and vomiting ( 2.9 % ) . Conclusion Nutritional inadequacy in mechanically ventilated Malaysian patients receiving enteral nutrition was not as common as expected . However , there is still room for improvement with regards to decreasing the number of patients who did not achieve their caloric requirement throughout their stay in the ICU OBJECTIVES To investigate the absorption of the gastrokinetic drug , cisapride , and effect of cisapride on gastric emptying in critically ill patients ; and to assess the usefulness of clinical signs of gastric emptying . DESIGN Prospect i ve , r and omized , controlled study . SETTING Medical/surgical/trauma intensive care unit ( ICU ) in a university hospital . PATIENTS Twenty-seven consecutively enrolled patients , aged 18 to 65 yrs , with normal hepatic and renal biochemistry who were not receiving enteral nutrition and who had no contraindications to enteral nutrition . These patients were expected to stay in the ICU for at least 4 days . INTERVENTIONS Patients were r and omized to receive either placebo or rectal cisapride , 60 mg initially followed by two doses of 30 mg at 8-hr intervals . MEASUREMENTS AND MAIN RESULTS Gastric emptying was estimated , using acetaminophen absorption on day 1 of the study . Placebo or cisapride was administered and a second acetaminophen absorption test for gastric emptying was carried out on day 2,24 hrs after the first test . Four patients were excluded because of incomplete data . Statistical analysis was performed , using the area under the acetaminophen absorption curve from 0 to 60 mins as the primary measure of gastric emptying . There was no significant change in the area under the acetaminophen absorption curve from 0 to 60 mins from day 1 to day 2 in patients who received placebo or cisapride . Using the combination of the time to maximum acetaminophen concentration ( < or = 30 mins ) with a maximum concentration ( > 12 mg/L ) to define " normal " emptying , on day 1 , four of the 11 placebo patients had the " normal " gastric emptying , and by day 2 , five patients fulfilled this criterion . Before administration of cisapride , four of the 12 patients fulfilled this criterion , whereas nine fulfilled the criterion after receiving cisapride . There was a large variation in gastric emptying from day 1 to day 2 ; a power calculation suggests that approximately 150 patients would have to be studied to determine the effect of cisapride . There was no correlation between gastric emptying and the volume of gastric aspirate or the presence of bowel sounds . Plasma cisapride concentrations 4 hrs after the third dose , during the second acetaminophen absorption test , averaged 53 ng/mL ( range 20 to 111 ) . CONCLUSIONS Rectal cisapride in the dose given achieved average plasma concentrations similar to those concentrations achieved in healthy subjects after 30 mg of cisapride rectally . There is a large variation in gastric emptying from one day to the next and large numbers of patients are required to determine if cisapride administration improves early gastric emptying in critically ill patients . The volume of gastric aspirate and the presence of bowel sounds do not correlate with gastric emptying PURPOSE The prupose was to identify , through the BreathID automatic breath-testing device , the best prokinetic therapy to enhance gastric-emptying rate ( GER ) in ventilated intensive care unit patients . MATERIAL S AND METHODS This was a prospect i ve , crossover , nonr and omized study . Consecutive ventilated patients who could be fed enterally and expected to require 5 days of ventilation were included . (13)C-
Output:
| Because of the poor method ological quality and high risk of bias in the included studies , this systematic review revealed no definite conclusion about the application of metoclopramide for the reduction of nosocomial pneumonia . |
MS210337 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Electrochemotherapy ( ECT ) is a new antitumor approach that combines systemic bleomycin ( BLM ) with electric pulses ( EP ) delivered locally at the tumor site . These EP permeabilize the cells in the tissue , allow BLM delivery inside the cells , and increase BLM cytotoxicity . As an extension of our initial Phase I trial on patients with head and neck squamous cell carcinoma ( HNSCC ) permeation nodules , we tested variations of ECT protocol to determine how to improve it OBJECTIVES To determine the safety and efficacy of electroporation with bleomycin in patients with advanced squamous cell carcinoma of the head and neck . METHODS Two open-label , multicenter , single-arm Phase II studies of intratumour electroporation therapy . Sixty-two patients with 86 squamous cell carcinoma tumours of the head and neck were enrolled . Twenty-five patients were treated with bleomycin alone . Fifty-four patients ( 17 initially treated with bleomycin alone ) were treated with electroporation and bleomycin therapy . Local tumour response was measured . RESULTS In the bleomycin alone group , one tumour showed a partial response and 36 tumours showed no response to treatment . In the bleomycin with electroporation groups , 17 tumours showed complete response , 22 tumours showed partial response and 30 failed to achieve more than a 50 % reduction in tumour size ( no response ) . Bleomycin with electroporation had a significantly ( p<0.001 ) greater number of patients showing a partial or complete response to the therapy when compared to bleomycin alone . Thirteen adverse events were reported which included five episodes of local bleeding , six local infections , one local tongue swelling and one cardiac arrhythmia . CONCLUSIONS Fifty-seven percent of squamous cell carcinomas of the head and neck demonstrated a partial or complete response to intratumour electroporation with bleomycin suggesting that further work investigating its use as a treatment for local control of these lesions should be pursued AIMS AND BACKGROUND Electrochemotherapy is a tumor ablation modality providing delivery into the cell interior of impermeant or poorly permeant chemotherapeutic drugs such as cisplatin and bleomycin . A locally applied electrical field enhances the membrane permeability allowing intracellular accumulation of the chemotherapeutic agent . The aim of the study was to evaluate the effectiveness of ECT for the treatment of a group of patients affected by recurrent of extended primary head and neck cancer and not suitable for st and ard therapeutic options . METHODS AND STUDY DESIGN From April 2009 to January 2011 , we treated with electrochemotherapy a total of 15 patients with head and neck cancers , 13 with squamous cell carcinoma , 1 with basaloid carcinoma and 1 with Merkel cell carcinoma . Electrical pulses were delivered to 33 lesions ( 3 primaries , 30 recurrences ) after an intravenous bolus injection of a dose of 15,000 IU/m2 of bleomycin . In 3 cases , the lesion treated was a pathologic lymph node . RESULTS Of the 31 lesions assessable for the study , 19 ( 61.5 % ) showed a complete response , 10 ( 32.5 % ) a partial response , 1 ( 3 % ) stable disease and 1 ( 3 % ) progression of the disease . The objective response 2 months after the procedure was 94 % . All the lesions that underwent complete regression were less than 3 cm in their maximum diameter . The 2 assessable cases of pathologic lymph nodes showed a partial or no response . After a follow-up of 2 to 20 months , 29 % of the patients were alive and free of disease , 50 % were alive with disease , 14 % died for disease and 7 % died for other causes . CONCLUSIONS Our study confirms the effectiveness of electrochemotherapy in the treatment or local control of recurrent or extended primary head and neck cancer in patients not suitable for st and ard therapeutic options Background . Electrochemotherapy is a new antitumor treatment consisting of electrical pulses administered to the tumor several minutes after intravenous injection of bleomycin . In mice , important antitumor effects were observed on subcutaneously transplanted tumors and on spontaneously occurring mammary carcinomas . Cures were obtained after one single treatment combining bleomycin and electric pulses . In humans , permeation nodules seemed an adequate oncologic situation to assay this new procedure . The authors report the first Phase I‐II trial of electrochemotherapy • Chemo‐electroporation therapy with bleomycin is a locoregional treatment modality for head and neck and skin cancer , with the potential to preserve function Many conventional chemotherapeutic drugs , as well as DNA for cancer gene therapy , require efficient access to the cells ' interior to be effective . The cell membrane is a formidable barrier to many of these drugs , including therapeutic DNA constructs . Electropermeabilization ( EP , often used synonymously with “ electroporation ” ) has become a useful method to temporarily increase the permeability of the cell membrane , allowing a broad variety of molecules efficient access to the cell interior . EP is achieved by the application of short electrical pulses of relatively high local field strength to the target tissue of choice . In cancer therapy , EP can be applied in vivo directly to the tumor to be treated , in order to enhance intracellular uptake of drugs or DNA . Alternatively , EP can be used to deliver DNA into cells of healthy tissue to achieve longer-lasting expression of cancer-suppressing genes . In addition , EP has been used in ex vivo therapeutic approaches for the transfection of a variety of cells in suspension . In this paper , we communicate results related to the development of a treatment for squamous cell carcinomas of the head and neck , using electropermeabilization to deliver the drug bleomycin in vivo directly into the tumor cells . This drug , which is not particularly effective as a conventional therapeutic , becomes highly potent when the intracellular concentration is enhanced by EP treatment . In animal model experiments we found a drug dose of 1 U/cm3 tumor tissue ( delivered in 0.25 mL of an aqueous solution/cm3 tumor tissue ) and an electrical field strength of 750 V/cm or higher to be optimal for the treatment of human squamous cell tumors grown subcutaneously in mice . Within 24–48 hours , the majority of tumor cells are rapidly destroyed by this bleomycin-electroporation therapy ( B-EPT ) . This raises the concern that healthy tissue may be similarly affected . In studies with large animals we showed that normal muscle and skin tissue , normal tissue surrounding major blood vessels and nerves , as well as healthy blood vessels and nerves themselves , are much less affected than tumor tissue . Normal tissues did show acute , focal , and transitory effects after treatment , but these effects are relatively minor under st and ard treatment conditions . The severity of these effects increases with the number of electric pulse cycles and applied voltage . The observed histological changes resolved 20 to 40 days after treatment or sooner , even after excessive EP treatment . Thus , B-EPT is distinct from other ablative therapies , such as thermal , cryo , or photodynamic ablation , which equally affect healthy and tumor tissue . In comparison to surgical or radiation therapy , B-EPT also has potential as a tissue-sparing and function-preserving therapy . In clinical studies with over 50 late stage head and neck cancer patients , objective tumor response rates of 55–58 % , and complete tumor response rates of 19–30 % have been achieved OBJECTIVES Electroporation therapy with intralesional bleomycin ( EPT ) is a novel , technically simple outpatient technique in which high-voltage electric impulses delivered into a neoplasm transiently increase cell membrane permeability to large molecules , including cytotoxic agents , causing localized progressive necrosis . Unlike many laser ablation methods , EPT can treat bulky tumors ( > 2 cm ) with complete penetration . Our recent publication confirms an excellent response rate in the use of EPT in a clinical trial . STUDY DESIGN , PATIENTS , AND METHODS Following our initial prospect i ve study report in 1998 , we have followed our entire initial cohort ( 10 patients ) of patients with head and neck cancer beyond 24-months follow-up . Additionally , we have used this approach to treat four additional patients ( total : 9 males/5 females ) with upper aerodigestive tract squamous cell carcinoma , including three with internal carotid artery ( ICA ) involvement up to or within the skull base . Two patients underwent preoperative balloon test occlusion with cerebral perfusion studies followed by carotid embolization . EPT was then done safely at least 2 weeks later to avoid the temporary hypercoagulable state . RESULTS Within the overall cohort ( 14 patients ) 6 patients had a complete response , 6 had a partial response , and 2 did not respond ( overall 85.7 % response rate ) . Both patients with ICA involvement had a partial or complete response to treatment ; neither patient had a hemorrhagic or neurologic complication . Overall , 13 of the 14 patients were treated for persistent or recurrent head and neck cancer . Two of the four patients with early recurrent stage tumors had no evidence of recurrence after EPT with an average follow-up of 31.5 months . The overall early stage tumor group had four complete responders out of five ( 80 % ) . On the contrary , only 2 of 9 patients with advanced recurrent stage tumors were disease-free at 18 months . Morbidity was low for early stage tumors , but higher for advanced tumors with complications , including poor wound healing , dysphagia , and osteomyelitis . There were no treatment-related deaths . CONCLUSION We found EPT to be safe and efficacious in patients with head and neck cancer , even with internal carotid artery involvement . Patients with early stage recurrences have the potential for prolonged survival beyond 2 years without the morbidity of surgery and radiation or toxicity of systemic chemotherapy . Because of its superb access qualities even for bulky tumors , EPT is a potential method of delivery for other tumoricidal agents such as in genetic-altering schemes
Output:
| No major side effects have been described in those who used electrochemotherapy as a mono modality palliative treatment .
This systematic review shows how st and ardization of treatment is still pivotal to achieve a more homogeneous response rate in the approach to head and neck tumors . |
MS210338 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The purpose of this study was to examine the psychometric properties ( test-retest and interrater reliability , criterion concurrent validity ) of 3 verbal pain- assessment tools ( Faces Pain Scale , Numerical Rating Scale , Present Pain Intensity Scale ) and a behavioural pain- assessment scale for use with an elderly population . The study used a repeated- measures design to examine the reliability and validity of the tools across 4 groups of participants with varying levels of cognitive impairment using a non-r and om stratified sample of 130 elderly long-term-care residents . The findings support the test-retest and interrater reliability of the behavioural pain- assessment tool across all levels of cognitive impairment , whereas the same measures of reliability for the verbal-report tools decreased with increasing cognitive impairment ; however , the majority of elderly with mild to moderate cognitive impairment were able to complete at least 1 of these tools . The findings are discussed in relation to their clinical and research implication BACKGROUND Nursing homes ( NHs ) are less well studied than hospices or hospitals as a setting for terminal care . For more targeted palliative care , more information is needed about the patient characteristics , symptoms , direct causes and underlying diseases , and incidence of terminally ill NH patients . These aspects are examined in this study . METHODS Prospect i ve observational cohort study in 16 NHs representative of the Netherl and s. All long-term care patients assessed by an NH physician to have a life expectancy of 6 weeks or less were enrolled in our study . RESULTS The terminal disease phase was marked with symptoms of low fluid and food intake , general weakness , and respiratory problems or dyspnea . Direct causes of these conditions were diseases of the respiratory system ( mainly pneumonia ) and general disorders ( eg , cachexia ) . The 2 main underlying diseases of the terminal phase were mental and behavioral disorders and diseases of the circulatory system . Cancer was the underlying disease in only 12 % of the patients . Patients with cancer showed a different pattern of symptoms than those without cancer . Per 100 beds per year , 34 NH patients entered the terminal phase . Most patients ( 82.9 % ) died within 7 days of inclusion . CONCLUSIONS For patients without cancer in Dutch NHs , the terminal disease phase is difficult to predict , and once diagnosed , patient survival time is short . A better identification of the symptom burden might improve the prognostication of life expectancy in elderly patients The aim of this study was to assess the Palliative care Outcome Scale ( POS ) for terminally ill nursing home ( NH ) patients in the Netherl and s. Methods : A prospect i ve observational study of patients with a life-expectancy of six weeks or less in 16 Dutch NHs . NH staff rated the patient characteristics and measured palliative care with the POS , including items on physical , psychosocial , informational , spiritual and practical aspects . Results : POS nonscores ( not applicable ; unknown ) were mainly found in the psychosocial and spiritual domains , particularly in patients with dementia . Mean scores for non-demented patients and patients with dementia were favourable for the majority of the POS items . Conclusion : According to the NH staff , fairly good quality care was provided , but the psychosocial and spiritual aspects of care need to be addressed more in the last days of the dying NH patient 's life . The results indicate that the POS is an appropriate instrument to assess not only cancer patients , but also non-cancer and ( moderately ) severely demented patients Pain is a common problem for many older adults , with up to 50 % of community-dwelling and 70 % to 80 % of nursing home residents experiencing pain regularly . Effective pain management requires thorough assessment , appropriate intervention , and systematic re assessment . Pain assessment , however , is complicated by dementia , which impairs memory , reasoning , recognition , and communication , and affects elders ' ability to verbally report pain . As such , observational measures are needed to assess pain in this vulnerable population . The Non-communicative Patient 's Pain Assessment Instrument ( NOPPAIN ) was developed for this purpose , but more validation of this measure is needed . Thus , the purpose of this study was to ( 1 ) evaluate reliability of the NOPPAIN tool when used by nurses and to ( 2 ) compare NOPPAIN ratings with self-report and other well-established behavioral rating procedures . Forty participants ( 20 cognitively intact and 20 impaired ) were r and omly selected for this study from a larger sample . In the parent study , participants were asked to perform everyday activities ( i.e. , sit , st and , walk in place , transfer in and out of bed ) while being videotaped . The tapes , all previously scored using microanalytic observational coding , were rated again by naïve raters using the NOPPAIN measure . Results indicated ( 1 ) high inter- and intrarater reliability of the NOPPAIN and ( 2 ) significant correlations of the NOPPAIN with self-reported pain and detailed behavioral coding . Findings support the reliability and validity of the NOPPAIN measurement tool and suggest this easy-to-use tool may be adequate for measuring pain indicators in older adults The Neuropsychiatric Inventory ( NPI ) is a vali date d clinical instrument for evaluating psychopathology in dementia . The authors developed a brief question naire form of the NPI ( NPI-Q ) , intended for use in routine clinical practice , and cross-vali date d it with the NPI in 60 Alzheimer 's patients . Test-retest reliability of the NPI-Q was acceptable . The prevalence of analogous symptoms reported on the NPI and NPI-Q differed on average by 5 % ; moderate or severe symptom ratings differed by less than 2 % . The NPI-Q provides a brief , reliable , informant-based assessment of neuropsychiatric symptoms and associated caregiver distress that may be suitable for use in general clinical practice & NA ; With the increasing numbers of older adults in our population , nurses are reexamining all aspects of nursing care in order to best meet the needs of these individuals . Normal age changes , the impact of decades of environmental challenges , successful adaptations , acute illnesses , trauma and chronic illnesses combine to create a challenge for accurate and effective assessment of elderly patients . The nurse finds her assessment skills challenged with increasing frequency by the elderly patient who is also acutely confused and experiencing discomfort . The purpose of this study was to explore the clinical utility , validity and reliability of four different approaches to nursing assessment of discomfort with this particularly vulnerable group of elders BACKGROUND depression is common but under-diagnosed in nursing-home residents . There is a need for a st and ardized screening instrument which incorporates daily observations of nursing-home staff . AIM to develop and vali date a screening instrument for depression using items from the Minimum Data Set of the Resident Assessment Instrument . METHODS we conducted semi-structured interviews with 108 residents from two nursing homes to obtain depression ratings using the 17-item Hamilton Depression Rating Scale and the Cornell Scale for Depression in Dementia . Nursing staff completed Minimum Data Set assessment s. In a r and omly assigned derivation sample ( n = 81 ) , we identified Minimum Data Set mood items that were correlated ( P < 0.05 ) with Hamilton and Cornell ratings . These items were factored using an oblique rotation to yield five conceptually distinct factors . Using linear regression , each set of factored items was regressed against Hamilton and Cornell ratings to identify a core set of seven Minimum Data Set mood items which comprise the Minimum Data Set Depression Rating Scale . We then tested the performance of the Minimum Data Set Depression Rating Scale against accepted cut-offs and psychiatric diagnoses . RESULTS a cutpoint score of 3 on the Minimum Data Set Depression Rating Scale maximized sensitivity ( 94 % for Hamilton , 78 % for Cornell ) with minimal loss of specificity ( 72 % for Hamilton , 77 % for Cornell ) when tested against cut-offs for mild to moderate depression in the derivation sample . Results were similar in the validation sample . When tested against diagnoses of major or non-major depression in a subset of 82 subjects , sensitivity was 91 % and specificity was 69 % . Performance compared favourably with the 15-item Geriatric Depression Scale . CONCLUSION items from the Minimum Data Set can be organized to screen for depression in nursing-home residents . Further testing of the instrument is now needed Purpose Quality of care for long-term care ( LTC ) residents with dementia at the end-of-life is often evaluated using st and ardized instruments that were not developed for or thoroughly tested in this population . Given the importance of using appropriate instruments to evaluate the quality of care ( QOC ) and quality of dying ( QOD ) in LTC , we compared the validity and reliability of ten available instruments commonly used for these purpose s. Methods We performed prospect i ve observations and retrospective interviews and surveys of family ( n = 70 ) and professionals ( n = 103 ) of LTC decedents with dementia in the Netherl and s. Results Instruments within the constructs QOC and QOD were highly correlated , and showed moderate to high correlation with overall assessment s of QOC and QOD . Prospect i ve and retrospective ratings using the same instruments differed little . Concordance between family and professional scores was low . Cronbach ’s alpha was mostly adequate . The EOLD – CAD showed good fit with pre-assumed factor structures . The EOLD – SWC and FPCS appear most valid and reliable for measuring QOC , and the EOLD – CAD and MSSE for measuring QOD . The POS performed worst in this population . Conclusions Our comparative study of psychometric properties of instruments allows for informed selection of QOC and QOD measures for LTC residents with dementia Objective To determine whether a systematic approach to the treatment of pain can reduce agitation in people with moderate to severe dementia living in nursing homes . Design Cluster r and omised controlled trial . Setting 60 clusters ( single independent nursing home units ) in 18 nursing homes within five municipalities of western Norway . Participants 352 residents with moderate to severe dementia and clinical ly significant behavioural disturbances r and omised to a stepwise protocol for the treatment of pain for eight weeks with additional follow-up four weeks after the end of treatment ( 33 clusters ; n=175 ) or to usual treatment ( control , 27 clusters ; n=177 ) . Intervention Participants in the intervention group received individual daily treatment of pain for eight weeks according to the stepwise protocol , with paracetamol ( acetaminophen ) , morphine , buprenorphine transdermal patch , or pregabaline . The control group received usual treatment and care . Main outcome measures Primary outcome measure was agitation ( scores on Cohen-Mansfield agitation inventory ) . Secondary outcome measures were aggression ( scores on neuropsychiatric inventory-nursing home version ) , pain ( scores on mobilisation-observation-behaviour-intensity-dementia-2 ) , activities of daily living , and cognition ( mini-mental state examination ) . Results Agitation was significantly reduced in the intervention group compared with control group after eight weeks ( repeated measures analysis of covariance adjusting for baseline score , P<0.001 ) : the average reduction in scores for agitation was 17 % ( treatment effect estimate −7.0 , 95 % confidence interval −3.7 to −10.3 ) . Treatment of pain was also significantly beneficial for the overall severity of neuropsychiatric symptoms ( −9.0 , −5.5 to −12.6 ) and pain ( −1.3 , −0.8 to −1.7 ) , but the groups did not differ significantly for activities of daily living or cognition . Conclusion A systematic approach to the management of pain significantly reduced agitation in residents of nursing homes with moderate to severe dementia . Effective management of pain can play an important part in the treatment of agitation and could reduce the number of unnecessary prescriptions for psychotropic drugs in this population . Trial registration Clinical Trials.gov NCT01021696 and Norwegian Medicines Agency EudraCTnr 2008 - 007490 - 20 A method for assessing affect states among older people with Alzheimer 's disease was developed for use in a study design ed to evaluate a special care unit for such residents of a nursing home . The 6-item Philadelphia Geriatric Center Affect Rating Scale was design ed for the use of research and other staff in assessing positive affect ( pleasure , interest , contentment ) and negative affect ( sadness , worry/anxiety , and anger ) by direct observation of facial expression , body movement , and other cues that do not depend on self-report , among 253 demented and 43 nondemented residents . Each affect scale was highly reliable , expressed in estimated portions of a 10-minute observation period when the affect expression occurred . Validity estimates were affirmative in showing discriminant correlations between the positive states and various independent measures of social and other outwardly engaged behavior and between negative states and other measures of depression , anger , anxiety , and withdrawal . Limited support for the two-factor dimensionality of the affect ratings was obtained , although positive and negative affect were correlated , rather than independent . Some hope is offered that the preference and aversions of Alzheimer patients may be better understood by observations of their emotional behaviors and that such methods may lead to a better ability to judge institutional quality OBJECTIVES To describe the end-of-life symptoms of nursing home ( NH ) and residential care/assisted living ( RC/AL ) residents , compare staff and family symptom ratings , and compare how staff assess pain and dyspnea for cognitively impaired and cognitively intact residents . DESIGN After-death interviews . SETTING Stratified r and om sample of 230 long-term care facilities in four states . PARTICIPANTS Staff ( n=674 ) and family ( n=446 ) caregivers for dying residents . MEASUREMENTS Interview items measured frequency and severity of physical symptoms , effectiveness of treatment , recommendations to improve care , and staff report of assessment
Output:
| The pain assessment s , PAINAD and PACSLAC had the strongest psychometric evidence .
The oral health , discomfort , and three psychological wellbeing measures were vali date d in this setting but require further psychometric evaluation .
Depression measures were poor at detecting depression in this population .
Conclusions Measures for pain are best developed for this population and setting . |
MS210339 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : To evaluate whether patient characteristics and /or radiographic disease patterns predict symptomatic response to treatment with glucosamine in osteoarthritis ( OA ) of the knee . Design : Exploratory prospect i ve correlational study . Setting : Institutional . Patients : 39 participants with chronic knee pain from the local community . Interventions : Glucosamine sulphate ( 1.5 g/day ) for 12 weeks . Main outcome measures : Pain and physical function were assessed with visual analogue scales ( VASs ) and participant-perceived global change scores ( GCSs ) . Regression modelling evaluated the relationship between treatment outcome and age , body mass index ( BMI ) , pain and function self-efficacy and presence/absence of osteophytes in the medial and lateral tibiofemoral joint ( TFJ ) and patellofemoral joint ( PFJ ) compartments . Results : 13 ( 33 % ) participants were men . The mean ( SD ) age and BMI were 53.6 ( 13.1 ) years and 27.9 ( 4.6 ) kg/m2 , respectively . 13 ( 33 % ) , 19 ( 49 % ) and 24 ( 62 % ) participants had medial TFJ , lateral TFJ and PFJ osteophytes , respectively . Glucosamine significantly improved pain ( mean change on VAS = −1.4 , 95 % CI −0.6 to −2.2 ; p = 0.002 ) and activity restriction ( −1.9 , 95 % CI −1.0 to −2.8 ; p<0.001 ) . At 12 weeks , 30 ( 77 % ) and 27 ( 69 % ) participants reported improvement in pain and physical function , respectively . Regression modelling showed that no evaluated variables predicted change in pain on VAS . Decreased function self-efficacy , presence of PFJ osteophytes and absence of medial TFJ osteophytes predicted functional improvement on VAS . BMI , pain self-efficacy and function self-efficacy predicted improvement in pain by GCS . Conclusions : Although glucosamine significantly improved symptoms , most of the variance in outcome at 12 weeks was unexplained by the predictors evaluated . However , glucosamine may be more effective at improving symptoms in patients with knee OA who have a lower BMI , PFJ osteophytes and lower functional self-efficacy OBJECTIVE To determine the effect of quadriceps strength in individuals with knee osteoarthritis ( OA ) on loss of cartilage at the tibiofemoral and patellofemoral joints ( assessed by magnetic resonance imaging [ MRI ] ) and on knee pain and function . METHODS We studied 265 subjects ( 154 men and 111 women , mean+/-SD age 67+/-9 years ) who met the American College of Rheumatology criteria for symptomatic knee OA and who were participating in a prospect i ve , 30-month natural history study of knee OA . Quadriceps strength was measured at baseline , isokinetically , during concentric knee extension . MRI of the knee at baseline and at 15 and 30 months was used to assess cartilage loss at the tibiofemoral and patellofemoral joints , with medial and lateral compartments assessed separately . At baseline and at followup visits , knee pain was assessed using a visual analog scale , and physical function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index . RESULTS There was no association between quadriceps strength and cartilage loss at the tibiofemoral joint . Results were similar in malaligned knees . However , greater quadriceps strength was protective against cartilage loss at the lateral compartment of the patellofemoral joint ( for highest versus lowest tertile of strength , odds ratio 0.4 [ 95 % confidence interval 0.2 , 0.9 ] ) . Those with greater quadriceps strength had less knee pain and better physical function over followup ( P<0.001 ) . CONCLUSION Greater quadriceps strength had no influence on cartilage loss at the tibiofemoral joint , including in malaligned knees . We report for the first time that greater quadriceps strength protected against cartilage loss at the lateral compartment of the patellofemoral joint , a finding that requires confirmation . Subjects with greater quadriceps strength also had less knee pain and better physical function over followup Background A recent study of adults aged ≥50 years reporting knee pain found an excess of radiographic knee osteoarthritis ( knee ROA ) in symptomatic males compared to females . This was independent of age , BMI and other clinical signs and symptoms . Since this finding contradicts many previous studies , our objective was to explore four possible explanations for this gender difference : X-ray views , selection , occupation and non-articular conditions . Methods A community-based prospect i ve study . 819 adults aged ≥50 years reporting knee pain in the previous 12 months were recruited by postal question naires to a research clinic involving plain radiography ( weight-bearing posteroanterior semiflexed , supine skyline and lateral views ) , clinical interview and physical examination . Any knee ROA , ROA severity , tibiofemoral joint osteoarthritis ( TJOA ) and patellofemoral joint osteoarthritis ( PJOA ) were defined using all three radiographic views . Occupational class was derived from current or last job title . Proportions of each gender with symptomatic knee ROA were expressed as percentages , stratified by age ; differences between genders were expressed as percentage differences with 95 % confidence intervals . Results 745 symptomatic participants were eligible and had complete X-ray data . Males had a higher occurrence ( 77 % ) of any knee ROA than females ( 61 % ) . In 50–64 year olds , the excess in men was mild knee OA ( particularly PJOA ) ; in ≥65 year olds , the excess was both mild and moderate/severe knee OA ( particularly combined TJOA/PJOA ) . This male excess persisted when using the posteroanterior view only ( 64 % vs. 52 % ) . The lowest level of participation in the clinic was symptomatic females aged 65 + . Within each occupational class there were more males with symptomatic knee ROA than females . In those aged 50–64 years , non-articular conditions were equally common in both genders although , in those aged 65 + , they occurred more frequently in symptomatic females ( 41 % ) than males ( 31 % ) . Conclusion The excess of knee ROA among symptomatic males in this study seems unlikely to be attributable to the use of comprehensive X-ray views . Although prior occupational exposures and the presence of non-articular conditions can not be fully excluded , selective non-participation bias seems the most likely explanation . This has implication s for future study design Objective Braces used to treat ( PF ) osteoarthritis ( OA ) may reduce contact stress across the PF joint . We hypothesised that in PF OA , braces would decrease knee pain and shrink PF bone marrow lesions ( BMLs ) . Methods Eligible subjects had painful PF OA . Subjects were r and omly allocated to brace or no brace for 6 weeks . Knee MRIs were acquired at baseline and 6 weeks . We measured BMLs on post-contrast fat suppressed sagittal and proton density weighted axial images . The primary symptom outcome was change in pain at 6 weeks during a preselected painful activity , and the primary structural outcome was BML volume change in the PF joint . Analyses used multiple linear regression . Results We r and omised 126 subjects aged 40–70 years ( mean age 55.5 years ; 72 females ( 57.1 % ) ) . Mean nominated visual analogue scale ( 0–10 cm ) pain score at baseline was 6.5 cm . 94 knees ( 75 % ) had PF BMLs at baseline . Subjects wore the brace for a mean of 7.4 h/day . 6 subjects withdrew during the trial . After accounting for baseline values , the brace group had lower knee pain than the control group at 6 weeks ( difference between groups −1.3 cm , 95 % CI −2.0 to −0.7 ; p<0.001 ) and reduced PF BML volume ( difference −490.6 mm3 , 95 % CI −929.5 to −51.7 ; p=0.03 ) but not tibiofemoral volume ( difference −53.9 mm3 , 95 % CI −625.9 to 518.2 ; p=0.85 ) . Conclusions A PF brace reduces BML volume in the targeted compartment of the knee , and relieves knee pain . Trial registration number UK . IS RCT N50380458 OBJECTIVE To determine whether a complete anterior cruciate ligament ( ACL ) tear , a frequent incidental finding on magnetic resonance imagings ( MRIs ) of individuals with established knee osteoarthritis ( OA ) , increases the risk for further knee OA progression . METHODS We examined 265 participants ( 43 % women ) with symptomatic knee OA in a 30-month , prospect i ve , natural history study of knee OA . The more symptomatic knee was imaged using MRI at baseline , 15 and 30 months . Cartilage was scored at the medial and lateral tibiofemoral joint and at the patellofemoral joint using the Whole-Organ MRI Score ( WORMS ) semi-quantitative method . Complete ACL tear was determined on baseline MRI . At each visit , knee pain was assessed using a knee-specific visual analog scale and physical function was assessed using the Western Ontario and McMaster Universities ( WOMAC ) physical function subscale . RESULTS There were 49 participants ( 19 % ) with complete ACL tear at baseline . Adjusting for age , body mass index , gender and baseline cartilage scores , complete ACL tear increased the risk for cartilage loss at the medial tibiofemoral compartment [ odds ratio ( OR ) : 1.8 , 95 % confidence interval ( CI ) : 1.1 , 3.2 ] . However , following adjustment for the presence of medial meniscal tears , no increased risk for cartilage loss was further seen ( OR : 1.1 , 95 % CI : 0.6 , 1.8 ) . Knee pain and physical function were similar over follow-up between those with and without a complete ACL tear . CONCLUSIONS Individuals with knee OA and incidental complete ACL tear have an increased risk for cartilage loss that appears to be mediated by concurrent meniscal pathology . The presence of a complete ACL tear did not influence the level of knee pain or physical function over short-term follow-up Details of the development of early knee osteoarthritis ( OA ) are largely unknown . The prevalence and progression of radiographic knee OA over 6 years in middle-aged subjects with chronic knee pain is investigated . In a prospect i ve population -based study , tibiofemoral ( TF ) and patellofemoral ( PF ) radiographs were grade d in 128 subjects ( mean age 45 ± 6.2 years ) for the presence of osteophytes and joint space narrowing ( JSN ) . Radiographic progression was defined as : ( i ) the presence of osteophytes and /or JSN in subjects with no previous OA or ( ii ) an increase in the grade and /or number of already existing osteophytes and /or JSN . Altogether 56 % ( 72/128 ) of subjects had knee OA , the majority of them was diagnosed with OA grade 1 . In 57 % of cases , radiographic OA was based on the presence of osteophytes alone versus 13 % on JSN . More than 1/3 of subjects had isolated PF joint involvement . Knee OA progression rate over 6 years was 56 % ( 71/128 ) . During 6 years , a non-linear course of radiographic OA progression with intermittent periods of progression and stabilization was observed . Individual course of OA revealed distinct subsets of radiographic progression . Osteophytosis is an important early radiographic sign of OA and its progression . Isolated PF joint involvement is a frequent expression of knee OA . In middle-aged subjects , the progression rate of knee OA over 6 years was 56 % . A non-linear course of radiographic OA progression was observed . Several radiographic subsets refer to the heterogeneity of the OA process OBJECTIVE Patellofemoral joint osteoarthritis ( PFJ OA ) contributes considerably to knee OA symptoms . This study aim ed to determine the efficacy of a PFJ-targeted exercise , education manual-therapy and taping program compared to OA education alone , in participants with PFJ OA . METHODS A r and omised , participant-blinded and assessor-blinded clinical trial was conducted in primary -care physiotherapy . 92 people aged ≥40 years with symptomatic and radiographic PFJ OA participated . Physiotherapists delivered the PFJ-targeted exercise , education , manual-therapy and taping program , or the OA-education ( control condition ) in eight sessions over 12 weeks . Primary outcomes at 3-month ( primary ) and 9-month follow-up : ( 1 ) patient-perceived global rating of change ( 2 ) pain visual analogue scale ( VAS ) ( 100 mm ) ; and ( 3 ) activities of daily living ( ADL ) subscale of the Knee injury and Osteoarthritis Outcome Score ( KOOS ) . RESULTS 81 people ( 88 % ) completed the 3-month follow-up and data analysed on an intention-to-treat basis . Between-group baseline similarity for participant characteristics was observed
Output:
| Prevalence of MRI findings was high in symptomatic and asymptomatic population . |
MS210340 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different PURPOSE In North America , no effective therapy has been available for patients with progressive metastatic colorectal cancer after front-line treatment with irinotecan , bolus fluorouracil ( FU ) , and leucovorin ( IFL ) . PATIENTS AND METHODS Patients with metastatic colorectal cancer who progressed after IFL therapy were r and omly assigned to bolus and infusional FU and leucovorin ( LV5FU2 ) , single-agent oxaliplatin , or the combination ( FOLFOX4 ) . This planned interim analysis evaluated objective response rate ( RR ) , time to tumor progression ( TTP ) , and alleviation of tumor-related symptoms ( TRS ) in an initial cohort of patients . RESULTS Between November 2000 and September 2001 , 463 patients from 120 sites in North America were r and omly assigned to treatment . FOLFOX4 proved superior to LV5FU2 in all measures of clinical efficacy . Objective RRs determined by an independent radiology panel were 9.9 % for FOLFOX4 versus 0 % for LV5FU2 ( Fisher 's exact test , P < .0001 ) . Median TTP was 4.6 months for FOLFOX4 versus 2.7 months for LV5FU2 ( two-sided , stratified log-rank test , P < .0001 ) . Relief of TRS occurred in 33 % of patients treated with FOLFOX4 versus 12 % of patients treated with LVFU2 ( chi2 test , P < .001 ) . Single-agent oxaliplatin was not superior to LV5FU2 in any measure of efficacy . Patients treated with FOLFOX4 experienced a higher incidence of clinical ly significant toxicities than patients treated with LV5FU2 , but these toxicities were predictable and did not result in a higher rate of treatment discontinuation or 60-day mortality rate . CONCLUSION For patients with metastatic colorectal cancer , second-line treatment with FOLFOX4 is superior to treatment with LVFU2 in terms of RR , TTP , and relief of TRS PURPOSE We performed this phase III study to compare the irinotecan , leucovorin ( LV ) , and fluorouracil ( FU ) regimen ( FOLFIRI ) versus the oxaliplatin , LV , and FU regimen ( FOLFOX4 ) in previously untreated patients with advanced colorectal cancer . PATIENTS AND METHODS A total of 360 chemotherapy-naive patients were r and omly assigned to receive , every 2 weeks , either arm A ( FOLFIRI : irinotecan 180 mg/m(2 ) on day 1 with LV 100 mg/m(2 ) administered as a 2-hour infusion before FU 400 mg/m(2 ) administered as an intravenous bolus injection , and FU 600 mg/m(2 ) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [ LV5FU2 ] ) or arm B ( FOLFOX4 : oxaliplatin 85 mg/m(2 ) on day 1 with LV5FU2 regimen ) . RESULTS One hundred sixty-four and 172 patients were assessable in arm A and B , respectively . Overall response rates ( ORR ) were 31 % in arm A ( 95 % CI , 24.6 % to 38.3 % ) and 34 % in arm B ( 95 % CI , 27.2 % to 41.5 % ; P = .60 ) . In both arms A and B , median time to progression ( TTP ; 7 v 7 months , respectively ) , duration of response ( 9 v 10 months , respectively ) , and overall survival ( OS ; 14 v 15 months , respectively ) were similar , without any statistically significant difference . Toxicity was mild in both groups : alopecia and gastrointestinal disturbances were the most common toxicities in arm A ; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms , and no statistical significant difference was observed . CONCLUSION There is no difference in ORR , TTP , and OS for patients treated with the FOLFIRI or FOLFOX4 regimen . Both therapies seemed effective as first-line treatment in these patients . The difference between these two combination therapies is mainly in the toxicity profile PURPOSE To determine the activity of biweekly oxaliplatin , combined with weekly bolus fluorouracil ( FU ) and low-dose leucovorin ( LV ) chemotherapy ( bFOL ) , as first-line therapy for patients with metastatic colorectal cancer . PATIENTS AND METHODS Patients with measurable metastatic colorectal cancer ; no previous therapy for advanced disease ( adjuvant therapy allowed if > 6 months since completion ) ; and performance status 0 , 1 , or 2 were eligible and were treated with oxaliplatin 85 mg/m2 days 1 and 15 plus LV 20 mg/m2 over 10 to 20 minutes , followed by a 500 mg/m2 bolus dose of FU on days 1 , 8 , and 15 every 28 days . Patients underwent response evaluation by computed tomographic scan every 2 months . RESULTS Forty-two patients were entered , and 41 patients were treated , including 20 men and 22 women , nine with previous adjuvant chemotherapy and four with radiation therapy . Three patients achieved complete response , and 23 patients achieved partial response , for a response rate of 63 % ( 95 % CI , 49 % to 78 % ) . Major toxicities included cumulative neuropathy grade 2 ( 24 % ) and grade 3 ( 12 % ; requiring discontinuation of oxaliplatin ) , diarrhea grade 3 to 4 ( 29 % ) and grade 3 to 4 hematologic toxicity ( 10 % ) . Median time to progression was 9.0 months ( 95 % confidence interval , 7.1 to 10.8 months ) with median survival of 15.9 months ( 95 % confidence interval , 11.4 to 19.7 months ) . CONCLUSION The bFOL regimen seems to have activity comparable to be infusional programs of FU combined with oxaliplatin . Prospect i ve trials are warranted to determine the relative merits of this schedule compared with the currently indicated schedules PURPOSE In a previous study of treatment for advanced colorectal cancer , the LV5FU2 regimen , comprising leucovorin ( LV ) plus bolus and infusional fluorouracil ( 5FU ) every 2 weeks , was superior to the st and ard North Central Cancer Treatment Group/Mayo Clinic 5-day bolus 5FU/LV regimen . This phase III study investigated the effect of combining oxaliplatin with LV5FU2 , with progression-free survival as the primary end point . PATIENTS AND METHODS Four hundred twenty previously untreated patients with measurable disease were r and omized to receive a 2-hour infusion of LV ( 200 mg/m(2)/d ) followed by a 5FU bolus ( 400 mg/m(2)/d ) and 22-hour infusion ( 600 mg/m(2)/d ) for 2 consecutive days every 2 weeks , either alone or together with oxaliplatin 85 mg/m(2 ) as a 2-hour infusion on day 1 . RESULTS Patients allocated to oxaliplatin plus LV5FU2 had significantly longer progression-free survival ( median , 9.0 v 6.2 months ; P = .0003 ) and better response rate ( 50.7 % v 22.3 % ; P = .0001 ) when compared with the control arm . The improvement in overall survival did not reach significance ( median , 16.2 v 14.7 months ; P = . 12 ) . LV5FU2 plus oxaliplatin gave higher frequencies of National Cancer Institute common toxicity criteria grade 3/4 neutropenia ( 41 . 7 % v 5.3 % of patients ) , grade 3/4 diarrhea ( 11.9 % v 5.3 % ) , and grade 3 neurosensory toxicity ( 18.2 % v 0 % ) , but this did not result in impairment of quality of life ( QoL ) . Survival without disease progression or deterioration in global health status was longer in patients allocated to oxaliplatin treatment ( P = .004 ) . CONCLUSION The LV5FU2-oxaliplatin combination seems beneficial as first-line therapy in advanced colorectal cancer , demonstrating a prolonged progression-free survival with acceptable tolerability and maintenance of
Output:
| For second-line treatment after fluoropyrimidine monotherapy , folfox is a reasonable alternative for patients with contraindications to second-line irinotecan .
Evidence from a single r and omized trial suggests that additional benefits can be expected with the addition of bevacizumab to the folfox regimen in second-line treatment .
The folfox regimen has superior rates of median survival and tumour response .
Compared with ifl , folfox has lower incidences of severe nausea , vomiting , diarrhea , and febrile neutropenia , but a higher incidence of peripheral neuropathy .
The folfox regimen is a reasonable alternative for patients with contraindications to the use of second-line irinotecan .
After progression on both irinotecan and an anti-thymidylate synthase agent , folfox is the preferred therapy .
Recent trials suggest that , as compared with folfox alone , folfox combined with bevacizumab provides additional survival benefits . |
MS210341 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives Describe proportions of individuals with patellofemoral pain ( PFP ) with an unfavourable recovery over 12 months ; identify clinical predictors of poor recovery at 3 and 12 months ; and determine baseline values of predictors that identify those with poor 12-month prognosis . Methods An observational analysis utilised data from 310 individuals with PFP enrolled in two r and omised clinical trials . Thirteen baseline variables ( participant , PFP , study characteristics ) were investigated for their prognostic ability . Pain , function and global recovery were measured at 3 and 12 months . Multivariate backward stepwise regression analyses ( treatment-adjusted , p<0.10 ) were performed for each follow-up measure . Receiver operator characteristic curves identified cut-points associated with unfavourable recovery at 12 months . Results 55 % and 40 % of participants had an unfavourable recovery at 3 and 12 months , respectively . Longer baseline pain duration was significantly associated with poor 3-month and 12-month recovery on measures of pain severity ( β 11.36 to 24.94 ) , Anterior Knee Pain ( AKP ) Scale ( −4.44 to −11.33 ) and global recovery ( OR : 2.32 to 6.11 ) . Greater baseline pain severity and lower AKP Scale score were significantly associated with poor recovery on multiple measures ( p<0.05 ) . Baseline duration > 2 months and AKP Scale score < 70/100 were associated with unfavourable 12-month recovery . Conclusions A substantial number of individuals with PFP have an unfavourable recovery over 12 months , irrespective of intervention . Knee pain duration > 2 months is the most consistent prognostic indicator , followed by AKP Scale score < 70 . Sports medicine practitioners should utilise interventions with known efficacy in reducing PFP , and promote early intervention to maximise prognosis . Trial registration Australian study : Australian Clinical Trials Registry ( ACTRN012605000463673 ) , Clinical Trials.gov ( NCT00118521 ) ; Dutch study : International St and ard R and omised Controlled Trial Number Register ( IS RCT N83938749 We examined the effects of medially wedged foot orthoses on knee and hip joint mechanics during running in females with and without patellofemoral pain syndrome ( PFPS ) . We also tested if these effects depend on st and ing calcaneal eversion angle . Twenty female runners with and without PFPS participated . Knee and hip joint transverse and frontal plane peak angle , excursion , and peak internal knee and hip abduction moment were calculated while running with and without a 6 ° full-length medially wedged foot orthoses . Separate 3-factor mixed ANOVAs ( group [ PFPS , control ] x condition [ medial wedge , no medial wedge ] x st and ing calcaneal angle [ everted , neutral , inverted ] ) were used to test the effect of medially wedged orthoses on each dependent variable . Knee abduction moment increased 3 % ( P = .03 ) and hip adduction excursion decreased 0.6 ° ( P < .01 ) using medially wedged foot orthoses . No significant group x condition or calcaneal angle x condition effects were observed . The addition of medially wedged foot orthoses to st and ardized running shoes had minimal effect on knee and hip joint mechanics during running thought to be associated with the etiology or exacerbation of PFPS symptoms . These effects did not appear to depend on injury status or st and ing calcaneal posture Anterior knee pain ( AKP ) is a common injury among runners and effectively treated with posted insoles and foot orthotics . While clinical ly effective , the underlying biomechanical mechanisms that bring about these improvements remain debatable . Several method ological factors contribute to the inconsistent biomechanical findings , including errors associated with removing and reattaching markers , inferring foot motion from markers placed externally on a shoe , and redefining segmental coordinate systems between conditions . Therefore , the purpose of this study was to evaluate the influence of medially posted insoles on lower extremity kinematics in runners with and without AKP while trying to limit the influence of these method ological factors . Kinematics of 16 asymptomatic and 17 runners with AKP were collected while running with and without insoles . Reflective markers were attached to the surface of the calcaneus and kept in place ( as opposed to detached ) between conditions , eliminating the error associated with reattaching markers and redefining segmental coordinate systems . Using these methods , no significant interactions between insole and injury and the main effect of injury were detected ( p>0.05 ) ; therefore , means were pooled across injury . Insoles , on average , reduced peak eversion by 3.6 ° ( 95 % confidence interval -2.9 ° to -4.3 ° ) , peak eversion velocity by 53.2 ° /s ( 95 % confidence interval -32.9 to -73.4 ) and eversion range of motion by 1.33 ( 95 % confidence interval -0.8 to -1.9 ) . However , while insoles systematic ally reduced eversion variables , they had small influences on the transverse plane kinematics of the tibia or knee , indicating that they may bring about their clinical effect by influencing other variables Treadmills are often used in research to analyse kinematic and physiological variables . The success of transfering the results to overground running depends on the comparability of the values between the two situations . The aim of the present study was to compare the kinematics and muscle activities in overground and treadmill running . Ten male physical education students with experience in treadmill running were asked to run with a speed of 4.0 and 6.0 m/s both overground and on a Woodway treadmill . The 3D-kinematics of the limbs were studied using a two camera video tracking system . Additionally the surface EMG of six lower limb muscles and the pattern of ground contact of the right foot was registered . Both the activities of the leg muscles and several kinematic variables showed systematic changes from overground to treadmill running . On the treadmill the subjects favoured a type of running that provided them with a higher level of security . The swing amplitude of the leg , the vertical displacement and the variance in vertical and horizontal velocity were lower in treadmill running . The angle between shoe sole and ground at foot impact was also lower and the forward lean of the upper body was higher in running on the treadmill compared with the overground mode . Most of the subjects reduced their step length and increased stride frequency in treadmill running . Furthermore , the contact time in treadmill running was shorter than for overground running . The above mentioned kinematic variables were significantly different ( p < 0.05 ) . The EMG patterns of the leg muscles were generally similar between overground and treadmill modes , but some minor differences could consistently be identified OBJECTIVE To examine the test-retest reliability , validity , and responsiveness of several outcome measures in the treatment of patellofemoral pain . DESIGN Evaluation of the clinimetric properties of individual outcome measures for patellofemoral pain treatment , using data collected from a previously published r and omized controlled trial ( RCT ) . SETTING General community and private practice . PARTICIPANTS The data from 71 persons enrolled in an RCT of a conservative intervention for patellofemoral pain were used to evaluate the measures ' validity and responsiveness . A subset of this cohort ( n=20 ) was used to assess reliability . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Three 10-cm visual analog scales ( VASs ) for usual pain ( VAS-U ) , worst pain ( VAS-W ) , and pain on 6 aggravating activities ( walking , running , squatting , sitting , ascending and descending stairs ) ( VAS-activity ) ; the Functional Index Question naire ( FIQ ) ; the Anterior Knee Pain Scale ( AKPS ) ; and the global rating of change . RESULTS The test-retest reliability ranged from poor ( intraclass correlation coefficient [ICC]=.49 ) to good ( ICC=.83 ) , and the measures correlated moderately with each other ( r range,.56-.72 ) . Median change scores differed significantly between improved and unimproved persons for all measures . The effect sizes for VAS-U ( .79 ) , VAS-W ( .88 ) , and the AKPS ( .98 ) were large , indicating greater responsiveness than the FIQ ( .37 ) and VAS-activity ( .66 ) . Similarly , the AKPS and VAS-W were the most efficient measures for detecting a treatment effect when compared with a reference measure ( VAS-U , which was assigned a value of 1 ) . The minimal difference that patients or clinicians consider clinical ly important for the AKPS is 10 ( out of 100 ) points and for the VAS it is 2 cm ( out of 10 cm ) . CONCLUSIONS The AKPS and VAS for usual or worst pain are reliable , valid , and responsive and are therefore recommended for future clinical trials or clinical practice in assessing treatment outcome in persons with patellofemoral pain BACKGROUND Excessive rearfoot eversion is thought to be a risk factor for patellofemoral pain syndrome development , based on theoretical rationale linking it to greater tibial internal rotation and hip adduction . This study aim ed to establish the relationship of rearfoot eversion with tibial internal rotation and hip adduction during walking in individuals with and without patellofemoral pain syndrome . METHODS Twenty-six individuals with patellofemoral pain syndrome and 20 controls ( 18 - 35years ) participated . Each underwent instrumented three-dimensional motion analysis during over-ground walking . Pearson 's correlation coefficients ( r ) were calculated to establish the relationship of rearfoot eversion with tibial internal rotation and hip adduction ( peak and range of motion ) . FINDINGS Greater peak rearfoot eversion was associated with greater peak tibial internal rotation in the patellofemoral pain syndrome group ( r=0.394 , P=0.046 ) . Greater rearfoot eversion range of motion was associated with greater hip adduction range of motion in the patellofemoral pain syndrome ( r=0.573 , P=0.002 ) and control ( r=0.460 , P=0.041 ) groups ; and greater peak hip adduction in the control group ( r=0.477 , P=0.033 ) . INTERPRETATION Associations between greater rearfoot eversion and greater hip adduction indicate that interventions targeted at the foot or hip in individuals with patellofemoral pain syndrome may have similar overall effects on lower limb motion and clinical outcomes . The relationship between rearfoot eversion and tibial internal rotation identified in the patellofemoral pain syndrome group may be related to aetiology . However , additional prospect i ve research is needed to confirm this OBJECTIVES This study evaluated the effects of unmodified prefabricated foot orthoses over a 12-week period on functional performance ; and subjective pain and function in individuals with patellofemoral pain syndrome ( PFPS ) . DESIGN Prospect i ve cohort study over 12 weeks . Each participant was prescribed prefabricated foot orthoses at baseline . PARTICIPANTS Sixty individuals with PFPS ( 18 - 35 years ) . MAIN OUTCOME MEASURES Change in pain and ease of completing a single leg squat ; change in the number of pain free step downs and single leg rises from sitting ; usual and worst pain in the previous week ; the anterior knee pain scale ( AKPS ) ; and the lower extremity functional scale ( LEFS ) . RESULTS At 12 weeks , significant improvements in single leg squat pain and ease , and the number of pain free step downs and single leg rises from sitting were found . Additionally , significant reductions in usual and worst pain , and improvements on the AKPS and LEFS were observed . CONCLUSIONS Functional performance improvements following unmodified prefabricated foot orthoses were greater at 12 weeks that those achieved immediately . Enhanced functional performance over time may have significant implication s for osteoarthritis prevention in some individuals with PFPS . Improvements in subjective pain and function appear to plateau over time BACKGROUND AND PURPOSE The effectiveness of soft foot orthotics in the treatment of patients who have patellofemoral pain syndrome was investigated . SUBJECTS Subjects were 20 adolescent female patients , aged 13 to 17 years ( mean = 14.8 , SD = 1.2 ) , who were diagnosed with patellofemoral pain syndrome and who exhibited excessive forefoot varus or calcaneal valgus . METHODS Subjects were r and omly assigned to one of two groups : a control group ( n = 10 ) , which took part in an exercise program , or a treatment group ( n = 10 ) , which used soft foot orthotics in addition to participating in the exercise program . The exercise program consisted of quadriceps femoris and hamstring muscle strengthening and stretching exercises . A visual analogue scale was used to assess the level of pain of the subjects over an 8-week period . RESULTS Both the treatment and control groups demonstrated a significant decrease in the level of pain , but the improvement of the treatment group was significantly greater than that of the control group . CONCLUSION AND DISCUSSION The results suggest that in addition to an exercise program , the use of soft foot orthotics is an effective means of treatment for the patient with patellofemoral pain syndrome BACKGROUND The aims of this study were to determine the prevalence and incidence of patellofemoral pain ( PFP ) in young female athletes and prospect ively evaluate measures of frontal plane knee loading during l and ing to determine their relationship to development of PFP . We hypothesized that increased dynamic knee abduction measured during preseason biomechanical testing would be increased in those who developed PFP relative to teammates who did not develop PFP . METHODS Middle and high school female athletes ( n=240 ) were evaluated by a physician for PFP and for l and ing biomechanics prior to their basketball season . The athletes were monitored for athletic exposures and PFP injury during their competitive seasons . FINDINGS At the
Output:
| Significant effects on pain and function were determined .
A slight effect on kinematics of the lower limb and muscle activation of selected lower limb muscles was identified .
Foot orthoses seem to be an effective treatment device in the therapy for PFPS .
An immediate and long-term reduction in pain and an improvement of function occurred following the intervention .
There was just a slight change in lower limb kinematics and muscle activation of selected lower limb muscles .
The relationship between biomechanical effects of orthoses and pain still seems to be unclear |
MS210342 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE Determine whether Multisystemic Therapy-Health Care ( MST-HC ) improved asthma knowledge and controller device use skills among African-American youth with poorly controlled asthma and whether any improvements mediated changes in illness management . METHODS A r and omized controlled trial was conducted with 170 adolescents with moderate to severe asthma . Families were r and omized to MST-HC or attention control . Data were collected at baseline and 6 and 12 months after intervention completion . RESULTS In linear mixed models , adolescents in the MST-HC group had increases in asthma knowledge ; asthma knowledge was unchanged for attention control . Controller device use skills increased for adolescents in the MST-HC group , while skills declined for attention control . Both knowledge and skills mediated the relationship between intervention condition and changes in illness management . CONCLUSIONS Tailored , home-based interventions that include knowledge and skills building components are one means by which illness management in African-American youth with poorly controlled asthma can be improved ABSTRACT Objective : To assess the feasibility of a mobile health , inhaled corticosteroid ( ICS ) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma . Methods : Children aged 2–13 with persistent asthma were enrolled in this pilot r and omized controlled trial during an asthma emergency department ( ED ) visit or hospitalization . Intervention arm participants received daily text message reminders for 30 days , and both arms received electronic sensors to measure ICS use . Primary outcomes were feasibility of sensor use and text message acceptability . Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories . Group-based trajectory modeling was used to examine adherence trajectories . Results : Forty-one participants ( mean age 5.9 ) were r and omized to intervention ( n = 21 ) or control ( n = 20 ) . Overall , 85 % were Black , 88 % had public insurance , and 51 % of the caregivers had a high school education or less . Thirty-two participant families ( 78 % ) transmitted medication adherence data ; of caregivers who completed the acceptability survey , 25 ( 96 % ) chose to receive daily reminders beyond that study interval . Secondary outcome analyses demonstrated similar average daily adherence between groups ( intervention = 36 % ; control = 32 % , P = 0.73 ) . Three adherence trajectories were identified with none ever exceeding 80 % adherence . Conclusions : Within a high-risk pediatric cohort , electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants , but there was no signal of effect . Adherence trajectories following severe exacerbation were suboptimal , demonstrating an important opportunity for asthma care improvement Real-time medication monitoring ( RTMM ) is a promising tool for improving adherence to inhaled corticosteroids ( ICS ) , but has not been sufficiently tested in children with asthma . We aim ed to study the effects of RTMM with short message service ( SMS ) reminders on adherence to ICS , asthma control , asthma-specific quality of life and asthma exacerbation rate ; and to study the associated cost-effectiveness . In a multicentre , r and omised controlled trial , children ( aged 4–11 years ) using ICS were recruited from five outpatient clinics and were given an RTMM device for 12 months . The intervention group also received tailored SMS reminders , sent only when a dose was at risk of omission . Outcome measures were adherence to ICS ( RTMM data ) , asthma control ( childhood asthma control test question naire ) , quality of life ( paediatric asthma quality of life question naire ) and asthma exacerbations . Costs were calculated from a healthcare and societal perspective . We included 209 children . Mean adherence was higher in the intervention group : 69.3 % versus 57.3 % ( difference 12.0 % , 95 % CI 6.7%–17.7 % ) . No differences were found for asthma control , quality of life or asthma exacerbations . Costs were higher in the intervention group , but this difference was not statistically significant . RTMM with tailored SMS reminders improved adherence to ICS , but not asthma control , quality of life or exacerbations in children using ICS for asthma . e-Monitoring with tailored SMS reminders improves adherence to ICS , but not clinical outcomes in children with asthma BACKGROUND Suboptimum adherence to preventive asthma treatment is associated with substantial morbidity and mortality , yet adherence often remains poor . We aim ed to investigate whether use of an inhaler with audiovisual reminders leads to improved adherence and asthma outcomes in school-aged children who presented to the emergency department with an asthma exacerbation . METHODS We did a r and omised controlled trial in patients aged 6 - 15 years who attended the regional emergency department in Auckl and , New Zeal and with an asthma exacerbation and were on regular inhaled corticosteroids . Using a simple , unrestricted block r and omisation with block sizes of 200 , we r and omly assigned patients to receive an electronic monitoring device for use with their preventer inhaler with the audiovisual reminder functions either enabled to support adherence to inhaled corticosteroids ( intervention group ) or disabled ( control group ) . Participants were followed up every 2 months for 6 months . The primary outcomes were adherence to preventive inhaled corticosteroids and number of days absent from school for any reason . Asthma control was assessed as a secondary outcome . All analyses were done in the intention-to-treat population . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12613001353785 . FINDINGS The study took place between May 10 , 2010 , and Feb 26 , 2012 . We r and omly assigned 220 patients , 110 to the intervention group and 110 to the control group . Median percentage adherence was 84 % ( 10th percentile 54 % , 90th percentile 96 % ) in the intervention group , compared with 30 % ( 8 % , 68 % ) in the control group ( p<0·0001 ) . The proportion of days absent from school for any reason was 1·9 % ( 10th percentile 0·0 % , 90th percentile 7·9 % ) in the intervention group and 1·7 % ( 0·0 % , 8·6 % ) in the control group . The change in asthma morbidity score from baseline to 6 months was significantly greater in the intervention group than in the control group ( p=0·008 ) , with a reduction of 2·0 points from a mean baseline score of 9·3 ( SD 2·2 ) to 7·3 ( 2·1 ) in the intervention group , compared with a reduction of 1·2 points from a baseline of 9·2 ( 2·5 ) to 8·0 ( 2·2 ) in the control group . INTERPRETATION Use of an electronic monitoring device with an audiovisual reminder led to significant improvements in adherence to inhaled corticosteroids in school-aged children with asthma . This intervention could be beneficial for the improvement of asthma control in patients for whom poor asthma control is related to poor adherence . FUNDING Health Research Council of New Zeal and and Cure Kids International guidelines recommend that severe asthma can only be diagnosed after contributory factors , including adherence , have been addressed . Accurate assessment of adherence is difficult in clinical practice . We hypothesised that electronic monitoring in children would identify nonadherence , thus delineating the small number with true severe asthma . Asthmatic children already prescribed inhaled corticosteroids were prospect ively recruited and persistence of adherence assessed using electronic monitoring devices . Spirometry , airway inflammation and asthma control were measured at the start and end of the monitoring period . 93 children ( 62 male ; median age 12.4 years ) were monitored for a median of 92 days . Median ( range ) monitored adherence was 74 % ( 21–99 % ) . We identified four groups : 1 ) good adherence during monitoring with improved control , 24 % ( likely previous poor adherence ) ; 2 ) good adherence with poor control , 18 % ( severe therapy-resistant asthma ) ; 3 ) poor adherence with good control , 26 % ( likely overtreated ) ; and 4 ) poor adherence with poor control , 32 % . No clinical parameter prior to monitoring distinguished these groups . Electronic monitoring is a useful tool for identifying children in whom a step up in treatment is indicated . Different approaches are needed in those who are controlled when adherent or who are nonadherent . Electronic monitoring is essential in a paediatric severe asthma clinic . Children with true , severe therapy-resistant asthma can not be identified without electronic adherence monitoring OBJECTIVE To determine whether a parent-youth teamwork intervention improved medication adherence and related outcomes among youth with asthma . METHODS We used a r and omized clinical trial with 48 youth ( aged 9 - 15 years ) assigned to 1 of 3 groups : Teamwork Intervention ( TI ) , Asthma Education ( AE ) , or St and ard Care ( SC ) . Treatment occurred across 2 months , with a 3-month follow-up assessment . Adherence to inhaled corticosteroids was assessed via the MDILog-II . Parent-adolescent conflict , asthma functional severity , and spirometry assessment s were obtained pre-treatment , post-treatment , and on follow-up . Mixed linear model analysis was used to evaluate group and time effects for outcome measures . RESULTS TI group had significantly higher adherence and lower functional severity scores than AE or SC conditions , and lower parent-reported conflict and a trend for higher spirometry values compared with the SC group . CONCLUSIONS Results suggest support for the efficacy of TI for improving medication adherence as youth acquire more responsibility for their asthma management BACKGROUND Poor adherence to inhaled corticosteroids ( ICS ) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents . OBJECTIVE This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS . METHODS Low-income African American and /or Hispanic adolescents , ages 11 - 16 years old , with persistent asthma , and poor ( ≤ 48 % ) adherence to prescription ICS during the 3-week run-in were r and omized to intervention or attention control groups ( ATG ) for the 10-week treatment . During treatment , the intervention arm subjects participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages that promoted adherence . The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 physician-recorded asthma messages . Adherence was measured by using self-report and the Doser CT , an electronic dose counter . The primary outcome was the difference in adherence at 10 weeks between the 2 arms . RESULTS Thirty-four subjects were r and omized to each arm . At 10 weeks , no statistical difference in objective ly measured adherence could be detected between the 2 arms when adjusting for baseline adherence ( P = .929 ) . Adherence declined in both groups over the course of the active treatment period . In both study arms , self-reported adherence by participants was significantly higher than their objective ly measured adherence at week 10 ( P < .0001 ) . CONCLUSION Improving medication adherence in longitudinal studies is challenging . Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes Purpose To investigate the association of ethnicity with objective ly , electronically measured adherence to inhaled corticosteroids ( ICS ) in a multicultural population of children with asthma in the city of Amsterdam . Methods The study was design ed as a prospect i ve , observational multicenter study in which adherence to ICS and potential risk factors for adherence to ICS were measured in a cohort of Moroccan and native Dutch children with asthma . Electronic adherence measurements were performed for 3 months per patient using a Real Time Medication Monitoring ( RTMM ) system . Ethnicity and other potential risk factors , such as socio-economic status , asthma control and parental medication beliefs , were extracted from medical records or parent interviews . The association between adherence and ethnicity was analysed using multivariate linear regression analysis . Results A total of 90 children ( aged 1–11 years ) were included in the study and data of 87 children were used for analysis . Average adherence to ICS was 49.3 % . Native Dutch children showed higher adherence to ICS than Moroccan children ( 55.9 vs. 42.5 % , respectively ; p = 0.044 , univariate analysis ) . After correction for confounders ( > 3 annual visits to the paediatric outpatient clinic , regular use of a spacer during inhalation ) , the final regression model showed that ethnicity was independently associated with adherence ( p = 0.028 ) . Conclusions In our Western European population of inner city children with asthma , poor adherence to ICS was a serious problem , and even somewhat more so in ethnic minorities . Paediatricians involved in asthma treatment should be aware of these cultural differences in medication-taking behaviour , but further studies are needed to eluci date the causal mechanism OBJECTIVE To
Output:
| Conclusion : Adherence rate in children with severe asthma is not satisfactory but it can be improved after proper interventions . |
MS210343 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Approximately 20 % of children experience internalizing or externalizing DSM-IV-TR disorders . This prevalence rate can not be reduced through treatment only . Effective preventive interventions are therefore urgently needed . The aim of the current investigation is to evaluate the two-year efficacy of the group Triple P parenting program administered universally for the prevention of child behavior problems . Methods Based on their respective preschool , N = 280 families were r and omly assigned either to the parent training or to the control group . The efficacy was analyzed using multi- source assessment s , including question naires by mother and father , behavioral observation of mother-child interaction , and teacher evaluations . Results At the 2-year follow-up , both parents in the Triple P intervention reported significant reductions in dysfunctional parenting behavior , and mothers also an increase in positive parenting behavior . In addition , mothers reported significant reductions in internalizing and externalizing child behavior . Single-parent mothers in the Triple P intervention did not report significant changes in parenting or child problem behavior which is primarily due to inexplicable high positive effects in single parent mothers of the control group . Neither mother-child interactions nor teacher ratings yielded significant results . Conclusions The results support the long-term efficacy of the Triple P - group program as a universal prevention intervention for changing parenting behavior in two-parent households , but not necessarily in single-parent mothers The efficacy of group parent training was assessed in improving compliance and time on task in preschoolers with attention-deficit disorder with hyperactivity . Positive effects were obtained on measures of child compliance , but not on measures of attention . Parental compliance-management skills and overall style of interaction were also positively affected . The use of parent training for early intervention with ADDH children is discussed OBJECTIVE This study examined the effects of the Webster-Stratton parenting program on the parenting skills of maltreating mothers and on the autonomy of their children ( 3 - 8 years ) . METHOD A r and omized controlled trial was used . Twenty-six maltreating families were r and omly assigned to one of two conditions : the 16-hour weekly intervention group , or the 4-month wait list control group . Pre- and post-intervention independent assessment s included a 2-hour home visit involving videotaped mother-child interactions during two prescribed , 10-minute play activities . RESULTS Compared to the control group , treatment mothers demonstrated significant improvement in involvement and marginally significant improvement in autonomy-support , but no improvement in structure . Treatment group children showed no significant improvement in autonomy when compared to control group children . CONCLUSIONS This parenting program proved effective with maltreating parents . The lack of demonstrated effect on children may reflect the need for a larger and more sustained treatment dose and /or the need to include parent-child interaction opportunities in the program . At the same time , while treatment gains were limited to the parent , the high treatment adherence rate ( 92 % attended six or more of the eight program sessions ) and low attrition rate ( n=1 ) indicate that the treatment gains may hold potential for more thorough examination The long-term effect of two parent training programs for conduct problem preschoolers is reported . Families of 54 behaviorally disturbed preschool-aged children were r and omly assigned to 1 of 3 treatment conditions : st and ard Parent – Child Interaction Therapy ( STD ) , an abbreviated form of PCIT ( ABB ) , and a no-treatment waitlist control group ( WL ) . Of the families who completed treatment ( STD and ABB ) , data were collected on 97 % and 94 % of families at 1- and 2-year follow-up , respectively . Follow-up assessment of parent report and independent observations indicated that treatment gains were largely maintained for both treatment conditions with little difference between the two treatments . The findings suggest that an abbreviated form of PCIT has long-term benefits for families with young children displaying early conduct problems Objective To present the design , methods , and rationale of the Child/Adolescent Anxiety Multimodal Study ( CAMS ) , a recently completed federally-funded , multi-site , r and omized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy ( CBT ) , sertraline ( SRT ) , and their combination ( COMB ) against pill placebo ( PBO ) for the treatment of separation anxiety disorder ( SAD ) , generalized anxiety disorder ( GAD ) and social phobia ( SoP ) in children and adolescents . Methods Following a brief review of the acute outcomes of the CAMS trial , as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders , the design and methods of the CAMS trial are described . Results CAMS was a six-year , six-site , r and omized controlled trial . Four hundred eighty-eight ( N = 488 ) children and adolescents ( ages 7 - 17 years ) with DSM-IV-TR diagnoses of SAD , GAD , or SoP were r and omly assigned to one of four treatment conditions : CBT , SRT , COMB , or PBO . Assessment s of anxiety symptoms , safety , and functional outcomes , as well as putative mediators and moderators of treatment response were completed in a multi-measure , multi-informant fashion . Manual-based therapies , trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity . A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial , study protocol s and quality assurance . Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls . CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidence d-based psychosocial ( CBT ) and pharmacologic ( SSRI ) treatments to date for the most commonly occurring pediatric anxiety disorders . Primary and secondary results of CAMS will hold important implication s for informing practice -relevant decisions regarding the initial treatment of youth with anxiety disorders . Trial registration Clinical Trials.gov NCT00052078 BACKGROUND Despite a wealth of evidence showing that behavioural family intervention is an effective intervention for parents of children with behavioural and emotional problems , little attention has been given to the relationship between parents functioning at work and their capacity to manage parenting and other home responsibilities . This study evaluated the effects of a group version of the Triple-P Positive Parenting Program ( WPTP ) design ed specifically for delivery in the workplace . METHOD Participants were 42 general and academic staff from a major metropolitan university who were reporting difficulties managing home and work responsibilities and behavioural difficulties with their children . Participants were r and omly assigned to WPTP , or to a waitlist control ( WL ) condition . RESULTS Following intervention , parents in WPTP reported significantly lower levels of disruptive child behaviour , dysfunctional parenting practice s , and higher levels of parental self-efficacy in managing both home and work responsibilities , than parents in the WL condition . These short-term improvements were maintained at 4-months follow-up . There were also additional improvements in reported levels of work stress and parental distress at follow-up in the WPTP group compared to post-intervention . CONCLUSIONS Implication s for the development of ' family-friendly ' work environments and the prevention of child behaviour problems are discussed BACKGROUND There is a pressing need for cost-effective population -based interventions to tackle early-onset antisocial behaviour . As this is determined by many factors , it would seem logical to devise interventions that address several influences while using an efficient means of delivery . The aim of this trial was to change four risk factors that predict poor outcome : ineffective parenting , conduct problems , attention deficit/hyperactivity disorder ( ADHD ) symptoms , and low reading ability . METHODS A r and omised controlled trial was carried out in eight schools in London , Engl and . Nine hundred and thirty-six ( 936 ) 6-year-old children were screened for antisocial behaviour , then parents of 112 high scorers were r and omised to parenting groups held in schools or control ; 109 were followed up a year later . The intervention lasted 28 weeks and was novel as it had components to address both child behaviour ( through the Incredible Years programme ) and child literacy ( through a new ' SPOKES ' programme to help parents read with their children ) . Fidelity of implementation was emphasised by careful training of therapists and weekly supervision . Controls received an information helpline . Assessment of conduct problems was by parent interview , parenting by direct observation and child reading by psychometric testing . RESULTS At follow-up parents allocated to the intervention used play , praise and rewards , and time out more often than controls , and harsh discipline less ; effect sizes ranged from .31 to .59 sd ( p-values .046 to .005 ) . Compared to control children , whose behaviour did n't change , intervention children 's conduct problems reduced by .52sd , ( p < .001 ) , dropping from the 80th to the 61st percentile ; oppositional-defiant disorder ( ODD ) halved from 60 % to 31 % ( p = .003 ) . ADHD symptoms reduced by .44sd ( p = .002 ) , and reading age improved by six months ( .36sd , p = .027 ) . Teacher-rated behaviour did n't change . The programme cost pound2,380 ( $ 3,800 ) per child . CONCLUSIONS Effective population -based early intervention to improve the functioning of with antisocial behaviour is practically feasible by targeting multiple risk factors and emphasising implementation fidelity BACKGROUND Controlling , uninvolved , and rejecting parenting in early childhood are strong predictors of later disruptive behavior disorders . However , there have been no evaluations of non-targeted groups for parents of very young children , despite their potential advantages . METHODS We r and omly assigned 79 mothers of 12- to 36-month-olds to an 8-session parent training program ( called ' COPEing with Toddler Behaviour ' ) or to a waiting list control condition . We investigated the immediate and short-term impact on parent-reported child behavior problems , observed parent-child interaction , and self-reported parenting behavior and parent functioning . RESULTS In an intent-to-treat design , the program yielded significant effects on child behavior problems , positive parent-child interaction , and parental overreactivity and depression but not observed negative child behavior or parental laxness . Most effects were significant at both post-test and 1-month follow-up and effects sizes were small to medium for the intervention group and inverse to small for the control group . CONCLUSIONS The potential of the program to prevent later behavior problems is supported by improvements in six of the eight outcomes . As part of a community strategy , groups such as COPEing with Toddler Behaviour may promote positive parent-child interaction and children 's mental health The purpose of this study was to evaluate the effectiveness of a 2-component intervention for biological and foster parent ( pairs ) to improve parenting practice s , co-parenting , and child externalizing problems . Participants were biological and foster parents ( N=128 ) of primarily neglected children ( ages 3 to 10 years ) placed in regular foster homes . Biological and foster parents were r and omly assigned in pairs to the intervention ( n=80 ) or a usual care ( n=48 ) condition . Intervention families received a 12-week parenting course ( Incredible Years ) and a newly developed co-parenting component . Key findings included significant gains in positive parenting and collaborative co-parenting for both biological and foster parents at the end of the intervention . At follow-up , intervention parents sustained greater improvement in positive parenting , showed gains in clear expectations , and reported a trend for fewer child externalizing problems . Findings supported the feasibility of offering joint parenting training to meet the needs of participating families and demonstrated that the co-parenting construct applied to families in the foster care system was amenable to intervention This paper examined the effects of a parenting intervention targeting working parents called Workplace Triple P. The intervention targeted both parenting and work factors , focusing on key transition times ( e.g. , from home to work ) and trained parents to more effectively manage these transitions . One-hundred- and -twenty-one working parents with children ranging in age from 1 - 16 years were r and omly assigned to either a Workplace Triple P condition ( WPTP ) or to a waitlist control condition ( WLC ) . Results showed that parents who had received the intervention reported significantly lower levels on measures of personal distress and dysfunctional parenting ; and higher levels of work commitment , work satisfaction , and self-efficacy . Implication s for the delivery of parenting interventions as employee assistance programs are discussed along with how such interventions can enhance work and family life A pilot trial provided some evidence that the Triple P Positive Parenting Program is effective with and acceptable to a Japanese population in Australia ( Matsumoto , Sofronoff , & S and ers , 2007 ) . This effectiveness study aim ed to address theoretical and practical concerns related to the parent training program in community setting s in Japan . The research used community re sources within an ecological framework . Fifty-four Japanese families living in a Tokyo metropolitan area were r and omly assigned to either a treatment or a wait-list control group . Program effects and acceptability were examined and then compared with the outcomes from the trial with Japanese parents living in Australia . The results showed significant program effects and high levels of acceptability of the program and core parenting skills , which was consistent with the pilot trial . The findings provided support for the effectiveness and sociocultural validation of Triple P in Japanese society . Intervention effects and program acceptability as well as limitations and future research are discussed Aims : To assess the effectiveness of a parenting programme , delivered by health visitors in primary care , in improving the mental health of children and their parents among a representative general practice population . Methods : Parents of children aged 2–8 years who scored in the upper 50 % on a behaviour inventory were r and omised to the Webster-Stratton 10 week parenting programme delivered by trained health visitors , or no intervention . Main outcome measures were the Eyberg Child Behaviour Inventory and the Goodman Strengths and Difficulties Question naire to
Output:
| We were unable to combine data for other outcomes and individual study results were inconclusive in terms of any effect on depressive symptoms , confidence or partner satisfaction .
AUTHORS ' CONCLUSIONS The findings of this review support the use of parenting programmes to improve the short-term psychosocial wellbeing of parents . |
MS210344 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background — Atrial fibrillation ( AF ) is common among patients with heart failure and preserved ejection fraction ( HFpEF ) , but its clinical profile and impact on exercise capacity remain unclear . RELAX ( Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in HFpEF ) was a multicenter r and omized trial testing the impact of sildenafil on peak VO2 in stable out patients with chronic HFpEF . We sought to compare clinical features and exercise capacity among patients with HFpEF who were in sinus rhythm ( SR ) or AF . Methods and Results — RELAX enrolled 216 patients with HFpEF , of whom 79 ( 37 % ) were in AF , 124 ( 57 % ) in SR , and 13 in other rhythms . Participants underwent baseline cardiopulmonary exercise testing , echocardiogram , biomarker assessment , and rhythm status assessment before r and omization . Patients with AF were older than those in SR but had similar symptom severity , comorbidities , and renal function . & bgr;-blocker use and chronotropic indices were also similar . Despite comparable left ventricular size and mass , AF was associated with worse systolic ( lower EF , stroke volume , and cardiac index ) and diastolic ( shorter deceleration time and larger left atria ) function compared with SR . Pulmonary artery systolic pressure was higher in AF . Patients with AF had higher N-terminal pro-B-type natriuretic peptide , aldosterone , endothelin-1 , troponin I , and C-telopeptide for type I collagen levels , suggesting more severe neurohumoral activation , myocyte necrosis , and fibrosis . Peak VO2 was lower in AF , even after adjustment for age , sex , and chronotropic response , and VE/VCO2 was higher . Conclusions — AF identifies an HFpEF cohort with more advanced disease and significantly reduced exercise capacity . These data suggest that evaluation of the impact of different rate or rhythm control strategies on exercise tolerance in patients with HFpEF and AF is warranted . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00763867 Background — Isolated atrial fibrillation ( AF ) is associated with mild enlargement of the left atrium ( LA ) and left ventricular ( LV ) diastolic dysfunction . The impact of ablation of isolated AF on left chamber size and function is unclear , and whether diastolic dysfunction is the cause or the consequence of AF remains unknown . The objective of this prospect i ve study was to evaluate the impact of sinus rhythm restoration by catheter ablation on LV diastolic dysfunction , LA morphology , and mechanical function . Methods and Results — Forty-eight patients with isolated AF were studied by serial echocardiographic studies at baseline and at 1- , 3- , 6- , 9- , and 12-month intervals after radiofrequency ablation . LA dimensions and mechanical function and LV systolic and diastolic functions were evaluated at each time interval . Diastolic function was assessed with conventional Doppler parameters and new indexes such as tissue Doppler imaging , mitral flow propagation velocity , and combined criteria . LV diastolic dysfunction was present in paroxysmal and chronic AF patients with a reduction of tissue Doppler imaging lateral early diastolic peak velocity in 37 % ( P<0.001 ) and 48 % ( P<0.01 ) , respectively , compared with healthy control subjects . At the end of the follow-up , LA area decreased significantly by 18 % ( P<0.001 ) in paroxysmal and 23 % ( P<0.05 ) in chronic AF patients . Diastolic function improved significantly with an increase in lateral early diastolic peak velocity of 29 % ( P<0.001 ) in paroxysmal AF and 46 % ( P<0.05 ) in chronic AF patients . A significant increase in LV ejection fraction was also noted for both groups : 7.7 % and 18.8 % , respectively . Conclusions — This study demonstrates reverse morphological remodeling of the LA and improvement of LV diastolic and systolic functions after restoration of sinus rhythm by ablation for isolated AF . Because patients with isolated AF have none of the traditional causes of LV diastolic dysfunction , our findings suggest that AF may be partly the cause rather than the consequence of diastolic dysfunction Background —Early detection of structural changes in left atrium ( LA ) before atrial fibrillation ( AF ) development could be helpful in identification of those at higher risk for AF . Using cardiac magnetic resonance imaging , we examined the association of LA volume and function , and incident AF in a multiethnic population free of clinical cardiovascular diseases . Methods and Results —In a case – cohort study embedded in MESA ( Multi-Ethnic Study of Atherosclerosis ) , baseline LA size and function assessed by cardiac magnetic resonance feature-tracking were compared between 197 participants with incident AF and 322 participants r and omly selected from the whole MESA cohort . Participants were followed up for 8 years . Incident AF cases had a larger LA volume and decreased passive , active , and total LA emptying fractions and peak global LA longitudinal strain ( peak LA strain ) at baseline . In multivariable analysis , elevated LA maximum volume index ( hazard ratio , 1.38 per SD ; 95 % confidence interval , 1.01–1.89 ) and decreased peak LA strain ( hazard ratio , 0.68 per SD ; 95 % confidence interval , 0.48–0.96 ) , and passive and total LA emptying fractions ( hazard ratio for passive LA emptying fractions , 0.55 per SD ; 95 % confidence interval , 0.40–0.75 and hazard ratio for active LA emptying fractions , 0.70 per SD ; 95 % confidence interval , 0.52–0.95 ) , but not active LA emptying fraction , were associated with incident AF . Conclusions —Elevated LA volumes and decreased passive and total LA emptying fractions were independently associated with incident AF in an asymptomatic multiethnic population . Including LA functional variables along with other risk factors of AF may help to better risk stratify individuals at risk of AF development OBJECTIVES The aim of this study was to investigate the utility of a comprehensive imaging protocol including echocardiography and cardiac magnetic resonance in the diagnosis and differentiation of hypertensive heart disease and heart failure with preserved ejection fraction ( HFpEF ) . BACKGROUND Hypertension is present in up to 90 % of patients with HFpEF and is a major etiological component . Despite current recommendations and diagnostic criteria for HFpEF , no noninvasive imaging technique has as yet shown the ability to identify any structural differences between patients with hypertensive heart disease and HFpEF . METHODS We conducted a prospect i ve cross-sectional study of 112 well-characterized patients ( 62 with HFpEF , 22 with hypertension , and 28 healthy control subjects ) . All patients underwent cardiopulmonary exercise and biomarker testing and an imaging protocol including echocardiography with speckle-tracking analysis and cardiac magnetic resonance including T1 mapping pre- and post-contrast . RESULTS Echocardiographic global longitudinal strain ( GLS ) and extracellular volume ( ECV ) measured by cardiac magnetic resonance were the only variables able to independently stratify among the 3 groups of patients . ECV was the best technique for differentiation between hypertensive heart disease and HFpEF ( ECV area under the curve : 0.88 ; GLS area under the curve : 0.78 ; p < 0.001 for both ) . Using ECV , an optimal cutoff of 31.2 % gave 100 % sensitivity and 75 % specificity . ECV was significantly higher and GLS was significantly reduced in subjects with reduced exercise capacity ( lower peak oxygen consumption and higher minute ventilation-carbon dioxide production ) ( p < 0.001 for both ECV and GLS ) . CONCLUSIONS Both GLS and ECV are able to independently discriminate between hypertensive heart disease and HFpEF and identify patients with prognostically significant functional limitation . ECV is the best diagnostic discriminatory marker of HFpEF and could be used as a surrogate endpoint for therapeutic studies BACKGROUND S Paroxysmal atrial fibrillation ( AF ) frequently , but not always , progresses to persistent/permanent AF . The aim of this study was to evaluate the echocardiographic predictors of AF progression in patients with paroxysmal AF . METHODS A multicenter , prospect i ve , observational study was conducted that included 313 patients with paroxysmal AF who underwent two-dimensional speckle-tracking echocardiography . The diameter , volume , and mechanical function of the left atrium , including global strain ( ε ) and ε rate , were measured . RESULTS Progression to persistent or permanent AF occurred in 52 patients ( 16.6 % ) during a median follow-up period of 26 months . Echocardiographic measure of left atrial ( LA ) diameter , volume , and function ( E velocity , E/A and E/e ' ratio , LA expansion index , active emptying fraction , global longitudinal ε and ε rate ) were associated with AF progression . LA ε ≤ 30.9 % was the strongest predictor of AF progression , which was associated with a more than fourfold hazard increase for AF progression ( hazard ratio , 4.224 ; P = .001 ) . LA diameter > 39 mm and maximal LA volume index > 34.2 mL/m(2 ) were associated with about a twofold hazard increase for AF progression ( hazard ratios , 1.994 and 2.649 ; P = .016 and P = .001 , respectively ) . When adjusted for a model combining maximal LA volume index , E velocity , LA expansion index , and active emptying fraction , LA ε ≤ 30.9 % maintained a more than threefold hazard increase for AF progression ( adjusted hazard ratio , 3.970 ; P = .003 ) . CONCLUSIONS Echocardiographic measures of LA diameter , volume , and mechanical function , including LA ε , were associated with AF progression . LA ε was the strongest independent predictor of AF progression and is expected to serve as a valuable predictor of AF progression Background — Atrial fibrillation ( AF ) is associated with diffuse left atrial fibrosis and a reduction in endocardial voltage . These changes are indicators of AF severity and appear to be predictors of treatment outcome . In this study , we report the utility of delayed-enhancement magnetic resonance imaging ( DE-MRI ) in detecting abnormal atrial tissue before radiofrequency ablation and in predicting procedural outcome . Methods and Results — Eighty-one patients presenting for pulmonary vein antrum isolation for treatment of AF underwent 3-dimensional DE-MRI of the left atrium before the ablation . Six healthy volunteers also were scanned . DE-MRI images were manually segmented to isolate the left atrium , and custom software was implemented to quantify the spatial extent of delayed enhancement , which was then compared with the regions of low voltage from electroanatomic maps from the pulmonary vein antrum isolation procedure . Patients were assessed for AF recurrence at least 6 months after pulmonary vein antrum isolation , with an average follow-up of 9.6±3.7 months ( range , 6 to 19 months ) . On the basis of the extent of preablation enhancement , 43 patients were classified as having minimal enhancement ( average enhancement , 8.0±4.2 % ) , 30 as having moderate enhancement ( 21.3±5.8 % ) , and 8 as having extensive enhancement ( 50.1±15.4 % ) . The rate of AF recurrence was 6 patients ( 14.0 % ) with minimal enhancement , 13 ( 43.3 % ) with moderate enhancement , and 6 ( 75 % ) with extensive enhancement ( P<0.001 ) . Conclusions — DE-MRI provides a noninvasive means of assessing left atrial myocardial tissue in patients suffering from AF and might provide insight into the progress of the disease . Preablation DE-MRI holds promise for predicting responders to AF ablation and may provide a metric of overall disease progression BACKGROUND Left atrial ( LA ) enlargement facilitates induction and /or maintenance of atrial fibrillation ( AF ) . However , little is known about risk factors for AF with normal LA size . METHODS We prospect ively followed 34713 initially healthy women for incident AF . Information on echocardiographic LA size at first AF diagnosis was abstract ed from medical charts during AF confirmation . LA enlargement was defined as LA diameter > 40 mm . Using a competing risk approach , we constructed Cox proportional-hazards models to calculate hazard ratios ( HR ) and 95 % confidence intervals ( CI ) of risk factors for incident AF with and without LA enlargement , respectively . RESULTS Among 796 women with incident AF and available LA size , 328 ( 41 % ) had LA enlargement . In multivariable competing risk models , the relationship between age and incident AF was stronger in those with ( HR 1.12 , 95 % CI 1.10 - 1.14 ) versus without ( HR 1.08 , 95 % CI 1.06 - 1.09 ) LA enlargement ( p for difference < 0.0001 ) . Body weight was associated with AF only in the presence of LA enlargement ( HR per 10 kg 1.34 , 95 % CI 1.26 - 1.43 ; versus 1.07 , 95 % CI 0.998 - 1.14 , p for difference<0.0001 ) . Hypertension and height were significantly associated with
Output:
| An integrated evaluation should be also applied to patients with a high arrhythmic risk , in whom eccentric LA remodelling and higher LA stiffness are associated with a greater AF risk .
