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MS211200 | ***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 assess the clinical relevance ( functional outcome ) of a 3-month allopurinol regimen in patients with high serum uric acid ( SUA ) levels and acute ischemic stroke without considering the changes in SUA levels . Material s and Methods : In a r and omized , double-blind , controlled study , 70 patients ( 45 females , 25 males ) with acute ischemic stroke who had elevated levels of SUA were included . They were divided in two 35-patient groups to investigate the effect of 3 months of an allopurinol ( 200 mg/day ) regimen versus placebo on their functional outcome , which was evaluated using a modified Rankin scale . Results : The overall mean age was 68.9 ± 11.33 years ( range 27 - 89 ) . The final favorable functional status ( mRS = 0 - 2 ) was 23 ( 65.7 % ) and 14 ( 40.0 % ) in the treated and placebo groups , respectively , which was strongly associated with allopurinol consumption ( OR = 4.646 , p = 0.014 ) and age ≤70 years ( OR = 0.139 , p = 0.005 ) in patients with ischemic stroke after adjusting for confounders . There was no significant difference in death between allopurinol-treated cases ( 3 ; 8.6 % ) and placebo-treated ones ( 6 ; 17.2 % ; p = 0.278 ) . Conclusion : Allopurinol treatment was well tolerated and improved the 3-month functional status of patients with acute ischemic stroke who had high levels of SUA without considering the decreasing effect of allopurinol on SUA Higher levels of serum uric acid are independently associated with endothelial dysfunction , a mechanism for incident hypertension . Overweight/obese individuals are more prone to endothelial dysfunction than their lean counterparts . However , the effect of lowering serum uric acid on endothelial dysfunction in these individuals has not been examined thoroughly . In this r and omized , double-blind , placebo-controlled trial of nonhypertensive , overweight , or obese individuals with higher serum uric acid ( body mass index ≥25 kg/m2 and serum uric acid ≥5.0 mg/dL ) , we assigned subjects to probenecid ( 500–1000 mg/d ) , allopurinol ( 300–600 mg/d ) , or matching placebo . The primary outcome was endothelium-dependent vasodilation measured by brachial artery ultrasound at baseline and 8 weeks . By the end of the trial , 47 , 49 , and 53 participants had been allocated to receive probenecid , allopurinol , and placebo , respectively . Mean serum uric acid levels significantly decreased in the probenecid ( from 6.1 to 3.5 mg/dL ) and allopurinol groups ( from 6.1 to 2.9 mg/dL ) but not in the placebo group ( 6.1 to 5.6 mg/dL ) . None of the interventions produced any significant change in endothelium-dependent vasodilation ( probenecid , 7.4±5.1 % at baseline and 8.3±5.1 % at 8 weeks ; allopurinol , 7.6±6.0 % at baseline and 6.2±4.8 % at 8 weeks ; and placebo , 6.5±3.8 % at baseline and 7.1±4.9 % at 8 weeks ) . In this r and omized , double-blind , placebo-controlled trial , uric acid lowering did not affect endothelial function in overweight or obese nonhypertensive individuals . These data do not support the hypothesis that uric acid is causally related to endothelial dysfunction , a potential mechanism for development of hypertension Background Previous studies of allopurinol and stroke risk have provided contradictory findings , ranging from a protective effect to an increased risk . Our objective was to assess whether allopurinol use is associated with the risk of stroke in the elderly . Methods We used the 5 % r and om sample of Medicare beneficiaries from 2006–2012 to study the association of new allopurinol initiation and incident stroke . We used multivariable-adjusted Cox regression models adjusted for age , gender , race , Charlson index , and cardio-protective medications ( beta-blockers , ACE inhibitors , diuretics , statins ) to calculate hazards ratio ( HR ) with 95 % confidence intervals ( CI ) . Sensitivity analyses adjusted for coronary artery disease ( CAD ) risk factors including hypertension , hyperlipidemia , diabetes , and smoking instead of Charlson index . Results Among 28,488 eligible episodes of incident allopurinol , 2,177 ended in incident stroke ( 7.6 % episodes ) . In multivariable-adjusted analyses , allopurinol use was associated with 9 % lower hazard ratio for stoke , 0.91 ( 95 % CI , 0.83 to 0.99 ) . Compared to no allopurinol use , allopurinol use duration s of 181 days to 2 years , 0.88 ( 95 % CI , 0.78 to 0.99 ) and > 2 years , 0.79 ( 95 % CI , 0.65 to 0.96 ) were significantly associated with lower multivariable-adjusted hazard of stroke . Sensitivity analyses adjusted for CAD risk factors confirmed these findings . In subgroup analyses , significant associations were noted between allopurinol use and the risk of ischemic stroke , 0.89 ( 95 % CI , 0.81 to 0.98 ) ; associations were not significant for hemorrhagic stroke , 1.01 ( 95 % CI , 0.79 to 1.29 ) . Conclusions Allopurinol use is associated with lower risk of stroke overall , more specifically ischemic stroke . This association is evident after 6-months of allopurinol use , and the hazard reduction increases with longer duration of use . Future studies need to examine underlying mechanisms OBJECTIVE The aim of this study was to investigate the long-term effective control of serum uric acid by allopurinol on the carotid intima-media thickness ( IMT ) in patients with type 2 diabetes ( T2DM ) and asymptomatic hyperuricemia ( HUA ) . METHODS This was a r and omized open parallel-controlled study . In this study , 176 patients with T2DM and asymptomatic HUA were r and omly allocated to the conventional or allopurinol treatment groups on the basis of a computer-generated r and om number table . Changes in the carotid IMT , biochemical indexes , high sensitive C-reactive protein ( hs-CRP ) and the incidence of hypertension in patients before and after three years of treatment were examined and compared between the groups . RESULTS There were no statistically significant differences in the baseline characteristics of the study participants between the two treatment groups ( p>0.05 for all ) . Nevertheless , the serum uric acid , triglyceride , and hs-CRP levels and the homeostasis assessment for insulin resistance ( HOMA-IR ) , systolic blood pressure , diastolic blood pressure and the carotid IMT in the allopurinol group were significantly lower than those in the conventional group after three years of treatment ( p<0.01 for all ) . The intention-to-treat analysis indicated that the incidence of new-onset hypertension in the allopurinol group showed a declining trend compared to that in the conventional treatment group ( 6.8 % vs. 13.6 % , p>0.05 ) . CONCLUSION The long-term effective control of serum uric acid by allopurinol may improve insulin resistance , decrease the serum levels of hs-CRP , reduce the carotid IMT , and may delay the development of atherosclerosis in patients with T2DM and asymptomatic HUA Background Previous observational studies that have examined the association of allopurinol with myocardial infa rct ion ( MI ) have provided contradictory results . One study showed that allopurinol reduced the risk , while another study showed an increased risk with allopurinol . Therefore , our objective was to assess whether allopurinol use is associated with a reduction in the risk of MI in the elderly . Method We used the 2006–2012 5 % r and om sample of Medicare beneficiaries to study the association of new allopurinol initiation and the risk of incident MI in a cohort study . Multivariable-adjusted Cox regression models adjusted for age , gender , race , and Charlson index , in addition to various cardio-protective medications ( beta-blockers , angiotensin-converting enzyme ( ACE ) inhibitors , diuretics , statins ) . We calculated hazard ratios ( HRs ) with 95 % confidence intervals ( CIs ) . Sensitivity analyses adjusted for coronary artery disease ( CAD ) risk factors , including hypertension , hyperlipidemia , diabetes , and smoking . Results Of the 29,298 episodes of incident allopurinol use , 1544 were associated with incident MI ( 5.3 % episodes ) . Allopurinol use was associated with reduced hazards of MI , with a HR of 0.85 ( 95 % CI , 0.77 to 0.95 ) . Compared to no allopurinol use , longer duration s of allopurinol use were associated with a lower HR of MI : 1–180 days , 0.98 ( 95 % CI , 0.84 to 1.14 ) ; 181 days to 2 years , 0.83 ( 95 % CI , 0.72 to 0.95 ) ; and > 2 years , 0.70 ( 95 % CI , 0.56 to 0.88 ) . Other factors associated with a higher hazard of MI were : age 75 to < 85 years and ≥85 years , male gender , higher Charlson index score , and the use of an ACE inhibitor . Adjustment for CAD risk factors confirmed these findings . Conclusion Incident allopurinol use was associated with a reduction in the risk of incident MI in the elderly . Longer duration s of allopurinol use reduced the risk of incident MI incrementally . Future studies should assess the underlying mechanisms for MI prevention and assess the risk-benefit ratio for allopurinol use OBJECTIVE To investigate the therapeutic effect of allopurinol treatment on acute coronary syndrome and to eluci date its possible mechanism . METHODS Patients with acute coronary syndrome ( n = 100 ) were recruited as research subjects in our hospital . The patients were r and omly divided into two groups , an allopurinol group ( n = 50 ) and a control group ( n = 50 ) . These two groups were treated with conventional antiplatelet , anticoagulation and anti-ischemic therapy ; allopurinol therapy was added to the allopurinol group based on conventional treatment indications . Biochemical markers such as serum creatinine , uric acid , BNP , blood glucose and blood lipid were compared between the two groups . Indicators of oxidative stress and inflammatory response ( MDA , OX-LDL , NO , hs-CRP and TNF-α ) , as well as cardiovascular events during 2-years follow-up , were recorded . RESULTS On admission , there was no difference in serum creatinine , uric acid , BNP , blood glucose or lipid levels between the two groups ( P > 0.05 ) . However , after 1 month of treatment , these levels were improved in patients in the allopurinol group compared to the control group ( P < 0.05 ) . MDA , OX-LDL , hs-CRP and TNF-α decreased after treatment periods of 14 days and 1 month . They were also decreased at 3 month , 6 month , 1 year , and 2 year follow-up visits . However , data from the allopurinol group demonstrated significantly lower levels than in the control group ( P < 0.05 ) . Additionally , compared with the control group , allopurinol treatment significantly elevated the level of NO ( P < 0.05 ) . The total effective rates of the allopurinol group are much higher than in the control group for both angina pectoris ( 93.2 % and 76 % , respectively ) and ECG ( 96 % and 82 % , respectively ) . Most patients in the allopurinol group ( n = 40 ) and the control group ( n = 41 ) received stent implantation with no significant difference shown between them . The incidence of cardiovascular events during 2 years of follow-up in the allopurinol group was 10 % ; it was 30 % in the control group . CONCLUSION Allopurinol has a remarkable effect in the treatment of ACS and can improve the oxidative stress and inflammatory reaction indicators of patients . The protective mechanism of allopurinol might be achieved by suppressing the secretion and release of inflammatory mediators such as TNF-α , hs-CRP , OX-LDL and MDA while increasing levels of NO Allopurinol ameliorates endothelial dysfunction and arterial stiffness among patients without chronic kidney disease ( CKD ) , but it is unknown if it has similar effects among patients with CKD . Furthermore , because arterial stiffness increases left ventricular afterload , any allopurinol-induced improvement in arterial compliance might also regress left ventricular hypertrophy ( LVH ) . We conducted a r and omized , double-blind , placebo-
Output:
| Accordingly , lower doses ( ≤ 300 mg/day ) of allopurinol reduced the risk of TCE , unlike higher doses .
Conclusions Purine-like XOI may reduce the incidence of adverse CV outcomes .
However , higher doses of allopurinol ( > 300 mg/day ) may be associated with loss of CV protection |
MS211201 | ***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 VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company OBJECTIVE Vascular endothelial growth factor ( VEGF ) receptor-mediated signaling contributes to ovarian cancer pathogenesis . Elevated VEGF expression is associated with poor clinical outcomes . We investigated ramucirumab , a fully human anti-VEGFR-2 antibody , in patients with persistent or recurrent epithelial ovarian , fallopian tube , or primary peritoneal carcinoma . Primary endpoints were progression-free survival at 6 months ( PFS-6 ) and confirmed objective response rate ( ORR ) . METHODS Women who received ≥ 1 platinum-based chemotherapeutic regimen and had a platinum-free interval of < 12 months with measurable disease were eligible . Patients received 8 mg/kg ramucirumab intravenously every 2 weeks . RESULTS Sixty patients were treated ; one patient remained on study as of September 2013 . The median age was 62 years ( range : 27 - 80 ) , and median number of prior regimens was 3 . Forty-five ( 75 % ) patients had platinum refractory/resistant disease . Thirty-nine patients ( 65.0 % ) had serous tumors . PFS-6 was 25.0 % ( n=15/60 , 95 % CI : 14.7 - 37.9 % ) . Best overall response was : partial response 5.0 % ( n=3/60 ) , stable disease 56.7 % ( n=34/60 ) , and progressive disease 33.3 % ( n=20/60 ) . The most common treatment-emergent adverse events possibly related to study drug were headache ( 65.0 % ; 10.0 % Grade ≥ 3 ) , fatigue ( 56.7 % ; 3.3 % Grade ≥ 3 ) , diarrhea ( 28.3 % ; 1.7 % Grade ≥ 3 ) , hypertension ( 25.0 % ; 3.3 % Grade ≥ 3 ) , and nausea ( 20.0 % ; no Grade ≥ 3 ) . Two patients experienced intestinal perforations ( 3.3 % Grade ≥ 3 ) . Pharmacodynamic analyses revealed changes in several circulating VEGF proteins following initial ramucirumab infusion , including increased VEGF-A , PlGF and decreased sVEGFR-2 . CONCLUSIONS Although antitumor activity was observed , the predetermined efficacy endpoints were not met BACKGROUND Ramucirumab is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2 . We aim ed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as second-line treatment for patients with stage IV non-small-cell-lung cancer ( NSCLC ) after platinum-based therapy . METHODS In this multicentre , double-blind , r and omised phase 3 trial ( REVEL ) , we enrolled patients with squamous or non-squamous NSCLC who had progressed during or after a first-line platinum-based chemotherapy regimen . Patients were r and omly allocated ( 1:1 ) with a central ised , interactive voice-response system ( stratified by sex , region , performance status , and previous maintenance therapy [ yes vs no ] ) to receive docetaxel 75 mg/m(2 ) and either ramucirumab ( 10 mg/kg ) or placebo on day 1 of a 21 day cycle until disease progression , unacceptable toxicity , withdrawal , or death . The primary endpoint was overall survival in all patients allocated to treatment . We assessed adverse events according to treatment received . This study is registered with Clinical Trials.gov , number NCT01168973 . FINDINGS Between Dec 3 , 2010 , and Jan 24 , 2013 , we screened 1825 patients , of whom 1253 patients were r and omly allocated to treatment . Median overall survival was 10·5 months ( IQR 5·1 - 21·2 ) for 628 patients allocated ramucirumab plus docetaxel and 9·1 months ( 4·2 - 18·0 ) for 625 patients who received placebo plus docetaxel ( hazard ratio 0·86 , 95 % CI 0·75 - 0·98 ; p=0·023 ) . Median progression-free survival was 4·5 months ( IQR 2·3 - 8·3 ) for the ramucirumab group compared with 3·0 months ( 1·4 - 6·9 ) for the control group ( 0·76 , 0·68 - 0·86 ; p<0·0001 ) . We noted treatment-emergent adverse events in 613 ( 98 % ) of 627 patients in the ramucirumab safety population and 594 ( 95 % ) of 618 patients in the control safety population . The most common grade 3 or worse adverse events were neutropenia ( 306 patients [ 49 % ] in the ramucirumab group vs 246 [ 40 % ] in the control group ) , febrile neutropenia ( 100 [ 16 % ] vs 62 [ 10 % ] ) , fatigue ( 88 [ 14 % ] vs 65 [ 10 % ] ) , leucopenia ( 86 [ 14 % ] vs 77 [ 12 % ] ) , and hypertension ( 35 [ 6 % ] vs 13 [ 2 % ] ) . The numbers of deaths from adverse events ( 31 [ 5 % ] vs 35 [ 6 % ] ) and grade 3 or worse pulmonary haemorrhage ( eight [ 1 % ] vs eight [ 1 % ] ) did not differ between groups . Toxicities were manageable with appropriate dose reductions and supportive care . INTERPRETATION Ramucirumab plus docetaxel improves survival as second-line treatment of patients with stage IV NSCLC . FUNDING Eli Lilly Purpose : To assess the efficacy and safety of the anti-VEGF receptor-2 ( VEGFR-2 ) antibody ramucirumab as first-line therapy in patients with advanced hepatocellular carcinoma and explore potential circulating biomarkers . Experimental Design : Adults with advanced hepatocellular carcinoma and no prior systemic treatment received ramucirumab 8 mg/kg every two weeks until disease progression or limiting toxicity . The primary endpoint was progression-free survival ( PFS ) ; secondary endpoints included objective response rate ( ORR ) and overall survival ( OS ) . Circulating biomarkers were evaluated before and after ramucirumab treatment in a subset of patients . Results : Forty-two patients received ramucirumab . Median PFS was 4.0 months [ 95 % confidence interval ( CI ) , 2.6–5.7 ] , ORR was 9.5 % ( 95 % CI , 2.7–22.6 ; 4/42 patients had a partial response ) , and median OS was 12.0 months ( 95 % CI , 6.1–19.7 ) . For patients with Barcelona Clinic Liver Cancer ( BCLC ) stage C disease , median OS was 4.4 months ( 95 % CI , 0.5–9.0 ) for patients with Child-Pugh B cirrhosis versus 18.0 months ( 95 % CI , 6.1–23.5 ) for patients with Child-Pugh A cirrhosis . Treatment-related grade ≥3 toxicities included hypertension ( 14 % ) , gastrointestinal hemorrhage and infusion-related reactions ( 7 % each ) , and fatigue ( 5 % ) . There was one treatment-related death ( gastrointestinal hemorrhage ) . After treatment with ramucirumab , there was an increase in serum VEGF and placental growth factor ( PlGF ) and a transient decrease in soluble VEGFR-2 . Conclusion : Ramucirumab monotherapy may confer anticancer activity in advanced hepatocellular carcinoma with an acceptable safety profile . Exploratory biomarker studies showed changes in circulating VEGF , PlGF , and sVEGFR-2 that are consistent with those seen with other anti-VEGF agents . Clin Cancer Res ; 19(23 ) ; 6614–23 . © 2013 AACR BACKGROUND Vascular endothelial growth factor ( VEGF ) and VEGF receptor-2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer . We aim ed to assess whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , prolonged survival in patients with advanced gastric cancer . METHODS We did an international , r and omised , double-blind , placebo-controlled , phase 3 trial between Oct 6 , 2009 , and Jan 26 , 2012 , at 119 centres in 29 countries in North America , Central and South America , Europe , Asia , Australia , and Africa . Patients aged 24 - 87 years with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression after first-line platinum-containing or fluoropyrimidine-containing chemotherapy were r and omly assigned ( 2:1 ) , via a central interactive voice-response system , to receive best supportive care plus either ramucirumab 8 mg/kg or placebo , intravenously once every 2 weeks . The study sponsor , participants , and investigators were masked to treatment assignment . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00917384 . FINDINGS 355 patients were assigned to receive ramucirumab ( n=238 ) or placebo ( n=117 ) . Median overall survival was 5·2 months ( IQR 2·3 - 9·9 ) in patients in the ramucirumab group and 3·8 months ( 1·7 - 7·1 ) in those in the placebo group ( hazard ratio [
Output:
| Hemorrhagic events associated with ramucirumab are modest and manageable while patients could continue to receive ramucizumab treatment to achieve their maximum clinical benefits |
MS211202 | ***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 Concurrent chemoradiotherapy ( CCRT ) has been shown to improve outcomes for stage III-IV nasopharyngeal carcinoma ( NPC ) patients compared with radiotherapy ( RT ) alone , but the effectiveness of the combined therapy for stage II NPC patients is unknown . METHODS Patients with Chinese 1992 stage II NPC were r and omly assigned to receive either RT alone ( n = 114 ) or CCRT ( n = 116 ) . The CCRT patients were given concurrent cisplatin ( 30 mg/m(2 ) on day 1 ) weekly during RT . The primary endpoint was overall survival ( OS ) . Secondary endpoints were progression-free survival ( PFS ) , distant metastasis-free survival , and locoregional relapse-free survival . All patients were analyzed by the intent-to-treat principle . The Cox proportional hazards model was used to calculate hazard ratios ( HRs ) with 95 % confidence intervals ( CIs ) and in multivariable analyses to test the independent statistical significance of treatment intervention . Toxic effects and the response to treatment were analyzed using the χ(2 ) test . All statistical tests were two-sided . RESULTS With a median follow-up of 60 months , adding chemotherapy statistically significantly improved the 5-year OS rate ( 94.5 % vs 85.8 % ; HR of death = 0.30 , 95 % CI = 0.12 to 0.76 ; P = .007 ) , PFS ( 87.9 % vs 77.8 % ; HR of progression = 0.45 , 95 % CI = 0.23 to 0.88 ; P = .017 ) , and distant metastasis-free survival ( 94.8 % vs 83.9 % ; HR of distant relapse = 0.27 , 95 % CI = 0.10 to 0.74 ; P = .007 ) ; however , there was no statistically significant difference in the 5-year locoregional relapse-free survival rate ( 93.0 % vs 91.1 % ; HR of locoregional relapse = 0.61 , 95 % CI = 0.25 to 1.51 ; P = .29 ) . Multivariable analysis showed that the number of chemotherapy cycles was the only independent factor that was associated with OS , PFS , and distant control in stage II NPC . The CCRT arm experienced statistically significantly more acute toxic effects ( P = .001 ) , although the rate of late toxic effects did not increase statistically significantly . CONCLUSION Concurrent chemotherapy and radiotherapy is associated with a considerable survival benefit for patients with stage II NPC Objectives : To evaluate the treatment outcome of patients with stage IIB nasopharyngeal carcinoma ( NPC ) after definitive intensity-modulated radiotherapy ( IMRT ) without concurrent chemotherapy . Methods : Between August 2003 and December 2006 , 107 patients with T1N1M0 ( 8 % ) , T2N0M0 ( 13 % ) , or T2N1M0 ( 79 % ) NPC were definitively treated with IMRT . Sixty-one received IMRT only , and 46 patients had various strategies of systemic treatment , consisting of abbreviated neoadjuvant ( 38 patients ) , concurrent ( 8 patients ) , or adjuvant ( 16 patients ) chemotherapy . Radiation doses prescribed to the planning tumor volume of the gross disease , high-risk clinical tumor volume , and low-risk clinical tumor volume were 66 to 70 Gy , 54 to 60 Gy , and 50–54 Gy , respectively . Results : With a median follow-up of 39 months ( range , 7–77 months ) , 6 patients had locoregional relapse : 1 local only , 1 locoregional , and 4 regional only . Five patients had distant failure . Five of 6 total deaths were cancer related . The 3-year estimated local control , regional control , metastasis-free survival , disease-free survival , and overall survival were 96.5 % , 98 % , 94.8 % , 90.7 % , and 95.8 % , respectively . No significant difference in treatment outcome was demonstrated in patients treated with or without chemotherapy of any schedule . Conclusions : IMRT without concurrent chemotherapy provides good outcome for patients with stage IIB NPC with acceptable toxicity . Neoadjuvant chemotherapy did not appear to provide significant additional benefit for this patient subgroup . Further investigation in the prospect i ve setting is warranted to explore the role of systemic agents in the treatment of NPC with limited primary disease and cervical lymphadenopathy when IMRT is used PURPOSE To investigate the feasibility of intensity-modulated radiation therapy ( IMRT ) with or without chemotherapy , and to assess toxicities , failure patterns , and survivals in patients with nasopharyngeal carcinoma ( NPC ) . PATIENTS AND METHODS Radiation consisted of 70 Gy given to the planning target volumes of primary tumor plus any N+ disease and 59.4 Gy given to sub clinical disease , delivered over 33 treatment days . Patients with stage T2b or greater or with N+ disease also received concurrent cisplatin ( 100 mg/m(2 ) ) on days 1 , 22 , and 43 followed by adjuvant cisplatin ( 80 mg/m(2 ) ) on day 1 ; fluorouracil ( 1,000 mg/m(2)/d ) on days 1 through 4 administered every 4 weeks for three cycles . Tumor , clinical status , and acute/late toxicities were assessed . The primary objective was to test the transportability of IMRT to a multi-institutional setting . RESULTS Between February 2003 and November 2005 , 68 patients with stages I through IVB NPC ( of which 93.8 % were WHO types 2 and 3 ) were enrolled . Prescribed IMRT ( target delineation ) was given to 83.8 % , whereas 64.9 % received chemotherapy per protocol . The estimated 2-year local progression-free ( PF ) , regional PF , locoregional PF , and distant metastasis-free rates were 92.6 % , 90.8 % , 89.3 % , and 84.7 % , respectively . The estimated 2-year PF and overall survivals were 72.7 % and 80.2 % , respectively . Acute grade 4 mucositis occurred in 4.4 % , and the worst late grade 3 toxicities were as follows : esophagus , 4.7 % ; mucous membranes , 3.1 % ; and xerostomia , 3.1 % . The rate of grade 2 xerostomia at 1 year from start of IMRT was 13.5 % . Only two patients complained of grade 3 xerostomia , and none had grade 4 xerostomia . CONCLUSION It was feasible to transport IMRT with or without chemotherapy in the treatment of NPC to a multi-institutional setting with 90 % LRPF rate reproducing excellent reports from single institutions . Minimal grade 3 and lack of grade 4 xerostomia were encouraging Abstract The objective of this study was to evaluate the necessity of concurrent chemotherapy in T1 - 2N1 nasopharyngeal carcinoma ( NPC ) patients treated with intensity-modulated radiation therapy (IMRT).The retrospective analysis was conducted using the paired comparison method . We matched cases to controls using the greedy matching algorithm with 1:1 control to case ratio . Controls were matched to cases by factors including age , gender , T stage , and duration of RT . The control group included patients received IMRT alone . In another group , concurrent chemotherapy ( DDP 40 mg/m2/w ) was administrated to each paired patient . From Jan 2009 to Dec 2011 , a total of 86 well-balanced T1 - 2N1 ( 2002 UICC staging system ) NPC patients were retrospectively analyzed . Half of them ( 43 patients ) received radical IMRT alone and another 43 received concurrent chemotherapy with IMRT ( CCRT ) . Median follow-up is 37.4 months ( 4.8–66.2 months ) . All patients received a radiation dose of 66Gy/30Fx . In the CCRT group , all patients received a cumulative dose of ≥200 mg/m2 . The differences of 3-year overall survival ( OS ) , 3-year progression-free survival ( PFS ) , 3-year relapse-free survival ( RFS ) , and 3-year metastasis-free survival ( MFS ) between 2 groups were not significant ( P > 0.05 ) . The most frequently increased toxicities related to chemotherapy were mild to moderate leukopenia ( P = 0.003 ) and mild anemia ( P = 0.008).Omission of weekly cisplatin chemotherapy result ed in comparable survival outcomes to CCRT in IMRT population s. More data from future r and omized trials are warranted to further confirm it OBJECTIVES To evaluate the long-term survival and the role of chemotherapy in nasopharyngeal carcinoma ( NPC ) patients in Stage II treated by intensity-modulated radiation therapy ( IMRT ) . METHODS Three hundred and eleven NPC patients in Stage II were review ed . All were treated with IMRT with or without chemotherapy , with 191 , 20 and 100 patients being defined as T1N1M0 , T2N0M0 and T2N1M0 stage , respectively . RESULTS At a median follow-up of 57 months , the 5-year overall survival , disease-specific survival , distant metastasis-free survival , loco-regional relapse-free survival ( LRRFS ) and progression-free survival were 91.1 , 93.5 , 90.6 , 95.9 and 87.6 % , respectively . T2N1 patients had significant poorer survival outcomes than T1N1 patients , with T2N0 patients in between . Further analysis showed that the addition of chemotherapy could only improve LRRFS [ hazard ratio ( HR ) 0.263 , 95 % confidence interval ( CI ) 0.083 - 0.839 , P = 0.024 ] , especially for T1N1 patients ( HR 0.209 , 95 % CI 0.046 - 0.954 , P = 0.043 ) . For those in the T2N1M0 group , chemotherapy , as used in our series , added no benefit to any endpoint . CONCLUSIONS IMRT in NPC patients in Stage II was quite therapeutic ; however , different subgroups have distinct survival outcomes . Distant metastasis was the main failure pattern , especially for those with T2N1 disease , and the chemotherapy currently in use failed to treat sub clinical metastatic foci effectively . Further prospect i ve study is warranted to find out the role and the optimal schedule of chemotherapy in this subgroup of patients To evaluate the long term impact of concurrent chemoradiotherapy ( CCRT ) compared to radiotherapy ( RT ) alone in patients with T2N1M0 nasopharyngeal carcinoma ( NPC ) retrospectively . Three hundred and ninety-two patients with T2N1M0 NPC according to the AJCC 2002 stage classification system were analyzed . Among them , 211 patients were treated with RT alone and the rest of 181 patients were treated with CCRT . A planned dose of 70 Gy was delivered in 2.0 Gy per fraction over 7 weeks to the primary tumor with 6-MV photons or (60)Cobalt γ-ray . The chemotherapy regimen of cisplatin with a dose of 100mg/m(2 ) was delivered for 2 - 3 cycles . With a median follow-up of 66 months ( range 2.4 - 117.1 months ) , the 5-year overall survival ( OS ) and disease-free survival ( DFS ) rates was higher in CCRT group compared to RT alone group , though they failed to reach statistical significance ( 80.2 % vs. 76.6 % , P=0.778 and 70.5 % vs. 64.2 % , P=0.413 , respectively ) . A significant improvement was detected in 5-year relapse-free survival ( RFS ) rate in CCRT group than RT alone group ( 91.5 % vs. 77.3 % , P=0.008 ) . Moreover , chemotherapy was the only independent prognostic factor for the 5-year RFS ( P=0.007 ) . Concurrent chemoradiotherapy appeared to improve the 5-year RFS rate for patients with T2N1M0 NPC . Large prospect i ve , r and omized clinical studies are needed to confirm its therapeutic gain PURPOSE Early-stage nasopharyngeal carcinoma ( NPC ) continues to carry a failure rate of 15 % to 30 % when treated with radiotherapy alone ; the benefit of concomitant radiotherapy and chemotherapy ( CCRT ) in early-stage NPC is unclear . The purpose of this report is to describe our efforts to improve treatment outcome in early-stage NPC after CCRT . PATIENTS AND METHODS Of 189 newly diagnosed NPC patients without evidence of distant metastases who were treated in our institution between 1990 and 1997 , 44 presented with early-stage ( stage I and II ) disease according to the American Joint Committee on Cancer ( AJCC ) 1997 NPC staging system . Twelve of these patients were treated with radiotherapy alone and 32 with CCRT . Each patient 's head and neck area was evaluated by magnetic resonance