Evaluation of LA size , volume , function and structure are m and atory in the management of patients with HT , HFpEF and AF .
A multi-modality approach could provide additional information , identifying subjects with more severe LA remodelling . |
MS210345 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To determine whether brief intervention and contact is effective in reducing subsequent suicide mortality among suicide attempters in low and middle-income countries . METHODS Suicide attempters ( n = 1867 ) identified by medical staff in the emergency units of eight collaborating hospitals in five culturally different sites ( Campinas , Brazil ; Chennai , India ; Colombo , Sri Lanka ; Karaj , Islamic Republic of Iran ; and Yuncheng , China ) participated , from January 2002 to October 2005 , in a r and omized controlled trial to receive either treatment as usual , or treatment as usual plus brief intervention and contact ( BIC ) , which included patient education and follow-up . Overall , 91 % completed the study . The primary study outcome measurement was death from suicide at 18-month follow-up . FINDINGS Significantly fewer deaths from suicide occurred in the BIC than in the treatment-as-usual group ( 0.2 % versus 2.2 % , respectively ; chi2 = 13.83 , P < 0.001 ) . CONCLUSION This low-cost brief intervention may be an important part of suicide prevention programmes for underre source d low- and middle-income countries ABSTRACT BACKGROUND Despite improvements in the diagnosis and treatment of depression , primary care provider ( PCP ) discussion regarding suicidal thoughts among patients with depressive symptoms remains low . OBJECTIVE To determine whether a targeted depression public service announcement ( PSA ) video or an individually tailored interactive multimedia computer program ( IMCP ) leads to increased primary care provider ( PCP ) discussion of suicidal thoughts in patients with elevated risk for clinical depression when compared to an attention control . DESIGN R and omized control trial at five different healthcare systems in Northern California ; two academic , two Veterans Affairs ( VA ) , and one group-model health maintenance organization ( HMO ) . PARTICIPANTS Eight-hundred sixty-seven participants , with mean age 51.7 ; 43.9 % women , 43.4 % from a racial/ethnic minority group . INTERVENTIONThe PSA was targeted to gender and socio-economic status , and design ed to encourage patients to seek depression care or request information regarding depression . The IMCP was an individually tailored interactive health message design ed to activate patients to discuss possible depressive symptoms . The attention control was a sleep hygiene video . MAIN MEASURES Clinician reported discussion of suicidal thoughts . Analyses were stratified by depressive symptom level ( Patient Health Question naire [ PHQ-9 ] score < 9 [ mild or lower ] versus ≥ 10 [ at least moderate]).KEY RESULTS Among patients with a PHQ-9 score ≥ 10 , PCP discussion of suicidal thoughts was significantly higher in the IMCP group than in the control group ( adjusted odds ratio = 2.33 , 95 % confidence interval = 1.5 , 5.10 , p = 0.03 ) . There were no significant effects of either intervention on PCP discussion of suicidal thoughts among patients with a PHQ-9 score < 9 . CONCLUSIONS Exposure of patients with at least moderate depressive symptoms to an individually tailored intervention design ed to increase patient engagement in depression care led to increased PCP discussion of suicidal thoughts BACKGROUND Depression and alcohol misuse are among the most prevalent diagnoses in suicide fatalities . The risk posed by these disorders is exacerbated when they co-occur . Limited research has evaluated the effectiveness of common depression and alcohol treatments for the reduction of suicide vulnerability in individuals experiencing comorbidity . METHODS Participants with depressive symptoms and hazardous alcohol use were selected from two r and omised controlled trials . They had received either a brief ( 1 session ) intervention , or depression-focused cognitive behaviour therapy ( CBT ) , alcohol-focused CBT , therapist-delivered integrated CBT , computer-delivered integrated CBT or person-centred therapy ( PCT ) over a 10-week period . Suicidal ideation , hopelessness , depression severity and alcohol consumption were assessed at baseline and 12-month follow-up . RESULTS Three hundred three participants were assessed at baseline and 12 months . Both suicidal ideation and hopelessness were associated with higher severity of depressive symptoms , but not with alcohol consumption . Suicidal ideation did not improve significantly at follow-up , with no differences between treatment conditions . Improvements in hopelessness differed between treatment conditions ; hopelessness improved more in the CBT conditions compared to PCT and in single-focused CBT compared to integrated CBT . LIMITATIONS Low retention rates may have impacted on the reliability of our findings . Combining data from two studies may have result ed in heterogeneity of sample s between conditions . CONCLUSIONS CBT appears to be associated with reductions in hopelessness in people with co-occurring depression and alcohol misuse , even when it is not the focus of treatment . Less consistent results were observed for suicidal ideation . Establishing specific procedures or therapeutic content for clinicians to monitor these outcomes may result in better management of individuals with higher vulnerability for suicide BACKGROUND AND AIMS In the past decade , a large body of research has demonstrated that internet-based interventions can have beneficial effects on depression . However , only a few clinical trials have compared internet-based depression therapy with an equivalent face-to-face treatment . The primary aim of this study was to compare treatment outcomes of an internet-based intervention with a face-to-face intervention for depression in a r and omized non-inferiority trial . METHOD A total of 62 participants suffering from depression were r and omly assigned to the therapist-supported internet-based intervention group ( n=32 ) and to the face-to-face intervention ( n=30 ) . The 8 week interventions were based on cognitive-behavioral therapy principles . Patients in both groups received the same treatment modules in the same chronological order and time-frame . Primary outcome measure was the Beck Depression Inventory-II ( BDI-II ) ; secondary outcome variables were suicidal ideation , anxiety , hopelessness and automatic thoughts . RESULTS The intention-to-treat analysis yielded no significant between-group difference ( online vs. face-to-face group ) for any of the pre- to post-treatment measurements . At post-treatment both treatment conditions revealed significant symptom changes compared to before the intervention . Within group effect sizes for depression in the online group ( d=1.27 ) and the face-to-face group ( d=1.37 ) can be considered large . At 3-month follow-up , results in the online group remained stable . In contrast to this , participants in the face-to-face group showed significantly worsened depressive symptoms three months after termination of treatment ( t=-2.05 , df=19 , p<.05 ) . LIMITATIONS Due to the small sample size , it will be important to evaluate these outcomes in adequately-powered trials . CONCLUSIONS This study shows that an internet-based intervention for depression is equally beneficial to regular face-to-face therapy . However , more long term efficacy , indicated by continued symptom reduction three months after treatment , could be only be found for the online group We conducted a r and omized controlled trial to test whether a Brief Mobile Treatment ( BMT ) intervention could improve outcomes relative to usual care among suicide attempters . The intervention included training in problem solving therapy , meditation , a brief intervention to increase social support as well as advice on alcohol and other drugs , and mobile phone follow-up . The effect of the intervention was measured in terms of a reduction in suicidal ideation , depression and self-harm at Baseline , six and 12 months . A wait-list control group received usual care . A total of 68 participants was recruited from a Sri Lankan hospital following a suicide attempt . Participants who received the intervention were found to achieve significant improvements in reducing suicidal ideation and depression than those receiving usual care . The BMT group also experienced a significant improvement of social support when compared to the control group . However , the BMT group did not demonstrate a significant effect in reducing actual self-harm and most substance use , and differential effects on alcohol use were restricted to men . Although the present study was limited in revealing which component of the intervention was more effective in preventing suicide , it showed its efficacy in reducing suicide as a whole Background : prevention of suicide is one of priority world health . Suicide is one of the preventable causes of death . The aim of this study is evaluation of telephone follow up on suicide reattempt . Material s and Methods : This r and omized controlled clinical trial is a prospect i ve study which has been done in Noor Hospital of Isfahan-Iran , at 2010 . 139 patients who have suicide attempt history divided in one of two groups , r and omly , 70 patients in " treatment as usual ( TAU ) " and 69 patients in " brief interventional control ( BIC ) . Seven telephone contact with BIC group patients have been done " during six months " and two question naires have been filled in each session . The data has been analyzed by descriptive and Chi-square test , under SPSS . Results : No significant differences of suicide reattempt has been found between two groups ( P = 0.18 ) , but significant reduction in frequency of suicidal thoughts ( P = 0.007 ) and increase in hope at life ( P = 0.001 ) was shown in intervention group . Conclusion : Telephones follow up in patients with suicide history decrease suicidal thought frequency " and increase hope in life , significantly OBJECTIVE This pilot r and omized controlled trial examined the effect of an online intervention for college students at risk for suicide , Electronic Bridge to Mental Health Services ( eBridge ) , which included personalized feedback and optional online counseling delivered in accordance with motivational interviewing principles . Primary outcomes were readiness to seek information or talk with family and friends about mental health treatment , readiness to seek mental health treatment , and actual treatment linkage . METHOD Participants were 76 college students ( 45 women , 31 men ; mean age = 22.9 years , SD = 5.0 years ) at a large public university who screened positive for suicide risk , defined by at least 2 of the following : suicidal thoughts , history of suicide attempt , depression , and alcohol abuse . Racial/ethnic self- identification s were primarily Caucasian ( n = 54 ) and Asian ( n = 21 ) . Students were r and omized to eBridge or the control condition ( personalized feedback only , offered in plain report format ) . Outcomes were measured at 2-month follow-up . RESULTS Despite relatively modest engagement in online counseling ( 29 % of students posted ≥1 message ) , students assigned to eBridge reported significantly higher readiness for help-seeking scores , especially readiness to talk to family , talk to friends , and see a mental health professional . Students assigned to eBridge also reported lower stigma levels and were more likely to link to mental health treatment . CONCLUSIONS Findings suggest that offering students personalized feedback and the option of online counseling , using motivational interviewing principles , has a positive impact on students ' readiness to consider and engage in mental health treatment . Further research is warranted to determine the robustness of this effect , the mechanism by which improved readiness and treatment linkage occurs , and the longer term impact on student mental health outcomes BACKGROUND Studies on the effects of interventions in patients who have attempted suicide in China have not reported so far . AIMS To describe the basic situation surrounding the interventions and follow-up of patients who have attempted suicide and to determine whether the interventions would be effective in reducing repeat suicide attempts . METHOD 239 patients who had attempted suicide were evaluated in the emergency departments of four general hospitals . They were r and omized into three groups : cognitive therapy group , telephone intervention group , and control group . Postintervention the participants were evaluated at 3 , 6 , and 12 months separately by the following measurements : a detailed structured question naire , Beck Suicide Ideation Scale ( SIS ) , Hamilton Rating Scale for Depression ( HAMD ) , and a quality -of-life scale . RESULTS After 12 months , the cumulative dropout rate was 69.5 % ( n = 57 ) for the cognitive therapy group , 55.0 % ( n = 44 ) for the telephone intervention group , and 64.9 % ( n = 50 ) for the control group . One patient ( 1.2 % ) in the cognitive therapy group , one patient ( 1.3 % ) in the telephone intervention group , and five patients ( 6.5 % ) in the control group made at least one subsequent suicide attempt . The rates of repeated attempted suicide among the three groups were not significantly different ( χ² = 5.077 , p = .08 ) . Five patients ( 6.1 % ) received cognitive therapy , and 60 patients ( 75.0 % ) received telephone intervention . There were no differences regarding the score of HAMD , a quality -of-life scale , and the rates of subsequent suicide attempt and suicide ideation among the three groups at follow-up . CONCLUSIONS The dropout rates were higher than those reported in developed countries . Most participants in the cognitive therapy group refused to receive cognitive therapy so that the effect of cognitive therapy for these patients can not be evaluated . The participants in the telephone intervention group had good compliance , but the effect of telephone intervention could not be confirmed , so that more studies are needed in the future . Consequently , interventions can not be evaluated accurately in their preventing suicide attempts for patients who have attempted suicide in China at present OBJECTIVE We developed a primary care/Internet-based intervention for adolescents at risk for depression ( CATCH-IT , Competent Adulthood Transition with Cognitive-behavioral , Humanistic and Interpersonal Training ) . This phase II clinical trial compares two forms of primary care provider ( PCP ) engagement ( motivational interview [ MI ] and brief advice [ BA ] ) for adolescents using the Internet program . METHOD ADOLESCENTS SCREENING POSITIVE FOR DEPRESSION WERE RECRUITED FROM PRIMARY CARE PRACTICE S AND R AND OMLY ASS
Output:
| Conclusion Intervention effectiveness was variable , but several technology-enhanced interventions have demonstrated effectiveness in reducing suicidal ideation and mental health co-morbidities . |
MS210346 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract · Background : An investigation was carried out to compare post-operative inflammation following deep sclerectomy with collagen implant ( DSCI ) versus st and ard trabeculectomy . · Methods : In this prospect i ve r and omized study , 46 eyes of 46 Caucasian patients with medically uncontrolled chronic open-angle glaucoma and without previous glaucoma surgery underwent filtering surgery . Twenty-four eyes underwent DSCI . Twenty-two eyes underwent st and ard trabeculectomy . Pre- and post-operative flare , measured using laser flare photometry , were compared between the two groups . · Results : In both groups , the mean anterior chamber flare increased on the first post-operative day , then decreased progressively . DSCI was associated with lower flare measurements post-operatively . The difference was statistically significant up to 1 month post-operatively : 16.3±7.8 vs 72.5±38.9 ( P<0.001 ) at 1 day , 7.8±4.6 vs 44.7±29.2 ( P<0.001 ) at 1 week , 5.9±1.6 vs 7.0±2.8 ( P=0.012 ) at 1 month , 6.4±1.8 vs 6.5±1.9 ( P=0.77 ) at 2 months , 5.9±1.8 vs 6.1±1.6 ( P=0.65 ) at 3 months . · Conclusion : Surgically induced inflammation can be reduced with DSCI . This may be due to the lack of iridectomy , irrigation , and penetration of the anterior chamber . Eyes at increased risk of post-operative inflammation , such as those with uveitic or traumatic glaucoma , may benefit from this procedure . Further studies are needed to evaluate the long-term functional and anatomical outcomes of DSCI Results of trabeculectomy ( TE ) and viscocanalostomy ( VCO ) were compared in a prospect i ve r and omised study in two fellow eyes of 22 consecutive patients with bilateral symmetrical high-tension glaucoma . Rates of overall surgical success with intraocular pressures ( IOP ) ≤ 18 mm Hg with or without medications were 91 for the TE , and 95 for the VCO group after a mean follow-up of 18 months . Complete success rates without medications were 64 and 59 for TE and VCO groups , respectively ( p=0.750 ) . Both procedures significantly reduced IOP , however , IOP course following trabeculectomy was significantly lower ( p=0.026 ) . Rates of complications were not found to be different between the two groups of eyes , except for an apparent – though not significant ( p=0.066 ) – increase in cataract progression with TE . Various types of conjunctival blebs were detected in all eyes with surgical success in both groups , however , diffuse , elevated or multi-cystic functional blebs appeared to be more predominant in eyes with TE , compared to the VCO group in which low-lying , localised blebs had a higher incidence ( p=0.015 ) . Viscocanalostomy was found to be a safe and effective filtration technique in patients with uncomplicated high-tension glaucoma , though IOP decrease was more pronounced with trabeculectomy Purpose : To study the need , the safety and the success rate of collagen implant in eyes that underwent deep sclerectomy , a new non penetrating filtration procedure , we compared the results of deep sclerectomy with ( DSCI ) and without ( DS ) collagen implant . Methods : Of 168 patients ( 168 eyes ) with various types of medically uncontrolled open angle glaucoma , 86 ( 86 eyes ) underwent DSCI , and 82 ( 82 eyes ) underwent DS . Visual acuity , slit lamp examination , intraocular pressure ( IOP ) measurements were performed before surgery and prospect ively at days 1 and 7 and months , 1 , 2 , 3 , 6 , 9 , 12 , 15 , 18 , and 24 after surgery . Deep sclerectomy was performed according to Kozlov 's original technique . The collagen implant drainage device was radially secured in the center of the deep sclerectomy dissection . Results : The mean follow-up period was 9.7 ± 6.5 months for DSCI , and 9.0 ± 4.8 months for DS . The mean preoperative IOP was 26.9 ± 8.8 mmHg for DSCI and 25.8 ± 8.5 mmHg for DS . The mean postoperative IOP and visual acuity were similar between the two groups . Complete and qualified success rates were better when the collagen implant was used ( Log-Rank test : p = 0.0002 and 0.033 for complete and qualified success respectively ) . The need for postoperative glaucoma medications was significantly lower when the collagen implant was used ( 0.2 ± 0.5 versus 0.5 ± 0.7 medication per patient in the DSCI and DS respectively , Student 's t test : p = 0.0038 ) . There was significantly less bleb fibrosis when the collagen implant was used ( 2 % and 11 % in DSCI and DS respectively , p = 0.029 ) . Conclusion : The collagen implant device is safe , increases the success rate of deep sclerectomy , and lowers the need for postoperative glaucoma medications Aims : To compare the long-term effects of low-dosage mitomycin C ( MMC ) in both deep sclerectomy ( DSMMC ) and trabeculectomy ( TPMMC ) on intraocular pressure ( IOP ) . Methods : Analysis of extended follow-up of data from a prospect i ve clinical trial . Forty patients were originally r and omised to undergo either DSMMC ( 19 eyes ) or TPMMC ( 21 eyes ) . Follow-up was performed at postoperative day 1 , weeks 1 , 2 and 3 , as well as months 1 , 3 , 6 , 9 , 12 , 18 , 24 , 36 and 48 . Two- to three-week data were not included in the statistical analysis . Postoperative complications , number of antiglaucoma medications and IOP were recorded at each visit . Complete ( no medications ) and qualified ( with or without medications ) successes were assessed at 2 target IOPs ( ≤21 and ≤17 mm Hg ) and evaluated by Kaplan-Meier curves . Results : At 48 months , the mean IOP ( ± SD ) was 17.6 ± 3.4 and 17.8 ± 3.6 mm Hg in the DSMMC and TPMMC eyes , respectively , a significant reduction from preoperative IOP in each group ( p < 0.0005 ) . Complete success was achieved at the ≤21 mm Hg target IOP in 10 ( 52.6 % ) and 14 ( 66.6 % ) eyes and qualified success in 15 ( 78.9 % ) and 18 ( 85.7 % ) eyes in the DSMMC and TPMMC groups , respectively . There were no differences in the Kaplan-Meier curves . Hypotony and shallow anterior chamber were significantly more frequent in the TPMMC group . Conclusions : Either procedure controlled IOP efficaciously at our endpoint . Low-dosage MMC can be considered a mild enhancement of deep sclerectomy IOP-lowering effect Purpose To compare the intraocular pressure lowering effect and the frequency of postoperative complications in two of the most used filtration surgery techniques : trabeculectomy and non-penetrating deep sclerectomy ( NPDS ) without collagen implants . Methods Thirty-four eyes of 17 patients with medically uncontrolled symmetrical primary open-angle glaucoma were included in the study . One r and omly selected eye per patient had either trabeculectomy or NPDS without collagen implants as the first surgical procedure . The other eye underwent the second filtration surgery technique less than 6 weeks later . Post-operatively , the intraocular pressure ( IOP ) diurnal curves were determined at 1 , 2 , 3 , 6 , 12 and 18 months . The intergroup differences in IOP lowering effect were determined in an analysis of covariance ( ANCOVA ) , with pre-operative IOP as a changing covariate . Kaplan-Meier survival curves were drawn for IOP , and intercurve analysis was performed . Comparisons of the number of post-operative antiglaucomatous medications , as well as of the complication rate , were done by 2 × 2 frequency tables . A p value of less than 0.05 was considered statistically significant . Results There were statistically significant differences in post-operative IOP level between the two groups at 1 , 2 , 3 , 6 , 12 and 18 months , with a lower level in the trabeculectomy group . Using the Kaplan Meier cumulative survival curve , the trabeculectomy patients had a better complete success rate than the NPDS patients at 18 months post-operatively . There were statistically significantly fewer complications in the NPDS group . Conclusion Trabeculectomy lowers the IOP more than the NPDS technique . However , the complication rate seems to be lower in NPDS Purpose : To compare IOP behavior after deep sclerectomy ( DS ) and trabeculectomy with the Crozafon-De Laage Punch ( TP ) , using low-dosage intraoperative mitomycin C ( MMC ) in both techniques . Methods : The study was a prospect i ve r and omized clinical trial . All patients met inclusion and exclusion criteria , and were scheduled for glaucoma surgery . Forty patients were r and omized to undergo either a nonpenetrating DS with MMC ( DSMMC ) ( 19 eyes ) or a TP with MMC ( TPMMC ) ( 21 eyes ) . Postoperative examinations were performed at the 1st day , the 1st , 2nd and 3rd weeks and the 1st , 3rd , 6th , 9th and 12th months . Postoperative complications , number of antiglaucoma medications and the IOP level were checked at each control . Complete success ( without antiglaucoma medications ) and qualified success ( with or without medications ) were assessed at two target IOP levels , namely ≤21 and ≤17 mm Hg in both groups . Moreover , the success rates at ≤21 mm Hg target IOP level were compared with those from previous series of patients who had undergone DS without MMC ( historical control group ) . Results : Data from all eyes were available until the 12th month . The mean preoperative IOP ± SD was 29.6 ± 5.8 mm Hg in DSMMC eyes , 28.0 ± 6.0 in TPMMC eyes ; the mean IOP at the 1st postoperative day was 12.5 ± 4.2 and 13.9 ± 6.5 mm Hg , while at the endpoint the mean IOP was 14.5 ± 4.0 and 16.1 ± 3.8 , respectively , with significant reduction ( p < 0.0005 ) of the preoperative IOP in both groups . Complete success ( ≤21 mm Hg target IOP ) in 15 eyes ( 78.9 % ) of the DSMMC group and in 15 eyes ( 71.4 % ) of the TPMMC group was respectively found , while qualified success was achieved in all the eyes . When a ≤17 mm Hg target IOP was considered , complete success in 12 eyes ( 63.1 % ) and 13 eyes ( 61.9 % ) , and qualified success in 13 eyes ( 68.4 % ) and 15 eyes ( 71.4 % ) were found in the DSMMC and TPMMC groups , respectively . No significant intergroup differences were found in terms of success rate . There is no statistical significance in the Kaplan-Meier cumulative survival curves as for complete and qualified success rate in both surgical groups for a ≤17 mm Hg target IOP ( log rank , p = 0.918 and p = 0.429 , respectively ) . As for the frequency of postoperative complications , hypotony and shallow anterior chamber were significantly more frequent in TPMMC when compared with the DSMMC group . The historical comparison between the DSMMC group and simple DS cases shows no significant difference between the groups , with a mild positive trend in DSMMC when compared with DS eyes . Conclusions : Both techniques , DSMMC and TPMMC , control IOP efficaciously at our endpoint . Our results indicate that low-dosage MMC can be considered a mild enhancement of DS IOP lowering effect without any negative effect on the well-known intra- and postoperative safety of the technique Purpose To compare the intraocular pressure-lowering effect and safety of viscocanalostomy and trabeculectomy with mitomycin C. Methods Twenty-five patients with bilateral primary open-angle glaucoma were enrolled in a prospect i ve clinical study . The eyes of each patient were r and omly assigned to receive viscocanalostomy in one eye and trabeculectomy with mitomycin C in the other eye . The patients were followed up for 12 months . At each visit , best-corrected visual acuity , intraocular pressure , and the appearance of the surgical wound , anterior chamber , and indirect ophthalmoscopy were recorded . Results The mean baseline intraocular pressure was 25.0±2.2 mmHg in viscocanalostomy-treated eyes and 24.8±2.6 mmHg in trabeculectomy-treated eyes . The mean postoperative intraocular pressure was 15.3±1.7 mmH
Output:
| This review provides some limited evidence that control of IOP is better with trabeculectomy than viscocanalostomy .
This may reflect surgical difficulties in performing non-penetrating procedures and the need for surgical experience .
Since it is unlikely that better IOP control will be offered by NPFS , but that these techniques offer potential gains for patients in terms of quality of life , we feel that such a trial is likely to be of a non-inferiority design with quality of life measures |
MS210347 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To assess whether a pragmatic policy of perioperative beta-blockade , with metoprolol , reduced the 30-day cardiovascular morbidity and mortality and reduced the length of hospital stay in average patients undergoing infrarenal vascular surgery . METHODS This was a double-blind r and omized placebo-controlled trial that occurred in vascular surgical units in four UK hospitals . Participants were 103 patients without previous myocardial infa rct ion who had infrarenal vascular surgery between July 2001 and March 2004 . Interventions were oral metoprolol ( 50 mg twice daily , supplemented by intravenous doses when necessary ) or placebo from admission until 7 days after surgery . Holter monitors were kept in place for 72 hours after surgery . RESULTS Eighty men and 23 women ( median age , 73 years ) were r and omized , 55 to metoprolol and 48 to placebo , and 97 ( 94 % ) underwent surgery during the trial . The most common operations were aortic aneurysm repair ( 38 % ) and distal bypass ( 29 % ) . Intraoperative inotropic support was required in 64 % and 92 % of patients in the placebo and metoprolol groups , respectively . Within 30 days , cardiovascular events occurred in 32 patients , including myocardial infa rct ion ( 8 % ) , unstable angina ( 9 % ) , ventricular tachycardia ( 19 % ) , and stroke ( 1 % ) . Four ( 4 % ) deaths were reported . Cardiovascular events occurred in 15 ( 34 % ) and 17 ( 32 % ) patients in the placebo and metoprolol groups , respectively ( unadjusted relative risk , 0.94 ; 95 % confidence interval , 0.53 - 1.66 ; adjusted [ for age , sex , statin use , and aortic cross-clamping ] relative risk , 0.87 ; 95 % confidence interval , 0.48 - 1.55 ) . Time from operation to discharge was reduced from a median of 12 days ( 95 % confidence interval , 9 - 19 days ) in the placebo group to 10 days ( 95 % confidence interval , 8 - 12 days ) in the metoprolol group ( adjusted hazard ratio , 1.71 ; 95 % confidence interval , 1.09 - 2.66 ; P < .02 ) . CONCLUSIONS Myocardial ischemia was evident in a high proportion ( one third ) of the patients after surgery . A pragmatic regimen of perioperative beta-blockade with metoprolol did not seem to reduce 30-day cardiovascular events , but it did decrease the time from surgery to discharge BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P<0.001 for both comparisons between the groups ) . The cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P<0.001 ) in the intervention group . The reduction in the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects Abstract Objectives To evaluate the long term effects of perioperative β blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery . Design R and omised placebo controlled and blinded multicentre trial . Analyses were by intention to treat . Setting University anaesthesia and surgical centres and one coordinating centre . Participants 921 patients aged > 39 scheduled for major non-cardiac surgery . Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days . Main outcome measures The composite primary outcome measure was time to all cause mortality , acute myocardial infa rct ion , unstable angina , or congestive heart failure . Secondary outcome measures were time to all cause mortality , cardiac mortality , and non-fatal cardiac morbidity . Results Mean duration of intervention was 4.6 days in the metoprolol group and 4.9 days in the placebo group . Metoprolol significantly reduced the mean heart rate by 11 % ( 95 % confidence interval 9 % to 13 % ) and mean blood pressure by 3 % ( 1 % to 5 % ) . The primary outcome occurred in 99 of 462 patients in the metoprolol group ( 21 % ) and 93 of 459 patients in the placebo group ( 20 % ) ( hazard ratio 1.06 , 0.80 to 1.41 ) during a median follow-up of 18 months ( range 6 - 30 ) . All cause mortality was 16 % ( 74/462 ) in the metoprolol group and 16 % ( 72/459 ) in the placebo group ( 1.03 , 0.74 to 1.42 ) . The difference in risk for the proportion of patients with serious adverse events was 2.4 % ( − 0.8 % to 5.6 % ) . Conclusions Perioperative metoprolol did not significantly affect mortality and cardiac morbidity in these patients with diabetes . Confidence intervals , however , were wide , and the issue needs re assessment . Trial registration Current Controlled Trials IS RCT N58485613 [ controlled-trials.com OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P < 0.05 ) . When analyzed by clinic , each of the active intervention groups differed significantly from the control clinics ( P < 0.05 ) . The relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI < or ≥ 25 kg/m2 ) . In a proportional hazards analysis adjusted for differences in baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P < 0.03 ) , 46 % ( P < 0.0005 ) , and 42 % ( P < 0.005 ) reductions in risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT The preliminary results of the twelfth Medical Research Council acute myeloid leukemia trial show no evidence of a survival advantage for five courses of therapy compared to four courses in a r and omized comparison involving 1078 patients ( hazard ratio 1.09 , 95 % confidence interval [ CI ] 0.87 - 1.37 , p=0.4 ) . However , the data presented to the independent data monitoring and ethics committee ( DMEC ) at both its review s in 1998 suggested large benefits for the additional course with hazard ratios of 0.47 and 0.55 ( 95 % CIs 0.29 - 0.77 and 0.38 - 0.80 , p=0.003 and p=0.002 , respectively ) . Despite these highly significant findings , the DMEC did not recommend closure of the r and omization , a decision vindicated by the subsequent reversion to a null result . The main reason for not closing the r and omization was that the treatment effects observed in 1998 ( 53 % and 45 % reductions in the odds of death ) were considered too large to be clinical ly plausible , despite the p-values associated with them . Investigations have not identified any clinical explanations , such as different types of patients in the early and later parts of the trial , to explain the loss of benefit as the trial progressed . Thus , the most likely current explanation for the large benefit observed early on is the play of chance . Lessons to be learned from this example are that : fixed stopping rules based on some predetermined p-value should not be used and the decision to close a r and omization or not should take account of other factors such as the medical plausibility of the magnitude of the treatment effect ; chance effects do occur and happen more frequently than many clinicians realize ; it is important that DMEC members are experienced in the interpretation of clinical trial evidence and aware of the dangers of early stopping without wholly convincing evidence BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin A r and omized , double-blind study to determine the effect of intramuscular vitamin E on mortality and intracranial hemorrhage ( ICH ) was performed . One hundred forty-nine neonates with birth weights less than or equal to 1000 g
Output:
| These results , which are consistent with predictions from statistical theory ( 3 ) , suggest that stopping trials early for apparent benefit will systematic ally overestimate treatment effects .
Had the investigators terminated the trial in accordance with their stopping rule , subsequent patients with leukemia may have experienced the toxicity of an additional course of chemotherapy without benefit . |
MS210348 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: While r and omized clinical trials remain the " gold st and ard " for comparisons of treatment efficacy , conventional r and omized trials may not reflect the relative effectiveness of treatments under " real world " conditions . Observational data more closely reflect the conditions of actual practice , but are often limited in clinical detail and subject to bias in selection of treatments . The authors use available data on the cost-effectiveness of new antidepressant drugs to illustrate the limitations of these methods . Modifications to the traditional r and omized trial may allow more accurate assessment of effectiveness in everyday practice . The authors describe the design of such a " real world " r and omized trial comparing newer antidepressants with older alternatives The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas A 4-week double-blind controlled clinical trial was carried out in which fluspirilene , an injectable diphenylbutylpiperidine neuroleptic given weekly , was compared to chlorpromazine in the treatment of 40 newly admitted schizophrenic patients with acute exacerbation . Similar therapeutic improvement was obtained with both drugs , but men needed a significantly higher mean dose of fluspirilene ( 23 mg/week ) than women ( 13 mg/week ) . Fluspirilene induced more parkinsonism than chlorpromazine , but less drowsiness , dizziness , and dry mouth . The difference between the sexes in the potency of fluspirilene and its greater potential to induce parkinsonism may be related to its lesser presynaptic and D1-dopamine receptor blocking properties . The low incidence of autonomic side effects confirms the relative specificity of fluspirilene for dopamine receptors Five depot neuroleptics ( fluphenazinedeconoate , fluspirilene , pipothiazinepalmitate , penfluridol and perphenazine-enanthate ) were compared based on clinical trials in subacute and chronic schizophrenic patients . The psychopathological symptoms were documented by means of the AMP-system . Statistical analyses showed several differences between the effects of the five substances . The AMP-system proved a useful instrument to differentiate similar drugs BACKGROUND An increasing number of case reports indicate a superior therapeutic response of catatonialike symptoms , such as severe psychomotor disturbance and mutism , associated with psychiatric disorder to the benzodiazepine lorazepam ( LO ) . Equivocal results , however , are also reported with regard to other benzodiazepines for the treatment of this syndrome . The purpose of this study was to compare the effects of LO and oxazepam ( OX ) , benzodiazepines with comparable pharmacokinetics , on psychomotor retardation and mutism associated with psychiatric disorder . METHODS Twenty-one hospitalized patients with severe psychomotor retardation and mutism were treated with 2 mg LO and 60 mg OX in a double-blind crossover study design . RESULTS Both benzodiazepines significantly reduced psychomotor symptoms . When administered for the first time , 4 of 7 patients with LO and 6 of 10 patients with OX improved at least 50 % on visual analog scale ( VAS ) rating . Reduction in symptoms was significant with LO and OX treatment on either day of treatment . The second time , however , LO was significantly better compared with OX in alleviating the target symptoms . CONCLUSIONS Both OX and LO are effective for the treatment of psychomotor retardation . Thus , the beneficial effect of LO on psychomotor retardation and mutism is not a unique pharmacodynamic property but more likely due to its pharmacokinetic profile . The differential effect of the two benzodiazepines on the second day of treatment warrants further clarification . Several hypotheses are evaluated Little is known about patient compliance with topical aural antibiotic regimens . The compliance of 50 patients with unilateral otitis externa attending an otolaryngology clinic was studied by comparing the weight of dispensed topical ear preparations before and after completion of a 7-day-course of treatment . A st and ard was obtained from controlled administration of the preparation under laboratory conditions and the performance of different delivery systems evaluated . Thirty-seven patients re-attended for review with their medication . A total of 34 of 50 patients entering the study ( 70 % ) satisfied conventional criteria for compliance . However , over-use of preparations was common and stricter criteria are proposed and applied . Compliance was significantly increased when someone other than the patient administered the preparation A follow-up study of all patients entering the MRC double-blind trial of fluphenazine decanoate in chronic schizophrenic out- patients achieved a trace rate of 94 % . In general , these patients were severely disabled , continued under the care of the maintenance clinic , and their diagnoses remained remarkably consistent ; more than one-fifth were found to be in acute schizophrenic relapse and in over a half of these cases , the relapse was not known to the treatment agency . The maintenance clinic attenders were little different from those who no longer used such a facility A double-blind placebo trial of fluphenazine decanoate , a long-acting phenothiazine , was carried out to determine its value in maintenance therapy of chronic schizophrenic out patients already established on the drug for a minimum period of eight weeks . In low doses it was significantly more effective than placebo in preventing relapse and admission to hospital . Relapse was accompanied by a resurgence of specifically schizophrenic symptoms and by an increase in abnormalities described by the relatives . There was no difference between the experimental and control groups in the treatment required for depression . The group on active medication required more treatment for Parkinsonism , but this difference did not reach statistical significance . In the context of a well-run special clinic for outpatient follow-up of chronic schizophrenic patients these results confirm the usefulness of long-acting fluphenazine . By inference , the benefit of this treatment highlights the need for adequate community services to deal with the residual chronic disabilities which are characteristic of these patients OBJECTIVE To assess the method ologic quality of approaches used to allocate participants to comparison groups in r and omized controlled trials from one medical specialty . DESIGN Survey of published , parallel group r and omized controlled trials . DATA SOURCES All 206 reports with allocation described as r and omized from the 1990 and 1991 volumes of four journals of obstetrics and gynecology . MAIN OUTCOME MEASURES Direct and indirect measures of the adequacy of r and omization and baseline comparisons . RESULTS Only 32 % of the reports described an adequate method for generating a sequence of r and om numbers , and only 23 % contained information showing that steps had been taken to conceal assignment until the point of treatment allocation . A mere 9 % described both sequence generation and allocation concealment . In reports of trials that had apparently used unrestricted r and omization , the differences in sample sizes between treatment and control groups were much smaller than would be expected due to chance . In reports of trials in which hypothesis tests had been used to compare baseline characteristics , only 2 % of reported test results were statistically significant , lower than the expected rate of 5 % . CONCLUSIONS Proper r and omization is required to generate unbiased comparison groups in controlled trials , yet the reports in these journals usually provided inadequate or unacceptable information on treatment allocation . Additional analyses suggest that nonr and om manipulation of comparison groups and selective reporting of baseline comparisons may have occurred A modification of an earlier rating scale for extrapyramidal system disturbance is described , and evidence for the validity and reliability of the scale is presented . The usefulness of the scale in studies of neuroleptic drugs is discussed . By its application it is possible to quantify extrapyramidal side effects and to separate them into four principal factors Fifty chronic schizophrenics were r and omly assigned to a 16‐week treatment either with fluspirilene or with fluphenazine decanoate . The aim of the study was to compare the antipsychotic action and the side effects of the two neuroleptics . Fluphenazine decanoate caused more side effects and the difference between the two groups was statistically significant in the items tremor , severe extrapyramidal effects and parkinsonism . More patients in the fluspirilene group ( nine patients ) compared with only three in the fluphenazine decanoate group remained free of side effects during the whole trial . Judged from the BPRS fluspirilene proved an equally potent neuroleptic with fluphenazine decanoate although statistically significant improvement has been obtained in more items of the scale in the fluspirilene group . The improvement in the NOSIE‐30 was much more clear in the fluspirilene group . Although Clinical Global Impressions of the investigators and the nursing personnel favored fluspirilene , the differences between the two groups were not statistically significant BACKGROUND A recent review suggested an association between using unpublished scales in clinical trials and finding significant results . AIMS To determine whether such an association existed in schizophrenia trials . METHOD Three hundred trials were r and omly selected from the Cochrane Schizophrenia Group 's Register . All comparisons between treatment groups and control groups using rating scales were identified . The publication status of each scale was determined and cl aims of a significant treatment effect were recorded . RESULTS Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison ( relative risk 1.37 ( 95 % CI 1.12 - 1.68 ) ) . This effect increased when a ' gold-st and ard ' definition of treatment superiority was applied ( RR 1.94 ( 95 % CI 1.35 - 2.79 ) ) . In non-pharmacological trials , one-third of ' gold-st and ard ' cl aims of treatment superiority would not have been made if published scales had been used . CONCLUSIONS Unpublished scales are a source of bias in schizophrenia trials This study is a part of a multicentric study of some new long-acting psychotropic drugs and their possible application in the maintenance treatment of patients suffering from chronic schizophrenic syndromes ( Perris , ( Ed . ) 1974 ) . The present article deals with a controlled trial of fluspirilene and fluphenazine enanthate carried out simultaneously at Department I1 of the Lillhagen Psychiatric Hospital in Gothenburg ' " , at the Restad Psychiatric Hospital in Vanersborg ' > ) ) , and at the Umedal Psychiatric Hospital in Umeb'+ * ) . The social structure of the hospitals involved in the trial has been investigated in separate studies reported in detail elsewhere ( Malm , Perris , R a p p & Roma'n 1974 a , b ; Perris , Rapp G Romrin 1974 ) . Fluspirilene , 8-[~,~-bis(p-fluorophenyl)butyl]-l-phenyl-l,~,8-triazaspiro ( 4,5 ) decan-4-on is a new compound synthesized at the Janssen Pharmaceutica Research Laboratories and related to the butyrophenones . Fig. 1 shows its chemical structure . The substance is a yellowish-white amorphous or crystalline solid , almost insoluble in water . It is prepared as a micronized suspension in water for intramuscular administration . Pharmacological ( lanssen et al. 1970 , Heykants 1969 ) and preliminary clinical investigations ( Haase et al. 1968 , Sterkmans et al. 1968 , Zmmich et al. 1970 , Knaack 1969 ) have shown fluspirilene to be a highly potent neuroleptic drug with a duration of action ranging from 6 to 15 days ( Madalena 1968 ) . Few side effects , mainly of the extrapyramidal type have been described . No toxic reactions have been reported . Peak effects usually occur
Output:
| There are no convincing data showing fluspirilene decanoate 's advantage over oral chlorpromazine or other depot antipsychotics .
REVIEW ER 'S CONCLUSIONS The total numbers in each comparison were small and there were no clear differences demonstrated between fluspirilene and oral medication or other depots . |
MS210349 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : To compare the amount of furosemide needed to fulfil defined criteria for renal output if given intermittently or as a continuous infusion and to compare the effect of these two regimens on hemodynamic variables and urine electrolyte concentrations . Design : Prospect i ve r and omized study of postoperative hemodynamically stable pediatric cardiac patients . The patients were given furosemide according to the urine output , either as an intermittent bolus injection or as a continuous infusion . Setting : Pediatric intensive care unit in a university hospital Patients : The patients were r and omly assigned before admission to either the intermittent i. v. or the continuous furosemide i. v. infusion group . Measurements and results : Demographic and hemodynamic data were recorded for a maximum of 72 h , as were furosemide dose , urine output , and fluid and inotropic drug requirements . Forty-six patients completed the study . Maximal hourly urine output was significantly higher in the intermittent group . A significantly lower dose of furosemide in the intermittent group produced the same 24-h urine volume as in the continuous infusion group . Conclusions : Intermittent furosemide administration may be recommended in hemodynamically stable postoperative pediatric cardiac patients because of less drug requirement . However , the high maximal urine output may cause hemodynamic problems in patients who depend on high inotropic support BACKGROUND Use of intravenous furosemide is generally avoided in critically ill neonates and infants soon after open heart operations to prevent fluctuations in intravascular volume and result ing circulatory instability . METHODS To assess and compare the safety and efficacy of continuous versus intermittent intravenous furosemide , we undertook a prospect i ve , r and omized trial in 26 consecutive patients less than 6 months of age . Inclusion criteria were presence of low-output syndrome requiring inotropic support ( 24/26 patients ) or pulmonary hypertension requiring vasodilator therapy ( 10/26 patients ) within 6 hours of discontinuation of cardiopulmonary bypass . Eleven patients received 0.1 mg x kg(-1 ) x h(-1 ) continuous intravenous furosemide ( group 1 ) and 15 received 1 mg/kg bolus every 4 hours ( group 2 ) for 24 hours . Mean age ( 3.7 + /- 3.4 versus 1.8 + /- 2.5 months ) and weight ( 4.6 + /- 2.1 versus 4.3 + /- 1.7 kg ) were comparable . RESULTS Group 2 infants showed slightly greater absolute urinary output ( 2.5 + /- 1.1 mL/kg per hour versus 3.3 + /- 1.1 mL/kg per hour , p = 0.05 ) . However , urinary output per dose of drug was significantly larger in group 1 infants ( 1.0 + /- 0.4 versus 0.5 + /- 0.2 mL x kg(-1 ) x h(-1 ) ; p = 0.002 ) with lesser fluctuations ( variance , 1.9 + /- 1.6 versus 3.8 + /- 2.1 ; p = 0.02 ) and fluid replacement needs ( 20.6 + /- 3.8 versus 51.8 + /- 14.4 ; p = 0.001 ) . Electrolyte replacement requirements were similar . A trend toward greater hemodynamic instability in group 2 patients ( heart rate variance 88.4 + /- 79.8 versus 128.3 + /- 82.7 ; p = 0.09 ; central venous pressure variance 2.8 + /- 1.90 versus 4.1 + /- 3.7 ; p = 0.07 ; mixed venous oxygen saturation variance , 32.3 + /- 27.6 versus 45.7 + /- 20.4 ; p = 0.06 ) was noted . All patients who completed the study protocol survived operation and were discharged home . CONCLUSIONS We conclude that ( 1 ) commonly used doses of both intermittent and continuous intravenous furosemide infusion can be safely administered to critically ill neonates and infants as early as 6 hours after operation , ( 2 ) continuous infusion yields an almost comparable urinary output with a much lower dose of furosemide , and ( 3 ) intermittent administration is associated with greater fluctuations in urinary output and greater needs for fluid replacement therapy BACKGROUND Routine diuretic administration after cardiopulmonary bypass is common despite the lack of evidence for its benefit . We performed a prospect i ve study to evaluate if diuretics assist in weight loss or alter clinical outcome . METHODS Seventy-nine patients undergoing primary elective coronary bypass surgery were r and omized to either diuretic ( fusemide and amiloride ) or placebo ( lactose ) postoperatively until preoperative weight was achieved or for 5 days in total . Proportions were compared with chi2 or Fisher 's exact test . RESULTS Forty patients were r and omized to diuretics and 39 to placebo . By day 5 , 97 % of patients ( 37 of 38 ) still in the diuretic arm , and 74 % of patients ( 29 of 39 ) in the placebo arm , achieved preoperative weight ( p = 0.02 ) . There were no differences in clinical outcomes . CONCLUSIONS Routine diuretics promote an earlier diuresis but no clinical benefits are apparent in low risk patients with normal renal function . Clinicians should reconsider routine diuretic prescription in this setting We prospect ively evaluated the diuretic effect of furosemide administered by bolus injection and by continuous infusion in 18 cardiac surgery patients . Nine patients were r and omly assigned to receive 0.3 mg/kg of furosemide as a bolus injection at time 0 and again 6 hours later ( nine patients ) or 0.05 mg/kg per hour of furosemide as a constant infusion for 12 hours ( nine patients ) . There were no significant differences between groups with respect to age , weight , creatinine clearance , changes in serum sodium and potassium levels , total urinary concentrations of sodium and potassium , or total urine volume for 12 hours . Diuresis during continuous infusion of furosemide was less variable from hour to hour than after bolus injection of furosemide and was sustained throughout the infusion period . Although the continuous infusion of furosemide will not provide the rapid and vigorous diuresis that is necessary in some clinical situations , it may be useful whenever a gentle , sustained diuresis is desired BACKGROUND Acute renal failure occurring in the postoperative period , requiring dialysis after cardiac surgery is an important risk factor for an early mortality , and the overall mortality of this complication is as high as 40 % to 60 % . Dialysis in the early postoperative period is often complicated by acute hemodynamic , metabolic , and hematologic effects that adversely affect cardiopulmonary function in patients stabilizing from recent surgery . The purpose of this study was to avoid the need for dialysis by infusion of the solution of mannitol , furosemide , and dopamine in the early postoperative period in oliguric renal failure . METHODS One hundred patients with postoperative oliguric or anuric renal failure despite adequate postoperative cardiac output and hemodynamic function were r and omized . Forty patients ( group A ) were given intermittent doses of diuretics ( furosemide , bumetadine , and ethracrynic acid ) and fluids . Sixty patients ( group B ) were given continuous infusion of the solution of mannitol , furosemide , and dopamine ; the infusion was started within 6 hours ( mean 3.5 hours ) in subgroup B1 ( n = 30 ) , and later than 6 hours ( mean 7.5 hours ) in subgroup B2 ( n = 30 ) after the onset of renal failure . RESULTS Diuresis occurred in 93.3 % of group B ( n = 56 ) versus 10 % in group A ( n = 4 ; patients with preop normal renal function ) . Ninety percent of group A ( n = 36 ) required dialysis versus only 6.7 % of group B ( n = 4 ; patients with preexisting renal disease of subgroup B2 ) . Renal function returned to preoperative normal ( serum creatinine 0.9 + /- 0.05 , p < 0.0001 ) or baseline value ( serum creatinine 2.5 + /- 0.01 , p < 0.0001 ) after first postoperative week in subgroup B1 and third postoperative week in subgroup B2 . CONCLUSIONS Infusion of solution of mannitol , furosemide , and dopamine promoted diuresis in patients with acute postoperative renal failure with adequate postoperative cardiac output and had decreased the need for dialysis in the majority of patients . Early administration of this solution in acute renal failure caused early restoration of renal function to normal or baseline status . It remains to be determined whether routine administration of this solution in the early postoperative period for oliguric renal failure influences the long-term mortality and morbidity in those patients who do require dialysis Because development of acute renal failure is one of the most potent predictors of outcome in cardiac surgery patients , the prevention of renal dysfunction is of utmost importance in perioperative care . In a double-blind r and omized controlled trial , the effectiveness of dopamine or furosemide in prevention of renal impairment after cardiac surgery was evaluated . A total of 126 patients with preoperatively normal renal function undergoing elective cardiac surgery received a continuous infusion of either " renal-dose " dopamine ( 2 microg/kg per min ) ( group D ) , furosemide ( 0.5 microg/kg per min ) ( group F ) , or isotonic sodium chloride as placebo ( group P ) , starting at the beginning of surgery and continuing for 48 h or until discharge from the intensive care unit , whichever came first . Renal function parameters and the maximal increase of serum creatinine above baseline value within 48 h ( deltaCrea(max ) ) were determined . The increase in plasma creatinine was twice as high in group F as in groups D and P ( P < 0.01 ) . Acute renal injury ( defined as deltaCreamax ) > 0.5 mg/dl ) occurred more frequently in group F ( six of 41 patients ) than in group D ( one of 42 ) and group P ( zero of 40 ) ( P < 0.01 ) . ( The difference between group D and group P was not significant . ) Creatinine clearance was lower in group F ( P < 0.05 ) . Two patients in group F required renal replacement therapy . The mean volume of infused fluids , blood urea nitrogen , serum sodium , serum potassium , and osmolar- and free-water clearance was similar in all groups . It was shown that continuous infusion of dopamine for renal protection was ineffective and was not superior to placebo in preventing postoperative dysfunction after cardiac surgery . In contrast , continuous infusion of furosemide was associated with the highest rate of renal impairment . Thus , renaldose dopamine is ineffective and furosemide is even detrimental in the protection of renal dysfunction after cardiac surgery OBJECTIVE Acute kidney injury ( AKI ) is a devastating complication following cardiac surgery and the ideal management is controversial . This prospect i ve , r and omized , open-label and double-blinded study analyzed the renoprotective effects of furosemide infusion and intermittent bolus therapy administered with dopamine infusion in cardiac surgical patients . METHODS Between August 1 , 2007 and July 31 , 2008 , 100 adult patients undergoing elective coronary artery bypass surgery ( CABG ) surgery with normal renal function ( creatinine < 1.4 mg/dl ) were enrolled in the study . The patients were r and omized for the comparison of intermittent ( Group 1 , n=50 , 1mg-3mg/kg ) and continuous infusion of furosemide ( Group 2 , n=50 , 10mg/ml ) . Continuous variables were expressed as mean+/- SD and compared by unpaired Student 's t test or ANOVA for repeated measures . Statistical significance was assumed if p value was < 0.05 . RESULTS Renal replacement therapy ( RRT ) was used in 5 % of patients ( all in group 1 , p=0.028 ) . The 30-day mortality was 5 % . Only 2 patients became hemodialysis dependent in group 1 . Group 2 patients showed a continuous and higher urine output postoperatively than group 1 ( p<0.001 ) . Both groups had significant increase in peak postoperative serum creatinine values ( p<0.001 ) , however peak postoperative creatinine-clearance was significantly lower in group 1 ( p<0.001 ) . CONCLUSION Acute kidney injury necessitating RRT makes a small percentage of patients undergoing cardiac surgery and if RRT is not required the survival is excellent . Continuous infusion of furosemide seems to be effective in promoting diuresis and decreasing the need for RRT . However further multicenter studies with different doses of furosemide are required to confirm these results OBJECTIVE Renal dysfunction following cardiac surgery is more apparent in high-risk patients with pre-existing renal dysfunction , diabetes and impaired left-ventricular function , and following complicated procedures involving prolonged cardiopulmonary bypass ( CPB ) . The aim of this prospect ively r and omised double-blinded placebo-controlled study was to evaluate reno-protective effect of low-dose furosem
Output:
| The systematic review of seven RCTs and one observational study has demonstrated that in patients who have undergone cardiac surgery , a more consistent and sustained diuresis is produced by a continuous infusion of furosemide compared with intermittent bolus doses of furosemide .
We conclude that continuous furosemide infusion in the perioperative period promotes a gentle and sustained diuresis in cardiac surgery patients .
The evidence supporting the benefit of this strategy in terms of reducing the need for RRT is weak .
At the same time , current best available evidence , albeit from small RCTs , suggests that the timely introduction of continuous furosemide infusion does not increase the incidence of renal impairment after cardiac surgery |
MS210350 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: Purpose : Somatic mutations in the epidermal growth factor receptor ( EGFR ) have been detected in patients with non – small cell lung cancer ( NSCLC ) and are associated with sensitivity to treatment with gefitinib or erlotinib . Our study explored the relationship between the two most common types of somatic EGFR mutations , exon 19 deletions and the L858R point mutation , and outcomes of patients following treatment with gefitinib or erlotinib . Experimental Design : Tumor specimens obtained before treatment with gefitinib or erlotinib were analyzed for EGFR mutations . Patients with exon 19 deletion or L858R mutations were identified . The response rate , time to progression , and overall survival were determined for the two groups . Results : We identified 36 patients with NSCLC and an EGFR mutation who were treated with gefitinib or erlotinib . Patients with an exon 19 deletion had a significantly longer overall survival compared with patients with an L858R mutation ( 38 versus 17 months ; P = 0.04 ) . There were also trends toward higher response rate ( 73 % versus 50 % ) and improved time to progression ( 24 versus 10 months ) for the patients with an exon 19 deletion , although these were not independently significant in a multivariate analysis . A difference in response rate for patients treated with gefitinib compared with erlotinib was also noted [ 18 of 23 ( 78 % ) versus 3 of 9 ( 33 % ) ; P = 0.04 ] . No obvious difference in time to progression or overall survival was noted between gefitinib- and erlotinib-treated patients . Conclusions : Patients with NSCLC and EGFR exon 19 deletions have a longer survival following treatment with gefitinib or erlotinib compared with those with the L858R mutation . Pooling of greater numbers of patients and completion of prospect i ve trials are needed to further define the predictive and prognostic roles of different EGFR mutations with respect to treatment with gefitinib , erlotinib , and other EGFR inhibitors Background In Non-small cell lung cancer ( NSCLC ) , an overactive epidermal growth factor receptor ( EGFR ) pathway is a component of the malignant phenotype . Two tyrosine kinase inhibitors ( TKIs ) of EGFR , gefinitib and erlotinib , have been used with variable benefit . Methods We have analyzed outcome data of a population of NSCLC patients that received these TKIs to determine the benefit derived and to define the clinical and molecular parameters that correlate with response . Tumor tissue from a subgroup of these patients was analyzed by immunohistochemistry to measure the expression level of EGFR and four activated ( phosphorylated ) members of the pathway , pEGFR , pERK , pAKT , and pSTAT3 . Results Erlotinib was slightly superior to gefitinib in all measures of response , although the differences were not statistically significant . The most robust clinical predictors of time to progression ( TTP ) were best response and rash ( p < 0.0001 ) . A higher level of pEGFR was associated with longer TTP , while the total EGFR level was not associated with response . Higher levels of pAKT and pSTAT3 were also associated with longer TTP . In contrast , a higher level of pERK1/2 was associated with shorter TTP . Conclusion These observations suggest the hypothesis that tumor cells that have activated EGFR pathways , presumably being utilized for survival , are clinical ly relevant targets for pathway inhibition . An accurate molecular predictive model of TKI response should include activated members of the EGFR pathway . TKIs may be best reserved for tumors expressing pEGFR and pAKT or pSTAT , and little pERK . In the absence of molecular predictors of response , the appearance of a rash and a positive first scan are good clinical indicators of response BACKGROUND The irreversible ErbB family blocker afatinib and the reversible EGFR tyrosine kinase inhibitor gefitinib are approved for first-line treatment of EGFR mutation-positive non-small-cell lung cancer ( NSCLC ) . We aim ed to compare the efficacy and safety of afatinib and gefitinib in this setting . METHODS This multicentre , international , open-label , exploratory , r and omised controlled phase 2B trial ( LUX-Lung 7 ) was done at 64 centres in 13 countries . Treatment-naive patients with stage IIIB or IV NSCLC and a common EGFR mutation ( exon 19 deletion or Leu858Arg ) were r and omly assigned ( 1:1 ) to receive afatinib ( 40 mg per day ) or gefitinib ( 250 mg per day ) until disease progression , or beyond if deemed beneficial by the investigator . R and omisation , stratified by EGFR mutation type and status of brain metastases , was done central ly using a vali date d number generating system implemented via an interactive voice or web-based response system with a block size of four . Clinicians and patients were not masked to treatment allocation ; independent review of tumour response was done in a blinded manner . Co primary endpoints were progression-free survival by independent central review , time-to-treatment failure , and overall survival . Efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug . This ongoing study is registered with Clinical Trials.gov , number NCT01466660 . FINDINGS Between Dec 13 , 2011 , and Aug 8 , 2013 , 319 patients were r and omly assigned ( 160 to afatinib and 159 to gefitinib ) . Median follow-up was 27·3 months ( IQR 15·3 - 33·9 ) . Progression-free survival ( median 11·0 months [ 95 % CI 10·6 - 12·9 ] with afatinib vs 10·9 months [ 9·1 - 11·5 ] with gefitinib ; hazard ratio [ HR ] 0·73 [ 95 % CI 0·57 - 0·95 ] , p=0·017 ) and time-to-treatment failure ( median 13·7 months [ 95 % CI 11·9 - 15·0 ] with afatinib vs 11·5 months [ 10·1 - 13·1 ] with gefitinib ; HR 0·73 [ 95 % CI 0·58 - 0·92 ] , p=0·0073 ) were significantly longer with afatinib than with gefitinib . Overall survival data are not mature . The most common treatment-related grade 3 or 4 adverse events were diarrhoea ( 20 [ 13 % ] of 160 patients given afatinib vs two [ 1 % ] of 159 given gefitinib ) and rash or acne ( 15 [ 9 % ] patients given afatinib vs five [ 3 % ] of those given gefitinib ) and liver enzyme elevations ( no patients given afatinib vs 14 [ 9 % ] of those given gefitinib ) . Serious treatment-related adverse events occurred in 17 ( 11 % ) patients in the afatinib group and seven ( 4 % ) in the gefitinib group . Ten ( 6 % ) patients in each group discontinued treatment due to drug-related adverse events . 15 ( 9 % ) fatal adverse events occurred in the afatinib group and ten ( 6 % ) in the gefitinib group . All but one of these deaths were considered unrelated to treatment ; one patient in the gefitinib group died from drug-related hepatic and renal failure . INTERPRETATION Afatinib significantly improved outcomes in treatment-naive patients with EGFR-mutated NSCLC compared with gefitinib , with a manageable tolerability profile . These data are potentially important for clinical decision making in this patient population . FUNDING Boehringer Ingelheim PURPOSE The epidermal growth factor receptor ( EGFR ) tyrosine kinase has been an important target for non-small-cell lung cancer . Several EGFR tyrosine kinase inhibitors ( TKIs ) are currently approved , and both gefitinib and erlotinib are the most well-known first-generation EGFR-TKIs . This r and omized phase III study was conducted to investigate the difference between these two EGFR-TKIs . PATIENTS AND METHODS Previously treated patients with lung adenocarcinoma were r and omly assigned to receive gefitinib or erlotinib . This study aim ed to investigate the noninferiority of gefitinib compared with erlotinib . The primary end point was progression-free survival ( PFS ) . RESULTS Five hundred sixty-one patients were r and omly assigned , including 401 patients ( 71.7 % ) with EGFR mutation . All baseline factors ( except performance status ) were balanced between the arms . Median PFS and overall survival times for gefitinib and erlotinib were 6.5 and 7.5 months ( hazard ratio [ HR ] , 1.125 ; 95 % CI , 0.940 to 1.347 ; P = .257 ) and 22.8 and 24.5 months ( HR , 1.038 ; 95 % CI , 0.833 to 1.294 ; P = .768 ) , respectively . The response rates for gefitinib and erlotinib were 45.9 % and 44.1 % , respectively . Median PFS times in EGFR mutation-positive patients receiving gefitinib versus erlotinib were 8.3 and 10.0 months , respectively ( HR , 1.093 ; 95 % CI , 0.879 to 1.358 ; P = .424 ) . The primary grade 3 or 4 toxicities were rash ( 2.2 % for gefitinib v 18.1 % for erlotinib ) and alanine aminotransferase (ALT)/aspartate aminotransferase ( AST ) elevation ( 6.1%/13.0 % for gefitinib v 2.2%/3.3 % for erlotinib ) . CONCLUSION The study did not demonstrate noninferiority of gefitinib compared with erlotinib in terms of PFS in patients with lung adenocarcinoma according to the predefined criteria BACKGROUND AND OBJECTIVE It has been proven that epidermal growth factor receptor-tyrosine kinase inhibitor ( EGFR-TKI ) significantly benefits advanced non-small cell lung cancer ( NSCLC ) patients harboring EGFR mutations in progression-free survival time with better tolerance . This study is undertaken to analyze efficacy and tolerance of advanced NSCLC patients harboring EGFR mutations taking EGFR-TKI as a first-line therapy . METHODS Tumor sample s from 54 patients with advanced NSCLC were examined for EGFR activating mutations ( deletion mutation in exon 19 and the L858R point mutation in exon 21 ) by direct sequencing . The patients were first-line treated with oral administration of EGFR-TKI until disease progression . The efficacy and adverse events were observed , and survival was followed up . RESULTS Among the patients , 61 % ( 33 of 54 ) had EGFR exon 19 deletion , and 39 % ( 21 of 54 ) had EGFR L858R point mutation . All patients received first-line TKI therapy . The total response rate was 96 % , median progression free survival ( PFS ) was 8.3 months and median survival was 19.5 months . The patients with EGFR exon 19 deletion had significantly longer median PFS ( 9 versus 7 months , P=0.002 ) and longer median overall survival (OS)(25 versus 16 months , P=0.001 ) than patients with EGFR L858R point mutation . There is no significance in efficacy between gefitinib and erlotinib , and gefitinib is safer than erlotinib . The most common adverse events were rash and diarrhea . Two ( 4 % ) grade 4 skin toxity effects , two ( 4 % ) grade 3 aminotransferase level elevations , and one ( 1 ) grade 3 stomatitis were observed . CONCLUSION The first-line EGFR-TKI treatment in advanced NSCLC patients harboring EGFR mutations is efficient and safe , which is more efficient in patients with EGFR exon 19 deletion than those with EGFR L858R mutation Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more PURPOSE To establish the safety and tolerability of ZD1839 ( Iressa ) , a selective epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitor , and to explore its pharmacokinetic and pharmacodynamic effects in patients with selected solid tumor types . PATIENTS AND METHODS This was a phase I dose-escalating trial of oral ZD1839 150 mg/d to a maximum of 1,000 mg/d given once daily for at least 28 days . Patients with either advanced non-small-cell lung , ovarian , head and neck , prostate , or colorectal cancer were recruited . RESULTS Eighty-eight patients received ZD1839 ( 150 to 1,000 mg/d ) . At 1
Output:
| No solid evidence was found that afatinib had greater efficacy than gefitinib or erlotinib in first-line treatment of EGFR-mutant NSCLC .
However , afatinib was more effective than erlotinib as second-line treatment of patients with advanced squamous cell carcinoma .
The grade 3/4 adverse events rate of afatinib was comparable to that of erlotinib but higher than that of gefitinib |
MS210351 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES the aim of this r and omized-controlled clinical trial was to compare the objective and subjective esthetic outcomes of two types of screwed-retained single-implant crowns . MATERIAL S AND METHODS participants were r and omly assigned to the test ( all-ceramic ) and control [ porcelain-fused-to-ceramic ( PFM ) ] groups and were seen under investigation at baseline ( B ) , crown insertion ( CI ) , 1-year follow-up ( 1Y ) , and 2-year follow-up ( 2Y ) . Objective parameters were assessed by an intra-oral digital photograph ( 1:1 ratio ) , a study cast , a st and ardized radiograph , periodontal/peri-implant measurements , and question naires were obtained for the subjective parameters . In addition , pink esthetic score ( PES ) and white esthetic score ( WES ) were calculated for both groups . For the subjective evaluation , a visual analogue scale ( VAS ) question naire was used to assess the level of patient satisfaction regarding the esthetic outcome . Then , nine expert clinicians visually inspected and assessed subjective evaluation at the professional level . Statistical analysis was used to compare between groups and investigational appointments . RESULTS twenty patients were included in the study , 10 allocated to the all-ceramic group and 10 to the PFM group . No statistically significant differences were observed for the objective measurements comparing the test and control groups . Minor chipping of the ceramic veneering material was observed in the two patients of control group . The mean difference for all groups comparing objective parameters revealed an increase of papilla height between time points . A slight recession ( 0.26 mm ) of the peri-implant mucosal margin at the implant site was observed between 1Y and 2Y . Mean values for PES and WES were 13.9 and 13.1 for the PFM group and for the all-ceramic group , respectively . These values were not statistically significant . Implant crown volume , outline , translucency , and characterization showed major discrepancies with the contra-lateral natural teeth . As for subjective parameters , VAS patients ' responses regarding their perceptions of the esthetic outcome showed no statistical differences between groups and clinicians ' accuracy scores were 50 % and 47 % for PFM and all-ceramic crowns , respectively . CONCLUSION PFM and all-ceramic single-implant restorations may be indistinguishable from each other regarding the objective /subjective assessment of esthetic integration . The material chosen for fabricating an implant crown per se does not ensure an optimal esthetic outcome if other esthetic parameters are not present INTRODUCTION Up-to- date studies comparing endodontic treatment versus implant-supported prosthesis have shown similar clinical outcome and survival rates . However , no data are available comparing both treatment modalities based on the patient 's perception of quality of life . This study was design ed to qualitatively describe and compare the quality of life of patients with restored , single endodontically treated teeth versus patients with single implant-supported fixed prostheses . METHODS Forty-eight patients agreed to participate in the study ( n = 24 from each treatment modality ) . Of those , 37 actually participated in the study : 17 were endodontically treated and 20 had an implant-supported prosthesis . Patients in each of the two groups were r and omly selected from the Graduate Endodontics and Graduate Periodontics Departments , respectively . Six focus group discussion s ( n = 3 per treatment group ) were held and audio-recorded for subsequent thematic analysis . Data were analyzed to identify common themes within each category and compared to assess any differences in quality of life between the two treatments . Additionally , a quality of life survey , the shortened version of the Oral Health Impact Profile ( OHIP-14 ) , was given before the discussion group and the responses analyzed . RESULTS The results obtained from this study show similar overall OHIP scores and show a high rate of satisfaction with both treatment modalities . Content analysis of the discussion groups revealed several themes and subthemes . The major themes were importance of overall health , financial implication s of the treatments , perception of the treatments and its outcomes , time since treatment , and follow-up dental visits . CONCLUSIONS The results help identify patients ' perception and concerns with each treatment modality and assist the clinician and patient in the selection of an optimal treatment for their given situation . In addition to the prognosis and outcomes , clinicians should consider patients ' perceptions and preferences as well as the influence each therapy may have on their quality of life , both short- and long-term . Overall , all the participants in this study were pleased with the treatment received and expressed a clear message to save their natural dentition whenever possible OBJECTIVE To evaluate and compare marginal bone loss around mini-implants supporting maxillary overdentures with either partial or full palatal coverage . METHOD AND MATERIAL S Nineteen edentulous patients complaining of retention problems involving their maxillary dentures were r and omly allocated in two groups . Group I ( n = 10 ) received maxillary dentures with full palatal coverage , and group II ( n = 9 ) received maxillary dentures with partial palatal coverage . In total , 114 mini-implants ( 6 per patient ) were inserted using the nonsubmerged flapless surgical approach and loaded immediately with maxillary overdentures . Each implant was evaluated at the time of initial prosthetic loading and at 6 , 12 , and 24 months thereafter . Radiographic evaluation was performed in terms of vertical and horizontal bone loss . Implant mobility ( via Periotest values ) was measured using a Periotest device , and patient satisfaction was evaluated with a visual analog scale . The cumulative survival rate was calculated using Kaplan-Meier analysis . RESULTS After 2 years , the mean vertical bone loss in groups I and II was 5.38 and 6.29 mm , respectively , while the mean horizontal bone loss in groups I and II was 1.52 and 1.93 mm , respectively . Most bone resorption occurred within 6 months after overdenture insertion in both groups . Group II recorded significant higher vertical bone loss and Periotest values than group I at all observation times . The cumulative survival rates of the mini-implants were 78.4 % and 53.8 % for groups I and II , respectively . All patients were satisfied with their maxillary overdentures in terms of retention and chewing ability . CONCLUSION Rehabilitation of edentulous maxillae with unsplinted mini-implants supporting overdentures and in particular with a combination of partial palatal coverage is not recommended because of excessive marginal bone resorption and the higher failure rate of mini-implants than was expected Background Very few studies on the impact of implant therapy on Oral Health Related Quality of Life ( OHRQoL ) in partially edentulous patients have been published . Aim This study aim ed at analysing the improvement of OHRQoL of patients who underwent dental implant treatment using the “ functional ” , “ psychosocial ” and “ pain and discomfort ” categories of the Geriatric Oral Health Assessment Index ( GOHAI ) . Methods Within a prospect i ve cohort of patients rehabilitated with Straumann dental implants , the OHRQoL of 176 patients ( 104 women and 72 men ) was assessed using the GOHAI question naire , at two different times , before and after implant placement . The degree of oral treatment was categorised into three classes : “ Single Tooth Implant ” ( n = 77 ) , “ Fixed Partial Denture ” ( n = 75 ) , “ Fixed or Retained Full Prostheses ” ( n = 24 ) . The participants ’ characteristics ( gender , age , tobacco habits , periodontal treatment , time between both evaluations ) were assessed . Results Before treatment , the GOHAI score was lower for participants with fewer teeth ( F = 19 , P < 0.001 ) . After treatment , no difference was observed between participants ; significant improvements were observed in the GOHAI scores obtained ( repeated measures , analysis , ( F = 177 , P < 0.001 ) ) for each of the GOHAI fields studied ( functional , psychosocial and pain & discomfort ) , regardless of the degree of treatment . The best improvement was observed in patients who needed complete treatment ( P < 0.001 ) . The presence of preliminary periodontal treatment , tobacco habits , age and gender of the participants did not have a significant impact on OHRQoL. Changing the time between the two evaluations ( before and after treatment ) had no impact on the changes in the GOHAI score . Conclusions Implants enhanced the OHRQoL of participants that needed oral treatment OBJECTIVES To study patient satisfaction and masticatory efficiency of single implant-retained m and ibular overdentures using the stud and magnetic attachments in a r and omized clinical trial with a crossover design . METHODS Patients received a single implant placed in the midline of the m and ible and either a stud ( Locator ) or a magnetic ( Magfit ) attachment , assigned at r and om . Patient satisfaction , including patient comfort , speech , chewing ability and retention , and masticatory efficiency measured by chewing peanuts , were assessed before and 3 months after attachment insertion . Patient satisfaction and masticatory efficiency were evaluated again 3 months after insertion of the alternate attachment bodies . The outcomes were compared before and after insertion of the attachments and between the two types of attachments using Wilcoxon signed rank tests . RESULTS Patient overall satisfaction , comfort , speech , chewing ability , and retention improved significantly after insertion of both types of attachment bodies ( p<0.05 ) . Masticatory efficiencies also increased in both the Locator and the Magfit groups ( p<0.05 ) . There were no statistically significant differences in patient overall satisfaction , comfort , speech , and retention between the two types of attachments ( p>0.05 ) . The Locator attachments performed better in perceived chewing ability than the Magfit ( p<0.05 ) , but there was no statistically significant difference in masticatory efficiency between the two attachment types ( p>0.05 ) . CONCLUSIONS Clinical outcomes were significantly improved in single implant-retained m and ibular overdentures using either the Locator or the Magfit magnetic attachments . There was no difference in masticatory efficiency between the two attachment types STATEMENT OF PROBLEM There is a widespread belief that maxillary overdenture prostheses are associated with a higher frequency of complications and require more maintenance than fixed implant prostheses . PURPOSE This prospect i ve clinical study compared the treatment outcomes of fixed and removable implant-supported restorations in the edentulous maxilla with the main emphasis on the clinician 's point of view . MATERIAL AND METHODS Ten patients were treated with fixed screw-retained implant prostheses ( group 1 ) , and 10 patients were treated with removable implant-supported overdentures ( group 2 ) in the edentulous maxilla . Recall was scheduled at 6-month intervals to investigate the prosthodontic treatment outcomes , including implant survival , prosthesis time until retreatment , and maintenance issues . Clinical parameters gingival index ( GI ) , plaque index ( PI ) , the clinical attachment level , and radiographic marginal bone levels measured , along with any biologic and mechanical complications were recorded . RESULTS Patients were followed over a mean period of 39 months ( SD=7 ; group 1 ) and 27 months ( SD=10 ; group 2 ) after implant placement . Cumulative implant survival was 97.6 % for group 1 and 94.4 % for group 2 after an 18-month observation period . The mean time until retreatment after prostheses insertion was 23.4 months for group 1 and 19.8 months for group 2 ( n.s . ) . In both groups , the increase over time in the radiographically investigated bone level was found to be significant . The indices given for the mucosal health and oral hygiene status ( GI and PI ) were highly correlated in both groups at each recall appointment , but no significant differences were found between groups 1 and 2 . CONCLUSION In groups 1 and 2 , comparable prosthodontic treatment outcomes were achieved . The majority of mechanical complications could be managed chairside during recall visits and did not require additional appointments , so that the time and costs involved in providing maintenance were kept down Prosthetic outcome and patient satisfaction were evaluated in order to investigate whether there is a need or advantage to splint two implants in the m and ible retaining a hinging overdenture . This study included 36 fully edentulous patients r and omly divided into three groups according to the attachment system they received : magnets , ball attachments or straight bars ( reference group ) . None of the implants failed during the whole observation period in any of the groups . After 5 years of observation , the Bar group presented the highest retention capacity and the least prosthetic complications but revealed more mucositis and gingival hyperplasia . Patient satisfaction rated similar for all groups although the Magnet group showed lower retention forces . All patients would repeat the same treatment even though the majority of the Magnet group would prefer a more retentive solution because of limited denture stability BACKGROUND Patient-based outcomes with maxillary overdentures on a minimum number of implants , opposing m and ibular 2-implant overdentures are not evident in the literature . PURPOSE To evaluate patient 's satisfaction with maxillary 3-implant overdentures , opposing m and ibular 2-implant overdentures , using two different attachment systems over the first 2 years of service . MATERIAL S AND METHODS Forty participants wearing m and ibular 2-implant overdentures for 3 years were r and omly allocated to one of two similar implant system groups to receive maxillary 3-implant overdentures . Twenty participants were allocated to splinted and unsplinted attachment system treatment groups for each system . Patient satisfaction with pre-treatment complete maxillary dentures , with maxillary 3-implant overdentures at baseline and annually for 2 years , was measured using visual analogue scale question naires and the oral health impact profiles . Palatal coverage of the maxillary overdentures was reduced at the first annual recall . RESULTS Data showed significant improvement in pain reduction , comfort , stability , and function
Output:
| This may not hold true for fully edentulous patients in the maxilla .
In general , fully edentulous patients seem to opt for a fixed or removable rehabilitation on implants for specific reasons .
In these patients , the timing of implant placement does not seem to affect patient satisfaction .
Patients seem to prefer straightforward implant surgery over complex surgery that includes bone grafting .
Fully edentulous patients in the m and ible experience higher satisfaction with an IOD when compared to a CD . |
MS210352 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE To determine whether a diet low in fat and high in fruits , vegetables , and fiber may be protective against prostate cancer by having an impact on serial levels of serum prostate-specific antigen ( PSA ) . METHODS Six hundred eighty-nine men were r and omized to the intervention arm and 661 to the control arm . The intervention group received intensive counseling to consume a diet low in fat and high in fiber , fruits , and vegetables . The control group received a st and ard brochure on a healthy diet . PSA in serum was measured at baseline and annually thereafter for 4 years , and newly diagnosed prostate cancers were recorded . RESULTS The individual PSA slope for each participant was calculated , and the distributions of slopes were compared between the two groups . There was no significant difference in distributions of the slopes ( P = .99 ) . The two groups were identical in the proportions of participants with elevated PSA at each time point . There was no difference in the PSA slopes between the two groups ( P = .34 ) and in the frequencies of elevated PSA values for those with elevated PSA at baseline . Incidence of prostate cancer during the 4 years was similar in the two groups ( 19 and 22 in the control and intervention arms , respectively ) . CONCLUSION Dietary intervention over a 4-year period with reduced fat and increased consumption of fruits , vegetables , and fiber has no impact on serum PSA levels in men . The study also offers no evidence that this dietary intervention over a 4-year period affects the incidence of prostate cancer during the 4 years The relationship between risk of prostate cancer and dietary intake of energy , fat , vitamin A , and other nutrients was investigated in a case-control study conducted in Ontario , Canada . Cases were men with a recent , histologically confirmed diagnosis of adenocarcinoma of the prostate notified to the Ontario Cancer Registry between April 1990 and April 1992 . Controls were selected r and omly from assessment lists maintained by the Ontario Ministry of Revenue , and were frequency-matched to the cases on age . The study included 207 cases ( 51.4 percent of those eligible ) and 207 controls ( 39.4 percent of those eligible ) , and information on dietary intake was collected from them by means of a quantitative diet history . There was a positive association between energy intake and risk of prostate cancer , such that men at the uppermost quartile level of energy intake had a 75 percent increase in risk . In contrast , there was no clear association between the non-energy effects of total fat and monounsaturated fat intake and prostate cancer risk . There was some evidence for an inverse association with saturated fat intake , although the dose-response pattern was irregular . There was a weak ( statistically nonsignificant ) positive association between polyunsaturated fat intake and risk of prostate cancer . Relatively high levels of retinol intake were associated with reduced risk , but there was essentially no association between dietary β-carotene intake and risk . There was no alteration in risk in association with dietary fiber , cholesterol , and vitamins C and E. Although these patterns were evident both overall and within age-strata , and persisted after adjustment for a number of potential confounding factors , they could reflect ( in particular ) the effect of nonrespondent bias A rising level of prostate-specific antigen ( PSA ) , after primary surgery or radiation therapy , is the hallmark of recurrent prostate cancer and is often the earliest sign of extraprostatic spread in patients who are otherwise asymptomatic . While hormonal therapy may slightly extend survival in a minority of patients , it is not curative and produces side effects including hot flashes , decreased libido , and loss of bone mass . Alternatively , dietary modification may offer an important tool for clinical management . Epidemiologic studies have associated the Western diet not only with prostate cancer incidence but also with a greater risk of disease progression after treatment . Conversely , many elements of plant-based diets have been associated with reduced risk of progression . However , dietary modification can be stressful and difficult to implement . We therefore conducted a 6-month pilot clinical trial to investigate whether adoption of a plant-based diet , reinforced by stress management training , could attenuate the rate of further PSA rise . Urologists at the University of California , San Diego , and San Diego Veterans Affairs Medical Centers recruited 14 patients with recurrent prostate cancer . A pre-post design was employed in which each patient served as his own control . Rates of PSA rise were ascertained for each patient for the following periods : from the time of posttreatment recurrence up to the start of the study ( pre study ) and from the time immediately preceding the intervention ( baseline ) to the end of the intervention ( 0 - 6 months ) . There was a significant decrease in the rate of PSA rise from pre study to 0 to 6 months ( P < .01 ) . Four of 10 evaluable patients experienced an absolute reduction in their PSA levels over the entire 6-month study . Nine of 10 had a reduction in their rates of PSA rise and an improvement of their PSA doubling times . Median PSA doubling time increased from 11.9 months ( pre study ) to 112.3 months ( intervention ) . These results provide preliminary evidence that adoption of a plant-based diet , in combination with stress reduction , may attenuate disease progression and have therapeutic potential for clinical management of recurrent prostate cancer Epidemiological studies have shown an inverse association between dietary intake of lycopene and prostate cancer risk . We conducted a clinical trial to investigate the biological and clinical effects of lycopene supplementation in patients with localized prostate cancer . Twenty-six men with newly diagnosed prostate cancer were r and omly assigned to receive a tomato oleoresin extract containing 30 mg of lycopene ( n = 15 ) or no supplementation ( n = 11 ) for 3 weeks before radical prostatectomy . Biomarkers of cell proliferation and apoptosis were assessed by Western blot analysis in benign and cancerous prostate tissues . Oxidative stress was assessed by measuring the Peripheral blood lymphocyte ONA oxidation product 5-hydroxymethyl-deoxyuridine ( 5-OH-mdU ) . Usual dietary Intake of nutrients was assessed by a food frequency question naire at baseline . Prostatectomy specimens were evaluated for pathologic stage , Gleason score , volume of cancer , and extent of high- grade prostatic intraepithelial neoplasia . Plasma levels of lycopene , insulin-like growth factor-1 , insulin-like growth factor binding protein-3 , and prostate-specific antigen were measured at baseline and after 3 weeks of supplementation or observation . After intervention , subjects in the intervention group had smaller tumors ( 80 % vs 45 % , less than 4 ml ) , less involvement of surgical margins and /or extra-prostatic tissues with cancer ( 73 % vs 18 % , organ-confined disease ) , and less diffuse involvement of the prostate by high- grade prostatic intraepithelial neoplasia ( 33 % vs 0 % , focal involvement ) compared with subjects in the control group . Mean plasma prostate-specific antigen levels were lower in the intervention group compared with the control group . This pilot study suggests that lycopene may have beneficial effects in prostate cancer . Larger clinical trials are Warranted to investigate the potential preventive and /or therapeutic role of lycopene in prostate cancer BACKGROUND Multivitamin supplements are used by millions of Americans because of their potential health benefits , but the relationship between multivitamin use and prostate cancer is unclear . METHODS We prospect ively investigated the association between multivitamin use and risk of prostate cancer ( localized , advanced , and fatal ) in 295,344 men enrolled in the National Institutes of Health (NIH)-AARP Diet and Health Study who were cancer free at enrollment in 1995 and 1996 . During 5 years of follow-up , 10,241 participants were diagnosed with incident prostate cancer , including 8765 localized and 1476 advanced cancers . In a separate mortality analysis with 6 years of follow-up , 179 cases of fatal prostate cancer were ascertained . Multivitamin use was assessed at baseline as part of a self-administered , mailed food-frequency question naire . Relative risks ( RRs ) and 95 % confidence intervals ( CIs ) were calculated by use of Cox proportional hazards regression , adjusted for established or suspected prostate cancer risk factors . RESULTS No association was observed between multivitamin use and risk of localized prostate cancer . However , we found an increased risk of advanced and fatal prostate cancers ( RR = 1.32 , 95 % CI = 1.04 to 1.67 and RR = 1.98 , 95 % CI = 1.07 to 3.66 , respectively ) among men reporting excessive use of multivitamins ( more than seven times per week ) when compared with never users . The incidence rates per 100,000 person-years for advanced and fatal prostate cancers for those who took a multivitamin more than seven times per week were 143.8 and 18.9 , respectively , compared with 113.4 and 11.4 in never users . The positive associations with excessive multivitamin use were strongest in men with a family history of prostate cancer or who took individual micronutrient supplements , including selenium , beta-carotene , or zinc . CONCLUSION These results suggest that regular multivitamin use is not associated with the risk of early or localized prostate cancer . The possibility that men taking high levels of multivitamins along with other supplements have increased risk of advanced and fatal prostate cancers is of concern and merits further evaluation PURPOSE The effects of a low-fat diet or a low-fat diet with the addition of a soy supplement were investigated in a pilot Phase II study for asymptomatic , hormonally naive prostate cancer patients with rising prostate-specific antigen ( PSA ) levels . EXPERIMENTAL DESIGN A two-step intervention was implemented . During step 1 patients were begun on a low-fat diet with a goal to reduce fat intake to 15 % of total daily calories . On PSA progression , a soy protein supplement was added to the diet ( step 2 ) . The primary end point was PSA reduction by 50 % . Secondary end points were PSA doubling time and time to progression ( TTP ) . Serum was analyzed for changes in the sex hormone and insulin-like growth factor ( IGF-I ) axes . RESULTS Among 18 evaluable patients , ( median follow-up on study 10.5 months ) , no patient on either step had a PSA reduction by 50 % at any time . There was a trend toward a longer PSA doubling time ( P = 0.06 ) and a prolongation in estimated median TTP of approximately 3 months ( P = 0.018 ) during step 2 compared with step 1 of the study . During step 1 , free testosterone levels decreased by 5 % ( P < 0.01 ) , and during step 2 , IGF-I levels increased by 22 % ( P = 0.02 ) . CONCLUSIONS A low-fat diet with the subsequent addition of a soy supplement did not result in a significant decline in PSA levels . The addition of soy protein had a modest effect on TTP . A potentially undesirable effect associated with the administration of soy was an increase in IGF-I serum levels The purpose of this study was to determine the effects of soy protein isolate consumption on circulating hormone profiles and hormone receptor expression patterns in men at high risk for developing advanced prostate cancer . Fifty-eight men were r and omly assigned to consume 1 of 3 protein isolates containing 40 g/d protein : 1 ) soy protein isolate ( SPI+ ) ( 107 mg/d isoflavones ) ; 2 ) alcohol-washed soy protein isolate ( SPI- ) ( < 6 mg/d isoflavones ) ; or 3 ) milk protein isolate ( 0 mg/d isoflavones ) . For 6 mo , the men consumed the protein isolates in divided doses twice daily as a partial meal replacement . Serum sample s collected at 0 , 3 , and 6 mo were analyzed for circulating estradiol , estrone , sex hormone-binding globulin , and rostenedione , and rostanediol glucuronide , dehydroepi and rosterone sulfate , dihydrotestosterone , testosterone , and free testosterone concentrations by RIA . Prostate biopsy sample s obtained pre- and postintervention were analyzed for and rogen receptor ( AR ) and estrogen receptor-beta expression by immunohistochemistry . At 6 mo , consumption of SPI+ significantly suppressed AR expression but did not alter estrogen receptor-beta expression or circulating hormones . Consumption of SPI- significantly increased estradiol and and rostenedione concentrations , and tended to suppress AR expression ( P = 0.09 ) . Although the effects of SPI- consumption on estradiol and and rostenedione are difficult to interpret and the clinical relevance is uncertain , these data show that AR expression in the prostate is suppressed by soy protein isolate consumption , which may be beneficial in preventing prostate cancer OBJECTIVES Epidemiological studies have shown significant relationships between the use of dietary components and prostate cancer incidence and mortality . Large studies of primary prevention , which confirm these findings , are desirable but costly and difficult to design . The present tertiary prevention study reports on the effect of a dietary supplement in comparison with placebo on the rate of increase of prostate-specific antigen ( PSA ) . METHODS 49 patients with a history of prostate cancer and rising PSA levels after radical prostatectomy ( n = 34 ) or radiotherapy ( n = 15 )
Output:
| Although conclusive evidence is limited , the current data are indicative that a diet low in fat , high in vegetables and fruits , and avoiding high energy intake , excessive meat , excessive dairy products and calcium intake , is possibly effective in preventing PC .