Output:
| Adding concurrent chemotherapy to IMRT led to no survival benefit and increased acute toxicity reactions for stage II nasopharyngeal carcinoma |
MS211203 | ***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 Several disorders have been attributed to measles-mumps-rubella ( MMR ) vaccination during the past decade . The aim of this prospect i ve follow-up study was to identify serious adverse events causally related to MMR vaccination . METHODS When the MMR vaccination program was launched in Finl and in 1982 , a countrywide surveillance system was set up to detect serious adverse events associated with MMR . To obtain detailed case histories vaccinees ' clinical charts were review ed . Serum sample s were analyzed to trace concurrent infections . SETTING All hospitals and health centers in Finl and from 1982 through 1996 . RESULTS Immunization of 1.8 million individuals and consumption of almost 3 million vaccine doses by the end of 1996 gave rise to 173 potentially serious reactions cl aim ed to have been caused by MMR vaccination . In all , 77 neurologic , 73 allergic and 22 miscellaneous reactions and 1 death were reported , febrile seizure being the most common event . However , 45 % of these events proved to be probably caused or contributed by some other factor , giving an incidence of serious adverse events with possible or indeterminate causal relation with MMR vaccination of 5.3 per 100,000 vaccinees or 3.2 per 100,000 vaccine doses . CONCLUSIONS Causality between immunization and a subsequent untoward event can not be estimated solely on the basis of a temporal relation . Comprehensive analysis of the reported adverse reactions established that serious events causally related to MMR vaccine are rare and greatly outweighed by the risks of natural MMR diseases Background : Febrile seizures affect 2 to 4 % of children , and 2 to 10 % develop subsequent unprovoked seizures . Secondary analyses of two large cohorts identified neurodevelopmental abnormalities , complex febrile seizures , and a family history of epilepsy as predictors of unprovoked seizures . We present an analysis of children prospect ively followed from their first febrile seizure to reassess these three factors , examine factors of equivocal importance , and assess the importance of some new factors that we identified as predictors of recurrent febrile seizures . Methods : Children ( N = 428 ) were prospect ively identified for a first febrile seizure through pediatric emergency departments of four hospitals . Information was collected from medical records and interviews with parents . Children were followed for 2 years or more . Results : Unprovoked seizures occurred in 26 ( 6 % ) . Neurodevelopmental abnormalities , complex febrile seizures , and a family history of epilepsy were associated with an increased risk of unprovoked seizures . Recurrent febrile seizures and brief duration of fever before the initial febrile seizure were also risk factors . A family history of febrile seizures , temperature and age at the initial febrile seizure , sex , and race were not associated with unprovoked seizures . Conclusions : We confirmed the increased risk associated with traditionally accepted predictors of epilepsy following febrile seizures . Also , the risk clearly increased with recurrent febrile seizures . In general , predictors of subsequent unprovoked seizures differ from predictors of recurrent febrile seizures . One notable exception , brief duration of fever before the initial febrile seizure , predicts both types of outcome and may be a marker for an increased susceptibility to seizures . NEUROLOGY 1996;47 : 562 - Visual inspection and volumetric analysis of MRIs allow mesial temporal sclerosis ( MTS ) to be reliably identified in patients with temporal lobe epilepsy . The presence of unilateral MTS ipsilateral to the side of habitual seizure onset is an indicator for the prognosis of good outcome after temporal lobe resection . There is evidence to suggest that widespread temporal lobe pathology , leading to atrophy , may be associated with MTS and such abnormal tissue may play an important role in epileptogenesis . We have analysed quantitatively the volumes of the mesial and lateral temporal lobe substructures in MRIs from 62 patients with intractable mesial temporal lobe epilepsy and in 20 normal controls . We found significant atrophy in these structures in patients , ranging from 8.3 to 18.4 % compared with controls . The degree of atrophy in the extrahippocampal structures correlated with the degree of hippocampal atrophy , suggesting that a common process may be responsible . There was no correlation between the degree of atrophy in the extrahippocampal structures and the duration of epilepsy , a history of febrile convulsions or of generalized seizures . These findings suggest that there may be widespread pathological abnormalities in the temporal lobe associated with MTS . The importance of extrahippocampal atrophy to surgical outcome and whether it occurs in temporal lobe epilepsy not associated with MTS remain to be investigated A cohort of 92 children with an initial febrile convulsion ( FC ) , prospect ively identified in a community-based study 1985 - 1987 , was compared with a cohort of 185 age- and sex-matched referents from the same study area . The median time of follow-up was 6.7 years ( range : 5.7 - 7.7 ) and the median age at follow-up was 8.3 years ( range 6.5 - 14 ) . The cases had their first FC at a median age of 18 months ( range 5 - 67 months ) , their second FC at 24 months ( 11 - 108 months ) and their third FC at 26 months ( 13 - 92 months ) . FC recurred in 42 % of the FC cohort , and 3.8 % of the children in the referent cohort experienced FC . Single or recurrent afebrile seizures occurred in 4.3 % and epilepsy in 3.3 % of the FC cohort , while no afebrile seizures occurred in the referent cohort . The risk of having a sibling with FC was three times ( 95 % confidence interval 1.3 - 6.2 ) higher in the FC cohort , while there was no difference between the cohorts in the risk of siblings developing afebrile seizures . There was no difference between the cohorts in the utilization of health services during the follow-up period . Two children in the FC cohort went to a school for the mentally retarded . There was no aetiological relationship between the FC and the mental retardation in these cases . All other children attended normal schools and none needed remedial instruction Abstract Objective : To compare the safety and efficacy of midazolam given intranasally with diazepam given intravenously in the treatment of children with prolonged febrile seizures . Design : Prospect i ve r and omised study . Setting : Paediatric emergency department in a general hospital . Subjects : 47 children aged six months to five years with prolonged febrile seizure ( at least 10 minutes ) during a 12 month period . Interventions : Intranasal midazolam ( 0.2 mg/kg ) and intravenous diazepam ( 0.3 mg/kg ) . Main outcome measures : Time from arrival at hospital to starting treatment and cessation of seizures . Results : Intranasal midazolam and intravenous diazepam were equally effective . Overall , 23 of 26 seizures were controlled with midazolam and 24 out of 26 with diazepam . The mean time from arrival at hospital to starting treatment was significantly shorter in the midazolam group ( 3.5 ( SD 1.8 ) minutes , 95 % confidence interval 3.3 to 3.7 ) than the diazepam group ( 5.5 ( 2.0 ) , 5.3 to 5.7 ) . The mean time to control of seizures was significantly sooner ( 6.1 ( 3.6 ) , 6.3 to 6.7 ) in the midazolam group than the diazepam group ( 8.0 ( 0.5 ) , 7.9 to 8.3 ) . No significant side effects were observed in either group . Conclusion : Seizures were controlled more quickly with intravenous diazepam than with intranasal midazolam , although midazolam was as safe and effective as diazepam . The overall time to cessation of seizures after arrival at hospital was faster with intranasal midazolam than with intravenous diazepam . The intranasal route can possibly be used not only in medical centres but in general practice and , with appropriate instructions , by families of children with recurrent febrile seizures at home In order to evaluate the effectiveness of diazepam for the reduction in the recurrence of febrile seizures we carried out a prospect i ve study in two groups of children ; Group A : 45 children ( 25 female , 20 male ) , receiving oral prophylaxis with diazepam , and Group B : 65 children ( 35 female , 30 male ) who did not receive any oral prophylaxis . All subjects of both groups were followed for at least 4 years and finally re-evaluated at the mean age of 6.7+/-1.4 years . Among the patients of Group A , recurrent febrile seizures ( FS ) occurred in five of the 45 children ( 11.1 % ) . Among the 65 children of Group B , 20 ( 30.7 % ) went on to have one or more additional episodes . In conclusion , our study demonstrates that oral diazepam , given only when fever is present , is an effective means of reducing the risk of recurrences of FS Febrile status epilepticus ( SE ) represents the extreme end of the complex febrile seizure spectrum . If there are significant sequelae to febrile seizures , they should be more common in this group . We have prospect ively identified 180 children aged 1 month to 10 years who presented with febrile SE over a 10-year period in Bronx , New York , and Richmond , Virginia . They were compared with 244 children who presented with their first febrile seizure ( not SE ) in a prospect i ve study done in the Bronx . The mean age of the children with febrile SE was 1.92 years , and of the comparison group , 1.85 years . Duration of SE was 30 - 59 min in 103 ( 58 % ) , 60 - 119 min in 43 ( 24 % ) , and > or = 120 min in 34 ( 18 % ) . Focal features were present in 64 ( 35 % ) of cases . There were no deaths and no cases of new cognitive or motor h and icap . Children with febrile SE were more likely to be neurologically abnormal ( 20 % vs. 5 % ; p < 0.001 ) , to have a history of neonatal seizures ( 3 % vs. 0 ; p = 0.006 ) and a family history of epilepsy ( 11 % vs. 5 % ; p = 0.05 ) and less likely to have a family history of febrile seizures ( 15 % vs. 27 % ; p = 0.01 ) than were children in the comparison group . The short-term morbidity and mortality of febrile SE are low . There are differences in the types of children who have febrile SE compared with those who experience briefer febrile seizures . Long-term follow-up of this cohort may provide insight into the relationship of prolonged febrile seizures and subsequent mesial temporal sclerosis Summary : Purpose : A prospect i ve population ‐based case‐control study was performed to ascertain whether febrile convulsion ( FC ) in early childhood is associated with neurocognitive attention deficits in school age We report a 12-year follow-up study of children with febrile convulsions ( FCs ) . The National General Practice Study of Epilepsy ( NGPSE ) is a large prospect i ve community-based cohort study of 1,195 patients of all ages from first presentation with an identified seizure . Two hundred and twenty children with a first febrile convulsion were identified from the above study between 1984 and 1987 . Children were prospect ively followed up to ascertain subsequent seizures , neurological problems and treatment . Two hundred and seven patients were followed for a minimum of 8.4 years ( median 11.2 years ) . In the FC cohort , 6 % of the children developed subsequent epilepsy , which compares with a population risk of about 1.4 % . Ten percent had neurological sequelae . Eleven percent of the children had received medication to prevent recurrence of FC , and in one third of these cases , this was for simple FCs . Using a time-dependent covariate Cox proportional hazards model , the number of FCs was associated with an increased risk of epilepsy ( hazard ratio 2.48 ; 95 % confidence limits , CL 1.68 , 3.65 ) up to a limit of 4 . A statistically significant association between occurrence of complex FC and subsequent epilepsy was not found , but a review of other studies quantified the odds ratio for epilepsy after a complex first FC as 3.4 ( 95 % CL 2.1 , 5.4 ) . Epilepsy is a significant if infrequent sequel to FCs . Factors associated with subsequent epilepsy are the number of FCs or a complex first FC . Overtreatment of this condition continues Interictal diffusion imaging studies in patients with medial temporal lobe epilepsy ( MTLE ) accompanied by hippocampal sclerosis ( HS ) have shown an increased diffusivity in the epileptogenic hippocampus . In this study , we wanted to explore the whole brain in order to determine if MTLE could have an impact on the organization and the architecture of a large cerebral network and to identify clinical factors that could mediate diffusion abnormalities . Diffusion tensor imaging ( DTI ) and statistical parametric mapping of the entire brain were performed in 35 well-defined MTLE patients and in 36 healthy volunteers . SPM analyses identified three abnormal areas : an increased diffus
Output:
| We found that simple febrile seizures do not carry a risk of death , but there is a very small risk of death after complex febrile seizures ( CFSs ) , particularly febrile status epilepticus .
There is no evidence that SUDEP ( sudden unexpected death in epilepsy ) occurs in association with febrile seizures .
There is no evidence of any risk of hippocampal or mesial temporal sclerosis ( HS/MTS ) in association with simple febrile seizures . |
MS211204 | ***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 was to analyse the magnitude , direction and predictors of change in the main hospital discharge diagnosis ( HDD ) after a clinical expert review , among patients included in a multicentre molecular epidemiologic study of biliopancreatic diseases . Methods : A total of 602 patients with a suspicion diagnosis of pancreas cancer ( PC ) , cancer of the extrahepatic biliary system ( CEBS ) or benign biliopancreatic pathologies ( BPP ) were prospect ively recruited at five general hospitals . A structured form was used to collect information from medical records . A panel of experts revised all diagnostic information and established the main clinico-pathological diagnosis ( CPD ) by consensus . Results : Of the 204 cases with a HDD of PC , 176 ( 86 % ) were deemed to have a CPD of PC , eight of CEBS , twelve a neoplasm of different origin , four BPP and four syndromic diagnoses . Thus , 28 cases ( 14 % ) were false positives . Of the 129 patients with a HDD of CEBS , 15 ( 12 % ) were false positives . Nine of the 396 cases with a HDD of non-PC ( 2 % ) had a CPD of PC ( false negatives ) , whilst 14 of 471 patients with a HDD of non-CEBS ( 3 % ) were deemed to have CEBS . Overall , sensitivity and specificity of HDD for PC were , respectively , 95 and 93 % , and for CEBS , 89 and 97 % . Cytohistological confirmation and laparotomy were independent predictors of diagnostic change . Conclusions : Validity of the HDD was high , but its association with some clinical variables suggests that sole reliance on HDD can significantly bias results , and highlights the need to review all HDDs . Alternatively , only patients at high risk of misdiagnosis could be review ed : primarily , those lacking a cytohistological diagnosis or a laparotomy . No exclusions appear warranted solely on the basis of age , gender or tumour spread Clinical data repositories represent a potential gold mine of information and knowledge . Rapid access to such information can help bridge the gap between clinical care and research , support clinical and executive decision making , and improve the quality of care . A clinical data base can be used in four ways : to display information about an individual patient ( results reporting ) ; to find data on a patient with similarities to one being seen ( case finding ) ; to describe a group of patients with at least one attribute in common ( cohort description ) ; and to analyze data patterns in terms of trends or relationships ( predictive modeling ) . It seems unlikely that many important clinical questions will be subject to r and omized clinical trials because of the ethics , logistics , and expense that would be involved . Evolving statistical and epidemiological methods allow us to approach these clinical data repositories with the purpose of building predictive models , but a clear underst and ing of the limitations of routinely collected clinical data and the inherent biases is necessary . The largest barrier to using routinely collected clinical data is not the limitations of the data themselves , but rather the lack of a data paradigm for the decision-maker . We present some of the problems and pitfalls in obtaining and using routinely collected data , based upon the use of ClinQuery at Boston 's Beth Israel Hospital and the re sources and traditions at the Mayo Clinic Information on coronary heart disease ( CHD ) obtained from the Finnish Hospital Discharge and Cause-of-Death Registers was compared with that collected in the Helsinki Heart Study ( HHS ) during an 8.5-year follow-up . The purpose of the comparison was two-fold , firstly , to study the accuracy of registration of CHD and secondly , to find out what diagnostic codes to use for CHD in register-based follow-up studies . The HHS cases were used as the ' golden st and ard ' and the CHD deaths and definite nonfatal acute myocardial infa rct ions ( AMIs ) ( all diagnoses ) were taken from the registers to establish the sensitivity of the Hospital Discharge and Cause-of-Death Registers combined . The sensitivity was 0.84 during the period 1980 - 86 and 0.87 during 1987 - 90 , with the positive predictive values 0.94 and 0.92 respectively . The treatment effects seen in the HHS were compared with the effects that would have emerged , if register-based information only had been used with different definitions of CHD . Of the register-based calculations , the one with the definition ' all CHD deaths and hospitalizations with the ICD-8 code 410 ' came closest to the HHS result , with a 32 % reduction ( P=0.028 one-sided ) of CHD incidence , while the original HHS result was a 34 % reduction ( P=0.008 one sided ) . However , when comparing Kaplan-Meier plots of cumulative hazards of CHD , the plot with a wider definition of CHD ( ICD-8 and ICD-9 codes 410 - 414 ) came closest to the HHS experience , especially if revascularizations were included in the latter . Definite AMI as a single definition of CHD might thus not be sufficient when study ing CHD risk , instead , at least two parallel definitions of CHD should be used OBJECTIVE : To assess the validity of obstetric complications , including the Joint Commission on Accreditation of Healthcare Organizations ( JCAHO ) Core Measure on perineal lacerations , in the California Patient Discharge Data Set . METHODS : We r and omly sample d 1,611 deliveries from 52 of the 267 hospitals that performed more than 678 eligible deliveries in California in 1992–1993 . We compared hospital-reported complications against our recoding of the same records . RESULTS : Third- and fourth-degree perineal lacerations were reported accurately , with estimated sensitivities exceeding 90 % and positive predictive values exceeding 65 % ( weighted to account for the stratified sampling design ) or 85 % ( unweighted ) . Based on in-depth review of discrepant cases , we estimate the actual positive predictive value at over 90 % . Most coding discrepancies were between no injury and first degree , or between first and second degree . Most postpartum complications , including urinary tract and wound infections , endometritis , anesthesia complications , and postpartum hemorrhage were reported with less than 70 % sensitivity , but at least 80 % positive predictive value . Composite measures from Health Grade s and Solucient , which include these complication codes , also suffer from high false-negative rates . CONCLUSION : Third- and fourth-degree perineal lacerations are accurately reported on hospital discharge abstract s , confirming the validity of related quality indicators sponsored by the Agency for Healthcare Research and Quality and JCAHO . Administrative data seem less useful for monitoring other in-hospital postpartum complications . LEVEL OF EVIDENCE : In order to measure the coverage and accuracy of the Hospital In-patient Enquiry Scheme data in a large acute hospital in Dublin , 793 patient charts were selected r and omly from all the discharges in 1990 . The capture rate was 56 % . Whether a diagnosis was captured for the Hospital In-patient Enquiry Scheme depended partly upon geographical factors within the hospital and partly upon the nature of the diagnosis . " Non-capture " was not r and om and was particularly likely to occur where the case was complex , e.g. oncology , HIV infection . The coding accuracy of primary diagnoses was 59 % and the completeness of recording of secondary diagnoses was 56 % . Both were significantly associated with the presence in the hospital chart of discharge summaries and with the clarity and source of written diagnoses . The factors that affected accuracy were not the same as those affecting the capture rate BACKGROUND Concept-based Indexing is purported to provide more granular data representation for clinical records.1,2 This implies that a detailed clinical terminology should be able to provide improved access to clinical records . To date there is no data to show that a clinical reference terminology is superior to a precoordinated terminology in its ability to provide access to the clinical record . Today , ICD9-CM is the most commonly used method of retrieving clinical records . OBJECTIVE In this study , we compare the sensitivity , specificity , positive likelihood ratio , positive predictive value and accuracy of SNOMED-RT vs. ICD9-CM in retrieving ten diagnoses from a r and om sample of 2,022 episodes of care . METHOD We r and omly selected 1,014 episodes of care from the inpatient setting and 1,008 episodes of care from the outpatient setting . Each record had associated with it , the free text final diagnoses from the Master Sheet Index at the Mayo Clinic and the ICD9-CM codes used to bill for the encounters within the episode of care . The free text diagnoses were coded by two expert indexers ( disagreements were addressed by a Staff Clinician ) as to whether queries regarding one of 5 common or 5 uncommon diagnoses should return this encounter . The free text entries were automatically coded using the Mayo Vocabulary Processor . Each of the ten diagnoses was exploded in both SNOMED-RT and ICD9-CM and using these entry points , a retrieval set was generated from the underlying corpus of records . Each retrieval set was compared with the Gold St and ard created by the expert indexers . RESULTS SNOMED-RT produced significantly greater specificity in its retrieval sets ( 99.8 % vs. 98.3 % , p<0.001 McNemar Test ) . The positive likelihood ratios were significantly better for SNOMED-RT retrieval sets ( 264.9 vs. 33.8 , p<0.001 McNemar Test ) . The positive predictive value of a SNOMED-RT retrieval was also significantly better than ICD9-CM ( 92.9 % vs. 62.4 % , p<0.001 McNemar Test ) . The accuracy defined as 1 ( the total error rate ( FP+FN ) / Total # episodes queried ( 20,220 ) ) was significantly greater for SNOMED-RT ( 98.2 % vs. 96.8 % , p=0.002 McNemar Test ) . Interestingly , the sensitivity of the SNOMED-RT generated retrieval set was not significantly different from ICD9-CM , but there was a trend toward significance ( 60.4 % vs. 57.6 % , p=0.067 McNemar Test ) . However , if we examine only the outpatient practice SNOMED-RT produced a more sensitive retrieval set than ICD9-CM ( 54.8 % vs. 46.4 % , p=0.002 McNemar Test ) . CONCLUSIONS Our data clearly shows that information regarding both common and rare disorders is more accurately identified with automated SNOMED-RT indexing using the Mayo Vocabulary Processor than it is with traditional h and picked constellations of codes using ICD9-CM . SNOMED-RT provided more sensitive retrievals of outpatient episodes of care than ICD9-CM The accuracy of the discharge diagnoses recorded in hospital medical records , and the accuracy of their ICD codes , were retrospectively examined in 174 r and omly chosen hospital patients . There was a 29 % error rate in the recorded ICD codes when compared at a three digit level to the results obtained by retrospectively review ing the records , establishing diagnoses and coding them . The error rate increased when medical records coders , rather than medically trained personnel , undertook the task of establishing the discharge diagnoses How well can hospital discharge abstract s be used to estimate patient health status ? This paper compares information on comorbidity obtained from hospital discharge abstract s for patients undergoing prostatectomy or cholecystectomy at a Winnipeg teaching hospital with clinical data on preoperative medical conditions prospect ively collected during an Anesthesia Follow-up study . The diagnostic information on cardiovascular disease , respiratory disease , and metabolic disorders showed considerable agreement , ranging from 65 to over 90 % correspondence across the two data sets . Certain conditions noted by the anesthesiologist were often absent from the cl aims data ; cardiovascular disease was recorded in the clinical data but absent from the cl aims for 31 % of prostatectomy and 17 % of cholecystectomy cases . Such patients were less likely to have been assigned a high score on the ASA Physical Status measure or to have high-risk diagnoses on the hospital file . Similar findings result ed from comparing the two sources in their ability to predict such adverse outcomes as mortality and readmission to hospital : the anesthesia file generally included less serious comorbidity AIMS To investigate the accuracy of admission and discharge coding of traumatic brain injury ( TBI ) in a New Zeal and hospital . METHOD Prospect i ve study of all patients over fifteen years of age admitted to Hutt Hospital over a six-month period with an actual or potential diagnosis suggesting TBI . RESULTS During the six month period of study , 65 patients with the diagnosis of TBI were admitted to Hutt Hospital . Of these , 21 ( 32.3 % ) met the criteria for diagnosis of TBI ( ' Definite TBI ' ) . A further eighteen patients , not admitted with a diagnosis of TBI , met the TBI criteria . Only 14/39 ( 35.9 % ) of ' Definite TBI ' cases were identified at both admission and discharge . Discharge diagnosis of TBI identified correctly 26/39 ( 66.7 % ) of definite cases , with 34/60 ( 56.7 % ) cases with a discharge diagnosis of TBI not meeting our criteria for the diagnosis of TBI . Six out of 39 ' Definite TBI ' cases ( 15.4 % ) were not identified by either admission or discharge diagnosis . Thirty of the 65 patients ( 46.2 % ) admitted to hospital with the diagnosis of TBI showed clinical evidence of having taken alcohol , although only 12 had blood alcohol concentration measured .
Output:
| Variability in quality of care between setting s can easily be overshadowed by variability in data quality .
However , the use of DHDD by physicians to evaluate their own medical practice may be useful .
But only if physicians are willing to critically interpret the meaning of the information for their medical practice assessment |
MS211205 | ***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: 200 adult respiratory distress syndrome patients were included in a prospect i ve multicenter r and omized trial to determine the efficacy of computerized decision support . The study was done in 10 medical centers across the United States . There was no significant difference in survival between the two treatment groups ( mean 2 = 0.49 p = 0.49 ) or in ICU length of stay between the two treatment groups when controlling for survival ( F(1df ) = 0.88 , p = 0.37 . ) There was a significant reduction in morbidity as measured by multi-organ dysfunction score in the protocol group ( F(1df ) = 4.1 , p = 0.04 ) as well as significantly lower incidence and severity of overdistension lung injury ( F(1df ) = 45.2 , p < 0.001 ) . We rejected the null hypothesis . Efficacy was best for the protocol group . Protocol s were used for 32,055 hours ( 15 staff person years , 3.7 patient years or 1335 patient days ) . Protocol s were active 96 % of the time . 38,546 instructions were generated . 94 % were followed . This study indicates that care using a computerized decision support system for ventilator management can be effectively transferred to many different clinical setting s and significantly improve patient morbidity We developed a computer-stored medical record system containing a limited set of the total clinical data base -- primarily diagnostic studies and treatments . This system responds to its own content according to physician-authored reminder rules . To determine the effect of the reminder messages generated by 1490 rules on physician behavior , we r and omly assigned practitioners in a general medicine clinic to study or control groups . The computer found indications for six different actions per patient in 12 467 patients during a 2-year study : 61 study group residents who received computer reminders responded to 49 % of these indications ; 54 control group residents , to only 29 % ( p less than 0.0001 ) . Preventive care ( occult blood testing , mammographic screening , weight reduction diets , influenza and pneumococcal vaccines ) was affected . The intentions of the study group to use a given action for an indication predicted their response to the indications ( p less than 0.03 , r2 = 0.33 ) . The intentions of the control residents did not Three dosage-prediction methods for initial in-hospital stabilization of warfarin therapy were evaluated . Adult in patients who had received warfarin sodium 10 mg daily for less than three days were eligible for the study . After receiving their third warfarin dose , patients were r and omly assigned to have their warfarin dosages adjusted using one of three dosage-prediction methods : by analog computer ( n = 31 ) , linear regression ( n = 22 ) , or empiric dosing by the physician ( n = 34 ) . A prothrombin time ( PT ) ratio ( patient PT divided by control PT ) between 1.3 and 2.5 was considered to be in the therapeutic range . For patients who achieved a stable PT ratio ( defined as a PT ratio between 1.3 and 2.5 that varied by less than 0.05 on two consecutive days or by less than 0.1 on three consecutive days without a dosage change ) before discharge , the number of days ( time to stabilization ) from administration of the first warfarin dose to achievement of the warfarin dosage that produced a stable PT ratio ( stabilization dosage ) was compared . A total of 54 patients met the study criteria for a stable PT ratio before hospital discharge ( analog computer , n = 20 ; linear regression , n = 15 ; empiric dosing , n = 19 ) . The mean times to stabilization were 6.8 days in the analog-computer group , 7.3 days in the linear-regression group , and 8.4 days in the empiric-dosing group ; these times were not significantly different . All 20 stabilized patients in the analog-computer group achieved a stable PT ratio by the fourth dosage prediction . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To compare effects on premature infants ' weight gain of a computer-generated and a nurse-determined incubator humidity strategy . An optimal humidity protocol is thought to reduce time to regain birthweight . DESIGN Prospect i ve r and omized controlled design . SETTING Level IIIC neonatal intensive care unit in the Netherl and s. PARTICIPANTS Infants of 24 to 30 weeks gestational age with a birthweight less than 1,500 g. INTERVENTION Two incubator humidity strategies were studied : computer-generated and nurse-determined humidity . MAIN OUTCOME MEASURE Time needed to regain birthweight . RESULTS One hundred thirty six infants were enrolled : 65 were exposed to the computer-generated strategy and 71 to the nurse-determined strategy . Demographic characteristics were well balanced between groups , with birthweight 981 + /- 245 versus 991 + /- 213 g , mean gestational age 27.7 + /- 1.7 versus 27.7 + /- 1.6 weeks . Main outcome did not significantly differ between strategies : survival analysis showed an equal number of days needed to regain birthweight ( median 9 days , with 95 % CIs 8 - 10 and 7 - 11 for infants exposed to the computer-generated and nurse-determined humidity strategy , respectively ) . CONCLUSION Computer-generated strategy does not reduce the time needed to regain birthweight Guided dosing within a computerized provider order entry ( CPOE ) system is an effective method of individualizing therapy for patients . Physicians ' responses to guided dosing decision support have not been extensively studied . As part of a r and omized trial evaluating efficacy of dosing advice on reducing falls in the elderly , CPOE prompts to physicians for 88 drugs included tailored messages and guided dose lists with recommended initial doses and frequencies . The study captured all prescribing activity electronically . The primary outcome was the ratio between prescribed dose and recommended dose . Over 9 months , 778 providers entered 9111 study -related medication orders on 2981 patients . Physicians using guided orders chose recommended doses more often than controls(28.6 % vs. 24.1 % , p<0.001 ) . Selected doses were significantly lower in the intervention group ( median ratio of actual to recommended 2.5 , interquartile range [ 1.0,4.0 ] ) than the control group ( median 3.0 interquartile range [ 1.5,5.0 ] , p<0.001 ) . While physicians selected the recommended dose less than a third of the time , guided geriatric dosing modestly improved compliance with guidelines Background : To investigate whether intensive treatment with methotrexate ( MTX ) according to a strict protocol and a computerised decision program is more beneficial compared to conventional treatment with MTX in early rheumatoid arthritis . Methods : In a two-year multicentre open label strategy trial , 299 patients with early rheumatoid arthritis were r and omly assigned to the intensive strategy group or the conventional strategy group . Patients in both groups received MTX , the aim of treatment being remission . Patients in the intensive treatment group came to the outpatient clinic once every month ; adjustment of the MTX dosage was tailored to the individual patient on the basis of predefined response criteria , using a computerised decision program . Patients of the conventional strategy group came to the outpatient clinic once every three months ; they were treated according to common practice . Cyclosporine was added if patients had an inadequate response to maximal tolerated MTX doses . Results : Seventy six ( 50 % ) patients in the intensive strategy group achieved at least one period of remission during the two year trial , versus 55 patients ( 37 % ) in the conventional strategy group ( p = 0.03 ) . Areas under the curve for nearly all clinical variables were significantly lower — that is , there was a better clinical effect for the intensive treatment group compared with the conventional treatment group . Conclusion : The results of this study show that it is possible to substantially enhance the clinical efficacy early in the course of the disease by intensifying treatment with MTX , aim ing for remission , tailored to the individual patient . Furthermore , participating rheumatologists indicated that the computerised decision program could be a helpful tool in their daily clinical practice This study was undertaken to determine if a computerized pharmacokinetic program for adjusting theophylline infusion rates could attain a goal serum theophylline level more accurately than physician‐derived adjustments and what clinical impact this would have . Thirty‐five patients with diagnoses of asthma or chronic obstructive pulmonary disease were r and omized to a control group ( empiric ) or experimental group ( kinetic ) after initial theophylline levels were drawn from each group . After second levels were drawn , patients in the kinetic group had their infusion rates adjusted by the computerized pharmacokinetic program to achieve a level of 15 mg/L , whereas patients in the empiric group had their infusions adjusted empirically by the primary care physicians to achieve a serum theophylline level of 15 mg/L. A final theophylline level was obtained just before the infusion was discontinued . The kinetic group was closer to the goal level of 15 mg/L than the empiric group , but this was not statistically significant ( 14.8 ± 4.4 versus 12.6 ± 4.1 ; p > 0.05 ) . The total number of days that patients were receiving intravenous theophylline was slightly longer for the kinetic group ( 4.1 ± 3.3 versus 3.2 ± 1.5 ; p > 0.05 ) as was the total number of hospital days , but neither of these were statistically significant ( 11.4 ± 21.6 versus 8.8 ± 15.4 days ; p > 0.05 ) . There were no differences between the two groups in the number of subtherapeutic or toxic levels , and there were no significant differences in arterial blood gas measurements . We were unable to show in this study any clinical advantage to adjusting the dosage of a theophylline infusion by a computerized pharmacokinetic program compared with adjustments made empirically by a physician OBJECTIVE To assess the impact of an automated intraoperative alert to redose prophylactic antibiotics in prolonged cardiac operations . DESIGN R and omized , controlled , evaluator-blinded trial . SETTING University-affiliated hospital . PATIENTS Patients undergoing cardiac surgery that lasted more than 4 hours after the preoperative administration of cefazolin , unless they were receiving therapeutic antibiotics at the time of surgery . INTERVENTION R and omization to an audible and visual reminder on the operating room computer console at 225 minutes after the administration of preoperative antibiotics ( reminder group , n = 137 ) or control ( n = 136 ) . After another 30 minutes , the circulating nurse was required to indicate whether a follow-up dose of antibiotics had been administered . RESULTS Intraoperative redosing was significantly more frequent in the reminder group ( 93 of 137 ; 68 % ) than in the control group ( 55 of 136 ; 40 % ) ( adjusted odds ratio , 3.31 ; 95 % confidence interval , 1.97 to 5.56 ; P < .0001 ) . The impact of the reminder was even greater when compared with the 6 months preceding the study period ( 129 of 480 ; 27 % ; P < .001 ) , suggesting some spillover effect on the control group . Redosing was formally declined for 19 of the 44 patients in the reminder group without redosing . The rate of surgical-site infection in the reminder group ( 5 of 137 ; 4 % ) was similar to that in the control group ( 8 of 136 ; 6 % ; P = .42 ) , but significantly lower than that in the pre- study period ( 48 of 480 ; 10 % ; P = .02 ) . CONCLUSION The use of an automatic reminder system in the operating room improved compliance with guidelines on perioperative antibiotic prophylaxis OBJECTIVES To evaluate the effectiveness of computer-assisted decision support in reducing potentially inappropriate prescribing to older adults . DESIGN R and omized , controlled trial . SETTING An academic emergency department ( ED ) in Indianapolis , Indiana , where computerized physician order entry was used to write all medication prescriptions . PARTICIPANTS Sixty-three emergency physicians were r and omized to the intervention ( 32 physicians ) or control ( 31 physicians ) group . INTERVENTION Decision support that advised against use of nine potentially inappropriate medications and recommended safer substitute therapies . MEASUREMENTS The primary outcome was the proportion of ED visits by seniors that result ed in one or more prescriptions for an inappropriate medication . The main secondary outcomes were the proportions of medications prescribed that were inappropriate and intervention physicians ' reasons for rejecting the decision support . RESULTS The average age of the patients was 74 , two-thirds were female , and just over half were African American . Decision support was provided 114 times to intervention physicians , who accepted 49 ( 43 % ) of the recommendations . Intervention physicians prescribed one or more inappropriate medications during 2.6 % of ED visits by seniors , compared with 3.9 % of visits managed by control physicians ( P=.02 ; odds ratio=0.55 , 95 % confidence interval=0.34 - 0.89 ) . The proportion of all prescribed medications that were inappropriate significantly decreased from 5.4 % to 3.4 % . The most common reason for rejecting decision support was that the patient had no prior problems with the medic
Output:
| Conclusion The majority of CCDSSs demonstrated improvements in process of care , but patient outcomes were less likely to be evaluated and far less likely to show positive results |
MS211206 | ***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 aim of the present study was to compare the effect of transcutaneous electric nerve stimulation ( TENS ) with the flat occlusal splint in the treatment of temporom and ibular joint ( TMJ ) disk displacement without reduction . Thirty-one patients were included and r and omly selected to be treated 6 weeks with either TENS ( 90 Hz , 30 min , three times/day ) or with a flat occlusal splint ( 24 h/day . Those selected for the TENS group had one electrode placed over the painful TMJ and another electrode over the anterior temporal muscle . The splint group used a conventional flat occlusal splint with cuspid guidance . Both treatment groups visited the clinic once a week . Symptoms and signs were registered before and after treatment . The intensity of pain was recorded with a visual analogue scale ( VAS ) and with an electronic pocket-sized recorder ( Pain-Track ) carried 1 week before and also the last week of treatment for continuous registration of pain . Measured with the VAS , half of the patients treated with splints became pain-free or their TMJ pain improved at least 50 % both at rest and with jaw function compared with only 6 % in the TENS-treated group . With regard to strictly chewing pain , the VAS-registered pain improved in two-thirds of the splint group , compared with 50 % of the TENS group . With the Pain-Track device it was found that in most individuals pain was aggrevated at mealtimes . The conclusion was that flat occlusal splints in several respects are better than TENS in the treatment of symptoms associated with TMJ disk displacement without reduction BACKGROUND The authors compared the efficacy of bilateral balanced and canine guidance ( occlusal ) splints in the treatment of temporom and ibular joint ( TMJ ) pain in subjects who experienced joint clicking with a nonoccluding splint in a double-blind , controlled r and omized clinical trial . METHODS The authors r and omly assigned 57 people with signs of disk displacement and TMJ pain into three groups according to the type of splint : bilateral balanced , canine guidance and nonoccluding . The authors followed the groups for six months using analysis of a visual analog scale ( VAS ) , palpation of the TMJ and masticatory muscles , m and ibular movements and joint sounds . They used repeated analysis of variance and a chi(2 ) test to test the hypothesis . RESULTS The type of guidance used did not influence the pain reduction , yet both occlusal splints were superior to the nonoccluding splint , on the basis of the VAS . Despite similar outcomes in relation to opening , left lateral and protrusive movements , TMJ and muscle pain on palpation , subjects who used the occlusal splints had improved clinical outcomes . The frequency of joint noises decreased over time , with no significant differences among groups . Subjects in the groups using the occlusal splints reported more comfort . CONCLUSION The type of lateral guidance did not influence the subjects ' improvement . All of the subjects had a general improvement on the VAS , though subjects in the occlusal splint groups had better results that did subjects in the nonoccluding splint group AIMS To compare the short-term efficacy of treatment with a stabilization appliance compared with that of a non-occlusal , control appliance in patients with temporom and ibular disorders ( TMD ) of mainly myogenous origin . METHODS A r and omized , controlled trial was performed with 60 patients suffering from myofascial pain . Patients were r and omly assigned to a treatment or a control group . The treatment group was treated by means of a stabilization appliance and the control group by means of a non-occlusal appliance . Symptoms and signs were registered before and after 10 weeks of treatment . RESULTS Improvement of overall subjective symptoms was reported in both groups , but significantly more often in the treatment group than in the control group ( P = .000 ) . The prevalence of daily or constant pain showed a significant reduction in the treatment group ( P = .028 ) compared with the control group . There was a significant decrease in the number of tender masticatory muscles in the treatment group ( P = .018 ) compared with the control group . CONCLUSION The results of this short-term evaluation suggest that the stabilization appliance is more effective in alleviating symptoms and signs in patients with TMD of mainly myogenous origin than a control , non-occlusal appliance . The stabilization appliance can therefore be recommended for the therapy of these patients PURPOSE We performed a comparative evaluation of different types of splint therapy for anterior disc displacement without reduction ( ADDWR ) of the temporom and ibular joint . PATIENTS AND METHODS Seventy-four patients agreed to participate ( 65 females and 9 males ) . All patients were examined using a clinical temporom and ibular joint disorder examination protocol , including muscle palpation , m and ibular range-of-motion measurement , and joint sound detection . Additionally , the patients marked their pain ( during chewing , m and ibular movements , and rest position ) and limitation levels on a visual analog scale . Bilateral magnetic resonance images were acquired , confirming ADDWR in at least one joint . After clinical examination and imaging , r and omized splint therapy was provided : 38 patients received a centric splint , while 36 received a distraction splint . After 1 , 3 , and 6 months of therapy , outcome was evaluated using the Wilcoxon signed rank test for matched pairs . Success after 6 months was defined as improvement in active mouth opening of greater than 20 % and pain reduction ( on chewing ) of at least 50 % . Success was statistically verified using logistic regression test . RESULTS The improvements in mouth opening were significant in both groups . The improvements in pain on chewing , pain during other functions , pain at rest , functional limitation on chewing , and other functions were also comparable in both groups . However , the logistic regression test suggested that patients using centric splints were treated more successfully than the others ( confidence interval , 1.014 to 8.741 , odds ratio = 2.785 ) . CONCLUSIONS Centric splints seem to be more effective than distraction splints . Therefore , before the surgical treatment of ADDWR , centric splints should be used instead of distraction splints In order to evaluate and compare the effects of biofeedback and occlusal splint therapy on m and ibular dysfunction , 30 patients were r and omly divided into two treatment groups . The patients were women aged 20 - -40 years without any obvious organic reasons for their symptoms . There were no significant differences between the two groups before the start of treatment in respect of signs and symptoms of m and ibular dysfunction . One group used full coverage splints at night for 6 weeks . The other group received biofeedback training up to six times , 30 min per session . One month after completion of the therapy the patients were re-examined . Both groups showed a significant reduction in symptoms , both subjectively and clinical ly . No significant differences between the groups were found . The two treatments were thus equally effective in the short-term perspective in patients with signs and symptoms of m and ibular dysfunction Sixty-three patients with an arthrographic diagnosis of disk displacement with reduction were r and omly assigned to three treatment groups : ( I ) onlays to maintain disk repositioning , ( II ) flat occlusal splint , or ( III ) untreated controls . Guidance for construction of the disk-repositioning onlays was established during arthrography to obtain a recaptured disk position relative to the condyle . The onlays were cemented to the teeth and maintained the new intercuspal position anteriorly and inferiorly . The flat occlusal splint was used at night only and was adjusted to maintain a maximal occlusal contact in centric relation and centric occlusion . Clinical examinations were performed before and after 6 months of treatment . The disk-repositioning onlays improved joint function and reduced joint and muscle pain when compared with the flat occlusal splint and with nontreatment . The signs and symptoms in the flat occlusal splint group were no different from those in the control group . It is concluded that disk-repositioning onlays are effective in reducing pain and dysfunction associated with disk displacement with reduction in patients in whom the disk can be maintained in a normal relationship to the condyle with the aid of such onlays . The symptoms , however , returned when the onlays were removed after 6 months ; this raises the question of whether a permanent change in the intercuspal position is necessary for long-term success Forty-five individuals with long-st and ing facial pain or headache of muscular origin were r and omly allocated into three groups . The first group was treated with acupuncture , the second group received an occlusal splint , and the third group served as controls . Both acupuncture and occlusal splint therapy significantly reduced subjective symptoms and clinical signs from the stomatognathic system . No differences between these two groups were found with regard to treatment effects . It is concluded that acupuncture is an alternative method to conventional stomatognathic treatment for individuals with craniom and ibular disorders of muscular origin To assess the differential efficacy of two commonly used treatments for temporom and ibular disorders ( TMD ) , intraoral appliances ( IAs ) and biofeedback ( BF ) , separately and in combination , two studies were conducted . The first study directly compared IA treatment , a combination of biofeedback and stress management ( BF/SM ) , and a waiting list control group in a sample of 80 TMD patients . Both treatments were determined to be equally credible to patients , ruling out this potential threat to the validity of the results obtained . The results demonstrated that the IA treatment was more effective than the BF/SM treatment in reducing pain after treatment , but at a 6-month follow-up the IA group significantly relapsed , especially in depression , whereas the BF/SM maintained improvements on both pain and depression and continued to improve . The second study examined the combination of IA and BF/SM in a sample of 30 TMD patients . The results of this study demonstrated that the combined treatment approach was more effective than either of the single treatments alone , particularly in pain reduction , at the 6-month follow-up . These results support the importance of using both dental and psychologic treatments to successfully treat TMD patients if treatment gains are to be maintained BACKGROUND Treatment recommendations for patients with painful temporom and ibular disorders ( TMDs ) range from conservative treatments such as physiotherapy to aggressive and irreversible treatments such as restorative reconstruction and joint surgery . METHODS The authors r and omized 200 subjects diagnosed with TMD into three groups : usual conservative , dentist-prescribed self-care treatment without any intraoral splint appliance ( UT ) ; UT plus a conventional flat-plane hard acrylic splint ( HS ) ; and UT plus a soft vinyl ( a low-cost athletic mouth guard ) splint ( SS ) . Subjects completed question naires and clinical examinations at three , six and 12 months . RESULTS The authors observed no significant differences among the groups in TMD-related pain levels or other common signs and symptoms of TMD at baseline ( BL ) or at any follow-up . The changes from BL were comparable for all three groups . The authors did not note any significant differences at any follow-up for compliance with study protocol s or for occurrences of adverse effects from either splint type . For HS versus SS , there were significant differences in rates of splint use , but these differences were not accompanied by differences in either self-reported symptoms or in clinical findings . CONCLUSIONS All patients improved over time , and traditional splint therapy offered no benefit over the SS splint therapy . Neither splint therapy provided a greater benefit than did self-care treatment without splint therapy . CLINICAL IMPLICATION S These findings suggest that clinicians who treat patients with TMD should consider prescribing low-cost nonsplint self-care therapy for most patients The aim of this study was to investigate if the difference in treatment outcome between patients provided with a stabilisation appliance and a control appliance was due to the treatment and /or other factors in patients with temporom and ibular disorders ( TMD ) of arthrogeneous origin . Sixty patients were assigned to two equally sized groups : a treatment group , treated with a stabilisation appliance , and a control group given a control appliance . Thirteen possible background variables for the treatment outcome were correlated to changes in severity of temporom and ibular joint ( TMJ ) pain on a verbal scale in the two patient groups . The logistic regression analyses revealed that , after correcting for the background variables , stabilisation appliance treatment was a strong explanatory factor for a positive treatment outcome , with a significance of P = 0.0013 compared to patients belonging to the control group . Background variables of significant importance for the treatment outcome were male sex ( positive ) ( P = 0.0268 ) , and severe or very severe TMJ pain ( negative ) ( P = 0.0034 ) . These findings indicate that not only the treatment with a stabilisation appliance but also sex and the intensity of the TMJ pain before treatment might influence the treatment outcome in patients with TMD of arthrogeneous origin The aim of the investigation was to compare the effect on signs and symptoms of temporom and ibular disorders ( TMD ) of two different interocclusal appliances . Thirty patients with signs and symptoms of TMD received either a stabilisation splint or a new kind of splint based on the concept of nociceptive trigeminal inhibition ( NTI ) . A clinical examination was performed and subjective symptoms were registered before start of treatment and after 3 and 6 months . All participants were offered to change to the other type of splint at the 3-month follow-up in case of no improvement or impairment of their symptoms . One subject in each group was lost early during the investigation . The mean time for taking impressions , to make inter-occlusal recording and to adjust the stabilisation splints was 17 minutes . The mean time to fit and adjust the NTI splints was 27 minutes . At the 3-month follow-up , 4 patients that had received NTI splints accepted the offer to change to stabilisation splints due to no improvement or impairment of their symptoms . These treatments were judged as failures . No one in the stabilisation splint group utilised the offer to change treatment . At the 6-month follow-up , 7 of the remaining 10 subjects with NTI splints reported some ( n = 1 ) or significant ( n = 6 ) improvement
Output:
| Hard stabilization appliances , when adjusted properly , have good evidence of modest efficacy in the treatment of TMJD pain compared to non-occluding appliances and no treatment .