The dietary recommendations for patients diagnosed with PC are similar to those aim ing to reduce their risk of PC |
MS210353 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: A prospect i ve analysis of patients hospitalized with pneumococcal infection at two Rochester ( NY ) hospitals was performed during an 18-month period to assess the feasibility of a pneumococcal vaccination program directed at in patients . Of the 113 patients hospitalized with pneumococcal infection , only nine patients ( 8 % ) had previously received pneumococcal vaccine and 76 patients ( 67 % ) had been hospitalized at least once in the previous three years . Of the 104 patients who had a source of regular medical care , 100 % had made at least one outpatient visit in the previous three years . The association between the acquisition of a serious pneumococcal infection and hospitalization within the previous three years suggests that a vaccination strategy directed at hospitalized high-risk patients would be potentially effective . Also , vaccination of high-risk ambulatory patients remains a viable strategy to prevent serious pneumococcal infection Pneumococcal vaccine effectiveness was assessed in a r and omized trial among 1,686 old people ( mean age : 74 , st and ard deviation : 4 years ) living in 24 geriatric hospitals and 26 homes for the aged in our district ; 937 were vaccinated with Merck-Sharp and Dohme pneumococcal vaccine ( 14 serotypes ) . The 749 others composed the reference group . This study was performed during 2 years , since December 1980 . Both groups were r and omized after a two- criteria stratification : by clinical risk assessed before the study , and by type of homes for the aged . Forty pneumonias were diagnosed , with 13 proved pneumococcal etiology . The incidence of pneumonia was significantly reduced in the vaccinated group ( p less than 10(-4 ) but the mortality rate was not modified . We concluded in favor of the effectiveness of pneumococcal vaccine : etiological fraction 77.1 % ( 51.2%-89.3 % confidence limits , 95 % risk ) in the population we studied . The incidence of pneumococcal-proved pneumonia was not significantly reduced CONTEXT Many groups have developed guidelines to shorten hospital length of stay in pneumonia in order to decrease costs , but the length of time until a patient hospitalized with pneumonia becomes clinical ly stable has not been established . OBJECTIVE To describe the time to resolution of abnormalities in vital signs , ability to eat , and mental status in patients with community-acquired pneumonia and assess clinical outcomes after achieving stability . DESIGN Prospect i ve , multicenter , observational cohort study . SETTING Three university and 1 community teaching hospital in Boston , Mass , Pittsburgh , Pa , and Halifax , Nova Scotia . PATIENTS Six hundred eighty-six adults hospitalized with community-acquired pneumonia . MAIN OUTCOME MEASURES Time to resolution of vital signs , ability to eat , mental status , hospital length of stay , and admission to an intensive care , coronary care , or telemetry unit . RESULTS The median time to stability was 2 days for heart rate ( < or = 100 beats/min ) and systolic blood pressure ( > or = 90 mm Hg ) , and 3 days for respiratory rate ( < or = 24 breaths/min ) , oxygen saturation ( > or = 90 % ) , and temperature ( < or = 37.2 degrees C [ 99 degrees F ] ) . The median time to overall clinical stability was 3 days for the most lenient definition of stability and 7 days for the most conservative definition . Patients with more severe cases of pneumonia at presentation took longer to reach stability . Once stability was achieved , clinical deterioration requiring intensive care , coronary care , or telemetry monitoring occurred in 1 % of cases or fewer . Between 65 % to 86 % of patients stayed in the hospital more than 1 day after reaching stability , and fewer than 29 % to 46 % were converted to oral antibiotics within 1 day of stability , depending on the definition of stability . CONCLUSIONS Our estimates of time to stability in pneumonia and explicit criteria for defining stability can provide an evidence -based estimate of optimal length of stay , and outline a clinical ly sensible approach to improving the efficiency of inpatient management OBJECTIVE To study the effect of a length of stay practice guideline on patient outcomes . DESIGN A prospect i ve , nonr and omized , interventional trial . SETTING Six geographically distributed hospitals . PATIENTS Two hundred forty-two consecutively hospitalized " low-risk " patients with pneumonia . MEASUREMENTS AND RESULTS One hundred fifty-two patients ( 63 % ) completed the mailed postdischarge survey and were included in the analysis . Data were prospect ively collected for 85 patients from the baseline observation period ( B ) and 67 patients from the intervention period ( I ) . During the I , case managers provided physicians with patient risk information based on guideline recommendations . There was no significant change in guideline compliance ( B vs I : 76.5 % vs 83.6 % ; p=0.32 ) or length of stay ( B vs I : 3.5 days [ 95 % confidence interval , 3.2 to 3.8 ] vs 3.6 days [ 95 % confidence interval , 3.3 to 4.0 ] ) . Also , there were no statistically significant effects of the intervention on patient outcomes , care following hospital discharge , and patient satisfaction scores . CONCLUSION Patients in this study often had shorter lengths of stay than recommended by the practice guideline . This suggests that the external environment may have had a greater effect on physician behavior and length of stay than the practice guideline itself . Moreover , it demonstrates the importance of continuous assessment of physician practice s immediately prior to , during , and after application of the clinical practice guideline This study compared three interventions design ed to increase acceptance of influenza and pneumococcal vaccines among elderly hospitalized patients . All individuals 65 and older able to give informed consent ( 73 patients ) who were admitted to one medical floor of an acute care hospital were r and omized to one of three groups . All groups received informational pamphlets explaining influenza and pneumococcal disease , their respective vaccines , and indications for their use . The first group received pamphlets only , the second received nursing follow-up , and the third received trained volunteer follow-up . Patients on another medical floor served as controls . The results showed a significant improvement in vaccine acceptance in all three study groups compared to controls for both influenza ( 78 % vs 0 % ) and pneumococcal ( 75 % vs 0 % ) vaccines . The differences among the three groups were not significant . No significant differences were found among patients accepting or refusing vaccination with regard to diagnosis , age , length of stay , sex , or having a private physician . We conclude that a simple educational program followed by offering vaccination before hospital discharge can be easily implemented , and dramatically increase immunization rates in this high risk group CONTEXT Large variations exist among hospitals in the use of treatment re sources for community-acquired pneumonia ( CAP ) . Lack of a common approach to the diagnosis and treatment of CAP has been cited as an explanation for these variations . OBJECTIVE To determine if use of a critical pathway improves the efficiency of treatment for CAP without compromising the well-being of patients . DESIGN Multicenter controlled clinical trial with cluster r and omization and up to 6 weeks of follow-up . SETTING Nineteen teaching and community hospitals in Canada . PATIENTS A total of 1743 patients with CAP presenting to the emergency department at 1 of the participating institutions between January 1 and July 31 , 1998 . INTERVENTION Hospitals were assigned to continue conventional management ( n = 10 ) or implement the critical pathway ( n = 9 ) , which consisted of a clinical prediction rule to guide the admission decision , levofloxacin therapy , and practice guidelines . MAIN OUTCOME MEASURES Effectiveness of the critical pathway , as measured by health-related quality of life on the Short-Form 36 Physical Component Summary ( SF-36 PCS ) scale at 6 weeks ; and re source utilization , as measured by the number of bed days per patient managed ( BDPM ) . RESULTS Quality of life and the occurrence of complications , readmission , and mortality were not different for the 2 strategies ; the 1-sided 95 % confidence limit of the between-group difference in the SF-36 PCS change score was 2.4 points , which was within a predefined 3-point boundary for equivalence . Pathway use was associated with a 1.7-day reduction in BDPM ( 4.4 vs 6.1 days ; P = .04 ) and an 18 % decrease in the admission of low-risk patients ( 31 % vs 49 % ; P = .01 ) . Although in patients at critical pathway hospitals had more severe disease , they required 1.7 fewer days of intravenous therapy ( 4.6 vs 6.3 days ; P = .01 ) and were more likely to receive treatment with a single class of antibiotic ( 64 % vs 27 % ; P<.001 ) . CONCLUSION In this study , implementation of a critical pathway reduced the use of institutional re sources without causing adverse effects on the well-being of patients BACKGROUND Vaccination rates for healthy senior citizens are lower than those for senior citizens with underlying medical conditions such as chronic heart or lung disease . Uncertainty about the benefits of influenza vaccination for healthy senior citizens may contribute to lower rates of utilization in this group . OBJECTIVE To clarify the benefits of influenza vaccination among low-risk senior citizens while concurrently assessing the benefits for intermediate- and high-risk senior citizens . METHODS All elderly members of a large health maintenance organization were included in each of 6 consecutive study cohorts . Subjects were grouped according to risk status : high risk ( having heart or lung disease ) , intermediate risk ( having diabetes , renal disease , stroke and /or dementia , or rheumatologic disease ) , and low risk . Outcomes were compared between vaccinated and unvaccinated subjects after controlling for baseline demographic and health characteristics . RESULTS There were more than 20000 subjects in each of the 6 cohorts who provided 147551 person-periods of observation . The pooled vaccination rate was 60 % . There were 101 619 person-periods of observation for low-risk subjects , 15 482 for intermediate-risk , and 30 450 for high-risk subjects . Vaccination over the 6 seasons was associated with an overall reduction of 39 % for pneumonia hospitalizations ( P<.001 ) , a 32 % decrease in hospitalizations for all respiratory conditions ( P<.001 ) , and a 27 % decrease in hospitalizations for congestive heart failure ( P<.001 ) . Immunization was also associated with a 50 % reduction in all-cause mortality ( P<.001 ) . Within the risk subgroups , vaccine effectiveness was 29 % , 32 % , and 49 % for high- , intermediate- , and low-risk senior citizens for reducing hospitalizations for pneumonia and influenza ( for high and low risk , P < or = .002 ; for intermediate risk , P = .11 ) . Effectiveness was 19 % , 39 % , and 33 % ( for each , P < or = .008 ) , respectively , for reducing hospitalizations for all respiratory conditions and 49 % , 64 % , and 55 % for reducing deaths from all causes ( for each , P<.001 ) . Vaccination was also associated with direct medical care cost savings of $ 73 per individual vaccinated for all subjects combined ( P = .002 ) . Estimates of cost savings within each risk group suggest that vaccination would be cost saving for each subgroup ( range of cost savings of $ 171 per individual vaccinated for high risk to $ 7 for low risk ) , although within the subgroups these findings did not reach statistical significance ( for each , P > or = .05 ) . CONCLUSIONS This study confirms that healthy senior citizens as well as senior citizens with underlying medical conditions are at risk for the serious complications of influenza and benefit from vaccination . All individuals 65 years or older should be immunized with this vaccine Since the introduction of the prospect i ve payment system ( PPS ) , anecdotal evidence has accumulated that patients are leaving the hospital " quicker and sicker . " We developed valid measures of discharge impairment and measured these levels in a nationally representative sample of patients with one of five conditions prior to and following the PPS implementation . Instability at discharge ( important clinical problems usually first occurring prior to discharge ) predicted the likelihood of postdischarge deaths . At 90 days postdischarge , 16 % of patients discharged unstable were dead vs 10 % of patients discharged stable . After the PPS introduction , instability increased primarily among patients discharged home . Prior to the PPS , 10 % of patients discharged home were unstable ; after the PPS was implemented , 15 % were discharged unstable , a 43 % relative change . Efforts to monitor the effect of this increase in discharge instability on health should be implemented OBJECTIVE To compare three approaches for improving compliance with influenza and pneumococcal vaccination of elderly patients . DESIGN R and omized controlled trial using three parallel group practice s at a public urban teaching hospital . SETTING Public teaching hospital . SUBJECTS All patients 65 years of age and older ( n = 1202 ) seen by resident physicians ( n = 66 ) attending three ambulatory medical practice s from October 1 , 1989 to March 31 , 1990 . INTERVENTIONS All three provider groups received intensive education in immunization st and ards . The control group received no further intervention . Staff in the second group offered education to patients at their visits . In the third group , the prevention team , a flowsheet was used , patient education offered , and staff had their tasks redefined to facilitate compliance ; for vaccinations , eg , nurses could vacc
Output:
| The systematic review ( 22 ) found that interventions aim ed at hospitalized patients may have the greatest effect on increasing influenza vaccinations .
The Advisory Committee on Immunization Practice s recommendation , which is based on an informal review of the literature , identifies st and ing orders as the most effective method to increase pneumococcal vaccination rates .
Quality Indicator 5 Influenza Vaccination of Health Care Workers IF a health care organization cares for vulnerable elders , THEN it should have a formal plan to offer and encourage influenza vaccination among its employees BECAUSE vaccination of health care workers is associated with reductions in total patient mortality and in the incidence of influenza-like illness .
Results of this study support recommendations for influenza vaccination of health care workers employed in long-term geriatric care .
Quality Indicator 6 Smoking Cessation IF a vulnerable elder smoker develops pneumonia , THEN the smoker should be advised to quit smoking BECAUSE interventions tailored for such acutely ill patients may increase the rate of long-term cessation of smoking .
This , in turn , may ultimately reduce the risk for developing recurrent pneumonia or other long-term complications of cigarette smoking .
A meta- analysis ( 36 ) and a large observational study , the Pneumonia Patient Outcomes Research Team ( PORT ) cohort study ( 37 ) , support the finding that interventions to advise smokers with pneumonia to quit smoking may increase the rate of long-term cessation of smoking . |
MS210354 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: In spite of current therapies , the overall health status of patients with SLE is poor . High-dose cyclophosphamide ( 50 mg/kg for 4 days ) with or without stem-cell rescue has been introduced as a new therapy for severe SLE , including renal and central nervous system (CNS)-SLE . Long-term durable responses have been found to be 40 % . A r and omised clinical trial was completed comparing high-dose cyclophosphamide with monthly intravenous cyclophosphamide ( 750 mg/m squared bovine serum albumin ) in patients with SLE who need cyclophosphamide for the first time . The primary outcome of the trial was complete clinical response . In this report , we compare the treatment groups with respect to quality of life . The patients in this study had a mean age of 35.3 ± 10.1 years , were of Caucasian ( 35 % ) , African-American ( 51 % ) , Hispanic ( 8 % ) and Asian ( 6 % ) people , and 88 % were women . The organ leading to treatment was renal lupus in 29 % , CNS-lupus in 45 % and other organs in 26 % . Quality of life was measured at each visit using the Medical Outcome Study Short-Form 36 ( SF-36 ) . At 6 months , the patients in the high-dose cyclophosphamide trial arm had significantly greater improvement than patients in the monthly intravenous cyclophosphamide arm ( P = 0.026 ; P = 0.0082 , respectively ) in the categories of general health and social functioning . At 18 months , the improvement in the role-physical score was significantly greater in the high-dose cyclophosphamide trial arm than in the monthly-dose cyclophosphamide arm ( P = 0.025 ) . At the end of the two and a half-year study , there were no significant differences between the groups with respect to changes in SF-36 . By pooling the groups , at 30 months , there was a statistically significant ( P < 0.05 ) improvement over baseline in 6 of the 8 SF-36 domains . This study shows earlier improvement in SF-36 measures at 6 months in the high-dose cyclophosphamide group but equal improvement in both arms at two and one and a half years . Eventual improvements in quality -of-life with both cyclophosphamide regimens are clinical ly meaningful to both patients and treating physicians Objective . To evaluate health-related quality of life ( HRQOL ) and corticosteroid use in patients with moderate to severely active SLE enrolled in two international , multicentre , r and omized controlled trials of epratuzumab ( ALLEVIATE-1 and -2 ) and a long-term extension study ( SL0006 ) . Methods . Ninety ALLEVIATE patients ( 43 % BILAG A , mean BILAG score 13.2 ) were r and omized to receive 360 mg/m2 ( n = 42 ) or 720 mg/m2 ( n = 11 ) epratuzumab or placebo ( n = 37 ) , plus st and ard of care , in 12-week cycles . Corticosteroid use , patient and physician global assessment s of disease activity ( PtGA and PGA ) and 36-item Medical Outcomes Survey Short Form ( SF-36 ) results were recorded at baseline and every 4 weeks . Both trials were prematurely discontinued due to a drug supply interruption ; patients followed for ≥6 months were analysed . Twenty-nine patients continued in SL0006 , with interim analysis at a median exposure of 120 ( range 13–184 ) weeks . Results . At week 12 , proportions of patients with a PGA ≥20 % above baseline or with a PtGA improvement greater than or equal to the minimum clinical ly important difference were higher in the epratuzumab arms than the placebo arm . PGA and PtGA improvements were sustained but did not reach statistical significance . At week 24 , mean cumulative corticosteroid doses with epratuzumab 360 and 720 mg/m2 were 1051 and 1973 mg less than placebo ( P = 0.034 and 0.081 , respectively ) . At week 48 , SF-36 scores approached or exceeded US age- and gender-matched norms in five domains with the 360 mg/m2 treatment . Improvements were maintained in SL0006 over ∼2 years . Conclusion . Epratuzumab treatment produced clinical ly meaningful and sustained improvements in PGA , PtGA and HRQOL and reductions in corticosteroid doses OBJECTIVE B cells are likely to contribute to the pathogenesis of systemic lupus erythematosus ( SLE ) , and rituximab induces depletion of B cells . The Exploratory Phase II/III SLE Evaluation of Rituximab ( EXPLORER ) trial tested the efficacy and safety of rituximab versus placebo in patients with moderately-to-severely active extrarenal SLE . METHODS Patients entered with > or=1 British Isles Lupus Assessment Group ( BILAG ) A score or > or=2 BILAG B scores despite background immunosuppressant therapy , which was continued during the trial . Prednisone was added and subsequently tapered . Patients were r and omized at a ratio of 2:1 to receive rituximab ( 1,000 mg ) or placebo on days 1 , 15 , 168 , and 182 . RESULTS In the intent-to-treat analysis of 257 patients , background treatment was evenly distributed among azathioprine , mycophenolate mofetil , and methotrexate . Fifty-three percent of the patients had > or=1 BILAG A score at entry , and 57 % of the patients were categorized as being steroid dependent . No differences were observed between placebo and rituximab in the primary and secondary efficacy end points , including the BILAG-defined response , in terms of both area under the curve and l and mark analyses . A beneficial effect of rituximab on the primary end point was observed in the African American and Hispanic subgroups . Safety and tolerability were similar in patients receiving placebo and those receiving rituximab . CONCLUSION The EXPLORER trial enrolled patients with moderately-to-severely active SLE and used aggressive background treatment and sensitive cutoffs for nonresponse . No differences were noted between placebo and rituximab in the primary and secondary end points . Further evaluation of patient subsets , biomarkers , and exploratory outcome models may improve the design of future SLE clinical trials Objectives The aim was to evaluate the cross-cultural validity of the Lupus Impact Tracker ( LIT ) in five European countries and to assess its acceptability and feasibility from the patient and physician perspectives . Methods A prospect i ve , observational , cross-sectional and multicentre validation study was conducted in clinical setting s. Before the visit , patients completed LIT , Short Form 36 ( SF-36 ) and care satisfaction question naires . During the visit , physicians assessed disease activity [ Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI ] , organ damage [ SLICC/ACR damage index ( SDI ) ] and flare occurrence . Cross-cultural validity was assessed using the Differential Item Functioning method . Results Five hundred and sixty-nine SLE patients were included by 25 specialists ; 91.7 % were out patients and 89.9 % female , with mean age 43.5 ( 13.0 ) years . Disease profile was as follows : 18.3 % experienced flares ; mean SELENA-SLEDAI score 3.4 ( 4.5 ) ; mean SDI score 0.8 ( 1.4 ) ; and SF-36 mean physical and mental component summary scores : physical component summary 42.8 ( 10.8 ) and mental component summary 43.0 ( 12.3 ) . Mean LIT score was 34.2 ( 22.3 ) ( median : 32.5 ) , indicating that lupus moderately impacted patients ' daily life . A cultural Differential Item Functioning of negligible magnitude was detected across countries ( pseudo- R 2 difference of 0.01 - 0.04 ) . Differences were observed between LIT scores and Physician Global Assessment , SELENA-SLEDAI , SDI scores = 0 ( P < 0.035 ) and absence of flares ( P = 0.004 ) . The LIT showed a strong association with SF-36 physical and social role functioning , vitality , bodily pain and mental health ( P < 0.001 ) . The LIT was well accepted by patients and physicians . It was reliable , with Cronbach α coefficients ranging from 0.89 to 0.92 among countries . Conclusion The LIT is vali date d in the five participating European countries . The results show its reliability and cultural invariability across countries . They suggest that LIT can be used in routine clinical practice to evaluate and follow patient-reported outcomes in order to improve patient-physician interaction Introduction A recent metabolomic screen of sera from patients with Systemic Lupus Erythematosus ( SLE ) found reduction of antioxidants and substrates for energy generation . These metabolic alterations may underlie one of the most common features of SLE - fatigue . The metabolomic studies also noted reduced omega-3 fatty acids , which are powerful anti- oxidants . This deficiency may be causally related to oxidative stress , inflammation , disease activity , and fatigue in SLE . Supplementation of omega-3 fatty acids using fish oil in SLE has been shown to reduce oxidative stress in other studies . The objective of this study is to evaluate the effect of fish oil supplementation on clinical measures of fatigue , quality of life , and disease activity as part of a r and omized clinical trial . Methods Fifty SLE patients recruited in outpatient clinics were r and omized 1:1 to fish oil supplementation or olive oil placebo , and blinded to their treatment group . At baseline and after 6 months of treatment , R AND Short Form-36 ( R AND SF-36 ) , Fatigue Severity Scale ( FSS ) , SLE Disease Activity Index ( SLEDAI ) , and Physician Global Assessment ( PGA ) were completed ; serum was also collected for soluble mediator analysis . Results Thirty-two patients completed the study . PGA improved significantly in the fish oil group compared with the placebo group ( p = 0.015 ) . The R AND SF-36 Energy/fatigue and Emotional well-being scores demonstrated improvement trends ( p = 0.092 and 0.070 ) . No clear difference was seen in FSS and SLEDAI ( p = 0.350 and p = 0.417 ) . Erythrocyte sedimentation rate and serum IL-12 were reduced ( p = 0.008 and p = 0.058 ) ; while serum IL-13 was increased by fish oil supplementation ( p = 0.033 ) . Conclusions In this r and omized , placebo-controlled 6-month trial , SLE patients r and omized to fish oil supplementation demonstrated improvement in their PGA , R AND SF-36 , and some circulating inflammatory markers . Trial registration Clinical Trials.gov Identifier : NCT02021513 ( registered 13 December 2013 ) Introduction This trial evaluated the safety , biologic activity , and pharmacokinetics of belimumab , a fully human monoclonal antibody that inhibits the biologic activity of the soluble form of the essential B-cell survival factor B-lymphocyte stimulator ( BLyS ) in patients with systemic lupus erythematosus ( SLE ) . Methods Seventy patients with mild-to-moderate SLE were enrolled in a phase I , double-blind , r and omized study and treated with placebo ( n = 13 ) or belimumab ( n = 57 ) at four different doses ( 1.0 , 4.0 , 10 , and 20 mg/kg ) as a single infusion or two infusions 21 days apart . Patients were followed for 84 to 105 days to assess adverse events , pharmacokinetics , peripheral blood B-cell counts , serology , and SLE disease activity . Data from the study were summarized using descriptive statistics . χ2 type tests were used to analyze discrete variables . The Kruskal-Wallis test , the Wilcoxon test , and the analysis of covariance were used to analyze the continuous variables , as appropriate . The analysis was performed on all r and omized patients who received study agent . Results The incidences of adverse events and laboratory abnormalities were similar among the belimumab and placebo groups . Belimumab pharmacokinetics were linear across the 1.0 to 20 mg/kg dose range . Long terminal elimination half-life ( 8.5 to 14.1 days ) , slow clearance ( 7 ml/day per kg ) , and small volume of distribution ( 69 to 112 ml/kg ) were consistent with a fully human antibody . Significant reductions in median percentages of CD20 + B cells were observed in patients treated with a single dose of belimumab versus placebo ( day 42 : P = 0.0042 ; and day 84 : P = 0.0036 ) and in patients treated with two doses of belimumab versus placebo ( day 105 : P = 0.0305 ) . SLE disease activity did not change after one or two doses of belimumab . Conclusions Belimumab was well tolerated and reduced peripheral B-cell levels in SLE patients . These data support further studies of belimumab in autoimmune disorders . Trial Registration NCT0
Output:
| All measures had good convergent and discriminant validity .
PROMIS provided the strongest evidence for known-group validity and reliability among generic instruments ; however , data on its responsiveness have not been published .
Across measures , st and ardised response means were generally indicative of poor-moderate sensitivity to longitudinal change .
In RCTs , clinical ly important improvements were reported in SF36 scores from baseline ; however , between-arm differences were frequently non-significant and non-important .
SF36 , PROMIS , LupusQoL and LIT had the strongest evidence for acceptable measurement properties , but few measures aside from the SF36 have been incorporated into clinical trials . |
MS210355 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Substantial progress has been made in the awareness , treatment , and prevention of cardiovascular disease ( CVD ) in women since the first women-specific clinical recommendations for the prevention of CVD were published by the American Heart Association ( AHA ) in 1999.1 The myth that heart disease is a “ man 's disease ” has been debunked ; the rate of public awareness of CVD as the leading cause of death among US women has increased from 30 % in 1997 to 54 % in 2009.2 The age-adjusted death rate result ing from coronary heart disease ( CHD ) in females , which accounts for about half of all CVD deaths in women , was 95.7 per 100 000 females in 2007 , a third of what it was in 1980.3,4 Approximately 50 % of this decline in CHD deaths has been attributed to reducing major risk factors and the other half to treatment of CHD including secondary preventive therapies.4 Major r and omized controlled clinical trials such as the Women 's Health Initiative have changed the practice of CVD prevention in women over the past decade.5 The investment in combating this major public health issue for women has been significant , as have the scientific and medical achievements . Despite the gains that have been made , considerable challenges remain . In 2007 , CVD still caused ≈1 death per minute among women in the United States.6 These represent 421 918 deaths , more women 's lives than were cl aim ed by cancer , chronic lower respiratory disease , Alzheimer disease , and accidents combined.6 Reversing a trend of the past 4 decades , CHD death rates in US women 35 to 54 years of age now actually appear to be increasing , likely because of the effects of the obesity epidemic.4 CVD rates in the United States are significantly higher for black females compared with their white counterparts ( 286.1/100 000 versus We reported previously that two otherwise identical training programs at lower ( LI ) and higher intensity ( HI ) similarly reduced resting systolic blood pressure ( BP ) by approximately 4 - 6 mmHg . Here , we determined the effects of both programs on BP-regulating mechanisms , on biomarkers of systemic inflammation and prothrombotic state and on the heart . In this cross-over study ( 3 × 10 weeks ) , healthy participants exercised three times 1 h/week at , respectively , 33 % and 66 % of the heart rate ( HR ) reserve , in a r and om order , with a sedentary period in between . Measurements , performed at baseline and at the end of each period , involved blood sampling , HR variability , systolic BP variability ( SBPV ) and cardiac magnetic resonance imaging . Thirty-nine participants ( 18 men ; mean age 59 years ) completed the study . Responses were not different between both programs ( P>0.05 ) . Pooled data from LI and HI showed a reduction in HR ( -4.3 ± 8.1 % ) and an increase in stroke volume ( + 11 ± 23.1 % ) . No significant effect was seen on SBPV , plasma renin activity , basal nitric oxide and left ventricular mass . Our results suggest that the BP reduction observed appears to be due to a decrease in systemic vascular resistance ; training intensity does not significantly affect the results on mechanisms , biomarkers and the heart Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P < 0.001 ] , observers 1 and 3 ( ICC = 0.96 , 95 % CI 0.89–0.98 , P < 0.001 ) and observers 2 and 3 ( ICC = 0.91 , 95 % CI 0.75–0.96 , P < 0.001 ) . Conclusions : The TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more No previous studies have examined the effects of isometric training intensity upon resting blood pressure ( BP ) . The aims of this study were ( a ) to compare the effects of leg isometric training , performed at two intensities , upon resting systolic-SBP , diastolic-DBP and mean arterial-MAP BP ; and ( b ) to examine selected cardiovascular variables , in an attempt to explain any changes in resting BP following training . Thirty-three participants were r and omly allocated to either control , high- ( HI ) or low-intensity ( LI ) training for 8 weeks . Participants performed 4 × 2 min exercise bouts 3 × weekly . Resting BP was measured at baseline , 4-weeks and post-training . SBP , DBP and MAP fell significantly in both groups after training . Changes were –5.2 ± 4.0 , –2.6 ± 2.9 and –2.5 ± 2.2 mmHg [ HI ] ; –3.7 ± 3.7 , –2.5 ± 4.8 and –2.6 ± 2.5 mmHg [ LI ] for SBP , DBP and MAP , respectively . There were no significant changes in BP at 4 weeks . No significant changes were observed in any of the other cardiovascular variables examined . These findings suggest that isometric training causes reductions in SBP , DBP and MAP at a range of exercise intensities , when it is performed over 8 weeks . Furthermore , it is possible to reduce resting BP using a much lower isometric exercise intensity than has previously been shown Objectives Isometric h and grip ( IHG ) training ( four , 2-min sustained contractions at 30 % of maximal voluntary contraction , three times per week for 8–10 weeks ) lowers resting arterial blood pressure ( BP ) in hypertensive patients , including those receiving pharmacotherapy , although the mechanisms remain elusive . Ambulatory BP measurements are more efficacious in predicting cardiovascular disease-related events , yet the effects of IHG training on ambulatory BP are unknown . The objective of the current investigation was to test the hypotheses that 8 weeks of IHG training lowers resting and 24 h ambulatory BP concomitantly in medicated hypertensive patients , and may be the result of improved vagal modulation . Methods BP was assessed using brachial artery oscillometry , and coarse-graining spectral analysis was used to determine spectral power . Resting and 24 h ambulatory BP and heart rate variability ( HRV ) were measured pretraining , midtraining , and post-training in 11 medicated hypertensive patients ( mean±SD , resting BP : 113.9±12.7/60.7±11.6 mmHg ) , and in nine medicated hypertensive controls ( resting BP : 117.8±14.3/67.5±4.2 mmHg ) . Results Indices of BP and HRV were not significantly altered with IHG training ( all P>0.05 ) . Conclusion IHG training does not lower resting or ambulatory BP in hypertensive patients successfully treated with pharmacotherapy to within the normal range ( ⩽120/80 mmHg ) , nor does it improve HRV . Future studies should examine alternative IHG training protocol s in well-managed hypertensive patients and /or target poorly controlled medicated hypertensive patients Abstract To reduce resting blood pressure , a minimum isometric exercise training ( IET ) intensity has been suggested , but this is not known for short-term IET programmes . We therefore compared the effects of moderate- and low-intensity IET programmes on resting blood pressure . Forty normotensive participants ( 22.3 ± 3.4 years ; 69.5 ± 15.5 kg ; 170.2 ± 8.7 cm ) were r and omly assigned to groups of differing training intensities [ 20%EMGpeak ( ~23%MVC , maximum voluntary contraction , or 30%EMGpeak ( ~34%MVC ) ] or control group ; 3 weeks of IET at 30%EMGpeak result ed in significant reductions in resting mean arterial pressure ( e.g. −3.9 ± 1.0 mmHg , P < 0.001 ) , whereas 20%EMGpeak did not ( −2.3 ± 2.9 mmHg ; P > 0.05 ) . Moreover , after pooling all female versus male participants , IET induced a 6.9-mmHg reduction in systolic blood pressure in female participants , but only a 1.5-mmHg reduction in systolic blood pressure in male participants , although the difference was not significant . An IET intensity between 20%EMGpeak and 30%EMGpeak is sufficient to elicit significant resting blood pressure reductions in a short-term training period ( 3 weeks ) . In addition , sexual dimorphism may exist in the magnitude of reductions , but further work is required to confirm this possibility , which could be important in underst and ing the mechanisms responsible PURPOSE Research has demonstrated the efficacy of isometric h and grip ( IHG ) training to attenuate resting blood pressure . These studies have relied on the use of programmable digital h and grips for training . This study aim ed to determine the effectiveness of simple , inexpensive spring-loaded h and grip devices in producing hypotensive effects . METHODS The study was a r and omized controlled trial of 49 normotensive participants ( 66.4 ± 0.9 years ; 57 % women ) . Participants in the exercise group ( n = 25 ) trained and had blood pressure measured twice weekly for 8 weeks . Control participants ( n = 24 ) completed weekly blood pressure measurements . Pre- and posttraining measurements were each assessed over 3 visits . Statistical analysis of the pre-post data involved analyses of variance and hierarchical linear modeling was used to examine changes over time . RESULTS Following 8 weeks , IHG participants demonstrated significant reductions in resting blood pressure . Systolic and diastolic blood pressures were reduced from 122 ± 3 mm Hg to 112 ± 3 mm Hg ( P < .001 ) and from 70 ± 1 mm Hg to 67 ± 1 mm Hg ( P < .05 ) , respectively . Hierarchical linear modeling analysis also revealed a significant cross-level ( ie , group ÷ time ) interaction , with an estimated reduction in systolic blood pressure of 5.4 mm Hg ( P < .001 ) over the training period in the IHG group . CONCLUSIONS In agreement with previous studies , IHG training reduced resting arterial pressure following 8 weeks of training . Hypotensive effects linked to IHG training may be achieved using simple , inexpensive spring h and grip training devices and may provide a convenient and affordable therapeutic alternative or adjunctive therapy for lowering blood pressure PURPOSE This study examined the effects of isometric h and grip training on resting arterial blood pressure , heart rate variability , and blood pressure variability in older adults with hypertension . METHODS Nine subjects performed four 2-min isometric h and grip contractions at 30 % of the maximum voluntary contraction force , 3 d.wk(-1 ) for 10 wk , and eight subjects served as controls . RESULTS After training , there was a significant reduction in resting systolic pressure and mean arterial pressure . In addition , power spectral analysis of heart rate variability demonstrated that the low frequency : high frequency area ratio tended to decrease . CONCLUSIONS It is concluded that isometric training at a moderate intensity elicits a hypotensive response and a simultaneous increase in vagal modulation in older adults with hypertension Abstract In this study , we examined the correlations between selected markers of isometric training intensity and subsequent reductions in resting blood pressure . Thirteen participants performed a discontinuous incremental isometric exercise test to volitional exhaustion at which point mean torque for the final 2-min stage ( 2min-torquepeak ) and peak heart rate peak ( HRpeak ) were identified . Also , during 4 weeks of training ( 3 sessions per week , comprising 4 × 2 min bilateral leg isometric exercise at 95 % HRpeak ) , heart rate ( HRtrain ) , torque ( Torquetrain ) , and changes in EMG amplitude ( ΔEMGamp ) and frequency ( ΔEMGfreq ) were determined . The markers of training intensity were : Torquetrain relative to the 2min-torquepeak ( % 2min-torquepeak ) , EMG relative to EMGpeak ( % EMGpeak ) , HRtrain ΔEMGamp , ΔEMGfreq , and % MVC . Mean systolic ( −4.9 mmHg ) and arter
Output:
| Our study indicated that IRT lowers SBP , DBP and MAP .
The magnitude of effect may be larger in hypertensive males aged ⩾45 years , using unilateral arm IRT for > 8 weeks |
MS210356 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary In a bid to minimise dosage and possible side-effects when relieving post episiotomy pain , the NSAID Indomethacin was studied in combination with a systemic haemostat Ethamsylate which has been shown to selectively inhibit some prostagl and ins . Comparative groups also took Indomethacin alone and placebo in a double blind non-crossover comparison . Efficacy was judged in terms of side-effects and assessment s of pain intensity , pain relief and global assessment of pain . There was some evidence of a beneficial interaction between Indomethacin and Ethamsylate when adjustments were made for the patient ’s age and initial pain score . Side-effects were most common in the combination therapy group Meclofenamate sodium , a nonsteroidal anti-inflammatory drug with proven analgesic effects , was compared at two dose levels ( 200 mg and 100 mg ) with codeine ( 60 mg ) and placebo in a double-blind , r and omized study of 327 women experiencing episiotomy pain after normal delivery . Meclofenamate sodium at either dose was significantly better than codeine or placebo in reducing pain intensity and increasing pain relief , and it had a longer duration of action . Adverse effects were minimal , and their frequency did not differ significantly among treatment groups . Meclofenamate sodium appears to be as safe as and more effective than codeine for the management of episiotomy pain OBJECTIVE The study was carried out to compare the analgesic effect of diclofenac sodium and indomethacin suppositories for management of right mediolateral episiotomy repair . METHOD A total of 70 patients who gave birth vaginally with right mediolateral episitomy were r and omly assigned to receive 100 mg diclofenac sodium suppositories/day ( G1 , n = 35 ) or 100 mg indomethacin supposotories/day ( G2 , n = 35 ) after episiotomy repair and postpartum for three days . Pain ratings were recorded before , the first hour and 24 hours after medication . The verbal rating scale ( VRS ) and visual analog scale ( VAS ) were used for pain recording . The independent T test , Mann-Whitney U and Wilcoxon rank test were used for statistical analysis and Spearman correlation analysis was used for comparison between VRS and VAS . RESULTS Diclofenac sodium was a more effective analgesic than indomethacin suppositories for right mediolateral episiotomy pain . For G1 the first hour VRS was 2.6 + /- 0.5 points and VAS 4.9 + /- 0.8 points ; for G2 the first hour VRS was 3.4 + /- 0.6 points VAS 6.6 + /- 1.2 points ; this difference was statistically significant ( p < 0.05 , Mann-Whitney U test ) . For G1 at the 24th hour VRS was 1.2 + /- 0.4 points and VAS 2.4 + /- 0.9 points ; for G2 at the 24th hour VRS was 2 + /- 0.7 points and VAS was 3.4 + /- 1.3 points ; the difference was statistically significant ( p < 0.05 , Mann-Whitney U test ) . The first and 24th hour pain scores ( VAS1-VAS24 , VRS1-VRS24 ) were decreased dramatically for both groups ( p < 0.05 , Wilcoxon rank test ) . A positive correlation was obtained between the first and 24th hour VRS and VAS by Spearman correlation analysis ( r(s ) = 0.9 , n = 70 , p = 0.000 ) . CONCLUSION The two analgesics were effective after episiotomy repair , however diclofenac sodium suppositories may be the preferred choice because they were more effective One hundred and ten patients who had episiotomies to aid normal vaginal delivery without epidural analgesia were = allocated at r and om to receive either diclofenac ( n = 56 ) or = placebo ( n = 54 ) suppositories . Pain after episiotomy was assessed at 24 and 48 hours using a combination of a visual analogue scale , a modified pain score and a review of additional analgesia required . All patients in both groups were allowed routine hospital analgesia on request . Our data suggests that very few patients suffered severe pain , even in the placebo group . However , the prophylactic use of diclofenac suppositories significantly reduced perineal pain in the first 24 hours , although the difference was less marked by 48 hours . Overall additional analgesia requirement was correspondingly less in the diclofenac group Objective To determine if diclofenac suppositories administered prophylactically produce effective A double-blind , placebo-controlled trial was carried out in 299 patients suffering from post-episiotomy pain to compare the analgesic effectiveness and tolerance of single doses of 500 mg dipyrone and 500 mg paracetamol . Assessment s of pain relief over a 6-hour period showed that dipyrone produced significantly better results than placebo within half an hour of intake and maintained this superiority throughout the 6 hours . It also afforded consistently better pain relief than paracetamol and was significantly more effective at the 6-hour assessment . Side-effects were few and mild Background : Pain is a worldwide problem that often originates from disease process , and diagnostic and treatment procedures such as surgical operations . Objectives : This trial was performed to compare the effectiveness of two analgesics for the management of perineal pain caused by episiotomy . Material s and Methods : A total of 170 nulliparous women who gave birth vaginally with episiotomy between March 2009 and November 2010 were r and omly assigned to receive either ibuprofen or celecoxib which were given orally every 6 or 12 hours , respectively . Pain levels were measured before the intervention , and at 1 , 2 , 4 , 8 and 12 hours after providing the first dose on a 10-cm visual analogue scale . Results : The results showed that the two groups had no significant differences regarding demographic characteristics , maternal , neonatal , and post-delivery factors , and mean premedication pain severity . Means of pain severity were different between the two groups as patients in the celecoxib group had lower means than the other group at 1,2,4,8 and 12 hours ( 4.01 ± 1.8 vs. 4.46 ± 1.9 , 3.17 ± 1.9 vs. 3.79 ± 1.7 , 2.89 ± 1.3 vs. 2.96 ± 1.5 , 2.19 ± 1.8 vs. 2.55 ± 1.4 , and 1.98 ± 1.1 vs. 2.45 ± 1.2 , respectively ) after administration of analgesics . Conclusions : Patients who received celecoxib had lower VAS in comparison with others . Although these differences were not significant , as celecoxib has longer half-life , fewer upper GI symptoms , and is better tolerated based on the previous studies , and this study is in favor of using it OBJECTIVES To evaluate efficacy of ibuprofen compared with acetaminophen for relief of perineal pain after childbirth , side effects of ibuprofen compared with acetaminophen and patient satisfaction in treatment between the 2 groups . MATERIAL AND METHOD A total of 210 women who gave birth by spontaneous vaginal delivery with mediolateral episiotomy between June 2006 and November 2006 were r and omly assigned to receive either ibuprofen ( 400 mg ) ( n = 106 ) or acetaminophen ( 1000 mg ) ( n = 104 ) , both given orally when suturing was completed . Pain ratings were recorded before the treatment and at 1 , 2 , 3 and 4 hours after the treatment on a 10-cm visual analogue scale . Side effects and patient satisfaction were assessed at 24 hours . RESULTS Pain in the ibuprofen group was considerably more reduced than the acetaminophen group at 1 hour of treatment ( mean pain rating 2.18 vs. 2.88 , respectively ; p < 0.003 ) . Even though , at 2 , 3 and 4 hours of treatment ibuprofen seemed to give more reliefof pain than acetaminophen , they did not reach statistically significant differences ( mean pain rating ; at 2 hour : 1.59 vs. 1.97 , p = 0.093 ; at 3 hour : 1.08 vs. 1.31 , p = 0.183 ; and at 4 hour : 0.69 vs. 0.85 , p = 0.169 ; respectively ) . There were no side effects and no significant differences in overall patient satisfaction between the two groups . CONCLUSION Ibuprofen was consistently better than acetaminophen at 1 hour after treatment for relief of perineal pain after childbirth without any side effects . After 2 hours , ibuprofen and acetaminophen had similar analgesic properties Our purpose was to evaluate the analgesic efficacy of single oral doses of ketoprofen 25 , 50 , and 100 mg compared with aspirin 650 mg and placebo in the relief of moderate to severe postepisiotomy , uterine cramping , or cesarean section pain . One hundred and fifty-six patients participated in a r and omized , double-blind , stratified , parallel-group study . They were observed over a six-hour period by one nurse-observer . Several of the st and ard summary measures of analgesia were derived from the interview data , including the sum of pain intensity differences ( SPID ) and the sum of the hourly relief values ( TOTAL ) . The study showed significant differences between aspirin and placebo for four-hour SPID and several other parameters and between ketoprofen at all dose levels and placebo for the four- and six-hour SPID and many other parameters . The two higher doses of ketoprofen were significantly more effective than aspirin as as assessed by the four- and six-hour SPID , TOTAL , and other summary measures . The low dose of ketoprofen , although not significantly different from aspirin for SPID and TOTAL , showed a significantly faster onset of relief and had a better global rating . This study suggests that 50 mg of ketoprofen may be the clinical dose of choice as an analgesic . There were no adverse effects reported The analgesic activity of 300 and 600 mg . of flufenisal , a fluorinated phenyl derivative of aspirin , was compared to 600 and 1,200 mg . of aspirin and to placebo under r and omized double‐blind conditions in 100 patients with pain due to episiotomy . Over the 8 hours of evaluation , pain reduction greater than 50 per cent was observed in at least 60 per cent of patients treated with both doses of flufenisal , whereas it was 40 per cent with 600 mg . of aspirin , 55 per cent with 1,200 mg . of aspirin , and 26 per cent with placebo . On a time‐effect basis with the two grade d doses of both flufenisal and aspirin , pain relief , as measured by pain intensity differences , was similar with respect to time of onset and maximal effect attained . However , with the flufenisal significant analgesia persisted at the eighth hour ( p < 0.02 ) , while with the aspirin there was none after the fifth hour . On the basis of these data , flufenisal at one fourth to one half the dose of aspirin appears to provide analgesia of almost double the duration of aspirin and is equivalent to aspirin in time of onset and degree of relief of episiotomy pain . This raises the possibility that in some clinical conditions flufenisal may be effective in providing prolonged pain relief A double-blind , r and omised placebo-controlled study was carried out to assess the efficacy of indometacin suppositories as a post-episiotomy analgesic . Thirty patients received 2 X 100 mg indometacin suppositories , and 30 patients received placebo suppositories within 15 min of an episiotomy repair operation . Local infiltration of the episiotomy incision was performed using 20 ml of 0.5 % lignocaine in every case . Subjective symptoms of pain were evaluated 15 , 30 , 60 and 90 min post-episiotomy repair . Average numbers of hours as lying in patients after delivery is 4 h. None of the patients who received indometacin complained of post-episiotomy pain ; whereas the patients on placebo manifested varying degrees of pain To determine the efficacy and safety of 2 inexpensive and easily deliverable antiretroviral ( ARV ) regimens for the prevention of mother-to-child transmission ( MTCT ) of human immunodeficiency virus ( HIV ) type 1 during labor and delivery , HIV-infected pregnant women were screened at 11 maternity health institutions in South Africa and were enrolled in an open-label short course ARV regimen of either nevirapine ( Nvp ) or multiple-dose zidovudine and lamivudine ( Zdv/3TC ) . The overall estimated HIV-1 infection rates in 1307 infants by 8 weeks were 12.3 % ( 95 % confidence interval [ CI ] , 9.7 - 15.0 ) for Nvp and 9.3 % ( 95 % CI , 7.0 - 11.6 ) for Zdv/3TC ( P=.11 ) . Excluding infections detected within 72 h ( intrauterine ) , new HIV-1 infections were detected in 5.7 % ( 95 % CI , 3.7 - 7.8 ) and 3.6 % ( 95 % CI , 2
Output:
| Neonatal adverse effects were not assessed in any of the included studies .Comparisons of different NSAIDs and different doses of the same NSAID did not demonstrate any differences in their effectiveness on any of the primary outcome measures ; however , few data were available on some NSAIDs .
In women who are not breastfeeding and who sustained perineal trauma , NSAIDs ( compared to placebo ) provide greater pain relief for acute postpartum perineal pain and fewer women need additional analgesia when treated with a NSAID . |
MS210357 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Efficacy and safety of protein kinase C inhibitor sotrastaurin ( STN ) with tacrolimus ( TAC ) was assessed in a 24‐month , multicenter , phase II study in de novo liver transplant recipients . A total of 204 patients were r and omized ( 1:1:1:1 ) to STN 200 mg b.i.d . + st and ard‐exposure TAC ( n = 50 ) or reduced‐exposure TAC ( n = 52 ) , STN 300 mg b.i.d . + reduced‐exposure TAC ( n = 50 ) , or mycophenolate mofetil ( MMF ) 1 g b.i.d . + st and ard‐exposure TAC ( control , n = 52 ) ; all with steroids . Owing to premature study termination , treatment comparisons were only conducted for Month 6 . At Month 6 , composite efficacy failure rates ( treated biopsy‐proven acute rejection episodes of Banff grade ≥1 , graft loss , or death ) were 25.0 % , 16.5 % , 20.9 % and 15.9 % for STN 200 mg + st and ard TAC , STN 200 mg + reduced TAC , STN 300 mg + reduced TAC and control groups , respectively . Median estimated glomerular filtration rates were 84.0 , 83.3 , 81.1 and 75.3 mL/min/1.73 m2 , respectively . Gastrointestinal events ( constipation , diarrhea , and nausea ) , infection , and tachycardia were more frequent in STN groups . More patients in STN groups experienced serious adverse events compared with the control group ( 62.3–70.8 % vs. 51.9 % ) . STN‐based regimens were associated with a higher efficacy failure rate and higher incidence of adverse events with no significant difference in renal function between the groups BACKGROUND Tacrolimus ( Tac ) and mycophenolate mofetil ( MMF ) are newly approved immunosuppressive agents . However , the safety and efficacy of the combination of MMF and Tac in primary liver transplantation has not been determined . METHODS An Institutional Review Board-approved , open-label prospect i ve r and omized protocol was initiated to study the efficacy and toxicity of Tac and steroids ( double-drug therapy ) versus Tac , steroids , and MMF ( triple-drug therapy ) in primary adult liver transplant recipients . Both groups of patients began on the same doses of Tac and steroids . Patients r and omized to triple-drug therapy also received 1 g of MMF twice a day . RESULTS Between August 1995 and January 1997 , 200 patients were enrolled , 99 in double-drug therapy and 101 in triple-drug therapy . All patients were followed until May 1997 , with a mean follow-up of 12.7 months . During the study period , 28 of 99 patients in double-drug therapy received MMF to control ongoing acute rejection , nephrotoxicity , and /or neurotoxicity . On the other h and , 61 patients in triple-drug therapy discontinued MMF for infection , myelosuppression , and /or gastrointestinal disturbances . By an " intention-to-treat analysis , " the actuarial 1-year patient survival rate was 85.1 % in double-drug therapy and 83.1 % in triple-drug therapy ( P=0.77 ) . The actuarial 1-year graft survival rate was 80.2 % for double-drug therapy and 79.2 % for triple-drug therapy ( P=0.77 ) . Forty-one patients ( 41.4 % ) in double-drug therapy and 32 ( 31.7 % ) in triple-drug therapy had at least one episode of rejection , but this was not statistically significant ( P=0.15 ) . The mean maintenance dose of corticosteroids was slightly lower in triple-drug compared with double-drug therapy . CONCLUSION Patient and graft survival rates were similar in both groups . There was a trend to a lower incidence of rejection , reduced nephrotoxicity , and a lesser amount of maintenance corticosteroids in triple-drug therapy compared with double-drug therapy Although steroid withdrawal has been successfully performed in heart and kidney transplant recipients , no controlled studies of SW have been carried out in liver transplant patients . To evaluate this possibility a prospect i ve controlled study was carried out in 46 liver transplant recipients operated on after may 1991 . They all received a sequential quadruple immunosuppression consisting of 3 mg/kg antithymocyte globulins ( RATG ) for the first 5 postoperative days , cyclosporin A ( starting from day 3 - 5 and maintaining parenteral whole-blood trough levels at 200 - 300 ng/ml during the first month and at 150 - 250 thereafter ) , azathioprine ( 1 mg/kg per day for the first month ) and steroids . Prednisone was started at a dose of 200 mg per day 1 and then tapered to 20 mg/day over the first posteroperative week ; this dose was maintained until day 90 when the patients were r and omly allocated either to long-term steroid therapy ( 0.1 mg/kg per day ) or to steroid withdrawal . Minimum follow-up after r and omization was 6 months ( 6 - 27 months ) . Liver biochemistry was checked at regular intervals throughout the follow-up period . Liver biopsies were performed whenever clinical ly indicated and also in the first 19 patients during readmission for annual review . The incidence ot acute and chronic rejection 90 days from liver transplantation was 2.5 % in patients maintained on long-term therapy . No patient in the steroid-withdrawal group had experienced either an acute or a chronic rejection episode so far . Steroid-related complications did not differ significantly between the two groups . The most recent interim analysis showed that steroid withdrawal is a safe undertaking in liver transplant recipients and may be successfully accomplished in almost all patients We studied the outcome of 345 liver transplant patients who received tacrolimus‐based immunosuppressive therapy either as a dual regimen ( with corticosteroids , n=172 ) or as a triple regimen ( with corticosteroids and azathioprine , n=173 ) for 3 months after transplantation ( 3‐month cohort ) . A further analysis was conducted for the first 195 patients r and omised ( dual n=100 , triple n=95 ) who were followed up for 12 months after transplantation ( 12‐month cohort ) . For the 3‐month cohort , patient survival was 90.7 % ( dual ) and 91.9 % ( triple ) , graft survival after 3 months was 88.4 % ( dual therapy ) and 89.6 % ( triple therapy ) . Acute rejections were experienced by 67/172 , 39.0 % of patients on dual therapy and by 60/173 , 34.7 % of patients on triple therapy ; corticosteroid‐resistant rejections were reported in 9 patients ( 5.2 % ) in either treatment group . The overall safety profile was similar for the two treatment groups . Significant differences , however , were found for thrombocytopenia ( dual 13/172 , 7.6 % , triple 37/173 , 21.4 % , p<0.001 ) and leukopenia ( dual 4/172 , 2.3 % , triple 24/173 , 13.9 % , p<0.001 ) . For the 12‐month cohort , patient survival was 85.6 % ( dual ) and 88.4 % ( triple ) after 1 year . Graft survival was 81.7 % ( dual ) and 85.2 % ( triple ) 12 months after transplantation . Acute rejections were reported for 38/100 , 38.0 % of patients on dual therapy and 36/95 , 37.9 % of patients on triple therapy , corticosteroid‐resistant rejections were 7/100 , 7.0 % ( dual ) and 7/95 , 7.4 % ( triple ) of patients . In the 12‐month cohort , no significant differences in the safety profiles of the treatment groups were found . We conclude that both tacrolimus‐based dual and triple drug regimens provide effective and safe immunosuppression following orthotopic liver transplantation This r and omized , prospect i ve , multicenter trial compared the safety and efficacy of steroid-free immunosuppression ( IS ) to the safety and efficacy of 2 st and ard IS regimens in patients undergoing transplantation for hepatitis C virus ( HCV ) infection . The outcome measures were acute cellular rejection ( ACR ) , severe HCV recurrence , and survival . The patients were r and omized ( 1:1:2 ) to tacrolimus ( TAC ) and corticosteroids ( arm 1 ; n = 77 ) , mycophenolate mofetil ( MMF ) , TAC , and corticosteroids ( arm 2 ; n = 72 ) , or MMF , TAC , and daclizumab induction with no corticosteroids ( arm 3 ; n = 146 ) . In all , 295 HCV RNA-positive subjects were enrolled . At 2 years , there were no differences in ACR , HCV recurrence ( biochemical evidence ) , patient survival , or graft survival rates . The side effects of IS did not differ , although there was a trend toward less diabetes in the steroid-free group . Liver biopsy sample s revealed no significant differences in the proportions of patients in arms 1 , 2 , and 3 with advanced HCV recurrence ( ie , an inflammation grade ≥ 3 and /or a fibrosis stage ≥ 2 ) in years 1 ( 48.2 % , 50.4 % , and 43.0 % , respectively ) and 2 ( 69.5 % , 75.9 % , and 68.1 % , respectively ) . Although we have found that steroid-free IS is safe and effective for liver transplant recipients with chronic HCV , steroid sparing has no clear advantage in comparison with traditional IS Background . Calcineurin inhibitors ( CNIs ) play the key role in immunosuppressive protocol s yet are often associated with numerous side effects . Renal insufficiency , hypertension , hyperglycemia , and increased risk of secondary malignancy are major problems in short- and long-term follow-up of liver transplant patients . Mycophenolate mofetil ( MMF ) has proved to be a potent immunosuppressive agent free of the CNI-associated side effects . Patients and Methods . One hundred fifty patients who received liver transplantation at our institution ( 1998–2003 ) were prospect ively r and omized : 75 patients continued CNI st and ard therapy , 75 patients were switched to MMF monotherapy , and follow-up was 5 years . Incidence of rejection , renal complication , cardiovascular , neurological and gastrointestinal adverse effects , and diabetes and malignancy development was recorded . Graft biopsies were performed every 2 to 3 years . Results . No significant difference regarding the incidence of acute rejection was detected . A trend to higher rejection frequency was apparent in the MMF monotherapy group . Chronic rejection was absent ; organ and patient survival were identical in the two groups . No significant difference occurred concerning the incidence of cardiovascular , gastrointestinal or neurological adverse effects , or the development of malignancies . Renal function improved significantly in patients with renal insufficiency when patients treated with CNI were switched to MMF monotherapy . Conclusion . MMF monotherapy may serve as safe long-term immunosuppression after liver transplantation for a subgroup of patients . Especially for patients with renal insufficiency MMF offers immunosuppression without the risk of nephrotoxicity Hepatitis C is the most common indication for liver transplantation ( LT ) in the United States . Recurrence of hepatitis C virus ( HCV ) infection post-LT remains a problem for which there is no completely satisfactory treatment . The aim of the present study is to evaluate mycophenolate mofetil ( MMF ) , which has both immunosuppressive and antiviral properties , to determine whether it is associated with a difference in the rate of HCV recurrence and also examine its impact on patient and graft survival . Between August 1995 and May 1998 , a total of 106 patients who were HCV positive before LT were r and omized to tacrolimus ( TAC ) and prednisone versus TAC , prednisone , and MMF therapy . The rate of recurrence of HCV , patient and graft survival , incidences of rejection , and histological findings were examined . Fifty six patients were r and omized to TAC and steroid therapy ( double [ D ] drug ; group D ) , and 50 patients were r and omized to TAC , steroid , and MMF therapy ( triple [ T ] drug ; group T ) . Liver biopsies were performed when liver function was abnormal ; protocol liver biopsies were not performed . Mean follow-up was 4.3 + /- 0.8 years . Actuarial patient survivals at 4 years were 72.6 % in group D and 73.8 % in group T ( P = not significant ) . Actuarial graft survivals at 4 years were 65.6 % in group D and 65.
Output:
| Based on very low- quality evidence from network meta- analysis , we found no evidence of difference between different immunosuppressive regimens .
We found very low- quality evidence from network meta- analysis and low- quality evidence from direct comparison that cyclosporine A causes more retransplantation compared with tacrolimus . |
MS210358 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To evaluate whether baseline or procedural stress during in vitro fertilization ( IVF ) or gamete intrafallopian transfer ( GIFT ) affects pregnancy or live birth delivery rates . DESIGN Prospect i ve study . SETTING Seven clinics in Southern California between 1993 and 1998 . PATIENT(S ) One hundred and fifty-one women completed two question naires . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) The number of oocytes aspirated and fertilized , the number of embryos transferred , the achievement of a pregnancy , live birth delivery , and infant outcomes . RESULT ( S ) Positive-affect negative-affect score at baseline negatively influenced the number of oocytes retrieved and embryos transferred . A higher expectation of pregnancy was associated with greater numbers of oocytes fertilized and embryos transferred . At baseline , the risk of no live birth was 93 % lower for women who had the highest positive-affect score compared to those with the lowest score . Furthermore , the score on the Infertility Reaction Scale was related to negative outcomes in live birth delivery , infant birth weight , and multiple births . During the time of the procedure , the PANAS and Bipolar Profile of Moods States results were related to the number of oocytes fertilized and embryos transferred ; stress did not affect pregnancy or delivery . CONCLUSION ( S ) Baseline ( acute and chronic ) stress affected biologic end points ( i.e. , number of oocytes retrieved and fertilized ) , as well as pregnancy , live birth delivery , birth weight , and multiple gestations , whereas ( procedural ) stress only influenced biologic end points In a case-control study an association was found between mothers ' smoking habits and the frequency of dizygotic twinning . As cases were included all twins born in Denmark in 1984 and 1985 . A r and om sample of 1.5 % of mothers to singletons , born in the same period were selected as controls . Only live-borns , conceived after no hormonal treatment , were included in the study . The finding may be due to the well-known anti-estrogen effect of smoking In the present study we investigated the effect of a woman 's smoking status on the quality of the oocyte , zygote , and on day 3 pre-embryo , as well as the likelihood of achieving an ongoing pregnancy at 8 weeks . Smokers presented a higher number of nonfertilized oocytes than nonsmokers ( 20.1 % vs. 10.8 % of fertilization failure ) , by comparable clinical pregnancy rate for smokers ( 40.8 % ; 28/72 ) and for nonsmokers ( 39.2 % ; 23/58 ) We investigated whether cigarette smoking , measured by follicular fluid concentrations of cotinine ( a major metabolite of nicotine ) , affects the maturity of oocytes from women undergoing in-vitro fertilization ( IVF ) and embryo transfer . In 234 women , follicular fluid sample s were assessed for cotinine and their 2020 oocytes were assessed for maturity stage . Data on individual proportions of oocytes which were mature ( OM ) and were fertilized ( OF ) were analysed by regression in relation to age and follicular fluid cotinine . OF gave an independent assessment of oocyte maturity . Both age and follicular fluid cotinine entered the OM and OF regressions and were significant . The age-adjusted regression coefficients for log cotinine were positive ; greater cotinine concentrations usually accompanied greater OM and OF . The cotinine effect on OM was positive in younger women , but it became negative ( decreased OM with increasing cotinine concentrations ) in older women ( > or = 40 years ) . We further found in older women an average reduction of approximately 50 % in the number of mature oocytes ; this reduced number was lower than the number of embryos usually transferred . Smoking can reduce the number of mature oocytes even further , therefore risking a negative IVF-embryo transfer outcome . This may be the reason why the negative effects of smoking become clinical ly detectable in older women OBJECTIVE This study determines whether smoking influences ovarian vascularization which thus may impair follicular development . DESIGN Prospect i ve laboratory study of follicular fluids and granulosa cells from patients undergoing in vitro fertilization . SETTING University Hospital Aachen , Germany . PATIENT(S ) Fifty smoking women and 50 nonsmoking women . INTERVENTION(S ) Cultivation of human granulosa cells . Cultivation of human umbilical vein endothelial cells ( HUVECs ) with either granulosa cell-conditioned medium or follicular fluid . Determination of clinical parameters . MAIN OUTCOME MEASURE(S ) Quantification of soluble vascular endothelial growth factor receptor 1 ( sVEGFR-1 ) and cotinine . RESULT ( S ) Mean sVEGFR-1 concentration in follicular fluid of smokers was 499.6 pg/mL compared with 159.2 pg/mL in nonsmokers . Correspondingly , supernatant of HUVECs cultured with follicular fluid from smoking and nonsmoking women showed , respectively , 1,174.1 pg/mL versus 794.2 pg/mL sVEGFR-1 . The HUVECs incubated with conditioned medium from smokers ' granulosa cells at culturing days 5 , 9 , 13 , and 17 secreted , respectively , 1,712.4 , 1,560.6 , 1,619.0 , and 1,635.0 pg/mL sVEGFR-1 , whereas nonsmokers showed , respectively , 1,147.6 , 1,067.2 , 1,135.9 , and 1,206.3 pg/mL sVEGFR-1 . Mean cotinine concentration in smoking women was 83.9 ng/mL and in nonsmoking was 2.8 ng/mL. In all four comparisons , differences between groups reached statistical significance . CONCLUSION ( S ) This study showed that smokers secrete significantly higher amounts of sVEGFR-1 than nonsmokers , which may result in decreased ovarian vascularization and reduced oocyte maturation A prospect i ve cohort study of 222 consecutive couples undergoing 297 cycles of in-vitro fertilization and embryo transfer ( IVF-ET ) was conducted to evaluate the impact of cigarette smoking in males and females . Compared with non-smokers , females smoking at the time of treatment had more previous pregnancies ( 1.16 versus 0.63 , P less than 0.001 ) , consumed more coffee per day ( 3.29 versus 1.85 cups , P = 0.001 ) and were less likely to hold a professional or skilled job ( 41 % versus 66 % ) . There was no difference in the response to ovarian stimulation in terms of the duration and dose of human menopausal gonadotrophin , peak oestradiol level or number of oocytes retrieved . The fertilization rate was actually higher in heavy smokers than in non-smokers ( 79.3 % versus 61.3 % , P = 0.007 ) . The rate of embryo cleavage was retarded in a dose-dependent fashion . In smokers of 1 - 14 cigarettes/day , the likelihood of transferring an embryo at greater than or equal to 4-cell stage was 0.87 [ 95 % confidence limits ( CL ) 0.56 - 1.4 ] and in smokers of greater than or equal to 15 cigarettes/day , the likelihood was 0.52 ( 95 % CL 0.31 - 0.88 ) . However , evaluation of interrelated factors using logistic regression suggested that a low socioeconomic status had a greater detrimental effect on embryo cleavage rate than female smoking . No significant difference was noted in the clinical outcome following embryo transfer . A study of larger sample size is required to evaluate whether the effects of cigarette smoking are independent of socioeconomic status and other related factors and whether they result in reduced ongoing clinical pregnancy and live birth rates The aim of the present study was to evaluate consequences of cigarette smoking on male gametes . In this prospect i ve study , sperm parameters such as sperm density , motility , viability and normal morphology were measured according to the WHO criteria . In addition to these st and ard parameters , we analysed the degree of DNA fragmentation in spermatozoa using the TUNEL-assay with flow cytometry detection in 57 non-smokers and 51 smokers seeking for infertility counselling . The smoking intoxication was assessed by question naire and measured with the CO-Tester . We show that smokers ' spermatozoa have a significantly higher DNA fragmentation than non-smokers ( 32 % versus 25.9 % , p<0.01 ) . In contrast there is no significant difference in conventional parameters between smokers and non-smokers . The degree of sperm DNA fragmentation is not significantly correlated with any of the conventional parameters . These findings suggest that cigarette smoking may have deleterious effects on sperm nuclear quality and that sperm DNA fragmentation can therefore be considered as an independent parameter with diagnostic , prognostic , and strategic value in the treatment of infertility Purpose : The aim of the present study was to investigate the influence of smoking on different parameters such as oocyte count , embryo score , and basal hormone values within the scope of in vitro fertilization – embryo transfer ( IVF-ET ) . Methods : Eight hundred thirty-four women undergoing IVF-ET treatment were classified as smokers or nonsmokers on the basis of question naires . Additionally , we divided them into three groups according to their stimulation protocol —“combined stimulation ” [ I ; clomiphene citrate plus human menopausal gonadotropin ( hMG ) ] , “ ultrashort ” [ II ; gonadotropin releasing hormone agonist ( GnRHa ) plus hMG or follicle-stimulating hormone ( FSH ) ] , and “ long downregulation protocol ” (III)— and further classified again as smokers or nonsmokers within the groups . Results : In general , smoking patients were significantly ( P = 0.0195 ) younger than nonsmokers and showed a significantly ( P = 0.0379 ) lower embryo score and a tendency ( P = 0.0931 ) to produce fewer oocytes . There was no significant difference concerning the number of normally or pathologically fertilized and transfered oocytes and embryos suitable for cryopreservation . Women who smoked had significantly ( P = 0.0112 ) higher basal 17-β-estradiol ( E2 ) , luteinizing hormone ( LH ) ( P = 0.0001 ) , and dehydroepi and rosteronesulfate ( DHEAS ) ( P = 0.0039 ) levels , but their basal human prolactin ( HPRL ) levels were significantly ( P = 0.0033 ) lower than those of nonsmokers . According to the stimulation protocol used , we found the following results . Smoking patients in group I showed a significantly ( P = 0.023 ) lower embryo score and produced fewer oocytes ( P = 0.0113 ) , with fewer of them being fertilized ( P = 0.0072 ) and transferred ( P = 0.0067 ) . Women who smoked had significantly ( P = 0.0002 ) higher basal LH levels , but their HPRL levels were significantly ( P = 0.031 ) lower than those of nonsmokers . Furthermore , they had a thinner endometrium on the day of embryo transfer ( P = 0.0366 ) . In group II we measured significantly elevated basal E2levels ( P = 0.0089 ) and higher LH values ( P = 0.0092 ) in smokers . Group III showed a trend ( P = 0.0565 ) toward lower HPRL values in smokers . Conclusions : Although the fertilization rate of oocytes and the pregnancy rate were not significantly different between smokers and nonsmokers , we found significantly alterated hormonal parameters and negatively influenced oocyte parameters , particularly after clomiphene stimulation . So we might consider using only GnRHa protocol s for smoking patients . Additionally , we advise our patients to stop smoking before an IVF-ET treatment because of the complex effects of smoking on the reproductive and hormonal system BACKGROUND No information exists in the literature regarding the factors affecting the blood flow towards the endometrial and subendometrial regions during IVF treatment . METHODS We examined the effect of women 's age , their smoking habits , their type of infertility ( i.e. primary or secondary ) and parity , causes of infertility and serum estradiol ( E2 ) concentration on endometrial and subendometrial blood flows as measured by a three-dimensional ( 3D ) power Doppler ultrasound during IVF treatment . All patients received a st and ard long protocol of ovarian stimulation and serum E2 concentration was determined on the day of hCG . 3D ultrasound examination with power Doppler was performed on the day of oocyte collection to determine vascularization index ( VI ) , flow index ( FI ) and vascularization flow index ( VFI ) of endometrial and subendometrial regions . RESULTS The age of women , their smoking habits , their types of infertility and parity and causes of infertility had no effect on the endometrial and subendometrial 3D power Doppler flow indices . There was a negative correlation between serum E(2 ) concentration and end
Output:
| This effect is expressed by worse in-vitro fertilization parameters in cycles performed on women with smoking habits .
Also , uterine receptiveness is significantly altered by the smoking habit .
In men , cigarette smoking reduces sperm production , increases oxidative stress , and DNA damage .
Spermatozoa from smokers have reduced fertilizing capacity , and embryos display lower implantation rates .
Even in-utero exposition to tobacco constituents leads to reduced sperm count in adult life .
SUMMARY A strong body of evidence indicates that the negative effect of cigarette smoking on fertility comprises fairly every system involved in the reproductive process . |
MS210359 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract 1680 participants were r and omized over the recruitment period in MAPT study . A total of 1290 participants were recruited in the 7 University Hospital centers , and 390 participants in the 6 memory clinics around Toulouse Gerontopole / Alzheimer Disease research clinical center . The first r and omization was on May 30 , 2008 , and the targeted number of r and omized participants was reached on February 24 , 2011 ; 2595 subjects were finally screened , of which 1680 fulfilled the eligibility criteria which represents 64.8 % . Approximately , one quarter of screened people refused to participate after the detailed presentation of the study and 4.3 % were still interested in participating but missed for unknown reasons the baseline visit even after repeated contacts . Of the 1810 subjects who signed the consent for participating to the study at the baseline visit , 130 ( 7.1 % ) were excluded because one of the eligibility criteria was not satisfied . Interestingly , the higher percentage of r and omizations compared to screened participants is the personal contact source ; almost 85 % of screened participants entered in the study . In an equivalent way , Medias and conferences are efficient recruiting sources to enrol volunteers in the study . Unexpectedly , only about 60 % of screened participants from the hospital and GP sources were r and omized and 33.2 % from health care services . Almost a quarter of the r and omized participants come from the hospital out patients clinics and approximately 20 % from public conferences . A total of 1128 contacts yielded to 556 screened volunteers and 345 r and omized participants in the coordinating center of Toulouse . Thus , 30 % of contacts were recruited Objective : This study presents a new comprehensive educational group intervention that offers psycho-education about cognitive aging and context ual factors ( i.e. , negative age stereotypes , beliefs , health , and lifestyle ) , focuses on skills and compensatory behavior , and incorporates group discussion . Its effects were investigated in community-dwelling older women who report normal age-related cognitive complaints . Methods : A r and omized controlled trial with an experimental and waiting-list control condition was carried out in a sample of 50 women aged 60–75 years . As the main problem of these individuals were perceived cognitive deficits without actual cognitive decrements , metacognition served as the primary outcome measure . Objective cognitive functioning and psychological well-being were secondary outcome measures . A double baseline and a follow-up assessment were carried out . Results : Participants in the experimental condition reported significantly fewer negative emotional reactions toward cognitive functioning ( U = 164.500 , p = 0.004 ) . The reported effect size ( δ = −0.473 ) could be interpreted as large . Conclusions : This new comprehensive educational group intervention reduces negative emotional reactions toward cognitive functioning , which seems a prerequisite for improved subjective cognitive functioning and well-being . It can potentially contribute the well-being of an important and large group of older adults OBJECTIVE The objective of this study was to determine the effects of a 14-day healthy longevity lifestyle program on cognition and cerebral metabolism in people with mild age-related memory complaints . METHODS Seventeen nondemented subjects , aged 35 - 69 years ( mean : 53 years , st and ard deviation : 10 ) with mild self-reported memory complaints but normal baseline memory performance scores were r and omly assigned to 1 ) the intervention group ( N = 8) : a program combining a brain healthy diet plan , relaxation exercises , cardiovascular conditioning , and mental exercise ( brain teasers and verbal memory training techniques ) ; or 2 ) the control group ( N = 9 ) : usual lifestyle routine . Pre- and postintervention measures included self- assessment s of memory ability , objective tests of cognitive performance , and determinations of regional cerebral metabolism during mental rest with [fluorine-18]fluorodeoxyglucose ( FDG ) positron emission tomography ( PET ) . RESULTS Subjects in the intervention group objective ly demonstrated greater word fluency . Concomitantly , their FDG-PET scans identified a 5 % decrease in activity in the left dorsolateral prefrontal cortex . The control group showed no significant change in any of the measures . CONCLUSIONS A short-term healthy lifestyle program combining mental and physical exercise , stress reduction , and healthy diet was associated with significant effects on cognitive function and brain metabolism . Reduced resting activity in left dorsolateral prefrontal cortex may reflect greater cognitive efficiency of a brain region involved in working memory CONTEXT Cognitive function in older adults is related to independent living and need for care . However , few studies have addressed whether improving cognitive functions might have short- or long-term effects on activities related to living independently . OBJECTIVE To evaluate whether 3 cognitive training interventions improve mental abilities and daily functioning in older , independent-living adults . DESIGN R and omized , controlled , single-blind trial with recruitment conducted from March 1998 to October 1999 and 2-year follow-up through December 2001 . SETTING AND PARTICIPANTS Volunteer sample of 2832 persons aged 65 to 94 years recruited from senior housing , community centers , and hospital/clinics in 6 metropolitan areas in the United States . INTERVENTIONS Participants were r and omly assigned to 1 of 4 groups : 10-session group training for memory ( verbal episodic memory ; n = 711 ) , or reasoning ( ability to solve problems that follow a serial pattern ; n = 705 ) , or speed of processing ( visual search and identification ; n = 712 ) ; or a no-contact control group ( n = 704 ) . For the 3 treatment groups , 4-session booster training was offered to a 60 % r and om sample 11 months later . MAIN OUTCOME MEASURES Cognitive function and cognitively dem and ing everyday functioning . RESULTS Thirty participants were incorrectly r and omized and were excluded from the analysis . Each intervention improved the targeted cognitive ability compared with baseline , durable to 2 years ( P<.001 for all ) . Eighty-seven percent of speed- , 74 % of reasoning- , and 26 % of memory-trained participants demonstrated reliable cognitive improvement immediately after the intervention period . Booster training enhanced training gains in speed ( P<.001 ) and reasoning ( P<.001 ) interventions ( speed booster , 92 % ; no booster , 68 % ; reasoning booster , 72 % ; no booster , 49 % ) , which were maintained at 2-year follow-up ( P<.001 for both ) . No training effects on everyday functioning were detected at 2 years . CONCLUSIONS Results support the effectiveness and durability of the cognitive training interventions in improving targeted cognitive abilities . Training effects were of a magnitude equivalent to the amount of decline expected in elderly persons without dementia over 7- to 14-year intervals . Because of minimal functional decline across all groups , longer follow-up is likely required to observe training effects on everyday function What is the neurocognitive basis for the considerable individual differences observed in functioning of the adult mind and brain late in life ? We review the evidence that in healthy old age the brain remains capable of both neuronal and cognitive plasticity , including in response to environmental and experiential factors . Neuronal plasticity ( e.g. , neurogenesis , synaptogenesis , cortical re-organization ) refers to neuron-level changes that can be stimulated by experience . Cognitive plasticity ( e.g. , increased dependence on executive function ) refers to adaptive changes in patterns of cognition related to brain activity . We hypothesize that successful cognitive aging requires interactions between these two forms of plasticity . Mechanisms of neural plasticity underpin cognitive plasticity and in turn , neural plasticity is stimulated by cognitive plasticity . We examine support for this hypothesis by considering evidence that neural plasticity is stimulated by learning and novelty and enhanced by both dietary manipulations ( low-fat , dietary restriction ) and aerobic exercise . We also examine evidence that cognitive plasticity is affected by education and training . This is a testable hypothesis which could be assessed in humans in r and omized trials comparing separate and combined effects of cognitive training , exercise , and diet on measures of cognitive and brain integrity . Greater underst and ing of the factors influencing the course of cognitive aging and of the mechanisms underlying those factors could provide information on which people could base choices that improve their ability to age successfully CONTEXT Frequent participation in cognitively stimulating activities has been hypothesized to reduce risk of Alzheimer disease ( AD ) , but prospect i ve data regarding an association are lacking . OBJECTIVE To test the hypothesis that frequent participation in cognitive activities is associated with a reduced risk of AD . DESIGN Longitudinal cohort study with baseline evaluations performed between January 1994 and July 2001 and mean follow-up of 4.5 years . PARTICIPANTS AND SETTING A total of 801 older Catholic nuns , priests , and brothers without dementia at enrollment , recruited from 40 groups across the United States . At baseline , they rated frequency of participation in common cognitive activities ( eg , reading a newspaper ) , from which a previously vali date d composite measure of cognitive activity frequency was derived . MAIN OUTCOME MEASURES Clinical diagnosis of AD by a board-certified neurologist using National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer 's Disease and Related Disorders Association criteria and change in global and specific measures of cognitive function , compared by cognitive activity score at baseline . RESULTS Baseline scores on the composite measure of cognitive activity ranged from 1.57 to 4.71 ( mean , 3.57 ; SD , 0.55 ) , with higher scores indicating more frequent activity . During an average of 4.5 years of follow-up , 111 persons developed AD . In a proportional hazards model that controlled for age , sex , and education , a 1-point increase in cognitive activity score was associated with a 33 % reduction in risk of AD ( hazard ratio , 0.67 ; 95 % confidence interval , 0.49 - 0.92 ) . Results were comparable when persons with memory impairment at baseline were excluded and when terms for the apolipoprotein E epsilon4 allele and other medical conditions were added . In r and om-effects models that controlled for age , sex , education , and baseline level of cognitive function , a 1-point increase in cognitive activity was associated with reduced decline in global cognition ( by 47 % ) , working memory ( by 60 % ) , and perceptual speed ( by 30 % ) . CONCLUSION These results suggest that frequent participation in cognitively stimulating activities is associated with reduced risk of AD In an interdisciplinary project on maintaining and supporting independent living in old age , ( a ) competence training , ( b ) memory training and ( c ) psychomotor training as well as ( d ) combined competence and psychomotor training and ( e ) combined memory and psychomotor training was performed with n = 309 elderly of 75 to 89 years of age for 9 months . Regardless of treatment conditions , an age-related decline of health and subjective well-being was found 1 year after the end of the training . The specific training measures each led to highly significant specific improvements of the trained functions . A favorable influence of competence training on everyday coping and hence on active strategies for staying independent as well as of memory training on all cognitive functions and especially on memory performance was found . While global psychomotor performance was not significantly improved , effects of psychomotor training on specific functions were detected . In addition , the combined psychomotor and memory training led to an improvement of psychomotor performance and to a reduction of symptoms of dementia , even though neither psychomotor training alone nor memory training alone result ed in such effects . Neurophysiological changes leading to a provision of reserve-capacity of CNS-performance are among other effects assumed as an explanation The objective of the study was to examine the effectiveness of two types of memory training ( collective and individual ) , compared to control ( waiting list ) , on memory performance . Participants were 139 community-dwelling older individuals recruited through media advertisements asking for people with subjective memory complaints to participate in a study . Data were collected at baseline , and at 1 week and 4 months after the intervention . Training efficacy was assessed using measures of subjective and objective memory performance . After the intervention , participants in the collective training group reported more stability in memory functioning and had fewer feelings of anxiety and stress about memory functioning . In addition , positive effects were found on objective memory functioning . Compared with the other two groups , the collective training group participants had an improved recall of a previously learned word list . Compared to controls , participants in the individual training group reported fewer feelings of anxiety and stress in relation to memory functioning PURPOSE To compare the efficacy of cognitive training ( CT ) and cognitive stimulation ( CS ) programs for the community elderly with subjective memory complaints ( SMC ) . METHOD The single-blind non-r and omized controlled study was applied . The numbers of CT and CS participants were 14 and 11 . The mean ages of CT and CS participants were 68.71 and 70.36 . Memory training and problem solving strategies were applied in the CT group . There were ten 2-hourly sessions of CT , held twice weekly . CS group met once weekly in a 1.5-h class for eight classes . Cognitive performance tests of general cognitive performance , verbal memory and executive function were measured before/after the training and at 6 months follow-up . RESULTS In both training conditions , the general cognitive performance were enhanced . The CT group showed improvement in the verbal memory test . The CS group did not trigger any training effect in the verbal memory test but the executive function . All cognitive progresses remained at follow-up . CONCLUSION Both cognitive training and cognitive stimulation programs showed training effects and remained until 6 months CONTEXT Cognitive training has been
Output:
| Overall , most interventions showed to objective ly improve cognitive performance in subjects with SCCs .
Conversely , there is a current lack of evidence in the literature about the efficacy of nonpharmacological cognitive interventions for preventing dementia or cognitive impairment |
MS210360 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE The present follow-up study was carried out to evaluate the performance of Class II Cerec inlays after 10 years of clinical service . MATERIAL S AND METHODS Sixty-six Class II CAD/CAM ceramic inlays were placed in 27 patients . Each patient received at least one inlay luted with a dual-cured resin composite and one inlay luted with a chemically cured resin composite . At the 10-year recall , 25 ( 93 % ) patients with 61 ( 92 % ) inlays were available for evaluation using a slight modification of the USPHS criteria . RESULTS Fifty-four ( 89 % ) of the 61 inlays reevaluated still functioned well at the 10-year recall . During the follow-up period , seven ( 11 % ) of the inlays required replacement because of : four inlay fractures , one cusp fracture , endodontic problems in one case , and postoperative symptoms in one case . All the replaced inlays had been luted with the dual-cured resin composite . The fractured inlays were all placed in molars . The estimated survival rate after 10 years was 89 % , 77 % for the dual-cured resin composite-luted inlays and 100 % for the chemically cured resin composite-luted ones . The difference was statistically significant . CONCLUSION Patient satisfaction with and acceptance of the Cerec inlays were high , and the performance after 10 years of clinical service was acceptable , especially regarding the inlays luted with the chemically cured resin composite . The properties of the luting agents seem to affect the longevity of the type of ceramic inlays evaluated OBJECTIVES To evaluate fixed dental prostheses ( FDPs ) and single crowns made of zirconia substructures veneered with new fluorapatite veneering porcelain . METHOD AND MATERIAL S Thirty-eight patients received 18 FDPs and 50 single crowns . Zirconia substructures were fabricated by a CAD/CAM system and veneered using the powder buildup technique . All restorations were cemented with glass ionomer . Baseline evaluation was performed 2 weeks after cementation with recall examinations at 12 , 24 , and 36 months by calibrated investigators . SEM was performed on replicas of all restorations . Survival probabilities according to Kaplan-Meier were calculated . RESULTS The mean service time was 35 ( + /- 14 ) months . After 3 years of clinical service , three biologic and five technical failures were recorded . All failures occurred in the FDP group . One FDP was removed after biologic failure of one abutment tooth . The Kaplan-Meier survival probability was 88.2 % after 35 months for all types of failures and 98.5 % concerning restorations in service . The type of restoration showed significant influence on the survival probability ( P < .001 , log-rank test ) . No influence on gingival parameters from the restorations was observed compared to control teeth . CONCLUSIONS Zirconia substructures veneered with fluorapatite veneering porcelain seem to be a reliable treatment option . More research has to be conducted to investigate differences between single crowns and FDPs PURPOSE The objective of this follow-up study was to examine the performance of Cerec inlays and onlays in terms of clinical quality over a functional period of 10 years . MATERIAL S AND METHODS Of 200 Cerec inlays and onlays placed in a private practice between 1989 and early 1991 , 187 restorations were observed over a period of 10 years . The restorations were fabricated chairside using the Cerec-1 computer-aided design /manufacturing ( CAD/CAM ) method and Vita MK I feldspathic ceramic . An adhesive technique and luting composite resin were used for seating the restorations . After 10 years , the clinical performance of the restorations was evaluated using modified USPHS criteria . The results were used to classify success and failure . RESULTS According to Kaplan-Meier analysis , the success rate of Cerec inlays and onlays dropped to 90.4 % after 10 years . A total of 15 ( 8 % ) failures were found in 11 patients . Of these failures , 73 % were caused by either ceramic fractures ( 53 % ) or tooth fractures ( 20 % ) . The reasons for the remaining failures were caries ( 20 % ) and endodontic problems ( 7 % ) . The three-surface Cerec reconstructions were found to have the most failures . CONCLUSION The failure rate of 8 % and the drop of the survival probability rate to 90.4 % after 10 years of clinical service of Cerec-1 CAD/CAM restorations made of Vita MK I feldspathic ceramic appear to be acceptable in private practice . This is particularly true in light of the very high patient satisfaction Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results This study prospect ively evaluated the clinical performance of computer-assisted design and computer-assisted manufacturing (CAD/CAM)-generated In-Ceram Alumina core crowns in Japanese patients for up to 5 years . A total of 101 In-Ceram crowns with aluminium copings fabricated using the GN-I system were placed in Japanese patients . The crowns were evaluated using a California Dental Association ( CDA ) quality assessment system at baseline and at all follow-up examinations . Gingival condition was assessed using plaque and bleeding scores . The survival of anterior and posterior crowns was analysed according to the Kaplan-Meier method . The scores of gingival condition were compared between restored crowns and contralateral teeth using a t-test . During the observation period , six crowns were lost to follow-up . Five crowns were fractured from the copings and removed , and four crowns were removed for other reasons . Chipping within the porcelain was detected in three crowns , which were then polished . The cumulative survival rates after 60 months were 96·9 % for anterior crowns and 87·7 % for posterior ones , and there were no significant differences between anterior and posterior crowns . According to the CDA criteria , most of the crowns were rated as satisfactory during the observation period . There were significant differences in soft tissue conditions between In-Ceram crowns and control teeth at 2- and 5-year examinations . Despite the five fractures from copings , In-Ceram Alumina crowns with copings fabricated using the CAD/CAM ( GN-I system ) for replacing both anterior and posterior teeth showed predictable results during a 5-year observation period OBJECTIVE The aim of this study was to evaluate the clinical performance of ceramic inlays made from machinable ceramic blocks . METHOD AND MATERIAL S The 2 inlay systems involved computer-aided design and computer-aided machining ( Cerec Cos 2.1 ) or copy-milling technique ( Celay ) . The study comprised 15 Celay inlays and 15 Cerec inlays placed in 17 patients . The inlays were evaluated clinical ly at baseline ( 1 week ) as well as 1 and 3 years later ( modified California Dental Association quality evaluation system ) . RESULTS One Celay inlay fractured after 1 year of service , and 2 Cerec inlays were replaced , 1 after 6 months and 1 after 1 year , because of pulpal pain and persisting hypersensitivity . One Celay inlay lost retention after 2 years . At the 3-year evaluation , chipping and hairline cracks were seen in 2 Celay inlays . Progressive disintegration of the marginal luting cement was seen for both Celay and Cerec inlays . The remaining 25 inlays performed satisfactorily throughout the 3-year period . CONCLUSION Because of their relatively high failure rate , these inlays should be reserved for esthetic indications The authors conducted a long-term clinical study of 50 CEREC ( Siemens AG ) CAD-CAM inlay restorations in 28 patients . After four years , they found the inlays to rate very highly in color matching , interfacial staining , secondary caries , anatomic contour , marginal adaptation , surface texture and postoperative sensitivity . They monitored cement loss along the occlusal margins and found it to be relatively low , with an unusual decrease in measured cement wear from the third to the fourth year . The favorable results of this long-term clinical study of these CAD-CAM restorations portend significant success for this restorative approach Procera AllCeram crowns were prospect ively evaluated clinical ly in both anterior and posterior regions in Japanese . One-hundred and one crowns were fabricated for 57 patients at the Tsurumi University Dental Hospital from August 2001 to October 2002 and evaluated according to the California Dental Association ( CDA ) quality evaluation system at baseline and annually at all follow-up examinations for 5 years . The plaque index ( PI ) and gingival index ( GI ) were recorded , and chipping and fracture were checked at the same time as well . A total of 75 Procera AllCeram crowns were evaluated , and the cumulative survival rate was 90.2 % over the 5-year clinical trial . Six crowns experienced fractures within the veneering porcelain and from aluminium oxide coping , all of which occurred on the premolar and molar regions , and they had to be removed . Small chipping was observed on three crowns . According to the CDA criteria , 98 % of Procera AllCeram crowns were rated as satisfactory , and PI and GI were comparable to those of control teeth during the observation period The purpose of this study was to evaluate Cerec CAD/CAM inlays processed of two industrially made machinable ceramics during an 8-yr follow-up period . Each of 16 patients received two similar ceramic inlays . Half the number of the inlays were made of a feldspathic ( Vita Mark II ) and the other of a glass ceramic ( Dicor MGC ) block . The inlays were luted with a dual resin composite and evaluated clinical ly using modified USPHS criteria at baseline , 8 months , 2 , 3 , 5 , 6 and 8 yr , and indirectly using models . At baseline , 84 % of the inlays were estimated as optimal and 16 % as acceptable . Postoperative sensitivity was reported by one patient for 8 months . Of the 32 inlays evaluated during the 8 yr , 3 failed due to fracture of the material . No secondary caries was found adjacent to the inlays . No significant differences in the clinical performance were found between inlays made of the two ceramics . It can be concluded that the CAD/CAM inlays processed of the two ceramics functioned well during the 8-yr follow-up period The aim of this prospect i ve r and omised controlled clinical trial was to evaluate the clinical outcome of shrinkage-free ZrSiO4 -ceramic full-coverage crowns on premolars and molars in comparison with conventional gold crowns over a 5-year period . Two hundred and twenty-three patients were included and r and omly divided into two treatment groups . One hundred and twenty-three patients were restored with 123 ZrSiO4 -ceramic crowns , and 100 patients received 100 gold crowns , which served as the control . All crowns were conventionally cemented with glass-ionomer cement . After an observation period of 6 , 12 , 24 , 36 , 48 and 60 months , the survival probability ( Kaplan-Meier ) for the shrinkage-free ZrSiO4 -ceramic crowns was 98·3 % , 92·0 % , 84·7 % , 79 % and 73·2 % and for the gold crowns , 99 % , 97·9 % , 95·7 % , 94·6 % and 92·3 % , respectively . The difference between the test and
Output:
| The overall survival rate of single-tooth ceramic restorations fabricated with CAD/CAM technology was similar to those conventionally manufactured |
MS210361 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE Assessed the feasibility , acceptability , and sustainability of Planet Health , an interdisciplinary , integrated health education curriculum implemented in six public middle schools . METHODS Workshops on Planet Health implementation were attended by 129 teachers ( language arts , math , science , and social studies ) over three school years ( 1999 - 2000 , 2000 - 2001 , and 2001 - 2002 ) . Question naires were administered post-implementation and in the fall and spring of each year . Outcomes were dose , acceptability , feasibility , and intent to continue use . RESULTS The average number of lessons taught per teacher per year was 1.7 to 3.1 , compared to a goal of 2 to 3 . Each year , teachers reported high acceptability and perceived feasibility of the intervention , and the majority indicated they intended to continue using the curriculum . CONCLUSIONS Planet Health was feasible and acceptable in a participatory research model involving a public school-university partnership , and it was also sustainable independent of the research effort Purpose . Examine the reach , efficacy , adoption , implementation , and maintenance of a physical activity and nutrition curriculum for middle-school students . Design . Nonexperimental pilot evaluation of a statewide dissemination trial . Setting . California middle schools during the 2006 to 2007 school year . Subjects . Sixteen classes ( N = 668 students and 16 teachers ) sample d from the statewide pool who used the program . Intervention . An eight-lesson nutrition and physical activity curriculum , “ Exercise Your Options ” ( EYO ) , including a teacher guide , video clips , a student activity booklet , and ancillary material s was made available to teachers . Measures . Program records , classroom observations , teacher surveys , and student presurveys and postsurveys ( assessing physical activity , sedentary behaviors , and dietary intake ) . Analysis . Descriptive statistics and multilevel r and om-coefficient modeling . Results . The EYO program reached 234 , 442 middle-school students in California . During the program , total physical activity increased ( p ≤ .001 ) , whereas watching TV/DVDs and playing electronic games/computer use decreased ( p ≤ .05 ) . Intake of dairy products increased ( p < .05 ) , whereas consumption of sugars/sweets decreased ( p < .001 ) . Forty-two percent of eligible middle-school classrooms ordered the program material s. Eighty-six percent of sample d teachers implemented all of the lessons . Over the past 5 years , 51 % of all middle-school students in California were exposed to the program . Conclusions . The EYO program showed its potential for moderate to high public health impact among California middle-school students Background The evidence -based Dutch Obesity Intervention in Teenagers ( DOiT ) program is a school-based obesity prevention program for 12 to 14-year olds attending the first two years of prevocational education . This paper describes the study protocol applied to evaluate ( a ) the nationwide dissemination process of DOiT in the Netherl and s , and ( b ) the relationship between quality of implementation and effectiveness during nationwide dissemination of the program in the Netherl and s. Methods In order to explore facilitating factors and barriers for dissemination of DOiT , we monitored the process of adoption , implementation and continuation of the DOiT program among 20 prevocational schools in the Netherl and s. The study was an observational study using qualitative ( i.e. semi-structured interviews ) and quantitative methods ( i.e. question naires and logbooks ) . Eight process indicators were assessed : recruitment , context , reach , dosage , fidelity , satisfaction , effectiveness and continuation . All teachers , students and parents involved in the implementation of the program were invited to participate in the study . As part of the process evaluation , a cluster-controlled trial with ten control schools was conducted to evaluate the effectiveness of the program on students ’ anthropometry and energy balance-related behaviours and its association with quality of implementation . Discussion The identified impeding and facilitating factors will contribute to an adjusted strategy promoting adoption , implementation and continuation of the DOiT program to ensure optimal use and , thereby , prevention of obesity in Dutch adolescents . Trial registration Current Controlled Trials IS RCT N92755979 Reconnecting Youth ( RY ) is a school-based drug prevention program design ed to address academic , substance use and mood management goals among youth at risk of dropping out of high school . This paper presents the organizational factors and RY program characteristics that either promoted or hindered the implementation of the program during a r and omized controlled effectiveness trial in 10 schools in two school districts in the United States . Data were collected using surveys and interviews from teachers and school and district staff who participated in the implementation of the RY program in these schools . Results suggest that certain RY program characteristics made it difficult to implement . Small class size , re source -intensive procedures for student selection and recruitment and special training , qualities and skills needed to be an effective RY teacher meant that schools had to significantly change their usual practice s to implement the program . Organizational barriers included a lack of financial re sources and leadership support for program implementation , and low priority for non-academic courses for high-risk students . Transient student population s , staff turnover and district-wide scheduling and curriculum changes all result ed in high levels of organizational turbulence at most schools , further hindering program implementation Research consistently indicates that schools fail to implement m and atory physical activity policies . This review aim ed to describe factors ( barriers and facilitators ) that may influence the implementation of school physical activity policies which specify the time or intensity that physical activity should be implemented and to map these factors to a theoretical framework . A systematic search was undertaken in six data bases for quantitative or qualitative studies published between 1995-March 2016 that examined teachers ' , principals ' or school administrators ' reported barriers and /or facilitators to implementing m and ated school physical activity policies . Two independent review ers screened texts , extracted and coded data from identified articles using the Theoretical Domains Framework ( TDF ) . Of the 10,346 articles identified , 17 studies met the inclusion criteria ( 8 quantitative , 9 qualitative ) . Barriers and facilitators identified in qualitative studies covered 9 and 10 TDF domains respectively . Barriers and facilitators reported in quantitative studies covered 8 TDF domains each . The most common domains identified were : ' environmental context and re sources ' ( e.g. , availability of equipment , time or staff ) , ' goals ' ( e.g. , the perceived priority of the policy in the school ) , ' social influences ' ( e.g. , support from school boards ) , and ' skills ' ( e.g. , teachers ' ability to implement the policy ) . Implementation support strategies that target these factors may represent promising means to improve implementation of physical activity policies and increase physical activity among school-aged children . Future studies assessing factors that influence school implementation of physical activity policies would benefit from using a comprehensive framework to help identify if any domains have been overlooked in the current literature . REGISTRATION This review was prospect ively registered with PROSPERO ( CRD42016051649 ) on the 8th December 2016 Background A fundamental challenge of implementation is identifying context ual determinants ( i.e. , barriers and facilitators ) and determining which implementation strategies will address them . Numerous conceptual frameworks ( e.g. , the Consoli date d Framework for Implementation Research ; CFIR ) have been developed to guide the identification of context ual determinants , and compilations of implementation strategies ( e.g. , the Expert Recommendations for Implementing Change compilation ; ERIC ) have been developed which can support selection and reporting of implementation strategies . The aim of this study was to identify which ERIC implementation strategies would best address specific CFIR-based context ual barriers . Methods Implementation research ers and practitioners were recruited to participate in an online series of tasks involving matching specific ERIC implementation strategies to specific implementation barriers . Participants were presented with brief descriptions of barriers based on CFIR construct definitions . They were asked to rank up to seven implementation strategies that would best address each barrier . Barriers were presented in a r and om order , and participants had the option to respond to the barrier or skip to another barrier . Participants were also asked about considerations that most influenced their choices . Results Four hundred thirty-five invitations were emailed and 169 ( 39 % ) individuals participated . Respondents had considerable heterogeneity in opinions regarding which ERIC strategies best addressed each CFIR barrier . Across the 39 CFIR barriers , an average of 47 different ERIC strategies ( SD = 4.8 , range 35 to 55 ) was endorsed at least once for each , as being one of seven strategies that would best address the barrier . A tool was developed that allows users to specify high-priority CFIR-based barriers and receive a prioritized list of strategies based on endorsements provided by participants . Conclusions The wide heterogeneity of endorsements obtained in this study ’s task suggests that there are relatively few consistent relationships between CFIR-based barriers and ERIC implementation strategies . Despite this heterogeneity , a tool aggregating endorsements across multiple barriers can support taking a structured approach to consider a broad range of strategies given those barriers . This study ’s results point to the need for a more detailed evaluation of the underlying determinants of barriers and how these determinants are addressed by strategies as part of the implementation planning process Background . The aim of the present study was to investigate factors influencing the adoption , implementation , and institutionalization process of JUMP-in — a multilevel school-based physical activity promotion program — to optimize the dissemination of the intervention and improve its effectiveness . The process evaluation concerned the constraints and success and failure factors at sociopolitical , organizational , user , and intervention levels . Methods . A mixed methods approach including qualitative and quantitative data was conducted during two school years ( 2006 - 2008 ) . Results . JUMP-in was successfully embedded in the Amsterdam municipal policy and in the organizational structure and daily practice s of the sectors involved . A general impeding factor was the complexity of the multilevel programme requiring multidisciplinary collaboration between organizations . In addition , there was a discrepancy between the recommendation to st and ardize and simplify the innovation and the need to tailor the strategies to local environmental , social , and cultural aspects . Conclusions . This process evaluation provides challenges and remedies for managing discrepancies between prerequisites for an effective innovation and dem and s of daily implementation practice . The main recommendations are ( a ) st and ardized , simplified guidelines ; ( b ) stepwise implementation ; ( c ) formalized coalitions , integration of policy , and synchronization of tasks and protocol s ; and ( d ) smart planning and control by clear communication and feedback instruments . If these recommendations are incorporated into the JUMP-in intervention and organization , increased effectiveness and long-term effects can be expected
Output:
| Conclusions Implementation model use was predominately centered on the interpretation of results and analyses , with few examples of use across all study phases as a planning tool and to underst and results .
This lack of implementation models applied may explain the limited success of interventions when delivered under real-world conditions or at scale . |
MS210362 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background In many parts of continental Africa house construction does not appear to impede entry of malaria vectors and , given their generally late biting cycle , the great majority of transmission takes place indoors . In contrast , many houses in São Tomé , 140 km off the coast of Gabon , are raised on stilts and built of wooden planks . Building on stilts is a time-honoured , but largely untested , way of avoiding mosquito bites . Exposure may also be affected by mosquito activity times and age composition of host-seeking females . A study was therefore undertaken on the isl and of São Tomé to determine if exposure to Anopheles gambiae , the only vector on the isl and , varied with house construction or time of the night . Methods A series of all-night l and ing collection s were undertaken out of doors at ground level , inside houses at ground level , on the ver and as of , and inside houses built on stilts . The gonotrophic age of an unselected sample of insects from the first three hours of l and ing collection ( 18:00–21:00 ) was determined by dissection . In addition , 1,149 miniature light-trap collection s were obtained from 125 houses in the study area . Numbers collected were related to house construction . Results Biting of An . gambiae took place primarily outside at ground level . Less than one third of biting occurred inside houses . Houses built on stilts had half the number of An . gambiae in them compared to those built at ground level . Conversely houses with an eaves gap had more An . gambiae in them than houses without such a gap . Gonotrophic age did not affect house entry rates in An . gambiae . House construction affected Culex quinquefasciatus less than An . gambiae . Mean density per house , derived from a series of 1,490 r and omly assigned light-trap collection s , was over-dispersed with 18 % of houses having 70 % of the vectors . Conclusion House construction plays an important role in determining exposure to malaria vectors in São Tomé . Neighbours can have very different exposure levels . Recommendations for improvement in control are given Background One of the best ways to control the transmission of malaria is by breaking the vector-human link , either by reducing the effective population size of mosquitoes or avoiding infective bites . Reducing house entry rates in endophagic vectors by obstructing openings is one simple way of achieving this . Mosquito netting has previously been shown to have this effect . More recently different material s that could also be used have come onto the market . Therefore , a pilot study was conducted to investigate the protective effect of three types of material against Anopheles funestus and Anopheles gambiae s.l entry into village houses in Mozambique when applied over the large opening at the gables and both gables and eaves . Methods A two-step intervention was implemented in which the gable ends of houses ( the largest opening ) were covered with one of three material s ( four year old mosquito bed nets ; locally purchased untreated shade cloth or deltamethrin-impregnated shade cloth ) followed by covering both gable ends and eaves with material . Four experimental rounds ( each of three weeks duration ) , from four houses r and omly assigned to be a control or to receive one of the three intervention material s , were undertaken from March to August 2010 in the village of Furvela in southern Mozambique . Mosquito entry rates were assessed by light-trap collection and the efficacy of the different material s was determined in terms of incidence rate ratio ( IRR ) , obtained through a Generalized Estimating Equations ( GEE ) , of mosquito entry in a treated house compared to the untreated ( control ) house . Results Altogether 9,692 An . funestus and 1,670 An . gambiae s.l . were collected . Houses treated with mosquito netting or the untreated shade cloth had 61.3 % [ IRR = 0.39 ( 0.32 - 0.46 ) ; P < 0.0001 ] and 70 % [ IRR = 0.30 ( 0.25 – 0.37 ) ; P < 0.001 ] fewer An . funestus in relation to untreated houses , but there was no difference in An . funestus in houses treated with the deltamethrin-impregnated shade cloth [ IRR = 0.92 ( 0.76 –1.12 ) ; P = 0.4 ] compared to untreated houses . Houses treated with mosquito netting reduced entry rates of An . gambiae s.l , by 84 % [ IRR = 0.16 ( 0.10 – 0.25 ) ; P < 0.001 ] , whilst untreated shade cloth reduced entry rates by 69 % [ IRR = 0.31 ( 0.19 –0.53 ) ; P < 0.001 ] and entry rates were reduced by 76 % [ IRR = 0.24 ( 0.15 0.38 ) ; P < 0.001 ] in houses fitted with deltamethrin-impregnated shade cloth OBJECTIVE To identify risk factors for uncomplicated malaria in highl and areas of East Africa at higher risk of malaria epidemics , in order to design appropriate interventions . METHODS Prospect i ve , population -based , case-control study in the N and i Hills , a highl and area of western Kenya , to identify environmental , sociodemographic and behavioural factors associated with clinical malaria . Data were collected using field observation , a structured question naire , and a global positioning system device . RESULTS We interviewed 488 cases of slide-confirmed malaria and 980 age-matched controls . Multivariate analyses associated higher malaria risk with living < 250 m of a forest [ OR = 3.3 ( 95 % CI 1.5 , 7.1 ) ] , < 250 m of a swamp [ 2.8 ( 1.3 , 5.9 ) ] , < 200 m of maize fields [ 2.0 ( 1.2 , 3.4 ) ] , in the absence of trees < 200 m [ 1.6 ( 1.2 , 2.2 ) ] , on flat l and [ 1.6 ( 1.2 , 2.2 ) ] , in houses without ceilings [ 1.5 ( 1.1 , 2.2 ) ] , in houses with a separate kitchen building [ 1.8 ( 1.4 , 2.3 ) ] and in households where the female household head had no education [ 1.9 ( 1.1 , 3.1 ) ] . Travelling out of the study site [ 2.2 ( 1.2 , 4.1 ) ] was also associated with increased risk . CONCLUSIONS ; In this East African highl and area , risk of developing uncomplicated malaria was multifactorial with a risk factor profile similar to that in endemic regions . Households within close proximity to forest and swamp borders are at higher risk of malaria and should be included in indoor residual spraying campaigns Background Several studies conducted in Northeast Tanzania have documented declines in malaria transmission even before interventions were scaled up . One explanation for these reductions may be the changes in socio-environmental conditions associated with economic development , and in particular improvements in housing construction . Objective This analysis seeks to identify ( 1 ) risk factors for malaria incidence among young children and ( 2 ) household and environmental factors associated with mosquito vector numbers collected in the child ’s sleeping area . Both analyses focus on housing construction quality as a key determinant . Methodology For 435 children enrolled in a larger trial of intermittent preventive treatment for malaria in infants in the Korogwe District in Tanga , Northeastern Tanzania , detailed information on their dwelling characteristics were collected in the last year of the trial . Principal components analysis was used to construct an index of housing structure quality and converted to quintile units for regression analysis . Univariate and multivariate r and om effects negative binomial regressions were used to predict risk factors for child malaria incidence and the mean total number of indoor female Anopheles gambiae and funestus mosquitoes collected per household across three occasions . Findings Building material s have substantially improved in Korogwe over time . Multivariate regressions showed that residing in rural areas ( versus urban ) increased malaria incidence rates by over three-fold and mean indoor female A. gambiae and funestus numbers by nearly two-fold . Compared to those residing in the lowest quality houses , children residing in the highest quality houses had one-third lower malaria incidence rates , even when wealth and rural residence were controlled for . Living in the highest quality houses reduced vector numbers while having cattle near the house significantly increased them . Conclusions Results corroborate findings from other studies that show associations between malaria incidence and housing quality ; associations were concentrated amongst the highest quality houses Background Underst and ing the role of local environmental risk factors for malaria in holo-endemic , poverty-stricken setting s will be critical to more effectively implement- interventions aim ed at eventual elimination . Household-level environmental drivers of malaria risk during the dry season were investigated in rural southern Malawi among children < five years old in two neighbouring rural Traditional Authority ( TA ) regions dominated by small-scale agriculture . Methods Ten villages were r and omly selected from TA Sitola ( n = 6 ) and Nsamala ( n = 4 ) . Within each village , during June to August 2011 , a census was conducted of all households with children under-five and recorded their locations with a geographic position system ( GPS ) device . At each participating house , a nurse administered a malaria rapid diagnostic test ( RDT ) to children under five years of age , and a question naire to parents . Environmental data were collected for each house , including l and cover within 50-m radius . Variables found to be significantly associated with P. falciparum infection status in bivariate analysis were included in generalized linear models , including multivariate logistic regression ( MLR ) and multi-level multivariate logistic regression ( MLLR ) . Spatial clustering of RDT status , environmental factors , and Pearson residuals from MLR and MLLR were analysed using the Getis-Ord Gi * statistic . Results Of 390 children enrolled from six villages in Sitola ( n = 162 ) and four villages in Nsamala ( n = 228 ) , 45.6 % tested positive ( n = 178 ) for Plasmodium infection by RDT . The MLLR modelled the statistical relationship of Plasmodium positives and household proximity to agriculture ( < 25-m radius ) , controlling for the child sex and age ( in months ) , bed net ownership , elevation , and r and om effects intercepts for village and TA-level unmeasured factors . After controlling for area affects in MLLR , proximity to active agriculture remained a significant predictor of positive RDT result ( OR 2.80 , 95 % CI 1.41 - 5.55 ) . Mapping of Pearson residuals from MLR showed significant clustering ( Gi * z > 2.58 , p < 0.01 ) predominantly within TA Sitola , while residuals from MLLR showed no such clustering . Conclusion This study provides evidence for significant , dry-season heterogeneity of malaria prevalence strongly linked to peridomestic l and use , and particularly of elevated risk associated with nearby crop production Background Identification and better underst and ing of potential risk factors for malaria are important for targeted and cost-effective health interventions . Housing conditions have been suggested as one of the potential risk factors . This study aims to further investigate this risk factor , and is focused on the effect of the type of roof on Plasmodium falciparum infection among children below five years in the North West of Burkina Faso . Methods In a cross-sectional study design , 661 children aged six to 60 months were r and omly selected from three rural and one semi-urban site at the end of the rainy season ( November 2003 ) . The children were screened for fever and tested for Plasmodium falciparum infection . In addition , data on bed net use and house characteristics was collected from the household were each child lived . Using adjusted odds ratios , children living in house roofed with iron-sheet were compared with those in house with mud or grass roof . Results Overall P. falciparum infection prevalence was 22.8 % with a significant variation between ( Chi-square , p < 0.0001 ) . The prevalence in Cissé ( 33.3 % ) and Goni ( 30.6 % ) were twice times more than in Nouna ( 15.2 % ) and Kodougou ( 13.2 % ) . After adjusting for age , sex , use of bed net and housing conditions , children living in houses with mud roofs had significantly higher risk of getting P. falciparum infection compared to those living in iron-sheet roofed houses ( Odds Ratio 2.6 ; 95 % Confidence Interval , 1.4–4.7 ) . Conclusion These results suggest that house characteristics should be taken into consideration when design ing health intervention against P. falciparum infection and particular attention should be paid to children living in houses with mud roofs Background In the pre-intervention year of a r and omized controlled trial investigating the protective effects of house screening against malaria-transmitting vectors , a multi-factorial risk factor analysis study was used to identify factors that influence mosquito house entry . Methods Mosquitoes were sample d using CDC light traps in 976 houses , each on one night , in Farafenni town and surrounding villages during the malaria-transmission season in The Gambia . Catches from individual houses were both ( a ) left unadjusted and ( b ) adjusted relative to the number of mosquitoes caught in four sentinel houses that were operated nightly throughout the period , to allow for night-to-night variation . Houses were characterized by location , architecture , human occupancy and their mosquito control activities , and the number and type of domestic animals within the compound . Results 106,536 mosquitoes were caught , of which 55 % were Anopheles gambiae sensu lato , the major malaria vectors in the region . There were seven fold higher numbers of An . gambiae s.l . in the
Output:
| Conclusions Despite low quality evidence , the direction and consistency of effects indicate that housing is an important risk factor for malaria . |
MS210363 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The relationship between risk of prostate cancer and dietary intake of energy , fat , vitamin A , and other nutrients was investigated in a case-control study conducted in Ontario , Canada . Cases were men with a recent , histologically confirmed diagnosis of adenocarcinoma of the prostate notified to the Ontario Cancer Registry between April 1990 and April 1992 . Controls were selected r and omly from assessment lists maintained by the Ontario Ministry of Revenue , and were frequency-matched to the cases on age . The study included 207 cases ( 51.4 percent of those eligible ) and 207 controls ( 39.4 percent of those eligible ) , and information on dietary intake was collected from them by means of a quantitative diet history . There was a positive association between energy intake and risk of prostate cancer , such that men at the uppermost quartile level of energy intake had a 75 percent increase in risk . In contrast , there was no clear association between the non-energy effects of total fat and monounsaturated fat intake and prostate cancer risk . There was some evidence for an inverse association with saturated fat intake , although the dose-response pattern was irregular . There was a weak ( statistically nonsignificant ) positive association between polyunsaturated fat intake and risk of prostate cancer . Relatively high levels of retinol intake were associated with reduced risk , but there was essentially no association between dietary β-carotene intake and risk . There was no alteration in risk in association with dietary fiber , cholesterol , and vitamins C and E. Although these patterns were evident both overall and within age-strata , and persisted after adjustment for a number of potential confounding factors , they could reflect ( in particular ) the effect of nonrespondent bias The association between plasma carotenoids and prostate cancer risk was investigated in a case-control study nested within the prospect i ve Health Professionals Follow-up Study . We matched 450 incident prostate cancer cases diagnosed from 1993–1998 to 450 controls by age , time , month , and year of blood donation . Modest inverse , but not statistically significant , associations were observed among plasma α-carotene , β-carotene , and lycopene concentrations , and overall risk of prostate cancer diagnosis { odds ratio ( highest versus lowest quintile ; OR ) , α-carotene : OR , 0.67 [ 95 % confidence interval ( CI ) , −0.40–1.09 ] ; β-carotene : OR , 0.78 ( 95 % CI , 0.48–1.25 ) ; lycopene : OR , 0.66 ( 95 % CI , 0.38–1.13)}. The inverse association between plasma lycopene concentrations and prostate cancer risk was limited to participants who were 65 years or older ( OR , 0.47 ; 95 % CI , 0.23–0.98 ) and without a family history of prostate cancer ( OR , 0.48 ; 95 % CI , 0.26–0.89 ) . Combining , older age and a negative family history provided similar results ( OR , 0.43 ; 95 % CI , 0.18–1.02 ) . Inverse associations between β-carotene and prostate cancer risk were also found among younger participants ( < 65 years of age ; OR , 0.36 ; 95 % CI , 0.14–0.91 ; Ptrend = 0.03 ) . Combining dietary intake and plasma data confirmed our results . We found a statistically significant inverse association between higher plasma lycopene concentrations and lower risk of prostate cancer , which was restricted to older participants and those without a family history of prostate cancer . This observation suggests that tomato products may exhibit more potent protection against sporadic prostate cancer rather than those with a stronger familial or hereditary component . In addition , our findings also suggest that among younger men , diets rich in β-carotene may also play a protective role in prostate carcinogenesis BACKGROUND Several human studies have observed a direct association between retinol ( vitamin A ) intake and risk of prostate cancer ; other studies have found either an inverse association or no association of intake of beta-carotene ( the major provitamin A ) with risk of prostate cancer . Data regarding carotenoids other than beta-carotene in relation to prostate cancer risk are sparse . PURPOSE We concluded a prospect i ve cohort study to examine the relationship between the intake of various carotenoids , retinol , fruits , and vegetables and the risk of prostate cancer . METHODS Using responses to a vali date d , semiquantitative food-frequency question naire mailed to participants in the Health Professionals Follow-up Study in 1986 , we assessed dietary intake for a 1-year period for a cohort of 47,894 eligible subjects initially free of diagnosed cancer . Follow-up question naires were sent to the entire cohort in 1988 , 1990 , and 1992 . We calculated the relative risk ( RR ) for each of the upper categories of intake of a specific food or nutrient by dividing the incidence rate of prostate cancer among men in each of these categories by the rate among men in the lowest intake level . All P values result ed from two-sided tests . RESULTS Between 1986 and 1992 , 812 new cases of prostate cancer , including 773 non-stage A1 cases , were documented . Intakes of the carotenoids beta-carotene , alpha-carotene , lutein , and beta-cryptoxanthin were not associated with risk of non-stage A1 prostate cancer ; only lycopene intake was related to lower risk ( age- and energy-adjusted RR = 0.79 ; 95 % confidence interval [ CI ] = 0.64 - 0.99 for high versus low quintile of intake ; P for trend = .04 ) . Of 46 vegetables and fruits or related products , four were significantly associated with lower prostate cancer risk ; of the four -- tomato sauce ( P for trend = .001 ) , tomatoes ( P for trend = .03 ) , and pizza ( P for trend = .05 ) , but not strawberries -- were primary sources of lycopene . Combined intake of tomatoes , tomato sauce , tomato juice , and pizza ( which accounted for 82 % of lycopene intake ) was inversely associated with risk of prostate cancer ( multivariate RR = 0.65 ; 95 % CI = 0.44 - 0.95 , for consumption frequency greater than 10 versus less than 1.5 servings per week ; P for trend = .01 ) and advanced ( stages C and D ) prostate cancers ( multivariate RR = 0.47 ; 95 % CI = 0.22 - 1.00 ; P for trend = .03 ) . No consistent association was observed for dietary retinol and risk of prostate cancer . CONCLUSIONS These findings suggest that intake of lycopene or other compounds in tomatoes may reduce prostate cancer risk , but other measured carotenoids are unrelated to risk . IMPLICATION S Our findings support recommendations to increase vegetable and fruit consumption to reduce cancer incidence but suggest that tomato-based foods may be especially beneficial regarding prostate cancer risk In order to learn about the influence of dietary factors and obesity on prostatic cancer in our environment , a case-control study was performed . The group of cases consisted of 90 men histologically diagnosed with prostatic cancer in the ' La Paz ' hospital ( Madrid ) during the 4-year period of 1983 - 1987 . The controls were 180 men selected to obtain a r and om sample of males from the same hospital , stratified according to age and date of admission as compared with the prostatic cancer patients . The results of the study revealed that a diet rich in animal fats as well as high in meat consumption increased the risk of prostatic cancer . Low ingestion of vitamin A or vitamin C and obesity were unassociated to the disease Previously , tomato powder ( TP ) diets initiated postweaning have been shown to be effective in reducing prostate cancer in the transgenic adenocarcinoma of the mouse prostate ( TRAMP ) model . The TRAMP model develops and progresses through all stages of carcinogenesis similarly to humans . We hypothesized that a 10 % TP diet intervention after puberty would reduce carcinogenesis at 12 , 16 , and 20 weeks of age in TRAMP mice . Eight-week-old male C57BL/6 X FVB F1 TRAMP mice were r and omized to consume either an AIN-93 G + 10 % TP diet ( n = 90 ) or the AIN-93 G control diet ( n = 88 ) and r and omized to 1 of 3 end point ages : 12 ( n = 59 ) , 16 ( n = 60 ) , or 20 ( n = 59 ) weeks of age . There was no difference between diets in overall cancer incidence at any time point . However , at 16 weeks of age , TP significantly increased high- grade PIN ( P = .014 ) and significantly decreased poorly differentiated ( P = .024 ) lesions compared with the control diet suggesting a delay in the progression of prostate cancer . Two variables that may explain the modest effect of TP in this study are as follows : the low amount of lycopene in the TP diet ( 12.3 ppm ) and the timing of the intervention ( 8 weeks of age ) . The TP diet contained 30-fold less lycopene than previous studies in our laboratory . In addition , the initiation of the diet intervention time of 8 weeks of age instead of 4 weeks of age may have been too late in cancer progression to substantially impact carcinogenesis . In conclusion , a low-lycopene TP intervention failed to reduce carcinogenesis in TRAMP mice BACKGROUND The amount of dietary fat required for optimal bioavailability of carotenoids in plant matrices is not clearly defined . OBJECTIVE The objective was to quantify the appearance of carotenoids in plasma chylomicrons after subjects ingested fresh vegetable salads with fat-free , reduced-fat , or full-fat salad dressings . DESIGN The subjects ( n = 7 ) each consumed 3 salads consisting of equivalent amounts of spinach , romaine lettuce , cherry tomatoes , and carrots with salad dressings containing 0 , 6 , or 28 g canola oil . The salads were consumed in r and om order separated by washout periods of > or = 2 wk . Blood sample s were collected hourly from 0 to 12 h. Chylomicrons were isolated by ultracentrifugation , and carotenoid absorption was analyzed by HPLC with coulometric array detection . RESULTS After ingestion of the salads with fat-free salad dressing , the appearance of alpha-carotene , beta-carotene , and lycopene in chylomicrons was negligible . After ingestion of the salads with reduced-fat salad dressing , the appearance of the carotenoids in plasma chylomicrons increased relative to that after ingestion of the salads with fat-free salad dressing ( P < 0.04 ) . Similarly , the appearance of the carotenoids in plasma chylomicrons was higher after the ingestion of salads with full-fat than with reduced-fat salad dressing ( P < 0.02 ) . CONCLUSIONS High-sensitivity HPLC with coulometric array detection enabled us to quantify the intestinal absorption of carotenoids ingested from a single vegetable salad . Essentially no absorption of carotenoids was observed when salads with fat-free salad dressing were consumed . A substantially greater absorption of carotenoids was observed when salads were consumed with full-fat than with reduced-fat salad dressing BACKGROUND There is limited evidence that supports etiologically distinct molecular subtypes of prostate cancer , the identification of which may improve prevention . Given their antioxidant properties , we hypothesized that lycopene and tomato sauce may be especially protective against diseases harboring the common gene fusion transmembrane protease , serine 2 (TMPRSS2):v-ets avian erythroblastosis virus E26 oncogene homolog ( ERG ) . OBJECTIVE We aim ed to examine associations between estimated lycopene and tomato sauce intake and the risk of prostate cancer defined by ERG protein expression subtype . DESIGN Our study population consisted of a prospect i ve cohort of 46,719 men from the Health Professionals Follow-Up Study . TMPRSS2:ERG was assessed by ERG immunohistochemistry on tumor tissue microarrays constructed from radical prostatectomy specimens . We used multivariable competing risk models to calculate HRs and 95 % CIs for the risk of ERG-positive and , separately , ERG-negative disease . We implemented inverse probability weighting to account for evaluating ERG status only in surgically treated cases . RESULTS During 23 y of follow-up , 5543 men were diagnosed with prostate cancer , among whom 884 were assayed for ERG ( 426 ERG-positive ) . With inclusion of only the latter cases , increasing cumulative average tomato sauce intake was associated with a decreased risk of prostate cancer overall ( ≥2 servings/wk compared with < 1 serving/mo ; multivariable HR : 0.70 ; 95 % CI : 0.52 , 0.95 ; P-trend = 0.002 ) . With respect to molecular subtypes , cumulative average tomato sauce intake was associated with a decreased risk of ERG-positive disease ( HR : 0.54 ; 95 % CI : 0.37 , 0.81 ; P-trend = 0.004 ) but not with ERG-negative disease ( HR : 0.96 ; 95 % CI : 0.
Output:
| Conclusions Our data demonstrate that increased tomato consumption is inversely associated with PCa risk .
These findings were accompanied with dose – response relationships for total tomato consumption and for cooked tomatoes and sauces . |
MS210364 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Recent studies have shown that a transcutaneous electrical nerve stimulation ( TENS ) and interferential current ( IFC ) application reduces pain in subjects with musculoskeletal disorders . However there are no clinical trials evaluating or comparing the muscle relaxation generated for these devices . PURPOSE To compare the muscle relaxation of the upper trapezius induced by the application of TENS and IFC in females with chronic nonspecific neck discomfort . METHODS Sixty-four females between 18 and 40 years of age and a history of nonspecific neck discomfort were r and omly assigned to a TENS or an IFC group . The women in the TENS ( N = 32 ; mean age 22 years ) and IFC ( N = 32 , mean age 23 years ) group were su bmi tted to current application during 3 consecutive days and were assessed by electromyography ( EMG ) in different times aim ing to quantify the muscular tension of the upper trapezius . A visual analogue scale ( VAS ) was used as pain measure at baseline ( before TENS or IFC application ) and at the end of the study . RESULTS At baseline , demographic , pain , and EMG assessment data were similar between groups . Those in the IFC group had a significant trapezius relaxation after 3 IFC applications when compared to baseline and intermediate evaluations ( P < 0.05 ) . In contrast , the same analysis showed no significant difference between all assessment s in the TENS group ( P > 0.05 ) . In relation to pain relief , both groups showed an improvement at the end of the study when compared to baseline ( both , P < 0.05 ) . The between-group analysis showed no difference for the subjects who received such IFC as TENS application ( P < 0.05 ) . CONCLUSION IFC induced the upper trapezius relaxation after 3 sessions in females with neck discomfort , but the TENS application did not change the muscular tension . However , these results should be carefully interpreted due to the lack of differences between groups . A significant pain decrease was found in the subjects of both groups , however , only the IFC application presented a clinical ly important improvement OBJECTIVE To compare the effectiveness of transcutaneous electrical nerve stimulation ( TENS ) , interferential currents ( IFCs ) , and shortwave diathermy ( SWD ) against each other and sham intervention with exercise training and education as a multimodal package . DESIGN A double-blind , r and omized , controlled , multicenter trial . SETTING Departments of physical medicine and rehabilitation in 4 centers . PARTICIPANTS Patients ( N=203 ) with knee osteoarthritis ( OA ) . INTERVENTIONS The patients were r and omized by the principal center into the following 6 treatment groups : TENS sham , TENS , IFCs sham , IFCs , SWD sham , and SWD . All interventions were applied 5 times a week for 3 weeks . In addition , exercises and an education program were given . The exercises were carried out as part of a home-based training program after 3 weeks ' supervised group exercise . MAIN OUTCOME MEASURES Primary outcome was a visual analog scale ( 0 - 100 mm ) to assess knee pain . Other outcome measures were time to walk a distance of 15 m , range of motion , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , Nottingham Health Profile , and paracetamol intake ( in grams ) . RESULTS We found a significant decrease in all assessment parameters ( P<.05 ) , without a significant difference among the groups except WOMAC stiffness score and range of motion . However , the intake of paracetamol was significantly lower in each treatment group when compared with the sham groups at 3 months ( P<.05 ) . Also , the patients in the IFCs group used a lower amount of paracetamol at 6 months ( P<.05 ) in comparison with the IFCs sham group . CONCLUSIONS Although all groups showed significant improvements , we can suggest that the use of physical therapy agents in knee OA provided additional benefits in improving pain because paracetamol intake was significantly higher in the patients who were treated with 3 sham interventions in addition to exercise and education Objectives . Newly developed bidirectional modulated sine waves ( BMW ) might provide some derived benefit to patients with low back pain . Pain relief by transcutaneous electric nerve stimulation ( TENS ) with BMWs was tested . Material s and Methods . Analgesic effects of BMWs and conventional bidirectional pulsed waves on chronic back pain in 28 patients were compared , and effects of repeated TENS using BMWs on chronic back pain were investigated in 21 patients by means of a r and omized double-blind , sham-controlled , parallel-group method . Pain intensity was assessed using numerical rating scale ( NRS ) . Results . There was significant immediate reduction in NRS in patients receiving BMWs , and 60 min after treatment compared to sham TENS . Weekly repeated treatments using massage and TENS with BMWs for 5 weeks result ed in a decrease of NRS , but there were no significant differences between the TENS plus massage and sham TENS plus massage groups . Conclusions . This study shows that TENS with BMWs significantly inhibits chronic back pain , and treatment effects are attained within a day . The results also suggest that there were no statistically significant long-term effects of TENS with BMW in the repeated treatment UNLABELLED Transcutaneous electrical nerve stimulation ( TENS ) is an electrophysical modality used for pain management . This study investigated the dose response of different TENS intensities on experimentally induced pressure pain . One hundred and thirty TENS naïve healthy individuals ( 18 - 64 years old ; 65 males , 65 females ) were r and omly allocated to 5 groups ( n = 26 per group ) : Strong Non Painful TENS ; Sensory Threshold TENS ; Below Sensory Threshold TENS ; No Current Placebo TENS ; and Transient Placebo TENS . Active TENS ( 80 Hz ) was applied to the forearm for 30 minutes . Transient Placebo TENS was applied for 42 seconds after which the current amplitude automatically reset to 0 mA. Pressure pain thresholds ( PPT ) were recorded from 2 points on the h and and forearm before and after TENS to measure hypoalgesia . There were significant differences between groups at both the h and and forearm ( ANOVA ; P = .005 and .002 ) . At 30 minutes , there was a significant hypoalgesic effect in the Strong Non Painful TENS group compared to : Below Sensory Threshold TENS , No Current Placebo TENS and Transient Placebo TENS groups ( P < .0001 ) at the forearm ; Transient Placebo TENS and No Current Placebo TENS groups at the h and ( P = .001 ) . There was no significant difference between Strong Non Painful TENS and Sensory Threshold TENS groups . The area under the curve for the changes in PPT significantly correlated with the current amplitude ( r(2 ) = .33 , P = .003 ) . These data therefore show that there is a dose-response effect of TENS with the largest effect occurring with the highest current amplitudes . PERSPECTIVE This study shows a dose response for the intensity of TENS for pain relief with the strongest intensities showing the greatest effect ; thus , we suggest that TENS intensity should be titrated to achieve the strongest possible intensity to achieve maximum pain relief CONTEXT AND OBJECTIVE Transcutaneous electrical nerve stimulation ( TENS ) and interferential current are the most used electrotherapy methods , although there is little scientific evidence to support their use . The aim of this study was to compare the effects of TENS and interferential current among patients with nonspecific chronic low back pain . DESIGN AND SETTING Single-blind r and omized controlled trial in the Department of Physiotherapy , Centro Universitário de Maringá . METHODS One hundred and fifty patients were r and omly divided into three groups : TENS ( group 1 ) , interferential current ( group 2 ) and controls ( group 3 ) . The patients design ated for electrotherapy received ten 30-minute sessions , while the control group remained untreated . All patients and controls were evaluated before and after treatment using a visual analog scale and the McGill Pain and Rol and Morris question naires , and regarding their use of additional medications . RESULTS There was a mean reduction on the visual analog scale of 39.18 mm with TENS , 44.86 mm with interferential current and 8.53 mm among the controls . In the Rol and Morris question naire , group 1 had a mean reduction of 6.59 ; group 2 , 7.20 ; and group 3 , 0.70 points . In group 1 , 84 % of the patients stopped using medications after the treatment ; in group 2 , 75 % ; and in group 3 , 34 % . There was no statistically significant difference between the TENS and interferential current groups ( P > 0.05 ) ; a difference was only found between these groups and the controls ( P < 0.0001 ) . CONCLUSION There was no difference between TENS and interferential current for chronic low back pain treatment . CLINICAL TRIAL REGISTRATION NCT01017913 Background In the currently available research publications on electrical therapy of low back pain , generally no control groups or detailed r and omization were used , and such studies were often conducted with relatively small groups of patients , based solely on subjective question naires and pain assessment scales ( lacking measurement methods to objectify the therapeutic progress ) . The available literature also lacks a comprehensive and large-scale clinical study . The purpose of this study was to assess the effects of treating low back pain using selected electrotherapy methods . The study assesses the influence of individual electrotherapeutic treatments on reduction of pain , improvement of the range of movement in lower section of the spine , and improvement of motor functions and mobility . Material / Methods The 127 patients qualified for the therapy ( ultimately , 123 patients completed the study ) and assigned to 6 comparison groups : A – conventional TENS , B – acupuncture-like TENS , C – high-voltage electrical stimulation , D – interferential current stimulation , E – diadynamic current , and F – control group . Results The research showed that using electrical stimulation with interferential current penetrating deeper into the tissues results in a significant and more efficient elimination of pain , and an improvement of functional ability of patients suffering from low back pain on the basis of an analysis of both subjective and objective parameters . The TENS currents and high voltage were helpful , but not as effective . The use of diadynamic currents appears to be useless . Conclusions Selected electrical therapies ( interferential current , TENS , and high voltage ) appear to be effective in treating chronic low back pain Background Chronic pain is a public health problem although there is a paucity of prevalence data from countries in the Middle East and North Africa . The aim of this study was to estimate the prevalence of chronic pain and neuropathic pain in a sample of the general adult population in Libya . Methods A cross-sectional telephone survey was conducted before the onset of the Libyan Civil War ( February 2011 ) on a sample of self-declared Libyans who had a l and line telephone and were at least 18 years of age . R and om sampling of household telephone number dialling was undertaken in three major cities and interviews conducted using an Arabic version of the Structured Telephone Interviews Question naire on Chronic Pain previously used to collect data in Europe . In addition , an Arabic version of S-LANSS was used . 1212 individuals were interviewed ( response rate = 95.1 % , mean age = 37.8 ± 13.9 years , female = 54.6 % ) . Results The prevalence of chronic pain ≥ 3 months was 19.6 % ( 95 % CI 14.6 % to 24.6 % ) with a mean ± SD duration of pain of 6 · 5 ± 5 · 7 years and a higher prevalence for women . The prevalence of neuropathic pain in the respondents reporting chronic pain was 19 · 7 % ( 95 % CI 14 · 6 - 24 · 7 ) , equivalent to 3 · 9 % ( 95 % CI 2 · 8 to 5 · 0 % ) of the general adult population . Only , 71 ( 29 · 8 % ) of respondents reported that their pain was being adequately controlled . Conclusions The prevalence of chronic pain in the general adult population of Libya was approximately 20 % and comparable with Europe and North America . This suggests that chronic pain is a public health problem in Libya . Risk factors are being a woman , advanced age and unemployment . There is a need for improved health policies in Libya to ensure that patients with chronic pain receive effective management OBJECTIVE To compare the effectiveness of transcutaneous electrical nerve stimulation and interferential current in primary dysmenorrhea . DESIGN A prospect i ve , r and omized , and controlled study . SETTING Hacettepe University School of Physical Therapy and Rehabilitation . PATIENTS Thirty-four volunteer subjects with primary dysmenorrhea ( mean age : 21.35 + /- 1.70 years ) were included . Statistical analyses were performed in 32 subjects who completed all measures . INTERVENTIONS Fifteen subjects received interferential current application for 20 minutes and 17 subjects received transcutaneous electrical nerve stimulation for 20 minutes when they were experiencing dysmenorrhea . OUTCOME MEASURES Physical characteristics , years since menarche , length of menstrual cycle ( days ) , and duration of menstruation ( days ) were recorded . Visual analog scale ( VAS ) intensities of menstrual pain , referred lower limb pain , and low back pain were recorded before treatment , and immediately , 8 hours , and 24 hours after treatment . RESULTS Intensities of the evaluated parameters decreased beginning from just after the applications
Output:
| In general , both transcutaneous electrical nerve stimulation and interferential current improved pain and functional outcomes without a statistical difference between them . |
MS210365 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Diabetes may confer an increased risk for the cardiovascular health effects of particulate air pollution , but few human clinical studies of air pollution have included people with diabetes . Ultrafine particles ( UFP , ≤100 nm in diameter ) have been hypothesized to be an important component of particulate air pollution with regard to cardiovascular health effects . Methods 17 never-smoker subjects 30–60 years of age , with stable type 2 diabetes but otherwise healthy , inhaled either filtered air ( 0–10 particles/cm3 ) or elemental carbon UFP ( ~107 particles/cm3 , ~50 ug/m3 , count median diameter 32 nm ) by mouthpiece , for 2 hours at rest , in a double-blind , r and omized , crossover study design . A digital 12-lead electrocardiogram ( ECG ) was recorded continuously for 48 hours , beginning 1 hour prior to exposure . Results Analysis of 5-minute segments of the ECG during quiet rest showed reduced high-frequency heart rate variability with UFP relative to air exposure ( p = 0.014 ) , paralleled by non-significant reductions in time-domain heart rate variability parameters . In the analysis of longer duration s of the ECG , we found that UFP exposure increased the heart rate relative to air exposure . During the 21- to 45-hour interval after exposure , the average heart rate increased approximately 8 beats per minute with UFP , compared to 5 beats per minute with air ( p = 0.045 ) . There were no UFP effects on cardiac rhythm or repolarization . Conclusions Inhalation of elemental carbon ultrafine particles alters heart rate and heart rate variability in people with type 2 diabetes . Our findings suggest that effects may occur and persist hours after a single 2-hour exposure Previous reports suggest that inflammatory bowel diseases may be accompanied by abnormalities in the neural autonomic profile . We tested the hypotheses that 1 ) an exaggerated sympathetic activity characterizes active ulcerative colitis ( UC ) and 2 ) a reduction of sympathetic activity by clonidine would be associated with clinical changes of UC . In 23 patients with UC and 20 controls , muscle sympathetic nerve activity ( MSNA ) , ECG , blood pressure , and respiration were continuously recorded , and plasma catecholamine was evaluated both at rest and during a 75 degrees head-up tilt . Autonomic profile was assessed by MSNA , norepinephrine , epinephrine , spectral markers of low-frequency ( LF ) cardiac sympathetic ( LF(RR ) ; normalized units ) and high-frequency ( HF ) parasympathetic ( HF(RR ) ; normalized units ) modulation and sympathetic vasomotor control ( LF systolic arterial pressure ; LF(SAP ) ) , obtained by spectrum analysis of the R-R interval and systolic pressure variability . Among UC patients , 16 agreed to be r and omly assigned to 8-wk transdermal clonidine ( 15 mg/wk , 9 subjects ) , or placebo ( 7 patients ) . An autonomic profile , Disease Activity Index ( DAI ) , and endoscopic pattern were compared before and after clonidine/placebo . At rest , MSNA , heart rate ( HR ) , LF(RR ) , LF/HF , and LF(SAP ) were higher and HF(RR ) was lower in patients than in controls . Tilt decreased HF(RR ) and increased MSNA and LF(RR ) less in patients than in controls . Clonidine decreased HR , MSNA , epinephrine , LF(RR ) , and increased HF(RR ) , whereas placebo had no effects . Changes of the autonomic profile after clonidine were associated with reduction of DAI score . An overall increase of sympathetic activity characterized active UC . Normalization of the autonomic profile by clonidine was accompanied by an improvement of the disease Epidemic of diabetes , affecting about 3–5 % of Western population s , is one of the main threats to human health in the 21st century ( 1 ) . Changes in the human environment , behavior , and lifestyle have result ed in a dramatic increase in the incidence and prevalence of diabetes in people with genetic susceptibility to diabetes . The global number of people with diabetes was 151 million in 2000 , and it is projected to increase to 221 million in 2010 ( an increase of 46 % ) both in developed and developing countries ( 2 ) . Chronic hyperglycemia leads to many long-term complications in the eyes , kidneys , nerves , heart , and blood vessels . Individuals with pre-diabetes , undiagnosed type 2 diabetes , and long-lasting type 2 diabetes are at high risk of all complications of macrovascular disease , coronary heart disease ( CHD ) , stroke , and peripheral vascular disease . More than 70 % of patients with type 2 diabetes die of cardiovascular causes ( 3 ) . Therefore , the epidemic of type 2 diabetes will be followed by an epidemic of diabetes-related cardiovascular disease ( CVD ) . Over the years , epidemiological studies have produced important information on the prevalence and incidence of diabetes complications in different population s. They have also given important information on different risk factors determining susceptibility to diabetes complications ( Fig. 1 ) . This information is crucial for mechanistic studies in physiology at the tissue level and for molecular biology studies at the cellular level . A good example is glycated hemoglobin . Several studies have indicated that glycated hemoglobin is associated with diabetes complications in prospect i ve epidemiological studies . That information has been crucial for the planning of clinical trials to test the hypothesis that the treatment of chronic hyperglycemia leads to reduction in long-term diabetes complications . Moreover , information from epidemiology has led to several mechanistic studies and the elucidation of molecular level insights how insulin resistance and hyperglycemia lead to diabetes complications . We examined whether an injection of intravenous insulin and intravenous glucose would affect frequency-domain measures of heart rate variability ( HRV ) , i.e. , the high-frequency ( HF- ) b and and the ratio of the low frequency ( LF- ) to the HF-b and in healthy humans . Using a classical conditioning protocol , we also assessed whether the measures of HRV are subject to classical conditioning . Thirty healthy men were divided into three groups , given a conditioned stimulus ( CS ) and an intravenous injection of either insulin ( 0.05IU/kg ) in Group 1 , glucose ( 15 % , 0.5g/kg ) in Group 2 , or placebo ( physiological saline [ 0.9 % ] ) in Group 3 during the 4-day acquisition phase . All subjects were given an olfactory CS ( rosewood-peppermint smell ) and placebo injection on day 5 ( test ) . Due to their high inter-individual variability , HF and LF/HF-ratio were analysed by intragroup comparisons , using a pre-injection baseline interval ( min -15 to -5 ) , and three functional post-injection intervals : a ) the interval to the maximum insulin level , i. e. insulin peak ( min 0 - 5 ) in Groups 1 and 2 , b ) the interval to the maximum of insulin-induced hypoglycaemia ( min 20 - 25 ) in Group 1 , and c ) the end of the session ( min 70 - 75 ) . On days 1 to 4 , we found significant increases of the HF-b and from baseline to interval min 0 - 5 in Group 1 , and an even more pronounced increase in the glucose-treated Group 2 . At the test ( Day 5 ) , both experimental groups responded with an HF-increase in the interval of the former insulin peak , and also at the other measurement intervals , reflecting some general increase of vagal activity remaining as a conditioned response . On days 1 to 4 , the HF-b and was positively correlated with the change of peripheral insulin levels in Group 1 , reaching statistical significance on days 3 and 4 . This pattern only emerged in tendency on Day 4 in Group 2 . In conclusion , insulin triggers an increase in parasympathetic tone at maximum hyperinsulinaemia , and our data support the notion that this response pattern can become classically conditioned Introduction The need for colonoscopy is common among diabetics . In this study , we aim ed to evaluate the effect of autonomous neuropathy on bowel preparation in type 2 diabetes mellitus ( DM ) patients . Material s and methods The study population consisted of 45 patients with DM and 48 non-diabetic , age- and sex-matched subjects . All colonoscopies were performed 5 h after the last dose of sodium phosphate . Colonoscopists rated the bowel preparation quality during the procedure using the Aronchick scale . All patients underwent a detailed cardiologic examination and 24-h Holter rhythm monitoring . Orthostatic hypotension and impairment in heart rate variability were accepted as indicators of autonomous neuropathy . Results Gender , age , blood pressure , and heart rates did not differ significantly between groups ( p > 0.05 ) . Autonomous neuropathy was detected in 14 ( 31.1 % ) patients in the DM group and in two ( 4.2 % ) in the control group ( p < 0.05 ) . Optimal bowel cleansing was achieved in 93.8 % of controls and 73.3 % of diabetics ; bowel cleansing was suboptimal in 26.7 % of diabetics and 6.2 % of controls ( p < 0.05 ) . Optimal bowel cleansing was achieved in six of 14 ( 42.8 % ) diabetic patients with autonomous neuropathy ; however , optimal bowel cleansing was achieved in 27 of 31 ( 87.1 % ) diabetic patients without autonomous neuropathy ( p < 0.05 ) . Although optimal bowel cleansing was more prevalent among control patients than in diabetic patients without autonomous neuropathy , the difference was not significant ( 87.1 % vs 93.8 % ; p > 0.05 ) . Conclusion These data suggest that optimal bowel cleansing is poorer in diabetics with autonomous neuropathy than in those without autonomous neuropathy and controls Objectives Appropriate reporting is central to the application of findings from research to clinical practice . The Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) recommendations consist of a checklist of 22 items that provide guidance on the reporting of cohort , case – control and cross-sectional studies , in order to facilitate critical appraisal and interpretation of results . STROBE was published in October 2007 in several journals including The Lancet , BMJ , Annals of Internal Medicine and PLoS Medicine . Within the framework of the revision of the STROBE recommendations , the authors examined the context and circumstances in which the STROBE statement was used in the past . Design The authors search ed the Web of Science data base in August 2010 for articles which cited STROBE and examined a r and om sample of 100 articles using a st and ardised , piloted data extraction form . The use of STROBE in observational studies and systematic review s ( including meta-analyses ) was classified as appropriate or inappropriate . The use of STROBE to guide the reporting of observational studies was considered appropriate . Inappropriate uses included the use of STROBE as a tool to assess the method ological quality of studies or as a guideline on how to design and conduct studies . Results The authors identified 640 articles that cited STROBE . In the r and om sample of 100 articles , about half were observational studies ( 32 % ) or systematic review s ( 19 % ) . Comments , editorials and letters accounted for 15 % , method ological articles for 8 % , and recommendations and narrative review s for 26 % of articles . Of the 32 observational studies , 26 ( 81 % ) made appropriate use of STROBE , and three uses ( 10 % ) were considered inappropriate . Among 19 systematic review s , 10 ( 53 % ) used STROBE inappropriately as a tool to assess study quality . Conclusions The STROBE reporting recommendations are frequently used inappropriately in systematic review s and meta-analyses as an instrument to assess the method ological quality of observational studies To investigate the effects of obesity and weight loss on cardiovascular autonomic function , we examined 28 obese patients referred for weight-reducing gastroplasty , 24 obese patients who received dietary recommendations , and 28 lean subjects . Body weight , blood pressure , and 24-hour urinary norepinephrine excretion were measured , and time and frequency domain indexes of heart rate variability ( HRV ) were obtained from 24-hour Holter recordings . A measure of long-term HRV , the SD of all normal RR intervals ( SDANN ) , was used as an index of sympathetic activity and the high-frequency ( HF ) component of the frequency domain , reflecting short-term HRV , as an estimate of vagal activity . All 3 study groups were investigated at baseline , and the 2 obese groups were reexamined at 1-year follow-up . Obese patients had higher blood pressure , higher urinary norepinephrine excretion , and attenuated SDANN and HF values than lean subjects ( p < 0.01 ) . Obese patients treated with surgery had a mean weight loss of 32 kg ( 28 % ) , whereas the obese group treated with dietary recommendations remained weight stable ( p < 0.001 ) . At follow-up the weight-loss group displayed decreases in blood pressure and norepinephrine excretion and showed increments in SDANN
Output:
| Levels of blood glucose and HbA1c were associated with several HRV parameters , as well as Time from diagnosis of T2DM .
T2DM was associated with an overall decrease in the HRV of T2DM patients .
Both sympathetic and parasympathetic activity were decreased , which can be explained by the deleterious effects of altered glucose metabolism on HRV , leading to cardiac autonomic neuropathy |
MS210366 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives To evaluate the efficacy and safety of certolizumab pegol ( CZP ) after 24 weeks in RAPID-PsA ( NCT01087788 ) , an ongoing Phase 3 trial in patients with psoriatic arthritis ( PsA ) . Methods Patients were r and omised 1:1:1 to placebo , 200 mg CZP every 2 weeks ( Q2W ) or 400 mg CZP every 4 weeks ( Q4W ) . Patients could have had exposure to one previous tumour necrosis factor ( TNF ) inhibitor therapy . Primary endpoints were American College of Rheumatology 20 % ( ACR20 ) response at week 12 and modified Total Sharp Score change from baseline at week 24 . Secondary endpoints included ; Psoriatic Arthritis Response Criteria ( PsARC ) score , Health Assessment Question naire Disability Index ( HAQ-DI ) , Psoriasis Area and Severity Index , Leeds Enthesitis Index , Leeds Dactylitis Index , and Modified Nail Psoriasis Severity Index . Results Of 409 patients r and omised , 368 completed 24 weeks of treatment . ACR20 response was significantly greater in CZP 200 mg Q2W and 400 mg Q4W-treated patients than placebo ( 58.0 % and 51.9 % vs 24.3 % ( p<0.001 ) ) at week 12 , with improvements observed by week 1 . There was a statistically significant improvement in physical function from baseline , measured by HAQ-DI in CZP patients compared with placebo ( −0.50 vs −0.19 , p<0.001 ) and more patients treated with CZP 200 mg Q2W and CZP 400 mg achieved an improvement in PsARC at week 24 than placebo ( 78.3 % and 77.0 % vs 33.1 % ( p<0.001 ) ) . Sustained improvements were observed in psoriatic skin involvement , enthesitis , dactylitis and nail disease . Higher ACR20 response with CZP was independent of prior TNF inhibitor exposure . No new safety signals were observed . Conclusions Rapid improvements in the signs and symptoms of PsA , including joints , skin , enthesitis , dactylitis and nail disease were observed across both CZP dosing regimens Background : Certolizumab pegol is a PEGylated tumour necrosis factor inhibitor . Objective : To evaluate the efficacy and safety of certolizumab pegol versus placebo , plus methotrexate ( MTX ) , in patients with active rheumatoid arthritis ( RA ) . Methods : An international , multicentre , phase 3 , r and omised , double-blind , placebo-controlled study in active adult-onset RA . Patients ( n = 619 ) were r and omised 2:2:1 to subcutaneous certolizumab pegol ( liquid formulation ) 400 mg at weeks 0 , 2 and 4 followed by 200 mg or 400 mg plus MTX , or placebo plus MTX , every 2 weeks for 24 weeks . The primary end point was ACR20 response at week 24 . Secondary end points included ACR50 and ACR70 responses , change from baseline in modified Total Sharp Score , ACR core set variables and physical function . Results : Significantly more patients in the certolizumab pegol 200 mg and 400 mg groups achieved an ACR20 response versus placebo ( p⩽0.001 ) ; rates were 57.3 % , 57.6 % and 8.7 % , respectively . Certolizumab pegol 200 and 400 mg also significantly inhibited radiographic progression ; mean changes from baseline in mTSS at week 24 were 0.2 and −0.4 , respectively , versus 1.2 for placebo ( rank analysis p⩽0.01 ) . Certolizumab pegol-treated patients reported rapid and significant improvements in physical function versus placebo ; mean changes from baseline in HAQ-DI at week 24 were −0.50 and −0.50 , respectively , versus −0.14 for placebo ( p⩽0.001 ) . Most adverse events were mild or moderate , with low incidence of withdrawals due to adverse events . Five patients developed tuberculosis . Conclusion : Certolizumab pegol plus MTX was more efficacious than placebo plus MTX , rapidly and significantly improving signs and symptoms of RA and physical function and inhibiting radiographic progression . Trial registration number : Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objectives This 52-week , r and omised , double-blind phase IIIb study assessed efficacy and safety of certolizumab pegol ( CZP ) as add-on therapy to non-biologic disease-modifying antirheumatic drugs ( DMARDs ) in rheumatoid arthritis ( RA ) patients with low to moderate disease activity , and stopping therapy in patients in sustained remission . Methods Patients were r and omised 1:1 to CZP ( 400 mg at weeks 0 , 2 and 4 , then 200 mg every 2 weeks ) or placebo ( every 2 weeks ) plus current non-biologic DMARDs . At week 24 , patients who achieved the primary endpoint of Clinical Disease Activity Index ( CDAI ) remission at both weeks 20 and 24 stopped study treatment and continued in the study until week 52 . Results Of 194 patients ( CZP=96 ; placebo=98 ) , > 90 % had moderate disease activity at baseline . Significantly more CZP patients met the primary endpoint than placebo patients ( week 20 and 24 CDAI remission rates : 18.8 % vs 6.1 % ; p≤0.05 ) . At week 24 , 63.0 % vs 29.7 % of CZP versus placebo patients ( p<0.001 ) achieved LDA . Disease activity score ( ESR ) based on 28-joint count and Simplified Disease Activity Index remission rates were also significantly higher with CZP versus placebo ( 19.8 % vs 3.1 % ; p≤0.01 and 14.6 % vs 4.1 % ; p≤0.05 ) . CZP patients reported improvements in physical function versus placebo ( mean Health Assessment Question naire-Disability-Index change from baseline : CZP , −0.25 vs placebo , −0.03 ; p≤0.01 ) . During the period following withdrawal of CZP or placebo , only 3/17 prior CZP patients and 2/6 prior placebo patients maintained CDAI remission until week 52 , but CZP reinstitution allowed renewed improvement . Adverse and serious adverse event rates were comparable between CZP and placebo groups . Conclusions Addition of CZP to non-biologic DMARDs is an effective treatment in RA patients with predominantly moderate disease activity , allowing low-disease activity or remission to be reached in a majority of the patients . However , the data suggest that CZP can not be withdrawn in patients achieving remission . Trial registration number NCT00674362 Abstract Objective . This 24-week , placebo-controlled , double-blind , r and omized study ( NCT00791921 ) investigated efficacy and safety of certolizumab pegol ( CZP ) in Japanese rheumatoid arthritis ( RA ) patients in whom methotrexate ( MTX ) can not be administered . Methods . A total of 230 patients were r and omized to subcutaneous CZP 200 mg ( induction dosing : 400 mg at Weeks 0 , 2 and 4 ) or placebo every 2 weeks . Results . ACR20 responses with CZP were rapid and significant versus placebo at Week 1 , sustained to Week 12 ( 67.2 % vs. 14.9 % ) and Week 24 ( 63.8 % vs. 11.4 % ) . Week 24-modified Total Sharp Score ( mTSS ) change from baseline ( CFB ) was 0.48 ( CZP ) versus 2.45 ( placebo ) . CZP treatment was associated with higher Week 12 ACR20 responses versus placebo ( with non-MTX disease modifying antirheumatic drugs [ DMARDs ] , 74.2 % vs. 20.0 % ; without [ monotherapy ] , 59.3 % vs. 8.2 % ) and inhibition of radiographic progression at Week 24 ( mTSS CFB ; with non-MTX DMARDs , 0.24 vs. 1.61 ; monotherapy , 0.68 vs. 3.65 ) . Incidences of serious adverse events were 11.2 % ( CZP ) and 2.6 % ( placebo ) ; one CZP patient died of dissecting aortic aneurysm . Conclusion . CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX can not be administered result ed in rapid , sustained reductions in RA signs and symptoms . Notably , CZP monotherapy showed significant inhibition of radiographic progression Objectives To evaluate the efficacy and safety of certolizumab pegol ( CZP ) after 24 weeks in RAPID-axSpA ( NCT01087762 ) , an ongoing Phase 3 trial in patients with axial spondyloarthritis ( axSpA ) , including patients with ankylosing spondylitis ( AS ) and non-radiographic axSpA ( nr-axSpA ) . Methods Patients with active axSpA were r and omised 1:1:1 to placebo , CZP 200 mg every 2 weeks ( Q2W ) or CZP 400 mg every 4 weeks ( Q4W ) . In total 325 patients were r and omised . Primary endpoint was ASAS20 ( Assessment of SpondyloArthritis international Society 20 ) response at week 12 . Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index ( BASFI ) , Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) , and Bath Ankylosing Spondylitis Metrology Index ( BASMI ) linear . Results Baseline disease activity was similar between AS and nr-axSpA. At week 12 , ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo ( 57.7 and 63.6 vs 38.3 , p≤0.004 ) . At week 24 , combined CZP arms showed significant ( p<0.001 ) differences in change from baseline versus placebo in BASFI ( −2.28 vs −0.40 ) , BASDAI ( −3.05 vs −1.05 ) , and BASMI ( −0.52 vs −0.07 ) . Improvements were observed as early as week 1 . Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA sub population s. Adverse events were reported in 70.4 % vs 62.6 % , and serious adverse events in 4.7 % vs 4.7 % of All CZP versus placebo groups . No deaths or malignancies were reported . Conclusions CZP rapidly reduced the signs and symptoms of axSpA , with no new safety signals observed compared to the safety profile of CZP in RA . Similar improvements were observed across CZP dosing regim
Output:
| ConclusionS afety data on CZP suggest an overall favorable tolerability profile , with infections being the most common AE .
However , CZP-treated patients had a twofold higher risk of infectious SAEs than control patients .