Other types of appliances , including soft stabilization appliances , anterior positioning appliances , and anterior bite appliances , have some RCT evidence of efficacy in reducing TMJD pain . |
MS211207 | ***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 The purpose of this study was to estimate whether the efficacy of treatment with intravaginal misoprostol for first-trimester pregnancy failure is enhanced by the addition of saline solution . STUDY DESIGN Eighty women with embryonic/fetal death or anembryonic pregnancy were assigned r and omly to receive either 800 microg of misoprostol with saline solution ( group I , 41 women ) or without ( group II , 39 women ) . Treatment was repeated on day 3 if the gestational sac remained . Curettage was performed if the gestational sac remained on day 8 or as necessary during at least 30 days of follow-up . Data were analyzed with the Student t test and the chi(2 ) or Fisher exact test . RESULTS By the first follow-up visit , 73 % ( group I ) and 64 % ( group II ) of women passed the gestational sac ( P=.38 ) . By the second follow-up visit , expulsion rates were 83 % and 87 % , respectively ( P=.59 ) . Five subjects in each group underwent curettage . CONCLUSION Misoprostol is effective for the treatment of failed first-trimester pregnancy . The expulsion rate is not improved by adding saline solution BACKGROUND We aim ed to compare patients ' health-related quality of life after a misoprostol strategy to a curettage in women with early pregnancy failure after failed expectant management . METHODS A multicentre r and omized clinical trial was performed in The Netherl and s. In all , 154 women with early pregnancy failure confirmed at ultrasonography who had been managed expectantly unsuccessfully for > or = 1 week were r and omly assigned to undergo either treatment with misoprostol ( n=79 ) or curettage ( n=75 ) . The main outcome measures were health-related quality of life and satisfaction with treatment . RESULTS In the misoprostol strategy 47 % of the women needed additional curettage , as compared to 4 % after curettage . In both groups , health-related quality of life was impaired most severely 2 days after treatment . In the misoprostol group , health-related quality of life was more severely impaired ; after 2 days this was due to more pain and after 2 and 6 weeks this was due to a worse general health perception . Health-related quality of life was temporarily significantly more impaired in women in whom misoprostol failed as compared to women in whom misoprostol treatment was successful . In both treatment groups , an equal percentage of women ( 58 % ) would choose the same treatment in the future . In women treated with misoprostol , however , this choice depended on the initial success of misoprostol : in cases where misoprostol had caused complete evacuation , 76 % of the women would opt for the same treatment , whereas only 38 % of women who needed curettage after unsuccessful misoprostol would do so ( P<0.01 ) . CONCLUSION Our study shows that , although both the misoprostol strategy and the curettage strategy result ed in complete evacuation in the end , women are willing to accept some disadvantages of misoprostol to avoid curettage . A treatment inconvenience using misoprostol is accepted as long as initial evacuation rate is high . This finding should be an integral part of counselling women when deciding upon management of early pregnancy failure BACKGROUND Responses to miscarriage range from relief to devastation , yet there have been no r and omized controlled studies that demonstrate significant effects of counseling with women who miscarry . OBJECTIVE To test the effects of caring-based counseling , measurement , and time on the integration of loss ( miscarriage impact ) and women 's emotional well-being ( moods and self-esteem ) in the first year after miscarrying . METHOD ANCOVA was used in this r and omized , longitudinal Solomon four-group experimental investigation . Enrolled were 242 ; 185 completed . Outcomes included : self-esteem , overall emotional disturbance , anger , depression , anxiety , confusion , overall miscarriage impact , personal significance , devastating event , lost baby , and isolated . RESULTS During the first year after loss ( a ) caring was effective in reducing overall emotional disturbance , anger , and depression ; and ( b ) time passing led to increased self-esteem and decreased anxiety , depression , anger , confusion , and personal significance of loss . CONCLUSION Caring , measurement , and time had some positive and significant effects on the integration of loss and enhancement of well-being in the first year subsequent to miscarrying BACKGROUND Dilatation and curettage ( D&C ) has been the usual treatment for early pregnancy failure ( EPF ) . Medical management with misoprostol may be an effective alternative . Bleeding patterns during and after medical management of EPF are unknown . METHODS A prospect i ve cohort study was conducted at University-based clinics and physician offices . Eighty women < 11 weeks estimated gestational age with a diagnosis of missed abortion or fetal demise were enrolled . Treatment consisted of either 800 micro g of moistened ( 2 ml of saline ) or dry vaginal misoprostol . Self-reported bleeding and sanitary product usage were recorded in a daily 2 week diary . Haemoglobin was assessed at enrollment and 2 weeks later . RESULTS After misoprostol treatment , patients reported bleeding or spotting every day for the 14 days observed . Self-assessed heavy bleeding days were few ( median 3 ) and usually occurred immediately after treatment . Sanitary pad use was highly variable ( mean 30.5 , range 2 - 125 pads over the 2 week period ) and not related to changes in haemoglobin . The mean decrease in haemoglobin was 0.5 g/dl ( SD 1.2 ) . Complete expulsion without D&C occurred in 85 % of subjects . CONCLUSIONS Bleeding for at least 2 weeks after vaginal misoprostol for EPF is common . Heavy bleeding is usually limited to a few days after treatment . Clinical ly important changes in haemoglobin are rare OBJECTIVE The purpose of this study was to compare the psychologic impact and client satisfaction of routine surgical evacuation of the uterus with medical evacuation in cases of spontaneous abortion . STUDY DESIGN This was a prospect i ve , r and omized controlled trial . Two hundred eighteen women who were admitted to a university teaching hospital after spontaneous abortion and who consented to the study were r and omized to routine surgical evacuation or medical evacuation of the uterus with the use of misoprostol . General psychologic well-being , level of depression , fatigue symptoms , psychiatric morbidity , social functioning , client satisfaction , and acceptance were measured in the 2 groups . RESULTS The 2 groups did not differ in any of the measured psychological outcomes . Significantly more participants who experienced successful evacuation of the uterus with the misoprostol protocol would choose the same mode of treatment if they were able to choose again . However , participants for whom the medical treatment failed to evacuate the uterus and subsequent surgical evacuation was required are significantly less satisfied with the treatment . CONCLUSION Medical treatment of spontaneous abortion with misoprostol is psychologically safe and more compatible with the ethnomedical beliefs of our Chinese participants . Client satisfaction and acceptance should be taken into consideration in the evaluation of treatment outcomes OBJECTIVE To evaluate serial hormone concentrations in subjects treated with vaginally administered misoprostol for early pregnancy failure . DESIGN As part of a r and omized clinical trial , serum was collected on treatment days 1 , 3 , 8 , and 15 . SETTING Multicenter clinical trial . PATIENT(S ) Women with a nonviable first-trimester pregnancy . INTERVENTION(S ) Serum concentrations of human chorionic gonadotropin ( hCG ) , progesterone , and sex hormone binding globulin ( SHBG ) were evaluated . MAIN OUTCOME MEASURE(S ) A logistic regression model was constructed to assess the associations of percent and complete expulsion of the gestational sac and /or successful management . RESULT ( S ) The percent change from the day of treatment until the first follow-up visit was predictive for complete expulsion for progesterone ( P ) ( P<.005 ) and hCG ( P<.005 ) , but not for SHBG . The actual value was not significantly associated with complete expulsion or successful management . A decrease ( day 1 - 3 ) of 79 % for both hCG and P was associated with a 90 % probability of complete passage of the gestational sac . A 90 % probability of successful management was noted if P decreased by 78 % on day 3 or 59 % on day 7 , or hCG decreased by 74 % on day 3 or 78 % on day 7 compared with pretreatment values . CONCLUSION ( S ) Percent change , but not absolute change , in serial hormone values are strongly associated with both the complete expulsion of the gestational sac with one dose of misoprostol and ultimate success BACKGROUND The increased pressure on health care expenses implies that physicians should consider economic aspects as part of the clinical decision-making process . Direct and indirect costs of a strategy starting with misoprostol in treatment of early pregnancy failure as compared to curettage is therefore performed . METHODS We performed a cost-minimization analysis alongside a multicentre r and omized trial . Clinical data and data on the use of medical re sources were obtained from a r and omized trial comparing misoprostol and curettage , which had shown that misoprostol reduced the need for curettage in 53 % . In a sensitivity analysis the percentage of women who needed curettage after misoprostol varied between 25 and 90 % . RESULTS Direct costs per case were significantly lower in the misoprostol group ( mean 433 ) than in the curettage group ( mean 683 ) ( mean difference 250 , 95 % CI 184 to 316 , P < 0.001 ) . These significant differences existed under a wide range of alternative assumptions about unit costs . The differences in direct cost in favour of misoprostol were large for women who had complete evacuation after initial misoprostol treatment as compared to those who needed additional curettage after failed misoprostol . Mean indirect costs were equal for both groups ( misoprostol mean 486 ; curettage mean 428 ; mean difference 60 , 95 % CI -61 to 179 , P = 0.51 ) . The mean total costs for a strategy starting with misoprostol was 915 versus 1107 for curettage , with a mean difference between both groups of 192 ( 95 % CI 33 to 351 , P = 0.04 ) . An increase of the complete evacuation rates for initial misoprostol therapy to 90 % in the sensitivity analysis increased the cost difference between misoprostol and curettage to 550 . CONCLUSION The use of misoprostol for early pregnancy failure after failed expectant management is less costly than curettage Objectives To compare fertility rates after the three methods of managing early miscarriage in women recruited to the MIST ( miscarriage treatment ) r and omised controlled trial . Setting Early pregnancy clinics of acute hospitals in the south west region of Engl and . Participants 1199 women who had had an early miscarriage ( < 13 weeks ) confirmed by scan . Intervention Expectant , medical , or surgical management . Main outcome measures Self reported pregnancy rates and live birth rates . Results Of 1199 women recruited to the trial , 1128 consented to follow-up . Of these , 762 women replied giving pregnancy details ( 68 % response rate ) . Respondents were representative of the trial participants . The live birth rate five years after the index miscarriage was similar in the three management groups : 177/224 ( 79 % , 95 % confidence interval 73 % to 84 % ) in the expectant management group , 181/230 ( 79 % , 73 % to 84 % ) in the medical group , and 192/235 ( 82 % , 76 % to 86 % ) in the surgical group . There was also no significant difference according to previous birth history . Older women and those with previous miscarriages were significantly less likely to subsequently give birth . Conclusion Method of miscarriage management does not affect subsequent pregnancy rates with around four in five women giving birth within five years of the index miscarriage . Women can be reassured that long term fertility concerns need not affect their choice of miscarriage management . Trial registration National Research Register N0467011677/N0467073587 Objective To estimate and compare the costs of surgical and medical treatment of miscarriage to the National Health Service OBJECTIVES To assess if there was any potential relationship between endometrial thickness and final treatment outcome in women successfully treated with misoprostol for a first trimester anembryonic gestation , embryonic demise or fetal demise . METHODS Eighty women were treated with up to two doses of misoprostol 800 microg vaginally for early pregnancy failure . Subjects were scheduled to return 2 ( range 1 - 4 ) , 7 ( range 5 - 9 ) and 14 ( range 12 - 17 ) days after treatment . Transvaginal ultrasonography was performed at each follow-up visit . RESULTS The median endometrial thickness at each of the follow-up visits for women who had expelled the gestational sac was 14 mm , 10 mm , and 7 mm , respectively . The endometrial thickness at the first follow-up visit exceeded 15 mm in 20 subjects ( 36 % ) and 30 mm in four subjects ( 7 % ) . Only three women had a suction aspiration for bleeding after documented expulsion . The endometrial thickness for these women was 11 , 13 , and 14 mm at the first follow-up visit . CONCLUSIONS There is no obvious relationship between increasing endometrial thick
Output:
| Limited evidence suggests that women generally seem satisfied with their care .
The available evidence suggests that medical treatment , with misoprostol , and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service re sources to support all three approaches . |
MS211208 | ***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 atypical antipsychotic zotepine was compared to haloperidol in 126 patients suffering from acute exacerbation of schizophrenia ( DSM-III-R ) in a r and omized , double-blind study . After 8-weeks , 150 to 300 mg zotepine improved scores on the Brief Psychiatric Rating Scale ( BPRS ) more than 10 to 20 mg haloperidol ( -17.03 versus -13.45 ; 95%CI for zotepine-haloperidol -9.34/2.04 ) . BPRS subscores and Clinical Global impressions ( CGI ) Severity and improvement subscales showed comparable gains , but scores on the Scale for the Assessment of Negative Symptoms ( SANS ) improved significantly more with zotepine ( -23.82 ) than haloperidol ( -15.15 ; P < .05 ; 95%CI for zotepine haloperidol -18.03/-0.18 ) . Adverse events were reported by 71 percent of zotepine and 78 percent of haloperidol patients . Extrapyramidal side effect ( EPMS ) scores decreased with zotepine ( -0.34 ) but increased with haloperidol ( + 2.32 ; P < .05 ) . Seven haloperidol patients reported akathisia but no zotepine patients did ( p < .05 ) . Uric acid reductions ( which appear to have no clinical consequence ) and transient raised liver enzymes were recorded with zotepine . Weight increased on zotepine ( 2.32 kg ; P < .001 ) and a small increase in pulse rate occurred ( P < .05 ) . Both drugs were effective in reducing positive symptoms of schizophrenia ; zotepine was significantly more effective against negative symptoms and reduced EPMS 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 Several studies reported specific effects for atypical neuroleptics ( e.g. clozapine and risperidone ) in managing schizophrenic patients with aggression ( Volavka et al. , 1993 ; Chiles et al. , 1994 ; Czobor et al. , 1995 ) . There are no studies comparing different atypicals with regard to hostility . The main research question of this study was whether there are differential effects on hostility between the three atypical antipsychotics zotepine , olanzapine and risperidone . The data were collected in an open-label , r and omized , acute-phase trial . Patients were r and omized according to a fixed protocol on either olanzapine , zotepine , or risperidone after a washout period of at least 3 days . Patients did not receive any concommitant neuroleptic or antidepressant agents , while the occasional administration of benzodiazepines was allowed . Dosage range at discharge was as follows : olanzapine ( 2.5–20 mg ; mean : 11.88 ( SD : 5.94 ) ) , zotepine ( 50–275 mg ; mean : 152.27 ( SD : 76.20 ) ) , risperidone ( 1–8 mg ; mean : 3.88 ( SD:1.45 ) ) . Psychopathology was assessed at admission and discharge using the Positive and Negative Syndrome Scale ( PANSS ; Kay et al. , 1987 ) . We assessed effects on hostility and the hostile excitement syndrome ( Mass et al. , 2000 ) , which includes the PANSS-items excitement , gr and iosity , hostility , tension , mannerisms and posturing , uncooperativeness and poor impulse control . Sedation was measured with the UKU-side effect rating scale ( Lingjaerde et al. , 1987 ) . Statistical analyses had three principle objectives : ( 1 ) to assess whether there were significant changes in hostility and the hostile excitement syndrome during treatment ; ( 2 ) to test whether there were different changes in the three groups ; ( 3 ) whether these changes were not exclusively mediated by sedation or effects on positive symptoms . Sixty-nine patients fulfilling ICD-10 criteria of schizophrenia or schizoaffective-disorder participated in the study . One-way analyses of variance ( ANOVA ) revealed that all three sample s did not differ regarding age ( F = 1.84 ; NS ) , gender distribution ( m = 1.06 ; NS ) , number of cases with first episode psychosis ( m = 2.55 ; NS ) , duration of current treatment ( F = 1.79 ; NS ) and school ( F = 0.56 ; NS ) . The baseline severity of hostility of the whole group showed a range between 1 ( absent ) and 6 ( severe ) with a mean of 2.00 ( SD : 1.28 ) ) and showed no significant differences between the three subgroups ( F = 0.51 ; NS ) . Also excitement ( F = 0.35 ; NS ) , gr and iosity ( F = 0.18 ; NS ) , tension ( F = 0.43 ; NS ) , mannerisms and posturing ( F = 0.76 ; NS ) , uncooperativeness ( F = 0.63 ; NS ) and poor impulse control ( F = 0.61 ; NS ) showed no differences between the three groups at baseline . ( Table 1 ) . Paired t-tests ( admission vs. discharge ) were conducted separately for all three groups : patients Clinical interest in the so-called atypical antipsychotics currently focuses on the possibility of improving the negative symptoms of schizophrenia and the cognitive dysfunction associated with the disease . While clozapine has been shown to be effective in this respect , no data are available on zotepine . We report on a double-blind r and omized study design ed to evaluate the impact of zotepine and clozapine on cognitive dysfunction in schizophrenia . Cognitive function was operationalized by a maze test in which patients traversed computer-displayed mazes of increasing complexity . Passage time , route , and motor errors were evaluated . 25 schizophrenic ( DSM-IIIR ) patients were included in each group . After washout , they were r and omized on zotepine or clozapine and given up to 450 mg of substance each . Patients were followed for six weeks and evaluated weekly . We report on a sub sample of 26 patients matched for baseline BPRS , SANS , and age . 13 matched healthy persons were recruited as controls . ANOVA with group and course over time as factors was used for analysis . Both clozapine and zotepine achieved a highly significant decrease in overall symptoms ( BPRS ) and negative symptoms ( SANS ) . Zotepine and clozapine were equally effective . In the maze tests , motor errors in simple mazes were stable over time and differentiated schizophrenics from controls as a " trait " marker . In passage time and maze route , schizophrenics performed worse than controls . An improvement by medication was evident in both medication groups , but was more pronounced in the zotepine-treated group . The study confirms previous results on the efficacy of clozapine and zotepine in treating negative symptoms of schizophrenia . The data presented show for the first time that zotepine is efficacious in improving cognitive dysfunction , confirming this substance 's value as an atypical antipsychotic & NA ; Zotepine , a neuroleptic agent with additional 5‐HT2 blocking properties , was compared with haloperidol in the treatment of schizophrenic patients with predominantly negative symptoms using a double‐blind design . During the investigation period zotepine treated patients showed significant improvements in all rating instruments whereas haloperidol treated patients did not . Patients in the zotepine group developed fewer clinical side effects . The results of the presented study confirm the positive impressions gained in earlier open trials with zotepine Abstract . Rationale : Zotepine is an antipsychotic drug with proven efficacy for treatment of acute episodes of schizophrenia . Antipsychotic drugs also require to be effective in prevention of recurrence . Objective : This trial was design ed to compare the effects of zotepine and placebo in the prevention of recurrence of acute episodes in a population of patients with chronic schizophrenia . Methods : The study was a double-blind , parallel group , 26-week comparison of zotepine ( 300 mg daily , with fall back to 150 mg if necessary ) versus placebo in 121 patients with chronic schizophrenia and a history of recurrence in the previous 18 months . The primary outcome measure was the time to recurrence . Other evaluations included the brief psychiatric rating scale ( BPRS ) , the scale for the assessment of negative symptoms ( SANS ) , the clinical global impression ( CGI ) severity and improvement scales , and the Simpson and Angus scale for extrapyramidal symptoms ( EPS ) . Results : Fewer zotepine patients experienced recurrence over 26 weeks than placebo patients ( 4 versus 21 , respectively ) . The estimated 26-week risk of recurrence was six times lower for zotepine than placebo ( 8.7 % versus 52.8 % ; hazard ratio 0.16 , 95 % CI 0.053 , 0.484 ; P<0.001 ) . Scores on the BPRS and CGI supported the efficacy of zotepine . There was no difference between the treatments with respect to EPS . Conclusions : Zotepine is effective in preventing recurrence in patients with chronic schizophrenia . The level of EPS was not different between zotepine and placebo Zotepine and thiothixene were compared for clinical efficacy and safety in a double-blind trial . Using overall improvement ratings and Gorham 's BPRS , zotepine rated higher improvement in motor retardation , suspiciousness , mannerisms and posturing symptoms , suggesting that it has both activating and antipsychotic activities . Thiothixene produced higher improvement ratings in symptoms such as hallucinatory behavior , somatic concerns , anxiety , guilt feelings , tension , depressive mood and uncooperativeness . As for side effects , there was a significantly lower frequency of dry mouth and insomnia with zotepine when compared with thiothixene . The lower incidence of insomnia is interesting in view of zotepine 's clinical activating effects . There were no abnormal laboratory findings Zotepine , a neuroleptic exercising a 5-HT2-antagonistic effect , was employed in a double-blind study in the treatment of schizophrenic patients with predominantly negative symptoms and was compared to haloperidol . In contrast to the patients treated with haloperidol , significant improvements were seen in the zotepine group during the observation period , according to all assessment scales that were employed . The patients of the zotepine group also developed fewer clinical side effects . The results of the study confirm previous positive impressions gained in earlier open studies with zotepine Controlled clinical trials of the treatment of acute myocardial infa rct ion offer a unique opportunity for the study of the potential influence on outcome of bias in treatment assignment . A group of 145 papers was divided into those in which the r and omization process was blinded ( 57 papers ) , those in which it may have been unblinded ( 45 papers ) , and those in which the controls were selected by a nonr and om process ( 43 papers ) . At least one prognostic variable was maldistributed ( P less than 0.05 ) in 14.0 per cent of the blinded-r and omization studies , in 26.7 per cent of the unblinded-r and omization studies , and in 58.1 per cent of the nonr and omized studies . Differences in case-fatality rates between treatment and control groups ( P less than 0.05 ) were found in 8.8 per cent of the blinded-r and omization studies , 24.4 per cent of the unblinded-r and omization studies , and 58.1 per cent of the nonr and omized studies . These data emphasize the importance of keeping those who recruit patients for clinical trials from suspecting which treatment will be assigned to the patient under consideration The clinical action of Zotepine was examined in an open and in a r and omised double-blind controlled study in in- patients displaying a productive or minus pattern of symptoms within the framework of a schizophrenic disease or schizoaffective psychosis . The present paper discusses only the results achieved in treating schizophrenic minus patterns of signs and symptoms . In Study I 20 schizophrenic patients were treated with two different Zotepine dosages . Group 2 ( n = 12 ) showed at an average daily dose of 168 + /- 15 mg ( 150 - 190 mg ) a significant improvement ( p less than 0.05 ) of the anergy subscore in the BPRS scale as well as a significant improvement of the subscores affective flattening , anhedonia
Output:
| For the comparison with typical drugs , limited data suggest that zotepine may be as effective as these older medications .
Zotepine may result in less movement disorder adverse effects than typical antipsychotic drugs .
Trials have not highlighted clear differences between zotepine and other atypical drugs .
Zotepine may be a valuable addition to the class of atypical antipsychotic drugs . |
MS211209 | ***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 Although early death from perioperative myocardial infa rct ion ( PMI ) after vascular surgery is well established , long-term outcome in patients surviving PMI is unknown . This prospect i ve study was design ed to determine cardiac outcome and survival rates in patients with symptomatic and asymptomatic nonfatal PMI associated with peripheral vascular surgery . METHODS During a 36-month period for 1989 to 1992 , all patients undergoing vascular surgery at our institution were monitored for PMI with serial creatine kinase and myocardial b and isoenzymes and electrocardiography . PMIs were classified as symptomatic ( associated with chest pain , arrhythmia , congestive heart failure , or hypotension ) or asymptomatic ( electrocardiographic changes and /or elevated creatine kinase and myocardial b and isoenzymes ) . Patients with PMI were then prospect ively monitored and compared for late survival , with control patients undergoing vascular surgery without PMI during the same interval . RESULTS During the study period 1561 major peripheral vascular procedures were performed . There were 47 PMIs ( 3.0 % ) . Eleven ( 0.7 % ) PMIs were fatal , 31 were nonfatal , and five other patients with PMI died during operation of non-heart-related causes . Eight of 31 patients with nonfatal PMI had a " chemical PMI " with creatine kinase and myocardial b and isoenzyme elevation as the sole indicator of PMI . During follow-up ( mean 27.7 months ) , there was a higher incidence of both subsequent myocardial infa rct ion and coronary artery revascularization among the patients with nonfatal PMI compared with control subjects ( p < 0.05 ) ; however , survival for patients with nonfatal PMI at 1 and 4 years ( 80 % and 51 % ) did not differ from that of control patients ( 90 % and 60 % ) ( p > 0.05 ) . Patients with " chemical PMI " had similar patterns of subsequent myocardial infa rct ion and coronary intervention as control patients . CONCLUSIONS Patients surviving nonfatal PMI after peripheral vascular surgery have a higher incidence of subsequent adverse cardiac events and coronary artery revascularization than patients undergoing vascular surgery without PMI , but they have similar survival rates at 1 and 4 years . Patients in the enzyme-only PMI group have a similar outcome compared with control subjects suggesting that a perioperative " chemical MI " may not be a significant clinical event This article describes the patient population and operative management of 666 patients with nonruptured aneurysms of the abdominal aorta . Statistical significance of variables was determined by the chi-square test and logistic regression analysis . There were no statistically significant differences ( p greater than 0.05 ) in mortality rate for abdominal aortic aneurysm ( AAA ) on the basis of indication for surgery ( asymptomatic , 3.9 % ; asymptomatic but with evidence of enlargement , 4.9 % ; and symptomatic , 7.2 % ) or the urgency of operation ( elective operation , 4.5 % ; and urgent operation , 7.1 % ) . Characteristics of the 72 participating surgeons did not influence the operative mortality rate . A family history of AAA was documented in 6.1 % of cases and was more common if the patient was female ( p = 0.03 ) and less than 65 years of age ( p = 0.04 ) . Patients without clinical evidence of coronary artery disease had a 0.8 % mortality rate from cardiac disease compared with 6.2 % if any stigmata of coronary disease were present . Prior aortocoronary bypass surgery did not reduce the incidence of postoperative cardiac events or operative mortality rate . Patients having " routine " angiography did not have a less complicated operative course , fewer thrombotic complications , or lower mortality rate than those not having it . Those patients with an inflammatory AAA ( 4.5 % ) did not have a significantly higher incidence of pain . Heparin administration ( 84.8 % ) did not reduce the complications of graft thrombosis , " trash , " distal thrombosis , and /or amputation . The 6.8 % of patients requiring suprarenal aortic cross-clamping had a higher incidence of postoperative renal dysfunction ( p = 0.02 ) and intraoperative blood loss ( p less than 0.001 ) , but cardiac events were not more frequent . When the aortic cross-clamping time was prolonged ( more than 70 minutes ) , the requirement for crystalloid fluid administration increased ( p less than 0.001 ) and postoperative myocardial infa rct ion was more common ( p = 0.004 ) . After ligation of the left renal vein in 7.9 % , renal damage or dialysis was more frequent ( p = 0.01 ) . Patients having an intra-abdominal graft ( tube , 38.5 % and biiliac , 30.7 % ) had fewer wound infections ( p = 0.02 ) and graft thromboses ( p less than 0.001 ) than the patients with a femoral anastomosis . When the internal iliac artery flow was interrupted bilaterally ( 12 % ) , diarrhea ( p = 0.03 ) and ischemic colitis ( p = 0.03 ) were more frequent complications . Reimplantation of the inferior mesenteric artery was carried out in 4.8 % . After renal artery bypass in 2.1 % , the mortality rate was not increased , but the incidence of transient renal dysfunction was increased ( p = 0.03 ) . ( ABSTRACT TRUNCATED AT 400 WORDS Physicians must make decisions about screening patients for abdominal aortic aneurysms ( AAAs ) , monitoring or referring for surgery patients with AAAs of various sizes , and assessing patients with symptoms that may be related to AAAs . This review article analyzes the evidence for each scenario . The effectiveness and cost-effectiveness of screening for AAA is based on results from four r and omized controlled trials . A cost-effectiveness analysis using a Markov model showed that ultrasound screening of white men beginning at age 65 is both effective and cost-effective in preventing AAA-related death . Such screening would have a small but real impact over a 20-year period in these men . For patients with a known AAA — which is often detected incidentally — the evidence clearly suggests periodic ultrasound surveillance for those with small AAAs ( 3.0–3.9 cm in diameter ) and elective surgical repair for those with large AAAs ( = 5.5 cm ) . Two recent r and omized controlled trials have shown that early surgical repair confers no survival benefit compared with periodic surveillance for patients with intermediate-sized AAAs ( 4.0–5.5 cm in diameter ) , so those patients can also be monitored . Some centers choose to increase the frequency of monitoring to every 3 to 6 months when the AAA reaches 5.0 cm . Factors to consider in assessing symptomatic patients include the high risk of life-threatening conditions , the potential increased risk of death or poor outcome with delay in diagnosis , the limitations of ultrasound in identifying whether symptoms are due to known or suspected AAA , and the timely availability of computed tomography or other imaging tests . If available , computed tomography is preferred in patients with recent or severe symptoms , since it is better at detecting retroperitoneal hemorrhage and other complications and in providing preoperative definition of the anatomy CONTEXT Among patients with abdominal aortic aneurysm ( AAA ) who have high operative risk , repair is usually deferred until the AAA reaches a diameter at which rupture risk is thought to outweigh operative risk , but few data exist on rupture risk of large AAA . OBJECTIVE To determine the incidence of rupture in patients with large AAA . DESIGN AND SETTING Prospect i ve cohort study in 47 Veterans Affairs medical centers . PATIENTS Veterans ( n = 198 ) with AAA of at least 5.5 cm for whom elective AAA repair was not planned because of medical contraindication or patient refusal . Patients were enrolled between April 1995 and April 2000 and followed up through July 2000 ( mean , 1.52 years ) . MAIN OUTCOME MEASURE Incidence of AAA rupture by strata of initial and attained diameter . RESULTS Outcome ascertainment was complete for all patients . There were 112 deaths ( 57 % ) and the autopsy rate was 46 % . Forty-five patients had probable AAA rupture . The 1-year incidence of probable rupture by initial AAA diameter was 9.4 % for AAA of 5.5 to 5.9 cm , 10.2 % for AAA of 6.0 to 6.9 cm ( 19.1 % for the subgroup of 6.5 - 6.9 cm ) , and 32.5 % for AAA of 7.0 cm or more . Much of the increased risk of rupture associated with initial AAA diameters of 6.5 - 7.9 cm was related to the likelihood that the AAA diameter would reach 8.0 cm during follow-up , after which 25.7 % ruptured within 6 months . CONCLUSION The rupture rate is substantial in high-operative-risk patients with AAA of at least 5.5 cm in diameter and increases with larger diameter PURPOSE We present extended follow-up findings of the Kingston prospect i ve sizing program for patients with abdominal aortic aneurysm ( AAA ) smaller than 5.0 cm in diameter , with gender-specific analysis . METHODS From 1976 to 2001 , 895 patients ( 688 men , 207 women ) with AAA smaller than 5.0 cm were entered , regardless of fitness , in a prospect i ve sizing program in which computed tomography scans were obtained every 6 months . Operations were performed in fit patients with an increase in AAA size to 5 cm ( n = 190 ) , AAA expansion greater than 0.5 cm in 6 months ( n = 27 ) , or for other reasons ( n = 33 ) . Follow-up continued until AAA rupture , surgery , death , or removal from the program . RESULTS No AAA smaller than 5.0 cm ruptured during prospect i ve follow-up . There was a statistically significant increase in expansion rate relative to size at entry , with the highest mean expansion rate of 0.52 cm/y for AAA 4.5 to 4.9 cm in diameter . There was no significant difference in AAA expansion rate between men and women . The frequency of surgery was inversely related to age at entry , but was positively related to AAA size at entry , with patients with AAA 4.5 to 4.9 cm at entry 6.8 times more likely ( 95 % confidence interval , 4.3 - 10.7 ) to undergo surgery than those with AAA 3.0 to 3.4 cm at entry . Women were older than men at entry , and age at entry in those undergoing surgery was significantly greater in women . CONCLUSIONS The study confirms the results of the United Kingdom Small Aneurysm Trial and the Aneurysm Detection and Management Study , that is , that risk for rupture is extremely unlikely with AAA smaller than 5.0 cm , which enables safe follow-up surveillance programs in both men and women with AAA smaller than 5.0 cm Gloucestershire 's screening project shows the potential benefits of a national programme and how it could be run Every year about 6000 men die from a ruptured abdominal aortic aneurysm in Engl and and Wales.1 Although this represents only about 2 % of all deaths in men , the condition is largely preventable . It is also a disease that seems to be increasingly prevalent , at least in Scotl and , despite the fact that deaths from other atherosclerotic conditions are reducing.2 This article explores the requirements for a national aortic screening programme , using as a model the Gloucestershire aneurysm screening project , which has been running for 13 years.3 Ultrasound screening for abdominal aortic aneurysms fulfils all the criteria for a population screening programme,4 5although only in men.6 The recent multicentre aneurysm screening study found that screening reduced the mortality from aneurysm disease in men by 42 % after four years of follow up ; it is expected , with further study , to show a small but significant decrease in the population mortality.7 The study also showed that screening is as cost effective as other current screening programmes , at a cost of £ 28 000 for each added year of life.8 ! [ ] [ 1 ] Ruptured abdominal aortic aneurysm is largely preventable Credit : GCa/SPL This information builds on data from previous smaller r and omised studies , 9–11 and has encouraged debate about the value of a national screening programme for aortic aneurysms.12 13 The National Screening Committee in the United Kingdom is currently assessing the evidence before making any recommendation .14 Our experience in Gloucestershire shows how a screening programme could work . Screening for abdominal aortic aneurysm was introduced in Gloucestershire in September 1990 . All men reaching the age of 65 who are registered with general practice s in the county are offered an ultrasound scan of … [ 1 ] : Background and Purpose — Very few studies have provided information regarding long-term prognosis after stroke . We aim ed to determine the absolute and relative survival over 10 years among patients with first-ever stroke from a population -based study in Perth , Western Australia . Methods — For a 12-month period beginning February 1989 , all individuals with a suspected acute stroke or transient ischemic attack who were resident in a geographically defined and representative region of Perth , Western Australia , were
Output:
| Our results support the economic viability of a national screening program for men reaching 65 years of age in Canada . |
MS211210 | ***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: Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Total sagittal knee laxity and postural control in the sagittal and frontal planes were measured in 25 patients at a mean of 36 months ( range , 27 to 44 ) after anterior cruciate ligament reconstruction and in a control group consisting of 20 uninjured age- and activity-matched subjects . Body sway was measured in the sagittal plane on a stable and on a sway-referenced force plate in single-legged stance , double-legged stance , or both , with the eyes open and closed . Postural reactions to perturbations in the sagittal and frontal planes were recorded in the single-legged stance with the eyes open . Total sagittal plane laxity was significantly greater in the anterior cruciate ligament-reconstructed knee ( 11.2 mm ; range , 6 to 15 ) than in the uninjured knee ( 8.9 mm ; range , 6 to 12 ) or in the control group ( 6.0 mm ; range , 5 to 8) . In spite of this , the patients , in comparison with the controls , exhibited normal postural control except in two variables — the reaction time and the latency between the start of force movement to maximal sway in the sagittal plane perturbations . This supports the hypothesis that rehabilitation , with proprioceptive and agility training , is an important component in restoring the functional stability in the anterior cruciate ligament-reconstructed knee The correlation between the prospect i ve course of proprioceptive improvement and knee stability after anterior cruciate ligament reconstruction was investigated in 38 patients . Proprioception , on the basis of the patient ’s capacity to reposition the limb accurately , was evaluated at 3-month intervals for 24 months after hamstring graft anterior cruciate ligament surgery . Knee stability was evaluated concurrently with a KT-2000 knee arthrometer . Thirty patients experienced improvement in postoperative position sense in at least one of the examinations , although eight patients had no improvement at any time . Of the 30 patients who had improvement , 28 maintained improved position sense from 18 months to the final followup . Thirty patients maintained significantly better knee stability for a postoperative period of at least 24 months . These results indicated that a minimum of 18 months after anterior cruciate ligament reconstruction may be needed for complete restoration of the proprioceptive function in knees , although the mean position sense in all patients gradually improved from 9 months . Improvement in postoperative knee stability may have facilitated recovery of proprioception The efficacy of two non-operative rehabilitation programs was studied in a consecutive r and omized controlled clinical trial of 100 patients after 12 months subsequent to an acute anterior cruciate ligament ( ACL ) injury . Follow up of r and omization to two training models was evaluated after 3 and 12 months : A self-monitored training program ( SM ) of traditional mobility and muscle strength training of the injured leg was compared to a supervised ( SV ) training model exercising postural function in closed kinetic-chains . Nearly 50 % of the patients in the SM group required supervision after 6 weeks . An intention-to-treat analysis was performed and showed significantly better values in most of the results of the supervised group at 3 and 12 months . An alternative analysis of subgroups showed a significant difference between transferred male patients and original SV male patients at 3 months but not at 12 months , indicating the importance of initial guiding after an ACL injury . No such difference was observed in the female patients
Output:
| Insufficient evidence was found to support the efficacy of one exercise intervention over another .