Large observational studies and data from national registries are needed to detect rare AEs , which might occur after long-term exposures to CZP |
MS210367 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The most effective highly active antiretroviral therapy ( HAART ) to prevent mother-to-child transmission of human immunodeficiency virus type 1 ( HIV-1 ) in pregnancy and its efficacy during breast-feeding are unknown . METHODS We r and omly assigned 560 HIV-1-infected pregnant women ( CD4 + count , > or = 200 cells per cubic millimeter ) to receive coformulated abacavir , zidovudine , and lamivudine ( the nucleoside reverse-transcriptase inhibitor [ NRTI ] group ) or lopinavir-ritonavir plus zidovudine-lamivudine ( the protease-inhibitor group ) from 26 to 34 weeks ' gestation through planned weaning by 6 months post partum . A total of 170 women with CD4 + counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine ( the observational group ) . Infants received single-dose nevirapine and 4 weeks of zidovudine . RESULTS The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery ( 96 % in the NRTI group , 93 % in the protease-inhibitor group , and 94 % in the observational group ) or throughout the breast-feeding period ( 92 % in the NRTI group , 93 % in the protease-inhibitor group , and 95 % in the observational group ) . By 6 months of age , 8 of 709 live-born infants ( 1.1 % ) were infected ( 95 % confidence interval [ CI ] , 0.5 to 2.2 ) : 6 were infected in utero ( 4 in the NRTI group , 1 in the protease-inhibitor group , and 1 in the observational group ) , and 2 were infected during the breast-feeding period ( in the NRTI group ) . Treatment-limiting adverse events occurred in 2 % of women in the NRTI group , 2 % of women in the protease-inhibitor group , and 11 % of women in the observational group . CONCLUSIONS All regimens of HAART from pregnancy through 6 months post partum result ed in high rates of virologic suppression , with an overall rate of mother-to-child transmission of 1.1 % . ( Clinical Trials.gov number , NCT00270296 . Background : Risk factors associated with preeclampsia in HIV-infected women remain largely unknown . Systemic angiogenic imbalance contributes to preeclampsia in HIV-uninfected women , but changes in angiogenic markers after highly active antiretroviral therapy ( HAART ) initiation have not been studied . Methods : The Mma Bana study r and omized 560 HIV-infected , HAART-naive pregnant women with CD4 counts ≥200 cells per cubic millimeter between 26 and 34 weeks gestation to lopinavir/ritonavir/zidovudine/lamivudine or abacavir/zidovudine/lamivudine . Another 170 participants with CD4 counts less than 200 cells per cubic millimeter initiated nevirapine/zidovudine/lamivudine between 18 and 34 weeks gestation . Characteristics of 11 women who developed preeclampsia were compared with the remaining 722 Mma Bana participants who delivered using logistic regression . Plasma sample s drawn at HAART initiation and 1 month later from 60 women without preeclampsia and at HAART initiation for all 11 preeclamptic women were assayed for placental growth factor ( PlGF ) and soluble FMS toll-like tyrosine kinase-1 ( sFlt-1 ) . Results : Pre-HAART viral load greater than 100,000 copies per milliliter was associated with preeclampsia ( odds ratio : 5.8 , 95 % confidence interval : 1.8 to 19.4 , P = 0.004 ) . Median pre-HAART PlGF level was lower and sFlt-1 was higher in women who developed preeclampsia vs those who did not ( 130 vs 992 pg/mL , P = 0.001 ; 17.5 vs 9.4 pg/mL , P = 0.03 , respectively ) . In multivariate analysis , PlGF and viral load remained significantly associated with preeclampsia . No significant changes in angiogenic factors were noted after 1 month of HAART treatment among non-preeclamptic women . Conclusions : Pre-HAART viral load greater than 100,000 copies per milliliter and PlGF predicted preeclampsia among women starting HAART in pregnancy . Among non-preeclamptic women , HAART treatment did not significantly alter levels of PlGF or sFlt-1 after 1 month of treatment Purpose To compare the outcome of pregnancy between HIV positive pregnant women on highly active antiretroviral therapy ( HAART ) and HIV negative controls . Methods A prospect i ve matched case – control study . Results HIV positive women were significantly more likely to have anaemia in pregnancy [ p < 0.001 , odds ratio ( 95 % CI ) 5.66 ( 3.0–10.5 ) ] , intrauterine growth restriction [ p = 0.002 , odds ratio ( 95%CI ) 13.82 ( 1.8–106.7 ) ] , preterm labour [ p = 0.03 , odds ratio ( 95 % CI ) 2.89 ( 1.2–7.0 ) ] and birth weight less than 2,500 g [ p < 0.0001 , odds ratio ( 95 % CI ) 5.43 ( 2.4–12.0 ) ] . The 5-min apgar score less than 7 , admission into neonatal unit , stillbirth and perinatal mortality were comparable between the two groups . Conclusion Anaemia in pregnancy , intrauterine growth restriction , preterm labour and birth weight less than 2,500 g are important complications among HIV positive pregnant women . This information is vital for strategic antenatal care planning to improve obstetric and perinatal outcome in these women Abstract Objective : To estimate and interpret time trends in vertical transmission rates for HIV using data from national obstetric and paediatric surveillance registers . Design : Prospect i ve study of HIV infected women reported through obstetric surveillance . HIV infection status of the child and onset of AIDS were reported through paediatric surveillance . Rates of vertical transmission and progression to AIDS rate were estimated by methods that take account of incomplete follow up of children with indeterminate infection status and delay in AIDS reporting . Setting : British Isles . Subjects : Pregnant women infected with HIV whose infection was diagnosed before delivery , and their babies . Main outcome measures : Mother to child transmission of infection and progression to AIDS in children . Results : By January 1999 , 800 children born to diagnosed HIV infected women who had not breast fed had been reported . Vertical transmission rates rose to 19.6 % ( 95 % confidence interval 8.0 % to 32.5 % ) in 1993 before falling to 2.2 % ( 0 % to 7.8 % ) in 1998 . Between 1995 and 1998 use of antiretroviral treatment increased significantly each year , reaching 97 % of live births in 1998 . The rate of elective caesarean section remained constant , at around 40 % , up to 1997 but increased to 62 % in 1998 . Caesarean section and antiretroviral treatment together were estimated to reduce risk of transmission from 31.6 % ( 13.6 % to 52.2 % ) to 4.2 % ( 0.8 % to 8.5 % ) . The proportion of infected children developing AIDS in the first 6 months fell from 17.7 % ( 6.8 % to 30.8 % ) before 1994 to 7.2 % ( 0 % to 15.7 % ) after , coinciding with increased use of prophylaxis against Pneumocystis carinii pneumonia . Conclusions : In the British Isles both HIV related morbidity and vertical transmission are being reduced through increased use of interventions Key messages Reliable estimates of HIV vertical transmission rates can be derived from surveillance data Infected pregnant women are increasingly taking up elective caesarean section and antiretroviral treatment to reduce the risk of transmitting HIV to their babies Vertical transmission rates have fallen greatly over the past four years and progression to AIDS among infected children may also have slowed These benefits can occur only if infected women are diagnosed before or during OBJECTIVE : In view of recent suggestions that human immunodeficiency virus ( HIV ) infection may protect against preeclampsia , this study was done to evaluate whether untreated HIV-positive pregnant women have a lower rate of preeclampsia-eclampsia than HIV-negative women . METHODS : Subjects for this study were pregnant women from Soweto , South Africa , who gave birth from March to December 2002 at midwife-run clinics or at the Chris Hani Baragwanath Hospital and in whom the HIV status was known . A sample size calculation indicated that 2,588 subjects would be required to show statistical significance at P < .05 with a power of 80 % for a reduction in the rate of preeclampsia from 8 % to 5 % with HIV seropositivity , assuming an HIV seroprevalence rate of 30 % . Data collection was by record review from r and omly selected patient files and birth registers . RESULTS : In the total sample of 2,600 women , 1,797 gave birth at the hospital and 803 at the midwife-run clinics . The HIV seroprevalence rate was 27.1 % . Hypertension was found in 17.3 % of women , with 5.3 % having preeclampsia-eclampsia . The rates of preeclampsia-eclampsia were 5.2 % in HIV-negative and 5.7 % in HIV-positive women ( P = .61 ) . CD4 count results were available for only 13 women ( 0.5 % ) . CONCLUSION : Human immunodeficiency virus seropositivity was not associated with any reduction in the risk of developing preeclampsia-eclampsia . LEVEL OF EVIDENCE : OBJECTIVE We assessed the effect of prenatal and peripartum antibiotics on maternal morbidity and mortality among HIV-infected and uninfected women . METHODS A multicenter trial was conducted at clinical sites in 4 Sub-Saharan African cities : Blantyre and Lilongwe , Malawi ; Dar es Salaam , Tanzania ; and Lusaka , Zambia . A total of 1558 HIV-infected and 271 uninfected pregnant women who were eligible to receive both the prenatal and peripartum antibiotic/placebo regimens were enrolled . Pregnant women were interviewed at 20 - 24 weeks of gestation and a physical examination was performed . Women were r and omized to receive either antibiotics or placebo . At the 26 - 30 week visit , participants were given antibiotics or placebo to be taken every 4 hours beginning at the onset of labor and continuing after delivery 3 times a day until a 1-week course was completed . Logistic regression and Cox proportional hazards models were used . RESULTS There were no significant differences between the antibiotic and placebo groups for medical conditions , obstetric complications , physical examination findings , puerperal sepsis , and death in either the HIV-infected or the uninfected cohort . CONCLUSION Administration of study antibiotics during pregnancy had no effect on maternal morbidity and mortality among HIV-infected and uninfected pregnant women BACKGROUND Hematological abnormalities are common manifestations of advanced HIV-1 infection that could affect the outcomes of highly-active antiretroviral therapy ( HAART ) . Although most HIV-1-infected individuals live in re source -constrained countries , there is little information about the frequency of hematological abnormalities such as anemia , neutropenia , and thrombocytopenia among individuals with advanced HIV-1 disease . METHODS This study compared the prevalence of pre-antiretroviral therapy hematological abnormalities among 1571 participants in a r and omized trial of antiretroviral efficacy in Africa , Asia , South America , the Caribbean , and the USA . Potential covariates for anemia , neutropenia , and thrombocytopenia were identified in univariate analyses and evaluated in separate multivariable models for each hematological condition . RESULTS The frequencies of neutropenia ( absolute neutrophil count ≤1.3 × 10⁹/l ) , anemia ( hemoglobin ≤10g/dl ) , and thrombocytopenia ( platelets ≤125 × 10⁹/l ) at initiation of antiretroviral therapy were 14 % , 12 % , and 7 % , respectively , and varied by country ( p<0.0001 for each ) . In multivariable models , anemia was associated with gender , platelet count , and country ; neutropenia was associated with CD4 + lymphocyte and platelet counts ; and thrombocytopenia was associated with country , gender , and chronic hepatitis B infection . CONCLUSIONS Differ
Output:
| This meta- analysis shows no significant association between HIV positivity and PIH , pre-eclampsia , or eclampsia . |
MS210368 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background Exercise is a modifiable factor that is inversely related to risk for breast cancer . To determine if physical activity has a preventative effect on development of premalignant breast lesions , we examined the association between exercise and the incidence of proliferative benign breast disease . Methods In 1997 , the Nurses ’ Health Study II cohort reported levels of physical activity during adolescence and adulthood using a vali date d recall instrument . We followed 40,318 participants free from benign breast disease ( BBD ) or cancer prospect ively for four years and confirmed 232 proliferative benign breast lesions by central ized pathology review . Cox proportional hazards models estimated the age-adjusted and multivariable-adjusted relative risks for physical activity and proliferative benign breast disease . Results We observed a significant inverse association for walking and incidence of BBD , risk was reduced by 9 % per hour of walking ( 95 % CI 0 % to 17 % ) , ( p trend = 0.05 ) . Despite a small number of cases , risk of columnar cell lesions also suggested an inverse association with strenuous activity ( RR for 4 or more hours of strenuous activity per week = 0.62 ; 0.31–1.22 compared to < 1 h per week ) . Conclusions This study suggests that exercise may be inversely associated with the risk of developing proliferative benign breast disease , one of the earliest steps in the development of breast cancer BACKGROUND The risk of invasive breast cancer associated with benign breast disease ( BBD ) other than atypical hyperplasia and in situ breast cancer , especially with nonproliferative diagnosis , has not been explored extensively . This report evaluates the risk of breast cancer associated with this lower-category BBD ( LC-BBD ) . METHODS 11 307 women without prior history of atypical hyperplasia or in situ breast cancer at r and omization ( 1992 - 1997 ) were identified from the cohort of the National Surgical Adjuvant Breast and Bowel Project 's Breast Cancer Prevention Trial . Pathologic findings from breast biopsy reports through August 2002 were review ed , and Cox proportional hazards models were used to determine the relative risks ( RRs ) of breast cancer with 95 % confidence intervals ( CIs ) . The relative risks of breast cancer for LC-BBD were adjusted for treatment and for breast cancer risk as determined by the modified Gail model . RESULTS Of the 11 307 women , 1376 had LC-BBD , of whom 47 developed breast cancer , and of the 9931 women without LC-BBD , 291 developed breast cancer . The RR of breast cancer for women with LC-BBD relative to women without LC-BBD was 1.60 ( 95 % CI = 1.17 to 2.19 ) . Among women 50 years of age and older , the RR of breast cancer for those with LC-BBD was 1.95 ( 95 % CI = 1.29 to 2.93 ) . After adjustment for treatment and breast cancer risk , the RR of breast cancer for women with LC-BBD was 1.41 ( 95 % CI = 1.03 to 1.94 ) . CONCLUSIONS Women with LC-BBD had a statistically significant increased risk of breast cancer . The elevation of breast cancer risk was especially evident in women 50 years of age and older . Furthermore , this risk was independent of that associated with key epidemiologic breast cancer risk factors Specific histologic types of benign breast disease ( BBD ) may increase breast cancer risk . The authors analyzed data from a population ‐based , case‐control study of women aged 20 to 54 with newly diagnosed breast cancer and control subjects r and omly selected from the general population . A panel of pathologists classified the histologic findings of biopsy slides for 433 women with breast cancer and 261 control subjects , all of whom had a history of biopsy for BBD , as to the presence of epithelial hyperplasia , atypia , and other histologic features . When compared with women who had never had a breast biopsy , women with BBD without hyperplasia had an odds ratio of 1.5 ( 95 % confidence limits [ CL ] 1.3 to 1.9 ) , women with hyperplasia without atypia had an odds ratio of 1.8 ( CL = 1.3 , 2.4 ) , and women with hyperplasia and atypia had an odds ratio of 2.6 ( CL = 1.6 , 4.1 ) . Fibroadenoma was an independent risk factor for breast cancer ( odds ratio = 1.7 ; CL = 1.1 , 2.5 ) . These findings suggest that women with BBD with epithelial hyperplasia either with or without atypia and women with fibroadenoma should be monitored carefully because of their elevated risk for breast cancer . Cancer 1992 ; 69:1408‐1414 Objective We examined the association between adolescent fiber intake and proliferative BBD , a marker of increased breast cancer risk , in the Nurses ’ Health Study II . Methods Among 29,480 women who completed a high school diet question naire in 1998 , 682 proliferative BBD cases were identified and confirmed by central ized pathology review between 1991 and 2001 . Multivariate-adjusted Cox proportional hazards regression was used to estimate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) . Results Women in the highest quintile of adolescent fiber intake had a 25 % lower risk of proliferative BBD ( multivariate HR ( 95 % CI ) : 0.75 ( 0.59 , 0.96 ) , p-trend = 0.01 ) than women in the lowest quintile . High school intake of nuts was also related to significantly reduced BBD risk . Women consuming ≥2 servings of nuts/week had a 36 % lower risk ( multivariate HR ( 95 % CI ) : 0.64 ( 0.48 , 0.85 ) , p-trend < 0.01 ) than women consuming < 1 serving/month . Results were essentially the same when the analysis was restricted to prospect i ve cases ( n = 142 ) diagnosed after return of the high school diet question naire . Conclusions These findings support the hypothesis that dietary intake of fiber and nuts during adolescence influences subsequent risk of breast disease and may suggest a viable means for breast cancer prevention OBJECTIVE : To investigate prospect ively , using alcoholic beverage consumption data collected in real time , the association between adolescent drinking and risk of biopsy-confirmed benign breast disease ( BBD ) in young women . PARTICIPANTS AND METHODS : The Growing Up Today Study is a prospect i ve cohort study of US girls , aged 9 to 15 years at baseline , with annual question naires from 1996 through 2001 , followed by question naires in 2003 , 2005 , and 2007 . On the 2003 survey , the participants ( then aged 16–23 years ) provided information about their alcoholic beverage consumption in the previous year . On the 2005 and 2007 surveys , a total of 6899 women ( aged 18–27 years ) reported whether a health care provider had ever diagnosed them with BBD ( n = 147 cases ) and whether it was confirmed by biopsy ( n = 67 cases ) ; 6752 women reported never being diagnosed with BBD . RESULTS : Adjusted for age and BMI , quantity of alcohol consumed was associated with increased risk of biopsy-confirmed BBD ( odds ratio : 1.50 per drink per day [ 95 % confidence interval : 1.19–1.90 ] ) . Girls who typically drank 6 or 7 days/week were at higher risk ( odds ratio : 5.50 [ 95 % confidence interval : 1.23–24.53 ] ) compared with those who never drank or who drank less than once per week . CONCLUSIONS : Higher amounts consumed , and more frequent consumption , of alcoholic beverages in adolescence may increase the occurrence of BBD in young women . Advising teenagers to avoid alcoholic beverages , along with smoking and sun exposure , may reduce cancer incidence in adulthood Background Data from the Shanghai Breast Cancer Study were analyzed to evaluate the relationship between benign breast disease ( BBD ) and breast cancer among Chinese women with a self-report of physician-diagnosed BBD . Methods Study participants consisted of 3,452 breast cancer cases and 3,474 population controls recruited by the Shanghai Breast Cancer Study . In-person interviews were conducted to collect information on demographics and suspected risk factors for breast cancer , including a detailed history of BBD . Unconditional logistic regression was used to derive adjusted odds ratios ( ORadj ) and 95 % confidence intervals ( CI ) for the association between self-reported BBD and breast cancer . Results Women with breast cancer were significantly more likely to have a self-reported history of BBD including lobular proliferation ( ORadj = 1.6 ; 95 % CI 1.4–1.8 ) , fibroadenoma ( ORadj = 1.9 ; 95 % CI 1.6–2.3 ) , and other BBD ( ORadj = 1.6 ; 95 % CI 1.3–2.1 ) . Breast cancer risk was lower for surgically treated fibroadenoma as compared to non-surgically treated and higher for other BBDs that were surgically treated versus non-surgically treated . Conclusions Our results suggest that personal history of BBD is associated with an increased risk of future breast cancer among women in China . Surgical intervention for fibroadenoma may reduce the risk In adult women with retrospective data , childhood adiposity , pubertal growth and development were associated with benign breast disease ( BBD ) and /or breast cancer . The authors prospect ively evaluated these childhood/adolescent characteristics and BBD risk
Output:
| This meta- analysis demonstrates that proliferative benign breast disease with or without atypia is associated with a significant increase in risk of developing breast cancer . |
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Input: INTRODUCTION Tobacco use is a global health care problem . Repetitive exposure to nicotine produces neuroadaptation result ing in nicotine dependence . Smoking is associated with a range of diseases , causing high levels of morbidity and mortality and is one of the leading causes of preventable deaths , with more than 4.6 million smokers worldwide dying each year from smoking related illnesses . Stopping smoking has major health benefits . Quitting at any age provides both short and long term benefits . MATERIAL S AND METHODS 45 patients attending the outpatient department at the Oxford Dental College , Bangalore , were r and omly allocated to three groups of interventions namely placebo , counseling and nicotine replacement therapy ( NRT ) . Initially each one was assessed for carbon monoxide levels using a breath analyser ( pico smokerlyser bedfont UK ) . They were followed up for six months and the carbon monoxide levels were again assessed using the same instrument . The paired t test was used to compare the results before and after the intervention . RESULTS The scores before the initiation of intervention and after treatment were compared and all three interventions were found to be statistically significant after six months . It was noticed that patients with very low or low dependence followed by high dependence had good response in the placebo group ( 68 % and 47.6 % respectively ) , in the counseling group maximum response was seen in the medium followed by the very low group ( 61 % and 59 % respectively ) , and maximum response was seen in very high followed by the very low group with NRT ( 78.7 % and 60.5 % respectively ) . CONCLUSION The inference that can be drawn from the present study is that non-invasive , non pharmacological methods like placebo and counseling are effective in low to medium groups , and NRT is effective with higher nicotine dependence Background Tobacco is still the number one life style risk factor for ill health and premature death and also one of the major contributors to oral problems and diseases . Dentistry may be a potential setting for several aspects of clinical public health interventions and there is a growing interest in several countries to develop tobacco cessation support in dentistry setting . The aim of the present study was to assess the relative effectiveness of a high intensity intervention compared with a low intensity intervention for smoking cessation support in a dental clinic setting . Methods 300 smokers attending dental or general health care were r and omly assigned to two arms and referred to the local dental clinic for smoking cessation support . One arm received support with low intensity treatment ( LIT ) , whereas the other group was assigned to high intensity treatment ( HIT ) support . The main outcome measures included self-reported point prevalence and continuous abstinence ( ≥ 183 days ) at the 12-month follow-up . Results Follow-up question naires were returned from 86 % of the participants . People in the HIT-arm were twice as likely to report continuous abstinence compared with the LIT-arm ( 18 % vs. 9 % , p = 0.02 ) . There was a difference ( not significant ) between the arms in point prevalence abstinence in favour of the HIT- protocol ( 23 % vs. 16 % ) . However , point prevalence cessation rates in the LIT-arm reporting additional support were relatively high ( 23 % ) compared with available data assessing abstinence in smokers trying to quit without professional support . ConclusionS creening for willingness to quit smoking within the health care system and offering smoking cessation support within dentistry may be an effective model for smoking cessation support in Sweden . The LIT approach is less expensive and time consuming and may be appropriate as a first treatment option , but should be integrated with other forms of available support in the community . The more extensive and expensive HIT- protocol should be offered to those who are unable to quit with the LIT approach in combination with other support . Trial Registration Trial registration number : BACKGROUND The efficacy of pharmacotherapy for smoking cessation is well documented . However , due to relapse rates and side effects , hypnotherapy is gaining attention as an alternative treatment option . The aim of this one-center r and omized study was to compare the efficacy of hypnotherapy alone , as well as hypnotherapy with nicotine replacement therapy ( NRT ) , to conventional NRT in patients hospitalized with a cardiac or pulmonary illness . METHODS We evaluated self-reported and biochemically verified 7-day prevalence smoking abstinence rates at 12 and 26 weeks post-hospitalization . Patients ( n=164 ) were r and omized into one of three counseling-based treatment groups : NRT for 30 days ( NRT ; n=41 ) , a 90-min hypnotherapy session ( H ; n=39 ) , and NRT with hypnotherapy ( HNRT ; n=37 ) . Treatment groups were compared to a " self-quit " group of 35 patients who refused intervention . RESULTS Hypnotherapy patients were more likely than NRT patients to be nonsmokers at 12 weeks ( 43.9 % vs. 28.2 % ; p=0.14 ) and 26 weeks after hospitalization ( 36.6 % vs. 18.0 % ; p=0.06 ) . Smoking abstinence rates in the HNRT group were similar to the H group . There was no difference in smoking abstinence rates at 26 weeks between " self quit " and participants in any of the treatment groups . In multivariable regression analysis adjusting for diagnosis and demographic characteristics , H and HNRT were over three times more likely than NRT participants to abstain at 26-weeks post-discharge ( RR=3.6 ; p=0.03 and RR=3.2 ; p=0.04 , respectively ) . CONCLUSION Hypnotherapy is more effective than NRT in improving smoking abstinence in patients hospitalized for a smoking-related illness , and could be an asset to post-discharge smoking cessation programs
Output:
| Conclusions There is considerable scientific evidence describing the programs for smoking cessation used in dentistry , which support their effectiveness . |
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Input: OBJECTIVE The authors sought to determine whether integrated mental health services or enhanced referral to specialty mental health clinics results in greater engagement in mental health/substance abuse services by older primary care patients . METHOD This multisite r and omized trial included 10 sites consisting of primary care and specialty mental health/substance abuse clinics . Primary care patients 65 years old or older ( N=24,930 ) were screened . The final study group consisted of 2,022 patients ( mean age=73.5 years ; 26 % female ; 48 % ethnic minority ) with depression ( N=1,390 ) , anxiety ( N=70 ) , at-risk alcohol use ( N=414 ) , or dual diagnosis ( N=148 ) who were r and omly assigned to integrated care ( mental health and substance abuse providers co-located in primary care ; N=999 ) or enhanced referral to specialty mental health/substance abuse clinics ( i.e. , facilitated scheduling , transportation , payment ; N=1,023 ) . RESULTS Seventy-one percent of patients engaged in treatment in the integrated model compared with 49 % in the enhanced referral model . Integrated care was associated with more mental health and substance abuse visits per patient ( mean=3.04 ) relative to enhanced referral ( mean=1.91 ) . Overall , greater engagement was predicted by integrated care and higher mental distress . For depression , greater engagement was predicted by integrated care and more severe depression . For at-risk alcohol users , greater engagement was predicted by integrated care and more severe problem drinking . For all conditions , greater engagement was associated with closer proximity of mental health/substance abuse services to primary care . CONCLUSIONS Older primary care patients are more likely to accept collaborative mental health treatment within primary care than in mental health/substance abuse clinics . These results suggest that integrated service arrangements improve access to mental health and substance abuse services for older adults who underuse these services The purpose of this study was to examine the impact of the Unified Psychogeriatric Biopsychosocial Evaluation and Treatment ( UPBEAT ) Program , an interdisciplinary mental health care management program , on the behavioral health symptoms of elderly veterans . Participants , 60 years and older , included 2637 veterans recruited from medical/surgical units who screened positively for significant depressive or anxiety symptoms and /or at-risk alcohol drinking . Participants were r and omized to UPBEAT or to usual care . Primary outcomes were measured at baseline and at 6 , 12 , and 24 months . Participant nonadherence to the protocol was common and is a major limitation . There were no differences between UPBEAT and usual care patients on symptom or functional outcomes at any follow-up point . Exploratory analyses suggested that among participants with more physical health problems , there were greater improvements in depressive symptoms in those assigned to UPBEAT care . Despite a theoretical and practically sound intervention , participation was low and treatment outcomes , while generally good , appeared unaffected by the addition of the program The purpose of the study was to compare the effectiveness of programmed and intensified intervention on lifestyle changes , including physical activity , cigarette smoking , alcohol consumption and diet , in patients aged ≥ 65 with the usual care of general practitioners ( GP ) . In this multicenter r and omized controlled trial , 738 patients aged ≥ 65 were r and omly assigned to receive intensified intervention ( N = 371 ) or usual care ( N = 367 ) of a GP for lifestyle changes , with 18-month follow-up . The main outcome measures were physical activity , smoking , alcohol consumption and diet . The study was conducted in 59 general practice s in Croatia between May 2008 and May 2010 . The patients ' mean age was 72.3 ± 5.2 years . Significant diet correction was achieved after 18-month follow-up in the intervention group , comparing to controls . More patients followed strictly Mediterranean diet and consumed healthy foods more frequently . There was no significant difference between the groups in physical activity , tobacco smoking and alcohol consumption or diet after the intervention . In conclusion , an 18-month intensified GP 's intervention had limited effect on lifestyle habits . GP intervention managed to change dietary habits in elderly population , which is encouraging since elderly population is very resistant regarding lifestyle habit changes . Clinical trial registration number . IS RCT N31857696 AIMS To examine whether a multi-faceted intervention among older at-risk drinking primary care patients reduced at-risk drinking and alcohol consumption at 3 and 12 months . DESIGN R and omized controlled trial . SETTING Three primary care sites in southern California . PARTICIPANTS Six hundred and thirty-one adults aged ≥ 55 years who were at-risk drinkers identified by the Comorbidity Alcohol Risk Evaluation Tool ( CARET ) were assigned r and omly between October 2004 and April 2007 during an office visit to receive a booklet on healthy behaviors or an intervention including a personalized report , booklet on alcohol and aging , drinking diary , advice from the primary care provider and telephone counseling from a health educator at 2 , 4 and 8 weeks . MEASUREMENTS The primary outcome was the proportion of participants meeting at-risk criteria , and secondary outcomes were number of drinks in past 7 days , heavy drinking ( four or more drinks in a day ) in the past 7 days and risk score . FINDINGS At 3 months , relative to controls , fewer intervention group participants were at-risk drinkers [ odds ratio ( OR ) 0.41 ; 95 % confidence interval ( CI ) 0.22 - 0.75 ] ; they reported drinking fewer drinks in the past 7 days [ rate ratio ( RR ) 0.79 ; 95 % CI 0.70 - 0.90 ] , less heavy drinking ( OR 0.46 ; 95 % CI 0.22 - 0.99 ) and had lower risk scores ( RR 0.77 95 % CI 0.63 - 0.94 ) . At 12 months , only the difference in number of drinks remained statistically significant ( RR 0.87 ; 95 % CI 0.76 - 0.99 ) . CONCLUSIONS A multi-faceted intervention among older at-risk drinkers in primary care does not reduce the proportions of at-risk or heavy drinkers , but does reduce amount of drinking at 12 months BACKGROUND Alcohol use in older adults is common . It is associated with depression , hypertension , diabetes , drug interactions , accidents , and increased rates of emergency department visits and hospitalizations . METHODS A controlled clinical trial ( Project GOAL --Guiding Older Adult Lifestyles ) tested the efficacy of brief physician advice in reducing the alcohol use and use of health care services of older adult problem drinkers . Twenty-four community-based primary care practice s in Wisconsin ( 43 family physicians and internists ) participated in the trial . Of the 6073 patients screened , 105 men and 53 women met inclusion criteria and were r and omized into a control group ( n = 71 ) or an intervention group ( n = 87 ) . Intervention group patients received two 10- to 15-minute physician-delivered counseling sessions that included advice , education , and contracting using a scripted workbook . A total of 146 patients ( 92.4 % ) participated in the 12-month follow-up procedure . RESULTS No significant differences were found between the control and intervention groups at baseline in alcohol use , age , socioeconomic status , depression , onset of alcohol use , smoking status , activity level , or use of mood-altering drugs . The older adults who received the physician intervention demonstrated a significant reduction in 7-day alcohol use , episodes of binge drinking , and frequency of excessive drinking ( P < .005 ) compared with the control group at 3 , 6 , and 12 months after the intervention . There was a 34 % reduction in 7-day alcohol use , 74 % reduction in mean number of binge-drinking episodes , and 62 % reduction in the percentage of older adults drinking more than 21 drinks per week in the intervention group compared with the control group . There were no significant changes in health status . Patterns of health care utilization were not extensively analyzed because of the small number of events . CONCLUSIONS This study provides the first direct evidence that brief physician advice can decrease alcohol use by older adults in community-based primary care practice Objectives The purpose of this study was to explore the efficacy in a primary care setting of a telephone-based disease management program for the acute management of depression and /or at-risk drinking . Material s and Methods Veterans ( N = 97 ) with depression and /or at-risk drinking were identified by systematic screening and assessment . Eligible subjects received either telephone disease management ( TDM ) program or usual care based on r and om assignment of their clinician . The TDM program consisted of regular contacts with each subject by a behavioral health specialist ( BHS ) to assist in assessment , education , support , and treatment planning . Symptomatic outcomes were assessed at 4 months . Results Overall response rates favored those assigned to TDM compared with those assigned to usual care ( 39.1 % responded vs. 17.6 % , p = 0.022 ) . Response rates within the separate diagnostic groups also favored TDM , but this was only significant for depressive disorders . Conclusions Although the sample size was modest and the sample was limited to veterans , findings strongly suggest that a telephone-based disease management program can improve outcomes for patients with a behavioral health problem . Findings also suggest that a health specialist can focus and manage patients with different diagnoses , thus exp and ing the role beyond just depression care . TDM may be a viable , low-cost , model for primary care clinicians to deliver manual guideline -adherent behavioral health care , especially in a VA clinical setting The authors examined the efficacy of naltrexone as an adjunctive treatment for alcohol dependence in older adults . Forty-four veterans over 50 years of age were enrolled in a 12-week , double-blind , placebo-controlled efficacy study of naltrexone ( the equivalent of 50 mg per day ) . There were no differences in the frequency of any self-reported adverse effects or in liver enzyme values between the placebo- and naltrexone-treated groups . There were no differences between the treatment groups in the number of subjects remaining abstinent or in the number of subjects who relapsed . However , all placebo-treated subjects relapsed after sampling alcohol , whereas only three of six naltrexone-treated subjects met relapse criteria after alcohol exposure ( P = 0.024 ) . The authors conclude that naltrexone was well tolerated and efficacious in preventing relapse in subjects who drank One hundred thirty-seven older alcoholic patients were r and omly assigned to two different inpatient treatment programs at a Veterans Affairs medical center and followed for one year after discharge . The older alcoholic rehabilitation ( OAR ) program was operated by a tolerant staff that specialized in treating elderly alcoholics . Treatment included reminiscence therapy with goals of developing patient self-esteem and peer relationships . The traditional care program emphasized confrontation to focus on patients ' past failures and present conflicts . Patient care costs were slightly lower ( 2.5 percent lower ) in the OAR program than in the more traditional program , and OAR patients were 2.1 times more likely to report abstinence at one year . Response to the OAR program was best for patients over 60 years of age OBJECTIVE Adherence to treatment has been demonstrated to be an important factor for remission from alcohol dependence . The authors compared therapy and medication adherence for treatment of alcohol dependence in older adults with adherence in younger adults . METHODS All subjects were participants in a r and omized , double-blind , placebo-controlled efficacy trial of naltrexone for the treatment of alcohol dependence . All subjects received a medically-based psychosocial intervention focused on motivating patients to change and on adherence to treatment . The therapy is nonconfrontational and is delivered by a nurse-practitioner . RESULTS Compared with younger adults , older adults had greater attendance at therapy sessions and greater adherence to the medication . Age-group was the only pretreatment factor associated with adherence . The greater adherence in older adults translated to less relapse than in younger adults . CONCLUSION Treatment for alcohol dependence can be effective for older adults . Older adults appear to respond well to a medically-oriented program that is supportive and individualized . In fact , findings from this study suggest that older adults can be treated in mixed-age treatment setting s when psychotherapeutic strategies are used that are age-appropriate and delivered on an individual basis OBJECTIVE The purpose of this study was to examine the effectiveness of a patient-provider educational intervention in reducing at-risk drinking among older adults . METHOD This was a cluster-r and omized controlled trial of 31 primary care providers and their patients ages 60 years and older at a community-based practice with seven clinics . Recruitment occurred from July 2005 to August 2007 . Eligibility was determined by telephone and a baseline mailed survey . A total of 1,186 at-risk drinkers were identified by the Comorbidity Alcohol Risk Evaluation Tool . Follow-up patient surveys were administered at 3 , 6 , and 12 months after baseline . Study physicians and their patients were r and omly assigned to usual care ( n = 640 patients ) versus the Project SHARE ( Senior Health and Alcohol Risk Education ) intervention ( n = 546 patients ) , which included personalized reports , educational material s , drinking diaries , physician advice during office visits , and telephone counseling delivered by a health educator . Main outcomes were alcohol consumption , at-risk drinking
Output:
| Our results are counter-intuitive at first instance , but some other authors have found the same results .
In the preparation of this editorial , we found a lack of research in patients who started drinking excessive amounts of alcohol very late in life .
This is in contrast with , for example , a fair amount of research in LOD and at least some research in LOS |
MS210371 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Around a quarter of the world 's neonatal and maternal deaths occur in India . Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles . Few interventions to improve maternal and newborn health outcomes with government-m and ated community health workers have been rigorously evaluated at scale in this setting .The study aims to assess the impact of a community mobilisation intervention with women 's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkh and and Orissa . Methods / design The study is a cluster-r and omised controlled trial and will be implemented in five districts , three in Jharkh and and two in Orissa . The unit of r and omisation is a rural cluster of approximately 5000 population . We identified villages within rural , tribal areas of five districts , approached them for participation in the study and enrolled them into 30 clusters , with approximately 10 ASHAs per cluster . Within each district , 6 clusters were r and omly allocated to receive the community intervention or to the control group , result ing in 15 intervention and 15 control clusters . R and omisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated r and om number sequence . The intervention is a participatory learning and action cycle where ASHAs support community women 's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems , implement strategies to address these and evaluate the result . The cycle is design ed to fit with the ASHAs ' m and ate to mobilise communities for health and to complement their other tasks , including increasing institutional delivery rates and providing home visits to mothers and newborns . The trial 's primary endpoint is neonatal mortality during 24 months of intervention . Additional endpoints include home care practice s and health care-seeking in the antenatal , delivery and postnatal period . The impact of the intervention will be measured through a prospect i ve surveillance system implemented by the project team , through which mothers will be interviewed around six weeks after delivery . Cost data and qualitative data are collected for cost-effectiveness and process evaluations . Study registration IS RCT N : IS RCT Background Maternal , perinatal and neonatal mortality remains high in low-income countries . We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi . Methods We evaluated a rural participatory women ’s group community intervention ( CI ) and a quality improvement intervention at health centres ( FI ) via a two-by-two factorial cluster r and omized controlled trial . Consenting pregnant women were followed-up to 2 months after birth using key informants . Primary outcomes were maternal , perinatal and neonatal mortality . Clusters were health centre catchment areas assigned using stratified computer-generated r and omization . Following exclusions , including non-birthing facilities , 61 clusters were analysed : control ( 17 clusters , 4912 births ) , FI ( 15 , 5335 ) , CI ( 15 , 5080 ) and FI + CI ( 14 , 5249 ) . This trial was registered as International St and ard R and omised Controlled Trial [ IS RCT N18073903 ] . Outcomes for 14 576 and 20 576 births were recorded during baseline ( June 2007–September 2008 ) and intervention ( October 2008–December 2010 ) periods . Results For control , FI , CI and FI + CI clusters neonatal mortality rates were 34.0 , 28.3 , 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2 , 55.1 , 48.0 and 48.4 per 1000 births , during the intervention period . Adjusting for clustering and stratification , the neonatal mortality rate was 22 % lower in FI + CI than control clusters ( OR = 0.78 , 95 % CI 0.60–1.01 ) , and the perinatal mortality rate was 16 % lower in CI clusters ( OR = 0.84 , 95 % CI 0.72–0.97 ) . We did not observe any intervention effects on maternal mortality . Conclusions Despite implementation problems , a combined community and facility approach using participatory women ’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi BACKGROUND Women 's groups and health education by peer counsellors can improve the health of mothers and children . We assessed their effects on mortality and breastfeeding rates in rural Malawi . METHODS We did a 2 × 2 factorial , cluster-r and omised trial in 185,888 people in Mchinji district . 48 equal-sized clusters were r and omly allocated to four groups with a computer-generated number sequence . 24 facilitators guided groups through a community action cycle to tackle maternal and child health problems . 72 trained volunteer peer counsellors made home visits at five timepoints during pregnancy and after birth to support breastfeeding and infant care . Primary outcomes for the women 's group intervention were maternal , perinatal , neonatal , and infant mortality rates ( MMR , PMR , NMR , and IMR , respectively ) ; and for the peer counselling were IMR and exclusive breastfeeding ( EBF ) rates . Analysis was by intention to treat . The trial is registered as IS RCT N06477126 . FINDINGS We monitored outcomes of 26,262 births between 2005 and 2009 . In a factorial model adjusted only for clustering and the volunteer peer counselling intervention , in women 's group areas , for years 2 and 3 , we noted non-significant decreases in NMR ( odds ratio 0.93 , 0.64 - 1.35 ) and MMR ( 0.54 , 0.28 - 1.04 ) . After adjustment for parity , socioeconomic quintile , and baseline measures , effects were larger for NMR ( 0.85 , 0.59 - 1.22 ) and MMR ( 0.48 , 0.26 - 0.91 ) . Because of the interaction between the two interventions , a stratified analysis was done . For women 's groups , in adjusted analyses , MMR fell by 74 % ( 0.26 , 0.10 - 0.70 ) , and NMR by 41 % ( 0.59 , 0.40 - 0.86 ) in areas with no peer counsellors , but there was no effect in areas with counsellors ( 1.09 , 0.40 - 2.98 , and 1.38 , 0.75 - 2.54 ) . Factorial analysis for the peer counselling intervention for years 1 - 3 showed a fall in IMR of 18 % ( 0.82 , 0.67 - 1.00 ) and an improvement in EBF rates ( 2.42 , 1.48 - 3.96 ) . The results of the stratified , adjusted analysis showed a 36 % reduction in IMR ( 0.64 , 0.48 - 0.85 ) but no effect on EBF ( 1.18 , 0.63 - 2.25 ) in areas without women 's groups , and in areas with women 's groups there was no effect on IMR ( 1.05 , 0.82 - 1.36 ) and an increase in EBF ( 5.02 , 2.67 - 9.44 ) . The cost of women 's groups was US$ 114 per year of life lost ( YLL ) averted and that of peer counsellors was $ 33 per YLL averted , using stratified data from single intervention comparisons . INTERPRETATION Community mobilisation through women 's groups and volunteer peer counsellor health education are methods to improve maternal and child health outcomes in poor rural population s in Africa . FUNDING Saving Newborn Lives , UK Department for International Development , and Wellcome Trust BACKGROUND Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years . 90 % of deliveries in the poorest quintile of households happen at home . We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates . METHODS We pair-matched 42 geopolitical clusters in Makwanpur district , Nepal , selected 12 pairs r and omly , and r and omly assigned one of each pair to intervention or control . In each intervention cluster ( average population 7000 ) , a female facilitator convened nine women 's group meetings every month . The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them . We monitored birth outcomes in a cohort of 28?931 women , of whom 8 % joined the groups . The primary outcome was neonatal mortality rate . Other outcomes included stillbirths and maternal deaths , uptake of antenatal and delivery services , home care practice s , infant morbidity , and health-care seeking . Analysis was by intention to treat . The study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N31137309 . FINDINGS From 2001 to 2003 , the neonatal mortality rate was 26.2 per 1000 ( 76 deaths per 2899 livebirths ) in intervention clusters compared with 36.9 per 1000 ( 119 deaths per 3226 livebirths ) in controls ( adjusted odds ratio 0.70 [ 95 % CI 0.53 - 0.94 ] ) . Stillbirth rates were similar in both groups . The maternal mortality ratio was 69 per 100000 ( two deaths per 2899 livebirths ) in intervention clusters compared with 341 per 100000 ( 11 deaths per 3226 livebirths ) in control clusters ( 0.22 [ 0.05 - 0.90 ] ) . Women in intervention clusters were more likely to have antenatal care , institutional delivery , trained birth attendance , and hygienic care than were controls . INTERPRETATION Birth outcomes in a poor rural population improved greatly through a low cost , potentially sustainable and scalable , participatory intervention with women 's groups Background Progress on neonatal survival has been slow in most countries . While there is evidence on what works to reduce newborn mortality , there is limited knowledge on how to deliver interventions effectively when health systems are weak . Cluster r and omized trials have shown strong reductions in neonatal mortality using community mobilisation with women 's groups in rural Nepal and India . A similar trial in Bangladesh showed no impact . A main hypothesis is that this negative finding is due to the much lower coverage of women 's groups in the intervention population in Bangladesh compared to India and Nepal . For evidence -based policy making it is important to examine if women 's group coverage is a main determinant of their impact . The study aims to test the effect on newborn and maternal health outcomes of a participatory women 's group intervention with a high population coverage of women 's groups . Methods A cluster r and omised trial of a participatory women 's group intervention will be conducted in 3 districts of rural Bangladesh . As we aim to study a women 's group intervention with high population coverage , the same 9 intervention and 9 control unions will be used as in the 2005 - 2007 trial . These had been r and omly allocated using the districts as strata . To increase coverage , 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial . An open cohort of women who are permanent residents in the union in which their delivery or death was identified , is enrolled . Women and their newborns are included after birth , or , if a woman dies during pregnancy , after her death . Excluded are women who are temporary residents in the union in which their birth or death was identified . The primary outcome is neonatal mortality in the last 24 months of the study . A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population . Data on home care practice s and health care use are collected through interviews . Trial registration IS RCT N : IS RCT Increased interest in the potential contribution of insecticide-impregnated bed nets ( ITBN ) to malaria control has led to research efforts to determine the impact and sustainability of ITBN programmes in differing environments . There is a need to develop effective , feasible educational strategies that will both inform and motivate community members , and thus maximize the correct usage of ITBN . This is especially true in communities where indigenous usage of bed nets is low . This paper describes the educational component of a r and omized controlled community intervention trial of ITBN , with childhood malaria morbidity as an outcome . The educational approach and messages for the ITBN trial were developed from anthropological survey data collected 4 years before the trial , and from community surveys conducted by project research ers . Low levels of underst and ing amongst mothers of the aetiological link between mosquitos and malaria led to the exclusion of the term ' malaria ' from the initial educational messages promoting the use of ITBN . Appropriate individuals within the existing district health care structure were trained as community educators in the project . These educators conducted intensive teaching in the community through public meetings and group teaching in the first 6 months of the trial . The impact of these initial activities was assessed through interviews with a r and om sample of 100 mothers and 50 household heads . This allowed the identification of messages which had not been well understood and further educational methods were chosen to address the areas pinpointed . The community assessment also demonstrated that , in 1994 , over 90 % of mothers understood a protective role for bed nets against malaria and the ITBN education messages were changed to take account of this . The school programme was evaluated through determining outreach (
Output:
| The review concluded that programs working collaboratively or achieving shared leadership with a community can lead to behavior change and cost-effective sustained transformation to improve critical health behaviors and reduce poor health outcomes in low- and middle-income countries .
Overall , community engagement is an understudied component of improving child outcomes |
MS210372 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE This r and omized clinical trial tested hypotheses that there are no differences in patient satisfaction , component costs , or treatment and maintenance times when m and ibular overdentures are retained by one or two implants . MATERIAL S AND METHODS Subjects wearing conventional complete dentures were r and omized to receive either one midline or two bilateral m and ibular implants followed by a m and ibular denture reline to incorporate implant retention . They indicated on a visual analog scale satisfaction with their dentures before implants and at 2 months and 1 year after implant retention . Satisfaction outcomes between the two groups were compared using the Wilcoxon/Mann-Whitney nonparametric rank test , while changes within each group were analyzed using signed-rank tests . Component costs and times for surgery , prosthodontic treatment , and maintenance were compared using nonparametric and t tests . RESULTS Eighty-six subjects enrolled in this study and 85 completed the 1-year follow-up , at which median satisfaction was 93 ( maximum 100 ) in the single-implant group and 94 in the two-implant group ( P > .5 ) . Within each group , median improvement in satisfaction was similarly dramatic ( approximately 44 ) and significant ( P < .001 ) . Prosthodontic maintenance time was similar for both groups ( P > .37 ) , but the single-implant group had significantly lower component costs ( P < .001 ) and lower times for surgery ( P = .002 ) , postsurgical denture maintenance ( P = .021 ) , and denture reline ( P < .001 ) . Five implants failed in four subjects , all in the two-implant group and all before denture reline . CONCLUSION Lower component costs and treatment times , with comparable satisfaction and maintenance time over the first year , indicate that a m and ibular overdenture retained by a single midline implant may be an alternative to the customary two-implant overdenture for maladaptive denture patients The effectiveness of dental implants is widely studied , especially in terms of their clinical outcomes . However , from the policymaker 's point of view , variables other than safety and efficacy , such as the costs and effectiveness of dental implants as compared to other treatment alternatives , are vital in decision making . This paper compares the costs of different treatment strategies in a r and omized clinical trial in patients with resorbed m and ibles and persistent problems with their conventional dentures : treatment with a m and ibular overdenture on permucosal dental implants , an overdenture on a transm and ibular implant , new dentures after preprosthetic surgery , and new dentures only . Data were gathered on an individual patient level to gain insight into specific cost episodes . Direct costs were subdivided into labor , material , technique , and overhead . Data concerning these components were gathered during the consecutive treatment phases in the first year . Results show that the re sources used to treat a patient with an overdenture supported by a transm and ibular implant are seven times those of a complete new set of dentures . Comparison of the cost ratio of an implant-retained overdenture supported by permucosal implants and conventional new prostheses proves less unfavorable : 1:3 . New dentures after preprosthetic surgery are almost as expensive as treatment with permucosal implants PURPOSE The purpose of this study was to compare elderly patients ' satisfaction and oral health-related quality of life with m and ibular two-implant overdentures and conventional dentures . MATERIAL S AND METHODS Sixty edentulous subjects aged 65 to 75 years were r and omly assigned to two groups treated with maxillary conventional dentures and either a m and ibular conventional denture ( n = 30 ) or an overdenture supported by two implants with ball retainers ( n = 30 ) . Subjects rated their general satisfaction , as well as other features of their dentures ( comfort , stability , ability to chew , speech , esthetics , and cleaning ability ) , prior to treatment and 2 months postdelivery . Changes in ratings on the original Oral Health Impact Profile ( OHIP ) and its short form ( OHIP-EDENT ) were also used as indicators of oral health-related quality of life . RESULTS The primary outcome of this study , ratings of general satisfaction 2 months postdelivery , was significantly better in the group treated with m and ibular two-implant overdentures ( P = .001 ) . In addition , the implant group gave significantly higher ratings on comfort , stability , and ability to chew . Furthermore , using OHIP-EDENT , subjects who received m and ibular two-implant overdentures had significantly fewer oral health-related quality of life problems than did the conventional group . CONCLUSION These short-term results suggest that m and ibular two-implant overdentures combined with maxillary conventional dentures provide better function and oral health-related quality of life than conventional dentures Implementation of new therapies is usually governed by financial considerations , so efficacy studies should also include cost comparisons . The cost and effectiveness of m and ibular conventional dentures ( CD , n = 30 ) and two-implant overdentures ( IOD , n = 30 ) were compared in elderly subjects . Effectiveness ( Oral Health Impact Profile , OHIP-20 ) and cost were measured up to one year post-treatment . Data for subsequent years were estimated by the Delphi method . Using an average life expectancy of 17.9 years , the equalized annual costs ( in Canadian dollars ) were $ 399 for CD and $ 625 for IOD ( p < 0.001 ) , and the equalized annual values for the outcome ( OHIP-20 ) were 47.0 for CD and 31.3 for IOD treatment ( p < 0.05 ) . These values translate into a yearly additional cost for IOD treatment of $ 14.41 per OHIP-20 point . These results are key to the implementation of programs to provide this form of therapy for edentulous adults UNLABELLED Implant overdentures and conventional prostheses have been compared in several trials using a variety of functional and oral health-related quality of life ( OHQOL ) outcomes . In this paper , we describe the impact of implant overdentures on general and OHQOL in seniors . OBJECTIVES To compare the oral health-related and general quality of life of seniors ( aged 65 - 75 years ) who received either m and ibular implant overdentures or conventional dentures . METHODS Sixty edentulous patients were recruited . Thirty received m and ibular overdentures retained by two implants ( IOD ) and a conventional maxillary denture , the other 30 subjects received new maxillary and m and ibular conventional complete dentures ( CD ) . All completed the 20-item version of the Oral Health Impact Profile ( OHIP-20 ) before treatment , then at two and 6 months after delivery of the dentures . The SF-36 general health question naire was completed at baseline and 6 months only . RESULTS Pretreatment and 6-month data from 55 subjects were analyzed . Those who received the IODs had significantly better OHIP-20 total scores at 6 months . Results for IOD subjects were also superior in the functional limitation , physical pain , physical disability and psychological disability subscales . While no significant between group difference was found on the SF-36 health survey , significant pre-post-treatment differences within the IOD group were detected for the role emotional , vitality and the social function scales . CONCLUSIONS M and ibular overdentures retained by two implants provide elderly patients with better OHQOL . General health-related quality of life improved in the implant group PURPOSE This study aim ed to compare the prosthetic aspects and patient satisfaction with prosthetic care in two-implant-retained m and ibular overdentures , whether implants were splinted with a bar or left with magnets or ball attachments . MATERIAL S AND METHODS Thirty-six completely edentulous patients had two Brånemark implants placed in the m and ibular canine area . A r and omized procedure allocated patients into three groups of equal size , each with a different attachment system : bars , magnets , or balls . Prosthesis retention and mechanical as well as soft tissue complications were recorded in addition to patient satisfaction . A linear mixed model was fitted with attachment type and time as classification variables and adjusted by Turkey 's multiple range test . RESULTS Ball-retained overdentures showed at year 10 the greatest vertical retention force ( 1,327 g ) , followed by bars ( 1,067 g ) and magnets ( 219 g ) . In the ball group , need for tightening of abutment screws was the most common mechanical complication ; in the magnet and bar groups , respectively , the most common complications were wear and corrosion , and the need for clip activation . Prosthesis stability and chewing comfort for the overdenture were rated significantly lower for the magnet group compared to the ball and bar groups . Prosthesis stability of the maxillary denture was rated significantly lower in the bar group compared to ball and magnet groups . CONCLUSION The ball group scored best in relation to retention of the overdenture , soft tissue complications , and patient satisfaction at year 10 . The bar group scored lower for comfort and stability of the maxillary denture . Magnets offered patients the least comfort The importance of assessing the impact of treatments for chronic conditions on an individual 's quality of life has been well-established . In this r and omized clinical trial , oral-health-rclated quality of life , measured with the Oral Health Impact Profile ( OHIP ) , was compared between two groups of edentulous patients . One group ( n = 54 ) received m and ibular implant-supported overdentures , and the other group ( n = 48 ) received conventional dentures . Assessment s were performed pre-treatment and two months after the prostheses were delivered . The multivariate model showed that implant treatment was significantly associated with lower post-treatment OHIP scores ( p = 0.0002 ) , indicating a better quality of life . In addition , pre-treatment OHIP scores , treatment allocation , age , sex , and marital status explained 31 % of the variation in post-treatment OHIP scores ( F = 0.0001 ) . These results suggest that implant treatment provides significant short-term improvement over conventional treatment in oral-health-related quality of life Studies have shown that m and ibular implant overdentures significantly increase satisfaction and quality of life of edentulous elders . Improved chewing ability appears to have a positive impact on nutritional state . Therefore , it is important to determine the best design of this prosthesis over the long term . In this r and omized controlled trial , three groups of edentulous participants with atrophic m and ibles wore 3 types of implant overdentures . During an eight-year follow-up , only seven of the 110 participants had dropped out of this study . Almost all participants were still satisfied with their overdentures . Participant satisfaction concerning retention and stability of the m and ibular overdenture had decreased significantly in the two-implant ball attachment group , whereas the opinion of participants in the single- and triple-bar groups was still at the same level . The long-term results suggest that a m and ibular overdenture retained by 2 implants with a single bar may be the best treatment strategy for edentulous people with atrophic ridges PURPOSE This work compared implant-supported fixed prostheses and overdentures in the edentulous m and ible in a r and omized prospect i ve study of treatment results , clinical working hours , laboratory working hours , and laboratory costs including material s. MATERIAL S AND METHODS Seventeen subjects agreed to participate . Three st and ard Brånemark implants were placed between the mental foramina in each patient . After the connection of st and ard abutments , subjects were r and omly assigned to the fixed prosthesis group ( n = 11 ) or overdenture group ( n = 6 ) . Subjects in the fixed group were provided with prostheses according to the All-in-One concept . Subjects in the overdenture group received a conventional denture retained by a Dolder bar system . RESULTS One implant was lost in the fixed prosthesis group after 1 year . A new implant was placed , and the prosthesis was refitted . Mean clinical working hours were 3.1 in the fixed prosthesis group and 4.1 in the overdenture group . Mean laboratory working hours were 12.5 in the fixed prosthesis group and 7.7 in the overdenture group . Total laboratory costs , including material s , were on average about 1,700 US dollars for the fixed prosthesis and 1,350 US dollars for the overdenture . CONCLUSION A fixed implant-supported prosthesis in the edentulous m and ible could be provided at about the same cost as an overdenture using the method described . Provided that the early survival results prove to be long lasting , the choice between a fixed and a removable prosthesis need not be a matter of economy The loss of natural teeth compromises chewing efficiency , and edentulous patients often have a diet that is deficient in fibre and vitamins . Prostheses that are retained on implants offer the possibility of overcoming some of the limitations of conventional dentures in terms of chewing efficiency . The aim of this study was to test the hypothesis that improvement in satisfaction with oral prostheses would result in improved food selection in edentulous patients . This prospect i ve study involved three groups , namely ( i ) subjects who requested and received implants to stabilise a complete fixed or removable prosthesis ( IG , n = 26 ) , ( ii ) edentulous subjects who requested implant prostheses , but received conventional dentures ( CDG1 , n = 22 ) , and ( iii ) edentulous subjects who requested and received conventional dentures ( CDG2 , n = 35 ) . Data were collected using vali date d question naires pre- and postoperatively . Prior to treatment , all subjects were asked whether they ate a variety of hard and soft foods , to indicate the degree of difficulty they experienced when chewing these foods , and to rate their satisfaction with various aspects of their maxillary and m and ibular complete dentures . Following the completion of treatment , subjects completed the question naires again . Pre- and postoperative data
Output:
| Implant-supported prostheses were more cost-effective when compared to conventional dentures and fixed implant-supported prostheses .
Overdentures supported by two implants and magnet attachment were reported as cost-effective .
CONCLUSION Implant-supported overdentures are a cost-effective treatment for edentulous patients . |
MS210373 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: It is well known that gingivitis is a bacterially-elicited inflammation of the marginal gingiva . A number of chemical agents have been evaluated over the years with regard to their antimicrobial effects in the oral cavity ; however , all are associated with side effects that prohibit regular long-term use . Therefore , the effectiveness of a natural Mexican Sanguinaria extract ( Polygonum aviculare L. ) against gingivitis , was assessed in 60 male dentistry students between the ages of 18 and 25 years . Over a period of 2 weeks , these students used the Sanguinaria extract ( 1 mg/ml ) in oral rinse twice daily as a unique oral health measurement ( no tooth-brushing was allowed ) . The O'Leary Plaque Index and the Löe and Silness Gingivitis Index were recorded at baseline ( day 0 ) in all the subjects . Also , a complete prophylaxis was performed after both indices were obtained . The antibacterial and antiinflammatory effects of the extract were evaluated on days 7 , 11 and 14 . The results showed that the Mexican Sanguinaria extract in oral rinse significantly decreased gingivitis from day 0 ( -x=1 . 056 ) to day 14 ( -x=1.011 ) ( P</=0.05 ) . In contrast , a significant increase in dental plaque was observed from day 0 ( -x=91.38 ) to day 14 ( -x=98.69 ) ( P</=0.05 ) ; however , the consistency of this plaque permitted its mechanical flushing easily . From this study , it is concluded that the Mexican Sanguinaria extract in oral rinse can be employed supportively in the therapy of gingivitis The purpose of the present study was to establish in vitro the inhibiting effect of a herbal extract mixture on a selected number of micro-organisms and to test in vivo the effect of a mouthwash containing 6.3 mg/ml herbal extract mixture on plaque and gingivitis as compared to a minus active control mouthrinse . The herbal extract was a mixture of : Juniperus communis ( juniper ) , Urtica dioca ( nettle ) , Achillaea millefolium ( yarrow ) ; 1:1:1 . In the study , in-vitro , the effect of pure herbal extract mixture on acid production of Streptococcus mutans was tested and the minimum inhibitory concentrations ( MIC ) of the following micro-organisms were tested : Streptococcus mutans , Streptococcus mitis , Actynomyces viscosus , Actynomyces naeslundii , Actinobacillus actinomycetemcomitans , Prevotella intermedia , Campylobacter rectus , Fusobacterium nucleatum , Veillonella parvula . The MIC-values for A. viscosus and P. gingivalis were 100 mg/ml . The MIC-values for A. naeslundii and A. actinomycetemcomitans were considerably lower ( 10 mg/ml ) . S. mitis was the most susceptible of the tested organisms to the extract with a MIC value of 1 mg/ml . S. mutans , C. rectus , V. parvula , and F. nucleatum were not influenced by the extracts . No inhibitory effect of the 6.3 mg/ml herbal extract mixture was observed on the acid production of S. mutans . For the study in-vivo , 45 volunteers were selected on the basis of having moderate gingival inflammation . As efficacy parameters the plaque index , modified gingival index and angulated bleeding index were assessed . The subjects were r and omly divided among 3 experimental groups ( 2x test and 1 ' minus active ' control ) . The participants were requested to rinse with 10 ml of mouthwash twice a day for a period of three months . After 6 weeks and 3 months , the same clinical indices as at baseline were recorded . The results show no difference between the two test groups and the control group . In conclusion , the results of the present study have shown that the mixture of the 3 herbal extracts , Juniperus communis , Urtica dioca and Achillaea millefolium when used in a mouthrinse has no effect on plaque growth and gingival health Background : The key to good oral health is hidden in nature . Natural herbs like neem , tulsi , pudina , clove oil , ajwain , triphala and many more has been used since ages either as a whole single herb or as a combination against various oral health problems like bleeding gums , halitosis , mouth ulcers and preventing tooth decay . The aim of the study was to compare the efficacy of a commercially available herbal mouthrinse ( Herboral ) with that of chlorhexidine gluconate which is considered to be a gold st and ard as an anti-plaque agent . Material s and Methods : A r and omized , two-group , parallel study as a ‘ de novo ’ plaque accumulation model was carried out on 50 subjects ( 23 males and 27 females ) . At baseline , all participants received a professional prophylaxis and were r and omly assigned to the test ( Herbal mouthrinse ) and control ( Chlorhexidine Gluconate ) group . On the following three days , all subjects rinsed with 10 ml of the allocated mouthrinse twice daily for 1 min . They were asked to refrain from use of any other oral hygiene measures during the study . At the end of the experimental period , plaque was assessed and a question naire was filled by all subjects . Results : Chlorhexidine ( mean plaque score=1.65 ) inhibited plaque growth significantly more than the herbal mouthrinse ( mean plaque score=1.43 , P<0.001 ) . The results of the question naire showed that Herboral was preferred by patients for its taste , its convenience of use and taste duration ( aftertaste ) . However , Chlorhexidine was considered to be more effective in reducing plaque as compared to Herboral . Conclusion : Herbal mouthrinse was found to be a potent plaque inhibitor , though less effective than Chlorhexidine Gluconate . However , it can serve as a good alternative for the patients with special needs as in case of diabetics , xerostomics , and so on Background The aim of this study was to evaluate the antiplaque effect of a new alcohol free essential oil mouthwash with respect to a control of an essential oil with alcohol mouthwash , using an in vivo plaque regrowth model of 3-days . Methods The study was design ed as a double-masked , r and omized , crossover clinical trial , involving 30 volunteers to compare two different essential oil containing mouthwashes , during a 3-day plaque accumulation model . After receiving a thorough professional prophylaxis at the baseline , over the next 3-days each volunteer refrained from all oral hygiene measures and had two daily rinses with 20 ml of the test mouthwash ( alcohol free essential oil ) or the control mouthwash ( essential oil with alcohol ) . At the end of the each experimental period , plaque was assessed and the panelists filled out a question naire . Each subject underwent a 14 days washout period and there was a second allocation . Results The essential oil mouthwash with ethanol shows a better inhibitory effect of plaque regrowth in 3-days than the mouthwash test with only essential oil in the whole mouth ( plaque index = 2.18 against 2.46 , respectively , p < 0.05 ) ; for the lower jaw ( plaque index = 2.28 against 2.57 , respectively , p < 0.05 ) ; for the upper jaw ( plaque index = 2.08 against 2.35 , respectively , p < 0.05 ) ; for the incisors ( plaque index = 1.93 against 2.27 , respectively , p < 0.05 ) ; and the canines ( plaque index = 1.99 against 2.47 , respectively , p < 0.05 ) . Conclusion The essential oil containing mouthwash without alcohol seems to have a less inhibiting effect on the plaque regrowth than the traditional alcoholic solution . Trial Registration Clinical Trials.gov PURPOSE The purpose of this study was to determine the effects of two oral rinses-one 0.12 % chlorhexidine rinse ( CHX ) and one herbal rinse (HBR)-on gingival health status over time . METHODS Sixty-three participants were r and omly assigned to one of three treatment groups : CHX , HBR , or placebo . For three months , participants rinsed twice daily ( morning and evening ) with ( 1/2 ) ounce of allocated rinse after brushing and flossing . Individuals were given the same type of soft bristle toothbrush and whitening toothpaste . No attempt was made to modify participants ' routine oral care , except they were advised to refrain from use of any other oral rinse for the duration of the study . Data were collected at baseline ( B ) , month one ( 1 ) , two ( 2 ) , and three ( 3 ) utilizing the Gingival Index ( GI ) , Plaque Index ( PI ) , and bleeding on probing ( BOP ) . A full mouth periodontal probing was performed at baseline and at the completion of the study . A soft tissue oral assessment was completed at each visit . CHX , HBR , and placebo data were compared between three time intervals , B-1 , B-2 , and B-3 . Statistical analysis was conducted by means of multiple regression using generalized linear models . Paired comparison tests -- ANOVA followed by a post hoc Tukey test -- were used to confirm results . RESULTS CHX was the only oral rinse to demonstrate a statistically significant effect on the reduction of mean GI , BOP , and PI scores when compared to placebo . CHX demonstrated a 31 % reduction in the proportion of GI scores between B-2 and a 29 % reduction between B-3 ( p=.003 and p=.012 , respectively ) . CHX demonstrated a 19 % reduction of BOP sites between B-1 , 32 % reduction between B-2 , and 29 % reduction between B-3 ( p=.028 , p=.000 , and p=.005 , respectively ) . CHX demonstrated a 20 % reduction in PI scores between B-1 , and a 28 % reduction between B-2 ( p=.005 and p=.032 , respectively ) . The effects of HBR on reducing mean GI , BOP , and PI scores were not statistically greater than placebo at any time during the study OBJECTIVE The purpose of the present investigation was to determine if antimicrobial mouthrinses with different formulations could affect the composition of the subgingival microbiota and clinical parameters of adjacent tissues in periodontal maintenance subjects . METHODS One-hundred and sixteen subjects , who had been treated for chronic periodontitis and were in a maintenance program , were r and omly assigned one of four mouthrinses , to be used twice daily for three months . The mouthrinses were herbal 1 , herbal 2 , essential oil , and chlorhexidine . Clinical measurements and subgingival plaque sample s were taken at baseline and at three months . Plaque sample s were individually evaluated for 18 test species/taxa using checkerboard DNA-DNA hybridization . Significance of differences between baseline and three months for both microbiological and clinical parameters were determined using the Wilcoxon Signed Ranks test . Significance of difference among groups for change in clinical and microbiological parameters was determined using analysis of covariance ( ANCOVA ) , adjusting for baseline values . RESULTS Shifts in species proportions differed significantly for 9/18 test species/taxa among the four mouthrinse groups . Streptococcus and Capnocytophaga species were reduced most in the herbal rinse groups , while Veillonella parvula was reduced most in the essential oil and chlorhexidine groups . Actinomyces were also markedly reduced in the chlorhexidine group . Mean Plaque ( PI ) and Gingival Indices ( GI ) were reduced between baseline and three months in each group . Results emphasize that chlorhexidine ( p < 0.001 ) and herbal ( p < 0.05 ) rinses significantly reduced PI . Some subjects in each group responded better than others . CONCLUSION All four mouthrinses tested produced shifts in the composition of subgingival microbiota , although the results differed among the groups . The observed microbial changes were accompanied by improvements in clinical parameters in the periodontal maintenance subjects In the treatment of periodontal disease initial therapy aims at reducing marginal inflammation so allowing assessment of residual disease and further treatment options . The aim of the present study was to determine whether the use of a dentifrice and oral rinse containing sanguinaria extract led to a more rapid resolution of gingival inflammation following initial therapy . Thirty-four subjects , r and omly assigned to one of two treatment groups , took part in this r and omized double-blind parallel study . All subjects received initial therapy including oral hygiene instruction and scaling and root planing as required . One group also received an active dentifrice and oral rinse containing sanguinaria extract ( an antiplaque agent ) and zinc chloride . The other group received a placebo dentifrice and oral rinse . The gingival index ( GI ) , plaque index ( PLI ) and probing pocket depths ( PD ) were recorded at six sites per tooth at baseline , two weeks after initial therapy and six weeks after initial therapy . There was no significant difference between the groups for any of the parameters at the baseline examination . Two weeks following initial therapy both groups showed a statistically significant increase in the number of sites with PLI of 0 or 1 ( p < 0.0001 ) and a statistically significant increase in the number of sites with a GI of 0 or 1 ( that is , no bleeding on probing ) , ( p < 0.0001 ) . Also there was a statistically significant increase in the number of sites with probing depths < or = 3 mm ( p < 0.0001 ) compared with baseline . These changes were maintained through to six weeks post therapy . There was no significant advantage to the sanguinaria group . Results demonstrate that initial therapy in the form of oral hygiene instruction , scaling and
Output:
| Conclusions Evidence proving the effectiveness of NCCM as an adjunct to unsupervised oral hygiene for plaque and gingivitis control is still insufficient .
Clinical relevance This review provides an overview of the strength of clinical evidence regarding the effectiveness of natural compounds containing mouthrinses in promoting gingival health |
MS210374 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIM The purpose of the present study is to evaluate the healing of periapical lesions of teeth with positive and negative canal cultures at the time of obturation , and to evaluate the periapical healing of teeth treated in one visit ( without ) or in two visits with an interappointment dressing of calcium hydroxide . METHODOLOGY Thirty-nine patients received root-canal treatment . In the first visit , teeth were instrumented , and 18 of these teeth were filled ( after microbiological sampling ) with calcium hydroxide in sterile saline . The other 21 teeth were obturated with gutta-percha and AH-26 sealer after microbiological sampling . Four weeks later , the teeth with calcium hydroxide were accessed again and after microbiological sampling they were obturated with gutta-percha and AH-26 sealer . Healing of periapical radiolucency was recorded over a period up to 4.5 years . RESULTS In both the treatment groups , the size of the periapical lesions reduced significantly during the follow-up period . Complete radiographic healing was observed in 81 % of the cases in the one-visit group , and in 71 % of the cases in the two-visit group . The probability of success increased continuously over time for both treatment groups . Seven out of eight cases ( 87.5 % ) that showed a positive root-canal culture at the time of obturation healed . The number of colony forming units ( CFU ) in six out of eight positive canals was < 10(2 ) CFU mL(-1 ) . CONCLUSIONS Within the limitations of this study , no significant differences in healing of periapical radiolucency was observed between teeth that were treated in one visit ( without ) and two visits with inclusion of calcium hydroxide for 4 weeks . The presence of a positive bacterial culture ( CFU<10(2 ) ) at the time of filling did not influence the outcome of treatment OBJECTIVES This prospect i ve study was conducted to determine whether there is any significant difference in the incidence of postobturation pain after single- and multiple-visit root canal treatment ( RCT ) . METHODS The frequency of postobturation pain was recorded and evaluated over an observation period of 30 days in 291 of 300 consecutive patients receiving RCT . The patients were assigned r and omly and consecutively into either single- or multiple-visit groups . The canals of all teeth were prepared and filled by a single operator using the step-back and lateral condensation techniques . The data were analysed statistically to determine the relationship , if any , between the pain experienced and pulpal vitality , tooth type , pre-operative pain , and the sex and age of the patient . RESULTS Nine of the 300 patients were excluded from the analysis as they failed to attend for postoperative review s. A significantly higher incidence ( P < 0.01 ) of postobturation pain was found in the multiple-visit group ( 38 % ) than in the single-visit group ( 27 % ) within 24 h of obturation . The incidence of pain decreased thereafter , with all patients being sysmptom free at the end of the observation period . No significant correlation was found between postobturation pain and any other factor , with the exception that teeth which had nonvital pulp prior to treatment were associated with a significantly greater ( P < 0.005 ) incidence of postobutration pain . CONCLUSIONS Pain was significantly higher in the multiple-visit RCT group and significantly associated with the treatment of the nonvital pulp OBJECTIVES This prospect i ve study evaluated the frequency and intensity of postobturation pain and associated factors in adolescents undergoing one- and two-visit root canal treatment . METHODS 121 patients aged 11 - 18 years presenting with molars with pulp necrosis were assigned r and omly into two treatment groups : one- and two-visit ( including interappointment dressing with calcium hydroxide paste ) . The canals of all teeth were prepared using a preflaring ( 2/3 middle-cervical ) and step-back ( 1/3 apical ) preparation techniques and filled with laterally compacted gutta-percha and sealer . Postobturation pain was recorded on a visual analogue scale ( VAS ) of 0 - 5 . Data were statistically analyzed using multivariate logistic regression . RESULTS The frequencies of postobturation pain were 10.5 % ( 6/57 ) in the one-visit group and 23.0 % ( 14/61 ) in the two-visit group . There were no statistically significant differences between the groups ( p=0.07 ) . The intensity of the pain was similar in both groups , particularly flare-ups , with a prevalence of 1.75 % in the one-visit group and 1.65 % in the two-visit group . Postobturation pain was significantly associated with the presence of preoperative pain ( p=0.04 ; OR=3.54 ; CI 95%=1.02 - 12.30 ) and a positive culture at the time of obturation ( p=0.00 ; OR=9.43 ; CI 95%=2.93 - 30.35 ) . CONCLUSIONS Postobturation pain was more present in the two-visit group , but was not statistically significant . The intensity of postobturation pain was similar . Effective microbiological control and the presence of preoperative pain may influence the postobturation pain in adolescents Acute pain and swelling following endodontic treatment are a challenge for both the patient and the dentist . According to previous studies , the incidence of flare-ups increases after endodontic treatment of teeth with necrotic pulps . Calcium hydroxide is currently used as a multi- purpose drug in root canal therapy . The aim of this study was to evaluate the incidence and severity of flare-ups after treatment of pulpless teeth using calcium hydroxide as an intracanal dressing . Sixty patients with single-root necrotic teeth participated in this study . These patients were r and omly divided into three groups of 20 . The patients were treated in Group A in a single-visit approach , in group B with a two-visit approach without any intracanal dressing and group C with a two-visit approach using calcium hydroxide as an intracanal dressing for one week . All of the patients were followed for 72 hours after each treatment session . The information about the incidence and severity of pain and swelling was recorded in tables , using a modified Visual Analogue Scale for pain severity measurement and a scale with four degrees for measuring the severity of swelling . The data were analyzed by chi-square test and GENMODE procedure The choice of one-visit versus two-visit root canal therapy for necrotic teeth with apical periodontitis is a source of current debate . The primary objective of this r and omized controlled clinical trial was to compare radiographic evidence of periapical healing after root canal therapy completed in one visit or two visits with an interim calcium hydroxide/chlorhexidine paste dressing . Ninety-seven patients met the inclusion criteria and consented to participate in this study . Patients were r and omly assigned to either the one-visit or two-visit group , and root canal therapy was performed with a st and ardized protocol . Patients in the two-visit group received an intracanal dressing of calcium hydroxide/chlorhexidine paste . Sixty-three patients , 33 in the one-visit group and 30 in the two-visit group , were evaluated at 12 months . The primary outcome measure was change in apical bone density by using the periapical index ( PAI ) . Secondary outcome measures were proportion of teeth healed or improved in each group . Both groups exhibited equally favorable periapical healing at 12 months , with no statistically significant differences between groups The purpose of this study was to compare intracanal bacterial reduction on teeth instrumented with 0.04 tapered nickel-titanium ( NiTi ) rotary instrumentation to bacterial reduction when using a stainless-steel K-file step-back technique using sterile saline irrigation . Forty-eight patients with apical periodontitis were r and omly assigned treatment type . The canals were sample d before , during , and after instrumentation . The sample s were incubated anaerobically for 7 days at 37 degrees C , colony-forming unit numbers calculated , and a log transformation performed to normalize the counts . Teeth exhibiting apical periodontitis were uniformly infected , whereas vital control teeth were not . A similar and uniform reduction occurred with progressive filing , regardless of technique ( p < 0.0001 ) . There was no detectable difference in colony-forming unit count after NiTi rotary or stainless-steel h and instrumentation ( p = 0.42 ) . Neither technique could predictably render canals free of bacteria . The results of this study indicate NiTi rotary and stainless-steel h and K-file step-back instrumentation techniques were not significantly different in their ability to reduce intracanal bacteria The objective was to evaluate the clinical efficacy of chemomechanical preparation of the root canals with sodium hypochlorite and interappointment medication with calcium hydroxide in the control of root canal infection and healing of periapical lesions . Fifty teeth diagnosed with chronic apical periodontitis were r and omly allocated to one of three treatments : Single visit ( SV group , n = 20 ) , calcium hydroxide for one week ( CH group n = 18 ) , or leaving the canal empty but sealed for one week ( EC group , n = 12 ) . Microbiological sample s were taken to monitor the infection during treatment . Periapical healing was controlled radiographically following the change in the periapical index at 52 wk and analyzed using one-way ANOVA . All cases showed microbiological growth in the beginning of the treatment . After mechanical preparation and irrigation with sodium hypochlorite in the first appointment , 20 to 33 % of the cases showed growth . At the second appointment 33 % of the cases in the CH group revealed bacteria , whereas the EC group showed remarkably more culture positive cases ( 67 % ) . Sodium hypochlorite was effective also at the second appointment and only two teeth remained culture positive . Only minor differences in periapical healing were observed between the treatment groups . However , bacterial growth at the second appointment had a significant negative impact on healing of the periapical lesion ( p < 0.01 ) . The present study indicates good clinical efficacy of sodium hypochlorite irrigation in the control of root canal infection . Calcium hydroxide dressing between the appointments did not show the expected effect in disinfection the root canal system and treatment outcome , indicating the need to develop more efficient inter-appointment dressings The antimicrobial efficacy of endodontic procedures performed in one-visit ( including a 10-min intraappointment dressing with 5 % iodine-potassium-iodide ) was compared with a two-visit procedure ( including an interappointment dressing with calcium-hydroxide paste ) . Teeth with apical periodontitis ( n = 96 ) were r and omly assigned to either group . Root canal sampling and culturing were performed before and immediately after instrumentation , and after medication . Initial sampling demonstrated the presence of microorganisms in 98 % of the teeth . Postinstrumentation sampling showed reduction of cultivable microbiota . Antibacterial dressing further reduced the number of teeth with surviving microbes . In the postmedication sample s , residual microorganisms were recovered in 29 % of the one-visit teeth and in 36 % of the two-visit treated teeth . No statistically significant differences between the groups were discerned . It was concluded that from a microbiological point of view , treatment of teeth with apical periodontitis performed in two appointments was not more effective than the investigated one-visit procedure AIM This prospect i ve clinical study explored the influence of calcium hydroxide as an interappointment dressing on the healing of periapical lesions associated with pulpless teeth that had not been endodontically treated previously . This was achieved by comparing the prognosis after a two-visit root canal treatment with that following a one-visit treatment . METHODOLOGY Seventy-three patients were recruited having one tooth with an endodontically induced lesion . Of these patients , 67 could be re-examined . Calcium hydroxide was placed in the instrumented root canals of 31 teeth for at least one week and the treatment finished at the second visit . Thirty-six teeth were root canal treated at one visit . The criteria for success were the absence of signs and symptoms indicating an acute phase of periapical periodontitis and radiographically a periodontal ligament space of normal width . Methods for event time analysis were used to evaluate and compare the prognosis of both treatment approaches . RESULTS The probability that complete periapical healing will take place increased continuously with the length of the observation period . In both treatment groups the likelihood that the root canal treatment yields a success within an observation time of five years exceeded 90 % . A statistically significant difference between the two treatment groups could not be detected . CONCLUSIONS From a microbiological perspective , one-visit root canal treatment created favourable environmental conditions for periapical repair similar to the two-visit therapy when calcium hydroxide was used as antimicrobial dressing . One-visit root canal treatment is an acceptable alternative to two-visit treatment for pulpless teeth associated with an endodontically induced lesion OBJECTIVE The purpose of this clinical study was to determine the effect of 1- or 2-visit root canal treatment on the postoperative pain in the retreatment cases . STUDY DESIGN Two hundred eighteen cases that required retreatment were included in the study . Obturated and unfilled canal space and the status of periapical tissues were evaluated according to the PAI index . The patients were subcategorized in regard to the presence or the absence of preoperative pain . Approximately half of each category was treated in 1 appointment . After removing the previous root canal obturation material s and biomechanic preparation of root canals , the teeth in the 1-visit group were obturated at the first appointment by using AH 26 sealer and laterally compacted gutta-percha
Output:
| No significant difference was observed in the healing rate between single- versus multiple-visit root canal treatment , as well as the incidence of medium-term post-obturation pain .
On the basis of current studies , the healing rate of single- and multiple-visit root canal treatment is similar for infected teeth .
Patients experience less frequency of short-term post-obturation pain after single-visit than those having multiple-visit root canal treatment |
MS210375 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The federal menu labeling law will require chain restaurants to post caloric information on menus , but the impact of labeling is uncertain . PURPOSE The goal of the current study was to examine the effect of menu labeling on calories purchased , and secondarily , to assess self-reported awareness and use of labels . DESIGN Single-community pre-post-post cross-sectional study . Data were collected in 2008 - 2010 and analyzed in 2011 - 2012 . SETTING / PARTICIPANTS 50 sites from 10 chain restaurants in King County , Washington , selected through stratified , two-stage cluster r and om sampling . A total of 7325 customers participated . Eligibility criteria were : being an English speaker , aged ≥ 14 years , and having an itemized receipt . The study population was 59 % male , 76 % white non-Hispanic , and 53 % aged<40 years . INTERVENTION A regulation requiring chain restaurants to post calorie information on menus or menu boards was implemented . MAIN OUTCOME MEASURES Mean number of calories purchased . RESULTS No significant changes occurred between baseline and 4 - 6 months postregulation . Mean calories per purchase decreased from 908.5 to 870.4 at 18 months post-implementation ( 38 kcal , 95 % CI=-76.9 , 0.8 , p=0.06 ) in food chains and from 154.3 to 132.1 ( 22 kcal , 95 % CI=-35.8 , -8.5 , p=0.002 ) in coffee chains . Calories decreased in taco and coffee chains , but not in burger and s and wich establishments . They decreased more among women than men in coffee chains . Awareness of labels increased from 18.8 % to 61.7 % in food chains and from 4.4 % to 30.0 % in coffee chains ( both p<0.001 ) . Among customers seeing calorie information , the proportion using it ( about one third ) did not change substantially over time . After implementation , food chain customers using information purchased on average fewer calories compared to those seeing but not using ( difference=143.2 kcal , p<0.001 ) and those not seeing ( difference=135.5 kcal , p<0.001 ) such information . CONCLUSIONS Mean calories per purchase decreased 18 months after implementation of menu labeling in some restaurant chains and among women but not men Increased visibility of food labels is a potential method to reduce the rate of obesity . However , few empirical studies have investigated the impact of nutrition labeling on food selection or energy intake . This study tested the hypothesis that nutrition labeling in combination with nutrition label education would promote reductions in energy intake using a laboratory-based paradigm . Forty-seven male ( n=24 ) and female ( n=23 ) participants visited the Nutrition and Health Research Laboratory for a single lunch session during the months of May through August 2009 . Participants were r and omly assigned to one of two video groups ( Nutrition Labeling Education or Organic Food Movement ) and one of two labeling conditions ( Nutrition Labels or No Labels ) . Participants watched a short educational video and then consumed a buffet lunch . Data were analyzed using a three-way analysis of covariance with sex , video condition , and labeling group as the between-subject factors and age and race as covariates . There were main effects of sex and nutrition label condition on lunch energy intake with females consuming less than males and people with nutrition labels consuming less energy than those without , regardless of sex or video condition . Examination of energy intake from low-energy-density and high-energy-density foods showed that the nutrition labeling group consumed less energy from both low-energy-density and high-energy-density food sources . These data support the use of nutrition labels as a way to reduce energy intake Background Recent legislation has required calorie labels on restaurant menus as a means of improving Americans ’ health . Despite the growing research in this area , no consensus has been reached on the effectiveness of menu labels . This suggests the possibility of heterogeneity in responses to caloric labels across people with different attitudes and demographics . The purpose of this study was to explore the potential relationships between caloric intake and diners ’ socio-economic characteristics and attitudes in a restaurant field experiment that systematic ally varied the caloric information printed on the menus . Methods We conducted a field experiment in a full service restaurant where patrons were r and omly assigned to one of three menu treatments which varied the amount of caloric information printed on the menus ( none , numeric , or symbolic calorie label ) . At the conclusion of their meals , diners were asked to complete a brief survey regarding their socio-economic characteristics , attitudes , and meal selection s. Using regression analysis , we estimated the number of entrée and extra calories ordered by diners as a function of demographic and attitudinal variables . Additionally , irrespective of the menu treatment to which a subject was assigned , our study identified which types of people are likely to be low- , medium- , and high-calorie diners . Results Results showed that calorie labels have the greatest impact on those who are least health conscious . Additionally , using a symbolic calorie label can further reduce the caloric intake of even the most health conscious patrons . Finally , calorie labels were more likely to influence the selection of the main entrée as opposed to supplemental items such as drinks and desserts . Conclusions If numeric calorie labels are implemented ( as currently proposed ) , they are most likely to influence consumers who are less health conscious – probably one of the key targets of this legislation . Unfortunately , numeric labels did little for those consumers who were already more knowledgeable about health and nutrition . To reach a broader group of diners , a symbolic calorie label may be preferred as it reduced caloric intake across all levels of health consciousness We surveyed 7318 customers from 275 r and omly selected restaurants of 11 fast food chains . Participants purchased a mean of 827 calories , with 34 % purchasing 1000 calories or more . Unlike other chains , Subway posted calorie information at point of purchase and its patrons more often reported seeing calorie information than patrons of other chains ( 32 % vs 4 % ; P<.001 ) ; Subway patrons who saw calorie information purchased 52 fewer calories than did other Subway patrons ( P<.01 ) . Fast-food chains should display calorie information prominently at point of purchase , where it can be seen and used to inform purchases Objective To assess the impact of fast food restaurants adding calorie labelling to menu items on the energy content of individual purchases . Design Cross sectional surveys in spring 2007 and spring 2009 ( one year before and nine months after full implementation of regulation requiring chain restaurants ’ menus to contain details of the energy content of all menu items ) . Setting 168 r and omly selected locations of the top 11 fast food chains in New York City during lunchtime hours . Participants 7309 adult customers interviewed in 2007 and 8489 in 2009 . Main outcome measures Energy content of individual purchases , based on customers ’ register receipts and on calorie information provided for all items in menus . Results For the full sample , mean calories purchased did not change from before to after regulation ( 828 v 846 kcal , P=0.22 ) , though a modest decrease was shown in a regression model adjusted for restaurant chain , poverty level for the store location , sex of customers , type of purchase , and inflation adjusted cost ( 847 v 827 kcal , P=0.01 ) . Three major chains , which accounted for 42 % of customers surveyed , showed significant reductions in mean energy per purchase ( McDonald ’s 829 v 785 kcal , P=0.02 ; Au Bon Pain 555 v 475 kcal , P<0.001 ; KFC 927 v 868 kcal , P<0.01 ) , while mean energy content increased for one chain ( Subway 749 v 882 kcal , P<0.001 ) . In the 2009 survey , 15 % ( 1288/8489 ) of customers reported using the calorie information , and these customers purchased 106 fewer kilocalories than customers who did not see or use the calorie information ( 757 v 863 kcal , P<0.001 ) . Conclusion Although no overall decline in calories purchased was observed for the full sample , several major chains saw significant reductions . After regulation , one in six lunchtime customers used the calorie information provided , and these customers made lower calorie choices Chain restaurants will soon need to disclose calorie information on menus , but research on the impact of calorie labels on food choices is mixed . This study tested whether calorie information presented in different formats influenced calories ordered and perceived restaurant healthfulness . Participants in an online survey were r and omly assigned to a menu with either ( 1 ) no calorie labels ( No Calories ) ; ( 2 ) calorie labels ( Calories ) ; ( 3 ) calorie labels ordered from low to high calories ( Rank-Ordered Calories ) ; or ( 4 ) calorie labels ordered from low to high calories that also had red/green circles indicating higher and lower calorie choices ( Colored Calories ) . Participants ordered items for dinner , estimated calories ordered , and rated restaurant healthfulness . Participants in the Rank-Ordered Calories condition and those in the Colored Calories condition ordered fewer calories than the No Calories group . There was no significant difference in calories ordered between the Calories and No Calories groups . Participants in each calorie label condition were significantly more accurate in estimating calories ordered compared to the No Calories group . Those in the Colored Calories group perceived the restaurant as healthier . The results suggest that presenting calorie information in the modified Rank-Ordered or Colored Calories formats may increase menu labeling effectiveness OBJECTIVES We assessed the impact of restaurant menu calorie labels on food choices and intake . METHODS Participants in a study dinner ( n=303 ) were r and omly assigned to either ( 1 ) a menu without calorie labels ( no calorie labels ) , ( 2 ) a menu with calorie labels ( calorie labels ) , or ( 3 ) a menu with calorie labels and a label stating the recommended daily caloric intake for an average adult ( calorie labels plus information ) . Food choices and intake during and after the study dinner were measured . RESULTS Participants in both calorie label conditions ordered fewer calories than those in the no calorie labels condition . When calorie label conditions were combined , that group consumed 14 % fewer calories than the no calorie labels group . Individuals in the calorie labels condition consumed more calories after the study dinner than those in both other conditions . When calories consumed during and after the study dinner were combined , participants in the calorie labels plus information group consumed an average of 250 fewer calories than those in the other groups . CONCLUSIONS Calorie labels on restaurant menus impacted food choices and intake ; adding a recommended daily caloric requirement label increased this effect , suggesting menu label legislation should require such a label . Future research should evaluate menu labeling 's impact on children 's food choices and consumption Background Although point-of-purchase calorie labeling at restaurants has been proposed as a strategy for improving consumer food choices , a limited number of studies have evaluated this approach . Likewise , little research has been conducted to evaluate the influence of value size pricing on restaurant meal choices . Methods To examine the effect of point-of-purchase calorie information and value size pricing on fast food meal choices a r and omized 2 × 2 factorial experiment was conducted in which participants ordered a fast food meal from one of four menus that varied with respect to whether calorie information was provided and whether value size pricing was used . Study participants included 594 adolescents and adults who regularly ate at fast food restaurants . Study staff recorded the foods ordered and consumed by each participant . Participants also completed surveys to assess attitudes , beliefs and practice s related to fast food and nutrition . Results No significant differences in the energy composition of meals ordered or eaten were found between menu conditions . The average energy content of meals ordered by those r and omized to a menu that included calorie information and did not include value size pricing was 842 kcals compared with 827 kcals for those who ordered their meal from a menu that did not include calorie information but had value size pricing ( control menu ) . Results were similar in most analyses conducted stratified by factors such as age , race and education level . Conclusion Additional research is needed to better evaluate the effects of calorie labeling and value size pricing on fast food meal choices . Studies in which participants are repeatedly exposed to these factors are needed since long term exposure may be required for behavior change In a prospect i ve study of risk factors for ischemic heart disease , 792 54-yr-old men selected by year of birth ( 1913 ) and residence in Göteborg , Sweden , agreed to attend for question ing and a number of anthropometric and other measurements in 1967 . Thirteen and one-half years later , these baseline findings were review ed in relation to the number of men who had subsequently developed diabetes mellitus . This analysis focused on the importance of abdominal adipose tissue distribution , measured as the waistto- hip circumference ratio , as a predictor for development of diabetes . Even when the confounding effect of body mass index , as a measure of the total body fat mass , was accounted for , the waist-to-hip ratio was positively and significantly associated with the risk for diabetes . These results from a prospect i ve study strongly support previous cross-sectional findings indicating that not only the degree of obesity but also the localization of fat is a risk factor for diabetes OBJECTIVE To examine the influences of nutritional information and consumer characteristics on meal quality expectations , food selection and subsequent macronutrient intakes of consumers offered a reduced-fat option in a restaurant . DESIGN A target , full-fat ( FF ) main restaurant meal option was developed in a version substantially reduced in fat and energy ( RF ) . Restaurant patrons were r and omly placed into one of four treatment groups varying in provision
Output:
| Menu labeling away-from-home did not result in change in quantity or quality , specifically for carbohydrates , total fat , saturated fat , or sodium , of calories consumed among U.S. adults |
MS210376 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Pelvic floor electrical stimulation ( PFES ) has been shown to be effective for stress incontinence . However , its role in a multicomponent behavioral training program has not been defined . OBJECTIVE To determine if PFES increases efficacy of behavioral training for community-dwelling women with stress incontinence . DESIGN AND SETTING Prospect i ve r and omized controlled trial conducted from October 1 , 1995 , through May 1 , 2001 , at a university-based outpatient continence clinic in the United States . PATIENTS Volunteer sample of 200 ambulatory , nondemented , community-dwelling women aged 40 to 78 years with stress or mixed incontinence with stress as the predominant pattern ; stratified by race , type of incontinence ( stress only vs mixed ) , and severity ( frequency of episodes ) . INTERVENTIONS Patients were r and omly assigned to 8 weeks ( 4 visits ) of behavioral training , 8 weeks ( 4 visits ) of the behavioral training plus home PFES , or 8 weeks of self-administered behavioral treatment using a self-help booklet ( control condition ) . MAIN OUTCOME MEASURES Primary outcome was percentage reduction in the number of incontinent episodes as documented in bladder diaries . Secondary outcomes were patient satisfaction and changes in quality of life . RESULTS Intention-to-treat analysis showed that incontinence was reduced a mean of 68.6 % with behavioral training , 71.9 % with behavioral training plus PFES , and 52.5 % with the self-help booklet ( P = .005 ) . In comparison with the self-help booklet , behavioral training ( P = .02 ) and behavioral training plus PFES ( P = .002 ) were significantly more effective , but they were not significantly different from each other ( P = .60 ) . The PFES group had significantly better patient self-perception of outcome ( P<.001 ) and satisfaction with progress ( P = .02 ) . Significant improvements were seen across all 3 groups on the Incontinence Impact Question naire but with no between-group differences . CONCLUSIONS Treatment with PFES did not increase effectiveness of a comprehensive behavioral program for women with stress incontinence . A self-help booklet reduced incontinence and improved quality of life but not as much as the clinic-based programs Biofeedback is a method of pelvic floor rehabilitation using a surface electrode inserted into the vagina and a catheter in the rectum . Forty women with genuine urinary stress incontinence were r and omized to compare the efficacy of physiotherapy and physiotherapy in combination with biofeedback . The effect of the treatment was determined by a st and ardized pad-weighing test . Long-term status was determined using a question naire after 2–3 years . Thirty-four women completed the treatment . The study showed a statistically significant better improvement in the biofeedback group . The long-term effect in the biofeedback group seemed better and the patients were more motivated for training afterwards This study was a r and omized controlled trial to investigate the effect of treating women with stress or mixed urinary incontinence ( SUI or MUI ) by diaphragmatic , deep abdominal and pelvic floor muscle ( PFM ) retraining . Seventy women were r and omly allocated to the training ( n = 35 ) or control group ( n = 35 ) . Women in the training group received 8 individual clinical visits and followed a specific exercise program . Women in the control group performed self-monitored PFM exercises at home . The primary outcome measure was self-reported improvement . Secondary outcome measures were 20-min pad test , 3-day voiding diary , maximal vaginal squeeze pressure , holding time and quality of life . After a 4-month intervention period , more participants in the training group reported that they were cured or improved ( p < 0.01 ) . The cure/improved rate was above 90 % . Both amount of leakage and number of leaks were significantly lower in the training group ( p < 0.05 ) but not in the control group . More aspects of quality of life improved significantly in the training group than in the control group . Maximal vaginal squeeze pressure , however , decreased slightly in both groups . Coordinated retraining diaphragmatic , deep abdominal and PFM function could improve symptoms and quality of life . It may be an alternative management for women with SUI or MUI CONTEXT Previous research on urge urinary incontinence has demonstrated that multicomponent behavioral training with biofeedback is safe and effective , yet it has not been established whether biofeedback is an essential component that heightens therapeutic efficacy . OBJECTIVE To examine the role of biofeedback in a multicomponent behavioral training program for urge incontinence in community-dwelling older women . DESIGN Prospect i ve , r and omized controlled trial conducted from April 1 , 1995 , to March 30 , 2001 . SETTING University-based outpatient continence clinic in the United States . PATIENTS A volunteer sample of 222 ambulatory , nondemented , community-dwelling women aged 55 to 92 years with urge incontinence or mixed incontinence with urge as the predominant pattern . Patients were stratified by race , type of incontinence ( urge only vs mixed ) , and severity ( frequency of accidents ) . INTERVENTIONS Patients were r and omly assigned to receive 8 weeks ( 4 visits ) of biofeedback-assisted behavioral training ( n = 73 ) , 8 weeks ( 4 visits ) of behavioral training without biofeedback ( verbal feedback based on vaginal palpation ; n = 74 ) , or 8 weeks of self-administered behavioral treatment using a self-help booklet ( control condition ; n = 75 ) . MAIN OUTCOME MEASURES Reduction in the number of incontinence episodes as documented in bladder diaries , patients ' perceptions and satisfaction , and changes in quality of life . RESULTS Intention-to-treat analysis showed that behavioral training with biofeedback yielded a mean 63.1 % reduction ( SD , 42.7 % ) in incontinence , verbal feedback a mean 69.4 % reduction ( SD , 32.7 % ) , and the self-help booklet a mean 58.6 % reduction ( SD , 38.8 % ) . The 3 groups were not significantly different from each other ( P = .23 ) . The groups differed significantly regarding patient satisfaction : 75.0 % of the biofeedback group , 85.5 % of the verbal feedback group , and 55.7 % of the self-help booklet group reported being completely satisfied with treatment ( P = .001 ) . Significant improvements were seen across all 3 groups on 3 quality -of-life instruments , with no significant between-group differences . CONCLUSIONS Biofeedback to teach pelvic floor muscle control , verbal feedback based on vaginal palpation , and a self-help booklet in a first-line behavioral training program all achieved comparable improvements in urge incontinence in community-dwelling older women . Patients ' perceptions of treatment were significantly better for the 2 behavioral training interventions OBJECTIVE To compare the effect of individual pelvic floor muscle training with and without biofeedback in women with urodynamic stress incontinence METHODS The study was a single , blind , r and omized trial . All women completed 6 months of pelvic floor muscle training comprising three sets of ten contractions three times per day , supervised by a physical therapist . One group trained with a biofeedback apparatus at home , the other without biofeedback . The primary outcome measures were pad test with st and ardized bladder volume and self‐report of severity . RESULTS A total of 103 women were r and omized , and data from 94 women were analyzed . Mean age ( range ) was 46.6 ( 30–70 ) years , and mean ( range ) duration of symptoms was 9.7 ( 1–25 ) years . Seventy women had urodynamic stress incontinence alone , and 24 women reported additional urge symptoms . Women training with and without biofeedback showed a statistically significant reduction in leakage on pad test ( P < .01 ) after 6 months of pelvic floor muscle training . Objective cure ( 2 g or less of leakage ) in the total group was 58 % in women training with and 46 % in women training without biofeedback , and in the subgroup of women with urodynamic stress incontinence alone , 69 % in women training with and 50 % in women training without biofeedback . There was no statistically significant difference between the groups posttreatment in any outcome measure . CONCLUSION Cure rate was high , and the reduction in urinary leakage after treatment was statistically significant in both groups . However , there was no statistically significant difference in the effect of individual pelvic floor muscle training with and without biofeedback Pages I-H , Jahr S , Schaufele MK , Conradi E : Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women . Am J Phys Med Rehabil 2001;80:494–502 . Objective To compare the effectiveness of an intensive group physical therapy program with individual biofeedback training for female patients with urinary stress incontinence . Design R and omized study of two therapeutic interventions consisting of a specific physical therapy program ( PT ) or biofeedback training ( BF ) daily for 4 wk , followed by a 2-mo , unsupervised home exercise program in both groups in an outpatient clinic of a large university hospital . Forty women , referred by gynecologists for nonoperative treatment of genuine stress incontinence of mild-to-moderate severity , were included . Measurements of daytime/nocturnal urinary frequency and subjective improvement of incontinence were the main outcome measures at initial presentation , after completion of the therapy program , and at follow-up after 3 mo . St and ardized examinations of digital contraction strength , speculum tests , and manometric measurements were documented as secondary outcome measures . Results In the PT group , the daytime urination frequency decreased 22 % after 4 wk of therapy and 19 % after 3 mo ( P < 0.05 ) from baseline . The nocturnal urination frequency was reduced by 66 % after 4 wk of therapy and 62 % after 3 mo ( P < 0.001 ) . In the BF group , the daily urination frequency decreased 10 % after 4 wk of therapy and 5 % after 3 mo ( P > 0.05 ) . The nocturnal urination frequency declined 36 % after 4 wk of therapy and 66 % after 3 months ( P < 0.05 ) . Subjective assessment after 3 mo showed that in the PT group , 28 % of patients were free of incontinence episodes , 68 % reported improved symptoms ( incontinence episodes improved by > 50 % ) , and 4 % were unchanged . In the BF group , 62 % were free of incontinence episodes , and 38 % were improved . Results of the digital contraction strength assessment s , speculum tests , and manometric measurements showed statistically significant improvement in all variables in both groups after 3 months . Conclusion Four weeks of both intensive group physical therapy or individual biofeedback training followed by an unsupervised home exercise program for 2 mo are effective therapies for female urinary stress incontinence and result in a significantly reduced nocturnal urinary frequency and improved subjective outcome . Only group physical therapy result ed in reduced daytime urinary frequency . BF therapy result ed in a better subjective outcome and higher contraction pressures of the pelvic floor muscles OBJECTIVE To identify predictors of outcome of a multi-component behavioral training program for urge and stress incontinence in women . METHODS This report is a secondary analysis of data from three prospect i ve , r and omized , clinical trials testing behavioral interventions for urinary incontinence . Participants were a volunteer sample of 258 ambulatory , nondemented , community-dwelling women , aged 40–92 years , with stress , urge , or mixed urinary incontinence . Participants received 8 weeks ( four visits ) of multicomponent behavioral training in each study . The relationship between a number of variables and treatment success were explored by univariate and multivariable logistic regression analyses . RESULTS Successful treatment of predominantly urge incontinence ( 75 % reduction of incontinent episodes as recorded on bladder diary ) was associated with not wearing any form of protection for incontinence ( P = .045 ; 95 % confidence interval [ CI ] .282 , .987 ) . Achieving total continence ( 100 % reduction ) was associated with fewer incontinent episodes at baseline ( P < .001 ; 95 % CI .138 , .557 ) , previous surgery for incontinence ( P = .021 ; 95 % CI 1.169 , 6.543 ) , and lower education level ( P = .022 ; 95 % CI .175 , .871 ) . Successful treatment of predominantly stress incontinence ( 75 % reduction ) was related to not having previous evaluation or treatment for incontinence ( P = .001 ; 95 % CI .026 , .415 ) , and fewer incontinent episodes on baseline bladder diary ( P = .026 ; 95 % CI .210 , .907 ) . Outcomes were not associated with age , race , type of incontinence , or a number of other variables reflecting medical history , obstetric history , medications , pelvic examination , body mass index , urodynamic parameters , or psychological distress . CONCLUSION Aside from indicators of severity and previous treatment , there were few associations between baseline clinical variables and outcome of behavioral treatment UNLABELLED We performed a r and omized clinical trial on the efficacy of physical therapy on genuine stress incontinence . STUDY OBJECTIVE
Output:
| However , it was common for women in the biofeedback arms to have more contact with the health professional than those in the non-biofeedback arms .
There was much variety in the regimens proposed for adding feedback or biofeedback to PFMT alone , and it was often not clear what the actual intervention comprised or what the purpose of the intervention was .