This review has demonstrated an absence of evidence to support one form of exercise intervention against another and the use of supplementary exercises in the management of isolated ACL injuries . |
MS211211 | ***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: This paper provides an up-to- date overview of the occurrence , diagnosis , risk factors , prognostic indicators and outcome of shoulder disorder ( SD ) , and of the validity and reproducibility of diagnostic classifications and diagnostic imaging techniques for SD . Furthermore , the available evidence on the effectiveness of non-steroidal anti-inflammatory drugs ( NSAIDs ) , corticosteroid injections and physiotherapy for SD is summarized on the basis of r and omized controlled trials with an acceptable quality of their methods . The annual incidence of SD is estimated at about 7 % , its 1-year period prevalence at about 51 % and its lifetime prevalence at about 10 % . While approximately 50 % of all patients with SD seek medical care , about 95 % are treated in primary health care . Of all new episodes of SD presenting to primary care , approximately 50 % seem to resolve within 6 months , while about 40 % seem to persist for up to 12 months . Several prognostic indicators for a favourable or a poor outcome of SD have been identified , but a comprehensive prognostic model is not available . While evidence for the prognostic validity of popular diagnostic classifications of SD is lacking , their reproducibility has been shown to be poor . The accuracy and clinical usefulness of diagnostic imaging techniques appear to be sufficiently verified for SD in secondary care , while their clinical usefulness in primary care and prognostic validity are not . NSAIDs and steroid injections for SD have been shown to be effective within 6 weeks , but their effect on long-term outcome remains unclear . There is very limited evidence for the effectiveness in SD of physiotherapy , including exercise therapy , ultrasound , electrotherapy , laser , mobilization and manipulation OBJECTIVES To compare the effect of grade d physiotherapeutic training of the rotator cuff versus arthroscopic subacromial decompression in patients with subacromial impingement . METHODS R and omised controlled trial with 12 months ' follow up in a hospital setting . Ninety consecutive patients aged 18 to 55 years were enrolled . Symptom duration was between six months and three years . All fulfilled a set of diagnostic criteria for rotator cuff disease , including a positive impingement sign . Patients were r and omised either to arthroscopic subacromial decompression , or to physiotherapy with exercises aim ing at strengthening the stabilisers and decompressors of the shoulder . Outcome was shoulder function as measured by the Constant score and a pain and dysfunction score . " Intention to treat " analysis was used , with comparison of means and control of confounding variables by general equation estimation analysis . RESULTS Of 90 patients enrolled , 84 completed follow up ( 41 in the surgery group , 43 in the training group ) . The mean Constant score at baseline was 34.8 in the training group and 33.7 in the surgery group . After 12 months the mean scores improved to 57.0 and 52.7 , respectively , the difference being non-significant . No group differences in mean pain and dysfunction score improvement were found . CONCLUSIONS Surgical treatment of rotator cuff syndrome with subacromial impingement was not superior to physiotherapy with training . Further studies are needed to qualify treatment choice decisions , and it is recommended that sample s are stratified according to disability level In a r and omized prospect i ve study , we selected 15 patients for arthroscopic subacromial decompression ( ASD ) and 19 patients for open subacromial decompression ( OSD ) . All had impingement syndrome ( Neer grade II ) , and had been unsuccessfully treated without surgery for more than 6 months . The UCLA Shoulder Rating Scale , Visual Analogue Scales for pain and satisfaction , isokinetic dynamometer recordings and physical testing were assessed preoperatively and at 1 ( except isokinetic testing ) , 3 , 6 , and 12 months , and , finally , 8 years after surgery . We found essentially no differences in the clinical tests between the groups during this period . The use of ASD or OSD seems to be a matter of cosmesis and personal preference Objectives : To compare the prognosis of subacromial impingement ( SAI ) stage II treated conservatively or with subacromial decompression . Methods : A follow‐up study after 4–8 years in a r and omized controlled trial ( RCT ) with 90 adult cases with SAI treated in a Danish hospital from 1996 to 2000 with grade d physiotherapy and exercises or arthroscopic subacromial decompression . Outcomes were proportion of time per year with income transfers ( indexed 0–1 ) , including total transfers ( marginalization ) , sick leave and disability pension obtained from the registry at the Ministry of Work . Self‐reported function , working capability , employment status and global improvement were obtained by question naire in September 2004 . The main outcomes are given as differences in development from baseline . Results : Seventy‐nine ( 88 % ) responded to the question naire and registry data were obtained from 81 . After 1 year the marginalization index increased by 0.45 [ 95 % confidence interval ( CI ) 0.35–0.56 ] for surgery and 0.25 ( 0.16–0.34 ) for physiotherapy . Cases undergoing surgery also tended to have more sick payments during the first year , but the difference was not significant . Four years after inclusion , changes in indices did not differ between treatment groups . Self‐reported outcomes after 4–8 years did not differ between treatment groups . Conclusion : The results of surgical decompression were equal to those of conservative treatment , and the surgery group had more income transferrals during the first year of follow‐up Anterior acromioplasty as described by Neer has been an effective procedure for shoulder impingement syndrome . Artroscopic acromioplasty is regarded as a technically dem and ing procedure . Since 1988 we have developed a closed percutaneous acromioplasty using motorized instruments . The purpose of this r and omised clinical trial was to compare the results of open and closed percutaneous acromioplasty . We found a significant improvement in shoulder score , but no differences between the group treated with the open procedure and the group treated with the closed procedure OBJECTIVE To evaluate the effect of surgical treatment of the impingement syndrome of the shoulder on the fitness for work . DESIGN Retrospective . SETTING Academic Hospital Groningen , department of Orthopaedics , the Netherl and s. PATIENTS AND METHODS A group of 31 patients who had undergone an anterior shoulder decompression between 1 January 1984 and 31 December 1993 because of shoulder symptoms due to impingement lasting more than one year , were subjected in January 1996 to a study of the effect of the treatment on the pain , fitness for work and participation in the labour process . The results were measured using an objectivated score list for pain and function and with a comparison of the labour situations before and after the operation as described by the patients . RESULTS End results as measured with the score list were fair to good in 97 patients ( 74 % ) . The numbers of those completely fit for work before operation and at follow-up were identical , viz . 45 out of 131 ( 34 % ) . Thirty-four patients ( 26 % ) had other jobs or adjusted activities and 37 ( 28 % ) were completely unfit for work ( together 71 patients : 54 % ) ; 15 patients ( 11 % ) had stopped working for reasons of age . The probability to be definitely rejected for work after the operation was increased significantly by a job causing shoulder overstrain and by having been on sick leave with pay prior to the operation . CONCLUSION Although the objective results were reasonably good , the percentage of those completely fit for work was not changed appreciably by the surgical treatment OBJECTIVE --To compare the effectiveness of arthroscopic surgery , a supervised exercise regimen , and placebo soft laser treatment in patients with rotator cuff disease ( stage II impingement syndrome ) . DESIGN --R and omised clinical trial . SETTING --Hospital departments of orthopaedics and of physical medicine and rehabilitation . PATIENTS --125 patients aged 18 - 66 who had had rotator cuff disease for at least three months and whose condition was resistant to treatment . INTERVENTIONS --Arthroscopic subacromial decompression performed by two experienced surgeons ; exercise regimen over three to six months supervised by one experienced physiotherapist ; or 12 sessions of detuned soft laser treatment over six weeks . MAIN OUTCOME MEASURES --Change in the overall Neer shoulder score ( pain during previous week and blinded evaluation of function and range of movement by one clinician ) after six months . RESULTS --No differences were found between the three groups in duration of sick leave and daily intake of analgesics . After six months the difference in improvement in overall Neer score between surgery and supervised exercises was 4.0 ( 95 % confidence interval -2 to 11 ) and 2.0 ( -1.4 to 5.4 ) after adjustment for sex . The condition improved significantly compared with placebo in both groups given the active treatments . Treatment costs were higher for those given surgery ( 720 pounds v 390 pounds ) . CONCLUSIONS --Surgery or a supervised exercise regimen significantly , and equally , improved rotator cuff disease compared with placebo Forty-two patients with subacromial impingement syndrome entered a r and omized prospect i ve study comparing open anterior acromioplasty with a physiotherapy regime . The criterion for a successful outcome of treatment was a reduction of the initial pain score of more than 50 % using the visual analogue scale ( VAS ) technique . The evaluation was performed by an independent observer . At the 6-month follow-up , treatment in the surgical group had been successful in 12/21 ( 57 % ) patients versus 6/18 ( 33 % ) in the physiotherapy group . A one-year evaluation revealed 16/21 ( 76 % ) " successes " in the surgical group . A direct and unbiased comparison with the physiotherapy group was not possible at one year , since 13 patients chose surgery after initial physiotherapy . However , in " an intention to treat " analysis outcome at one year was significantly better in those r and omized to surgery . We found two st and ardized , composite , active movements -- the " Pour out of a Pot " manoeuvre requiring the emptying of a pot of water , and the " H and in Neck " manoeuvre -- to be of predictive value for the outcome of surgery . When combining three pain-related variables into a criterion for prediction of success , a sensitivity of 78 % ( p < 0.02 ) and a specificity of 90 % ( p < 0.03 ) were attained . We advance the hypothesis that pain in the impingement syndrome is mainly elicited by comparison of the subacromial bursa . In some patients a traction-responsive pain generator in the supraspinatus tendon may be present as well The results of open subacromial decompression ( OSD ) were compared with arthroscopic subacromial decompression ( ASD ) after 1 year in 32 subjects ( 4 bilateral ) , and the correlation between the two shoulder rating scales for impingement was documented . Patients were evaluated clinical ly on the modified University of California at Los Angeles ( UCLA ) shoulder rating scale , and Constant scale . Scapular position and rotation were evaluated as well as a rotation and abduction shoulder strength test using the Cybex II dynamometer . No parameters revealed significant differences between the groups , except for the UCLA score which indicated an advantage for the ASD group ( p = 0.046 ) . The OSD group scored 24.5 ( 5.45 ) on the UCLA scale and 73.8 ( 18.9 ) on the Constant scale , whereas the ASD group scored 28.3 ( 5.6 ) and 80.8 ( 16.4 ) . To study the correlation between both scales , the Pearson correlation product-moment coefficient was calculated and a high correlation ( r = 0.81 ) obtained . Less mobility was found in the operated arm for all parameters , with the exception of glenohumeral abduction in both groups and passive elevation in the OSD group . Only in the OSD group did the scapula in the operated extremity show more abduction of the inferior angle of the scapula . Weaker abduction strength in the operated side was found in the ASD group , whereas in the OSD group there was significantly less adduction and external rotation strength at 180 degrees/s en 240 degrees/s . We conclude that after one year the open group tends to catch up with the arthroscopic patients and that the main benefits after arthroscopic surgery as described in literature are more evident in the shorter period The effectiveness of arthroscopic surgery , supervised exercises , and placebo was compared in 125 patients with rotator cuff disease ( impingement syndrome stage II ) in a r and omized clinical trial . The median age was 48 years , and the median duration of complications was 1 to 2 years . The treatments were arthroscopic subacromial decompression performed by 2 experienced surgeons , an exercise regimen supervised for 3 to 6 months by 1 experienced physiotherapist , or 12 sessions of detuned soft laser ( placebo ) for 6 weeks . The criterion for success was a Neer shoulder score > 80 . Fifteen ( 50 % ) and 11 ( 22 % ) of the patients r and omized to placebo and exercises , respectively , had surgery during the 2 1/2-year follow-up period and were classified as having failure with the treatments . The success rate was higher ( P < .01 ) for patients r and omized to surgery ( 26 of 38 ) and exercises ( 27 of 44 ) compared with the placebo group ( 7 of 28 ) . The odds ratio for success after surgery compared with exercises was 1.5 ( 95 % confidence interval 0.6 to 3.7 ; P = .49 ) . Including all patients who underwent operation , the success rate in those not on sick leave ( 19 of 21 ) before
Output:
| According to the best- evidence synthesis , however , there is no evidence from the available RCTs for differences in outcome in pain and shoulder function between conservatively and surgically treated patients with SIS . |
MS211212 | ***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 Our objective was to compare intramuscular ( i.m . ) magnesium sulfate with a low dose intravenous ( i.v . ) magnesium sulfate regimen in prevention of convulsion recurrence and maternal deaths in women with eclampsia . METHODS This prospect i ve trial was conducted in Nilratan Sircar Medical College , India from January 2001 to December 2005 . All women with a clinical diagnosis of eclampsia were included in the trial . Magnesium sulfate ( 4 gm ) was given as an i.v . loading dose , followed by either i.m . injections as recommended by Pritchard or low dose i.v . infusions ( 0.6 gm/h ) . Primary measures of outcome were recurrence of convulsions and maternal death . Secondary measures of outcome were potentially life threatening events , events related to labor and delivery as well as perinatal mortality and morbidity . RESULTS Of the 630 women participating in the trial , 480 women received i.m . magnesium sulphate according to the Pritchard regimen and 150 women were subjected to a low dose i.v . regimen of magnesium sulphate . There was no significant difference in recurrence of convulsion ( 3.3 % in the i.m . and 2 % in the i.v . groups P = 0.586 ) . Maternal deaths were not significantly lower in the i.v . group than the i.m . group ( 5 % in the i.m . and 3.3 % in the i.v . groups , P = 0.506 ) There were no significant differences in other measures of serious maternal morbidity , in perinatal morbidity or mortality . CONCLUSION Low dose i.v . magnesium sulfate regimen is equally effective in prevention of convulsion recurrence and maternal deaths in eclamptic women when compared with an i.m . magnesium sulfate regimen Abstract Objectives : To measure the incidence of eclampsia , establish how often it is preceded by signs of pre-eclampsia , document the morbidity associated with eclampsia , and determine the maternal case fatality rates . Design : A prospect i ve , descriptive study of every case of eclampsia in the United Kingdom in 1992 . Information was collected from review s of hospital case notes and question naires to general practitioners . Setting : All 279 hospitals in the United Kingdom with a consultant obstetric unit . Results : Obstetricians and midwives notified 582 possible cases , and 383 were confirmed as eclampsia . The national incidence of eclampsia was 4.9/10000 maternities ( 95 % confidence interval 4.5 to 5.4 ) . Most convulsions occurred despite antenatal care ( 70 % ) and within one week of the woman 's last visit to a doctor or midwife ( 85 % ) . Three quarters of first seizures occurred in hospital , of which 38 % developed before both proteinuria and hypertension had been documented . Forty four per cent of cases occurred postpartum , more than a third ( 38 % ) antepartum , and the remainder ( 18 % ) intrapartum . Nearly one in 50 women ( 1.8 % ) died , and 35 % of all women had at least one major complication . The rate of stillbirths and neonatal deaths was 22.2/1000 and 34.1/1000 , respectively . Preterm eclampsia occurred more commonly antepartum and was associated with more maternal complications and fetuses that were small for gestational age , as well as with higher rates of stillbirth and neonatal mortality . Antepartum eclampsia , which was more likely to occur preterm , was associated with a higher rate of maternal complications and a higher neonatal mortality . Both factors ( gestational prematurity and antepartum occurrence ) contributed independently to the severity of the outcome . Conclusion : Eclampsia occurs in nearly one in 2000 maternities in the United Kingdom and is associated with high maternal morbidity and fatality in cases . It may present unheralded by warning signs . Preterm and antenatal eclampsia seem to be particularly severe Objective To determine whether the administration of prophylactic intravenous magnesium sulphate reduces the occurrence of eclempsia in women with severe pre‐eclampsia OBJECTIVES To investigate whether in utero exposure to magnesium sulfate ( MgSO4 ) was associated with a lower prevalence of cerebral palsy ( CP ) in infants born weighing < 1500 g. DESIGN Singleton infants weighing < 1500 g at birth ( very low birthweight , VLBW ) and surviving to 3 years with moderate or severe congenital CP were identified among 155,636 children born 1983 through 1985 in four California counties . VLBW children with CP were compared with r and omly selected VLBW control survivors with respect to whether their mothers received MgSO4 to prevent convulsions in preeclampsia or as a tocolytic agent , and other information abstract ed from labor and delivery records . RESULTS During the admission for delivery , 7.1 % of the 42 VLBW infants with later CP and 36 % of the 75 VLBW controls were exposed to MgSO4 ( odds ratio ( OR ) .14 , 95 % confidence interval ( CI ) .05 , .51 ) . The overall association of MgSO4 with reduced risk of CP was also observed in the subgroup of infants born to women who were not preeclamptic ( OR .25 , CI .08 , .97 ) . Infants with CP were less often exposed antenatally to MgSO4 whether or not there was cotreatment with non-MgSO4 tocolytics ( other tocolytics administered , OR for MgSO4 exposure .23 , CI .06 , 1.2 ; other tocolytics not administered , OR for MgSO4 .08 , CI .02 , .68 ) , or antenatal corticosteroids ( steroids given , OR for MgSO4 exposure .24 , CI .06 , 1.3 ; steroids not given , OR for MgSO4 , .08 , CI .02 , .72 ) . Apparent benefit of magnesium was observed in the presence or absence of a variety of characteristics of pregnancies , births , and infants . CONCLUSION In this observational study , in utero exposure to MgSO4 was more frequent in controls than in children with CP , suggesting a protective effect of MgSO4 against CP in these VLBW infants Background The Magpie Trial , a r and omised trial comparing magnesium sulphate with placebo for women with pre-eclampsia . This paper describes methods used for follow up in the UK , and presents additional data collected . Methods In the UK 774 women and their 827 children were included ; excluded were women discharged without a surviving child and families who opted out . General practitioners were sent a question naire when the child was around 18 months old . When the child was two years , or older , question naires asking about the health of the women and children were posted to families . A sample of families was offered a home visit , during which the child was assessed using the Bayley Scales of Infant Development . Results Of the women , 12 were lost to follow up and three died . Of the children , 12 were lost to follow up , 5 were excluded and 19 died . General practitioners returned 688/759 ( 91 % ) question naires , as did 619/759 ( 82 % ) women . Responses were largely comparable . 32 women had serious morbidity potentially related to pre-eclampsia . 30 % of children were reported to have been admitted to hospital . There were no clear differences between the r and omised groups in the child 's behaviour , women 's fertility or use of health service re sources . Conclusion Data presented here provide further reassurance about the longer term safety of magnesium sulphate when used for women with pre-eclampsia . Postal question naires in the UK to assess the longer term health and wellbeing of women and children recruited to trials are feasible , and can achieve a high response rate . Responses from families and general practitioners were comparableTrial registration Trial registration number of the Magpie Trial [ IS RCT N86938761 Background The Magpie Trial compared magnesium sulphate with placebo for women with pre-eclampsia . 10,141 women were recruited , 8804 before delivery . Overall , 9024 children were included in the analysis of outcome at discharge from hospital . Magnesium sulphate more than halved the risk of eclampsia , and probably reduced the risk of maternal death . There did not appear to be any substantive harmful effects on the baby , in the short term . It is now important to assess whether these benefits persist , and to provide adequate reassurance about longer term safety . The main objective of the Magpie Trial Follow Up Study is to assess whether in utero exposure to magnesium sulphate has a clinical ly important effect on the child 's chance of surviving without major neurosensory disability . Other objectives are to assess long term outcome for the mother , and to develop and assess appropriate strategies for following up large numbers of children in perinatal trials . Study design Follow up is only feasible in selected centres . We therefore anticipate contacting 2800–3350 families , for 2435–2915 of whom the woman was r and omised before delivery . A further 280–335 children would have been eligible for follow up if they had survived . The total sample size for the children is therefore 3080–3685 , 2680–3210 of whom will have been born to women r and omised before delivery . Families eligible for the follow up will be contacted , and surviving children screened using the Ages and Stages Question naires . Children who screen positive , and a sample of those who screen negative , will whenever possible have a paediatric and neurodevelopmental assessment . When women are contacted to ask how their child is , they will also be asked about their own health . The primary outcome is a composite measure of death or neurosensory disability for the child at 18 months . Discussion The Follow Up Study began in 2002 , and now involves collaborators in 19 countries . Data collection will close at the end of 2003 OBJECTIVE The primary outcome was to determine whether magnesium sulfate therapy prolongs the duration of labor in women with mild preeclampsia . Secondary outcomes were to assess the side effects associated with magnesium sulfate therapy : hours and maximum dose of oxytocin , incidence of progression to severe preeclampsia , incidence of cesarean delivery , change in maternal hematocrit , incidence of postpartum hemorrhage , incidence of maternal infection , and Apgar scores . STUDY DESIGN Women with a diagnosis of mild preeclampsia at term were r and omized to receive st and ard therapy during labor and for 12 hours post partum with either magnesium sulfate ( n = 67 ) or a matching placebo solution ( n = 68 ) . RESULTS There was no difference between magnesium sulfate and placebo with respect to the primary outcome variables : total length of labor ( median 17.8 hours vs 16.5 hours , p = 0.7 ) and length of the active phase of labor ( median 5.4 hours vs 6.0 hours , p = 0.5 ) . In addition , no difference was observed in the secondary outcome variables : hours of oxytocin use , change in hematocrit , frequency of maternal infection , progression to severe preeclampsia , incidence of cesarean delivery , and Apgar scores . Although not statistically significant , the incidence of postpartum hemorrhage was approximately fourfold greater in the magnesium sulfate group ( relative risk 4.1 , 95 % confidence interval 0.5 to 35.4 ) . There was a significant difference in the maximum dose of oxytocin used ( 13.9 + /- 8.6 mU/min with magnesium sulfate vs 11.0 + /- 7.6 mU/min with placebo , p = 0.036 ) . CONCLUSION The use of magnesium sulfate during labor in women with mild preeclampsia at term does not affect any component of labor but did necessitate a higher dose of oxytocin BACKGROUND Magnesium sulfate is used widely to prevent eclamptic seizures in pregnant women with hypertension , but few studies have compared the efficacy of magnesium sulfate with that of other drugs . Anticonvulsant prophylaxis with phenytoin for eclampsia has been recommended , but there are virtually no data to support its efficacy . Our objective was to compare magnesium sulfate with phenytoin in preventing seizures in hypertensive women during labor . METHODS We r and omly assigned women with hypertension who were admitted for delivery to receive either magnesium sulfate or phenytoin . The magnesium sulfate regimen consisted of a 10-g intramuscular loading dose followed by a maintenance dose of 5 g given intramuscularly every four hours . For women with severe preeclampsia , an additional 4-g loading dose was given intravenously . The phenytoin regimen included a 1000-mg loading dose infused over a period of 1 hour , followed by a 500-mg oral dose 10 hours later . With either regimen , anticonvulsant therapy was continued for 24 hours post partum . RESULTS Ten of 1089 women r and omly assigned to the phenytoin regimen had eclamptic convulsions , as compared with none of 1049 women r and omly assigned to magnesium sulfate ( P = 0.004 ) . There were no significant differences in any risk factors for
Output:
| Magnesium sulphate more than halves the risk of eclampsia , and probably reduces maternal death .
There is no clear effect on outcome after discharge from hospital .
A quarter of women report side effects with magnesium sulphate |
MS211213 | ***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: STUDY OBJECTIVE Exercise has the potential to improve the ability of a patient with cystic fibrosis ( CF ) to cope with the physical dem and s of everyday life , and may improve prognosis . The purpose of this study was to compare the effects of a home-based , semi-supervised , upper-body strength-training regimen with a similarly structured aerobic training regimen . DESIGN Data were collected during a 1-year r and omized clinical trial . SETTING Counselors conducted in-home visits with the participants once per week for the first 8 weeks followed by monthly visits for the remainder of the study . PATIENTS Sixty-seven patients with CF , aged 8 to 18 years , participated in the trial . INTERVENTION Participants in both exercise conditions were encouraged to exercise at least three times per week for 1 year . Each child in the aerobic group was given a stair-stepping machine , and each child in the upper-body strength training group was given an upper-body-only weight-resistance machine . MEASURES AND RESULTS Aerobic fitness , pulmonary function , quality of life , and strength were measured at baseline , at 6 months , and at 12 months . Strength training increased the maximum weight lifted for biceps curls significantly more than aerobic training ( p < 0.02 ) . However , this differential did not remain significant after control for increase in height . Both training procedures were associated with increased strength ( p < 0.002 ) and physical work capacity ( PWC ) [ p < 0.033 ] . CONCLUSIONS We concluded that strength and aerobic training may increase upper-body strength , and that both types of training may increase PWC for children with CF . Future trials should be conducted with no-training control subjects and larger sample s to increase statistical power BACKGROUND Children 's physical activity patterns are characterized by short-term anaerobic activities . Anaerobic exercise performance in children with cystic fibrosis ( CF ) has received little attention compared to aerobic performance . This study investigated the effects of anaerobic training in children with CF . DESIGN AND METHODS Twenty patients were r and omly assigned to the training group ( TG ) [ 11 patients ; mean ( + /- SD ) age , 13.6 + /- 1.3 years ; mean FEV(1 ) , 75.2 + /- 20.7 % predicted ] or the control group ( CG ) [ 9 patients ; mean age , 14.2 + /- 2.1 years ; FEV(1 ) , 82.1 + /- 19.1 % predicted ] . The TG trained 2 days per week for 12 weeks , with each session lasting 30 to 45 min . The training program consisted of anaerobic activities lasting 20 to 30 s. The control subjects were asked not to change their normal daily activities . Body composition , pulmonary function , peripheral muscle force , habitual physical activity , aerobic and anaerobic exercise performance , and quality of life were reevaluated at the end of the training program , and again after a 12-week follow-up period . RESULTS Patients in the TG significantly improved their anaerobic performance , aerobic performance , and quality of life . No significant changes were seen in other parameters , and no improvements were found in CG . After the follow-up period , only anaerobic performance and quality of life in TG were significantly higher compared to pretraining values . CONCLUSIONS Anaerobic training has measurable effects on aerobic performance ( although not sustained ) , anaerobic performance , and health-related quality of life in children with CF . Therefore , anaerobic training could be an important component of therapeutic programs for CF patients Bronchial hygiene therapy is a st and ard part of the treatment of patients with cystic fibrosis ( CF ) . Coughing alone promotes sputum expectoration and is probably the primary effective component of st and ard bronchial hygiene therapy . The purpose of this study was to determine whether substituting regular exercise , which also promotes coughing , for two of three daily bronchial hygiene treatments would affect the expected improvements in pulmonary function and exercise response in hospitalized patients with CF . Seventeen patients with CF hospitalized ( means length of stay = 13.0 + /- 2.6 days ) for an acute exacerbation of their pulmonary disease participated in the study . The patients were r and omly assigned to either a group that participated in two cycle ergometer exercise sessions and one bronchial hygiene treatment session per day ( EX Group [ n = 9 ] ) or a group that participated in three bronchial hygiene treatment sessions per day ( PD Group [ n = 8 ] ) . Pulmonary functions and responses to a progressive , incremental cycle ergometer exercise test were measured on admission and before discharge . Bronchial hygiene therapy consisted of postural drainage , in six positions , with chest percussion and vibration . Therapeutic exercise was of moderate intensity and was individually adjusted based on the patient 's heart rate and arterial oxygen saturation response to the admission exercise test . Coughing was encouraged during and after all treatments . Pulmonary function and exercise response were significantly improved over the period of hospitalization in both groups ; the improvements were the same in the two groups . These results indicate that , in some hospitalized patients with CF , exercise therapy may be substituted for at least part of the st and ard protocol of bronchial hygiene therapy Background : Short term studies of exercise training have shown benefits in cystic fibrosis . Transferring exercise programmes to the community and sustaining them long term is a challenge for the patient . The effectiveness of an individualised unsupervised home based exercise programme was examined in adults with cystic fibrosis over a 1 year period . Methods : Subjects were r and omised to undertake three sessions per week of upper and lower body exercise based on individualised preferences ( n = 30 ) or to a control group ( n = 18 ) . They were evaluated at baseline and at 12 months . The primary outcome measure was improved fitness as assessed by change in blood lactate concentration at the end of an identical constant work rate for both arm and leg ergometric testing . Secondary outcome measurements were heart rate and pulmonary function . Results : For leg exercise , significant differences were seen at 12 months between the active and control groups in the mean ( SE ) change in blood lactate levels ( −0.38 ( 0.23 ) mmol/l v 0.45 ( 0.25 ) mmol/l , p<0.05 ) and heart rate ( −4.8 ( 2.5 ) bpm v 3.4 ( 2.5 ) bpm , p<0.05 ) , confirming a training effect . For arm ergometry there was no change in lactate levels at 12 months but there was a significant difference in forced vital capacity ( 46 ( 72 ) ml v −167 ( 68 ) ml , p<0.05 ) . Conclusions : A training effect , as measured by a reduction in lactate levels and heart rate , can be achieved with unsupervised individualised home exercise in adults with cystic fibrosis . A benefit to pulmonary function was observed and together these findings suggest that exercise programmes should be encouraged as an important component of care in cystic fibrosis The aim of this study was to compare aerobic and resistance training in children with cystic fibrosis ( CF ) admitted to hospital with an intercurrent pulmonary infection with a control group . The subjects were r and omized into three groups on the first day of admission . The fat-free mass ( FFM ) was calculated , using the skin fold thickness from four sites ( biceps , triceps , subscapular , and iliac crest ) . Pulmonary function tests were performed within 36 hr of admission and repeated on discharge from the hospital , and again at 1 month after discharge . All subjects performed an incremental treadmill exercise test , using a modified Bruce protocol . Lower limb strength was measured using a Cybex dynamometer . An assessment of quality of life was made using the Quality of Well Being Scale , as previously reported . Activity levels were measured using a 7-day activity diary , and subjects also wore an accelerometer on their hips . There were no significant differences between the three groups in terms of disease severity , and length of stay in hospital . Subjects in all three groups received intravenous antibiotics and nutritional supplementation as determined by the physician . Children r and omized to the aerobic training group participated in aerobic activities for five sessions , each of 30-min duration , a week . The children r and omized to the resistance training group exercised both upper and lower limbs against a grade d resistance machine . Subjects in the control group received st and ard chest physiotherapy . Our study demonstrated that children who received aerobic training had significantly better peak aerobic capacity , activity levels , and quality of life than children who received the resistance training program . Children who received resistance training had better weight gain ( total mass , as well as fat-free mass ) , lung function , and leg strength than children who received aerobic training . A combination of aerobic and resistance training may be the best training program , and future studies to assess optimal training programs for CF patients are indicated Six girls and two boys with cystic fibrosis ( CF ) 10 - 13.5 years of age ( mean 11.5 years ) participated in a prescribed exercise program on a mini-trampoline , maximum 109 min/week , during 8 weeks . The training consisted of three short bouts of trampoline exercise . The CF children were divided into two groups . The first group was a control as the other group exercised on the trampoline and vice versa . Three patients in each group completed the study . Pulmonary and exercise tests were performed before and after the exercise/control periods . The pulmonary tests ( FVC , FEV1 , and PEFR ) showed minor changes during the exercise period , but a slight increase in FVC ( P less than 0.05 ) during the total time of the study was found . The two patients with more advanced lung disease improved their spirometric results during the training period . The maximal oxygen uptake ( VO2 max ) improved from 45 to 49 ml/kg/min ( P less than 0.025 ) during the exercise period . Trampoline exercise programs are suggested to supply other types of training to avoid monotony in the training for CF patients OBJECTIVES To evaluate the effects of a 3-year home exercise program on pulmonary function and exercise tolerance in mildly to moderately impaired patients with cystic fibrosis ( CF ) and to assess whether regular aerobic exercise is a realistic treatment option . STUDY DESIGN Seventy-two patients with CF ( 7 - 19 years ) were r and omly assigned to an exercise group ( a minimum of 20 minutes of aerobic exercise , at a heart rate of approximately 150 beats/min , 3 times weekly ) or a control group ( usual physical activity participation ) . Pulmonary function , exercise tolerance , clinical status , hospitalizations , and compliance with therapy were monitored during scheduled visits to the hospital 's CF clinic . RESULTS Sixty-five patients were included in the analyses . The control group demonstrated a greater annual decline in percent of predicted forced vital capacity compared with the exercise group ( mean slope + /- SD , -2.42 + /- 4.15 vs -0.25 + /- 2.81 ; P = .02 ) , with a similar trend for forced expiratory volume in 1 second ( -3.47 + /- 4.93 vs -1.46 + /- 3 . 55 ; P = .07 ) . Patients remained compliant with the exercise program over the study period . An improved sense of well-being was reported with exercise . CONCLUSIONS Pulmonary function declined more slowly in the exercise group than in the control group , suggesting a benefit for patients with CF participating in regular aerobic exercise . Consistent compliance with the home exercise program and a self-reported positive attitude toward exercise provide further evidence of the feasibility and value of including an aerobic exercise program in the conventional treatment regimen of patients with CF Exercise intolerance is common in cystic fibrosis ( CF ) . We examined the effects of a supervised three-month running program on exercise tolerance , pulmonary function , cardiorespiratory fitness ( peak oxygen consumption ) , and respiratory muscle endurance in CF patients . We studied 31 patients , 21 exercise and ten control , aged 10 to 30 years , with pulmonary involvement ranging from mild to severe . The exercise and control groups were not significantly different with respect to age , sex , pulmonary function , exercise tolerance , or cardiorespiratory fitness . After three months of physical conditioning , the exercise group had significantly increased exercise tolerance and peak oxygen consumption and significantly lower heart rates for submaximal work loads , while the nonexercising ( control ) group was unchanged in all these variables . The FEV1 decreased significantly in the control group . There were no other significant changes in pulmonary function in either the control or exercise group . Respiratory muscle endurance increased significantly in the exercise patients , and did not change in the control patients . There were no adverse effects of the program . The data suggest that a supervised running program can increase CF patients ' exercise tolerance and cardiorespiratory fitness , perhaps in part by increasing respiratory muscle tolerance . The effects of a much longer program deserve study
Output:
| This review does provide some limited evidence from both short- and long-term studies that aerobic or anaerobic physical training has a positive effect on primary outcomes ( exercise capacity , strength and lung function ) but improvements are not consistent between studies .
Physical training is already part of the care package offered to most people with cystic fibrosis and there is a lack of evidence to actively discourage this .
The benefits obtained from including physical training in a package of care may be influenced by the type of training programme . |
MS211214 | ***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 assessed the efficacy of trimethoprim/sulfamethoxazole ( TRM/SMX ) in vivo in relation to the frequency of dihydrofolate reductase ( dhfr ) and dihydropteroate synthase ( dhps ) alleles in 45 Sudanese malaria patients . Plasma levels of TRM , SMX , and acetylsulfamethoxazole ( AcSMX ) were measured before treatment and at days 3 , 7 , and 14 or upon recrudescence to ascertain drug absorption . Forty patients ( 89 % ) had an adequate clinical response , one patient ( 2 % ) had an early treatment failure response , while four patients ( 8 % ) showed late treatment failure responses . Genotyping of merozoite surface protein 1 , MSP-1 , MSP-2 , and glutamate-rich protein before treatment and upon recrudescence showed that all recurring parasites were recrudescences . The plasma levels of TRM , AcSMX , and SMX indicated adequate drug absorption in all patients . This suggests parasite resistance as a cause of treatment failure . The presence of dhfr Ile 51 and Asn 108 alone or coupled with dhps Ala-436 among parasites that were cleared after treatment indicates that these alleles alone are insufficient to cause in vivo resistance . However , the presence of the triple mutant dhfr ( Ile-51/Arg-59/Asn-108 ) with the dhps Gly-437 genotype in all recurring infections , suggests the importance of codon 59 and 437 alleles in susceptibility to TRM/SMX . However , the number is too little to make firm conclusions Background In Malawi , there has been a return of Plasmodium falciparum sensitivity to chloroquine ( CQ ) since sulfadoxine-pyrimethamine ( SP ) replaced CQ as first line treatment for uncomplicated malaria . When used for prophylaxis , Amodiaquine ( AQ ) was associated with agranulocytosis but is considered safe for treatment and is increasingly being used in Africa . Here we compare the efficacy , safety and selection of resistance using SP or CQ+SP or artesunate (ART)+SP or AQ+SP for the treatment of uncomplicated falciparum malaria . Methodology and Findings 455 children aged 1–5 years were recruited into a double-blinded r and omised trial comparing SP to the three combination therapies . Using intention to treat analysis with missing outcomes treated as successes , and without adjustment to distinguish recrudescence from new infections , the day 28 adequate clinical and parasitological response ( ACPR ) rate for SP was 25 % , inferior to each of the three combination therapies ( p<0.001 ) . AQ+SP had an ACPR rate of 97 % , higher than CQ+SP ( 81 % ) and ART+SP ( 70 % ) , p<0.001 . Nineteen children developed a neutropenia of ≤0.5 × 103 cells/µl by day 14 , more commonly after AQ+SP ( p = 0.03 ) . The mutation pfcrt 76 T , associated with CQ resistance , was detected in none of the pre-treatment or post-treatment parasites . The prevalence of the pfmdr1 86Y mutation was higher after treatment with AQ+SP than after SP , p = 0.002 . Conclusions The combination AQ+SP was highly efficacious , despite the low efficacy of SP alone ; however , we found evidence that AQ may exert selective pressure for resistance associated mutations many weeks after treatment . This study confirms the return of CQ sensitivity in Malawi and importantly , shows no evidence of the re-emergence of pfcrt 76 T after treatment with CQ or AQ . Given the safety record of AQ when used as a prophylaxis , our observations of marked falls in neutrophil counts in the AQ+SP group requires further scrutiny . Trial Registration Controlled-Trials.com IS RCT To determine the predictive value of chloroquine ( CQ ) resistance markers in Senegal , Plasmodium falciparum DNA polymorphisms in pfmdr1 and pfcrt were examined in relation to clinical outcome . Despite CQ treatment , 17 % of patients had parasitemia after 28 days . Examination of molecular markers of CQ resistance revealed that 64 % of all isolates had the T76 resistant allele at the pfcrt locus , while 30 % carried the Y86 resistant allele at the pfmdr1 locus . The pfcrt T76 allele was present not only in all in vivo resistant isolates , 89 % of in vitro resistant isolates , but also in 35 % of in vitro sensitive isolates . The pfmdr1 N86Y polymorphism did not correlate with in vitro or in vivo CQ resistance . Our data suggest that the pfcrt T76 allele alone is required but not a sufficient predictor for in vivo CQ resistance Both northern and southern Sudan are deploying artemisinin-based combinations against uncomplicated Plasmodium falciparum malaria ( artesunate+sulfadoxine-pyrimethamine [ AS+SP ] in the north , artesunate+amodiaquine [ AS+AQ ] in the south ) . In 2003 , we tested the efficacy of 3 day AS+SP and AS+AQ regimens in vivo in the isolated , seasonally endemic Nuba Mountains region ( the first study of AS combinations in southern Sudan ) . We also analysed pre-treatment blood sample s for mutations at the P. falciparum chloroquine transporter ( Pfcrt ) gene ( associated with CQ resistance ) , and at the dihydrofolate reductase ( Dhfr ) gene ( associated with pyrimethamine resistance ) . Among 161 r and omized children under 5 years , PCR-corrected cure rates after 28 days were 91.2 % ( 52/57 , 95 % CI 80.7 - 97.1 ) for AS+SP and 92.7 % ( 51/55 , 95 % CI 82.4 - 98.0 ) for AS+AQ , with equally rapid parasite and fever clearance . The Pfcrt K76 T mutation occurred in 90.0 % ( 144/160 ) of infections , suggesting CQ would work poorly in this region . Overall , 82.5 % ( 132/160 ) carried mutations at Dhfr ( N51I , C59R or S108N , but not I164L ) , but triple mutants ( more predictive of in vivo SP failure ) were rare ( 3.1 % ) . CQ use should be rapidly discontinued in this region . SP resistance may propagate rapidly , and AS+AQ is likely to be a better long-term option , provided AQ use is limited to the combination Plasmodium falciparum present in blood sample s collected before and 3 weeks after treatment with either pyrimethamine-sulfadoxine or chlorproguanil-dapsone was analyzed for variants of the genes coding for the target enzymes of antifolate drugs , dihydrofolate reductase ( DHFR ) and dihydropteroate synthetase ( DHPS ) . Fragments of the genes were amplified by polymerase chain reactions , and variants were identified by specific restriction endonuclease digestion . Treatment with either drug combination selected for the variants Ile51 , Arg59 , and Asn108 of DHFR , which have been associated with in vitro resistance to pyrimethamine and cycloguanil . The genotype Ser436 , Gly437 , and Glu540 of DHPS was selected by pyrimethamine-sulfadoxine but not chlorproguanil-dapsone treatment , showing that a combination of these three variants is important for in vivo resistance to sulfadoxine in the area studied Sulfadoxine-pyrimethamine efficacy was determined with a 28-day follow-up in 97 children between 6 months and 15 years of age . The polymerase chain reaction (PCR)-corrected treatment failure was 8.2 % and the uncorrected was 21.6 % . The presence of the dihydrofolate reductase ( DHFR ) and dihydropteroate synthetase ( DHPS ) mutations linked to sulfadoxine-pyrimethamine resistance before and after treatment was determined by PCR-restriction fragment length polymorphism ( RFLP ) and by a fluorogenic PCR assay . Before treatment , the prevalence of the triple DHFR mutations was higher among the patients having had a recurrent parasitemia ( either recrudescence or new infection ; 28.6 % versus 9.3 % ) , although the difference was not significant ( P = 0.1 ) . The double mutation Ala-436/Gly-437 was observed in 67 % of sample s , whereas no Glu-540 mutation was found . After treatment , the triple DHFR mutation was found in 76.2 % of patients with recurrent parasitemia , recrudescence , and new infection alike . Such high prevalence of mutant parasites indicates that sulfadoxine-pyrimethamine should not be used as monotherapy BACKGROUND Chloroquine ( CQ ) resistance has reached high levels in Africa in recent years . Little is known about variations of resistance between urban and rural areas . OBJECTIVES To compare the rates of in vivo resistance to CQ and the prevalences of the main molecular marker for CQ resistance among young children from urban and rural areas in Burkina Faso . METHODS The current analysis used the frame of a r and omized controlled trial ( IS RCT N27290841 ) on the combination CQ-methylene blue ( MB ) ( n=177 ) compared to CQ alone ( n=45 ) in young children with uncomplicated malaria . We examined clinical and parasitological failure rates as well as the prevalence of the Plasmodium falciparum chloroquine resistance transporter gene ( pfcrt ) T76 mutation . RESULTS Clinical and parasitological failure rates of CQ-MB differed significantly between urban ( 70 % ) and rural areas ( 29 % , p<0.0001 ) . Likewise , CQ failure rates were higher in the urban setting . Matching this pattern , pfcrt T76 was more frequently seen among parasite strains from urban areas ( 81 % ) when compared to rural ones ( 64 % , p=0.01 ) . In the presence of parasites exhibiting pfcrt T76 , the odds of overall clinical failure were increased to 2.6-fold ( [ 1.33 , 5.16 ] , p(LR)=0.005 ) . CQ was detected at baseline in 21 % and 2 % of children from the urban and the rural study area , respectively ( p(Chi)=0.002 ) . CONCLUSION Even within circumscribed geographical areas , CQ efficacy can vary dramatically . The differences in the prevalence of pfcrt T76 and in CQ failure rates are probably explained by a higher drug pressure in the urban area compared to the rural study area . This finding has important implication s for national malaria policies This study examines the relationship between malaria treatment failure after sulfadoxine-pyrimethamine ( S-P ) chemotherapy and presence of mutations in the Plasmodium falciparum dihydropteroate synthase ( dhps ) and dihydrofolate reductase ( dhfr ) genes ( associated with resistance in vitro to S and P ) before treatment . In Kenya , 38 malaria patients in a holoendemic area , and 21 in an epidemic area , participated in the trial in 1997 - 98 . In the 2 areas , drug failure occurred in 76 % and 75 % of cases where any mutation in dhfr was seen ( positive predictive values 76 % and 75 % : P = 0.003 and 0.008 ) and an identical association was seen with dhfr Asn-108 . In the holoendemic area all occurrences of > or = 2 mutations in dhfr predicted drug failure . Only 3 instances were seen in the epidemic focus , but treatment failed in all . Only in the epidemic focus , 7 ( 88 % ) of 8 occurrences of > or = 1 mutations in dhps , and all occurrences of the Gly-437 allele of dhps , predicted failure . Association between mutations in dhps and mutations in dhfr was noted in the combined sites , irrespective of outcome . Although this makes the relationship of combined dhfr and dhps mutations to failure more difficult to interpret , it nevertheless supports S-P selection acting on both genes . In the holoendemic site , treatment success increased with age . In this location , acquired immunity may mask the impact of mutations in dhps , since sulfadoxine is a less effective treatment than pyrimethamine The 4-aminoquinolines chloroquine ( CQ ) and amodiaquine ( AM ) were used to treat Gambian children with uncomplicated falciparum malaria in a r and omized drug trial . Blood sample s were taken immediately before treatment ( day 0 ) , and at day 7 and day 28 after treatment . Sample s from those parasitologically positive at day 7 following treatment ( ' early positives ' ) and those positive at day 28 but negative at day 7 ( ' late positives ' ) have been studied by PCR followed by restriction enzyme digestion to determine the allelic status of the pfmdr 1 locus at the codon-86 position ( asparagine or tyrosine ) , previously associated with resistance to CQ . A significantly higher prevalence of the tyr-86 allele was observed in sample s taken immediately before treatment ( day 0 ) in the early posit
Output:
| Genetic molecular markers were related to an increased risk of therapeutic failure . |
MS211215 | ***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 VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company Summary Background Cisplatin and fluoropyrimidine ( CF ) are st and ard first- line treatment in advanced gastric cancer , but no second-line treatment has yet been established . We present a phase II study in which we evaluated the efficacy and toxicity of the combination of Sorafenib ( S ) , and Oxaliplatin as second-line therapy . Methods Patients with progressive gastric adenocarcinoma after CF- first-line , ECOG 0–2 , and measurable disease were included . The primary objective was PFS . Treatment doses were Oxaliplatin 130 mg/m2/3 weeks and Sorafenib 800 mg/bid/d . Results We included 40 patients . CR was 2.5 % and SD was 47.2 % . Grade 3–4 toxic effects were neutropenia ( 9.8 % ) , thrombocytopenia ( 7.3 % ) , neurotoxicity ( 4.9 % ) and diarrhea ( 4.9 % ) . Median PFS was 3 months ( 95 % CI : 2.3–4.1 ) and median OS was 6.5 months ( 95 % CI : 5.2–9.6 ) . Time to progression ( TTP ) to first line therapy was a prognosis factor . Median OS was 9.7 months when time-to-progression during first-line chemotherapy was > 6 months and 5.6 m when it was < 6 months ( p = 0.04 ) . Conclusions Time-to-progression under a CF-based first-line therapy determines subgroups of GC patients with different prognosis . The combination of Oxaliplatin-Sorafenib in advanced GC patients previously treated with CF appears safe , but our results do not support the implementation of a phase III trial Summary Purpose . This phase II , open-label , multicenter study assessed the oral , multitargeted , tyrosine kinase inhibitor sunitinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had received prior chemotherapy . Experimental design . Patients received sunitinib 50 mg/day on Schedule 4/2 ( 4 weeks on treatment , followed by 2 weeks off treatment ) . The primary endpoint was objective response rate ; secondary endpoints included clinical benefit rate , duration of response , progression-free survival ( PFS ) , overall survival ( OS ) , pharmacokinetics , pharmacodynamics , safety and tolerability , and quality of life . Results . Of 78 patients enrolled , most had gastric adenocarcinoma ( 93.6 % ) and metastatic disease ( 93.6 % ) . All were evaluable for safety and efficacy . Two patients ( 2.6 % ) had partial responses and 25 patients ( 32.1 % ) had a best response of stable disease for ≥6 weeks . Median PFS was 2.3 months ( 95 % confidence interval [ CI ] , 1.6–2.6 months ) and median OS was 6.8 months ( 95 % CI , 4.4–9.6 months ) . Grade ≥3 thrombocytopenia and neutropenia were reported in 34.6 % and 29.4 % of patients , respectively , and the most common non-hematologic adverse events were fatigue , anorexia , nausea , diarrhea , and stomatitis . Pharmacokinetics of sunitinib and its active metabolite were consistent with previous reports . There were no marked associations between baseline soluble protein levels , or changes from baseline , and measures of clinical outcome . Conclusions . The progression-delaying effect and manageable toxicity observed with sunitinib in this study suggest that although single-agent sunitinib has insufficient clinical value as second-line treatment for advanced gastric cancer , its role in combination with chemotherapy merits further study Background : This study aim ed to determine whether combination S-1 plus cisplatin ( CDDP ) therapy , the most widely used therapy for Japanese patients with advanced gastric cancer , and the novel oral antiangiogenic agent TSU-68 could contribute to gastric cancer treatment . Methods : Ninety-three patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers were r and omised into two groups : TSU-68 plus S-1/CDDP ( group A ) and S-1/CDDP ( group B ) groups . Both patient groups received identical S-1 and CDDP dosages . TSU-68 was orally administered for 35 consecutive days . Group B patients received S-1 orally twice daily for three consecutive weeks , followed by intravenous CDDP on day 8 . The primary endpoint was progression-free survival ( PFS ) . Results : Median PFS periods were 208 and 213 days in groups A and B , respectively ( P=0.427 ) . Median survival periods for groups A and B were 497.0 and 463.5 days , respectively ( P=0.219 ) . No statistically significant differences were noted for PFS , survival or the adverse event ( AE ) incidence rate . All AEs were expected according to previous reports for TSU-68 , TS-1 , and CDDP . Conclusion : Combination therapy involving TSU-68 , S-1 , and CDDP was safe and well tolerated in patients with chemotherapy-naïve unresectable or recurrent advanced gastric cancers . However , factors related to therapeutic efficacy should be investigated further BACKGROUND Peri-operative chemotherapy and surgery is a st and ard treatment of localised oesophagogastric adenocarcinoma ; however , the outcomes remain poor . PATIENTS AND METHODS ST03 is a multicentre , r and omised , phase II/III study comparing peri-operative ECX with or without bevacizumab ( ECX-B ) . The primary outcome measure of phase II ( n = 200 ) was safety , specifically gastrointestinal ( GI ) perforation rates and cardiotoxicity . RESULTS Two hundred patients were r and omised between October 2007 and April 2010 . Ninety-one/101 ( 90 % ) ECX and 86/99 ( 87 % ) ECX-B patients completed pre-operative chemotherapy ; 7 ECX and 9 ECX-B patients stopped due to toxicity . Gastrointestinal perforations ( 3 ECX , 1 ECX-B ) , cardiac events ( 1 ECX , 4 ECX-B ) and venous thromboembolic events ( VTEs , 8 ECX , 7 ECX-B ) were uncommon . Arterial thromboembolic events ( ATEs , myocardial infa rct ion ( MI ) or cerebrovascular accident ) were more frequent with ECX-B ( 5 versus 1 with ECX ) . Delayed wound healing , anastomotic leaks and GI bleeding rates were similar . More asymptomatic left ventricular ejection fraction ( LVEF ) falls ( ≥15 % and /or to < 50 % ) occurred with ECX-B ( 21.2 % versus 11.1 % with ECX ) . Clinical ly significant falls ( ≥10 % to below lower limit of normal , LLN ) occurred in ( 15.3 % ) and ( 8.9 % ) respectively , with no associated cardiac failure ( median 22 months follow-up ) . CONCLUSIONS Addition of bevacizumab to peri-operative ECX chemotherapy is feasible with acceptable toxicity and no negative impact on surgical outcomes We design ed a single-arm , open label phase II study to determine the efficacy and toxicity of the combination of pazopanib with CapeOx ( capecitabine and oxaliplatin ) in metastatic /recurrent advanced gastric cancer ( AGC ) patients . Previously untreated AGC patients received capecitabine ( 850 mg/m2 bid , day 1–14 ) plus oxaliplatin ( 130 mg/m2 , day 1 ) in combination with pazopanib ( 800 mg , day 1–21 ) every three weeks . Treatment was continued until progression of the disease or intolerable toxicity was observed . In all , 66 patients were treated with pazopanib plus CapeOx . The median age of the patients was 51.5 years ( range , 23.0–77 ) , and the median ECOG performance status was 1 ( 0–1 ) . Among all 66 patients , one complete response and 37 partial responses were observed ( overall response rate , 62.4 % ; 95 % confidence interval ( CI ) , 45.7–73.5 % accounting for the 2-stage design of this trial ) . Stable disease was observed in 23 patients ( 34.8 % ) , revealing a 92.4 % disease control rate . The median progression free survival and overall survival were 6.5 months ( 95 % CI , 5.6–7.4 ) and 10.5 months ( 95 % CI , 8.1–12.9 ) , respectively . Thirty-four patients ( 51.5 % ) experienced a treatment-related toxicity of grade 3 or more . The most common toxicities of grade 3 or more were neutropenia ( 15.1 % ) , anemia ( 10.6 % ) , thrombocytopenia ( 10.6 % ) , anorexia ( 7.6 % ) , nausea ( 3.0 % ) , and vomiting ( 3.0 % ) . There were no treatment-related deaths . The combination of pazopanib and CapeOx showed moderate activity and an acceptable toxicity profile as a first-line treatment in metastatic / recurrent AGC patients ( Clinical Trials.gov NCT01130805 ) PURPOSE We evaluated the activity of regorafenib , an oral multikinase inhibitor , in advanced gastric adenocarcinoma . PATIENTS AND METHODS We conducted an international ( Australia and New Zeal and , South Korea , and Canada ) r and omized phase II trial in which patients were r and omly assigned at a two-to-one ratio and stratified by lines of prior chemotherapy for advanced disease ( one v two ) and region . Eligible patients received best supportive care plus regorafenib 160 mg or matching placebo orally on days 1 to 21 of each
Output:
| Second-line therapy with ramucirumab and third-line therapy with apatinib are the only anti-angiogenic agents so far shown to significantly improve survival of patients with advanced gastric cancer .