Feedback or biofeedback may provide benefit in addition to pelvic floor muscle training in women with urinary incontinence . |
MS210377 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Peri-operative red blood cell transfusions have been associated with post-operative complications in patients undergoing elective orthopaedic hip or knee replacement surgery . MATERIAL S AND METHODS We performed a post-hoc analysis of data extracted from a r and omised study on transfusion triggers using pre-storage leucocyte-depleted red blood cells . Patients who were assigned to the most restrictive transfusion policy ( " restrictive group " ) were compared with patients who were assigned to the most liberal policy ( " liberal group " ) . End-points were red blood cell use , hospital stay , haemoglobin levels , post-operative complications and quality of life scores . RESULTS Of 603 patients , 26.4 % patients in the restrictive group and 39.1 % in the liberal group were transfused ( P = 0.001 ) . The rate of post-operative infections was lower , although not statistically significantly so , in the restrictive group than in the liberal group ( 5.4 % vs. 10.2 % , respectively ) as was the rate of respiratory complications ( 1.7 % vs. 4.9 % , respectively ) , whereas hospital stay , cardiovascular complications and mortality rate were not different in the two groups . Quality of life scores were not associated with type of transfusion policy , the number of red blood cell transfusions or the transfusion status . DISCUSSION A restrictive transfusion protocol was not associated with worse outcome and result ed in a lower transfusion rate compared to the liberal policy . Well-being ( quality of life ) was not associated with transfusion policy or with red blood cell transfusions Background and purpose — Hip fracture ( HF ) in frail elderly patients is associated with poor physical recovery and death . There is often postoperative blood loss and the hemoglobin ( Hb ) threshold for red blood cell ( RBC ) transfusions in these patients is unknown . We investigated whether RBC transfusion strategies were associated with the degree of physical recovery or with reduced mortality after HF surgery . Patients and methods — We enrolled 284 consecutive post-surgical HF patients ( aged ≥ 65 years ) with Hb levels < 11.3 g/dL ( 7 mmol/L ) who had been admitted from nursing homes or sheltered housing . Allocation was stratified by residence . The patients were r and omly assigned to either restrictive ( Hb < 9.7 g/dL ; < 6 mmol/L ) or liberal ( Hb < 11.3 g/dL ; < 7 mmol/L ) RBC transfusions given within the first 30 days postoperatively . Follow-up was at 90 days . Results — No statistically significant differences were found in repeated measures of daily living activities or in 90-day mortality rate between the restrictive group ( where 27 % died ) and the liberal group ( where 21 % died ) . Per- protocol 30-day mortality was higher with the restrictive strategy ( hazard ratio ( HR ) = 2.4 , 95 % CI : 1.1–5.2 ; p = 0.03 ) . The 90-day mortality rate was higher for nursing home residents in the restrictive transfusion group ( 36 % ) than for those in the liberal group ( 20 % ) ( HR = 2.0 , 95 % CI : 1.1–3.6 ; p = 0.01 ) . Interpretation — According to our Hb thresholds , recovery from physical disabilities in frail elderly hip fracture patients was similar after a restrictive RBC transfusion strategy and after a liberal strategy . Implementation of a liberal RBC transfusion strategy in nursing home residents has the potential to increase survival Objectives It is still under debate that red blood cell ( RBC ) transfusions might increase the risk of healthcare-associated infections after hip fracture surgery . Previously , we found that a liberal RBC transfusion strategy improved survival in nursing home residents . Our aim , therefore , was to investigate whether a more liberal RBC transfusion strategy was associated with a higher infection risk in frail elderly hip fracture patients . Design Prospect i ve , assessor-blinded , r and omized and controlled trial . Setting sOrthopedic ward , Geriatric ward , and Hospital-at-home . Patients 284 consecutively hospital-admitted elderly with hip fracture from nursing homes or sheltered housing facilities were included . InterventionA restrictive RBC transfusion strategy ( hemoglobin < 9.7 g/dL ; 6 mmol/L ) compared with a liberal strategy ( hemoglobin < 11.3 g/dL ; 7 mmol/L ) administered within 30 days after surgery . Main outcome measurements Leukocytes and C-reactive protein ( CRP ) in repeated blood sample s within 30 days , and number of all infections ( pneumonia , urinary tract infection , and other infections ) within 10 days . Results 88 % of the patients received a RBC transfusion . A median of 1 RBC unit ( interquartile range ( IQR ) : 1–2 ) was transfused for the restrictive strategy group versus 3 RBC units ( IQR : 2–5 ) for the liberal group . Leukocytes and CRP measurements were similar for both groups . Rates of infection were 72 % for the restrictive group compared to 66 % for the liberal group ( risk ratio 1.08 ; 95 % confidence interval 0.93–1.27 , p value 0.29 ) . Conclusions A more liberal RBC transfusion strategy was not associated with higher risk of infection among residents from nursing homes or sheltered housing undergoing hip fracture surgery BACKGROUND The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial . We conducted a r and omized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture . METHODS We enrolled 2016 patients who were 50 years of age or older , who had either a history of or risk factors for cardiovascular disease , and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery . We r and omly assigned patients to a liberal transfusion strategy ( a hemoglobin threshold of 10 g per deciliter ) or a restrictive transfusion strategy ( symptoms of anemia or at physician discretion for a hemoglobin level of < 8 g per deciliter ) . The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up . RESULTS A median of 2 units of red cells were transfused in the liberal- strategy group and none in the restrictive- strategy group . The rates of the primary outcome were 35.2 % in the liberal- strategy group and 34.7 % in the restrictive- strategy group ( odds ratio in the liberal- strategy group , 1.01 ; 95 % confidence interval [ CI ] , 0.84 to 1.22 ) , for an absolute risk difference of 0.5 percentage points ( 95 % CI , -3.7 to 4.7 ) . The rates of in-hospital acute coronary syndrome or death were 4.3 % and 5.2 % , respectively ( absolute risk difference , -0.9 % ; 99 % CI , -3.3 to 1.6 ) , and rates of death on 60-day follow-up were 7.6 % and 6.6 % , respectively ( absolute risk difference , 1.0 % ; 99 % CI , -1.9 to 4.0 ) . The rates of other complications were similar in the two groups . CONCLUSIONS A liberal transfusion strategy , as compared with a restrictive strategy , did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk . ( Funded by the National Heart , Lung , and Blood Institute ; FOCUS Clinical Trials.gov number , NCT00071032 . ) Objectives To investigate whether a liberal blood transfusion strategy [ Hb levels ≥11.3 g/dL ( 7 mmol/L ) ] reduces the risk of postoperative delirium ( POD ) on day 10 , among nursing home residents with hip fracture , compared to a restrictive transfusion strategy [ Hb levels ≥9.7 g/dL ( 6 mmol/L ) ] . Furthermore , to investigate whether POD influences mortality within 90 days after hip surgery . Methods This is a post hoc analysis based on The TRIFE - a r and omized controlled trial . Frail anemic patients from the Orthopedic Surgical Ward at Aarhus University Hospital were enrolled consecutively between January 18 , 2010 and June 6 , 2013 . These patients ( aged ≥65 years ) had been admitted from nursing homes for unilateral hip fracture surgery . After surgery , 179 patients were included in this study . On the first day of hospitalization , all enrolled patients were examined for cognitive impairment ( assessed by MMSE ) and delirium ( assessed by CAM ) . Delirium was also assessed on the tenth postoperative day . Results The prevalence of delirium was 10 % in patients allocated to a liberal blood transfusion strategy ( LB ) and 21 % in the group with a restrictive blood transfusion strategy ( RB ) . LB prevents development of delirium on day 10 , compared to RB , odds ratio 0.41 ( 95 % CI 0.17–0.96 ) , p = 0.04 . Development of POD on day 10 increased the risk of 90-day death , hazard ratio 3.14 ( 95 % CI 1.72–5.78 ) , p < 0.001 . Conclusion In nursing home residents undergoing surgery for hip fracture , maintaining hemoglobin level above 11.3 g/dL reduces the rate of POD on day 10 compared to a RB . Development of POD is associated with increased mortality BACKGROUND To determine whether a restrictive strategy of red-cell transfusion and a liberal strategy produced equivalent results in critically ill patients , we compared the rates of death from all causes at 30 days and the severity of organ dysfunction . METHODS We enrolled 838 critically ill patients with euvolemia after initial treatment who had hemoglobin concentrations of less than 9.0 g per deciliter within 72 hours after admission to the intensive care unit and r and omly assigned 418 patients to a restrictive strategy of transfusion , in which red cells were transfused if the hemoglobin concentration dropped below 7.0 g per deciliter and hemoglobin concentrations were maintained at 7.0 to 9.0 g per deciliter , and 420 patients to a liberal strategy , in which transfusions were given when the hemoglobin concentration fell below 10.0 g per deciliter and hemoglobin concentrations were maintained at 10.0 to 12.0 g per deciliter . RESULTS Overall , 30-day mortality was similar in the two groups ( 18.7 percent vs. 23.3 percent , P= 0.11 ) . However , the rates were significantly lower with the restrictive transfusion strategy among patients who were less acutely ill -- those with an Acute Physiology and Chronic Health Evaluation II score of < or = 20 ( 8.7 percent in the restrictive- strategy group and 16.1 percent in the liberal- strategy group ; P=0.03 ) -- and among patients who were less than 55 years of age ( 5.7 percent and 13.0 percent , respectively ; P=0.02 ) , but not among patients with clinical ly significant cardiac disease ( 20.5 percent and 22.9 percent , respectively ; P=0.69 ) . The mortality rate during hospitalization was significantly lower in the restrictive- strategy group ( 22.3 percent vs. 28.1 percent , P=0.05 ) . CONCLUSIONS A restrictive strategy of red-cell transfusion is at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients , with the possible exception of patients with acute myocardial infa rct ion and unstable angina BACKGROUND A before and after study was undertaken to investigate the effect of universal leukoreduction ( ULR ) in the UK on postoperative length of hospital stay ( LOS ) and infections . STUDY DESIGN AND METHODS Consecutive patients undergoing elective coronary artery bypass grafting or total hip and /or knee replacement in 11 hospitals received non-WBC-reduced RBCs before implementation of ULR ( T1 , n=997 ) or WBC-reduced RBCs after implementation of ULR ( T2 , n=1098 ) . RESULTS Patients in T1 and T2 were comparable except patients in T2 received on average more units of RBCs but had lower discharge Hct levels . Postoperative LOS ( T1 , 10 + /- 8.9 days ; T2 , 9.6 + /- 6.9 days ) and the proportion of patients with suspected and proven postoperative infections ( T1 , 21.0 % ; T2 , 20.0 % ) were unchanged before and after ULR ( LOS , hazard ratio 1.01 , 95 % CI 0.92 - 1.10 ; infections , OR 0.83 , 95 % CI 0.77 - 1.02 ) . Subgroup analysis showed no significant interaction between storage age or dose of blood on responsiveness of primary outcomes to ULR . Secondary outcomes were unchanged overall . Analysis by surgical procedure gave conflicting results with both increased mortality ( p=0.031 ) and an increased proportion of cardiac patients with proven infections ( p=0.004 ) , whereas the proportion of orthopedic patients with proven infections was reduced ( p=0.
Output:
| INTERPRETATION Liberal transfusion strategies might produce better outcomes in geriatric patients than restrictive transfusion strategies .
This outcome contradicts current restrictive transfusion approaches . |
MS210378 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: PURPOSE Patients with completely resected high-risk endometrial cancer have a risk of disease recurrence even with the addition of adjuvant pelvic radiotherapy ( RT ) . A Phase II study was completed by the Radiation Therapy Oncology Group to assess the safety and toxicity of chemotherapy when combined with pelvic RT for these patients . METHODS AND MATERIAL S Eligibility requirements included a total abdominal hysterectomy and bilateral salpingo-oophorectomy with Grade 2 or 3 endometrial adenocarcinoma with > 50 % myometrial invasion , stromal invasion of the cervix , or pelvic-confined extrauterine disease . This study was design ed to administer 4500 cGy in 25 fractions to the pelvis , along with cisplatin ( 50 mg/m(2 ) ) on Days 1 and 28 . Vaginal brachytherapy with a low-dose-rate applicator ( 1 x 20 Gy to the surface ) or high-dose-rate applicator ( 3 x 6 Gy to the surface ) was performed after external beam RT . Four courses of cisplatin ( 50 mg/m(2 ) ) and paclitaxel ( 175 mg/m(2 ) ) were given at 4-week intervals after RT completion . RESULTS Forty-six patients were entered between October 1997 and April 1999 . Two patients were ineligible ( one with previous bladder cancer and one who had undergone surgery > 8 weeks before the start of RT ) . Follow-up ranged from 6.9 to 48.8 months ( median , 28.7 months ) . The disease was Stage III , II , and I in 66 % , 16 % , and 18 % of patients , respectively . Two patients were not assessable because of incomplete treatment data . The protocol completion rate was 98 % ( 41 of 42 assessable patients ) . Acute toxicity during RT/chemotherapy was Grade 1 in 27 % , Grade 2 in 43 % , Grade 3 in 27 % , and Grade 4 in 2 % . During adjuvant chemotherapy , the toxicity was Grade 1 in 7 % , Grade 2 in 7 % , Grade 3 in 21 % , and Grade 4 in 62 % . Severe toxicity was primarily hematologic . Chronic toxicity was Grade 1 in 20 % , Grade 2 in 39 % , Grade 3 in 16 % , and Grade 4 in 2 % , including 1 patient with a Grade 4 small bowel complication . At 24 months , the pelvic recurrence , regional recurrence , distant recurrence , disease-free survival , and overall survival rate was 2 % , 3 % , 17 % , 83 % , and 90 % , respectively . CONCLUSION This treatment protocol demonstrated an excellent treatment completion rate and expected toxicity . Longer follow-up is needed to assess the outcome . To assess the efficacy of this adjuvant treatment program , a Phase III trial ( Radiation Therapy Oncology Group 9905 ) was design ed with high-risk uterine-confined disease to be r and omized between pelvic RT alone and pelvic RT with chemotherapy BACKGROUND Postoperative radiotherapy for International Federation of Gynaecology and Obstetrics ( FIGO ) stage-1 endometrial carcinoma is a subject of controversy due to the low relapse rate and the lack of data from r and omised trials . We did a multicentre prospect i ve r and omised trial to find whether postoperative pelvic radiotherapy improves locoregional control and survival for patients with stage-1 endometrial carcinoma . METHODS Patients with stage-1 endometrial carcinoma ( grade 1 with deep [ > or = 50 % ] myometrial invasion , grade 2 with any invasion , or grade 3 with superficial [ < 50 % ] invasion ) were enrolled . After total abdominal hysterectomy and bilateral salpingo-oophorectomy , without lymphadenectomy , 715 patients from 19 radiation oncology centres were r and omised to pelvic radiotherapy ( 46 Gy ) or no further treatment . The primary study endpoints were locoregional recurrence and death , with treatment-related morbidity and survival after relapse as secondary endpoints . FINDINGS Analysis was done according to the intention-to-treat principle . Of the 715 patients , 714 could be evaluated . The median duration of follow-up was 52 months . 5-year actuarial locoregional recurrence rates were 4 % in the radiotherapy group and 14 % in the control group ( p<0.001 ) . Actuarial 5-year overall survival rates were similar in the two groups : 81 % ( radiotherapy ) and 85 % ( controls ) , p=0.31 . Endometrial-cancer-related death rates were 9 % in the radiotherapy group and 6 % in the control group ( p=0.37 ) . Treatment-related complications occurred in 25 % of radiotherapy patients , and in 6 % of the controls ( p<0.0001 ) . Two-thirds of the complications were grade 1 . Grade 3 - 4 complications were seen in eight patients , of which seven were in the radiotherapy group ( 2 % ) . 2-year survival after vaginal recurrence was 79 % , in contrast to 21 % after pelvic recurrence or distant metastases . Survival after relapse was significantly ( p=0.02 ) better for patients in the control group . Multivariate analysis showed that for locoregional recurrence , radiotherapy and age below 60 years were significant favourable prognostic factors . INTERPRETATION Postoperative radiotherapy in stage-1 endometrial carcinoma reduces locoregional recurrence but has no impact on overall survival . Radiotherapy increases treatment-related morbidity . Postoperative radiotherapy is not indicated in patients with stage-1 endometrial carcinoma below 60 years and patients with grade -2 tumours with superficial invasion AIM During the last decades , therapies targeting cervical cancer have been considerably improved . Surgery and radiotherapy ( RT ) represent the main common therapeutic approach in cervical cancer . In order to minimize the side effects of radiotherapy approach , several protocol s have been developed such as brachytherapy ( BRT ) . Among the side effects associated with RT , the vaginal atrophy is the most important and common one . Vaginal atrophy , in turn , leads to additional alterations like inflammation , associated to relevant symptoms such as itching , burning and dyspareunia . All these alterations heavily affect the quality of women 's life . The aim of our study was to evaluate the toxicity induced by RT on vaginal mucosa , and the adjuvant action of a product containing LMWHA , vitamin A , and Vitamin E ( Santes ® , Lo . Li . Pharma , Rome , Italy ) . The introduction of adjuvant therapies may have likely had a relevant place in providing that result . METHODS A prospect i ve r and omized study was design ed . From October 2006 to October 2008 , 45 women with a mean age 38 ± 6 years were enrolled . After surgery , all patients were treated with 4 weeks of RT and 4 weeks of BRT , concomitantly with chemiotherapy . They were r and omly assigned in two groups : 23 women were treated with two suppositories ( Santes ® ) per day for 4 months . For the first two months the preventive treatment was simultaneous to RT and BRT . Instead the control groups for composed by 22 patients and they did not undergo any treatment during RT . To evaluate the efficacy of Santes ® treatment three biopsies were performed . RESULTS At the second biopsy , after the BRT therapy , the treated group showed a statistically significant improvement ( P<0.05 vs. control ) on inflammation , cell atypia , fibrosis , mucositis and bleeding . At the third biopsy , two months after BRT , further statistically improvement were observed for all RT/BRT associated side effects . The treatment showed an efficacy also in terms of pain severity . CONCLUSION Our data suggest that low molecular weight HA shows good performances in treating RT-damaged tissue and plays a key role in all steps of the healing process . Indeed the results shows that women exposed to RT treatments and simultaneously treated with Santes ® , had an optimal resolution of vaginal atrophy and related symptoms Purpose The aim of the present study was to evaluate the effectiveness of hyaluronic acid ( HA ) in the prevention of acute and late vaginal toxicities after high-dose-rate ( HDR ) vaginal brachytherapy ( BT ) . Material and methods Between January 2011 and January 2015 , we retrospectively analyzed 126 patients with endometrial cancer who underwent extrafascial hysterectomy with or without lymphadenectomy and adjuvant HDR-vaginal BT + /– adjuvant chemotherapy . The total dose prescription was 21 Gy in 3 fractions ( one fraction for week ) . Vaginal ovules containing 5 mg of HA were given for whole duration of vaginal BT and for the two following weeks . Acute and late toxicities were evaluated according to CTCAE vs 4.02 . Results According to the revised FIGO 2009 classification , most tumors were in stage IA ( 30.9 % ) and in stage IB ( 57.9 % ) . Thirty-three patients ( 26.2 % ) received adjuvant chemotherapy before vaginal BT . Five-year disease-free survival ( DFS ) and five-year overall survival ( OS ) were 88 % and 93 % , respectively . The most common grade 1 - 2 acute toxicities were vaginal inflammation ( 18 patients , 14.3 % ) and dyspareunia ( 7 patients , 5.5 % ) . Two patients ( 1.6 % ) had more than one toxicity . Late toxicity occurred in 20 patients ( 15.9 % ) . Grade 1 - 2 late toxicities were fibrosis ( 14 patients , 11.1 % ) and telangiectasias ( 7 patients , 5.5 % ) . Six patients ( 4.8 % ) had more than one late toxicity . No grade 3 or higher acute or late toxicities were observed . Conclusions These results appear to suggest that the local therapy with HA is of clinical benefit for intermediate risk endometrial cancer patients who receive adjuvant HDR-vaginal BT after surgery . A r and omized trial comparing HA treatment vs. no local treatment in this clinical setting is warranted to further evaluate the efficacy of HA in preventing vaginal BT-related vaginal toxicity PURPOSE To compare two different fractionation schedules for postoperative vaginal high-dose-rate ( HDR ) irradiation in endometrial carcinomas . METHODS AND MATERIAL S In a complete geographic series of 290 low-risk endometrial carcinomas , the efficacy and side effects of two different fractionation schedules for postoperative vaginal irradiation were evaluated . The patients were treated during the years 1989 - 2003 . The tumors were in International Federation of Gynecology and Obstetrics Stages IA-IB and Grade s 1 - 2 . The HDR MicroSelectron afterloading equipment ( iridium-192 ) was used . Perspex vaginal applicators with diameters of 20 - 30 mm were used , and the dose was specified at 5 mm from the surface of the applicator . Six fractions were given , and the overall treatment time was 8 days . The size of the dose per fraction was r and omly set to 2.5 Gy ( total dose of 15.0 Gy ) or 5.0 Gy ( total dose of 30.0 Gy ) . One hundred forty-four patients were treated with the 2.5-Gy fraction and 146 patients with the 5.0-Gy fraction . RESULTS The overall locoregional recurrence rate of the complete series was 1.4 % and the rate of vaginal recurrences 0.7 % . There was no difference between the two r and omized groups . The vaginal shortening measured by colpometry was not significant ( p = 0.159 ) in the 2.5-Gy group ( mean , 0.3 cm ) but was highly significant ( p < 0.000001 ) in the 5.0-Gy group ( mean 2.1 cm ) after 5 years . Mucosal atrophy and bleedings were significantly more frequent in the 5.0-Gy group . Symptoms noted in the 2.5-Gy group were not different from what could be expected in a normal group of postmenopausal women . CONCLUSION The fractionation schedule recommended for postoperative vaginal irradiation in low-risk endometrial carcinoma is six fractions of 2.5 Gy when the HDR technique is used OBJECTIVE To determine the progression free survival ( PFS ) , toxicity , and patterns of failure for early stage , high-intermediate risk ( H-IR ) patients in a phase II trial with adjuvant vaginal cuff brachytherapy ( VCB ) and three cycles of carboplatin and paclitaxel . METHODS Surgically staged patients with stage I-IIb endometrial cancer with H-IR factors were treated with VCB ( 2100cGy ) followed by three cycles of carboplatin ( AUC 6 ) and paclitaxel ( 175 mg/m(2 ) ) . The primary endpoint was PFS at 2 years , with toxicity and sites of failure as secondary endpoints . Toxicity was assessed by patient report ( CTCAE v. 3 ) as well as by delays or dose modifications in treatment . RESULTS
Output:
| The most common early side effects due to HDR-BT treatment were vaginal inflammation , vaginal irritation , dryness , discharge , soreness , swelling , and fungal infection .
The most common late side effects consisted of vaginal discharge , dryness , itching , bleeding , fibrosis , telangiectasias , stenosis , short or narrow vagina , and dyspareunia .
Conclusions The data suggest that HDR endovaginal brachytherapy , with or without chemotherapy , is very well tolerated with low rates of acute and late vaginal toxicities . |
MS210379 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background : Failure to adhere to medication regimes is a significant problem in clinical and research setting s yet reliable , consistent identification of key psychosocial predictors remains elusive . Studies of mood and personality related to adherence show mixed results —compliance and objective ly measured cognitive function are intuitively related but empirical support is lacking . Purpose : This study is a secondary analysis to examine the relations between adherence with a medication regime for lowering serum cholesterol and several domains of psychological and cognitive functioning . Methods : Participants in the initial study completed a measure of personality and a battery of neuropsychological measures at baseline ; anxiety and depression were measured at baseline and at 4-week intervals . Medication adherence was tracked with electronic cap monitors for 24 weeks . Results : Only 23 % of the sample was fully adherent to medication regimes at least 80 % of the time over the 6-month study period . Conscientiousness , according to the Five Factor Theory of Personality , and estimated IQ remained robust predictors of adherence in hierarchical regression analyses . Depression and anxiety , mental flexibility , and visuospatial-constructional ability were less robust but statistically significant ( p < .05 ) correlates of adherence . Conclusions : Although results of this analysis explain only a portion of the variance in adherence , they demonstrate the importance of trait psychological and cognitive factors in adherence research Background Retirement has been suggested to reduce medication adherence , but no evidence is available for statins . We investigated changes in adherence to statins among Swedish adults after retirement . Methods A prospect i ve cohort study was carried out on all individuals living in Sweden on 31 December 2004 , alive in 2010 , having purchased statins in the second half of 2005 , and retired in 2008 ( n=11 718 ) . We used prescription dispensing data in 2006–2010 to determine nonadherence ( defined as < 80 % of days covered by filled prescriptions ) before and after old-age or disability retirement . Using multiple repeat measurements of filled statin prescriptions , we calculated the annual prevalence rates of nonadherence for those who continued therapy . Discontinuation was defined as no statin dispensations during a calendar year . Results After adjustment for age at retirement , the prevalence ratio ( PR ) of nonadherence after retirement in comparison with those before retirement was 1.23 [ 95 % confidence interval ( CI ) 1.17–1.29 ] for the men and 1.19 ( 95 % CI 1.13–1.26 ) for the women . A post-retirement increase in nonadherence was consistently observed across the strata of age at retirement , marital status , education , income , type of retirement , and participants with and without cardiovascular disease , the largest increases being observed for statin use in secondary prevention ( men : PR 1.38 , 95 % CI 1.26–1.54 ; women : PR 1.43 , 1.18–1.72 ) . For primary prevention , the corresponding prevalence ratios were 1.18 ( 95 % CI 1.13‒1.25 ) and 1.18 ( 95 % CI 1.11–1.24 ) , respectively . Interpretation Retirement appears to be associated with increased nonadherence to statin therapy among Swedish men and women BACKGROUND The objective of this study was to examine the association of Joint National Committee ( JNC-V ) blood pressure and National Cholesterol Education Program ( NCEP ) cholesterol categories with coronary heart disease ( CHD ) risk , to incorporate them into coronary prediction algorithms , and to compare the discrimination properties of this approach with other noncategorical prediction functions . METHODS AND RESULTS This work was design ed as a prospect i ve , single-center study in the setting of a community-based cohort . The patients were 2489 men and 2856 women 30 to 74 years old at baseline with 12 years of follow-up . During the 12 years of follow-up , a total of 383 men and 227 women developed CHD , which was significantly associated with categories of blood pressure , total cholesterol , LDL cholesterol , and HDL cholesterol ( all P<.001 ) . Sex-specific prediction equations were formulated to predict CHD risk according to age , diabetes , smoking , JNC-V blood pressure categories , and NCEP total cholesterol and LDL cholesterol categories . The accuracy of this categorical approach was found to be comparable to CHD prediction when the continuous variables themselves were used . After adjustment for other factors , approximately 28 % of CHD events in men and 29 % in women were attributable to blood pressure levels that exceeded high normal ( > or = 130/85 ) . The corresponding multivariable-adjusted attributable risk percent associated with elevated total cholesterol ( > or = 200 mg/dL ) was 27 % in men and 34 % in women . CONCLUSIONS Recommended guidelines of blood pressure , total cholesterol , and LDL cholesterol effectively predict CHD risk in a middle-aged white population sample . A simple coronary disease prediction algorithm was developed using categorical variables , which allows physicians to predict multivariate CHD risk in patients without overt CHD Background —Little is known about the impact of hospitalization for an acute myocardial infa rct ion ( AMI ) on subsequent adherence to statins . Methods and Results —Using administrative cl aims from a 5 % r and om sample of Medicare beneficiaries , we identified a cohort of Medicare patients aged ≥65 years , hospitalized from 2007 to 2011 , taking statins in the year before AMI hospitalization ( n=6618 ) . We then determined the proportion of patients nonadherent to statins ( proportion of days covered < 80 % ) in the year before AMI hospitalization who became statin adherent ( proportion of days covered ≥80 % ) in the year after AMI hospitalization . The proportion of statin-adherent patients who became nonadherent was also studied . These proportions were compared with patients hospitalized for pneumonia ( n=11 471 ) and patients not hospitalized ( n=158 099 ) in 2010 and 2011 . Among patients nonadherent to statins before AMI hospitalization , 37.7 % became adherent after discharge . Patients hospitalized for AMI were more likely to become adherent than patients hospitalized for pneumonia ( adjusted relative risk : 1.70 ; 95 % confidence interval , 1.57–1.84 ) or patients not hospitalized ( adjusted relative risk : 1.79 ; 95 % confidence interval , 1.68–1.90 ) . Among patients adherent to statins before AMI hospitalization , 32.6 % became nonadherent after discharge . Those hospitalized for AMI were less likely to become nonadherent than those hospitalized for pneumonia ( adjusted relative risk : 0.93 ; 95 % confidence interval 0.88–0.98 ) but more likely to become nonadherent than patients without hospitalizations ( adjusted relative risk : 1.41 ; 95 % confidence interval , 1.35–1.48 ) . Conclusions —Among nonadherent patients , hospitalization for AMI was associated with increased likelihood of becoming adherent to statins compared with hospitalization for pneumonia or no hospitalizations . Among adherent patients , hospitalization for AMI was associated with increased likelihood of becoming nonadherent to statins compared with no hospitalizations Background : Despite the importance of patients ’ adherence to their drug treatments for achieving desired therapeutic goals and the proven role 3-hydroxy-3-methylglutaryl coenzyme A inhibitors ( statins ) for the health status of patients with cardiovascular diseases , there is not enough information regarding diabetic patients ’ adherence to statin therapy in developing countries . In this clinical study we aim ed to assess the adherence of diabetes type 2 patients to statin therapy in a research based community clinic in Iran . Material s and Methods : In this prospect i ve clinical study which was done at Isfahan Endocrinology and Metabolism Research Center , 204 diabetic type 2 patients under treatment with statin were interviewed twice and their demographic data ( age , gender , body mass index , education ) , statin information ( type , dose ) and their serum lipid profile were recorded . Three months after the initial visits , patients were assessed using pill counting method and according to patients ’ self-reporting and also assessed low-density lipoprotein ( LDL ) cholesterol goal attainment < 100 mg/dl . Results : Adherence rate was 79.7 % and 69 % according to pill counting and self-reporting among study population . Moreover , 68.4 % of patients achieved their LDL cholesterol goal of < 100 mg/dl and adherent patients reached therapeutic goal significantly more than those who were considered non-adherence to statin therapy ( P < 0.01 ) . Conclusion : Adherence to statin therapy , as reflected by pill count method , is significantly related to LDL cholesterol goal achievement in patients with diabetes and dyslipidemia . Pill count method can be used to identify patients who are nonadherent to statin therapy and at high risk for failure to attain LDL cholesterol goals Background The purpose of this study was to evaluate the effectiveness of a patient education program developed to facilitate statin adherence . Methods A controlled trial was design ed to test the effectiveness of a multifaceted patient education program to facilitate statin adherence . The program included a brief , in-office physician counseling kit followed by patient mailings . The primary end point was adherence to filling statin prescriptions during a 120-day period . Patients new to statins enrolled and completed a survey . Data from a national pharmacy cl aims data base were used to track adherence . Results Patients new to statin therapy exposed to a patient counseling and education program achieved a 12.4 higher average number of statin prescription fill days and were 10 % more likely to fill prescriptions for at least 120 days ( p = .01 ) . Conclusion Brief in-office counseling on cardiovascular risk followed by patient education mailings can be effective in increasing adherence . Physicians found a one-minute counseling tool and pocket guidelines useful in counseling patients Background : Lipid-lowering treatment with statins has proven to be effective in reducing cardiovascular events and mortality . In daily practice , however , adherence to medication is often low and this compromises the therapeutic effect . The aim of this study was to assess the effectiveness of an electronic reminder device ( ERD ) with or without counseling to improve refill adherence and persistence for statin treatment in non-adherent patients . Methods : A multicenter , community pharmacy-based , r and omized controlled trial was conducted in 24 pharmacies in the Netherl and s among patients with pre-baseline refill adherence rates between 50 and 80 % . Eligible patients aged 65 years or older were r and omly assigned to 1 of 3 groups : ( 1 ) counseling with an ERD ( n = 134 ) , ( 2 ) ERD with a written instruction ( n = 131 ) , and a ( 3 ) control group that received the usual treatment ( n = 134 ) . Main outcome measure : refill adherence to statin treatment for a 360-day period after inclusion ( PDC360 ) . Patients with a refill rate ≥80 % were considered adherent . The effect among subgroups was also assessed . Results : There were no relevant differences at baseline . In the counseling with ERD group 54 of 130 eligible patients received the counseling with ERD . In the ERD group , 117 of 123 eligible patients received the ERD . The proportions of adherent patients in the counseling with ERD-group ( 69.2 % ) and in the ERD group ( 72.4 % ) were not higher than in the control group ( 64.8 % ) . Among women using statins for secondary prevention , more patients were adherent in the ERD group ( 86.1 % ) than in the control group ( 52.6 % ) ( p < 0.005 ) . In men using statins for secondary prevention the ERD was found to have no effect . Conclusion : In this r and omized controlled trial , no statistically significant improvement of refill adherence was found if an ERD was used with or without counseling . However , in a subgroup of women using statins for secondary prevention the ERD did improve adherence significantly BACKGROUND Adherence to statins in real-world practice setting s is known to be suboptimal . However , less is known about how adherence changes over time and whether changes in adherence are associated with adverse cardiovascular ( CV ) outcomes . OBJECTIVES To ( a ) characterize yearly changes in adherence among initially adherent patients taking statins for primary prevention and ( b ) assess the association between changes in statin adherence with subsequent risk of CV events . METHODS A 10 % r and om sample of the IMS LifeLink Health Plan Cl aims Data base covering the time period from July 1 , 1997 , to December 31 , 2008 , was used to identify a cohort of primary prevention statin users . Adherence was estimated in yearly segments beginning with the index statin prescription using proportion of days covered ( PDC ) . PDC was categorized into 3 levels : PDC ≥ 0.80 , 0.20 ≤ PDC < 0.80 , PDC < 0.20 . Patients were excluded if they experienced CV events or had PDC < 0.80 in their first year of statin exposure . Descriptive statistics were used to explore proportions of the cohort in each PDC category during each year . Cox-proportional ha
Output:
| Income associated with adherence more strongly in men than women , and highly educated men were more likely and highly educated women less likely to be adherent .
Alcohol misuse and high BMI associated with non-adherence .
There was no association between polypharmacy and statin adherence .
Current evidence suggests that patients with more traditional risk factors for CVD are more likely to be adherent to statins . |
MS210380 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND AND PURPOSE High intakes of calcium , potassium , and magnesium have been hypothesized to reduce risks of cardiovascular disease , but only a few prospect i ve studies have examined intakes of these cations in relation to risk of stroke . METHODS In 1980 , 85 764 women in the Nurses ' Health Study cohort , aged 34 to 59 years and free of diagnosed cardiovascular disease and cancer , completed dietary question naires from which we calculated intakes of calcium , potassium , and magnesium . By 1994 , after 1.16 million person-years of follow-up , 690 incident strokes ( 129 subarachnoid hemorrhages , 74 intraparenchymal hemorrhages , 386 ischemic strokes , and 101 strokes of undetermined type ) had been documented . RESULTS Intakes of calcium , potassium , and magnesium were each inversely associated with age- and smoking-adjusted relative risks of ischemic stroke , excluding embolic infa rct ion of nonatherogenic origin ( n=347 ) . Adjustment for other cardiovascular risk factors , including history of hypertension , attenuated these associations , particularly for magnesium intake . In a multivariate analysis , women in the highest quintile of calcium intake had an adjusted relative risk of ischemic stroke of 0.69 ( 95 % CI , 0.50 to 0.95 ; P for trend=0.03 ) compared with those in the lowest quintile ; for potassium intake the corresponding relative risk was 0.72 ( 95 % CI , 0.51 to 1.01 ; P for trend=0.10 ) . Further simultaneous adjustment for calcium and potassium intake suggested an independent association for calcium intake . The association of risk with calcium intake did not appear to be log linear ; the increase in risk was limited to the lowest quintile of intake , and intakes > approximately 600 mg/d did not appear to reduce risk of stroke further . The inverse association with calcium intake was stronger for dairy than for nondairy calcium intake . Intakes of calcium , potassium , and magnesium were not related to risk of other stroke subtypes . CONCLUSIONS Low calcium intake , and perhaps low potassium intake , may contribute to increased risk of ischemic stroke in middle-aged American women . It remains possible that women in the lowest quintile of calcium intake had unknown characteristics that made them susceptible to ischemic stroke Background and Purpose The etiology of ischemic stroke affects prognosis , outcome , and management . Trials of therapies for patients with acute stroke should include measurements of responses as influenced by subtype of ischemic stroke . A system for categorization of subtypes of ischemic stroke mainly based on etiology has been developed for the Trial of Org 10172 in Acute Stroke Treatment ( TOAST ) . Methods A classification of subtypes was prepared using clinical features and the results of ancillary diagnostic studies . “ Possible ” and “ probable ” diagnoses can be made based on the physician 's certainty of diagnosis . The usefulness and interrater agreement of the classification were tested by two neurologists who had not participated in the writing of the criteria . The neurologists independently used the TOAST classification system in their bedside evaluation of 20 patients , first based only on clinical features and then after review ing the results of diagnostic tests . Results The TOAST classification denotes five subtypes of ischemic stroke : 1 ) large-artery atherosclerosis , 2 ) cardioembolism , 3 ) small-vessel occlusion , 4 ) stroke of other determined etiology , and 5 ) stroke of undetermined etiology . Using this rating system , interphysician agreement was very high . The two physicians disagreed in only one patient . They were both able to reach a specific etiologic diagnosis in 11 patients , whereas the cause of stroke was not determined in nine . Conclusions The TOAST stroke subtype classification system is easy to use and has good interobserver agreement . This system should allow investigators to report responses to treatment among important subgroups of patients with ischemic stroke . Clinical trials testing treatments for acute ischemic stroke should include similar methods to diagnose subtypes of stroke OBJECTIVE To examine associations between type 2 diabetes and fiber , glycemic load ( GL ) , dietary glycemic index ( GI ) , and fiber-rich foods . RESEARCH DESIGN AND METHODS This was a prospect i ve study of 36,787 men and women aged 40 - 69 years without diabetes . For all self-reported cases of diabetes at 4-year follow-up , confirmation of diagnosis was sought from medical practitioners . Case subjects were those who reported diabetes at follow-up and for whom there was no evidence that they did not have type 2 diabetes . Data were analyzed with logistic regression , adjusting for country of birth , physical activity , family history of diabetes , alcohol and energy intake , education , 5-year weight change , sex , and age . RESULTS Follow-up was completed by 31,641 ( 86 % ) participants , and 365 cases were identified . The odds ratio ( OR ) for the highest quartile of white bread intake compared with the lowest was 1.37 ( 95 % CI 1.04 - 1.81 ; P for trend = 0.001 ) . Intakes of carbohydrate ( OR per 200 g/day 0.58 , 0.36 - 0.95 ) , sugars ( OR per 100 g/day 0.61 , 0.47 - 0.79 ) , and magnesium ( OR per 500 mg/day 0.62 , 0.43 - 0.90 ) were inversely associated with incidence of diabetes , whereas intake of starch ( OR per 100 g/day 1.47 , 1.06 - 2.05 ) and dietary GI ( OR per 10 units 1.32 , 1.05 - 1.66 ) were positively associated with diabetes . These relationships were attenuated after adjustment for BMI and waist-to-hip ratio . CONCLUSIONS Reducing dietary GI while maintaining a high carbohydrate intake may reduce the risk of type 2 diabetes . One way to achieve this would be to substitute white bread with low-GI breads This study assessed the hypothesis that greater magnesium intake is associated with reduced risk for cardiovascular disease ( CVD ) , including myocardial infa rct ion ( MI ) and stroke , in a large prospect i ve cohort of women . In 1993 , a semi-quantitative food frequency question naire was used to assess magnesium intake in 39,876 female health professionals aged 39 to 89 years who had no history of CVD or cancer . During a median of 10 years of follow-up , 1,037 incident cases of CVD were identified , including 280 nonfatal MIs and 368 strokes . After adjustment for age and r and omized treatment status , magnesium intake was not significantly associated with risk for incident CVD . Comparing the highest quintile of magnesium intake ( median 433 mg/day ) with the lowest quintile ( median 255 mg/day ) , the relative risks were 0.87 ( 95 % confidence interval [ CI ] 0.72 to 1.05 , p for trend = 0.24 ) for total CVD , 0.88 ( 95 % CI 0.70 to 1.12 , p for trend = 0.34 ) for coronary heart disease ( CHD ) , 1.03 ( 95 % CI 0.72 to 1.49 , p for trend = 0.96 ) for nonfatal MI , 1.11 ( 95 % CI 0.61 to 2.00 , p for trend = 0.95 ) for CVD death , and 0.87 ( 95 % CI 0.64 to 1.18 , p for trend = 0.55 ) for total stroke . Additional adjustment for other CVD risk factors did not material ly change the observed null associations . In conclusion , the results do not support the hypothesis that magnesium intake reduces the development of CHD , although a modest inverse association with stroke can not be ruled out Purpose Observational studies have reported increased colon cancer recurrence and mortality in patients with states of hyperinsulinemia , including type 2 diabetes , obesity , sedentary lifestyle , and high glycemic load diet . Nut intake has been associated with a lower risk of type 2 diabetes , metabolic syndrome , and insulin resistance . However , the effect of nut intake on colon cancer recurrence and survival is not known . Patients and Methods We conducted a prospect i ve , observational study of 826 eligible patients with stage III colon cancer who reported dietary intake on food frequency question naires while enrolled onto a r and omized adjuvant chemotherapy trial . Using Cox proportional hazards regression , we assessed associations of nut intake with cancer recurrence and mortality . Results After a median follow-up of 6.5 years , compared with patients who abstained from nuts , individuals who consumed two or more servings of nuts per week experienced an adjusted hazard ratio ( HR ) for disease-free survival of 0.58 ( 95 % CI , 0.37 to 0.92 ; Ptrend = .03 ) and an HR for overall survival of 0.43 ( 95 % CI , 0.25 to 0.74 ; Ptrend = .01 ) . In subgroup analysis , the apparent benefit was confined to tree nut intake ( HR for disease-free survival , 0.54 ; 95 % CI , 0.34 to 0.85 ; Ptrend = .04 ; and HR for overall survival , 0.47 ; 95 % CI , 0.27 to 0.82 ; Ptrend = .04 ) . The association of total nut intake with improved outcomes was maintained across other known or suspected risk factors for cancer recurrence and mortality . Conclusion Diets with a higher consumption of nuts may be associated with a significantly reduced incidence of cancer recurrence and death in patients with stage III colon cancer BACKGROUND Dietary carbohydrates may influence the development of type 2 ( non-insulin-dependent ) diabetes , for example , through effects on blood glucose and insulin concentrations . OBJECTIVE We examined the relations of baseline intake of carbohydrates , dietary fiber , dietary magnesium , and carbohydrate-rich foods and the glycemic index with incidence of diabetes . DESIGN This was a prospect i ve cohort study of 35988 older Iowa women initially free of diabetes . During 6 y of follow-up , 1141 incident cases of diabetes were reported . RESULTS Total grain , whole-grain , total dietary fiber , cereal fiber , and dietary magnesium intakes showed strong inverse associations with incidence of diabetes after adjustment for potential nondietary confounding variables . Multivariate-adjusted relative risks of diabetes were 1.0 , 0.99 , 0.98 , 0.92 , and 0.79 ( P for trend : 0.0089 ) across quintiles of whole-grain intake ; 1.0 , 1.09 , 1.00 , 0.94 , and 0.78 ( P for trend : 0.005 ) across quintiles of total dietary fiber intake ; and 1.0 , 0.81 , 0.82 , 0.81 , and 0.67 ( P for trend : 0.0003 ) across quintiles of dietary magnesium intake . Intakes of total carbohydrates , refined grains , fruit and vegetables , and soluble fiber and the glycemic index were unrelated to diabetes risk . CONCLUSION These data support a protective role for grains ( particularly whole grains ) , cereal fiber , and dietary magnesium in the development of diabetes in older women Microbial modulation of diabetes Short-chain fatty acids ( SCFAs ) are produced by various human gut microbes . SCFAs act as an energy source to the colonic epithelium and are also sensed by host signaling pathways that modulate appetite and inflammation . Deficiency of gut SCFAs is associated with type 2 diabetes . Zhao et al. found that adopting a high-fiber diet promoted the growth of SCFA-producing organisms in diabetic humans . The high-fiber diet induced changes in the entire gut microbe community and correlated with elevated levels of glucagon-like peptide-1 , a decline in acetylated hemoglobin levels , and improved blood-glucose regulation . Science , this issue p. 1151 Increasing dietary fiber intake increases the abundance of short-chain fatty acid – producing gut microbes and relieves diabetes . The gut microbiota benefits humans via short-chain fatty acid ( SCFA ) production from carbohydrate fermentation , and deficiency in SCFA production is associated with type 2 diabetes mellitus ( T2DM ) . We conducted a r and omized clinical study of specifically design ed isoenergetic diets , together with fecal shotgun metagenomics , to show that a select group of SCFA-producing strains was promoted by dietary fibers and that most other potential producers were either diminished or unchanged in patients with T2DM . When the fiber-promoted SCFA producers were present in greater diversity and abundance , participants had better improvement in hemoglobin
Output:
| Subgroup analyses suggested that the risk for total and ischaemic stroke was significantly decreased in females , participants with ≥25 mg/m2 body mass index and those with ≥12-year follow-up ; the reduced risk in Asians was not as notable as that in North American and European population s. CONCLUSIONS Magnesium intake has significantly inverse associations with T2D and total stroke in a dose-dependent manner . |
MS210381 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Objective : To determine the efficacy of epidural corticosteroid injections for sciatica . Methods : Three epidural injections ( two day intervals ) of 2 ml prednisolone acetate ( 50 mg ) or 2 ml isotonic saline were administered to patients with sciatica presumably due to a disk herniation lasting 15–180 days . Self evaluation was the main judgment criterion at day 20 . Patients who recovered or showed marked improvement were considered as success . Pain measured by VAS , the SLR test , Schober ’s test , Dallas pain question naire , and the Rol and -Morris index were evaluated at days 0 , 5 , 20 , and 35 . Only analgesics were authorised , patients requiring non-steroidal anti-inflammatory drugs ( NSAIDs ) before day 20 were considered as failure . Results : 42 patients were included in the control group ( CG ) , 43 in the steroid group ( SG ) . On an intention to treat analysis 15/42 ( 36 % ) in the CG and 22/43 ( 51 % ) in the SG ( p=0.15 ) were considered as success ( difference 15.5 % , 95 % CI ( −5.4 to 36.3 ) ) . Among the 48 failures , 14 patients ( 6 CG , 8 SG ) required NSAIDs , 3 ( 2 CG , 1 SG ) required surgery , and 7 ( 3 CG , 4 SG ) other treatments . On analysis according to protocol , in 74 remaining patients 12/35 ( 34 % ) in the CG and 22/39 ( 56 % ) in the SG ( p=0.057 ) were considered as success ( difference 22.1 % , 95 % CI ( 0.0 to 44.2 ) ) . For all secondary end points intragroup improvement with time was significant , but intergroup differences were not . Conclusion : The efficacy of isotonic saline administered epidurally for sciatica can not be excluded , but epidural steroid injections provide no additional improvement The management of sciatica due to lumbar nerve root compromise remains controversial , probably because few well-controlled studies of conservative management have been performed . This preliminary study assesses the efficacy of epidural injections of 80 mg triamcinolone acetonide plus 0.5 % procaine hydrochloride in saline , administered via the caudal route , in a double-blind , placebo controlled trial with 1 year follow-up . Twenty-three patients were entered into the study : 12 received treatment and 11 placebo . The active group showed significant pain relief ( P=0.02 ) and a significant increase in mobility ( P=0.01 ) at 4 weeks , which result ed in improved quality of life ( P=0.02 ) . At 1 year , subjective and objective measures improved in both groups . The improvement was greater in the actively treated group , but only the objective assessment ( straight leg raise ) was statistically significant BACKGROUND Although epidural corticosteroid injections are commonly used for sciatica , their efficacy has not been established . METHODS In a r and omized , double-blind trial , we administered up to three epidural injections of methylprednisolone acetate ( 80 mg in 8 ml of isotonic saline ) or isotonic saline ( 1 ml ) to 158 patients with sciatica due to a herniated nucleus pulposus . All patients had Oswestry disability scores higher than 20 ( on a scale of 1 to 100 , with scores of 20 or less indicating minimal disability , and higher scores greater disability ) . RESULTS At three weeks , the Oswestry score had improved by a mean of -8.0 in the methylprednisolone group and -5.5 in the placebo group ( 95 percent confidence interval for the difference , -7.1 to 2.2 ) . Differences in improvements between the groups were not significant , except for improvements in the finger-to-floor distance ( P=0.006 ) and sensory deficits ( P=0.03 ) , which were greater in the methylprednisolone group . After six weeks , the only significant difference was the improvement in leg pain , which was greater in the methylprednisolone group ( P=0.03 ) . After three months , there were no significant differences between the groups . The Oswestry score had improved by a mean of -17.3 in the methylprednisolone group and -15.4 in the placebo group ( 95 percent confidence interval for the difference , -9.3 to 5.4 ) . At 12 months , the cumulative probability of back surgery was 25.8 percent in the methylprednisolone group and 24.8 percent in the placebo group ( P=0.90 ) . CONCLUSIONS Although epidural injections of methylprednisolone may afford short-term improvement in leg pain and sensory deficits in patients with sciatica due to a herniated nucleus pulposus , this treatment offers no significant functional benefit , nor does it reduce the need for surgery The value of epidural injections of corticosteroid as an outpatient treatment of sciatica has been hitherto uncertain . An epidural injection of 80 mg methylprednisolone in 10 ml physiological saline was compared with an interspinous injection of 2 ml physiological saline in a double blind fashion amongst 39 out patients . Significant differences of pain relief were seen between the two groups within 2 weeks . This benefit disappeared for six ( 35 % ) patients within 6 months of treatment although 11 ( 65 % ) successfully treated subjects had sustained improvement up to this time . Outpatient epidural injections of corticosteroid are thus a useful short-term means of relieving pain in sciatica but probably have little effect on the long-term natural history of symptoms . Factors associated with a failure to respond to epidural steroid injections are discussed OBJECTIVE To determine the effectiveness and predictors of response to lumbar epidural corticosteroid injections ( ESI ) in patients with sciatica . We performed a 12-month , multicentre , double-blind , r and omized , placebo-controlled , parallel-group trial in four secondary pain-care clinics in the Wessex Region . METHODS Two hundred and twenty-eight patients with a clinical diagnosis of unilateral sciatica of 1 - 18 months ' duration were r and omized to either three lumbar ESIs of triamcinolone acetonide or interligamentous saline injections at intervals of 3 weeks . The main outcome measure was the Oswestry low back pain disability question naire ( ODQ ) . RESULTS At 3 weeks , the ESI group demonstrated a transient benefit over the placebo group ( patients achieving a 75 % improvement in ODQ , 12.5 vs 3.7 % ; number needed to treat , 11.4 ) . No benefit was demonstrated from 6 to 52 weeks . ESIs did not improve physical function , hasten return to work or reduce the need for surgery . There was no benefit of repeated ESIs over single injection . No clinical predictors of response were found . At the end of the study the majority of patients still had significant pain and disability regardless of intervention . CONCLUSIONS In this pragmatic study , ESIs offered transient benefit in symptoms at 3 weeks in patients with sciatica , but no sustained benefits in terms of pain , function or need for surgery . Sciatica is a chronic condition requiring a multidisciplinary approach . To fully investigate the value of ESIs , they need to be evaluated as part of a multidisciplinary approach OBJECTIVE To determine the difference in short- and long-term pain improvement between lumbar Epidural Steroid Injections ( ESIs ) and conservative management in patients with lumbar radiculopathy . STUDY DESIGN Quasi-experimental study . PLACE AND DURATION OF STUDY The Postgraduate Medical Institute of Hayatabad Medical Complex , Peshawar , from April 2005 to March 2007 . METHODOLOGY Fifty elective patients fulfilling the inclusion criteria were r and omly divided into two groups . Patients in the steroid group were treated with 80 mg of methylprednisolone injected in combination with 3 ml of 2 % plain xylocaine and 3 ml of normal saline in the lumbar epidural space , while patients in the conservative group were treated with bed rest , non-steroidal anti-inflammatory agents , muscle relaxants , and opioids . All the 50 patients in the two groups were regularly assessed at 2 weeks , 1 month , 3 months and 6 months of periods for pain score by the Visual Analogue Scale ( VAS ) , patients satisfaction score and any unwanted side effects . RESULTS A marked improvement of the pain score and patients satisfaction score were noticed in the steroid group . Less significant improvement was seen in the conservative group during the initial period i.e 2 weeks and 1 month ( p < 0.05 ) . The difference in Visual Analogue Scale ( VAS ) and patients satisfaction score was non-significant in chronic stages of treatment in both groups ( p > 0.05 ) . CONCLUSION Epidural steroid injections in acute symptoms of sciatica are considered to be a better option compared to conservative treatment OBJECTIVE Low back pain is a highly common problem and causes much morbidity and socioeconomic loss in the community . Although the use of caudal epidural injections in the management of the low back pain with radicular signs is commonplace , it has not been well investigated . We compare the effectiveness of caudal epidural injection versus non-steroidal anti-inflammatory drugs ( NSAIDs ) in the treatment of low back pain accompanied with radicular pain . METHODS The study was a controlled prospect i ve unblinded trial . A total of consecutive 64 patients with subacute or chronic low back pain accompanied with radicular pain were included . The patients were r and omly allocated to two groups . First group was caudal epidural injection plus therapeutic exercise group , and the second group was NSAIDs plus therapeutic exercise group . Patients were assessed with 10 cm visual analogue scale for pain , straight leg raising test and Oswestry low back pain disability question naire at the beginning and at 15th day , 1st and 3rd month . RESULTS It was seen that both groups ' improvement were good and statistically significant . On the other h and , caudal epidural injection group 's improvement was better and faster than the NSAID group 's , and the differences between assessment scores of the groups were statistically significant , except the 3rd month Oswestry scores . CONCLUSION Finally , caudal epidural injection in the management of the subacute/chronic low back and radicular pain is a preferable choice , if applied by experienced specialists Four treatment regimens for patients with specified combinations of low back pain and sciatica were evaluated . The largest group studied had low back pain with limited straight-leg raising ( SLR ) and in them the beneficial effect of manipulation in hastening pain relief was highly significant . In similar patients without limitation of SLR , the effect was of borderline significance . In all the other groups , treated patients also recovered more quickly than their controls . Traction , for patients with low back pain and sciatica , and epidural injections when a root palsy was present also produced some significant pain relief . The effect of sclerosants for back pain was less clear Study Design . A subgroup analysis of a prospect i ve , r and omized controlled trial was performed . Objective . To describe the cost effectiveness of periradicular infiltration with steroid in subgroups of patients with sciatica . Summary of Background Data . A recent trial on periradicular infiltration indicated that a methylprednisolone – bupivacaine combination had a short-term effect , as compared with that of saline . This report describes the efficacy and cost effectiveness of steroid in subgroups of patients with sciatic . Methods . This study involved 160 patients with unilateral sciatica . Outcome assessment s were leg pain ( 100-mm visual analog scale ) , disability on the Oswestry Low Back Disability Question naire , and the Nottingham Health Profile . Data on medical costs and sick leaves also were gathered . Patients were r and omized for periradicular infiltration with either methylprednisolone – bupivacaine or saline . The adjusted between-group treatment differences at each follow-up assessment , the number of patients free of leg pain ( responders , cutoff 75 % ) , and efficacy by the area-under-the-curve method were calculated . For the cost-effectiveness estimate , the total costs were divided by the number of responders . The rate of operations in different subgroups was evaluated by Kaplan-Meier analysis . Results . In the case of contained herniations , the steroid injection produced significant treatment effects and short-term efficacy in leg pain and in Nottingham Health Profile emotional reactions . For symptomatic lesions at L3–L4–L5 , steroid was superior to saline for leg pain , disability , and straight leg raising in the short term . By 1 year , steroid seemed to have prevented operations for contained herniations , costing $ 12,666 less per responder in the steroid group ( P < 0.01 ) . For extrusions , steroid seemed to increase the operation rate , and the steroid infiltration was more expensive , costing $ 4445 per responder ( P < 0.01 ) . Conclusions . In addition to short-term effectiveness for contained herniations and lesions at L3–L4–L5 , steroid treatment also prevented surgery for contained herniations . However , steroid was countereffective for extrusions . The results of the subgroup analyses call for a verification study Study Design . A r and omized , double-blind controlled trial . Objectives . To determine the treatment effect of corticosteroids in periradicular infiltration for chronic radicular pain . We also examined prognostic factors in relation to the outcome of the procedure . Summary of Background Data . Various studies have examined the therapeutic value of periradicular infiltration using treatment agents consisting of local anesthetic and cortic
Output:
| All-cause mortality was low in our analysis of patients attending specialty clinics .
In terms of spinal steroid injections , headache appeared to be the most common adverse effect .
Oral opioid therapy may be helpful for the treatment of low back pain , but it is unclear from the high- quality literature whether there are limitations from adverse effects .
Spinal steroid injections are beneficial for low back pain and disability in the short-term .
The high dropout rates caused by insufficient pain relief and adverse effects suggest that opioids may not be as effective as spinal steroid injections .
There is more high- quality literature to support the use of spinal steroid injections compared with oral opioids in this condition |
MS210382 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The Nrf2/ARE pathway is a major cellular defense mechanism that prevents damage by reactive oxygen species through induction of antioxidative phase II enzymes . However , the activity of the Nrf2/ARE system is not uniform with variability in response presumed to be dependent on the Nrf2 genotype . We recently completed a pilot human coffee intervention trial with healthy humans , where large interindividual differences in the antioxidative response to the study coffee were examined . Here , we address the question whether differences in the modulation of Nrf2 gene transcription , assessed as an induction of Nrf2 gene transcription by Q-PCR , might be correlated with specific Nrf2 genotypes . To date , nine single nucleotide polymorphisms ( SNPs ) have been identified in the Nrf2 ( NFE2L2 ) gene . Two of these , the −617C/A and −651G/A SNPs are located within the promoter region and have previously been reported to influence the activity of the Nrf2/ARE pathway by reducing Nrf2 transcriptional activity . Sequencing of the critical Nrf2 gene promoter region not only confirmed the existence of these SNPs within the participants of the trial at the expected frequency ( 33 % carrying the −617C/A , 17 % the −651G/A and 56 % the −653A/G SNP ) but also indicated reduced Nrf2 gene transcription associated with a normal diet if the SNPs at position −617 , −651 or −653 were present . Of note , the data also indicated the study coffee increased Nrf2 gene transcription even in SNP carriers . This further highlights the relevance of genotype-dependent induction of Nrf2 gene transcription that appears to be largely influenced by dietary factors Background The relationship between coffee consumption and mortality in diverse European population s with variable coffee preparation methods is unclear . Objective To examine whether coffee consumption is associated with all-cause and cause-specific mortality . Design Prospect i ve cohort study . Setting 10 European countries . Participants 521 330 persons enrolled in EPIC ( European Prospect i ve Investigation into Cancer and Nutrition ) . Measurements Hazard ratios ( HRs ) and 95 % CIs estimated using multivariable Cox proportional hazards models . The association of coffee consumption with serum biomarkers of liver function , inflammation , and metabolic health was evaluated in the EPIC Biomarkers subcohort ( n = 14 800 ) . Results During a mean follow-up of 16.4 years , 41 693 deaths occurred . Compared with nonconsumers , participants in the highest quartile of coffee consumption had statistically significantly lower all-cause mortality ( men : HR , 0.88 [ 95 % CI , 0.82 to 0.95 ] ; P for trend < 0.001 ; women : HR , 0.93 [ CI , 0.87 to 0.98 ] ; P for trend = 0.009 ) . Inverse associations were also observed for digestive disease mortality for men ( HR , 0.41 [ CI , 0.32 to 0.54 ] ; P for trend < 0.001 ) and women ( HR , 0.60 [ CI , 0.46 to 0.78 ] ; P for trend < 0.001 ) . Among women , there was a statistically significant inverse association of coffee drinking with circulatory disease mortality ( HR , 0.78 [ CI , 0.68 to 0.90 ] ; P for trend < 0.001 ) and cerebrovascular disease mortality ( HR , 0.70 [ CI , 0.55 to 0.90 ] ; P for trend = 0.002 ) and a positive association with ovarian cancer mortality ( HR , 1.31 [ CI , 1.07 to 1.61 ] ; P for trend = 0.015 ) . In the EPIC Biomarkers subcohort , higher coffee consumption was associated with lower serum alkaline phosphatase ; alanine aminotransferase ; aspartate aminotransferase ; γ-glutamyltransferase ; and , in women , C-reactive protein , lipoprotein(a ) , and glycated hemoglobin levels . Limitations Reverse causality may have biased the findings ; however , results did not differ after exclusion of participants who died within 8 years of baseline . Coffee-drinking habits were assessed only once . Conclusion Coffee drinking was associated with reduced risk for death from various causes . This relationship did not vary by country . Primary Funding Source European Commission Directorate-General for Health and Consumers and International Agency for Research on Cancer Recent results from prospect i ve cohort studies have shown that moderate coffee consumption is associated with a reduced risk for diabetes mellitus type II or Alzheimer 's disease . Since reactive oxygen species ( ROS ) are believed to be involved in the pathogenesis of these diseases , antioxidants in coffee might contribute to this risk reduction . We aim ed at elucidating whether a dark roast coffee beverage ( CB ) rich in N-methylpyridinium ions ( NMP : 785 μmol/L ) and low in chlorogenic acids ( CGA : 523 μmol/L ) has stronger antioxidant effects on human erythrocytes than a CB prepared from a light roast with opposite proportions ( CGA : 4538 μmol/L ; NMP : 56 μmol/L ) . Following a 2-wk wash out period , 500 mL of the respective CB was administered to 30 subjects daily for 4-wk . Blood and spot urine sample s were collected at the beginning and at the end of each intervention . Intake of the dark roast CB most effectively improved the antioxidant status of erythrocytes : superoxide dismutase and glutathione peroxidase activity decreased by 5.8 and 15 % , respectively , whereas tocopherol and total glutathione concentrations increased by 41 and 14 % , respectively . Furthermore , administration of the NMP-rich CB led to a significant body weight reduction in pre-obese subjects , whereas the CGA-rich CB did not BACKGROUND Coffee consumption has been associated with a lower risk of diabetes , but little is known about the mechanisms responsible for this association , especially related to the time when coffee is consumed . OBJECTIVE We examined the long-term effect of coffee , globally and according to the accompanying meal , and of tea , chicory , and caffeine on type 2 diabetes risk . DESIGN This was a prospect i ve cohort study including 69,532 French women , aged 41 - 72 y from the E3N/EPIC ( Etude Epidémiologique auprès de Femmes de la Mutuelle Générale de l'Education Nationale/European Prospect i ve Investigation into Cancer and Nutrition ) cohort study , without diabetes at baseline . Food and drink intakes per meal were assessed by using a vali date d diet-history question naire in 1993 - 1995 . RESULTS During a mean follow-up of 11 y , 1415 new cases of diabetes were identified . In multivariable Cox regression models , the hazard ratio in the highest category of coffee consumption [ > or =3 cups ( 375 mL)/d ] was 0.73 ( 95 % CI : 0.61 , 0.87 ; P for trend < 0.001 ) , in comparison with no coffee consumption . This inverse association was restricted to coffee consumed at lunchtime ( hazard ratio : 0.66 ; 95 % CI : 0.57 , 0.76 ) when comparing > 1.1 cup ( 125 mL)/meal with no intake . At lunchtime , this inverse association was observed for both regular and decaffeinated coffee and for filtered and black coffee , with no effect of sweetening . Total caffeine intake was also associated with a statistically significantly lower risk of diabetes . Neither tea nor chicory consumption was associated with diabetes risk . CONCLUSIONS Our data support an inverse association between coffee consumption and diabetes and suggest that the time of drinking coffee plays a distinct role in glucose metabolism BACKGROUND Consumption of caffeinated beverages such as coffee and tea has been associated with a lower risk of type 2 diabetes ( T2D ) . Paradoxically , short-term metabolic studies have shown that caffeine impairs postpr and ial glycemic control . OBJECTIVE The objective was to prospect ively examine the association of caffeinated compared with caffeine-free beverages , including coffee , tea , sugar-sweetened beverages ( SSBs ) , and carbonated artificially sweetened beverages ( ASBs ) , with T2D risk . DESIGN We prospect ively observed 74,749 women from the Nurses ' Health Study ( NHS , 1984 - 2008 ) and 39,059 men from the Health Professionals Follow-Up Study ( HPFS , 1986 - 2008 ) who were free of diabetes , cardiovascular diseases , and cancer at baseline . RESULTS We documented 7370 incident cases of T2D during 24 y of follow-up in the NHS and 2865 new cases during 22 y of follow-up in the HPFS . After major lifestyle and dietary risk factors were controlled for , caffeinated and caffeine-free SSB intake was significantly associated with a higher risk of T2D in the NHS ( RR per serving : 13 % for caffeinated SSBs , 11 % for caffeine-free SSBs ; P < 0.05 ) and in the HPFS ( RR per serving : 16 % for caffeinated SSBs , 23 % for caffeine-free SSBs ; P < 0.01 ) . Only caffeine-free ASB intake in NHS participants was associated with a higher risk of T2D ( RR : 6 % per serving ; P < 0.001 ) . Conversely , the consumption of caffeinated and decaffeinated coffee was associated with a lower risk of T2D [ RR per serving : 8 % for both caffeinated and decaffeinated coffee in the NHS ( P < 0.0001 ) and 4 % for caffeinated and 7 % for decaffeinated coffee in the HPFS ( P < 0.01 ) ] . Only caffeinated tea was associated with a lower T2D risk among NHS participants ( RR per serving : 5 % ; P < 0.0001 ) . CONCLUSION Irrespective of the caffeine content , SSB intake was associated with a higher risk of T2D , and coffee intake was associated with a lower risk of T2D OBJECTIVE We evaluated the influence of coffee consumption on diabetes incidence among the Hawaii component of the Multiethnic Cohort ( MEC ) . DESIGN Prospect i ve cohort . SETTING Population -based sample residing in Hawaii . SUBJECTS After exclusions , 75 140 men and women of Caucasian , Japanese American and Native Hawaiian ancestry aged 45 - 75 years were part of the current analysis . All participants provided information on diet and lifestyle through an FFQ . After 14 years of follow-up 8582 incident diabetes cases were identified using self-reports , medication question naires and health plan linkages . Hazard ratios ( HR ) and 95 % confidence intervals were calculated using Cox regression while adjusting for known covariates . RESULTS The risk for diabetes associated with total coffee consumption differed by sex ( P interaction < 0·0001 ) . Women consuming ≥3 cups of any type of coffee daily had a significantly lower risk ( HR = 0·66 ; 95 % CI 0·58 , 0·77 ; P trend < 0·0001 ) than those reporting < 1 cup/d , whereas the relationship in men was borderline ( HR = 0·89 ; 95 % CI 0·80 , 0·99 ; P trend = 0·09 ) . The same difference by sex was seen for regular coffee consumption , with HR of 0·65 ( 95 % CI 0·54 , 0·78 ; P trend < 0·0001 ) and 0·86 ( 95 % CI 0·75 , 0·98 ; P trend = 0·09 ) in men and women , respectively . No significant association with diabetes was apparent for decaffeinated coffee in women ( HR = 0·85 ; 95 % CI 0·72 , 1·01 ; P trend = 0·73 ) or men ( HR = 1·07 ; 95 % CI 0·93 , 1·23 ; P trend = 0·71 ) . Despite small differences by ethnicity , the interaction terms between coffee intake and ethnicity were not significant . CONCLUSIONS In this multiethnic population , regular , but not decaffeinated , coffee intake was much more protective against diabetes in women of all ethnic groups than in men BACKGROUND The long-term effects of caffeine intake on weight have not been examined prospect ively . OBJECTIVE The objective was to assess the relation between caffeine intake and 12-y weight change . DESIGN We conducted a prospect i ve study of 18 417 men and 39 740 women , with no chronic diseases at baseline , who were followed from 1986 to 1998 . Caffeine intake was assessed repeatedly every 2 - 4 y. Weight change was calculated as the difference between the self-reported weight in 1986 and in
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| Conclusions Available evidence indicates that coffee consumption is inversely associated with risk of T2D . |
MS210383 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Total hip or knee replacement is highly successful when judged by prosthesis-related outcomes . However , some people experience long-term pain . Objectives To review published studies in representative population s with total hip or knee replacement for the treatment of osteoarthritis reporting proportions of people by pain intensity . Data sources MEDLINE and EMBASE data bases search ed to January 2011 with no language restrictions . Citations of key articles in ISI Web of Science and reference lists were checked . Study eligibility criteria , participants and interventions Prospect i ve studies of consecutive , unselected osteoarthritis patients representative of the primary total hip or knee replacement population , with intensities of patient-centred pain measured after 3 months to 5-year follow-up . Study appraisal and synthesis methods Two authors screened titles and abstract s. Data extracted by one author were checked independently against original articles by a second . For each study , the authors summarised the proportions of people with different severities of pain in the operated joint . Results Search es identified 1308 articles of which 115 reported patient-centred pain outcomes . Fourteen articles describing 17 cohorts ( 6 with hip and 11 with knee replacement ) presented appropriate data on pain intensity . The proportion of people with an unfavourable long-term pain outcome in studies ranged from about 7 % to 23 % after hip and 10 % to 34 % after knee replacement . In the best quality studies , an unfavourable pain outcome was reported in 9 % or more of patients after hip and about 20 % of patients after knee replacement . Limitations Other studies reported mean values of pain outcomes . These and routine clinical studies are potential sources of relevant data . Conclusions and implication s of key findings After hip and knee replacement , a significant proportion of people have painful joints . There is an urgent need to improve general awareness of this possibility and to address determinants of good and bad outcomes Pain control is necessary for successful rehabilitation and outcome after total knee arthroplasty . Our goal was to compare the clinical efficacy of periarticular injections consisting of a long-acting local anesthetic ( ropivacaine ) and epinephrine with and without combinations of an α2-adrenergic agonist ( clonidine ) and /or a nonsteroidal anti-inflammatory agent ( ketorolac ) . In a double-blinded controlled study , we r and omized 160 patients undergoing total knee arthroplasty to receive 1 of 4 intraoperative periarticular injections : Group A , ropivacaine , epinephrine , ketorolac , and clonidine ; Group B , ropivacaine , epinephrine , and ketorolac ; Group C , ropivacaine , epinephrine , and clonidine ; Group D ( control ) , ropivacaine and epinephrine . Compared with Group D , Group A and B patients had significantly lower postoperative visual analog pain scores and nurse pain assessment and Group C patients had a significantly greater reduction in physical therapist pain assessment . We found no differences in other parameters analyzed Although the analgesic effects of periarticular multimodal drug injection ( PMDI ) after TKA have been well documented , there is little information about additional pain relieving effects of PMDI incorporated to contemporary multimodal pain control protocol s which have been proved to provide excellent analgesia . We performed a parallel-group , r and omised , controlled study to determine whether PMDI provides additional clinical benefits on contemporary multimodal analgesic protocol s including preemptive analgesics , continuous femoral nerve block , and IV-PCA . Eighty-seven patients were r and omized to a PMDI group ( n=45 ) or to a No-PMDI group ( n=42 ) . Pain level and opioid consumption were compared as primary outcomes . The incidences of narcotic and ropivacaine related side effects and complications , functional recovery , and satisfaction were also compared . The PMDI group experienced less pain during the operation night and the 1st postoperative day and showed lower opioid consumption over 24h after surgery . However , the PMDI group had a higher VAS pain score on the 1st postoperative day than during the operation night . No group differences in side-effects and complication incidences , functional recovery , and satisfaction were found . This study demonstrates that PMDI provides additional pain relief and reduces opioid consumption only during the early postoperative period in patients managed by the contemporary pain management protocol following TKA Background Several reports have confirmed the ability of intraoperative periarticular injections to control pain after THA . However , these studies used differing combinations of analgesic agents and the contribution of each , including the local anesthetic agent , is uncertain . Underst and ing the independent effects of the various agents could assist in improved pain management after surgery . Questions / purpose sWe therefore determined the ability of intraoperative periarticular infiltration of levobupivacaine to ( 1 ) reduce postoperative pain , ( 2 ) reduce postoperative morphine requirements , and ( 3 ) reduce the incidence of nausea and urinary retention . Patients and Methods A double-blinded , r and omized , placebo-controlled trial of patients undergoing primary THAs was performed . Patients were r and omized to receive a periarticular infiltration of 150 mg levobupivacaine in 60 mL 0.9 % saline ( n = 45 ) or a placebo consisting of 60 mL 0.9 % saline ( n = 46 ) . We obtained a short-form McGill pain score , visual analog scale ( VAS ) , and morphine requirements via patient-controlled analgesia ( PCA ) as primary measures . Postoperative antiemetic requirements and need for catheterization for urinary retention were determined as secondary measures . Results Subjectively reported pain scores and the overall intensity scores were similar for both groups in the postoperative period . At the same time the mean morphine consumption was less in the levobupivacaine group , most notable in the first 12 hours after surgery : treatment group 11.5 mg vs control group 21.2 mg . We observed no differences in the frequency of postoperative nausea and vomiting or urinary retention . Conclusions Our observations suggest periarticular injection of levobupivacaine can supplement available postoperative analgesic techniques and reduce postoperative morphine requirements after THA.Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence Background and Objectives : High-volume local infiltration analgesia ( LIA ) is widely applied as part of a multimodal pain management strategy in total hip arthroplasty ( THA ) . However , method ological problems hinder the exact interpretation of previous trials , and the evidence for LIA in THA remains to be clarified . Therefore , we evaluated whether intraoperative high-volume LIA , in addition to a multimodal oral analgesic regimen , would further reduce acute postoperative pain after THA . Methods : Patients scheduled for unilateral , primary THA under spinal anesthesia were included in this r and omized , double-blind , placebo-controlled trial receiving high-volume ( 150 mL ) wound infiltration with ropivacaine 0.2 % with epinephrine ( 10 & mgr;g/mL ) or saline 0.9 % . A multimodal oral analgesic regimen consisting of slow-release acetaminophen 2 g , celecoxib 400 mg , and gabapentin 600 mg was instituted preoperatively . Rescue analgesic consisted of oral oxycodone . Pain was assessed repeatedly the first 8 hrs after surgery using the 100-mm visual analog scale . The primary end point was pain during walking ( 5 m ) 8 hrs after surgery . Secondary end points were pain at rest , pain on 45 degrees of passive flexion of the hip with the leg straight , and cumulative consumption of oxycodone . Results : A total of 120 patients were included . Pain during walking ( median [ interquartile range ] [ 95 % confidence interval ] ) was low in the ropivacaine versus the placebo group ( 20 [ 14 - 38 ] [ 0 - 93 ] vs 22 [ 10 - 40 ] [ 0 - 83 ] ) and did not differ significantly ( P = 0.71 ) . Consumption of rescue oxycodone ( 5 mg [ 0 - 10 mg ] [ 0 - 24 mg ] vs 10 mg [ 0 - 15 mg ] [ 0 - 29 mg ] ) did not differ ( P = 0.45 ) . Conclusions : Intraoperative high-volume LIA with ropivacaine 0.2 % provided no additional reduction in acute pain after THA when combined with a multimodal oral analgesic regimen consisting of acetaminophen , celecoxib , and gabapentin and is therefore not recommended This study tests the null hypothesis that there is no difference between sciatic nerve block ( SNB ) and periarticular anesthetic infiltration ( PI ) as adjuncts to femoral nerve blockade ( FNB ) in total knee arthroplasty in terms of postoperative opioid requirements . Fifty-two patients undergoing total knee arthroplasty were r and omized to receive either ( a ) combined FNB-SNB or ( b ) combined FNB-PI . Average morphine consumption in the first 24 ( 20 vs 23 mg ) and 48 hours ( 26 vs 33 mg ) showed no significant difference . Visual Analogue Scale scores , knee flexion ( 60 ° vs 67.5 ° ) and extension lag ( 0 ° vs 5 ° ) were comparable . Anesthetic time , surgical time , and length of hospital stay ( 5.5 vs 6 days ) were similar . This study showed no significant difference between the 2 groups . The PI offers a practical and potentially safer alternative to SNB Purpose Several analgesic techniques are available for pain management after a major operation . Material s and Methods From December 2005 to February 2006 , a prospect i ve , double-blind study was performed involving 90 patients who had undergone a total knee arthroplasty . Patients were r and omly divided into three equal groups ( n = 30 ) . Demographic data , including age , height , weight , knee score , visual analogue scale ( VAS ) , and range of flexion were evaluated preoperatively . Before wound closure , patients were given intra-synovial injections of the following solutions : patients in group I received 40 mL of 300 mg ropivacaine with 1 : 200,000 epinephrine and 5 mg morphine ; patients in Group II received 40 mL of 300 mg ropivacaine with epinephrine ; and patients in Group III received 50 mL normal saline as a control . All patients received an epidural patient-controlled analgesia ( PCA ) for 24 postoperative hours . Analgesic efficacy was evaluated using the VAS at intervals of 2 , 4 , 6 , 12 , 24 , 32 , 40 , and 48 hours postoperatively . During this period , the side effects , the dosage of rescue analgesia required , and the range of knee flexion were recorded for each group . Results There were no significant differences among the three groups with regards to the VAS and the required dose of rescue analgesia ( p > 0.05 ) . None of the groups demonstrated significant differences in the range of knee flexion and the incidence of postoperative nausea and emesis ( p > 0.05 ) . Conclusion Therefore , we found that ropivacaine , alone or with morphine , injected into the synovial tissue , along with an epidural PCA has no additional benefits in pain control after a total knee arthroplasty Background For the majority of patients with osteoarthritis ( OA ) , joint replacement is a successful intervention for relieving chronic joint pain . However , between 10 - 30 % of patients continue to experience chronic pain after joint replacement . Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain . The aim of this r and omised controlled trial ( RCT ) is to determine if intra-operative local anaesthethic wound infiltration additional to a st and ard anaethesia regimen can reduce the severity of joint pain at 12-months after total knee replacement ( TKR ) and total hip replacement ( THR ) for OA . Methods 300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT . Participants are recruited before surgery and r and omised to either the st and ard care group or the intervention group . Participants and outcome assessors are blind to treatment allocation throughout the study . The intervention consists of an intra-operative local anaesthetic wound infiltration , consisting of 60 mls of 0.25 % bupivacaine with 1 in 200,000 adrenaline . Participants are assessed on the first 5 days post-operative , and then at 3-months , 6-months and 12-months . The primary outcome is the WOMAC Pain Scale , a vali date d measure of joint pain at 12-months . Secondary outcomes include pain severity during the in-patient stay , post-operative nausea and vomiting , satisfaction with pain relief , length of hospital stay , joint pain and disability , pain sensitivity , complications and cost-effectiveness . A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals . Discussion Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon , particulary in orthopaedics . The results from this trial will inform evidence -based recommendations for both short-term and long-term pain management after lower limb joint replacement . If a local anaesthetic wound infiltration is found to be an effective and cost-effective intervention , implementation into clinical practice could improve long-term pain outcomes for patients
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| There was no evidence of pain control additional to that provided by femoral nerve block .
Conclusions Local anaesthetic infiltration is effective in reducing short-term pain and hospital stay in patients receiving THR and TKR . |
MS210384 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: This prospect i ve study was design ed to look for and describe urologic and nephrologic consequences of urinary bilharziosis due to schistosoma haematobium in a hyperendemic hotbed in the middle west of Madagascar . Methodology included clinical examination , kidney and bladder ultrasonography , urine dipsticks and creatininemia . Amongst a population of 574 persons aged 5 years ore more , 436 ( 76 % ) had bilharziosis ova in the urine ( filtration method ) . From the clinical point of view , 257 patients ( 58.9 % ) had microscopic hematuria , 178 ( 40.8 % ) had presently an hematuria ; 111 patients ( 25.5 % ) suffered from dysuria ; 18 patients ( 4.1 % ) had limb oedema when 3 patients had present oedema ( 0.7 % ) . Among 436 checked people , 267 ( 61.2 % ) had an ultrasonography abnormality . In 252 , it was bladder wall abnormalities ( 57.8 % ) . They were wall irregularities in 182 cases ( 41.7 % ) ; vesico-ureteral reflux in 22 cases ( 5.3 % ) ; ureteral dilatations in 22 cases ( 5.3 % ) and pyelocalyceal dilatations in 61 cases ( 13.9 % ) . Prevalence of proteinuria 75.2 % ( 316 amongst 420 checked people ) of whom 5.7 % ( 24 cases ) had 5 g/l or more . Hematuria was found in 352 patients ( 83.8 % ) of whom 238 ( 56.7 % ) had more than 250 erythrocytes per microliter . Prevalence of leucocyturia was 56.7 % ( 238 cases ) . Creatininemia was measured in 140 people with positive filtration ; it was normal in all except two patients . This study highlights the parallel evolution between parasitic infection and uronephrological manifestations of the disease UNLABELLED An earlier reported laboratory assay , performed in The Netherl and s , to diagnose Schistosoma infections by detection of the parasite antigen CAA in serum was converted to a more user-friendly format with dry reagents . The improved assay requires less equipment and allows storage and worldwide shipping at ambient temperature . Evaluation of the new assay format was carried out by local staff at Ampath Laboratories , South Africa . The lateral flow ( LF ) based assay utilized fluorescent ultrasensitive up-converting phosphor ( UCP ) reporter particles , to be read by a portable reader ( UPlink ) that was also provided to the laboratory . Over a period of 18 months , about 2000 clinical sample s were analyzed prospect ively in parallel with a routinely carried out CAA-ELISA . LF test results and ELISA data correlated very well at CAA concentrations above 300 pg/mL serum . At lower concentrations the UCP-LF test indicates a better performance than the ELISA . The UCP-LF strips can be stored as a permanent record as the UCP label does not fade . At the end of the 18 months testing period , LF strips were shipped back to The Netherl and s where scan results obtained in South Africa were vali date d with different UCP scanning equipment including a novel , custom developed , small lightweight UCP strip reader ( UCP-Quant ) , well suited for testing in low re source setting s. CONCLUSION The dry format UCP-LF assay was shown to provide a robust and easy to use format for rapid testing of CAA antigen in serum . It performed at least as good as the ELISA with respect to sensitivity and specificity , and was found to be superior with respect to speed and simplicity of use . Worldwide shipping at ambient temperature of the assay reagents , and the availability of small scanners to analyze the CAA UCP-LF strip , are two major steps towards point-of-care ( POC ) applications in remote and re source poor environments to accurately identify low ( 30 pg CAA/mL serum ; equivalent to about 10 worm pairs ) to heavy Schistosoma infections Quantitative parasitological assessment and quantitative analysis of proteinuria , hematuria , and leukocyturia were carried out in 182 Sudanese schoolboys with mixed urinary and intestinal schistosomiasis . Pathological proteinuria was found in 73 % of patients ( median = 380 , 95 % confidence limits = 200 to 500 mg/liter ) . The median protein/creatinine ratio was 0.54 . SDS polyacrylamide gel electrophoresis showed an excretion of albumin , transferrin , and IgG consistent with a postrenal pattern of proteinuria . Pathological erythrocyturia occurred in 84 % of patients ( median = 255 , 95 % CL = 95 to 629 cells/microliter ) and leukocyturia in 77 % of patients ( median = 148 , 95 % CL = 93 to 246 cells/microliter ) . Phase contrast microscopy revealed intact erythrocytes , suggestive of postrenal hemorrhage . Proteinuria , erythrocyturia , and leukocyturia correlated significantly with the ova excretion in the urine , but not with egg excretion in the stool . Oxamniquine reduced ova excretion in the stool but did not influence pathological urine findings . In patients treated effectively with Praziquantel or Metrifonate , pathological PU , EU , and LU decreased markedly 1 month post treatment . PU in severely proteinuric patients reached physiological values 5 months post therapy . We suggest that the proteinuria , erythrocyturia , and leukocyturia in mixed schistosomiasis were of postrenal origin Health question naires and parasitologic examinations of urine and stool were performed upon a stratified r and om sample of 7,710 individuals from 1,109 households in 21 rural communities in Fayoum Governorate , Egypt in 1992 to investigate the prevalence of , risk factors for , and changing pattern of , infection with Schistosoma sp. in the governorate . A subset , every fifth household , or 1,038 subjects , had physical and ultrasound examinations to investigate prevalence of , and risk factors for , morbidity . The prevalence of S. haematobium ranged from 0 % to 27.1 % and averaged 13.7 % . The geometric mean egg count ( GMEC ) was 10.0 eggs/10 ml of urine . Age-stratified prevalence and intensity of infection were 18 - 25 % and 10 - 15 eggs/10 ml of urine in those 5 - 25 years of age . Schistosoma mansoni were detected in inhabitants of 13 communities , but 78.5 % of the infections were focally present in a group of 4 satellite hamlets around a single village . The overall prevalence of S. mansoni in the governorate was 4.3 % and the GMEC was 44.0 ova/g of stool . Risk factors for infection with either species were male gender , an age < 20 years , living in smaller communities , and exposures to canal water by males . Histories of burning micturation , blood in the urine , or prior schistosomiasis and reagent strip-detected hematuria and proteinuria were risks for S. haematobium , but not for S. mansoni . Both urinary tract and higher grade s of hepatic morbidity were rare . Obstructive uropathy was present in 6.3 % of the subjects and was more common in males and older people . Ultrasonography-detected bladder lesions were present in 5.2 % and correlated with S. haematobium only in younger subjects and in those with hematuria and proteinuria . The prevalences of hepatomegaly , splenomegaly , and periportal fibrosis ( PPF ) were associated with each other and increased with age and in males . Ultrasonography-detected hepatomegaly and splenomegaly were weakly associated with S. mansoni infections only in children . The prevalence of PPF was greater in the 4 communities with > 25 % S. mansoni infection rates in comparison with the 17 other villages and ezbas . Transmission of S. mansoni is focally well established in Fayoum , which also has the highest prevalence of S. haematobium in the governorates surveyed by the Epidemiology 1 , 2 , 3 Project . However , both urinary tract and hepatic morbidity are relatively rare in the governorate . This probably results from the long-st and ing schistosomiasis control program in Fayoum , which suppressed intensity more than prevalence of infection , leading to less community morbidity Using Hansel 's stain , eosinophiluria greater than 5 % of total urinary white blood cells was found in 59 % of a r and omly selected population sample in an area endemic for schistosomiasis hematobium . The prevalence and mean level of eosinophiluria were significantly higher in infected subjects than in noninfected subjects ( P less than 0.05 ) . The sensitivity ( 80 % ) , specificity ( 86 % ) , and positive predictive value ( 82 % ) of eosinophiluria as a diagnostic index for schistosomiasis hematobium were significantly higher ( Youdin index 0.66 ; P less than 0.05 ) than those of proteinuria , hematuria , and leukocyturia taken singly or in combination . However , unlike the latter three measurements , this method involves microscopy . There is a great need for a chemical method for measuring eosinophiluria Schistosomiasis is a public health problem in Nigeria . Although there is a national programme for its control , there is the need for reliable and simple means of rapidly diagnosing communities to provide a detailed map on the distribution of the disease in the country , in order to prioritize control activities , as well as to monitor the effectiveness of control operations . A rapid assessment technique using school question naires was tested in Borgu Local Government Area ( LGA ) , Niger State , north-western Nigeria . Following a series of focus group discussion s , the question naires were adapted before they were administered through the school system to 60 primary schools in Borgu LGA . Correctly completed question naires were returned from 58 schools ( 97 % ) within 4 weeks . Question naires were vali date d by reagent stick tests performed by trained teachers . Their results proved to be reliable compared to those obtained by our research team in 20 r and omly selected schools . Overall prevalences of microhaematuria at 1 + and 2 + levels were 45.7 % and 27 . 1 % , respectively . Highly significant correlations were obtained between school prevalence of microhaematuria and reported schistosomiasis , as well as reported blood in urine . The diagnostic performance of the question naires at the 2 + level of microhaematuria was very good . The design of our study also allowed data analysis on an individual level , and multivariate analysis revealed highly significant odds ratios for reported schistosomiasis and reported blood in urine to detect an individual with urinary schistosomiasis . Our results are in good agreement with reports from other African countries , and question naires can be recommended for rapid identification of communities at highest risk of urinary schistosomiasis in Nigeria , so that scarce re sources of the national control programme can be used most effectively To determine the effect of targeted field administration of oral chemotherapeutic agents on the prevalence , intensity , and morbidity of Schistosoma haematobium infections , we initiated a long-term school-based program in the Msambweni area of Kwale District , Coast Province , Kenya . Prior to treatment , 69 % of the children examined ( ages 4 - 21 , n = 2,628 ) were infected ; 34 % had moderate or heavy infections ( greater than 100 eggs/10 ml urine ) . Infected individuals were r and omized to receive , during one year , either metrifonate ( 10 mg/kg x 3 doses ) or praziquantel , ( 40 mg/kg x 1 dose ) . At the end of the first year , prevalence of infection fell to 19 % ; only 2 % of the pupils remained in the moderately and heavily infected groups . Corresponding decreases in the prevalence of hematuria ( 54 % in 1984 vs. 16 % in 1985 ) and proteinuria ( 56 % in 1984 vs. 26 % in 1985 ) were noted . These were associated with significant declines in bladder thickening and irregularities noted during ultrasound examinations , but not with decreases in hydronephrosis . There was no significant difference in the post-treatment prevalence or intensity of infection after treatment with metrifonate as compared with praziquantel . These results demonstrate that field-applied chemotherapy with either agent offers a practical strategy for the control of S. haematobium infection and its associated morbidity We evaluated the ability of circulating anodic antigen ( CAA ) to identify infection with Schistosoma mansoni in a prospect i ve cohort study of 257 Egyptian men , 147 with infection diagnosed by repeated Kato thick smears , and 110 without detectable infection . The CAA levels were obtained and the stool examinations were performed two weeks and one , two , four , and six months after praziquantel therapy for infected men . A CAA enzyme-linked immunosorbent assay was repeated twice on subjects who were otherwise negative for schistosomiasis . Circulating anodic antigen was detected in 117 cases , with an overall test sensitivity before treatment of 0.8 . Sensitivity was related to the intensity
Output:
| Authors ' conclusions Among the evaluated tests for S. haematobium infection , microhaematuria correctly detected the largest proportions of infections and non‐infections identified by microscopy .