Overall , agents that specifically target the vascular endothelial growth factor lig and or receptor have better safety profile compared to multi-target tyrosine kinase inhibitors |
MS211216 | ***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 Chronic fatigue syndrome ( CFS ) presents a challenge for patients , health care providers , and health insurance groups because of its incapacitating nature , unknown cause , and poorly understood prognosis . We conducted a longitudinal population -based study to characterize the clinical course of CFS . Methods Sixty-five CFS subjects were identified from a r and om-digit-dialing survey of Wichita , Kansas residents and followed for up to 3 years . We evaluated changes in CFS classification ( partial or total remission , alternative medical or psychiatric diagnoses ) , CFS case-defining criteria , wellness scores , hours of activities and sleep , and treatments used to reduce fatigue . Associations between risk factors and outcomes were determined by use of logistic regression and generalized estimating equations models . Results Only 20%-33 % of the subjects were classified as having CFS at follow-up , 56.9 % ever experienced partial or total remission , 10 % sustained total remission , and 23.1 % received alternative diagnoses , of which 20 % were sleep disorders . Higher fatigue severity scores and total number of symptoms were negatively associated with ever remitting . Duration of illness ≤ 2 years was positively associated with sustained remission . Unrefreshing sleep persisted in at least 79 % of the subjects across all periods but , as with most of the CFS symptoms , tended to be less frequent over time . The number of activities affected by fatigue decreased over time , while wellness scores increased . At any follow-up , more than 35 % of subjects reporting reduced fatigue used complementary and alternative medicine therapies , and of those subjects , at least 50 % thought these therapies were responsible for reducing their fatigue . Conclusions The clinical course of CFS was characterized by an intermittent pattern of relapse and remission . Remission rates documented by our population -based study were similar to those reported in clinical studies . Shorter illness duration was a significant predictor of sustained remission , and thus early detection of CFS is of utmost importance . The persistence of sleep complaints and identification of sleep disorders suggest that CFS subjects be evaluated for sleep disturbances , which could be treated AIM To evaluate the effects of a combination probiotic on symptoms and colonic transit in patients with irritable bowel syndrome ( IBS ) and significant bloating . METHODS Forty-eight patients with Rome II IBS were r and omized in a parallel group , double-blind design to placebo or VSL # 3 twice daily ( 31 patients received 4 weeks and 17 patients 8 weeks of treatment ) . Pre- and post-treatment colonic transit measurements were performed using scintigraphy with (111)In charcoal . Symptoms were summarized as an average daily score for the entire period of treatment and separately for the first 4 weeks of treatment . Weekly satisfactory relief of abdominal bloating was assessed . RESULTS Treatment with VSL # 3 was associated with reduced flatulence over the entire treatment period ( placebo 39.5 + /- 2.6 vs VSL # 3 29.7 + /- 2.6 , P = 0.011 ) ; similarly , during the first 4 weeks of treatment , flatulence scores were reduced ( placebo 40.1 + /- 2.5 vs VSL # 3 30.8 + /- 2.5 , P = 0.014 ) . Proportions of responders for satisfactory relief of bloating , stool-related symptoms , abdominal pain and bloating scores were not different . Colonic transit was retarded with VSL # 3 relative to placebo ( colon geometric center 2.27 + /- 0.20 vs 2.83 + /- 0.19 , P = 0.05 respectively ) . CONCLUSION VSL # 3 reduces flatulence scores and retards colonic transit without altering bowel function in patients with IBS and bloating Human intestinal microbiota plays an important role in the maintenance of host health by providing energy , nutrients , and immunological protection . Intestinal dysfunction is a frequent complaint in myalgic encephalomyelitis/chronic fatigue syndrome ( ME/CFS ) patients , and previous reports suggest that dysbiosis , i.e. the overgrowth of abnormal population s of bacteria in the gut , is linked to the pathogenesis of the disease . We used high-throughput 16S rRNA gene sequencing to investigate the presence of specific alterations in the gut microbiota of ME/CFS patients from Belgium and Norway . 43 ME/CFS patients and 36 healthy controls were included in the study . Bacterial DNA was extracted from stool sample s , PCR amplification was performed on 16S rRNA gene regions , and PCR amplicons were sequenced using Roche FLX 454 sequencer . The composition of the gut microbiota was found to differ between Belgian controls and Norwegian controls : Norwegians showed higher percentages of specific Firmicutes population s ( Roseburia , Holdemania ) and lower proportions of most Bacteroidetes genera . A highly significant separation could be achieved between Norwegian controls and Norwegian patients : patients presented increased proportions of Lactonifactor and Alistipes , as well as a decrease in several Firmicutes population s. In Belgian subjects the patient/control separation was less pronounced , however some abnormalities observed in Norwegian patients were also found in Belgian patients . These results show that intestinal microbiota is altered in ME/CFS . High-throughput sequencing is a useful tool to diagnose dysbiosis in patients and could help design ing treatments based on gut microbiota modulation ( antibiotics , pre and probiotics supplementation ) Purpose The aim of this study is to test in a double-blinded , r and omised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms , colonic transit and quality of life in irritable bowel syndrome ( IBS ) patients who meet Rome III criteria . Background There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS . Methods This is a double-blinded , r and omised placebo-controlled study of a symbiotic mixture ( Probinul , 5 g bid ) over 4 weeks after 2 weeks of run-in . The primary endpoints were global satisfactory relief of abdominal flatulence and bloating . Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief . The secondary endpoints were change in abdominal bloating , flatulence , pain and urgency by a 100-mm visual analog scale , stool frequency and bowel functions on vali date d adjectival scales ( Bristol Scale and sense of incomplete evacuation ) . Pre- and post-treatment colonic transit time ( Metcalf ) and quality of life ( SF-36 ) were assessed . Results Sixty-four IBS patients ( symbiotic n = 32 , 64 % females , mean age 38.7 ± 12.6 years ) were studied . This symbiotic mixture reduced flatulence over a 4-week period of treatment ( repeated- measures analysis of covariance , p < 0.05 ) . Proportions of responders were not significantly different between groups . At the end of the treatment , a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group . Conclusions This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients , a lack of adverse events and a good side-effect profile ; however , it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating . Further studies are warranted Background Recent data suggest a role for the intestinal microbiota in the pathogenesis of functional bowel disorders ( FBDs ) . Probiotic studies in FBDs generated inconsistent results suggesting a strain-specific and product-specific effect . Aim To investigate the clinical efficacy of Lactobacillus acidophilus NCFM ( L-NCFM ) and Bifidobacterium lactis Bi-07 ( B-LBi07 ) in nonconstipation FBDs . Methods A double-blind , placebo-control clinical trial of the probiotic bacterias L-NCFM and B-LBi07 twice a day ( 2 × 1011CFU/d ) versus placebo over 8 weeks . Primary endpoints were global relief of gastrointestinal symptoms and satisfaction with treatment . Secondary endpoints were change in symptoms severity , well-being , and quality of life . Microbiological effect was assessed by quantitative real time polymerase chain reaction on fecal sample s. Results Sixty patients ( probiotic , n=31 ; placebo , n=29 ) , 72 % females , 84 % whites , mean age 37 years . Abdominal bloating improved in the probiotics compared with the placebo group at 4 weeks ( 4.10 vs 6.17 , P=0.009 ; change in bloating severity P=0.02 ) and 8 weeks ( 4.26 vs 5.84 , P=0.06 ; change in bloating severity P<0.01 ) . Analyses on the irritable bowel syndrome subgroup ( n=33 ) showed similar results . Conclusions L-NCFM and B-LBi07 twice a day improve symptoms of bloating in patients with FBDs . These data supports the role of intestinal bacteria in the pathophysiology of FBD and the role for probiotic bacteria in the management of these disorders Certain therapeutic microbes , including Bifidobacteria infantis ( B. infantis ) 35624 exert beneficial immunoregulatory effects by mimicking commensal-immune interactions ; however , the value of these effects in patients with non-gastrointestinal inflammatory conditions remains unclear . In this study , we assessed the impact of oral administration of B. infantis 35624 , for 6‒8 weeks on inflammatory biomarker and plasma cytokine levels in patients with ulcerative colitis ( UC ) ( n = 22 ) , chronic fatigue syndrome ( CFS ) ( n = 48 ) and psoriasis ( n = 26 ) in three separate r and omized , double-blind , placebo-controlled interventions . Additionally , the effect of B. infantis 35624 on immunological biomarkers in healthy subjects ( n = 22 ) was assessed . At baseline , both gastrointestinal ( UC ) and non-gastrointestinal ( CFS and psoriasis ) patients had significantly increased plasma levels of C-reactive protein ( CRP ) and the pro-inflammatory cytokines tumor necrosis factor α ( TNF-α ) and interleukin-6 ( IL-6 ) compared with healthy volunteers . B. infantis 35624 feeding result ed in reduced plasma CRP levels in all three inflammatory disorders compared with placebo . Interestingly , plasma TNF-α was reduced in CFS and psoriasis while IL-6 was reduced in UC and CFS . Furthermore , in healthy subjects , LPS-stimulated TNF-α and IL-6 secretion by peripheral blood mononuclear cells ( P BMC s ) was significantly reduced in the B. infantis 35624-treated groups compared with placebo following eight weeks of feeding . These results demonstrate the ability of this microbe to reduce systemic pro-inflammatory biomarkers in both gastrointestinal and non-gastrointestinal conditions . In conclusion , these data show that the immunomodulatory effects of the microbiota in humans are not limited to the mucosal immune system but extend to the systemic immune system BACKGROUND Therapy trials with bacterial compounds in irritable bowel syndrome ( IBS ) have produced conflicting results and , so far , an E.-coli preparation has not been used . METHODS Two hundred and ninety-eight patients with lower abdominal symptoms diagnosed as IBS were treated for 8 weeks by the compound Symbioflor-2 ( Symbiopharm GmbH , Herborn , Germany ) , an Escherichia coli product ( N = 148 ) , or placebo ( n = 150 ) in a double-blinded , r and omized fashion . Patients were seen weekly by the physician , who assessed the presence of core IBS symptoms . Both an abdominal pain score ( APS ) as well as a general symptom score ( GSS ) were used as primary endpoints . Responders had to have complete absence of IBS core symptoms at > or = 1 visit during treatment . RESULTS The responder rate in GSS to the drug was 27 / 148 ( 18.2 % ) in comparison to placebo with 7 / 150 ( 4.67 % ) ( p = 0.000397 ) . The improvement in APS was 28 / 148 ( 18.9 % ) and 10 / 150 ( 6.67 % ) for placebo ( p = 0.001649 ) . The response was reached from visit 3 onwards with both medication and placebo . Post-hoc analysis revealed no significant differences in efficacy of the drug between the gender and different age groups . CONCLUSION Treatment of IBS with the probiotic Symbioflor-2 is effective and superior to placebo in reducing typical symptoms of IBS patients seen by general practitioners and by gastroenterologists Background and Aim . The efficacy of supplementation treatment with two multispecies probiotic formulates on subjects diagnosed with IBS-C and the assessment of their gut microbiota were investigated . Methods . A r and omized , double-blind , three-arm parallel group trial was carried out on 150 IBS-C subjects divided into three groups ( F_1 , F_2 , and F_3 ) . Each group received a daily oral administration of probiotic mixtures ( for 60 days ) F_1 or F_2 or placebo F_3 , respectively . Fecal microbiological analyses were performed by species-specific qPCR to assess the different amount of probiotics . Results . The percentage of responders for each symptom was higher in the probiotic
Output:
| The level of evidence identified for the use of probiotics in IBS was excellent in quality ; however , the evidence available for the use of probiotic interventions in CFS/ME was poor and limited .
There is currently insufficient evidence for the use of probiotics in CFS/ME patients , despite probiotic interventions being useful in IBS . |
MS211217 | ***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: Introduction Absence of pulmonary perfusion during cardiopulmonary bypass ( CPB ) may be associated with reduced postoperative oxygenation . Effects of active pulmonary artery perfusion were explored in patients with chronic obstructive pulmonary disease ( COPD ) undergoing cardiac surgery . Methods 90 patients were r and omised to receive pulmonary artery perfusion during CPB with either oxygenated blood ( n=30 ) or histidine-tryptophan-ketoglutarate ( HTK ) solution ( n=29 ) compared with no pulmonary perfusion ( n=31 ) . The co primary outcomes were the inverse oxygenation index compared at 21 hours after starting CPB and longitudinally in a mixed-effects model ( MEM ) . Secondary outcomes were tracheal intubation time , serious adverse events , mortality , days alive outside the intensive care unit ( ICU ) and outside the hospital . Results 21 hours after starting CPB patients receiving pulmonary artery perfusion with normothermic oxygenated blood had a higher oxygenation index compared with no pulmonary perfusion ( mean difference ( MD ) 0.94 ; 95 % CI 0.05 to 1.83 ; p=0.04 ) . The blood group had also a higher oxygenation index both longitudinally ( MEM , p=0.009 ) and at 21 hours ( MD 0.99 ; CI 0.29 to 1.69 ; p=0.007 ) compared with the HTK group . The latest result corresponds to a difference in the arterial partial pressure of oxygen of 23 mm Hg with a median fraction of inspired oxygen of 0.32 . Yet the blood or HTK groups did not demonstrate a longitudinally higher oxygenation index compared with no pulmonary perfusion ( MEM , p=0.57 and 0.17 ) . Similarly , at 21 hours there was no difference in the oxygenation index between the HTK group and those no pulmonary perfusion ( MD 0.06 ; 95 % CI −0.73 to 0.86 ; p=0.87 ) . There were no statistical significant differences between the groups for the secondary outcomes . Discussion Pulmonary artery perfusion with normothermic oxygenated blood during cardiopulmonary bypass appears to improve postoperative oxygenation in patients with COPD undergoing cardiac surgery . Pulmonary artery perfusion with hypothermic HTK solution does not seem to improve postoperative oxygenation . Trial registration number NCT01614951 ; Pre- results 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 Improved respiratory outcome has been shown after selective pulsatile pulmonary perfusion ( sPPP ) during cardiopulmonary bypass ( CPB ) . No contemporary study has analysed the impact of sPPP on alveolar and systemic inflammatory response in humans . METHODS Sixty-four patients undergoing a coronary artery bypass graft ( CABG ) were r and omized to sPPP or st and ard CPB ( 32 patients each ) . An alveolar-arterial oxygen gradient ( A-aDO(2 ) ) was measured preoperatively ( T0 ) , at ICU arrival ( T1 ) , 3 h postoperatively ( T2 ) and postextubation ( T3 ) . The bronchoalveolar lavage ( BAL ) was collected at T0 , T1 and T2 . White blood cells ( WBCs ) , neutrophils , mononucleates and lymphocytes in BAL infiltrates were compared between the two groups . A cytokine assay for interleukin-1 ( IL-1 ) , IL-8 , tumour necrosis factor alpha ( TNF-α ) , monocyte chemotactic protein-1 ( MCP-1 ) , growth regulated oncogene-alpha ( GRO-α ) and interferon (IFN)-γ was collected from the BAL and peripheral blood at the same time-points . Repeated-measure analysis of variance and non-parametric statistics were used to assess the between-group and during time differences . RESULTS The two groups proved comparable for perioperative variables . A-aDO(2 ) proved better after sPPP ( group-P = 0.0001 ; group time-P < 0.0001 ) . BAL infiltrates after sPPP showed lower WBCs , neutrophils and lymphocytes ( group-P = 0.0001 , group time-P = 0.0001 for all ) together with higher mononucleates ( group-P = 0.0001 , group time-P = 0.0001 ) . Proinflammatory cytokines and chemokine MCP-1 were lower in BAL after sPPP ( group-P = 0.005 , 0.034 , 0.036 and 0.005 , and group time-P = 0.001 , 0.009 , 0.001 and 0.0001 for IL-1 , IL-8 , TNF-α and MCP-1 , respectively ) , whereas the immune modulator IFN-γ significantly augmented after sPPP ( time-P = 0.0001 ) but remained stable after the st and ard CPB ( time-P = 0.101 , group-P = 001 , group time-P = 0.0001 ) . Indeed , serum cytokines were not different in the two groups during the study ( P = NS at single time-points and as a function of time ) . CONCLUSIONS sPPP attenuates alveolar inflammation , as demonstrated by the lower neutrophilic/lymphocytic alveolar infiltration , and the secretion of anti-inflammatory rather than proinflammatory mediators OBJECTIVE Acute lung injury still accounts for postoperative mortality after cardiopulmonary bypass ( CPB ) . The safety and the efficacy of pulsatile pulmonary perfusion ( PPP ) during CPB were analyzed . Preliminary results of the first PPP trial in human beings are reported . METHODS Thirty low-risk coronary artery bypass grafting ( CABG ) patients were prospect ively r and omized to receive PPP with oxygenated blood during CPB and aortic cross-clamping ( 15 patients , PPP-group ) or to conventional CPB ( 15 patients , control group ) . Alveolo-arterial oxygen gradient ( A-aDO(2 ) ) was set as the primary end point and collected preoperatively , at intensive care unit ( ICU ) arrival ( T1 ) , 3h postoperatively ( T2 ) , and post extubation ( T3 ) . Secondary end points were collected at the same time points and consisted of respiratory indices ( partial pressure of arterial oxygen/fraction of inspired O(2 ) ( PaO(2)/FiO(2 ) ) , lung compliance , mixed-venous partial pressure of oxygen ( pO(2 ) ) ) and hemodynamic pulmonary parameters ( indexed pulmonary vascular resistances ( PVRI ) , pulmonary arterial pressure ( PAP ) , pulmonary capillary wedge pressure ( PCWP ) , and cardiac index ( CI ) ) . Bronchoalveolar lavage ( BAL ) fluid was collected preoperatively , at ICU arrival ( T1-BAL ) and after 4h . RESULTS There were no PPP-related complications . Patients undergoing PPP showed a better preserved A-aDO(2 ) ( group-p=0.001 ) throughout the study period ( group × time-p = 0.0001 ) . PaO(2)/FiO(2 ) and lung compliance were better preserved by PPP ( group-p and group × time-p ≤ 0.05 for all ) . Pulmonary hemodynamic status was positively influenced by PPP , as shown by the higher CI ( group-p=0.0001 , group × time-p = 0.0001 ) , and the lower PVRI , PAP , and PCWP ( group-p ≤0.001 , group × time-p=0.0001 for all ) . Postoperative BAL specimens demonstrated a lower absolute count of white blood cells ( group-p=0.0001 ) , a higher percentage of monocytes/macrophages ( group-p=0.027 ) , and a lower percentage of neutrophils ( group-p=0.015 ) after PPP . CONCLUSIONS Oxygenated blood PPP proved safe and significantly ameliorated pulmonary hemodynamic parameters and respiratory indices in low-risk CABG OBJECTIVE We have recently shown that a considerable amount of pro-inflammatory cytokines is released during pulmonary passage after aortic declamping in patients undergoing coronary artery bypass grafting . The present study was performed to investigate whether bilateral extracorporeal circulation with the lungs as oxygenators can reduce the inflammatory responses of the lungs . METHODS Eighteen consecutive patients undergoing coronary artery bypass grafting were r and omly assigned to routine extracorporeal circulation with cannulation of right atrium and aorta ( routine circulation , ten patients ) or to a bilateral extracorporeal circulation with additional cannulation of left atrium and pulmonary artery ( bilateral circulation , eight patients ) . Blood was simultaneously drawn from right atrium and pulmonary vein at 1 , 10 and 20 min reperfusion . The levels of interleukin (IL)-6 and IL-8 and the adhesion molecules CD41 and CD62 on platelets and CD11b and CD41 on leukocytes were determined . Because of considerable interindividual scatter , the pulmonary venous levels are normalized to percent of the respective right atrial value at each time point . RESULTS At 1 min reperfusion pulmonary venous levels of IL-6 and IL-8 in routine circulation were + 44+/-15 % and + 43+/-28 % of the respective right atrial values . The respective values in bilateral circulation were -3+/-4 % and -6+/-7 % ( P=0.02 and P=0.05 vs. respective right atrium ) . Similar increments were found after 10 and 20 min . Platelet-monocyte coaggregates were retained during pulmonary passage at 1 min reperfusion in routine circulation ( -21+/-6 % ) , but washed out in bilateral circulation ( + 5+/-8 % , P=0 . 007 ) . At 20 min reperfusion , activated polymorphonuclear neutrophils ( PMN ) were retained in routine circulation ( -16+/-9 % ) but washed out in bilateral circulation ( + 19+/-29 % , P=0.05 ; all data given as mean+/-SEM ) . CONCLUSIONS Bilateral extracorporeal circulation without an artificial oxygenator significantly reduces the inflammatory responses during pulmonary passage after aortic declamping This review summarizes the (patho)-physiological effects of ventilation with high FiO2 ( 0.8–1.0 ) , with a special focus on the most recent clinical evidence on its use for the management of circulatory shock and during medical emergencies . Hyperoxia is a cornerstone of the acute management of circulatory shock , a concept which is based on compelling experimental evidence that compensating the imbalance between O2 supply and requirements ( i.e. , the oxygen dept ) is crucial for survival , at least after trauma . On the other h and , “ oxygen toxicity ” due to the increased formation of reactive oxygen species limits its use , because it may cause serious deleterious side effects , especially in conditions of ischemia/reperfusion . While these effects are particularly pronounced during long-term administration , i.e. , beyond 12–24 h , several retrospective studies suggest that even hyperoxemia of shorter duration is also associated with increased mortality and morbidity . In fact , albeit the clinical evidence from prospect i ve studies is surprisingly scarce , a recent meta- analysis suggests that hyperoxia is associated with increased mortality at least in patients after cardiac arrest , stroke , and traumatic brain injury . Most of these data , however , originate from heterogenous , observational studies with inconsistent results , and therefore , there is a need for the results from the large scale , r and omized , controlled clinical trials on the use of hyperoxia , which can be anticipated within the next 2–3 years . Consequently , until then , “ conserv
Output:
| Last , review authors found no comparable data for the secondary outcome inflammatory markers .