The CCA POC test for S. mansoni detects a very large proportion of infections identified by microscopy , but it misclassifies a large proportion of microscopy negatives as positives in endemic areas with a moderate to high prevalence of infection , possibly because the test is potentially more sensitive than microscopy . |
MS210385 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND We wondered whether short-term coseasonal sublingual immunotherapy ( SLIT ) can reduce the development of asthma in children with hay fever in an open r and omized study . OBJECTIVE We sought to determine whether SLIT is as effective as subcutaneous immunotherapy in reducing hay fever symptoms and the development of asthma in children with hay fever . METHODS One hundred thirteen children aged 5 to 14 years ( mean age , 7.7 years ) with hay fever limited to grass pollen and no other clinical ly important allergies were r and omized in an open study involving 6 Italian pediatric allergy centers to receive specific SLIT for 3 years or st and ard symptomatic therapy . All of the subjects had hay fever symptoms , but at the time of study entry , none reported seasonal asthma with more than 3 episodes per season . Symptomatic treatment was limited to cetirizine , loratadine , nasal budesonide , and salbutamol on dem and . The hay fever and asthma symptoms were quantified clinical ly . RESULTS The actively treated children used less medication in the second and third years of therapy , and their symptom scores tended to be lower . From the second year of immunotherapy , subjective evaluation of overall allergy symptoms was favorable in the actively treated children . Development of asthma after 3 years was 3.8 times more frequent ( 95 % confidence limits , 1.5 - 10.0 ) in the control subjects . CONCLUSIONS Three years of coseasonal SLIT improves seasonal allergic rhinitis symptoms and reduces the development of seasonal asthma in children with hay fever BACKGROUND Pollen immunotherapy is effective in selected patients with IgE-mediated seasonal allergic rhinitis , although it is question able whether there is long-term benefit after the discontinuation of treatment . METHODS We conducted a r and omized , double-blind , placebo-controlled trial of the discontinuation of immunotherapy for grass-pollen allergy in patients in whom three to four years of this treatment had previously been shown to be effective . During the three years of this trial , primary outcome measures were scores for seasonal symptoms and the use of rescue medication . Objective measures included the immediate conjunctival response and the immediate and late skin responses to allergen challenge . Cutaneous-biopsy specimens obtained 24 hours after intradermal allergen challenge were examined for T-cell infiltration and the presence of cytokine-producing T helper cells ( TH2 cells ) ( as evidence d by the presence of interleukin-4 messenger RNA ) . A matched group of patients with hay fever who had not received immunotherapy was followed as a control for the natural course of the disease . RESULTS Scores for seasonal symptoms and the use of rescue antiallergic medication , which included short courses of prednisolone , remained low after the discontinuation of immunotherapy , and there was no significant difference between patients who continued immunotherapy and those who discontinued it . Symptom scores in both treatment groups ( median areas under the curve in 1995 , 921 for continuation of immunotherapy and 504 for discontinuation of immunotherapy ; P=0.60 ) were markedly lower than those in the group that had not received immunotherapy ( median value in 1995 , 2863 ) . Although there was a tendency for immediate sensitivity to allergen to return late after discontinuation , there was a sustained reduction in the late skin response and associated CD3 + T-cell infiltration and interleukin-4 messenger RNA expression . CONCLUSIONS Immunotherapy for grass-pollen allergy for three to four years induces prolonged clinical remission accompanied by a persistent alteration in immunologic reactivity BACKGROUND It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma . METHODS We r and omly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate ( at a dose of 88 mug twice daily ) or masked placebo for two years , followed by a one-year period without study medication . The primary outcome was the proportion of episode-free days during the observation year . RESULTS During the observation year , no significant differences were seen between the two groups in the proportion of episode-free days , the number of exacerbations , or lung function . During the treatment period , as compared with placebo use , use of the inhaled corticosteroid was associated with a greater proportion of episode-free days ( P=0.006 ) and a lower rate of exacerbations ( P<0.001 ) and of supplementary use of controller medication ( P<0.001 ) . In the inhaled-corticosteroid group , as compared with the placebo group , the mean increase in height was 1.1 cm less at 24 months ( P<0.001 ) , but by the end of the trial , the height increase was 0.7 cm less ( P=0.008 ) . During treatment , the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth , albeit temporarily and not progressively . CONCLUSIONS In preschool children at high risk for asthma , two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third , treatment-free year . These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued . ( Clinical Trials.gov number , NCT00272441 . ) Background : Allergic rhinitis was recently classified by the ARIA guidelines as persistent or intermittent . Levocetirizine was shown to improve symptoms and health‐related quality of life of patients with persistent allergic rhinitis in the XPERTTM study , a 6‐month r and omized double blind placebo‐controlled trial BACKGROUND Data for trends in prevalence of asthma , allergic rhinoconjunctivitis , and eczema over time are scarce . We repeated the International Study of Asthma and Allergies in Childhood ( ISAAC ) at least 5 years after Phase One , to examine changes in the prevalence of symptoms of these disorders . METHODS For the ISAAC Phase Three study , between 2002 and 2003 , we did a cross-sectional question naire survey of 193,404 children aged 6 - 7 years from 66 centres in 37 countries , and 304,679 children aged 13 - 14 years from 106 centres in 56 countries , chosen from a r and om sample of schools in a defined geographical area . FINDINGS Phase Three was completed a mean of 7 years after Phase One . Most centres showed a change in prevalence of 1 or more SE for at least one disorder , with increases being twice as common as decreases , and increases being more common in the 6 - 7 year age-group than in the 13 - 14 year age-group , and at most levels of mean prevalence . An exception was asthma symptoms in the older age-group , in which decreases were more common at high prevalence . For both age-groups , more centres showed increases in all three disorders more often than showing decreases , but most centres had mixed changes . INTERPRETATION The rise in prevalence of symptoms in many centres is concerning , but the absence of increases in prevalence of asthma symptoms for centres with existing high prevalence in the older age-group is reassuring . The divergent trends in prevalence of symptoms of allergic diseases form the basis for further research into the causes of such disorders BACKGROUND The main aim of specific immunotherapy is sustained effect due to changes in the immune system that can be demonstrated only in long-term trials . OBJECTIVE To investigate sustained efficacy and disease modification in a 5-year double-blind , placebo-controlled trial , including 2 years of blinded follow-up after completion of a 3-year period of treatment , with the SQ-st and ardized grass allergy immunotherapy tablet , Grazax ( Phleum pratense 75,000 SQ-T/2,800 BAU,(∗ ) ALK , Denmark ) or placebo . METHODS A r and omized , double-blind , placebo-controlled , multinational , phase III trial included adults with a history of moderate-to-severe grass pollen-induced allergic rhinoconjunctivitis , with or without asthma , inadequately controlled by symptomatic medications . Two hundred thirty-eight participants completed the trial . End points included rhinoconjunctivitis symptom and medication scores , combined scores , asthma symptom and medication scores , quality of life , days with severe symptoms , immunologic end points , and safety parameters . RESULTS The mean rhinoconjunctivitis daily symptom score was reduced by 25 % to 36 % ( P ≤ .004 ) in the grass allergy immunotherapy tablet group compared with the placebo group over the 5 grass pollen seasons covered by the trial . The rhinoconjunctivitis DMS was reduced by 20 % to 45 % ( P ≤ .022 for seasons 1 - 4 ; P = .114 for season 5 ) , and the weighted rhinoconjunctivitis combined score was reduced by 27 % to 41 % ( P ≤ .003 ) in favor of active treatment . The percentage of days with severe symptoms during the peak grass pollen exposure was in all seasons lower in the active group than in the placebo group , with relative differences of 49 % to 63 % ( P ≤ .0001 ) . Efficacy was supported by long-lasting significant effects on the allergen-specific antibody response . No safety issues were identified . CONCLUSION The results confirm disease modification by SQ-st and ardized grass allergy immunotherapy tablet in addition to effective symptomatic treatment of allergic rhinoconjunctivitis BACKGROUND R and omized trials provide evidence to inform treatment decisions . The Consoli date d St and ards of Reporting Trials ( CONSORT ) Statement is a set of recommendations for the reporting of trials . OBJECTIVE We sought to assess the quality of reporting allergen-specific immunotherapy trials according to CONSORT criteria . METHODS The reporting of the procedure , r and omization , dropouts , strict conduct of intention-to-treat ( ITT ) analysis , and sample size calculation according to CONSORT were assessed in the 46 subcutaneous and 48 sublingual immunotherapy ( SLIT ) blind , placebo-controlled r and omized trials published between 1996 and 2009 in English . RESULTS One subcutaneous immunotherapy ( 2.2 % ) and 3 SLIT ( 6.6 % ) trials met CONSORT Statement criteria . These were used for the registration of sublingual tablets to the European Medicines Agency . In subcutaneous immunotherapy , 16 ( 35 % ) studies reported a CONSORT flow chart , and 12 ( 26 % ) provided a description of dropouts . Adequate r and omization was reported in 9 ( 35 % ) studies , and incomplete r and omization was reported in 15 ( 33 % ) . Power analysis was reported in 15 ( 33 % ) studies . In SLIT , 20 ( 42 % ) studies reported a CONSORT flow chart , and 16 ( 32 % ) a description of dropouts . ITT analysis was carried out in 1 ( 2.2 % ) SLIT study , and a modified ITT analysis was used in 1 ( 2.2 % ) subcutaneous immunotherapy study and 2 ( 4.4 % ) SLIT studies . Adequate r and omization was reported in 6 ( 12 % ) studies , and incomplete r and omization was reported in 16 ( 32 % ) . Power analysis was reported in 15 ( 27 % ) studies . CONCLUSION As in other areas of medicine , the quality of reporting of most immunotherapy trials is low , and only 4.2 % of SLIT r and omized controlled trials met all of the criteria of the CONSORT Statement . Use of the CONSORT criteria should be encouraged BACKGROUND It has long been assumed that allergic rhinitis leads to daytime sleepiness and a deterioration of nocturnal sleep , yet systematic studies have only been rarely conducted in this field . OBJECTIVE The aim of the present study was to investigate the effects of seasonal allergic rhinitis on subjective and objective sleep patterns , quality of life , and daytime sleepiness in otherwise healthy subjects in comparison with nonallergic volunteers . METHODS Twenty-five patients with seasonal allergic rhinitis and 25 healthy volunteers were enrolled in this prospect i ve , controlled clinical trial . Daytime sleepiness and quality of life were assessed with the help of question naires ( Epworth Sleepiness Scale , SF-36 ) ; 2 consecutive nights of fully attended polysomnography were performed before and during the pollen season of 2002 . RESULTS Statistically significant differences between groups were found in respect to changes in daytime sleepiness and selected parameters of quality of life . Impairment of daytime sleepiness and quality of life were related to the severity of the disease . Statistically significant differences were also found for selected parameters of the sleep studies , although the changes were only minimal , and all values were within normal ranges . CONCLUSION Seasonal allergic rhinitis leads to increased daytime sleepiness , as well as to an impairment of quality of life , depending on the severity of the disease . Objective measurements revealed a statistically significant influence of seasonal allergic rhinitis on selected sleep parameters , but changes were not of clinical relevance . Daytime sleepiness seems to be related to the condition itself rather than to an impairment of nocturnal sleep BACKGROUND Sustained and disease-modifying effects of sublingual immunotherapy have never before been confirmed in a large-scale r and omized , double-blind , place
Output:
| Years of basic science research , clinical trials , and systematic review s and meta-analyses have convincingly shown that allergen specific immunotherapy can achieve substantial results for patients , improving the allergic individuals ’ quality of life , reducing the long-term costs and burden of allergies , and changing the course of the disease .
Allergen specific immunotherapy not only effectively alleviates allergy symptoms , but it has a long-term effect after conclusion of the treatment and can prevent the progression of allergic diseases . |
MS210386 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background — The use of antithrombotic medications after ischemic stroke is recommended for deep vein thrombosis prophylaxis and secondary stroke prevention . We assessed the rate of receipt of these therapies among eligible ischemic stroke patients age ≥65 years and determined the effects of age and other patient characteristics on treatment . Methods and Results — The analysis included Medicare fee-for-service beneficiaries discharged with ischemic stroke ( ICD 433.x1 , 434.x1 , 436 ) r and omly selected for inclusion in the Medicare Health Care Quality Improvement Program 's National Stroke Project 1998 to 1999 , 2000 to 2001 . Patients discharged from nonacute facilities , transferred , or terminally ill were excluded . Receipt of in-hospital pharmacological deep vein thrombosis prophylaxis , antiplatelet medication , anticoagulants for atrial fibrillation , and antithrombotic medications at discharge were assessed in eligible patients , stratified by age ( 65 to 74 , 75 to 84 , and 85 + years ) . Descriptive models identified characteristics associated with treatment . Among 31 554 patients , 14.9 % of those eligible received pharmacological deep vein thrombosis prophylaxis , 83.9 % antiplatelet drugs , 82.8 % anticoagulants for atrial fibrillation , and 74.2 % were discharged on an antithrombotic medication . Rates of treatment decreased with age and were lowest for patients ages 85 years or older . Admission from a skilled nursing facility and functional dependence were associated with lower treatment rates . Conclusions — There was substantial underutilization of antithrombotic therapies among elderly ischemic stroke patients , particularly among the very elderly , those admitted from skilled nursing facilities , and patients with functional dependence . The reasons for low use of antithrombotic therapies , including the apparent underutilization of deep vein thrombosis prophylaxis in otherwise eligible patients , require further investigation BACKGROUND Recent guidelines have acknowledged that thrombolysis decreases mortality from acute myocardial infa rct ion ( AMI ) independently of age . The purpose of this study was to determine the age-related rates of thrombolytic administration and in-hospital mortality and the variables related to the use of thrombolytic therapy for patients with AMI . METHODS A prospect i ve cohort analysis involved a registry of 44 acute care Quebec hospitals that enrolled 3741 patients with AMI between January 1995 and May 1996 . The main outcomes of interest were crude and adjusted age-related in-hospital mortality rates and rates of use of thrombolytic therapy . RESULTS In-hospital mortality rates increased dramatically with age from 2.1 % in patients with AMI who were less than 55 years of age to 26.3 % in those who were 85 years of age or older . Overall , 35.8 % of the patients received thrombolysis . There was a pronounced inverse gradient in the use of thrombolysis with age , ranging from 46.2 % in the youngest age group ( < 55 years ) to 9.5 % in the oldest group ( > or = 85 years ) . After adjustment for potential confounders , the older patients remained significantly less likely to receive thrombolytic therapy . Compared with patients who were less than 55 years of age , the odds ratio of receiving thrombolytic therapy was 0.68 ( 95 % confidence interval [ CI ] 0.52 - 0.89 ) for patients aged 65 - 74 years , 0.48 ( 95 % CI 0.35 - 0.65 ) for patients aged 75 - 84 years and 0.13 ( 95 % CI 0.06 - 0.26 ) for patients aged 85 years or more . Other variables related to thrombolytic therapy were diabetes ( odds ratio [ OR ] 0.77 , 95 % CI 0.59 - 1.00 ) , cerebrovascular disease ( OR 0.46 , 95 % CI 0.30 - 0.72 ) , angina ( OR 0.73 , 95 % CI 0.56 - 0.95 ) , typical chest pain ( OR 2.56 , 95 % CI 1.88 - 3.47 ) ; ST elevation ( OR 8.93 , 95 % CI 7.24 - 11.00 ) , Q wave MI ( OR 5.26 , 95 % CI 4.20 - 6.60 ) and increased length of time between onset of symptoms and arrival at hospital . INTERPRETATION Age is an important independent predictor of in-hospital mortality and lower thrombolytic use following AMI . Other studies are required to further evaluate the appropriateness of thrombolytic therapy for elderly patients BACKGROUND Mortality among patients admitted to hospital after out-of-hospital cardiac arrest ( OHCA ) is high . Based on recent scientific evidence with a main goal of improving survival , we introduced and implemented a st and ardised post resuscitation protocol focusing on vital organ function including therapeutic hypothermia , percutaneous coronary intervention ( PCI ) , control of haemodynamics , blood glucose , ventilation and seizures . METHODS All patients with OHCA of cardiac aetiology admitted to the ICU from September 2003 to May 2005 ( intervention period ) were included in a prospect i ve , observational study and compared to controls from February 1996 to February 1998 . RESULTS In the control period 15/58 ( 26 % ) survived to hospital discharge with a favourable neurological outcome versus 34 of 61 ( 56 % ) in the intervention period ( OR 3.61 , CI 1.66 - 7.84 , p=0.001 ) . All survivors with a favourable neurological outcome in both groups were still alive 1 year after discharge . Two patients from the control period were revascularised with thrombolytics versus 30 ( 49 % ) receiving PCI treatment in the intervention period ( 47 patients ( 77 % ) underwent cardiac angiography ) . Therapeutic hypothermia was not used in the control period , but 40 of 52 ( 77 % ) comatose patients received this treatment in the intervention period . CONCLUSIONS Discharge rate from hospital , neurological outcome and 1-year survival improved after st and ardisation of post resuscitation care . Based on a multivariate logistic analysis , hospital treatment in the intervention period was the most important independent predictor of survival CONTEXT R and omized trials provide robust evidence for the impact of pharmacological and interventional treatments in patients with ST-segment elevation and non-ST-segment elevation acute coronary syndromes ( NSTE ACS ) , but whether this translates to changes in clinical practice is unknown . OBJECTIVE To determine whether changes in hospital management of patients with ST-segment elevation myocardial infa rct ion ( STEMI ) and NSTE ACS are associated with improvements in clinical outcome . DESIGN , SETTING , AND PATIENTS In the Global Registry of Acute Coronary Events ( GRACE ) , a multinational cohort study , 44 372 patients with an ACS were enrolled and followed up in 113 hospitals in 14 countries between July 1 , 1999 , and December 31 , 2006 . MAIN OUTCOME MEASURES Temporal trends in the use of evidence -based pharmacological and interventional therapies ; patient outcomes ( death , congestive heart failure , pulmonary edema , cardiogenic shock , stroke , myocardial infa rct ion ) . RESULTS Use of pharmacological medications increased over the study period ( beta-blockers , statins , angiotensin-converting enzyme inhibitors , thienopyridines with or without percutaneous coronary intervention [ PCI ] , glycoprotein IIb/IIIa inhibitors , low-molecular-weight heparin ; all P<.001 ) . Pharmacological reperfusion declined in patients with STEMI by -22 percentage points ( 95 % confidence interval [ CI ] , -27 to -17 ) , whereas primary PCI increased by 37 percentage points ( 95 % CI , 33 - 41 ) . In patients with non-STEMI , rates of PCI increased markedly by 18 percentage points ( 95 % CI , 15 - 20 ) . Rates of congestive heart failure and pulmonary edema declined in both population s : STEMI , -9 percentage points ( 95 % CI , -12 to -6 ) and NSTE ACS , -6.9 percentage points ( 95 % CI , -8.4 to -4.7 ) . In patients with STEMI , hospital deaths decreased by 18 percentage points ( 95 % CI , -5.3 to -1.9 ) and cardiogenic shock by -24 percentage points ( 95 % CI , -4.3 to -0.5 ) . Risk-adjusted hospital deaths declined -0.7 percentage points ( 95 % CI , -1.7 to 0.3 ) in NSTE ACS patients . Six-month follow-up rates declined among STEMI patients : stroke by -0.8 percentage points ( 95 % CI , -1.7 to 0.1 ) and myocardial infa rct ion by -2.8 percentage points ( 95 % CI , -6.4 to 0.9 ) . In NSTE ACS , 6-month death declined -1.6 percentage points ( 95 % CI , -3.0 to -0.1 ) and stroke by 0.7 percentage points ( 95 % CI , -1.4 to 0.1 ) . CONCLUSIONS In this multinational observational study , improvements in the management of patients with ACS were associated with significant reductions in the rates of new heart failure and mortality and in rates of stroke and mycoardial infa rct ion at 6 months Introduction Persistent coma is a common finding after cardiac arrest and has profound ethical and economic implication s. Evidence suggests that therapeutic hypothermia improves neurological outcome in these patients . In this analysis , we investigate whether therapeutic hypothermia influences the length of intensive care unit ( ICU ) stay and ventilator time in patients surviving out-of-hospital cardiac arrest . Methods A prospect i ve observational study with historical controls was conducted at our medical ICU . Fifty-two consecutive patients ( median age 62.6 years , 43 males , 34 ventricular fibrillation ) su bmi tted to therapeutic hypothermia after out-of-hospital cardiac arrest were included . They were compared with a historical cohort ( n = 74 , median age 63.8 years , 53 males , 43 ventricular fibrillation ) treated in the era prior to hypothermia treatment . All patients received the same st and ard of care . Neurological outcome was assessed using the Pittsburgh cerebral performance category ( CPC ) score . Univariate analyses and multiple regression models were used . Results In survivors , therapeutic hypothermia and baseline disease severity ( Acute Physiology and Chronic Health Evaluation II [ APACHE II ] score ) were both found to significantly influence ICU stay and ventilator time ( all P < 0.01 ) . ICU stay was shorter in survivors receiving therapeutic hypothermia ( median 14 days [ interquartile range ( IQR ) 8 to 26 ] versus 21 days [ IQR 15 to 30 ] in the control group ; P = 0.017 ) . ICU length of stay and time on ventilator were prolonged in patients with CPC 3 or 4 compared with patients with CPC 1 or 2 ( P = 0.003 and P = 0.034 , respectively ) . Kaplan-Meier analysis showed improved probability for 1-year survival in the hypothermia group compared with the controls ( log-rank test P = 0.013 ) . Conclusion Therapeutic hypothermia was found to significantly shorten ICU stay and time of mechanical ventilation in survivors after out-of-hospital cardiac arrest . Moreover , profound improvements in both neurological outcome and 1-year survival were observed Background —Acute coronary occlusion is the leading cause of cardiac arrest . Because of limited data , the indications and timing of coronary angiography and angioplasty in patients with out-of-hospital cardiac arrest are controversial . Using data from the Parisian Region Out of hospital Cardiac ArresT prospect i ve registry , we performed an analysis to assess the effect of an invasive strategy on hospital survival . Methods and Results —Between January 2003 and December 2008 , 714 patients with out-of-hospital cardiac arrest were referred to a tertiary center in Paris , France . In 435 patients with no obvious extracardiac cause of arrest , an immediate coronary angiogram was performed at admission followed , if indicated , by coronary angioplasty . At least 1 significant coronary artery lesion was found in 304 ( 70 % ) patients , in 128 ( 96 % ) of 134 patients with ST-segment elevation on the ECG performed after the return of spontaneous circulation , and in 176 ( 58 % ) of 301 patients without ST-segment elevation . The hospital survival rate was 40 % . Multivariable analysis showed successful coronary angioplasty to be an independent predictive factor of survival , regardless of the postresuscitation ECG pattern ( odds ratio , 2.06 ;
Output:
| Discussion The findings obtained from this systematic review should inform whether disparity exists in the provision of post-arrest care for the elderly ( ≥ 65 years old ) with OHCA or not .
Addressing this problem has a potential to substantially increase the number of > 65-year-old , long-term survivors .
The results of our review might also point to the gaps in the published literature that specifically examines disparity in provision of care for this population . |
MS210387 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To assess the impact and cost-effectiveness of two information-based provider reminder interventions design ed to improve self-care management and outcomes of heart failure ( HF ) patients . DATA SOURCES / STUDY SETTING Interview and agency administrative data on 628 home care patients with a primary diagnosis of HF . STUDY DESIGN Patients were treated by nurses r and omly assigned to usual care or one of two intervention groups . The basic intervention was an e-mail to the patient 's nurse highlighting six HF-specific clinical recommendations . The augmented intervention supplemented the initial nurse reminder with additional clinician and patient re sources . DATA COLLECTION Patient interviews were conducted 45 days post admission to measure self-management behaviors , HF-specific outcomes ( Kansas City Cardiomyopathy Question naire-KCCQ ) , health-related quality of life ( EuroQoL ) , and service use . PRINCIPAL FINDINGS Both interventions improved the mean KCCQ summary score ( 15.3 and 12.9 percent , respectively ) relative to usual care ( p < or = .05 ) . The basic intervention also yielded a higher EuroQoL score relative to usual care ( p < or = .05 ) . In addition , the interventions had a positive impact on medication knowledge , diet , and weight monitoring . The basic intervention was more cost-effective than the augmented intervention in improving clinical outcomes . CONCLUSIONS This study demonstrates the positive impact of targeting evidence -based computer reminders to home health nurses to improve patient self-care behaviors , knowledge , and clinical outcomes . It also advances the field 's limited underst and ing of the cost-effectiveness of selected strategies for translating research into practice Background The aim of this project was to assess whether outreach visits would improve the implementation of evidence based clinical practice in the area of falls reduction and stroke prevention in a residential care setting . Methods Twenty facilities took part in a r and omized controlled trial with a seven month follow-up period . Two outreach visits were delivered by a pharmacist . At the first a summary of the relevant evidence was provided and at the second detailed audit information was provided about fall rates , psychotropic drug prescribing and stroke risk reduction practice s ( BP monitoring , aspirin and warfarin use ) for the facility relevant to the physician . The effect of the interventions was determined via pre- and post-intervention case note audit . Outcomes included change in percentage patients at risk of falling who fell in a three month period prior to follow-up and changes in use of psychotropic medications . Chi-square tests , independent sample s t-test , and logistic regression were used in the analysis . Results Data were available from case notes at baseline ( n = 897 ) and seven months follow-up ( n = 902 ) , 452 residential care staff were surveyed and 121 physicians were involved with 61 receiving outreach visits . Pre- and post-intervention data were available for 715 participants . There were no differences between the intervention and control groups for the three month fall rate . We were unable to detect statistically significant differences between groups for the psychotropic drug use of the patients before or after the intervention . The exception was significantly greater use of " as required " antipsychotics in the intervention group compared with the control group after the pharmacy intervention ( RR = 4.95 ; 95%CI 1.69–14.50 ) . There was no statistically significant difference between groups for the numbers of patients " at risk of stroke " on aspirin at follow-up . Conclusions While the strategy was well received by the physicians involved , there was no change in prescribing patterns . Patient care in residential setting s is complex and involves contributions from the patient 's physician , family and residential care staff . The project highlights challenges of delivering evidence based care in a setting in which there is a paucity of well controlled trial evidence but where significant health outcomes can be attained BACKGROUND Benzodiazepine use by elderly patients is associated with adverse outcomes including increased risk of falls and fractures , motor vehicle accidents and cognitive impairment . Recent studies suggest that individualized feedback and education to physicians may improve drug prescribing . In this study , we evaluated an intervention to address the inappropriate prescribing of benzodiazepines for elderly patients . METHODS We identified 1624 primary care physicians who wrote at least 10 prescriptions for the target drugs in a 2-month period and r and omly assigned these physicians to the intervention group or the control group . We obtained data from the Ontario Drug Benefit cl aims data base , which covers all Ontario residents aged 65 years and over for drugs selected from a minimally restrictive formulary . Every 2 months for 6 months , confidential profiles of benzodiazepine prescription use coupled with evidence -based educational bulletins were mailed to the intervention group . The control group received feedback and educational bulletins about first-line antihypertension drug prescribing for elderly patients . Our main outcome measures were reductions in the proportion of each physician 's total benzodiazepine prescriptions for long-acting agents , combinations of benzodiazepines with other psychoactive medications ( including other benzodiazepines ) and long-term benzodiazepine therapy . RESULTS After r and omization , 168 physicians agreed to be in the intervention group and 206 in the control group . Their demographic and prescribing characteristics were similar . Although the proportion of long-acting benzodiazepine prescriptions decreased by 0.7 % in the intervention group between the baseline period and the end of the intervention period ( from 20.3 % , or a mean of 29.5 prescriptions , to 19.6 % , or a mean of 27.7 prescriptions ) and increased by 1.1 % in the control group ( from 19.8 % , or a mean of 26.4 prescriptions , to 20.9 % , or a mean of 27.7 prescriptions ) ( p = 0.036 ) , this difference was not clinical ly significant . There was no significant difference over the study period in either combination prescribing of benzodiazepines or in prescriptions for long-term benzodiazepine therapy . INTERPRETATION We did not find that a program of confidential feedback and educational material offered to Ontario primary care physicians had a clinical ly significant impact on their benzodiazepine prescribing Background Early identification of permanent hearing impairment in children enables appropriate intervention which reduces adverse developmental outcomes . The UK Government has introduced a universal hearing screening programme for neonates . All involved health professionals , including those in Primary Care , need to be aware of the service to enable them to offer appropriate support to their patients . A programme of information dissemination within Primary Care was therefore undertaken . The aim of the current study was to determine the extent to which the information had reached General Practitioners ( GPs ) , the GPs ' preferred mode of dissemination and the sources from which GPs accessed information Methods Postal question naire survey of a r and omised sample of 1000 GPs in the Phase I pilot sites of the Neonatal Hearing Screening Programme ( NHSP ) . Results Responses were received from 54.2 % of the sample . Just under 50 % of those responding had received information , 62.2 % of respondents said they would like to receive more information and the preferred methods of dissemination were the written word and web-sites to allow access when needed . Few GPs perceive themselves to have a core role in the delivery of the NHSP and thence a need for knowledge in the subject . Many are keen to delegate detail to a third party , usually the health visitor , who has traditionally had responsibility for hearing screening . Conclusions Dissemination efforts for service developments of relevance to GPs should concentrate on advertising a website address via brief but memorable posted literature and /or articles in relevant journals and magazines . The website should be GP-friendly , and have a dedicated area for GPs including information of specific relevance and downloadable information sheets OBJECTIVE To determine the extent of self-reported use of prescription medications in an Australian community sample . DESIGN , SETTING AND PARTICIPANTS Face-to-face interviews with a r and om , representative sample of the South Australian population ( aged > or = 15 years ) living in metropolitan and rural areas . The study , a Health Omnibus Survey , was conducted between March and June 2004 . MAIN OUTCOME MEASURES Reported number of prescribed medications used per person , most common categories of medication , and use by individuals of multiple medications for the same body system . RESULTS From 4700 households selected , 3015 participants were interviewed ( 65.9 % response rate ) . Of respondents , 46.8 % were using prescribed medications ; 171 respondents ( 5.7 % ) were taking six or more medications , and four were taking 16 or more ; 23.2 % were using medications for the cardiovascular system , with 11.9 % using agents acting on the renin-angiotensin system . Prescription medication use increased with age , with over 10 % of respondents aged > or = 55 years using six or more medications . CONCLUSIONS Use of multiple prescribed medications was common , with the potential for significant drug interactions . Assuming a similar pattern of medication use Australia-wide , reducing the number of prescribed medications by one for people taking six or more medications would save the federal government about 380 million dollars a year BACKGROUND Despite ongoing concern about adverse effects and dependence on benzodiazepines , approximately 2 % of Australians are still taking them on a regular basis . The aim of this study was to evaluate the effectiveness of an educational outreach or ' academic detailing ' program about prescribing of benzodiazepines . METHOD In this r and omised trial general practice registrars ( n = 157 ) in New South Wales were allocated to an intervention group ( n = 79 ) , which received a 20 minute educational outreach visit ; or a control group ( n = 78 ) which received an intervention on an unrelated topic . Prescribing behaviour was monitored by a pre-intervention and two post-intervention practice activity surveys . MAIN OUTCOME MEASURES These were the rate of benzodiazepine prescribing for all indications , for anxiety and for sleep disorders . RESULTS Overall benzodiazepine prescribing by the intervention group declined from 2.3 to 1.7 per 100 encounters , while the control group also declined from 2.2 to 1.6 per 100 encounters . Analysis of variance showed this was a significant drop over time ( P = 0.042 ) but there was no difference between groups ( P = 0.99 ) . The prescribing decrease observed was in continuing rather than initial prescriptions . CONCLUSIONS A marked decrease in benzodiazepine prescribing was seen over the course of the study in both intervention and control groups but no differential effect due to the educational outreach visit was found OBJECTIVE To describe how general practitioners use computers for clinical purpose s. DESIGN Mail survey of a cross-sectional national stratified r and om sample of 3000 GPs in primary care setting s between 10 October and 31 December 2005 . MAIN OUTCOME MEASURES Use of computers , and use of computerised clinical functions such as prescribing , medication checking , generating health summaries , running recall systems , and writing progress notes . RESULTS Of 1186 GPs responding ( 39.5 % response rate ) , 90 % used a clinical software package . GPs used clinical packages for prescribing ( 98 % ) , checking for drug-drug interactions ( 88 % ) , recording a reason for prescribing ( 65 % ) , to order laboratory tests ( 85 % ) , run recall systems ( 78 % ) , and record progress notes ( 64 % ) . Less frequently used functions included generating lists of patients needing vaccines ( 43 % ) and taking the same medication ( 39 % ) . Less than 20 % of GPs who used a clinical package accessed computerised information during the consultation . CONCLUSIONS Australian general practice has achieved near-universal clinical computerisation . Electronic prescribing alone has probably improved efficiency and quality of care , and reduced medication errors . Increasing the use of other functions , such as accessing online decision support and maintaining registries of patients , is likely to lead to further health gains , especially in managing chronic conditions INTRODUCTION Adverse drug events ( ADEs ) are associated with inappropriate prescribing ( IP ) and result in increased morbidity , mortality and re source utilisation . We used Beers ' Criteria to determine the three-month prevalence of IP in a non-selected community-dwelling population of acutely ill older people requiring hospitalisation . METHODS A prospect i ve , observational study of 597 consecutive acute admissions was performed . Diagnoses and concurrent medications were recorded before hospital physician intervention , and Beers ' Criteria applied . RESULTS Mean patient age ( SD ) was 77 ( 7 ) years . Median number of medications was 5 , range 0 - 13 . IP occurred in 32 % of patients ( n = 191 ) , with 24 % , 6 % and 2 % taking 1 , 2 and 3 inappropriate medications respectively . Patients taking > 5 medications were 3.3 times more likely to receive an inappropriate medication than those taking < or = 5 medications ( OR 3.34 : 95 % , CI 2.37 - 4.79 ; P<0.001 ) . Forty-nine per cent of patients with inappropriate prescriptions were admitted with adverse effects of the inappropriate medications . Sixteen per cent of all admissions were associated with such adverse effects . CONCLUSION IP is highly prevalent in acutely ill older patients and is associated with polypharmacy and hospitalisation . However , Beers ' Criteria can not be used as a gold st and ard as they do not comprehensively address all aspects of IP in older people OBJECTIVE : To determine whether reminder cards in medical records enhance the effectiveness of audit with feedback in improving the care of patients taking long term benzodiazepine drugs . DESIGN : R and omised trial , practice
Output:
| Conclusions Studies which used a multi-faceted approach had the largest and most sustained reductions in benzodiazepines use .
It appears that support groups for patients , non-voluntary recruitment of GPs , and oral delivery of alerts or feedback may all improve the outcomes of interventions .
The choice of outcome measures , delivery style of educational messages , and requests by GPs to stop benzodiazepines , either in a letter or face to face , showed no differences on the success rates of the intervention |
MS210388 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: This study was conducted to compare the diagnoses and specimen adequacy of the ThinPrep ( Cytyc Corporation , Boxborough , MA , USA ) and conventional Papanicolaou preparation methods for cervical cytology . Cervical specimens from 972 patients from our gynecology clinic were analyzed . A single sample of the uterine cervix taken from each patient was first used to prepare the conventional Papanicolaou smear . Afterward , the residual tissue on the sampling device was rinsed into a fluid preservative from which two slides were prepared by means of the ThinPrep method . Conventional and ThinPrep slides were examined independently . Cytologic diagnoses and specimen adequacy were classified according to the Bethesda System . The diagnoses based on the ThinPrep and conventional smears matched in 939 ( 96.6 % ) cases . Low- grade squamous epithelial or higher grade lesions were detected with at least one of the methods in 59 cases and with both methods in 42 cases . Fifteen more cases of low- grade squamous epithelial or higher grade lesions ( 58 vs 43 ; p < 0.001 ) and 10 more cases of high- grade squamous epithelial lesions or carcinoma ( 42 vs 32 ; p = 0.006 ) , were detected with ThinPrep than with conventional smears . The ThinPrep method yielded a higher rate of specimens that were satisfactory for cytologic examination than the conventional smears ( 89.8 % vs 70.9 % , p < 0.001 ) . The detection rate of infectious agents was also higher with the ThinPrep method ( 14.9 % vs 6.6 % ; p < 0.001 ) . The reproducibility rate of the twin slides prepared with the ThinPrep method was greater than 99 % . In conclusion , the ThinPrep method yielded a significantly higher positive detection rate of cervical abnormalities and more satisfactory specimens than conventional Papanicolaou smears The authors compared the accuracy of conventionally prepared smears and smears prepared by an automated , fluid-based , thin-layer processing device in the detection of cytologic abnormalities . A total of 3218 patients from five centers took part in this study , in which a single cervical sample was split into a matched pair . The conventional smear was made in the routine fashion ; the remainder of the cells on the sampling device were rinsed into a transport-fixation fluid . A slide was then prepared from the solution using the thin-layer processor . Diagnostic findings identified on the two preparations were compared in a blinded fashion , and a discrepancy resolution procedure was used to eliminate screening differences . Overall , there was a high correlation in the diagnoses of the two methods . For low- grade or more severe disease , the thin-layer method result ed in a 13 % increase in the rate of detection , as compared with the conventional Papanicolaou smear technique OBJECTIVE To obtain preliminary data on the Roche CytoRich thin-layer system for the preparation of gynecologic cytology specimens , derived from a pre clinical startup evaluation of the instrument and comparing the CytoRich method to conventional smears . STUDY DESIGN At six different clinical sites , 286 pairs of conventional and CytoRich slides derived from the same patient sample were compared for the following : final Bethesda classification diagnosis , specimen adequacy and presence of microorganisms . RESULTS The study showed agreement between the methods for an exact Bethesda diagnosis in 78 % and agreement within one Bethesda diagnosis category in 95 % . The CytoRich method diagnosed more cases of squamous intraepithelial lesion ( SIL ) than did the conventional method , and the differences in SIL detection were statistically significant . The CytoRich method identified similar numbers of cases with microorganisms as did the conventional smears , and the CytoRich system improved overall specimen adequacy as compared to the conventional method , with fewer cases of unsatisfactory and less-than-optimal smears . CONCLUSION The CytoRich method may improve the overall sensitivity and specificity of the cervical cytology procedure . Clinical trials to verify these preliminary data are ongoing OBJECTIVE To examine the efficacy of the ThinPrep method , an automated , fluid-based technique for the collection and preparation of exfoliated and aspirated cells in cervical cytology . STUDY DESIGN A total of 251 patients participated . From each patient a sample was obtained by scraping with a wooden spatula , split and prepared with both conventional Papanicolaou and ThinPrep methods . In the ThinPrep processor , epithelial cells were homogenized in a vial of preservative solution and r and omly sample d onto a microscopic slide . From a single vial of sample suspension a series of 10 ThinPrep slides of the same quality were made . All cells were concentrated within an approximately 20-mm-diameter circle in a uniform , thin layer on the ThinPrep slide . RESULTS Twenty-five percent of the screening area , 10 % of the epithelial cells observed and 50 % of the screening time were required to arrive at a final diagnosis as compared with the Papanicolaou smear . Virtually complete concurrence was ascertained between the Papanicolaou and ThinPrep diagnoses , for direct agreement of 95.3 % and agreement within one diagnostic grade of 99.5 % . CONCLUSION An overall improvement was ascertained in the preparation of microscopic slides and the recognition of abnormal cells with the ThinPrep method OBJECTIVE To compare the cytologic diagnoses and specimen adequacy of the ThinPrep Pap Test with historical data within a distinct patient population to assess test performance and its impact on clinical practice . STUDY DESIGN A total of 16,314 ThinPrep Pap tests were processed and evaluated at Fletcher Allen Health Care over a seven-month period . A subset of 8,574 tests from a selected provider group ( cohort ) was compared to the historical conventional cervical cytologic smear data from the cohort population for both cytologic diagnoses and specimen adequacy . The cohort consisted of 12 practice groups , including 60 physicians and providers , utilizing the ThinPrep Pap Test as their primary cervical cancer screening sampling technique . Cytologic diagnoses and specimen adequacy were classified using the Bethesda system . RESULTS Using a three-tiered diagnostic system similar to the Cytyc clinical trials ( within normal limits [ WNL ] , atypical squamous cells of undetermined significance [ASCUS]/atypical gl and ular cells of undetermined significance [ AGUS ] and low grade squamous intraepithelial lesion and higher [LSIL]+ ) , the ThinPrep method increased the percentage of cases that could be definitively diagnosed as WNL by 1.71 % , lowered the percentage of ambiguous or borderline cases diagnosed as ASCUS/AGUS by 26.59 % and increased the percentage of cases diagnostic of LSIL+ by 52.15 % in the cohort population . Further subdivision by the Bethesda classification showed that the identification of infectious agents increased 25.51 % and the detection of high grade squamous intraepithelial lesion/carcinoma increased 55.14 % . Concurrently , cases reported as benign cellular changes ( reactive/reparative ) decreased 23.1 % , and the percentage of cases reported as unsatisfactory/"limited by ... " was reduced 52.71 % . Histologic correlation of cases reported as squamous intraepithelial lesion revealed that the percentage of patients with subsequent benign biopsies was reduced by 31.7 % utilizing the ThinPrep technique . Further , the percentage of ThinPrep patients with histologically confirmed cervical intraepithelial neoplasia ( CIN ) 1 and CIN 2/3 increased by 16.3 % and 9.3 % , respectively . CONCLUSION Implementation of the ThinPrep Pap Test result ed in statistically significant improvements in both diagnostic yield and specimen adequacy , as seen by others in clinical trials . Comparison of results to historical data within a cohort population reinforced earlier data and lent further support to the cl aim that the ThinPrep Pap Test is " significantly more effective " than the conventional smear in clinical practice OBJECTIVE To compare the CytoRich system with conventional cervical cytology in a university medical center hospital laboratory . STUDY DESIGN The CytoRich system combines liquid preservation , selective reduction of blood/inflammation , thin-layer preparation and discrete staining . Two thous and thirty-two parallel conventional and CytoRich sample s were examined as part of a multicenter trial of the CytoRich/AutoCyte systems . Same-patient conventional and CytoRich slides were su bmi tted to separate cytotechnologists blindly . The results were compared , and all nonmatching sample pairs were review ed again . A consensus diagnosis was derived for all cases . The initial readings of the CytoRich and conventional smears were compared with each other and with the consensus diagnosis . RESULTS Of the 148 squamous intraepithelial lesions ( SILs ) found by either method , 85 % were found by CytoRich , while only 58.5 % were found by conventional smear . As compared with the consensus diagnosis , CytoRich slides had 86.7 % sensitivity for SIL and 99.1 % specificity , while the conventional slides had 63.6 % sensitivity and 99.7 % specificity . Consensus review result ed in upgrading to SIL in 1.8 % of conventional slides and 1.4 % of CytoRich slides . The biopsy correlation results were similar for the two methods . CONCLUSION The CytoRich system affords excellent cellular presentations and superior sensitivity for SILs when compared to the conventional technique OBJECTIVE To compare the accuracy of thin-layer cytology with Autocyte PREP ( TriPath Imaging Inc. , Burlington , North Carolina , U.S.A. ) with conventional smears in 500 women undergoing cervical cone biopsy . STUDY DESIGN The study was performed among 500 consecutive women presenting for cone biopsy for high grade cervical intraepithelial neoplasia ( CIN ) on biopsy in 350 ( 70 % ) and discrepant cytology/colpohistology in 150 ( 30 % ) . Before performing a cone biopsy , two cervical sample s were collected for conventional smears and thin-layer cytologic slides , with r and omization of the order . Conventional smears were stained and diagnosed at Pasteur Cerba , while thin-layer cytologic slides were processed at a local TriPath office ( Meylan , France ) and sent in a masked fashion for screening at Pasteur Cerba . Any slides initially read as normal were review ed again and reported without knowledge of the other cytologic or cone biopsy data . The final cytologic diagnoses for the two methods were compared with histopathology of the cone biopsy . RESULTS The conventional smear was unsatisfactory in 58 ( 11.6 % ) of cases , while there were 4 ( 0.8 % ) unsatisfactory thin-layer cytologic slides ( P < .001 ) . Endocervical cells were missing from 31 ( 6.2 % ) of conventional smears and 34 ( 6.8 % ) of thin-layer cytologic slides . For the pooled data , sensitivities of conventional smear and thin layer for detecting high grade CIN ( 0.82 % and 0.86 % , respectively ) were similar as were specificities ( 0.40 % and 0.43 % , respectively ) . When first sample s were compared , the sensitivities of the conventional smear and thin layer for high grade CIN were 0.79 % and 0.89 % , respectively ( P = .02 ) , with corresponding specificities of 0.41 % and 0.36 % ( P < .01 ) . CONCLUSION When controlled for sample order , the sensitivity of thin-layer cytology for detecting high grade CIN was significantly higher than that of conventional smears in patients with previous abnormal cytology , but at the expense of specificity OBJECTIVE To compare ThinPrep ( TP ) Papanicolaou smears ( Cytyc Corp. , Box-borough , Massachusetts , U.S.A. ) with matching conventional Papanicolaou ( CP ) smears for specimen adequacy , cytologic quality , diagnostic accuracy and screening time . STUDY DESIGN In this prospect i ve study of 1,024 women a split- sample , matched-pair design in favor of CP slides based on single-blind criteria was followed with a smear on a glass slide for CP and the remaining material collected in Preserv-Cyt solution ( Cytyc ) for a TP smear . A Cytobrush ( Medsc and , Hollywood , Florida , U.S.A. ) was used for smear preparation for CP . TP smears were processed in ThinPrep 2000 ( Cytyc ) . Smears were stained with Papanicolaou stain and were interpreted according to the Bethesda system . RESULTS The number of satisfactory but limited ( SBL ) cases with TP were 77 ( 7.5 % ) as compared to 127 ( 12.4 % ) with the CP method . This reduction in SBL smears with the TP method and consequent increase in satisfactory smears were highly significant ( P < .001 ) by McNemar 's test . As regards unsatisfactory smears in discordant pairs , although the number of unsatisfactory smears was higher with TP ( 41 cases ) as against CP ( 27 cases ) , the difference was not statistically significant ( P < .05 ) . The split- sample method showed a high correlation between the CP and TP diagnoses . TP smears had a significant advantage over CP smears in the reduction in the number of ASCUS and AGUS cases ( 14 vs. 29 ) ( P < .05 ) and increased the pickup rate of LSIL , 6 vs. 1 . Time taken to screen the TP sm
Output:
| INTERPRETATION We saw no evidence that liquid-based cytology reduced the proportion of unsatisfactory slides , or detected more high- grade lesions in high- quality studies , than conventional cytology .
This review does not lend support to cl aims of better performance by liquid-based cytology . |
MS210389 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The aim of the study was to compare bone mineral density ( BMD ) before insertion and at 18 months of use of etonorgestrel- and levonorgestrel-releasing contraceptive implants . METHODS One hundred and eleven women , 19 - 43 years of age , were r and omly allocated to two groups : 56 to etonorgestrel and 55 to levonorgestrel . BMD was evaluated at the midshaft of the ulna and at the distal radius of the non-dominant forearm using dual-energy X-ray absorptiometry before insertion and at 18 months of use . RESULTS There was no difference in baseline demographic or anthropometric characteristics , or in BMD of users of either model of implant . BMD was significantly lower at 18 months of use at the midshaft of the ulna in both groups of users . However , no difference was found at the distal radius . Multiple linear regression analysis showed that the variables associated with BMD at 18 months of use in both implant groups were baseline BMD , body mass index ( BMI ) and difference in BMI ( 0 versus 18 months of use ) . CONCLUSIONS Women of 19 - 43 years of age using either one of the implants showed lower BMD at 18 months of use at the midshaft of the ulna , however , without a difference at the distal radius BACKGROUND This Phase 3 , r and omized , open-label , multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous , daily regimen of levonorgestrel ( LNG ) 90 mcg/ethinyl estradiol ( EE ) 20 mcg compared with a 21-day , cyclic LNG 100 mcg/EE 20 mcg regimen . STUDY DESIGN Three hundred twenty-three healthy women were r and omized to continuous LNG 90 mcg/EE 20 mcg and 318 subjects to cyclic LNG 100 mcg/EE 20 mcg for 1 year ( 13 pill packs ) . Pearl index , adverse event ( AE ) incidence and bleeding profiles were assessed . RESULTS No pregnancies occurred with the continuous oral contraceptive ( OC ) ( Pearl index=0.00 ) . As the study progressed , the percentage of women who achieved amenorrhea during each 28-day pill pack increased : 40 % at pill pack 7 , 53 % at pill pack 13 . The percentage of women with no bleeding [ with or without spotting ( defined as not requiring sanitary protection ) ] was 50 % , 69 % and 79 % at pill packs 3 , 7 and 13 , respectively . The incidence of AEs was similar to that of the cyclic OC ( except for metrorrhagia and vaginal bleeding in the first 6 months ) . CONCLUSIONS Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC . Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous , low-dose OC Background The aim of this study was to evaluate bone mineral density ( BMD ) at baseline and at 18 and 36 months of use of etonogestrel (ENG)- and levonorgestrel (LNG)-releasing contraceptive implants . This is a continuation of a previous study in which BMD was evaluated at baseline and at 18 months of use . Methods A total of 111 women , 19–43 years of age , werer and omly allocated to use one of the two implants . At 36 months of follow-up , only 36 and 39 women were still using the ENG- and LNG-releasing implants , respectively . BMD was evaluated at the distal and at the ultra-distal radius of the non-dominant forearm using dual-energy X-ray absorptiometry . Results There was no difference in the BMD of users of either implant at 18 and at 36 months . BMD was significantly lower at 18 and at 36 months at the distal radius in both groups of users compared to pre-insertion values ; however , no difference was found at the ultra-distal radius . Conclusion Women 19–43 years of age using either one of these two contraceptive implants for 36 months had lower BMD values at the distal radius compared to pre-insertion values ; however , no difference was found at the ultra-distal radius OBJECTIVE The purpose of this clinical trial was to evaluate the effect of estrogen supplementation on bone mineral density in adolescent girls who received depot medroxyprogesterone acetate for contraception . STUDY DESIGN One hundred twenty-three adolescents who began receiving depot medroxyprogesterone acetate injections every 12 weeks were assigned r and omly to receive monthly injections of estradiol cypionate or placebo . The main outcome was bone mineral density that was measured by dual energy x-ray absorptiometry for 12 ( n = 69 ) to 24 ( n = 36 ) months . Participants , technicians , and physicians were blinded to estrogen treatment . RESULTS Over the 24-month period , the percentage of change from baseline bone mineral density at the lumbar spine was 2.8 % in the estradiol cypionate group versus -1.8 % in the placebo group ( P < .001 ) . At the femoral neck , the percentage of change from baseline bone mineral density was 4.7 % in the estradiol cypionate group versus -5.1 % in the placebo group ( P < .001 ) . CONCLUSION Our results suggest that estrogen supplementation is protective of bone in adolescent girls who receive depot medroxyprogesterone acetate injections AIM This 12-month study was conducted to evaluate the skeletal effects of two monophasic oral contraceptives containing 20 mug of ethinylestradiol and 100 mug of levonorgestrel ( LEVO ) or 150 mug of desogestrel ( DESO ) . METHODS Fifty-two women ( 18 - 24 years ) were r and omized into the DESO group or the LEVO group ; 36 women served as controls . The areal bone mineral density ( aBMD ) of the femoral neck and the lumbar spine was evaluated by DXA , and parameters of bone geometry and volumetric bone mineral density ( vBMD ) were assessed by peripheral quantitative computed tomography at the distal radius and the tibia . RESULTS The LEVO group did not lose vertebral aBMD , whereas women in the DESO group lost 1.5 % . At the distal radius and the tibia ( shank level , 14 % ) , LEVO induced an increase in total cross-sectional area , indicating increased periosteal bone formation . Radial trabecular vBMD declined by 1.4+/-1.8 % in the DESO group , while it remained unchanged in the LEVO group . CONCLUSION Our study suggests that the skeletal effects of OC preparations may be influenced by progestogenic components in young women BACKGROUND A formulation of depot medroxyprogesterone acetate ( DMPA ) has been developed that allows subcutaneous injection ( 104 mg/0.65 mL ; DMPA-SC ) and achieves highly effective contraception with a similar tolerability profile to intramuscular DMPA ( 150 mg/mL ; DMPA-IM ) . STUDY DESIGN This r and omized , evaluator-blinded study was design ed to compare efficacy , safety , and user satisfaction in women receiving DMPA-SC ( n=266 ) or DMPA-IM ( n=268 ) for 2 years with an option to continue for a third year . The primary objectives were to evaluate bone mineral density ( BMD ) changes and contraceptive efficacy after 2 years . RESULTS A total of 225 women completed the first 2 years of this study ( DMPA-SC , n=116 ; DMPA-IM , n=109 ) . After 2 years of DMPA use , BMD loss was marginally smaller in the DMPA-SC group than in the DMPA-IM group at both the total hip ( -3.3 % and -3.6 % , respectively ) and lumbar spine ( -4.3 % and -5.0 % , respectively ) . In those women who received DMPA during the third year , there were no statistically significant differences in BMD loss between DMPA-SC and DMPA-IM groups at the end of Year 3 . Recovery of BMD was observed in the small sub population of women who had discontinued DMPA-SC or DMPA-IM after the second year . The 2-year treatment-failure cumulative pregnancy rate was 0 % in the DMPA-SC group and 0.8 % ( 95 % confidence interval , 0.00 - 2.37 % ) in the DMPA-IM group ( life-table method ) . Adverse events were similar in the two groups except that injection site reactions were more common in the DMPA-SC group . CONCLUSION DMPA-SC is an effective and well-tolerated contraceptive option , providing comparable efficacy and BMD safety to DMPA-IM BACKGROUND Several studies , including an earlier analysis from the Royal College of General Practitioners ( RCGP ) Oral Contraception Study , have suggested that ever users of oral contraceptives have an increased risk of fracture when compared with never users . In this paper , we examined a subset of women in the RCGP study living in Scotl and to determine whether this risk has persisted . STUDY DESIGN A nested case-control study was carried out using data collected prospect ively for the RCGP Oral Contraception Study . Cases were women with a first ever diagnosis of fracture ( n=651 ) , age-matched to two controls ( n=1302 ) . Adjustments were made for smoking , social class and parity . RESULTS There was not a significant association between ever use of oral contraception and fracture ( adjusted odds ratio 1.05 , 95 % confidence interval 0.86 - 1.29 ) , compared with never users . Neither were significant associations found between fracture and smoking , social class and parity . The findings did not vary material ly with age or type of fracture . CONCLUSION Ever use of oral contraception was not associated with fracture in this study 2 preparations of a sequential oral contraceptive containing 11 tablets of .1 mg mestranol and 10 tablets of .1 mg mestranol and 2 mg chlormadinone were compared : 127 women took the pills with 7 placebos ( Eunomin ) for 848 cycles and 47 women took them without placebos ( GC 527 ) for 267 cycles . 1 pregnancy occurred due to patient error . No differences were recorded in weight changes , bone symptoms , breakthrough bleeding , breast symptoms , or increased libido . Mucorrhea and constipation were more common with the placebos . The side effects of nausea , nervousness , headache , fatigue , and decreased libido were frequent with placebos . 19.8 % discontinued Eunomin , while 23.4 % stopped taking CG 527 . 76.9 % of the women on Eunomin and 65.2 % of those on CG 527 did not have the side effects that they had experienced with previou s pills The question of differential effects on bone density by two different types of progestogen-only methods for contraception in premenopausal women was addressed . Data from a prospect i ve r and omized clinical trial among 22 premenopausal women , age 32.6 ( range 20 - 45 years ) , who were r and omly assigned to either of two treatments with continuous progestogens for contraception were analyzed ; depot-medroxyprogesterone acetate ( DMPA ) or continuous levonorgestrel treatment with subdermal implants ( Norplant ) , respectively . Forearm bone density ( BMDprox ) increased with 2.94 % ( p = 0.006 ) in women who were prescribed levonorgestrel , which was in contrast to stable values in those prescribed depot-medroxy-progesterone acetate ; group difference at 6 months for BMDprox 3.4 % ( 95 % CI 1.3 , 5.5 ; p = 0.025 ) and BMDdist 4.1 % ( 95 % CI - 1.3 , 9.6 ; p = 0.077 ) . The changes in bone density were consistent with the changes in biochemical indices for bone metabolism ; DMPA users showed signs of increased bone turnover and users of levonorgestrel showed increased bone formation with increased levels of both alkaline phosphatase ( p = 0.004 ) and osteocalcin ( p = 0.007 ) . The findings suggest an increase in bone density during treatment with levonorgestrel and stable values during short-term administration of DMPA , in st and ard clinical doses for contraception INTRODUCTION Prior studies have suggested that oral contraceptives ( OCs ) may be associated with an increased fracture risk . However , the previous studies have only performed a limited adjustment for other potential risk factors . SUBJECTS AND METHODS All women with a fracture ( n=64,548 ) in the year 2000 in Denmark served as cases . For each case , three age-matched controls were r and omly drawn from the general population ( n=193,641 ) . Exposure was use of OCs between January 1 , 1996 , and December 31 , 2000 . Adjustments were made for use of other drugs , pregnancy , prior fracture , other diseases and social variables . RESULTS In the unadjusted analysis , use of OCs
Output:
| Depot medroxyprogesterone acetate ( DMPA ) was associated with decreased bone mineral density ( BMD ) .
The placebo-controlled trials showed BMD increases for DMPA plus estrogen supplement and decreases for DMPA plus placebo supplement .
COCs did not appear to negatively affect BMD , and some formulations had more positive effects than others .
Where studies showed differences between groups in bone turnover markers , the results were generally consistent with those for BMD .
For implants , the single-rod etonogestrel group showed a greater BMD decrease versus the two-rod levonorgestrel group but results were not consistent across all implant comparisons .
For example , injectable contraceptives and implants provide effective , long-term birth control yet do not involve a daily regimen . |
MS210390 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The level of minimal residual disease during remission induction is the most important prognostic indicator in patients with acute lymphoblastic leukaemia ( ALL ) . We aim ed to establish the clinical significance of minimal residual disease in a prospect i ve trial that used sequential minimal residual disease measurements to guide treatment decisions . METHODS Between June 7 , 2000 , and Oct 24 , 2007 , 498 assessable patients with newly diagnosed ALL were enrolled in a clinical trial at St Jude Children 's Research Hospital . We provisionally classified the risk of relapse as low , st and ard , or high according to patients ' baseline clinical and laboratory features . Final risk assignment to establish treatment intensity was based mainly on minimal residual disease levels measured on days 19 and 46 of remission induction , and on week 7 of maintenance treatment . Additional measurements of minimal residual disease were made on weeks 17 , 48 , and 120 ( end of treatment ) . The primary aim was to establish the association between event-free survival and patients ' minimal residual disease levels during remission induction and sequentially post-remission . This trial was registered at Clinical Trials.gov , number NCT00137111 . FINDINGS Irrespective of the provisional risk classification , 10-year event-free survival was significantly worse for patients with 1 % or greater minimal residual disease levels on day 19 compared with patients with lower minimal residual disease levels ( 69·2 % , 95 % CI 49·6 - 82·4 , n=36 vs 95·5 % , 91·7 - 97·5 , n=244 ; p<0·001 for the provisional low-risk group and 65·1 % , 50·7 - 76·2 , n=56 vs 82·9 % , 75·6 - 88·2 , n=142 ; p=0·01 for the provisional st and ard-risk group ) . 12 patients with provisional low-risk ALL and 1 % or higher minimal residual disease levels on day 19 but negative minimal residual disease ( < 0·01 % ) on day 46 were treated for st and ard-risk ALL and had a 10-year event-free survival of 88·9 % ( 43·3 - 98·4 ) . For the 280 provisional low-risk patients , a minimal residual disease level of less than 1 % on day 19 predicted a better outcome , irrespective of the minimal residual disease level on day 46 . Of provisional st and ard-risk patients with minimal residual disease of less than 1 % on day 19 , the 15 with persistent minimal residual disease on day 46 seemed to have an inferior 10-year event-free survival compared with the 126 with negative minimal residual disease ( 72·7 % , 42·5 - 88·8 vs 84·0 % , 76·3 - 89·4 ; p=0·06 ) after receiving the same post-remission treatment for st and ard-risk ALL . Of patients attaining negative minimal residual disease status after remission induction , minimal residual disease re-emerged in four of 382 studied on week 7 , one of 448 at week 17 , and one of 437 at week 48 ; all but one of these six patients died despite additional treatment . By contrast , relapse occurred in only two of the 11 patients who had decreasing minimal residual disease levels between the end of induction and week 7 of maintenance therapy and were treated with chemotherapy alone . INTERPRETATION Minimal residual disease levels during remission induction treatment have important prognostic and therapeutic implication s even in the context of minimal residual disease-guided treatment . Sequential minimal residual disease monitoring after remission induction is warranted for patients with detectable minimal residual disease . FUNDING National Institutes of Health and American Lebanese Syrian Associated Charities The efficacy of allografting in acute lymphoblastic leukemia ( ALL ) is heavily influenced by remission status at the time of transplant . Using polymerase chain reaction (PCR)-based minimal residual disease ( MRD ) analysis , we have investigated retrospectively the impact of su bmi croscopic leukemia on outcome in 64 patients receiving allogeneic bone marrow transplantation ( BMT ) for childhood ALL . Remission BM specimens were taken 6 to 81 days ( median , 23 ) before transplant . All patients received similar conditioning therapy ; 50 received grafts from unrelated donors and 14 from related donors . Nineteen patients were transplanted in first complete remission ( CR1 ) and 45 in second or subsequent CR . MRD was analyzed by PCR of Ig or T-cell receptor delta or gamma rearrangements , electrophoresis , and allele-specific oligoprobing . Sample s were rated high-level positive ( clonal b and evident after electrophoresis ; sensitivity 10(-2 ) to 10(-3 ) ) , low-level positive ( MRD detected only after oligoprobing ; sensitivity 10(-3 ) to 10(-5 ) ) , or negative . Excluding 8 patients transplanted in CR2 for isolated extramedullary relapse ( all MRD- ) , MRD was detected at high level in 12 patients , low level in 11 , and was undetectable in 33 . Two-year event-free survival for these groups was 0 % , 36 % , and 73 % , respectively ( P < .001 ) . Follow-up in patients remaining in continuing remission is 20 to 96 months ( median , 35 ) . These results suggest that MRD analysis could be used routinely in this setting . This would allow identification of patients with resistant leukemia ( who may benefit from innovative BMT protocol s ) and of those with more responsive disease ( who may be c and i date s for r and omized trials of BMT versus modern intensive relapse chemotherapy ) Minimal residual disease ( MRD ) is a major predictive factor of the cure rate of acute lymphoblastic leukaemia ( ALL ) . Haematopoietic cell transplantation is a treatment option for patients at high risk of relapse . Between 2005 and 2008 , we conducted a prospect i ve study evaluating the feasibility and efficacy of the reduction of immunosuppressive medication shortly after a non‐ex vivo T depleted myeloablative transplantation . Immunoglobulin (Ig)H/T‐cell receptor MRD 30 d before transplant could be obtained in 122 of the 133 cases of high‐risk paediatric ALL enrolled . There were no significant demographic differences except remission status ( first or second complete remission ) between the 95 children with MRD < 10−3 and the 27 with MRD ≥10−3 . Multivariate analysis identified sex match and MRD as being significantly associated with 5‐year survival . MRD ≥10−3 compromised the 5‐year cumulative incidence of relapse ( 43·6 vs. 16·7 % ) . Complete remission status and stem cell source did not modify the relationship between MRD and prognosis . Thus , pre‐transplant MRD is still a major predictor of outcome for ALL . The MRD‐guided strategy result ed in survival for 72·3 % of patients with MRD<10−3 and 40·4 % of those with MRD ≥10−3 Relapse of pediatric acute lymphoblastic leukemia ( ALL ) remains the main cause of treatment failure after allogeneic stem cell transplantation ( alloSCT ) . A high level of minimal residual disease ( MRD ) before alloSCT has been shown to predict these relapses . Patients at risk might benefit from a preemptive alloimmune intervention . In this first prospect i ve , MRD-guided intervention study , 48 patients were stratified according to pre-SCT MRD level . Eighteen children with MRD level ⩾1 × 10−4 were eligible for intervention , consisting of early cyclosporine A tapering followed by consecutive , incremental donor lymphocyte infusions ( n=1–4 ) . The intervention was associated with graft versus host disease ⩾ grade II in only 23 % of patients . Event-free survival in the intervention group was 19 % . However , in contrast with the usual early recurrence of leukemia , relapses were delayed up to 3 years after SCT . In addition , several relapses presented at unusual extramedullary sites suggesting that the immune intervention may have altered the pattern of leukemia recurrence . In 8 out of 11 evaluable patients , relapse was preceded by MRD recurrence ( median 9 weeks , range 0–30 ) . We conclude that in children with high-risk ALL , immunotherapy-based regimens after SCT are feasible and may need to be further intensified to achieve total eradication of residual leukemic cells PURPOSE Minimal residual disease ( MRD ) before allogeneic stem-cell transplantation was shown to predict outcome in children with relapsed acute lymphoblastic leukemia ( ALL ) in retrospective analysis . To verify this , the Acute Lymphoblastic Leukemia Relapse Berlin-Frankfurt-Münster ( ALL-REZ BFM ) Study Group conducted a prospect i ve trial . PATIENTS AND METHODS Between March 1999 and July 2005 , 91 children with relapsed ALL treated according to the ALL-REZ BFM 96 or 2002 protocol s and receiving stem-cell transplantation in > or= second remission were enrolled . MRD quantification was performed by real-time polymerase chain reaction using T-cell receptor and immunoglobulin gene rearrangements . RESULTS Probability of event-free survival ( pEFS ) and cumulative incidence of relapse ( CIR ) in 45 patients with MRD > or= 10(-4 ) leukemic cells was 0.27 and 0.57 compared with 0.60 and 0.13 in 46 patients with MRD less than 10(-4 ) leukemic cells ( EFS , P = .004 ; CIR , P < .001 ) . Intermediate-risk patients ( strategic group S1 ) with MRD > or= 10(-4 ) leukemic cells ( n = 14 ) had a pEFS of 0.20 and CIR of 0.73 , whereas patients with MRD less than 10(-4 ) leukemic cells ( n = 21 ) had a pEFS of 0.68 and CIR of 0.09 ( EFS , P = .020 ; CIR , P < .001 ) . High-risk patients ( S3/4 , third complete remission ) who received transplantation with an MRD load of less than 10(-4 ) leukemic cells ( n = 25 ) showed a pEFS and CRI of 0.53 and 0.18 , respectively . In contrast , pEFS and CRI were 0.30 and 0.50 in patients who received transplantation with an MRD load of > or= 10(-4 ) leukemic cells . Multivariate Cox regression analysis revealed MRD as the only independent parameter predictive for EFS ( P = .006 ) . CONCLUSION MRD is an important predictor for post-transplantation outcome . As a result , new strategies with modified stem-cell transplantation procedures will be evaluated in ALL-BFM trials Relapse is the main reason for treatment failure in childhood acute lymphoblastic leukemia . Despite improvements in the up-front therapy , survival after relapse is still relatively poor , especially for high-risk relapses . The aims of this study were to assess outcomes following acute lymphoblastic leukemia relapse after common initial Nordic Society of Paediatric Haematology and Oncology protocol treatment ; to vali date currently used risk stratifications , and identify additional prognostic factors for overall survival . Altogether , 516 of 2735 patients ( 18.9 % ) relapsed between 1992 and 2011 and were included in the study . There were no statistically significant differences in outcome between the up-front protocol s or between the relapse protocol s used , but an improvement over time was observed . The 5-year overall survival for patients relapsing in the period 2002–2011 was 57.5±3.4 % , but 44.7±3.2 % ( P<0.001 ) if relapse occurred in the period 1992–2001 . Factors independently predicting mortality after relapse included short duration of first remission , bone marrow involvement , age ten years or over , unfavorable cytogenetics , and Down syndrome . T-cell immunophenotype was not an independent prognostic factor unless in combination with hyperleukocytosis at diagnosis . The outcome for early combined pre-B relapses was unexpectedly poor ( 5-year overall survival 38.0±10.6 % ) , which supports the notion that these patients need further risk adjustment . Although survival outcomes have improved over time , the development of novel approaches is urgently needed to increase survival in relapsed childhood acute lymphoblastic leukemia BACKGROUND We sought to improve outcome in patients with childhood acute myeloid leukaemia ( AML ) by applying risk-directed therapy that was based on genetic abnormalities of the leukaemic cells and measurements of minimal residual disease ( MRD ) done by flow cytometry during treatment . METHODS From Oct 13 , 2002 , to June 19 , 2008 , 232 patients with de-novo AML ( n=206 ) , therapy-related or myelodysplasia-related AML ( n=12 ) , or mixed-lineage leukaemia ( n=14 ) were enrolled at eight centres . 230 patients were assigned by block ,
Output:
| However , positive MRD prior to transplantation was not associated with a higher rate of nonrelapse mortality . |
MS210391 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Evidence -based practice involves the use of evidence from systematic review s and r and omised controlled trials , but the extent of this evidence in physiotherapy has not previously been surveyed . The aim of this survey is to describe the quantity and quality of r and omised controlled trials and the quantity of systematic review s relevant to physiotherapy . The Physiotherapy Evidence Data base ( PEDro ) was search ed . The quality of trials was assessed with the PEDro scale . The search identified a total of 2,376 r and omised controlled trials and 332 systematic review s. The first trial was published in 1955 and the first review was published in 1982 . Since that time , the number of trials and review s has grown exponentially . The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999 . There is a substantial body of evidence about the effects of physiotherapy . However , there remains scope for improvements in the quality of the conduct and reporting of clinical trials Background : Pulmonary complications , respiratory symptoms and depression are common occurrences which contribute to the morbidity and mortality seen in individuals living with HIV/AIDS . This study investigated the effect of aerobic exercise on the pulmonary functions , respiratory symptoms and psychological status of people living with HIV . Methods : This study was conducted in Lagos , Nigeria from October 2014 to May 2015 . Forty eligible individuals with HIV aged 18 yr and above participated , of which 33 cooperated to the end . They were recruited from the HIV/AIDS Prevention and Intervention Initiative ( APIN ) Clinic , Lagos University Teaching Hospital , Nigeria and were r and omly assigned to either the study or the control group . The study group received aerobic exercise training three times a week for six weeks and counselling while the control group received only counselling . Pulmonary functions , respiratory symptoms and psychological status were evaluated at baseline and at six weeks . Inferential statistics of paired and independent t-test were used to analyze the data . Results : Comparison of mean changes in the pulmonary variables of the study group with those of the control group showed significant differences in all but in the respiratory rate ( RR ) - [ Forced Expiratory Volume in one second : , P=0.001 , Forced Vital Capacity : P=0.001 , Peak Expiratory Flow : P=0.001 ] . There were also significant differences between the mean changes in respiratory symptoms ( P=0.001 ) and depressive symptoms ( P=0.001 ) of study group and those of the control group . Conclusions : Aerobic exercise training significantly improved pulmonary functions as well as significantly reduced respiratory and depressive symptoms in people living with HIV Exercise has the potential to impact disease by altering circulating anabolic and catabolic factors . It was the goal of this study to determine how different regimens of low-intensity and moderate-intensity exercise affected circulating levels of these anabolic and catabolic factors in HIV-infected men . Exercise-naive , HIV-infected men , medically cleared for study participation , were r and omized into one of the following groups : a moderate-intensity group ( MOD , who completed 30 min of moderate-intensity aerobic training followed by 30 min of moderate-intensity resistance training ; a low-intensity group ( LOW ) , who completed 60 min of treadmill walking ; or a control group ( CON ) , who attended the clinic but participated in no activity . Blood and saliva sample s were collected at selected time points before , during , and after each of the 3 required sessions . Compared with baseline , the MOD group ( n=14 ) had a 135 % increase in growth hormone ( GH ) ( p<0.05 ) and a 34 % decrease in cortisol ( CORT ) ( p<0.05 ) at the post time point , a 31 % increase in interleukin-6 ( IL-6 ) ( p<0.05 ) at 30-min post exercise , and a 23 % increase in IL-6 ( p<0.05 ) and a 13 % decrease in soluble tumor necrosis factor receptor 2 ( sTNFrII ) ( p<0.05 ) at 60-min post exercise . The LOW ( n=11 ) group had a 3.5 % decrease in sTNFrII ( < 0.05 ) at 30-min post exercise compared with baseline and a 49 % decrease ( p<0.05 ) in GH at 60-min post exercise . The CON group ( n=13 ) had a decrease in GH at 30-min ( 62 % , p<0.05 ) and 60-min ( 61 % , p<0.05 ) post exercise compared with baseline . The increase in GH from baseline to post was greater in the MOD group ( p<0.05 ) and the decrease in CORT from pre to post was greater in the MOD group ( p<0.05 ) than in the other groups . These data suggest that individual sessions of both low-intensity and moderate-intensity exercise can alter circulating anabolic and catabolic factors in HIV-infected men . The changes in the MOD group present potential mechanisms for the increases in lean tissue mass seen with resistance exercise training OBJECTIVE HIV-infected older adults ( HOA ) are at risk of functional decline . Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority . We conducted a r and omized , controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory ( SDT ) improves physical function , autonomous motivation , depression and the quality of life ( QOL ) in HOA . METHOD In total , 67 community-dwelling HOA with mild-to-moderate functional limitations were r and omized to 1 of 2 groups : a physical activity counseling group or the usual care control group . We used SDT to guide the development of the experimental intervention . Outcome measures that were collected at baseline and final study visits included a battery of physical function tests , levels of physical activity , autonomous motivation , depression , and QOL . RESULTS The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups . Overall physical performance , gait speed , measures of endurance and strength , and levels of physical activity improved in the treatment group compared to the control group ( p < .05 ) . Measures of autonomous regulation such as identified regulation , and measures of depression and QOL improved significantly in the treatment group compared with the control group ( p < .05 ) . Across the groups , improvement in intrinsic regulation and QOL correlated with an improvement in physical function ( p < .05 ) . CONCLUSION Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function , autonomous motivation , depression , and QOL in HOA with functional limitations . ( PsycINFO Data base Purpose : Highly active antiretroviral therapy has significantly extended survival of human immunodeficiency virus ( HIV ) infected patients . These drugs suppress replication of HIV but at the same time , have many physical and mental side effects which may affect daily activities of the patients . The present study assessed if moderate intensity exercise program helped in enhancing the physical fitness and quality of life ( QoL ) in HIV positive females which may reduce the comorbidities associated with the disease and medications . Aim and Objectives : The aim of this study is to study the effects of moderate intensity physical training on physical fitness parameters and QoL in HIV positive females . Methodology : Post IEC approval , a r and omized control , single-blinded , parallel group trial was conducted on 55 females ( 20 experimental HIV , 20 control HIV , 15 control normal ) matching the selection criteria . Post informed consent , their muscular endurance , flexibility , aerobic capacity , and QoL was assessed . Moderate intensity physical exercises were given to experimental HIV and control normal 5 days/week for 8 weeks and subjects were reassessed for above parameters . Intragroup analysis was performed using paired t-test while inter-group was by one-way ANOVA with alpha set at ≤0.05 . Results : Moderate-intensity exercises improved muscular endurance ( P < 0.05 ) , flexibility ( P < 0.05 ) , and aerobic capacity ( P < 0.05)in experimental HIV and control normal group as compared to control HIV group . QoL in experimental HIV showed improvement in all the domains . Conclusion : Moderate-intensity exercises help improve the physical fitness as well as enhance the QoL in HIV positive females The primary purpose of this investigation was to determine the impact of altering the set structure during an 8-week resistance training program on anthropometric , hormonal , and strength power characteristics . Thirty female volleyball players were recruited for participation and then r and omly assigned to 1 of 3 resistance training groups : ( i ) cluster sets ( CRT ; n = 10 ) , ( ii ) traditional sets ( TRT ; n = 10 ) , or ( iii ) control ( CON ; n = 10 ) . All athletes were evaluated for thigh and arm circumference , vertical jump , 20-m sprint , 4 × 9-m shuttle-run , 1-repetition maximum ( 1RM ) back squat , bench press , military press , and deadlift prior to and after an 8-week periodized training intervention . Blood sample s were taken before and after the 8-week training period to evaluate resting testosterone , cortisol , and insulin-like growth factor 1 responses to the training period . After 8 weeks of training the CRT group displayed a small but significant improvement in vertical jump ( CRT : effect size ( ES ) = 038 , 7.1 % ) performance when compared with the TRT group ( ES = 0.34 , 5.6 % ) . Both the CRT and TRT training interventions result ed in very large increases in the 1RM squat ( CRT : 8.4 % ± 1.2 % ; TRT : 7.3 % ± 0.6 % ) , bench press ( CRT : 8.3 % ± 2.0 % ; TRT : 8.7 % ± 1.9 % ) , military press ( CRT : 5.7 % ± 1.2 % ; TRT : 5.5 % ± 1.6 % ) , and deadlift ( CRT : 8.2 % ± 1.6 % ; TRT : 8.3 % ± 2.2 % ) . There were no significant differences in 20-m sprint or 4 × 9-m shuttle run times between the CRT , TRT , and CON groups . These results suggest that cluster sets allow for greater improvements in vertical jump performance and equal improvements in strength gains to those seen with traditional sets HIV/AIDS and its treatment often alter body composition and result in poorer physical functioning . The aim of this study was to determine the effects of a moderate-intensity exercise program on body composition and the hormones and cytokines associated with adverse health outcomes . HIV-infected males ( N = 111 ) were r and omized to an exercise group ( EX ) who completed 6 weeks of moderate-intensity exercise training , or to a nonintervention control group ( CON ) . In pre- and postintervention , body composition was estimated via DXA , peak strength was assessed , and resting blood sample s were obtained . There was a decrease in salivary cortisol at wake ( P = 0.025 ) in the EX and a trend ( P = 0.07 ) for a decrease 1 hour after waking . The EX had a significant increase in lean tissue mass ( LTM ) ( P < 0.001 ) following the intervention . Those in the EX below median body fat ( 20 % ) increased LTM ( P = 0.014 ) only , while those above 20 % decreased fat mass ( P = 0.02 ) , total fat ( N = 0.009 ) , and trunk fat ( P = 0.001 ) , while also increasing LTM ( P = 0.027 ) . Peak strength increased between 14 % and 28 % on all exercises in the EX group . These data indicate that 6 weeks of moderate-intensity exercise training can decrease salivary cortisol levels , improve physical performance , and improve body composition in HIV-infected men OBJECTIVES : Human Immunodeficiency Virus ( HIV ) infection worsens the frailty of elderly people , compromising their quality of life . In this study we prospect ively evaluated eleven patients living with HIV and 21 controls older than 60 years and without prior regular physical activity , who engaged in a one-year progressive resistance exercise program to compare its effects on muscular strength , physical fitness and body composition . METHODS : Exercises for major muscular groups were performed 2 times/week , under professional supervision . Strength increase was evaluated bimonthly , while body composition , lipid and glycaemic profiles ( only of those living with HIV ) and physical fitness were evaluated before and after the one-year training . RESULTS : The participants living with HIV were lighter , had smaller Body Mass Index and were initially much weaker than controls . However , their strength increased more ( 1.52 - 2.33 times the baseline values for those living with HIV x 1.21 - 1.48 times for controls , p<0.01 ) , nullifying the differences initially seen . These effects were seen independently of gender , age or baseline physical activity . In addition , those living with HIV improved their fasting glucose levels and showed a tendency to improve their lipids after the one year training program . These effects were slightly more pronounced among those not using protease inhibitors , although not significantly . CONCLUSIONS : Resistance exercise safely increased the strength of older patients living with HIV adults , allowing them to achieve performance levels observed among otherwise healthy controls . These findings favor the recommendation of resistance exercise for elderly adults living with HIV adults Loss
Output:
| Changes were higher after controlling for the risk of bias in upper and lower body strength and for supervised exercise in lower body strength .
Both resistance training alone and combined with aerobic exercise showed a positive change when studies with low risk of bias and professional supervision were analyzed , improving upper and , more critically , lower body muscle strength .
Also , this study found that exercise had a lowering effect on IL-6 levels in PLWH |
MS210392 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Female-initiated HIV-prevention options , such as microbicides , are urgently needed . We assessed Carraguard , a carrageenan-based compound developed by the Population Council , for its efficacy and long-term safety in prevention of HIV infection in women . METHODS We undertook a r and omised , placebo-controlled , double-blind trial in three South African sites in sexually-active , HIV-negative women , aged 16 years and older . 6202 participants , who were r and omly assigned by a block r and omisation scheme to Carraguard ( n=3103 ) or placebo ( methylcellulose [ n=3099 ] ) , were instructed to use one applicator of gel plus a condom during each vaginal sex act . Participants were followed up for up to 2 years . Visits every 3 months included testing for HIV presence and pregnancy , pelvic examinations , risk reduction counselling , and treatment for curable sexually transmitted infections and symptomatic vaginal infections . The primary outcome was time to HIV seroconversion . Analysis was in the efficacy population ( a subset of the intention-to-treat population , excluding participants for whom efficacy could not be assessed ) . This study is registered with Clinical Trials.gov , number NCT00213083 . FINDINGS For the primary outcome ( time to HIV seroconversion ) we analysed 3011 women in the Carraguard group and 2994 in the placebo group . HIV incidence was 3.3 per 100 woman-years ( 95 % CI 2.8 - 3.9 ) in the Carraguard group ( 134 events ) and 3.8 per 100 woman-years ( 95 % CI 3.2 - 4.4 ) in the placebo group ( 151 events ) , with no significant difference in the distribution of time to seroconversion ( p=0.30 ) . The covariate-adjusted hazard ratio was 0.87 ( 95 % CI 0.69 - 1.09 ) . Rates of self-reported gel use ( 96.2 % Carraguard , 95.9 % placebo ) and condom use ( 64.1 % in both groups ) at last sex acts were similar in both groups . On the basis of applicator testing , however , gel was estimated to have been used in only 42.1 % of sex acts , on average ( 41.1 % Carraguard , 43.1 % placebo ) . 1420 ( 23 % ) women in the intention-to-treat population had adverse events ( 713 Carraguard , 707 placebo ) , and 95 ( 2 % ) women had adverse events that were related to gel use ( 48 Carraguard , 47 placebo ) . Serious adverse events occurred in 72 ( 2 % ) women in the Carraguard group and 78 ( 3 % ) in the placebo group , only one of which was considered possibly related to gel use ( placebo group ) . INTERPRETATION This study did not show Carraguard 's efficacy in prevention of vaginal transmission of HIV . No safety concerns were recorded Introduction Since female learners in high schools in Cameroon fall within the age group hardest hit by HIV/AIDS , it is assumed that these learners might be exposed to sexual risk behaviours . However , little has been explored on the sexual risk behaviours of high school female learners in Cameroon . This study aim ed at examining the sexual risk behaviours of high school female learners in Mbonge subdivision of rural Cameroon . Methods A cross sectional design was adopted , using a self-administered question naire for data collection . Respondents were selected through disproportional stratified simple r and om sampling result ing in 210 female grade 10 to grade 12 learners from three participating high schools in Mbonge subdivision , Cameroon . Descriptive and inferential statistics were calculated using SPSS version 20 software program . Results Majority of the respondents , 54.0 % reported being sexually active , of whom only 39.8 % used condoms during first sex ; 49.5 % used condoms during last sex and 29.6 % used condoms consistently . Up to 32 % of the sexually active respondents had multiple sexual partners in the past one year before the study , while 9.3 % had multiple sexual partners during the study period . The mean age of first sex was 15.6 years . Lack of parental control , religion , academic profile , poverty , place of residence and perception of risk of HIV infection were the main factors significantly associated with sexual risk behaviours . Conclusion The findings indicate that sexual risk behaviours exist among high school female learners in Mbonge , Cameroon . There is need for campaigns and interventions to bring about sexual behaviour change BACKGROUND Underst and ing the signification of the word ' sex ' has implication s for both medical research and clinical practice . Little is known about how people of varying ages define sex and how situational qualifiers influence definitions across age groups . To our knowledge , this is the first study of a representative sample to assess attitudes about which sexual behaviours constitute having ' had sex ' and to examine possible mediating factors ( gender , age , giving/receiving stimulation , male ejaculation , female orgasm , condom use or brevity ) . METHODS A telephone survey of English-speaking residents of Indiana ( USA ) using r and om-digit-dialling produced a final sample of 204 men and 282 women ( n = 486 ) ranging in age from 18 to 96 years . Questions assessed the respondents ' attitudes on manual-genital ( MG ) , oral-genital ( OG ) , penile-vaginal intercourse ( PVI ) and penile-anal intercourse ( PAI ) behaviours . RESULTS There was no universal consensus on which behaviours constituted having ' had sex ' . More than 90 % responded ' yes ' to PVI but one in five responded ' no ' to PAI , three in 10 responded ' no ' to OG and about half endorsed MG . Fewer endorsed PVI with no male ejaculation ( 89.1 % ) compared with PVI without a qualifier ( 94.8 % , P < 0.001 ) . MG was endorsed more often when received ( 48.1 % ) than given ( 44.9 % , P < 0.001 ) . Among men , the oldest and youngest age groups were significantly less likely to believe certain behaviours constituted having ' had sex ' . CONCLUSIONS These findings highlight the need to use behaviour-specific terminology in sexual history taking , sex research , sexual health promotion and sex education . Research ers , educators and medical practitioners should exercise caution and not assume that their own definitions of having ' had sex ' are shared by their research participants or patients Background HIV acquisition in pregnancy and breastfeeding contributes significantly toward pediatric HIV infection . However , little is known about how sexual behavior changes during pregnancy and postpartum periods which will help develop targeted HIV prevention and transmission interventions , including pre-exposure prophylaxis ( PrEP ) . Methods Cross-sectional study in HIV-infected and uninfected pregnant and postpartum women in Cape Town , South Africa . Interviewers collected survey data on demographic , sexual behaviors , and alcohol use among pregnant and post-partum women . We report descriptive results of sexual behavior by trimester and postpartum period , and results of multivariable logistic regression stratified by pregnancy status . Results We enrolled 377 pregnant and postpartum women ( 56 % pregnant , 40 % HIV-infected ) . During pregnancy , 98 % of women reported vaginal sex ( 8 % anal sex , 44 % oral sex ) vs. 35 % and 88 % during the periods 0–6 and 7–12 months postpartum , respectively ( p<0.05 ) . More pregnant women reported having > 1 partner in the past 12-months compared to postpartum women ( 18 % vs. 13 % , respectively , p<0.05 ) . Sex frequency varied by trimester with greatest mean sex acts occurring during first trimester and > 6-months postpartum ( 13 mean sex acts in first trimester ; 17 mean sex acts > 6-months postpartum ) . Pregnant women had increased odds of reporting condomless sex at last sex ( aOR = 2.96;95%CI = 1.84–4.78 ) and ever having condomless sex in past 3-months ( aOR = 2.65;95%CI = 1.30–5.44 ) adjusting for age , HIV status , and sex frequency compared to postpartum women . Conclusion We identified that sexual behaviors and risk behaviors were high and changing during pregnancy and postpartum periods , presenting challenges to primary and secondary HIV prevention efforts , including PrEP delivery to pregnant and breastfeeding women Background Sex work has shifted from brothels to entertainment establishments ( EEs ) in Asia . Men who patronise EEs could act as a bridging population for human immunodeficiency virus ( HIV ) and sexually transmitted infection ( STI ) transmission through unprotected sex with the female EE workers to their spouses and regular partners . The aim of this study was to compare the prevalence and factors associated with risky sexual behaviours among the heterosexual men who patronised the EEs and brothels in Singapore . Methods This was a cross-sectional survey involving 569 heterosexual men ( 297 recruited from brothels and 272 from EEs ) . A 2-stage sampling involving proportional stratified r and om sampling of the brothels and EEs , followed by time location sampling of the men , was conducted . For multivariable analysis , we used a mixed effects logistic model with backward elimination to account for clustering by venue and to obtain the adjusted odds ratio ( aOR ) for the association of various factors with consistent condom use in vaginal and oral sex respectively . Results Men who patronised EEs were younger , more likely to be single , more highly-educated and comprised more professionals compared to the brothel group . On multivariable analysis , consistent condom use for vaginal sex decreased at the EE setting ( aOR 0.64 ; 95 % CI : 0.42 –0.97 ) and with alcohol use before sex ( aOR 0.67 ; 95 % CI : 0.46 – 0.98 ) and increased with perceived high risk of getting HIV/STIs from partner ( aOR 2.08 ; 95 % CI : 1.30 – 3.32 ) and partner ’s request for condom use ( aOR 5.48 ; 95 % CI : 1.20 – 25.11 ) . For consistent condom use with oral sex , this decreased at the EE setting ( aOR 0.64 ; 95 % CI : 0.39 – 0.98 ) and with alcohol use before sex ( aOR 0.50 ; 95 % CI : 0.31 – 0.81 ) and increased with partner ’s request for condom use ( aOR 5.19 ; 95 % CI : 1.38 – 19.57 ) . Conclusions Men who patronised EEs practised risker sexual behaviours compared to the brothel group . Priority should be given for intervention programmes to target men who patronise EEs , which could involve the female EE workers , the EE owners as well as the managers for effective HIV/STI prevention Vaginal Gel Versus HIV HIV prevention technologies for women are urgently needed , especially in sub-Saharan Africa where young women bear the greatest burden of the HIV epidemic . Abdool Karim et al. ( p. 1168 ; published online 19 July ) present the results of the CAPRISA 004 r and omized control trial . The nearly 3-year-long trial , conducted in urban and rural South African women , tested the efficacy of a vaginal gel containing the antiretroviral drug tenofovir in preventing HIV infection . The dosing strategy required application of the gel both before and after coitus , and with this regime HIV infection was reduced by approximately 39 % overall , by 54 % in women with high adherence to the protocol , and with no increase in overall adverse event rates . Tenofovir in a vaginal gel formulation shows significant protection against HIV infection in a r and omized control trial . The Centre for the AIDS Program of Research in South Africa ( CAPRISA ) 004 trial assessed the effectiveness and safety of a 1 % vaginal gel formulation of tenofovir , a nucleotide reverse transcriptase inhibitor , for the prevention of HIV acquisition in women . A double-blind , r and omized controlled trial was conducted comparing tenofovir gel ( n = 445 women ) with placebo gel ( n = 444 women ) in sexually active , HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal , South Africa . HIV serostatus , safety , sexual behavior , and gel and condom use were assessed at monthly follow-up visits for 30 months . HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years ( person time of study observation ) ( 38 out of 680.6 women-years ) compared with 9.1 per 100 women-years ( 60 out of 660.7 women-years ) in the placebo gel arm ( incidence rate ratio = 0.61 ; P = 0.017 ) . In high adherers ( gel adherence > 80 % ) , HIV incidence was 54 % lower ( P = 0.025 ) in the tenofovir gel arm . In intermediate adherers ( gel adherence 50 to 80 % ) and
Output:
| Higher prevalences of oral and anal sex were reported among population s at high-risk for sexually transmitted infections and HIV and university students and , in most studies , both behaviours were more commonly reported by males than females .
Heterosexual oral and anal sexual acts were associated with some high-risk behaviours such as inconsistent condom use and multiple sexual partners .
Conclusion Reported oral and anal sex between men and women are prevalent behaviours in sub-Saharan Africa . |
MS210393 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objectives To compare the efficacy of two different regimens of mifepristone followed by misoprostol for medical abortion in women with menstrual delay of ≤ 35 days OBJECTIVE To examine the clinical efficacy of mifepristone 100 mg followed 2 days later by misoprostol 400 μg orally or 800 μg vaginally in women at up to 49 days ' gestation . METHODS Eighty participants received mifepristone 100 mg and then were r and omized to misoprostol , administered 48 hours later , at a dose of 400 μg orally ( group 1 ) or 800 μg vaginally ( group 2 ) . Women returned for follow‐up evaluations 24 ± 1 hour after using the misoprostol and then 2–3 weeks later . If abortion still had not occurred and the pregnancy was nonviable , the subject returned again after an additional 3 weeks . RESULTS Twenty‐four hours after receiving misoprostol , 34 ( 85 % ; 95 % confidence interval [ CI ] 71 % , 94 % ) of the 40 women in group 1 and 38 ( 95 % ; 95 % CI 85 % , 99 % ) of the 40 women in group 2 had complete abortions . Overall , complete abortion without surgical intervention occurred in 34 women in group 1 ( 85 % ; 95 % CI 71 % , 94 % ) and 40 women in group 2 ( 100 % ; 95 % CI 91 % , 100 % ; P = .03 ) . Four women in group 1 required suction aspiration for continuing pregnancy at the second follow‐up , compared with none in group 2 ( P = .12 ) . Side effects occurred with similar frequency in both treatment groups . CONCLUSION Low‐dose mifepristone ( 100 mg ) combined with vaginal misoprostol 800 μg may be an effective alternative to regimens using 200 or 600 mg of mifepristone with misoprostol Two doses , 200 and 400 micrograms , of misoprostol , administered vaginally every 12 hours , up to four times , were tested in 101 and 133 healthy women , respectively , for interruption of pregnancies with 35 through 77 days of amenorrhea . The proportion of women who aborted increased with longer duration of treatment and was significantly higher with 400 than with 200 micrograms ( 66 versus 46 percent at 48 hours ) . Significance was maintained after controlling by age , body weight , parity , previous abortion and gestational age . Abortions were classified as incomplete or complete , according to the presence or not of embryonic tissue in the uterine cavity , diagnosed by vaginal sonography . Vacuum aspiration was carried out in all cases not classified as complete abortion 48 hours after the initiation of treatment , or earlier in case of persistent bleeding or woman 's request . The possibility of increasing effectiveness by using higher dose , shorter intervals or longer duration of treatment is discussed Objectives To compare the efficacy of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate whether the efficacy can be improved and the duration of bleeding shortened by continuing oral misoprostol for one week The purpose of this study was to compare tamoxifen to methotrexate , with respect to effectiveness , when followed by misoprostol to induce abortion . In the first phase , 198 women presenting for medical abortion at < 7 weeks gestation were r and omized to receive either 40 mg of tamoxifen , followed 2 to 3 days later by 800 micrograms of misoprostol self-administered vaginally or 50 mg/m2 of methotrexate , followed 5 to 7 days later by the same dose of misoprostol . In the second phase , 200 women were r and omized to receive 20 mg tamoxifen twice daily for 4 days , followed by 800 micrograms misoprostol or the same regimen of methotrexate and misoprostol as in phase 1 . The main outcome measure was success rate determined by the number of women who aborted without surgery . In phase 1 , the success rate was higher in the methotrexate group ( 93.0 % ) compared to the tamoxifen group ( 85.7 % ) ( p = 0.045 ) . In the tamoxifen group , nine of 98 women had incomplete abortions with symptoms requiring a surgical aspiration , compared to one of 100 women in the methotrexate group . In phase 2 , the success rates were 90.9 % in the methotrexate group compared to 84.7 % in the tamoxifen group ( p = 0.20 ) . The side effects were less in the tamoxifen group in phase 1 but not in phase 2 . When tamoxifen is given as a single dose , it is less effective than methotrexate but when it is given 20 mg twice daily for 4 days , there is no significant difference . Tamoxifen does not appear to have any benefits over methotrexate OBJECTIVE To compare the efficacy and side-effects of mifepristone 75 mg in capsule form versus 150 mg in tablet form followed by misoprostol for medical termination of early pregnancy . STUDY DESIGN In a prospect i ve r and omized , double-blind , placebo-controlled trial , a total of 480 women who were 49 days or less pregnant were r and omized by means of a r and om number table to receive either two tablets in the morning and one tablet 12 h later for 2 days ( group A ) or three capsules orally twice daily for 2 days , the first dose being double all subsequent doses ( group B ) . After a further 48 h , 600 microg misoprostol was given orally . Successful abortion was defined as complete abortion with no need for surgical aspiration . RESULTS There were no significant differences between the two study groups in the rates of complete abortion ( 95.4 % in group A versus 96.3 % in group B ) , incomplete abortion ( 3.8 % in group A , 3.3 % in group B ) and continued pregnancy ( 0.8 % in group A , 0.4 % in group B ) . No significant difference in the duration and amount of vaginal bleeding was observed . The incidence of side-effects , such as vomiting , nausea , headache , diarrhea and lower abdominal pain was similar in the two groups . CONCLUSIONS Our results indicate that 75 mg mifepristone in capsule form combined with 600 microg misoprostol is as effective and safe as 150 mg mifepristone in tablet form for the termination of pregnancy up to 49 days OBJECTIVE Our purpose was to determine whether vaginal misoprostol 7 days rather than 3 days after methotrexate injection increases the percent of successful abortions on the day of misoprostol administration . STUDY DESIGN A r and omized controlled trial was performed in women requesting an abortion at < or = 56 days ' gestation . Eighty-six women were treated with methotrexate 50 mg/m2 intramuscularly followed 3 days ( group 1 ) or 7 days ( group 2 ) later by vaginal misoprostol 800 micrograms . The misoprostol dose was repeated if the abortion did not occur . RESULTS Complete abortion occurred in 38 of 46 ( 83 % ) patients in group 1 and 39 of 40 ( 98 % ) in group 2 ( p = 0.033 ) . Of the women with complete abortions , 30 of 46 ( 65 % ) in group 1 and 27 of 40 ( 68 % ) in group 2 aborted the same day as the first or second dose of misoprostol ( p = 0.823 ) . Vaginal bleeding lasted 14 + /- 5 ( mean + /- SD ) days in group 1 and 17 + /- 9 days in group 2 . The remaining women aborted after a delay of 24 + /- 6 days in group 1 and 28 + /- 13 days in group 2 . For these women vaginal bleeding lasted 18 + /- 17 and 14 + /- 7 days , respectively , and the human chorionic gonadotropin-beta level was < or = 25 IU/L by 22 + /- 7 days after the abortion in group 1 and 19 + /- 9 days in group 2 . Treatment failures in group 1 were four continuing pregnancies ( 9 % ) , two incomplete abortions ( 4 % ) , and two women who requested surgical termination after receiving both medications ( 4 % ) . The treatment failure in group 2 was an incomplete abortion . Methotrexate and misoprostol side effects were infrequent . CONCLUSIONS Methotrexate and vaginal misoprostol are more effective abortifacients when the misoprostol is given 7 days rather than 3 days after methotrexate . This treatment regimen may offer an alternative to surgical abortion or the use of antiprogestins and prostagl and in for medical abortion OBJECTIVE We investigated safety , efficacy , and acceptability of an oral regimen of medical abortion compared with surgical abortion in three developing countries . STUDY DESIGN Women ( n = 1373 ) with amenorrhea < or = 56 days chose either surgical abortion ( as provided routinely ) or 600 mg of mifepristone followed after 48 hours by 400 micrograms of misoprostol . This is the appropriate design for study ing safety , efficacy , and acceptability among women selecting medical abortion over available surgical services . RESULTS The medical regimen had more side effects , particularly bleeding , than did surgical abortion but very few serious side effects . Failure rates for medical abortion , although low , exceeded those for surgical abortion : 8.6 % versus 0.4 % ( China ) , 16.0 % versus 4.0 % ( Cuba ) , and 5.2 % versus 0 % ( India ) . Nearly half of failures among medical clients were not true drug failures , however , but surgical interventions not medically necessary ( acceptability failures or misdiagnoses ) . Women were satisfied with either method , but more preferred medical abortion . CONCLUSION Medical abortion can be safe , efficacious , and acceptable in developing countries Objective To examine the clinical efficacy of mifepristone 600 mg followed on the same day or two days later by misoprostol 400μg orally in women undergoing medical termination of pregnancy whose pregnancies have a gestational age up to 49 days OBJECTIVE : To study the efficacy , safety , and acceptability of oral immediately swallowed and buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days since the last menstrual period ( LMP ) . METHODS : This seven-site study r and omly assigned 966 women seeking abortions to oral or buccal misoprostol 800 mcg 24–36 hours after mifepristone 200 mg with 7–14-day follow-up . RESULTS : Success rates in the oral and buccal groups were 91.3 % ( 389 of 426 ) and 96.2 % ( 405 of 421 ) , respectively ( P=.003 ; relative risk [ RR ] 0.95 , 95 % confidence interval [ CI ] 0.92–0.98 ) . Ongoing pregnancy occurred in 3.5 % ( 15 of 426 ) of women who took oral misoprostol compared with 1.0 % ( 4 of 421 ) of women in the buccal group ( P=.012 ; RR 3.71 , 95 % CI 1.24–11.07 ) . Through 49 days since the LMP , oral and buccal regimens performed similarly , but success with oral misoprostol decreased as pregnancy advanced . In pregnancies of 57–63 days since the LMP , success with oral misoprostol fell below 90 % , whereas that with buccal remained high ( oral 85.1 % [ 97 of 114 ] , buccal 94.8 % [ 109 of 115 ] , P=.015 , RR 0.90 , 95 % CI 0.82–0.98 ) . Furthermore , in this gestational age group , there were significantly more ongoing pregnancies among women who took misoprostol orally ( 7.9 % [ 9 of 114 ] ) compared with buccally ( 1.7 % [ 2 of 115 ] ; P=.029 , RR 4.54 , 95 % CI 1.0–20.55 ) . Adverse effect profiles were similar , although fever and chills were reported approximately 10 % more often among women who took buccal misoprostol . Satisfaction and acceptability were high for both methods . CONCLUSION : Buccal misoprostol 800 mcg after mifepristone 200 mg is a good option for medical abortion through 63 days since the LMP . Oral misoprostol 800 mcg is also a safe and effective alternative , although success rates diminish with increasing gestational age . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT0
Output:
| Misoprostol administered orally is less effective ( more failures ) than the vaginal route ( RR 3.00 , 95 % CI 1.44 to 6.24 ) and may be associated with more frequent side effects such as nausea and diarrhoea .
5 ) There was no difference in effectiveness with use of a divided dose compared to a single dose of prostagl and in .
Safe and effective medical abortion methods are available .
Combined regimens are more effective than single agents .
In the combined regimen , the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness .
Vaginal misoprostol is more effective than oral administration , and has less side effects than sublingual or buccal . |
MS210394 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Study question Can treatment of the symptoms of uncomplicated urinary tract infection ( UTI ) with ibuprofen reduce the rate of antibiotic prescriptions without a significant increase in symptoms , recurrences , or complications ? Methods Women aged 18 - 65 with typical symptoms of UTI and without risk factors or complications were recruited in 42 German general practice s and r and omly assigned to treatment with a single dose of fosfomycin 3 g ( n=246 ; 243 analysed ) or ibuprofen 3 × 400 mg ( n=248 ; 241 analysed ) for three days ( and the respective placebo dummies in both groups ) . In both groups additional antibiotic treatment was subsequently prescribed as necessary for persistent , worsening , or recurrent symptoms . The primary endpoints were the number of all courses of antibiotic treatment on days 0 - 28 ( for UTI or other conditions ) and burden of symptoms on days 0 - 7 . The symptom score included dysuria , frequency/urgency , and low abdominal pain . Study answer and limitations The 248 women in the ibuprofen group received significantly fewer course of antibiotics , had a significantly higher total burden of symptoms , and more had pyelonephritis . Four serious adverse events occurred that lead to hospital referrals ; one of these was potentially related to the trial drug . Results have to be interpreted carefully as they might apply to women with mild to moderate symptoms rather than to all those with an uncomplicated UTI . What this paper adds Two thirds of women with uncomplicated UTI treated symptomatically with ibuprofen recovered without any antibiotics . Initial symptomatic treatment is a possible approach to be discussed with women willing to avoid immediate antibiotics and to accept a somewhat higher burden of symptoms . Funding , competing interests , data sharing German Federal Ministry of Education and Research ( BMBF ) No 01KG1105 . Patient level data are available from the corresponding author . Patient consent was not obtained but the data are anonymised and risk of identification is low . Trial registration No Clinical TrialGov Identifier NCT01488955 Background Uncomplicated lower urinary tract infections ( UTI ) are usually treated with antibiotics . However , there is little evidence for alternative therapeutic options . This pilot study was set out 1 ) to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution , and 2 ) to demonstrate the feasibility of a double-blind , r and omized controlled drug trial in German general practice s. Methods We performed a double-blind , r and omized controlled pilot trial in 29 German general practice s. Eighty otherwise healthy women aged 18 to 85 years , presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors , were r and omly assigned to receive either ibuprofen 3 × 400 mg oral or ciprofloxacin 2 × 250 mg ( + 1 placebo ) oral , both for three days . Intensity of main symptoms - dysuria , frequency , low abdominal pain - was recorded at inclusion and after 4 , 7 and 28 days , scoring each symptom from 0 ( none ) to 4 ( very strong ) . The primary endpoint was symptom resolution on Day 4 . Secondary outcomes were the burden of symptoms on Days 4 and 7 ( based on the sum score of all symptoms ) , symptom resolution on Day 7 and frequency of relapses . Equivalence margins for symptom burden on Day 4 were pre-specified as + /- 0.5 sum score points . Data analysis was done by intention to treat and per protocol . R and omization was carried out on patient level by computer programme in blocks of six . Results Seventy-nine patients were analyzed ( ibuprofen n = 40 , ciprofloxacin n = 39 ) . On Day 4 , 21/36 ( 58.3 % ) of patients in the ibuprofen-group were symptom-free versus 17/33 ( 51.5 % ) in the ciprofloxacin-group . On Day 4 , ibuprofen patients reported fewer symptoms in terms of total sum score ( 1 ; SD 1,42 ) than ciprofloxacin patients ( 1,3 ; SD 1,9 ) , difference -0,33 ( 95 % CI ( -1,13 to + 0,47 ) ) , PP ( per protocol ) analysis . During Days 0 and 9 , 12/36 ( 33 % ) of patients in the ibuprofen-group received secondary antibiotic treatment due to ongoing or worsening symptoms , compared to 6/33 ( 18 % ) in the ciprofloxacin-group ( non significant ) . A total of 58 non-serious adverse events were reported , 32 in the ibuprofen group versus 26 in the ciprofloxacin group ( non significant ) . Conclusions Our results support the assumption of non-inferiority of ibuprofen compared to ciprofloxacin for treatment of symptomatic uncomplicated UTI , but need confirmation by further trials . Trial registration Trial registration number : IS RCT N00470468See Commentary http://www.biomed central .com/1471 - Objectives To explore the views of women with urinary tract infection on the acceptability of different strategies for managing the infection , including delayed use of antibiotics , and the cause of infection . Design Qualitative interview study with semistructured one to one interviews within a r and omised controlled trial of different management strategies . Analysis drew on some of the principles of constant comparison to generate key themes grounded in reported experiences and underst and ings . Setting Seven general practice s across four counties in southern Engl and . Participants 21 women presenting to general practice s who were taking part in the larger trial . Results Women preferred not to take antibiotics and were open to alternative management approaches . With a strategy of “ antibiotic delay ” some women felt a lack of validation or that they were not listened to by their general practitioner . Women attributed urinary tract infection to lifestyle habits and behaviours , such as poor hygiene , general “ negligence , ” and even a “ penalty of growing old . ” Conclusion A clear acknowledgment of women ’s triggers to consult is needed . If women are asked to delay taking antibiotics , the clinician must address the particular worries that women might have and explain the rationale for not using antibiotics immediately OBJECTIVES To determine the clinical effectiveness and cost-effectiveness of topical mometasone in children with bilateral otitis media with effusion ( OME ) . DESIGN A double-blind r and omised placebo-controlled trial with an intention to treat analysis ; the 10.6 % of patients lost to follow-up at 1 month were censored in the analysis . SETTING 76 Medical Research Council General Practice Research Framework practice s throughout the UK between 2004 and 2007 . PARTICIPANTS A sample of 217 children aged 4 - 11 years was selected from those presenting to their GP with one or more episodes of otitis media or ear-related problems in the previous 12 months whom the research nurse confirmed had bilateral glue ear using microtympanometry ( B B or B C2 types using a modified Jerger classification ) at r and omisation . INTERVENTIONS Mometasone 50 micrograms in each nostril or placebo spray once daily for 3 months . MAIN OUTCOME MEASURES The primary outcome was the proportions of children cleared of OME assessed by tympanometry at 1 month . Secondary outcomes included clearance at 3 months and 9 months ; adverse events ; OM8 - 30 scores ( a functional health status responsive disease-specific measure ) ; hearing loss ; days with otalgia ; cost-effectiveness ; and health utilities . RESULTS Of the topical steroid group , 40.6 % ( 39/96 ) demonstrated tympanometric clearance ( C1 or A type ) in one or both ears at 1 month , compared with 44.9 % ( 44/98 ) of the placebo group . The absolute risk reduction at 1 month was -4.3 % ( 95 % CI -18.05 % to 9.26 % ) ; the odds ratio ( OR ) was 0.84 ( 95 % CI 0.48 to 1.48 ) . Four covariates were pre-specified for inclusion in logistic regression analysis : age as a continuous variable ( p = 0.94 ) , season ( p = 0.70 ) , atopy ( p = 0.61 ) and clinical severity ( p = 0.006 ) . The adjusted OR ( AOR ) at 1 month for the main outcome was 0.93 ( 95 % CI 0.50 to 1.75 ) . Secondary analysis at 3 months showed 58.1 % of the steroid group had resolved and 52.3 % of the placebo group , AOR 1.45 ( 95 % CI 0.74 to 2.84 ) . At 9 months 55.6 % of the treated group remained clear in at least one ear and 65.3 % of the placebo group , AOR 0.82 ( 95 % CI 0.39 to 1.75 ) . Adverse events ( although relatively minor ) occurred in 7 - 22 % of children and included nasal stinging , epistaxis , dry throat and cough . The OM8 - 30 scores ( p = 0.55 ) reported hearing difficulty ( p = 0.08 ) , and days with otalgia ( p = 0.46 ) were not significantly different between groups at 3 months . The economic evaluation found the active treatment arm to be dominated by placebo , accruing slightly ( but not significantly ) higher costs and fewer quality -adjusted life-years ( QALYs ) , with a 24.2 % probability that topical steroids are a cost-effective use of NHS re sources at a ceiling ratio of 20,000 pounds per QALY gained . CONCLUSIONS Use of topical intranasal corticosteroids is very unlikely to be a clinical ly effective treatment for OME ( glue ear ) in the primary care setting . TRIAL REGISTRATION Current Controlled Trials IS RCT N38988331 Purpose Non-steroidal anti-inflammatory drugs ( NSAIDs ) are frequently prescribed or used as self-medication in cases of community-acquired pneumonia ( CAP ) . Nevertheless , the consequences of such medication on the risk of pleuroparenchymal complications are not well known . The aim was to investigate whether exposure to NSAIDs prior to hospital admission among patients suffering from CAP is associated with the development of pleural complications or a lung abscess . Methods All consecutive non-immunocompromised patients with CAP and admitted to a university hospital were prospect ively included ( 2-year period ) . The risk of pleuropulmonary complications was analyzed according to previous exposure to NSAIDs . Results Of the 221 included patients , 40 ( 18.1 % ) had developed a pleuropulmonary complication . NSAIDs intake prior to admission was reported for 24 patients ( 10.9 % ) who were younger ( 50.6 ± 18.5 vs. 66.5 ± 16.4 years ; p = 0.001 ) , had less comorbidities ( 60 vs. 25.1 % ; p = 0.001 ) , had a longer duration between the first symptoms of CAP and the start of an antibiotic therapy ( 6.1 ± 7.6 vs. 2.8 ± 3.8 days ; p = 0.001 ) , and who had a higher incidence of pleuropulmonary complications ( 33.3 vs. 16.2 % ; p = 0.048 ) . In multivariate analyses , two factors were independently associated with the development of pleuroparenchymal complications : NSAIDs intake [ Odds Ratio ( OR ) = 2.57 [ 1.02–6.64 ] ; p = 0.049 ] and alcohol abuse ( OR = 2.68 [ 1.27–5.69 ] ; p = 0.01 ) . Conclusions Our findings suggest that NSAIDs , often taken by young and healthy patients , may worsen the course of CAP with delayed therapy and a higher rate of pleuropulmonary complications Background Women presenting with symptoms of acute uncomplicated urinary tract infection ( UTI ) are often prescribed antibiotics . However , in 25 to 50 % of symptomatic women not taking antibiotics , symptoms recover spontaneously within one week . It is not known how many women are prepared to delay antibiotic treatment . We investigated how many women presenting with UTI symptoms were willing to delay antibiotic treatment when asked by their general practitioner ( GP ) . Methods From 18 April 2006 until 8 October 2008 , in a prospect i ve cohort study , patients were recruited in 20 GP practice s in and around Amsterdam , the Netherl and s. Healthy , non-pregnant women who contacted their GP with painful and /or frequent micturition for no longer than seven days registered their symptoms and collected urine for urinalysis and culture . GPs were requested to ask all patients if they were willing to delay antibiotic treatment , without knowing the result of the culture at that moment . After seven days , patients reported whether their symptoms had improved and whether they had used any antibiotics . Results Of 176 women , 137 were asked by their GP to delay antibiotic treatment , of whom 37 % ( 51/137 ) were willing to delay . After one week , 55 % ( 28/51 ) of delaying women had not used antibiotics , of whom 71 % ( 20/28 ) reported clinical
Output:
| For the outcomes of symptom resolution and complications in adult women with UTI , evidence favors antibiotics over NSAIDs .
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MS210395 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In a cluster r and omized trial , Kojo Yeboah-Antwi and colleagues find that integrated management of malaria and pneumonia in children under five by community health workers is both feasible and effective Background In tropical Africa , where malaria is highly endemic , low grade infections are asymptomatic and the diagnosis of clinical malaria is usually based on parasite density . Here we investigate how changes in malaria control and endemicity modify diagnostic criteria of Plasmodium falciparum attacks . Methods and Findings Parasitological and clinical data from the population of Dielmo , Senegal , monitored during 20 years , are analyzed in a r and om-effect logistic regression model to investigate the relationship between the level of parasitemia and risk of fever . Between 1990 and 2010 , P. falciparum prevalence in asymptomatic persons declined from 85 % to 1 % in children 0–3 years and from 34 % to 2 % in adults ≥50 years . Thresholds levels of parasitemia for attributing fever episodes to malaria decreased by steps in relation to control policies . Using baseline threshold during following periods underestimated P. falciparum attacks by 9.8–20.2 % in children and 18.9–40.2 % in adults . Considering all fever episodes associated with malaria parasites as clinical attacks overestimated P. falciparum attacks by 42.2–68.5 % in children and 45.9–211.7 % in adults . Conclusions Malaria control modifies in all age-groups the threshold levels of parasitemia to be used for the assessment of malaria morbidity and to guide therapeutic decisions . Even under declining levels of malaria endemicity , the parasite density method must remain the reference method for distinguishing malaria from other causes of fever and assessing trends in the burden of malaria Objective In 2010 , the World Health Organization ( WHO ) published up date d guidelines emphasizing and exp and ing recommendations for a parasitological confirmation of malaria before treating with antimalarials . This study aim ed to assess differences in historic ( 2007–2008 ) ( cohort 1 ) and recent ( 2011–2012 ) ( cohort 2 ) hospital cohorts in the diagnosis and treatment of febrile illness in a low malaria prevalence area of northern Tanzania . Material s and Methods We analyzed data from two prospect i ve cohort studies that enrolled febrile adolescents and adults aged ≥13 years . All patients received quality -controlled aerobic blood cultures and malaria smears . We compared patients ' discharge diagnoses , treatments , and outcomes to assess changes in the treatment of malaria and bacterial infections . Results In total , 595 febrile in patients were enrolled from two referral hospitals in Moshi , Tanzania . Laboratory-confirmed malaria was detected in 13 ( 3.2 % ) of 402 patients in cohort 1 and 1 ( 0.5 % ) of 193 patients in cohort 2 ( p = 0.041 ) . Antimalarials were prescribed to 201 ( 51.7 % ) of 389 smear-negative patients in cohort 1 and 97 ( 50.5 % ) of 192 smear-negative patients in cohort 2 ( p = 0.794 ) . Bacteremia was diagnosed from st and ard blood culture in 58 ( 14.5 % ) of 401 patients in cohort 1 compared to 18 ( 9.5 % ) of 190 patients in cohort 2 ( p = 0.091 ) . In cohort 1 , 40 ( 69.0 % ) of 58 patients with a positive blood culture received antibacterials compared to 16 ( 88.9 % ) of 18 patients in cohort 2 ( p = 0.094 ) . In cohort 1 , 43 ( 10.8 % ) of the 399 patients with known outcomes died during hospitalization compared with 12 ( 6.2 % ) deaths among 193 patients in cohort 2 ( p = 0.073 ) . Discussion In a setting of low malaria transmission , a high proportion of smear-negative patients were diagnosed with malaria and treated with antimalarials despite up date d WHO guidelines on malaria treatment . Improved laboratory diagnostics for non-malaria febrile illness might help to curb this practice Background Early diagnosis and prompt , effective treatment of uncomplicated malaria is critical to prevent severe disease , death and malaria transmission . We assessed the impact of rapid malaria diagnostic tests ( RDTs ) by community health workers ( CHWs ) on provision of artemisinin-based combination therapy ( ACT ) and health outcome in fever patients . Methodology /Principal Findings Twenty-two CHWs from five villages in Kibaha District , a high-malaria transmission area in Coast Region , Tanzania , were trained to manage uncomplicated malaria using RDT aided diagnosis or clinical diagnosis ( CD ) only . Each CHW was r and omly assigned to use either RDT or CD the first week and thereafter alternating weekly . Primary outcome was provision of ACT and main secondary outcomes were referral rates and health status by days 3 and 7 . The CHWs enrolled 2930 fever patients during five months of whom 1988 ( 67.8 % ) presented within 24 hours of fever onset . ACT was provided to 775 of 1457 ( 53.2 % ) patients during RDT weeks and to 1422 of 1473 ( 96.5 % ) patients during CD weeks ( Odds Ratio ( OR ) 0.039 , 95 % CI 0.029–0.053 ) . The CHWs adhered to the RDT results in 1411 of 1457 ( 96.8 % , 95 % CI 95.8–97.6 ) patients . More patients were referred on inclusion day during RDT weeks ( 10.0 % ) compared to CD weeks ( 1.6 % ) . Referral during days 1–7 and perceived non-recovery on days 3 and 7 were also more common after RDT aided diagnosis . However , no fatal or severe malaria occurred among 682 patients in the RDT group who were not treated with ACT , supporting the safety of withholding ACT to RDT negative patients . Conclusions / Significance RDTs in the h and s of CHWs may safely improve early and well-targeted ACT treatment in malaria patients at community level in Africa . Trial registration Clinical Trials.gov Objectives Parasitological confirmation of malaria prior to treatment is recommended for patients of all ages , with malaria rapid diagnostic tests ( mRDTs ) an important tool to target artemisinin-based combination therapies ( ACTs ) to patients with malaria . To evaluate the impact on case management practice s of routine government implementation of mRDTs , we conducted large-scale health facility surveys in three regions of Tanzania before and after mRDT roll-out . Methods Febrile patients at r and omly selected health facilities were interviewed about care received at the facility , and blood sample s were collected for reference blood smears . Health facility staff were interviewed about their qualifications and availability of malaria diagnostics and drugs . Results The percentage of febrile patients tested for malaria at the facility increased from 15.8 % in 2010 to 54.9 % in 2012 . ACTs were obtained by 65.8 % of patients positive by reference blood smear in 2010 and by 50.2 % in 2012 ( P = 0.0675 ) ; no antimalarial was obtained by 57.8 % of malaria-negative patients in 2010 and by 82.3 % in 2012 ( P < 0.0001 ) . Overall , ACT use decreased ( 39.9–21.3 % , P < 0.0001 ) and antibiotic use increased ( 31.2–48.5 % , P < 0.0001 ) . Conclusion Roll-out of mRDTs in Tanzania dramatically improved diagnostic testing for malaria and reduced overuse of ACTs for patients without parasitemia . However , post – roll-out almost 50 % of febrile patients did not receive a diagnostic test , and almost 50 % of patients testing positive did not receive ACTs . Stock-outs of ACTs and mRDTs were important problems . Further investigation is needed to determine reasons for not providing ACTs to patients with malaria and potential for inappropriate antibiotic use Background Presumptive treatment of all febrile patients with anti-malarials leads to massive over-treatment . The aim was to assess the effect of implementing malaria rapid diagnostic tests ( m RDTs ) on prescription of anti-malarials in urban Tanzania . Methods The design was a prospect i ve collection of routine statistics from ledger books and cross-sectional surveys before and after intervention in r and omly selected health facilities ( HF ) in Dar es Salaam , Tanzania . The participants were all clinicians and their patients in the above health facilities . The intervention consisted of training and introduction of m RDTs in all three hospitals and in six HF . Three HF without m RDTs were selected as matched controls . The use of routine m RDT and treatment upon result was advised for all patients complaining of fever , including children under five years of age . The main outcome measures were : ( 1 ) anti-malarial consumption recorded from routine statistics in ledger books of all HF before and after intervention ; ( 2 ) anti-malarial prescription recorded during observed consultations in cross-sectional surveys conducted in all HF before and 18 months after m RDT implementation . Results Based on routine statistics , the amount of artemether-lumefantrine blisters used post-intervention was reduced by 68 % ( 95%CI 57 - 80 ) in intervention and 32 % ( 9 - 54 ) in control HF . For quinine vials , the reduction was 63 % ( 54 - 72 ) in intervention and an increase of 2.49 times ( 1.62 - 3.35 ) in control HF . Before- and -after cross-sectional surveys showed a similar decrease from 75 % to 20 % in the proportion of patients receiving anti-malarial treatment ( Risk ratio 0.23 , 95%CI 0.20 - 0.26 ) . The cluster r and omized analysis showed a considerable difference of anti-malarial prescription between intervention HF ( 22 % ) and control HF ( 60 % ) ( Risk ratio 0.30 , 95%CI 0.14 - 0.70 ) . Adherence to test result was excellent since only 7 % of negative patients received an anti-malarial . However , antibiotic prescription increased from 49 % before to 72 % after intervention ( Risk ratio 1.47 , 95%CI 1.37 - 1.59 ) . Conclusions Programmatic implementation of m RDTs in a moderately endemic area reduced drastically over-treatment with anti-malarials . Properly trained clinicians with adequate support complied with the recommendation of not treating patients with negative results . Implementation of m RDT should be integrated h and -in-h and with training on the management of other causes of fever to prevent irrational use of antibiotics Background Early diagnosis , as well as prompt and effective treatment of uncomplicated malaria , are essential components of the anti-malaria strategy in Madagascar to prevent severe malaria , reduce mortality and limit malaria transmission . The purpose of this study was to assess the performance of the malaria rapid diagnostic tests ( RDTs ) used by community health workers ( CHWs ) by comparing RDT results with two reference methods ( microscopy and Polymerase Chain Reaction , PCR ) . Methods Eight CHWs in two districts , each with a different level of endemic malaria transmission , were trained to use RDTs in the management of febrile children under five years of age . RDTs were performed by CHWs in all febrile children who consulted for fever . In parallel , retrospective parasitological diagnoses were made by microscopy and PCR . The results of these different diagnostic methods were analysed to evaluate the diagnostic performance of the RDTs administered by the CHWs . The stability of the RDTs stored by CHWs was also evaluated . Results Among 190 febrile children with suspected malaria who visited CHWs between February 2009 and February 2010 , 89.5 % were found to be positive for malaria parasites by PCR , 51.6 % were positive by microscopy and 55.8 % were positive by RDT . The performance accuracy of the RDTs used by CHWs in terms of sensitivity , specificity , positive and negative predictive values was greater than 85 % . Concordance between microscopy and RDT , estimated by the Kappa value was 0.83 ( 95 % CI : 0.75 - 0.91 ) . RDTs stored by CHWs for 24 months were capable of detecting Plasmodium falciparum in blood at a level of 200 parasites/μl . Conclusion Introduction of easy-to-use diagnostic tools , such as RDTs , at the community level appears to be an effective strategy for improving febrile patient management and for reducing excessive use of anti-malarial drugs Background Accurate and practical malaria diagnostics , such as immunochromatographic rapid diagnostic tests ( RDTs ) , have the potential to avert unnecessary treatments and save lives . Volunteer community health workers ( CHWs ) represent a potentially valuable human re source for exp and ing this technology to where it is most needed , remote rural communities in sub-Saharan Africa with limited health facilities and personnel . This study reports on a training programme for CHWs to incorporate RDTs into their management strategy for febrile children in the Democratic Republic of Congo , a tropical African setting ravaged by human conflict . Methods Prospect i ve cohort
Output:
| CHWs showed high adherence to test results , but in some studies a substantial group of RDT negatives received treatment .
High risk of bias was found for morbidity and mortality studies , therefore , effects on morbidity and mortality could not be estimated .
Uptake and acceptance by the community was high , however negative-tested patients did not always follow up referral advice .
RDT-based CCMm was found to be cost effective for the correct treatment of malaria in areas with low to medium malaria prevalence , but study design s were not optimal .
Discussion Trained CHWs can deliver high quality care for malaria using RDTs .
However , lower RDT specificity could lead to missed diagnoses of non-malarial causes of fever .
Integrated CCM may solve some of these issues . |
MS210396 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A prospect i ve , r and omized pilot study was undertaken to compare the efficacy of continuous versus intermittent ceftazidime in ICU patients with nosocomial pneumonia . Ceftazidime was administered either as a 3 g/day continuous infusion ( CI ) or an intermittent infusion ( II ) of 2 g every 8 h. In addition , all patients received concomitant once-daily tobramycin . The demographics of the evaluable patients ( n = 35 ) were similar between the groups : age ( years ) , CI 46 + /- 16 , II 56 + /- 20 ; Apache score , CI 14 + /- 4 , II 16 + /- 6 ; time ( days ) from admission to diagnosis , CI 9 + /- 6 , II 9 + /- 6 . Clinical efficacy , defined as cure/improvement was similar between groups [ n ( % ) , CI 16/17 ( 94 ) , II 15/18 ( 83 ) ] , while microbiological response was also comparable [ n ( % ) , CI 10/13 ( 76 ) , II 12/15 ( 80 ) ] . Minimal inhibitory concentrations ( MICs ) for all isolates were measured throughout the treatment course ; there was no development of resistance during therapy for either regimen . While limited clinical data exist , our results suggest that the use of ceftazidime by CI administration maintains clinical efficacy , optimizes the pharmacodynamic profile and uses less antibiotic compared with the st and ard 2 g every 8 h intermittent dosing regimen OBJECTIVES To compare the plasma and subcutaneous tissue concentration-time profiles of meropenem administered by intermittent bolus dosing or continuous infusion to critically ill patients with sepsis and without renal dysfunction , and to use population pharmacokinetic modelling and Monte Carlo simulations to assess the cumulative fraction of response ( CFR ) against Gram-negative pathogens likely to be encountered in critical care units . PATIENTS AND METHODS We r and omized 10 patients with sepsis to receive meropenem by intermittent bolus administration ( n = 5 ; 1 g 8 hourly ) or an equal dose administered by continuous infusion ( n = 5 ) . Serial subcutaneous tissue concentrations were determined using microdialysis and compared with plasma data for first-dose and steady-state pharmacokinetics . Population pharmacokinetic modelling of plasma data and Monte Carlo simulations were then undertaken with NONMEM . RESULTS It was found that continuous infusion maintains higher median trough concentrations , in both plasma ( intermittent bolus 0 versus infusion 7 mg/L ) and subcutaneous tissue ( 0 versus 4 mg/L ) . All simulated intermittent bolus , extended and continuous infusion dosing achieved 100 % of pharmacodynamic targets against most Gram-negative pathogens . Superior obtainment of pharmacodynamic targets was achieved using administration by extended or continuous infusion against less susceptible Pseudomonas aeruginosa and Acinetobacter species . CONCLUSIONS This is the first study to compare the relative concentration-time data of bolus and continuous administration of meropenem at the subcutaneous tissue and plasma levels . We found that the administration of meropenem by continuous infusion maintains higher concentrations in subcutaneous tissue and plasma than by intermittent bolus dosing . Administration by extended or continuous infusion will achieve superior CFR against less-susceptible organisms in patients without renal dysfunction The extreme pharmacokinetic behaviour of drugs sometimes observed in critically ill patients poses a significant threat to the achievement of optimal antibiotic treatment outcomes . Scant information on beta-lactam antibiotic therapeutic drug monitoring ( TDM ) is available . The objective of this prospect i ve study was to evaluate the practicality and utility of a beta-lactam TDM programme in critically ill patients . TDM was performed twice weekly on all eligible patients at a 30-bed tertiary referral critical care unit . Blood concentrations were determined by fast-throughput high-performance liquid chromatography ( HPLC ) assays and were available within 12h of sampling . Dose adjustment was instituted if the trough or steady-state blood concentration was below 4 - 5x the minimum inhibitory concentration ( MIC ) or above 10x MIC . A total of 236 patients were subject to TDM over an 11-month period . The mean+/-st and ard deviation age was 53.5+/-18.3 years . Dose adjustment was required in 175 ( 74.2 % ) of the patients , with 119 of these patients ( 50.4 % ) requiring dose increases after the first TDM . For outcome of therapy , 206 ( 87.3 % ) courses result ed in a positive treatment outcome and there were 30 ( 12.7 % ) treatment failures observed including 14 deaths and 15 courses requiring escalation to broader-spectrum agents ; 1 course was ceased due to an adverse drug reaction . Using binomial logistic regression , only an elevated Acute Physiology and Chronic Health Evaluation ( APACHE ) II score ( P<0.01 ) and elevated plasma creatinine concentration ( P=0.05 ) were found to be predictive of mortality . In conclusion , further research is required to determine definitively whether achievement of optimal beta-lactam pharmacodynamic targets improves clinical outcomes Introduction Meropenem bactericidal activity depends on the time when the free drug concentrations remain above the minimum inhibitory concentration of pathogens . The goal of this study was to compare clinical and bacteriological efficacy of continuous meropenem infusion versus bolus administration in critically ill patients with severe infection , and to evaluate the safety of both dosing regimens . Methods Patients admitted to the interdisciplinary Intensive Care Unit ( ICU ) who suffered from severe infections and received meropenem were r and omized either in the Infusion group ( n = 120 ) or in the Bolus group ( n = 120 ) . Patients in the Infusion group received a loading dose of 2 g of meropenem followed by a continuous infusion of 4 g of meropenem over 24 hours . Patients in the Bolus group were given 2 g of meropenem over 30 minutes every 8 hours . Clinical and microbiological outcome , safety , meropenem-related length of ICU and hospital stay , meropenem-related length of mechanical ventilation , duration of meropenem treatment , total dose of meropenem , and ICU and in-hospital mortality were assessed . Results Clinical cure at the end of meropenem therapy was comparable between both groups ( 83.0 % patients in the Infusion vs. 75.0 % patients in the Bolus group ; P = 0.180 ) . Microbiological success rate was higher in the Infusion group as opposed to the Bolus group ( 90.6 % vs. 78.4 % ; P = 0.020 ) . Multivariate logistic regression identified continuous administration of meropenem as an independent predictor of microbiological success ( OR = 2.977 ; 95 % CI = 1.050 to 8.443 ; P = 0.040 ) . Meropenem-related ICU stay was shorter in the Infusion group compared to the Bolus group ( 10 ( 7 to 14 ) days vs. 12 ( 7 to 19 ) days ; P = 0.044 ) as well as shorter duration of meropenem therapy ( 7 ( 6 to 8) days vs. 8 ( 7 to 10 ) days ; P = 0.035 ) and lower total dose of meropenem ( 24 ( 21 to 32 ) grams vs. 48 ( 42 to 60 ) grams ; P < 0.0001 ) . No severe adverse events related to meropenem administration in either group were observed . Conclusions Continuous infusion of meropenem is safe and , in comparison with higher intermittent dosage , provides equal clinical outcome , generates superior bacteriological efficacy and offers encouraging alternative of antimicrobial therapy in critically ill patients Introduction Cefepime has been associated with a greater risk of mortality than other beta-lactams in patients treated for severe sepsis . Hypotheses for this failure include possible hidden side-effects ( for example , neurological ) or inappropriate pharmacokinetic/pharmacodynamic ( PK/PD ) parameters for bacteria with cefepime minimal inhibitory concentrations ( MIC ) at the highest limits of susceptibility ( 8 mg/l ) or intermediate-resistance ( 16 mg/l ) for pathogens such as Enterobacteriaceae , Pseudomonas aeruginosa and Staphylococcus aureus . We examined these issues in a prospect i ve non-interventional study of 21 consecutive intensive care unit ( ICU ) adult patients treated with cefepime for nosocomial pneumonia . Methods Patients ( median age 55.1 years , range 21.8 to 81.2 ) received intravenous cefepime at 2 g every 12 hours for creatinine clearance ( CLCr ) ≥ 50 ml/min , and 2 g every 24 hours or 36 hours for CLCr < 50 ml/minute . Cefepime plasma concentrations were determined at several time-points before and after drug administration by high-pressure liquid chromatography . PK/PD parameters were computed by st and ard non-compartmental analysis . Results Seventeen first-doses and 11 steady states ( that is , four to six days after the first dose ) were measured . Plasma levels varied greatly between individuals , from two- to three-fold at peak-concentrations to up to 40-fold at trough-concentrations . Nineteen out of 21 ( 90 % ) patients had PK/PD parameters comparable to literature values . Twenty-one of 21 ( 100 % ) patients had appropriate duration of cefepime concentrations above the MIC ( T > MIC ≥ 50 % ) for the pathogens recovered in this study ( MIC ≤ 4 mg/l ) , but only 45 to 65 % of them had appropriate coverage for potential pathogens with cefepime MIC ≥ 8 mg/l . Moreover , 2/21 ( 10 % ) patients with renal impairment ( CLCr < 30 ml/minute ) demonstrated accumulation of cefepime in the plasma ( trough concentrations of 20 to 30 mg/l ) in spite of dosage adjustment . Both had symptoms compatible with non-convulsive epilepsy ( confusion and muscle jerks ) that were not attributed to cefepime-toxicity until plasma levels were disclosed to the caretakers and symptoms resolved promptly after drug arrest . Conclusions These empirical results confirm the suspected risks of hidden side-effects and inappropriate PK/PD parameters ( for pathogens with upper-limit MICs ) in a population of ICU adult patients . Moreover , it identifies a safety and efficacy window for cefepime doses of 2 g every 12 hours in patients with a CLCr ≥ 50 ml/minute infected by pathogens with cefepime MICs ≤ 4 mg/l . On the other h and , prompt monitoring of cefepime plasma levels should be considered in case of lower CLCr or greater MICs ABSTRACT The pharmacokinetics of imipenem were studied in adult intensive care unit ( ICU ) patients during continuous venovenous hemofiltration ( CVVH ; n = 6 patients ) or hemodiafiltration ( CVVHDF ; n = 6 patients ) . Patients ( mean ± st and ard deviation age , 50.9 ± 15.9 years ; weight , 98.5 ± 15.9 kg ) received imipenem at 0.5 g every 8 to 12 h ( total daily doses of 1 to 1.5 g/day ) by intravenous infusion over 30 min . Pre- and postmembrane blood ( plasma ) and corresponding ultrafiltrate or dialysate sample s were collected 1 , 2 , 4 , and 8 or 12 h ( depending on dosing interval ) after completion of the drug infusion . Drug concentrations were measured using vali date d high-performance liquid chromatography methods . Mean systemic clearance ( CLS ) and elimination half-life ( t1/2 ) of imipenem were 145 ± 18 ml/min and 2.7 ± 1.3 h during CVVH versus 178 ± 18 ml/min and 2.6 ± 1.6 h during CVVHDF , respectively . Imipenem clearance was substantially increased during both CVVH and CVVHDF , with membrane clearance representing 25 % and 32 % of CLS , respectively . The results of this study indicate that CVVH and CVVHDF contribute to imipenem clearance to a greater degree than previously reported . Imipenem doses of 1.0 g/day appear to achieve concentrations adequate to treat most common gram-negative pathogens ( MIC up to 2 μg/ml ) during CVVH or CVVHDF , but doses of 2.0 g/day or more may be required to adequately treat and prevent resistance in pathogens with higher MICs ( MIC = 4 to 8 μg/ml ) . Higher doses should only be used after consideration of potential central nervous system toxicities or other risks of therapy in these severely ill patients BACKGROUND Beta-lactam antibiotics are a commonly used treatment for severe sepsis , with intermittent bolus dosing st and ard therapy , despite a strong theoretical rationale for continuous administration . The aim of this trial was to determine the clinical and pharmacokinetic differences between continuous and intermittent dosing in patients with severe sepsis . METHODS This was a prospect i ve , double-blind , r and omized
Output:
| Conclusions Pooled results from small RCTs suggest reduced clinical failure rates and intensive care unit length-of-stay when using continuous/extended infusions of antibiotics in critically ill patients .
Reduced mortality rates almost achieved statistical significance when the results of RCTs were combined with cohort studies .
These results support the conduct of adequately powered RCTs to define better the utility of continuous/extended infusions in the era of antibiotic resistance |
MS210397 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objectives To describe the association between religion and factors related to sexually transmitted diseases (STD)/AIDS in a country where religious leaders were involved early in prevention . Design A cross-sectional study conducted in a rural area in central Senegal . Methods Question naire-based interviews of a r and om sample of 858 adults from the general population aged 15–59 years and in-depth interviews of four religious leaders and 50 people . Results Seventy-six per cent of the respondents were Muslim , 24 % Catholic , 1 % Animist and 0.2 % Protestant . A total of 86 % of men and 87 % of women reported religion to be very important to them . Important prevention-related variables were inversely associated with the importance of religion . Men who considered religion to be very important were less likely to cite AIDS as a major health problem [ odds ratio ( OR ) 0.4 , P = 0.008 ] and were less likely to feel at risk of getting HIV ( OR 0.5 , P = 0.0005 ) . Women who considered religion to be very important were less likely to report an intention to change to protect themselves from AIDS ( OR 0.2 , P = 0.0001 ) , less likely to report having discussed AIDS with others ( OR 0.4 , P = 0.01 ) and much more likely to feel at risk of getting HIV ( OR 9.3 , P = 10−4 ) . Individuals who considered religion to be very important were not more likely to report intending to or actually having become faithful to protect themselves from AIDS . Conclusion These findings stress the need to intensify the involvement of religious authorities in HIV/STD prevention at the local level Environmental influences on sexual behavior are difficult to examine given their temporal distance from the sexual act and the cost of long-term longitudinal studies . We examined environmental influences on risky sexual behavior in young gay men using the Situational Presentation ( Sitpres ) methodology , where situations in which relevant environmental variables are presented as computer vignettes with the variables r and omly allocated , and participants rate the likelihood of their engaging in unsafe sexual behavior . A total of 100 gay men aged between 18 and 26 years of age completed 20 situational presentations with the outcome being the likelihood of engaging in unprotected anal intercourse . On regression analysis , 3 environmental variables significantly predicted safer sex : perceived gay/bisexual men 's norms toward condom use ; availability of HIV prevention messages ; and what one 's religion says about gay sex . Not significant were family , media , legal , and work/school attitudes to homosexuality . Demographic variables that were predictors included education , age , sexual orientation , and degree of being “ out ” about sexual orientation . These data suggest that environmental factors can be approximated using the Sitpres methodology , and that more proximal environmental variables have a stronger impact than distal ones Abstract This paper reports on an exploratory study investigating links between sexual health and social capital in a South African mining community . In this study , social capital is defined in terms of people 's membership of voluntary community organizations ( e.g. church , residents ' associations , youth groups ) . Using biomedical and social survey data from a stratified r and om sample of 1,211 Carletonville residents , we tested the hypothesis that organizational members were less likely to have HIV . Multivariate analysis of variance sought to identify significant associations between nine organizational memberships and HIV infection , as well as three risk factors for infection ( casual partners , condom use with casual partners and alcohol consumption ) . Analysis yielded a range of significant results , but findings varied across age and gender , and were not all in the hypothesized direction . For example , young men and young women who belonged to sports clubs were less likely to be HIV-positive , and young women who belonged to sports clubs were more likely to use condoms with casual partners than non-members . Amongst members of stokvels ( voluntary savings clubs accompanied by social festivities ) , however , young men were more likely to be HIV-positive , women of all ages were more likely to have a casual partner , and both young men and young women were more likely to drink alcohol than non-members . While our exploratory study has produced sufficient evidence to justify the need for further research in this area , it also highlights that the interface between HIV infection and social capital is a complex area that defies easy generalization Objective To study in depth sexual history and sexual behaviour variables as risk factors for HIV-1 infection in a rural Ug and an population . Methods Following a socioeconomic and serological survey of a rural population in Masaka District , south-west Ug and a , 233 r and omly selected HIV-1-positive cases and 233 negative controls matched on age and village of residence , were invited in October 1990 to participate in a case-control study . A total of 132 cases and 161 controls attended for in-depth investigation including an interview about sexual behaviour . Results The factor most strongly associated with increased risk of infection was a greater number of lifetime sexual partners , with odds ratios ( OR ) of 2.1 and 4.9 for those reporting 4–10 and 11 or more partners , respectively , compared with those reporting less than four partners . Having only one sexual partner did not provide complete protection , a total of seven ( one male , six female ) subjects reporting only one sexual partner were HIV-1-positive . Other significant factors were a history of genital ulcers |OR , 2.9 ; 95 % confidence intervals ( CI ) , 1.0–9.1 ) and not being a Muslim ( OR , 5.4 ; 95 % Cl , 1.8–16.5 ) suggesting a possible protective effect of circumcision . There was a suggestion that those who married within the last 7 years ( OR , 2.4 ; 95 % Cl , 0.9–6.1 ) and men exposed to menstrual blood ( OR , 5.7 ; 95 % Cl , 0.7–49.8 ) were at an increased risk of HIV-1 infection . Conclusions These results confirm the predominant role of sexual behaviour in the HIV-1 epidemic . Of particular concern is the observation of HIV-1 infection among those reporting only one partner . Where HIV-1 infection is widely distributed in the general population , risk reduction strategies should , in addition to the promotion of partner reduction , place strong emphasis on safe-sex techniques Whereas college students are not identified as a high-risk group for acquiring the HIV infection , they exhibit high-risk behaviors consistent with their age group , including multiple sexual partners and high rates of unprotected intercourse . This study was conducted to determine levels of HIV-related sexual behavior , along with knowledge and attitudes among students attending community colleges in a relatively affluent multiethnic community . This study used a r and om sample survey ( N = 319 ) of students attending selected classes at four community colleges in Orange County , California , to assess HIV/AIDS knowledge , attitudes , and patterns of past and present sexual behavior . The level of student knowledge concerning HIV disease was found to be relatively high , and pronounced differences in knowledge and sexual permissiveness were identified as a function of ethnicity and religion , with Asians showing lower knowledge and lower concern about HIV , and religion/religiosity related to these variables and also to levels of sexual permissiveness . Respondents ' comfort in asking a partner about his/her sexual history was positively associated with their level of self-esteem , and negatively related to peer pressure in this population . As in previous studies of college population s , HIV knowledge per se does not confer a protective effect against high-risk behavior . However , knowledge was found to be an enabling factor with regard to students ' comfort levels in asking about their partner 's sexual histories , and in requesting that partners take an AIDS test This study set out to investigate the influence of male circumcision and other factors on sexually transmitted infections in Botswana . A syndromic approach , which diagnoses a sexually transmitted infection based on the presence of urethral discharge or genital ulcers rather than on laboratory tests , was used . The data were from the 2001 Botswana AIDS Impact Survey where a nationally representative , r and omly selected sample of men and women aged 10 - 64 years were interviewed in both urban and rural areas . The sample selected for this study consisted of 216,480 men aged 15 - 64 years who had ever had sexual intercourse . The logistic regression technique was executed to examine the association between male circumcision and self-reported urethral discharge or genital ulcers , while controlling for all other independent variables in the analysis . The main finding of this study was that among men who are circumcised , the odds for self-reported urethral discharge or genital ulcers are significantly lower than for those men who are not circumcised in both urban and rural Botswana . The analysis also showed that the odds in favour of self-reported urethral discharge or genital ulcers , for men who drink alcohol , are twice as large as those for men who do not drink alcohol , controlling for all other independent variables in the analysis . Religion and ethnicity also came through as factors exerting a protective influence against self-reported symptoms of sexually transmitted infections . The conclusion is that while male circumcision appears to be significantly associated with the risk for self-reported urethral discharge or genital ulcers , it is man 's behaviour , irrespective of ethnicity or religious dictates , that continues to play a vital role in protection against self-reported symptoms of sexually transmitted infections in Botswana In view of the developmental approach to sexual behavior , this article presents the stages of sexual behavior leading to coitus in four grade s of high school students in Israel and the sociodemographic factors associated with initiating coitus . Analyses were based on data from the first national study dealing comprehensively with sexuality in 30 years . A self-administered question naire was completed by a r and om sample of 4,609 students of the General Educational ( secular ) system that included 68 % of the Hebrew-speaking sector or 55 % of all students in Israel . Our findings indicated a progressive set of stages of sexual behavior forming a Guttman scale , from kissing and petting over the clothes though petting under the clothes and genital touching to coitus . In comparison to results of a 1970 Israeli survey , we found an increase in practice in all Guttman scale stages of sexual behavior , as well as a diminished gap between genders . The gap fully disappeared in the three lower stages . Predictive variables of coitus initiation included gender , religiosity , immigration status , family structure , perceptions of academic achievements , and the proportion of peers practicing coitus . In addition to gender , perception of the proportion of peers that already practice d intercourse was the best predictor followed by grade , perception of academic achievement , and family structure . Marked differences were noticed between genders regarding associations with religiosity and immigration status . The discussion focused on comparisons to findings in other countries , the contribution of the findings to the underst and ing of Israeli adolescents ’ sexual behavior , and practical educational implication OBJECTIVES To assess differences in sexual health behaviors , outcomes , and potential sociocultural determinants among male college students in the United States and the Netherl and s. METHODS Survey data were collected from r and om sample s of students from both national cultures . RESULTS American men were more likely to report inadequate contraception , HIV/STD infection , and unintended pregnancy than were Dutch men . Religiosity and sexuality education were able to explain national differences in these sexual health outcomes . CONCLUSIONS Findings suggest that sexuality education seems to decrease , rather than increase , sexual risk in heterosexually active male college students Background The risk factors for sexually transmitted diseases ( STDs ) and having casual sex among the Chinese people are unknown . Goal The goal of the study was to estimate the prevalence of STDs and to develop a profile of risk behavior among patients attending STD clinics in Hong Kong . Study Design In a clinic-based , cross-sectional study , 448 patients attending two government STD clinics were r and omly sample d and interviewed by means of a structured question naire . Results The prevalence of STDs was 51 % ( 70 % of men and 35 % of women ) . Attendees who had STDs diagnosed were more likely to be male , never married , and smokers and alcohol users ( ever ) and to have had casual sex or sex during travel with someone not their usual partner . Those who did not always use condoms were more likely to be male and never married . Having had casual sex was reported by 63 % of the respondents . Those who reported having had casual sexual encounters were more likely to have the following characteristics : male ; never married ; no religious belief ; ever smoker and alcohol user ; current STD ; had sex during travel ; history of STD ; inconsistent condom user ; and perception of being at low risk for STD . After adjustment , only male gender was associated with casual sexual encounters . Conclusion The results of this study indicated several risk factors among Chinese patients for the acquisition of STDs , for not using condoms , and for having casual sex . This information is useful in strengthening and evaluating currently available STD prevention and control strategies for the Chinese population in Hong Kong and elsewhere Background : Data from sentinel serosurveillance are useful to estimate HIV infection in population s but may not be representative of the general population . General population ‐based surveys attempt to avoid selection bias and are the most appropriate for tracking changes in exposure to risk of HIV infection over time and assessing changes in behavior following prevention campaigns . Objectives : To provide baseline data for targeted sexually transmitted infection ( STI ) and HIV infection prevention interventions by study ing parameters of sexual behavior and knowledge of HIV infection and STIs , measuring health‐seeking behavior related to STIs , and measuring gonorrhea , Chlamydia , syphilis , and HIV‐1 prevalences . Design : Population ‐based survey with stratified sampling by age group from r and omly selected households in a suburb of Mombasa , Kenya . Methods : A st and ard question naire was administered to 1497 consenting adults between the ages of 15 and 49 years who lived in r and omly selected households . Urine and blood sample s were obtained for the estimation of gonorrhea , chlamydial infection , syphilis , and HIV‐1 infection prevalences . Results : Sexual activity in the past 12 months was limited to one
Output:
| This finding persists but is weaker when the outcome considered is condom use . |
MS210398 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To compare the safety and efficacy of three doses of acarbose ( 100 , 200 , and 300 mg three times daily ) with placebo for the treatment of non-insulin-dependent diabetes mellitus ( NIDDM ) in patients maintained on dietary therapy alone . RESEARCH DESIGN AND METHODS This multicenter double-blind placebo-controlled trial was 22 weeks in duration . The trial consisted of a 2-week screening period , a 4-week placebo run-in period , and a 16-week double-blind treatment period . The primary measure of drug efficacy was the mean change from baseline in HbA1c levels . Additional efficacy variables included the mean change from baseline in fasting and postpr and ial plasma glucose and serum insulin levels . RESULTS After 16 weeks of treatment , acarbose-treated patients had statistically significant reductions in mean HbA1c levels of 0.78 , 0.73 , and 1.10 % ( relative to placebo ) in the 100- , 200- , and 300-mg t.i.d . groups , respectively . Significant reductions in fasting and postpr and ial plasma glucose levels , glucose area under the time-concentration curve , and maximum glucose concentration were also observed in acarbose-treated patients . Although there were no statistically significant differences among the 100- , 200- , and 300-mg treatment groups , there was a trend toward a dose-response relationship for most plasma glucose variables that were measured . Gastrointestinal side effects ( e.g. , abdominal pain , flatulence , and diarrhea ) and serum transaminase elevations ( e.g. , aspartate aminotransferase [ AST ] and alanine aminotransferase [ ALT ] were more frequently reported in the acarbose-treated patients than in the placebo-treated control patients . Transaminase elevations occurred only at the 200- , and 300-mg dosages and were readily reversible on discontinuation of treatment . CONCLUSIONS Acarbose at doses of 100 , 200 , and 300 mg administered three times daily for 16 weeks significantly reduced HbA1c levels and postpr and ial hyperglycemia . Treatment with acarbose is a safe and effective adjunct to dietary therapy for the treatment of NIDDM Summary The effect of acarbose , an alpha-glucosidase inhibitor , on glycaemic control , was compared with placebo in a double-blind , r and omised , group comparison study during 16 weeks in 20 non-obese non-insulin dependent diabetic patients in whom sulphonylurea treatment had been withdrawn . There was significant deterioration in glycaemic control as assessed by HbA1 following withdrawal of the sulphonylurea . There was no significant improvement in HbA1 between weeks 0 and 16 in either the acarbose ( 11.3 % and 12.4 % respectively ) or the placebo group ( 10.6 % and 12.2 % respectively ) . In both the acarbose and placebo treated groups fasting glucose and insulin concentrations were unaltered . This study also suggests that acarbose was not an effective substitute for sulphonylureas in non-obese Type 2 diabetes uncontrolled by diet alone CONTEXT The worldwide explosive increase in type 2 diabetes mellitus and its cardiovascular morbidity are becoming major health concerns . OBJECTIVE To evaluate the effect of decreasing postpr and ial hyperglycemia with acarbose , an alpha-glucosidase inhibitor , on the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance ( IGT ) . DESIGN , SETTING , AND PARTICIPANTS International , multicenter double-blind , placebo-controlled , r and omized trial , undertaken in hospitals in Canada , Germany , Austria , Norway , Denmark , Sweden , Finl and , Israel , and Spain from July 1998 through August 2001 . A total of 1429 patients with IGT were r and omized with 61 patients ( 4 % ) excluded because they did not have IGT or had no postr and omization data , leaving 1368 patients for a modified intent-to-treat analysis . Both men ( 49 % ) and women ( 51 % ) participated with a mean ( SD ) age of 54.5 ( 7.9 ) years and body mass index of 30.9 ( 4.2 ) . These patients were followed up for a mean ( SD ) of 3.3 ( 1.2 ) years . INTERVENTION Patients with IGT were r and omized to receive either placebo ( n = 715 ) or 100 mg of acarbose 3 times a day ( n = 714 ) . MAIN OUTCOME MEASURES The development of major cardiovascular events ( coronary heart disease , cardiovascular death , congestive heart failure , cerebrovascular event , and peripheral vascular disease ) and hypertension ( > or = 140/90 mm Hg ) . RESULTS Three hundred forty-one patients ( 24 % ) discontinued their participation prematurely , 211 in the acarbose-treated group and 130 in the placebo group ; these patients were also followed up for outcome parameters . Decreasing postpr and ial hyperglycemia with acarbose was associated with a 49 % relative risk reduction in the development of cardiovascular events ( hazard ratio [ HR ] , 0.51 ; 95 % confidence interval [ CI ] ; 0.28 - 0.95 ; P = .03 ) and a 2.5 % absolute risk reduction . Among cardiovascular events , the major reduction was in the risk of myocardial infa rct ion ( HR , 0.09 ; 95 % CI , 0.01 - 0.72 ; P = .02 ) . Acarbose was also associated with a 34 % relative risk reduction in the incidence of new cases of hypertension ( HR , 0.66 ; 95 % CI , 0.49 - 0.89 ; P = .006 ) and a 5.3 % absolute risk reduction . Even after adjusting for major risk factors , the reduction in the risk of cardiovascular events ( HR , 0.47 ; 95 % CI , 0.24 - 0.90 ; P = .02 ) and hypertension ( HR , 0.62 ; 95 % CI , 0.45 - 0.86 ; P = .004 ) associated with acarbose treatment was still statistically significant . CONCLUSION This study suggests that treating IGT patients with acarbose is associated with a significant reduction in the risk of cardiovascular disease and hypertension BACKGROUND Acarbose is an oral antidiabetic mainly acting on postpr and ial blood glucose , inhibiting alphaglucosidase . Through this mechanism , it could improve the peripheral insulin sensitivity and /or increase the insulin secretion . The aim of the present study is to assess the therapeutic efficacy of Acarbose in obese type 2 diabetic patients on both insulin resistance and insulin secretion . METHODS 17 obese non insulin-dependent diabetic patients , well controlled with diet alone were r and omized into 2 groups : acarbose ( 2 x 50 mg ) or placebo during 16 weeks . A glucagon test allowed to evaluate insulin secretion before and after treatment as well as a triple test ( glucose-insulin-somatostatin ) with indirect calorimetry allowed to evaluate insulin sensitivity . RESULTS A significant improvement in post-pr and ial plasma glucose was detected only in the Acarbose group ( 8.0 + /- 0.5 mmol/l before vs 6.5 0.5 mmol/l after , p<0.05 ) . Basal C-peptide secretion was similar between groups and remained unchanged after treatment . However , stimulated insulin secretion was significantly increased by 30 % , p<0.05 , in the Acarbose group while no change was detected in the placebo group . Interestingly , the group receiving Acarbose disclosed a 15 % reduction in insulin resistance ( 15.0 + /- 1.8 mmol/l before vs 12.8 + /- 1.4 mmol/l after ) . CONCLUSIONS Our results show that a treatment with Acarbose is efficient even in diabetic patients presenting a good glucose control without any other associated treatment . By decreasing post-pr and ial blood glucose , acarbose improves both insulin sensitivity and secretion Water-extracted Touchi , a traditional Chinese food , exerts a strong inhibitory activity against rat intestinal alpha-glucosidase in foodstuffs , and Touchi-extract ( TE ) has been shown to have an antihyperglycemic effect in rats and humans after a single oral administration . In the present complementary study , the effects of powdered Houji-tea with or without ( placebo ) TE , a formula design ed to enhance good compliance , were monitored in a 3-mo double-blind r and omized group comparison study with placebo controls in humans with borderline and mild type-2 diabetes ( n = 36 ) . All subjects ingested Houji-tea with or without 0.3 g of TE before each of three meals per day for 3 mo . In the TE group , initial fasting blood glucose ( 6.9 + /- 0.1 mmol/L ) and glycated hemoglobin ( HbA(1c ) ; 6.1 + /- 0.1 % ) levels gradually decreased ; fasting blood glucose decreased significantly after 3 mo ( 6.4 + /- 0.3 mmol/L ; P < 0.05 ) as did HbA(1c ) ( 5.6 + /- 0.2 % ; P < 0.01 ) levels at 2 mo postingestion of TE and thereafter . In contrast , fasting blood glucose and HbA(1c ) levels did not change in the placebo group . In this study , other biochemical variables were not affected in any of the subjects , and no one complained of any side effects or abdominal distension . Moreover , there was no deterioration as assessed by fasting blood glucose and HbA(1c ) levels after withdrawal of TE ingestion . Thus , the alpha-glucosidase inhibitory TE demonstrated an antihyperglycemic effect and may prove useful for improving glycemic control in subjects suffering from borderline and type-2 diabetes mellitus The efficacy of the new intestinal alpha-glucosidase inhibitor , miglitol , and glibenclamide were compared in a 6-month double-blind controlled protocol involving 100 non-insulin dependent diabetic patients under diet alone . HbA1c levels ( initially between 7 and 11 % ) were reduced ( p < 0.05 ) : -0.78 + /- 0.21 % after miglitol and -1.18 + /- 0.20 % after glibenclamide . The difference between the two treatments was not significant , although glibenclamide appeared to be more active than miglitol at 8 ( p = 0.002 ) and 16 weeks ( p = 0.01 ) but not at 24 weeks . Fasting glycaemia decreased after miglitol ( 8.7 + /- 0.3 vs 9.6 + /- 0.3 mmol/l , p = 0.005 ) and after glibenclamide ( 8.0 + /- 0.3 vs 9.1 + /- 0.3 , p = 0.007 ) . After miglitol , a decrease was noted after breakfast ( p < 0.001 ) and lunch ( p < 0.001 ) . The same was true for glibenclamide ( p = 0.004 and p < 0.001 respectively ) . A significant reduction in glucose incremental area during a st and ard meal test was noted at the end of miglitol ( p = 0.008 ) or glibenclamide treatment ( p = 0.04 ) . Subgroups of nonresponders to both treatments were identified ( 10/49 with miglitol , 9/47 with glibenclamide ) . Side effects were recorded in 10 patients treated with miglitol ( flatulence and meteorism , diarrhoea , 1 discontinued therapy ) and in 10 treated with glibenclamide ( asthenia , sensation of hunger ) . This study indicates that miglitol is suitable for initial application in diet-resistant Type 2 diabetic patients , providing , a persistent effect and acceptable side effects OBJECTIVE To study the effect of acarbose , an alpha-glucosidase inhibitor , on insulin release and insulin sensitivity in elderly patients with type 2 diabetes . RESEARCH DESIGN AND METHODS Elderly patients with type 2 diabetes were r and omly treated in a double-blind fashion with placebo ( n = 23 ) or acarbose ( n = 22 ) for 12 months . Before and after r and omization , subjects underwent a meal tolerance test and a hyperglycemic glucose clamp study design ed to measure insulin release and sensitivity . RESULTS After 12 months of therapy there was a significant difference in the change in fasting plasma glucose levels ( 0.2 + /- 0.3 vs. -0.5 + /- 0.2 mmol/l , placebo vs. acarbose group , respectively ; P < 0.05 ) and in incremental postpr and ial glucose values ( -0.4 + /- 0.6 vs. -3.5 +
Output:
| We found a decreasing effect on post-load insulin and no clinical ly relevant effects on lipids or body weight .
Adverse effects were mostly of gastro-intestinal origin and dose dependent .
AUTHORS ' CONCLUSIONS It remains unclear whether alpha-glucosidase inhibitors influence mortality or morbidity in patients with type 2 diabetes .
Conversely , they have a significant effect on glycemic control and insulin levels , but no statistically significant effect on lipids and body weight .
These effects are less sure when alpha-glucosidase inhibitors are used for a longer duration .
Acarbose dosages higher than 50 mg TID offer no additional effect on glycated hemoglobin but more adverse effects instead .
Compared to sulphonylurea , alpha-glucosidase inhibitors lower fasting and post-load insulin levels and have an inferior profile regarding glycemic control and adverse effects |
MS210399 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Because of absorbed carbon dioxide ( CO2 ) and elevated intraabdominal pressure ( IAP ) , CO2 pneumoperitoneum ( CO2PP ) has potentially harmful intraoperative circulatory and ventilatory effects . Although not clinical ly significant for healthy patients , these effects are assumed to be deleterious for patients with a high risk for anesthesia ( American Society of Anesthesiology [ ASA ] 3 and 4 ) and significant cardiopulmonary , renal , or hepatic diseases . The authors assessed CO2PP-related adverse effects by comparing ASA 3 and 4 patients who underwent laparoscopic cholecystectomy ( LC ) with or without CO2PP . Methods A total of 20 successive ASA 3 and 4 patients who underwent LC were r and omized into CO2PP ( n = 10 ) and abdominal wall elevator ( Laparolift ) ( n = 10 ) groups . The parameters for perioperative hemodynamics , ventilation , perfusion of intraabdominal organs , and blood chemistry were recorded periodically from before the induction of the anesthesia until postoperative day 2 and compared between the groups . Results Mean age , height , weight , the proportional number of ASA 3 vs ASA 4 patients , the volume of perioperative fluid loading , and the dose of analgesics did not differ significantly between the groups . The length of the operation was 49.9 ± 10.6 min for the CO2PP group and 50.6 ± 17.2 min for Laparolift group ( nonsignificant difference ) . The mean central venous pressure ( CVP ) 30 min after insufflation was higher ( 12.3 ± 4.8 vs 7.9 ± 3.7 mmHg ) and the ( Gastric Mucosal pH ) pHi at the end of the operation was lower ( 7.29 ± 0.07 vs 7.35 ± 0.04 ) in the CO2PP group than in the Laparolift group ( p < 0.05 ) . Later , CVP and pHi did not differ significantly . Other parameters of hemodynamics including oxygenation , perfusion , and blood chemistry did not differ significantly . Conclusions For LC for patients with an ASA 3 and 4 risk for anesthesia , no significant adverse effects could be attributed to CO2 pneumoperitoneum . For high-risk patients , preoperative preparation and active perioperative monitoring are essential for safe anesthesia for LC with or without CO2PP We have compared , in a r and omized study , conventional carbon dioxide pneumoperitoneum with abdominal wall lift in 25 patients undergoing laparoscopic cholecystectomy . Intra-abdominal pressure ( IAP ) ( 11 ( SD 2 ) mm Hg vs 2.7 ( 9 ) mm Hg ) ( P < 0.01 ) and total amount of carbon dioxide used ( 40 ( 23 ) litre vs 9 ( 7 ) litre ) ( P < 0.001 ) were significantly less with abdominal wall lift . Pulmonary compliance was significantly greater ( P < 0.01 ) in the abdominal wall lift group throughout operation . During the first 15 min of insufflation , arterial pressures were lower with abdominal wall lift ( P < 0.05 ) . In the conventional pneumoperitoneum group , femoral vein pressure increased ( P < 0.01 ) and remained elevated for 3 h in the recovery room . Postoperative drowsiness was of significantly longer duration in the conventional pneumoperitoneum group than in the abdominal wall lift group ( 98 ( 46 ) min vs 13 ( 34 ) min ) ( P < 0.01 ) . Postoperative nausea and vomiting and right shoulder pain occurred more often in patients with conventional pneumoperitoneum ( P < 0.05 ) . We conclude that the benefits of abdominal wall lift may be attributed to avoiding excessive carbon dioxide and high IAP Abstract Background : Laparoscopic cholecystectomy using low-pressure pneumoperitoneum ( 8 mmHg ) minimizes adverse hemodynamic effects , reduces postoperative pain , and accelerates recovery . Similar cl aims are made for gasless laparoscopy using abdominal wall lifting . The aim of this study was to compare gasless laparoscopic cholecystectomy to low-pressure cholecystectomy with respect to postoperative pain and recovery . Methods : Thirty-six patients were r and omized to low-pressure or gasless laparoscopic cholecystectomy using a subcutaneous lifting system ( Laparotenser ) . Results : The characteristics of the patients were similar in the two groups . The procedure was completed in all patients in the low-pressure group , but two patients in the gasless group were converted to pneumoperitoneum . There were no significant differences in postoperative pain and analgesic consumption , but patients in the gasless group developed shoulder pain more frequently ( 50 % vs 11 % , p < 0.05 ) . Gasless operation took longer to perform ( 95 vs 72.5 min , p= 0.01 ) . Conclusions : Gasless and low-pressure laparoscopic cholecystectomy were similar with respect to postoperative pain and recovery . The gasless technique provided inferior exposure and the operation took longer , but the technique may still have value in high-risk patients with cardiorespiratory disease We have compared , in a r and omized study in 26 patients , immediate and late postoperative recovery after elective laparoscopic cholecystectomy using the gasless , mechanical abdominal wall lift method with conventional carbon dioxide pneumoperitoneum . After the gasless method , tracheal extubation was performed significantly earlier than after the conventional method ( P < 0.01 ) . End-tidal carbon dioxide concentrations were significantly higher after pneumoperitoneum for 30 min after operation ( P < 0.01 ) . In the conventional group , deviation in Maddox-Wing recordings from preoperative values remained at a significantly higher level during the 3-h recovery room period ( P < 0.01 ) . There was a positive correlation between the total amount of carbon dioxide used and duration of drowsiness ( r = 0.61 , P < 0.001 ) and the Maddox-Wing deviation ( r = 0.62 , P < 0.001 ) . Postoperative nausea and vomiting , and right shoulder pain occurred less often after the gasless method ( P < 0.05 ) . Late recovery criteria ( ability to drink , void and walk ) in patients in the gasless group were fulfilled approximately 7 h earlier than in those in the pneumoperitoneum group ( P < 0.01 ) . Gasless laparoscopic cholecystectomy result ed in more uneventful and faster immediate and late postoperative recovery than conventional carbon dioxide pneumoperitoneum Although laparoscopic cholecystectomy has rapidly developed in the treatment of gall bladder disease in the absence of controlled clinical trial data its outcome parameters compared with open cholecystectomy remain unclear . A prospect i ve audit of the introduction of laparoscopic cholecystectomy in the west of Scotl and over a two year period was carried out to attempt to assess this new procedure . A total of 45 surgeons in 19 hospitals performing laparoscopic cholecystectomy su bmi tted prospect i ve data from September 1990 - 1992 . A total of 2285 cholecystectomies were audited ( a completed data collection rate of 99 % ) . Laparoscopic cholecystectomy was attempted in 1683 ( 74 % ) patients and completed in 1448 patients ( median conversion rate to the open procedure 17 % ) . The median operation time in the completed laparoscopic cholecystectomy patients was 100 minutes ( range 30 - 330 ) and overall hospital stay three days ( 1 - 33 ) . There were nine deaths ( 0.5 % ) after laparoscopic cholecystectomy although only two were directly attributable to the laparoscopic procedure . In the laparoscopic cholecystectomy group there were 99 complications ( 5.9 % ) , 53 ( 3 % ) of these were major requiring further invasive intervention . Forty patients ( 2.4 % ) required early or delayed laparotomy for major complications such as bleeding or bile duct injuries . There were 11 ( 0.7 % ) bile duct injuries in the laparoscopic cholecystectomy series , five were noted during the initial procedure and six were recognised later result ing from jaundice or bile leaks . Ductal injuries occurred after a median of 20 laparoscopic cholecystectomies . In conclusion laparoscopic cholecystectomy has rapidly replaced open cholecystectomy in the treatment of gall bladder disease . Although the overall death and complication rate associated with laparoscopic cholecystectomy is similar to open cholecystectomy , the bile duct injury rate is higher We have studied the cardiorespiratory changes produced by abdominal wall elevation ( AWE ) or carbon dioxide pneumoperitoneum ( PN ) in 20 women undergoing gynaecological laparoscopy . Arterial pressure , heart rate , lung/chest complicance and blood-gas tensions were measured 10 min after induction of general anaesthesia ( T0 ) , 10 min after abdominal distension in the supine position ( T1 ) and 10 min after the Trendelenburg position was assumed ( T2 ) . Visual analogue scores for pain were recorded 1 and 6 h after the end of surgery . We found that lung/chest compliance was reduced significantly in group PN at T1 and T2 compared with both T0 and group AWE . Diastolic arterial pressure increased significantly in group PN at T1 and T2 compared with both T0 and group AWE , while it remained unchanged in group AWE . Arterial PCO2 increased significantly only in group PN after pneumoperitoneum , while oxygenation was almost unchanged in both groups . AWE patients had greater abdominal pain 1 h after surgery . Six hours after surgery pain was similar in the two groups . These data indicate that abdominal wall elevation reduced pulmonary compliance less than a pneumoperitoneum in patients undergoing gynaecological laparoscopy OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials Objective : Carbon dioxide ( CO2 ) pneumoperitoneum has been implicated as a possible factor in early immune preservation in laparoscopic surgery . Although the current analysis was not adequate to clarify this issue , the aim of this study was to compare CO2 insufflation laparoscopic cholecystectomy to gasless abdominal wall lift laparoscopic cholecystectomy with respect to preservation of the immune system . Method : An analysis of the temporal immune responses was performed in 2 similar groups of patients ( n = 50 ) who were divided r and omly into the categories of gas or abdominal wall lift laparoscopic cholecystectomy . The patients were matched with respect to age , weight , and operation time . The immune parameters ( serum white blood cell count , cortisol , erythrocyte sedimentation rate [ ESR ] , tumor necrosis factor-α[TNF-α ] , interferon-γ[INF-γ ] , interleukin-6 [ IL-6 ] , interleukin-8 [ IL-8 ] ) were assessed at preoperative 24 hours and at postoperative 24 and 72 hours for the 2 groups . During the operation , the levels of cytokines that were cultured in the peritoneal macrophages were also checked . Results : The serum white blood cell count , cortisol , and ESR levels were not statistically different in either of the 2 groups . Further , the serum TNF-α , INF-γ , IL-6 , and IL-8 levels in both groups were not significantly different from each other at preoperative 24 hours , and postoperative 24 and 72 hours . However , an immediate decrease in the cytokine levels at 24 hours after the operation was significant in both groups . The cytokine levels were particularly higher in the cultured peritoneal macrophages than in the serum , but were not statistically different between the 2 groups . Conclusion : Our results showed that the beneficial immune
Output:
| Abdominal wall lift with or without pneumoperitoneum does not seem to offer an advantage over pneumoperitoneum in any of the patient-oriented outcomes for laparoscopic cholecystectomy in people with low anaesthetic risk . |
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