The effects of pulmonary artery perfusion with blood during cardiopulmonary bypass ( CPB ) are uncertain owing to the small numbers of participants included in meta-analyses .
Risks of death and serious adverse events may be higher with pulmonary artery perfusion with blood during CPB , and robust evidence for any beneficial effects is lacking . |
MS211218 | ***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: Estrogens administered in high doses were commonly used for therapy of advanced breast cancer before the introduction of contemporary endocrine therapy . While the mechanism of the antitumor effect is unknown , in vitro investigations have shown estrogens in high concentrations to be toxic to cell growth . Further , it has been shown that exposure of MCF-7 cells to estrogens in low concentrations may enhance the sensitivity and also lower the toxicity threshold to estrogens . This study was design ed to evaluate treatment with diethylstilbestrol ( DES ) in postmenopausal women with advanced breast cancer becoming resistant to estrogen deprivation . Thirty-two patients with advanced breast cancer previously exposed to multiple endocrine treatment regimens ( median 4 , range 2–10 ) were enrolled . Their tumor should have revealed evidence of endocrine sensitivity ( previous partial response or at least stable disease for ≥6 months to therapy ) . Each patient received DES 5 mg t.i.d . Four patients terminated therapy after ≤2 weeks on therapy due to side effects ; another two patients terminated therapy before progression for similar reasons ( one patient after SD for 15 weeks and one with a PR after 39 weeks ) . Four patients obtained CR and six patients PR . In addition , two patients had SD for ≥6 months duration . Five patients had an objective response and one patient a SD lasting for ≥1 year . Our results reveal estrogens administered in high doses may have antitumor effects in breast cancer patients heavily pretreated with endocrine therapy . Such treatment represents a valuable alternative to chemotherapy in selected patients It was previously shown that letrozole ( Femara ) was significantly more potent than anastrozole ( Arimidex ) in inhibiting aromatase activity in vitro and in inhibiting total body aromatisation in patients with breast cancer . The objective of this study was to compare letrozole ( 2.5 mg per day ) and anastrozole ( 1 mg per day ) as endocrine therapy in postmenopausal women with advanced breast cancer previously treated with an anti-oestrogen . This r and omised , multicentre and multinational open-label phase IIIb/IV study enrolled 713 patients . Treatment was for advanced breast cancer that had progressed either during anti-oestrogen therapy or within 12 months of completing that therapy . Patients had tumours that were either positive for oestrogen and /or progesterone receptors ( 48 % ) or of unknown receptor status ( 52 % ) . The primary efficacy endpoint was time to progression ( TTP ) . Secondary endpoints included objective response , duration of response , rate and duration of overall clinical benefit ( responses and long-term stable disease ) , time to treatment failure , and overall survival , as well as general safety . There was no difference between the treatment arms in TTP ; median times were the same for both treatments . Letrozole was significantly superior to anastrozole in the overall response rate ( ORR ) ( 19.1 % versus 12.3 % , P=0.013 ) , including in predefined subgroups ( receptor status-unknown , and soft-tissue- and viscera-dominant site of disease ) . There were no significant differences between the treatment arms in the rate of clinical benefit , median duration of response , duration of clinical benefit , time to treatment failure or overall survival . Both agents were well tolerated and there were no significant differences in safety . These results support previous data documenting the greater aromatase-inhibiting activity of letrozole and indicate that advanced breast cancer is more responsive to letrozole than to anastrozole as second-line endocrine therapy Abstract Purpose . This retrospective evaluation of data from two r and omized , multicenter trials examined whether tumor responses to further endocrine therapy were seen in postmenopausal women with advanced breast cancer who had progressed on both initial endocrine therapy , usually tamoxifen , and on the estrogen receptor ( ER ) antagonist fulvestrant ( ' Faslodex ' ) . Patients and methods . A combined total of 423 patients received fulvestrant 250 mg as a monthly intramuscular injection . After progression on fulvestrant , some patients received another endocrine therapy . Responses to subsequent endocrine therapy were assessed using a question naire sent to the trial investigators . Best responses were classified as a complete or partial response ( CR or PR ) , stable disease ( SD ) lasting ≥24 weeks , or disease progression . Results . Follow-up data were available for 54 patients who derived clinical benefit ( CB , defined as CR , PR or SD ) from fulvestrant and who received subsequent endocrine therapy , result ing in a PR in 4 patients , SD in 21 patients , and disease progression in 29 patients . Data were available for 51 patients who derived no CB from fulvestrant and who received further endocrine therapy , result ing in a PR in 1 patient , SD in 17 patients , and disease progression in 33 patients . Aromatase inhibitors were used as subsequent endocrine therapy in > 80 % of patients . Conclusions . After progression on fulvestrant , patients may retain sensitivity to other endocrine agents . Fulvestrant provides an additional option to existing endocrine therapies for the treatment of advanced or metastatic breast cancer in postmenopausal women , and may provide the opportunity to extend the sequence of endocrine regimens before cytotoxic chemotherapy is required Fulvestrant ( ICI 182,780 ) is a new type of estrogen receptor ( ER ) antagonist that down‐regulates the ER and has no known agonist effects . The authors report the prospect ively planned combined analysis of data from 2 Phase III trials comparing fulvestrant 250 mg monthly ( n = 428 ) and anastrozole 1 mg daily ( n = 423 ) in postmenopausal women with advanced breast carcinoma ( ABC ) who previously had progressed after receiving endocrine treatment PURPOSE To compare two doses of letrozole ( 0.5 mg and 2.5 mg every day ) and megestrol acetate ( 40 mg qid ) as endocrine therapy in postmenopausal women with advanced breast cancer previously treated with antiestrogens . PATIENTS AND METHODS This double-blind , r and omized , multicenter , multinational study enrolled 602 patients , all of whom were included in the primary analysis in the protocol . Patients had advanced or metastatic breast cancer with evidence of disease progression while receiving continuous adjuvant antiestrogen therapy , had experienced relapse within 12 months of stopping adjuvant antiestrogen therapy given for at least 6 months , or had experienced disease progression while receiving antiestrogen therapy for advanced disease . Tumors were required to be estrogen receptor- and /or progesterone receptor-positive or of unknown status . Confirmed objective response rate was the primary efficacy variable . Karnofsky Performance Status and European Organization for Research and Treatment of Cancer quality -of-life assessment s were collected for 1 year . RESULTS There were no statistically significant differences among the three treatment groups for overall objective tumor response . Patients treated with letrozole 0.5 mg had improvements in disease progression ( P = .044 ) and a decreased risk of treatment failure ( P = .018 ) , compared with patients treated with megestrol acetate . Letrozole 0.5 mg showed a trend ( P = .053 ) for survival benefit when compared with megestrol acetate . Megestrol acetate was more likely to produce weight gain , dyspnea , and vaginal bleeding , and the letrozole groups were more likely to experience headache , hair thinning , and diarrhea . CONCLUSION Given a favorable tolerability profile , once-daily dosing , and evidence of clinical ly relevant benefit , letrozole is equivalent to megestrol acetate and should be considered for use as an alternative treatment of advanced breast cancer in postmenopausal women after treatment failure with antiestrogens Fulvestrant is an estrogen receptor antagonist with no agonist effects . In the second‐line treatment of advanced breast carcinoma , fulvestrant was shown previously to be as effective as the third‐generation aromatase inhibitor , anastrozole , in terms of time to disease progression and objective response rates . The authors reported the overall survival results from these studies PURPOSE Docetaxel and capecitabine , a tumor-activated oral fluoropyrimidine , show high single-agent efficacy in metastatic breast cancer ( MBC ) and synergy in pre clinical studies . This international phase III trial compared efficacy and tolerability of capecitabine/docetaxel therapy with single-agent docetaxel in anthracycline-pretreated patients with MBC . PATIENTS AND METHODS Patients were r and omized to 21-day cycles of oral capecitabine 1,250 mg/m(2 ) twice daily on days 1 to 14 plus docetaxel 75 mg/m(2 ) on day 1 ( n = 255 ) or to docetaxel 100 mg/m(2 ) on day 1 ( n = 256 ) . RESULTS Capecitabine/docetaxel result ed in significantly superior efficacy in time to disease progression ( TTP ) ( hazard ratio , 0.652 ; 95 % confidence interval [ CI ] , 0.545 to 0.780 ; P = .0001 ; median , 6.1 v 4.2 months ) , overall survival ( hazard ratio , 0.775 ; 95 % CI , 0.634 to 0.947 ; P = .0126 ; median , 14.5 v 11.5 months ) , and objective tumor response rate ( 42 % v 30 % , P = .006 ) compared with docetaxel . Gastrointestinal side effects and h and -foot syndrome were more common with combination therapy , whereas myalgia , arthralgia , and neutropenic fever/sepsis were more common with single-agent docetaxel . More grade 3 adverse events occurred with combination therapy ( 71 % v 49 % , respectively ) , whereas grade 4 events were slightly more common with docetaxel ( 31 % v 25 % with combination ) . CONCLUSION The significantly superior TTP and survival achieved with the addition of capecitabine to docetaxel 75 mg/m(2 ) , with the manageable toxicity profile , indicate that this combination provides clear benefits over single-agent docetaxel 100 mg/m(2 ) . Docetaxel/capecitabine therapy is an important treatment option for women with anthracycline-pretreated MBC PURPOSE Fulvestrant is an antiestrogen that leads to estrogen receptor degradation and has demonstrated efficacy in breast cancer patients who have had disease recurrence or progression after tamoxifen . This study was design ed to examine the efficacy and toxicity of fulvestrant in patients with disease progression on a third-generation aromatase inhibitor ( AI ) . PATIENTS AND METHODS A one-stage phase II trial was conducted in postmenopausal women with measurable disease by Response Evaluation Criteria in Solid Tumors criteria who experienced disease progression after treatment with a third-generation AI and , at most , one additional hormonal agent . Tumors must have been estrogen receptor and /or progesterone receptor positive . The primary end point was objective response rate , and secondary end points were time to disease progression , survival , duration of response , and toxicity . RESULTS Eighty patients were enrolled , and three were ineligible . Characteristics of the 77 eligible patients included median age of 68 years , performance score of 0 or 1 in 91 % of patients , visceral dominant disease in 88 % of patients , two prior hormonal treatments in 73 % of patients , and prior chemotherapy for metastatic disease in 32 % of patients . Eleven patients ( 14.3 % ) achieved a partial response , and 16 patients ( 20.8 % ) had stable disease for at least 6 months , for a clinical benefit rate of 35 % . Antitumor activity seemed to be higher in women with prior treatment with AI alone compared with women whose prior treatment also included tamoxifen . Median time to progression was 3 months , and median survival time was 20.2 months . Fulvestrant was well tolerated . CONCLUSION Fulvestrant is a well-tolerated treatment and has efficacy against breast cancers that have progressed after therapy with a third-generation AI PURPOSE To compare the efficacy and tolerability of fulvestrant ( formerly ICI 182,780 ) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment . PATIENTS AND METHODS In this double-blind , double-dummy , parallel-group study , postmenopausal patients were r and omized to receive either an intramuscular injection of fulvestrant 250 mg once monthly or a daily oral dose of anastrozole 1 mg . The primary end point was time to progression ( TTP ) . Secondary end points included objective response ( OR ) rate , duration of response ( DOR ) , and tolerability . RESULTS Patients ( n = 400 ) were followed for a median period of 16.8 months . Fulvestrant was as effective as anastrozole in terms of TTP ( hazard ratio , 0.92 ; 95.14 % confidence interval [ CI ] , 0.74 to 1.14 ; P = .43 ) ; median TTP was 5.4 months with fulvestrant and 3.4 months with anastrozole . OR rates were 17.5 % with both treatments . Clinical benefit rates ( complete response + partial response + stable disease > or = 24 weeks ) were 42.2 % for fulvestrant and 36.1 % for anastrozole ( 95 % CI , -4.00 % to 16.41 % ; P = .26 ) . In responding patients , median DOR ( from r and omization to progression ) was 19.0 months for fulvest
Output:
| Sensitivity analyses showed these results to be robust , demonstrating that fulvestrant is an economically viable additional endocrine option in the United Kingdom for the treatment of hormone responsive advanced breast cancer |
MS211219 | ***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 & AIMS Few treatments have demonstrated efficacy and safety for diarrhea-predominant irritable bowel syndrome ( IBS-D ) . A phase 3 , r and omized , double-blind , placebo-controlled trial was performed to evaluate the safety and efficacy of repeat treatment with the nonsystemic antibiotic rifaximin . METHODS The trial included adults with IBS-D , mean abdominal pain and bloating scores of 3 or more , and loose stool , located at 270 centers in the United States and Europe from February 2012 through June 2014 . Those responding to a 2-week course of open-label rifaximin 550 mg 3 times daily , who then relapsed during an observation phase ( up to 18 weeks ) , were r and omly assigned to groups given repeat treatments of rifaximin 550 mg or placebo 3 times daily for 2 weeks . The primary end point was percentage of responders after first repeat treatment , defined as a decrease in abdominal pain of ≥30 % from baseline and a decrease in frequency of loose stools of ≥50 % from baseline , for 2 or more weeks during a 4-week post-treatment period . RESULTS Of 1074 patients ( 44.1 % ) who responded to open-label rifaximin , 382 ( 35.6 % ) did not relapse and 692 ( 64.4 % ) did ; of these , 636 were r and omly assigned to receive repeat treatment with rifaximin ( n = 328 ) or placebo ( n = 308 ) . The percentage of responders was significantly greater with rifaximin than placebo ( 38.1 % vs 31.5 % ; P = .03 ) . The percentage of responders for abdominal pain ( 50.6 % vs 42.2 % ; P = .018 ) was significantly greater with rifaximin than placebo , but not stool consistency ( 51.8 % vs 50.0 % ; P = .42 ) . Significant improvements were also noted for prevention of recurrence , durable response , and bowel movement urgency . Adverse event rates were low and similar between groups . CONCLUSIONS In a phase 3 study of patients with relapsing symptoms of IBS-D , repeat rifaximin treatment was efficacious and well tolerated . Clinical Trials.gov ID : NCT01543178 BACKGROUND & AIMS Eluxadoline is approved by the Food and Drug Administration for the treatment of adults with irritable bowel syndrome with diarrhea ( IBS‐D ) . Eluxadoline is a locally acting mixed & mgr;‐opiod and & kgr;‐opioid receptor agonist and & dgr;‐opioid receptor antagonist . The abuse potential of eluxadoline was evaluated as part of the Phase 2 and 3 clinical trials assessing the efficacy , safety , and tolerability of the drug . METHODS One Phase 2 ( IBS‐2001 ) and two Phase 3 ( IBS‐3001 and IBS‐3002 ) r and omized controlled trials enrolled patients meeting Rome III criteria for IBS‐D. Patients received oral twice‐daily double‐blind treatment with eluxadoline or placebo for 12 , 26 , or 52 weeks . The primary end point of these studies was the proportion of patients who had a composite response of decrease in abdominal pain and improvement in stool consistency on the same day for at least 50 % of days . Safety data were pooled , and specific adverse event terms potentially related to abuse were assessed descriptively . Adverse events reported during a 2‐week post‐treatment period ( IBS‐3001 ) and a 4‐week single‐blind washout period ( IBS‐3002 ) were assessed for signs of opioid withdrawal . Potential withdrawal effects were assessed by using the Subjective Opiate Withdrawal Scale . RESULTS Overall , 807 and 1032 patients received 1 or more doses of eluxadoline ( 75 or 100 mg , respectively ) , and 975 patients received placebo . The overall incidence of adverse events potentially related to abuse did not differ significantly among the groups given placebo , eluxadoline 75 mg , or eluxadoline 100 mg ( 2.8 % , 2.7 % , and 4.3 % , respectively ) . The most common adverse events potentially related to abuse were anxiety and somnolence , which occurred in less than 2 % of patients in each group . Median overall Subjective Opiate Withdrawal Scale scores did not differ significantly among the groups given placebo , eluxadoline 75 mg , or eluxadoline 100 mg ( 3.0 , 2.0 , and 3.0 , respectively ) . CONCLUSIONS In an analysis of data from Phase 2 and Phase 3 trials of eluxadoline ( 75 or 100 mg ) for patients with IBS‐D , data revealed no signs of abuse potential for eluxadoline . Clinical Trials.gov numbers : NCT01130272 , NCT01553591 , NCT01553747 BACKGROUND Evidence suggests that gut flora may play an important role in the pathophysiology of the irritable bowel syndrome ( IBS ) . We evaluated rifaximin , a minimally absorbed antibiotic , as treatment for IBS . METHODS In two identically design ed , phase 3 , double-blind , placebo-controlled trials ( TARGET 1 and TARGET 2 ) , patients who had IBS without constipation were r and omly assigned to either rifaximin at a dose of 550 mg or placebo , three times daily for 2 weeks , and were followed for an additional 10 weeks . The primary end point , the proportion of patients who had adequate relief of global IBS symptoms , and the key secondary end point , the proportion of patients who had adequate relief of IBS-related bloating , were assessed weekly . Adequate relief was defined as self-reported relief of symptoms for at least 2 of the first 4 weeks after treatment . Other secondary end points included the percentage of patients who had a response to treatment as assessed by daily self-ratings of global IBS symptoms and individual symptoms of bloating , abdominal pain , and stool consistency during the 4 weeks after treatment and during the entire 3 months of the study . RESULTS Significantly more patients in the rifaximin group than in the placebo group had adequate relief of global IBS symptoms during the first 4 weeks after treatment ( 40.8 % vs. 31.2 % , P=0.01 , in TARGET 1 ; 40.6 % vs. 32.2 % , P=0.03 , in TARGET 2 ; 40.7 % vs. 31.7 % , P<0.001 , in the two studies combined ) . Similarly , more patients in the rifaximin group than in the placebo group had adequate relief of bloating ( 39.5 % vs. 28.7 % , P=0.005 , in TARGET 1 ; 41.0 % vs. 31.9 % , P=0.02 , in TARGET 2 ; 40.2 % vs. 30.3 % , P<0.001 , in the two studies combined ) . In addition , significantly more patients in the rifaximin group had a response to treatment as assessed by daily ratings of IBS symptoms , bloating , abdominal pain , and stool consistency . The incidence of adverse events was similar in the two groups . CONCLUSIONS Among patients who had IBS without constipation , treatment with rifaximin for 2 weeks provided significant relief of IBS symptoms , bloating , abdominal pain , and loose or watery stools . ( Funded by Salix Pharmaceuticals ; Clinical Trials.gov numbers , NCT00731679 and NCT00724126 . ) 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 : Eluxadoline is a mixed μ-opioid receptor ( OR ) and κ-OR agonist and δ-OR antagonist , approved for the treatment of irritable bowel syndrome with diarrhea ( IBS-D ) . This analysis evaluated the safety and tolerability of eluxadoline 75 and 100 mg twice daily ( BID ) in one Phase 2 ( IBS-2001 ) and two Phase 3 ( IBS-3001 and IBS-3002 ) studies . Methods : Adults with IBS-D ( Rome III criteria ) were r and omized to placebo or eluxadoline ( 75 or 100 mg ) BID for 12 ( IBS-2001 ) , 26 ( IBS-3002 ) , or 52 ( IBS-3001 ) weeks . Safety data were pooled . Adverse events ( AEs ) were assessed , with special focus on opioid-related AEs , including suspected sphincter of Oddi spasm ( SOS ) events . Results : 2,776 patients were included in the enrolled set ; the safety set comprised 2,814 patients , based on actual treatments received . The most frequent AEs in the placebo and eluxadoline 75 and 100 mg groups were constipation ( 2.5 , 7.4 , and 8.1 % , respectively ) and nausea ( 5.0 , 8.1 , and 7.1 % , respectively ) ; discontinuation due to constipation was uncommon ( 0.3 , 1.1 , and 1.5 % , respectively ) . Ten SOS events ( 10/1,839 ; 0.5 % ) occurred in eluxadoline-treated patients , manifesting as acute abdominal pain with elevated aminotransferases or lipase , or pancreatitis ; all occurred in patients without a gallbladder . Eight of these events occurred with the higher dose of eluxadoline , within 1 week of initiation of therapy , and all resolved with eluxadoline discontinuation . There were five events independently adjudicated as pancreatitis not associated with SOS , three of which were associated with heavy alcohol use . Conclusions : Eluxadoline was well tolerated in Phase 2 and 3 trials , with constipation and nausea the most common AEs . Consistent with the known adverse effects of opioid agonists , clinical ly apparent SOS events were observed in eluxadoline-treated patients . All occurred in patients without a gallbladder and the majority were observed in patients on the higher dose of eluxadoline , suggesting a possible association OBJECTIVE : There has been growing interest in the investigation of health-related quality of life ( HRQOL ) among patients with gastrointestinal ( GI ) disorders . We recently reported on the development and preliminary validation of the IBS-QOL , a specific quality -of-life measure for irritable bowel syndrome ( IBS ) . The aim of this study was to determine the longitudinal construct validity ( responsiveness ) of the IBS-QOL . METHODS : Female patients enrolled in a multicenter treatment trial for functional bowel disorders were studied pre- and posttreatment with the IBS-QOL and other health status measures . Based on the response to treatment for several variables ( pain/14-day score , daily function , and days in bed/3 months ) , patients were stratified into Responders , Partial Responders , and Nonresponders . Change scores in the IBS-QOL were then statistically compared with changes in the other variables to determine their correlation and whether Responders were significantly different from non- and Partial Responders on the IBS-QOL . RESULTS : There was a significant correlation between change scores on the IBS-QOL and the other measures of treatment effect ( Pain/14 days , r = 0.25 , p < 0.002 ; Sickness Impact Profile [ SIP ] Total Score , r = 0.28 , p < 0.0004 ) . In addition , the IBS-QOL scores significantly differentiated Responders from Nonresponders for most of the variables tested ( regression trend test for Pain/14 days , p < 0.04 ; SIP Total , p < 0.0001 ; SIP Physical , p < 0.0001 ; SIP Psychosocial , p < 0.002 , and SIP Eating , p < 0.04 ) . CONCLUSION : The IBS-QOL is responsive to treatment in a referral-based clinical population of patients with functional bowel disorders The mixed μ‐ and κ‐opioid receptor agonist and δ‐opioid receptor antagonist , eluxadoline , is licensed in the USA for the treatment of irritable bowel syndrome with diarrhoea ( IBS‐D ) , based on the results of two large Phase 3 clinical trials Effects of the currently marketed form of loperamide ( Imodium capsules ) that might relate to abuse potential were examined . Study I was a double‐blind “ dose run‐up ” in adult male subjects with a history of illicit drug use but no history of opioid addiction . Subjective responses to doses of loperamide ranging from 12 to 60 mg were compared with responses to 120 mg codeine sulfate ( 96 mg base ) and to placebo . Based on study I , loperamide ( 60 mg ) was used in study II and its effects were compared with those of codeine ( 96 mg base ) and placebo in an exaddict subject group . Study II subjects had had extensive opioid experience but were not actively addicted at the time of this double‐blind , inpatient study . In study II , as in
Output:
| It also improved IBS severity and other abdominal symptoms such as bloating , discomfort , and risk of urgency and fecal incontinence .
Conclusion Eluxadoline ’s place in clinical practice might prove useful since the pharmacological options of IBS-D are limited and eluxadoline showed a positive effect in treating the symptoms of |
MS211220 | ***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 the influence of attachments and interproximal reduction on canines undergoing rotational movement with Invisalign . MATERIAL S AND METHODS In this prospect i ve clinical study , 53 canines ( 33 maxillary and 20 m and ibular ) were measured from the virtual TREAT models of 31 participants treated with anterior Invisalign . The pretreatment virtual model of the predicted final tooth position was superimposed on the posttreatment virtual model using ToothMeasure , Invisalign 's proprietary measurement software . A one-way analysis of variance ( ANOVA ) ( P < .05 ) compared three treatment modalities : attachments only ( AO ) , interproximal reduction only ( IO ) , and neither attachments nor interproximal reduction ( N ) . Student 's t-tests ( P < .05 ) compared the mean accuracy of canine rotation between arches . RESULTS The mean accuracy of canine rotation with Invisalign was 35.8 % ( SD = 26.3 ) . Statistical analyses indicated that there was no significant difference in accuracy between groups AO , IO , and N ( P = .343 ) . There was no statistically significant difference ( P = .888 ) in rotational accuracy for maxillary and m and ibular canines for any of the treatment groups . The most commonly prescribed attachment shape was the vertical-ellipsoid ( 70.5 % ) . CONCLUSIONS Vertical-ellipsoid attachments and interproximal reduction do not significantly improve the accuracy of canine rotation with the Invisalign system OBJECTIVE Based on our previous pilot study , the objective of this extended study was to compare ( a ) casts to their corresponding digital ClinCheck ® models at baseline and ( b ) the tooth movement achieved at the end of aligner therapy ( Invisalign ® ) to the predicted movement in the anterior region . MATERIAL S AND METHODS Pre- and post-treatment casts as well as initial and final ClinChecks ® models of 50 patients ( 15 - 63 years of age ) were analyzed . All patients were treated with Invisalign ® ( Align Technology , Santa Clara , CA , USA ) . Evaluated parameters were : upper/lower anterior arch length and intercanine distance , overjet , overbite , dental midline shift , and the irregularity index according to Little . The comparison achieved/predicted tooth movement was tested for equivalence [ adjusted 98.57 % confidence interval ( - 1.00 ; + 1.00 ) ] . RESULTS Before treatment the anterior crowding , according to Little , was on average 5.39 mm ( minimum 1.50 mm , maximum 14.50 mm ) in the upper dentition and 5.96 mm ( minimum 2.00 mm , maximum 11.50 mm ) in the lower dentition . After treatment the values were reduced to 1.57 mm ( minimum 0 mm , maximum 4.5 mm ) in the maxilla and 0.82 mm ( minimum 0 mm , maximum 2.50 mm ) in the m and ible . We found slight deviations between pretreatment casts and initialClinCheck ® ranging on average from -0.08 mm ( SD ± 0.29 ) for the overjet and up to -0.28 mm ( SD ± 0.46 ) for the upper anterior arch length . The difference between achieved/predicted tooth movements ranged on average from 0.01 mm ( SD ± 0.48 ) for the lower anterior arch length , up to 0.7 mm ( SD ± 0.87 ) for the overbite . All parameters were significantly equivalent except for the overbite ( -1.02 ; -0.39 ) . CONCLUSION Performed with aligners ( Invisalign ® ) , the resolvement of the partly severe anterior crowding was successfully accomplished . Resolving lower anterior crowding by protrusion of the anterior teeth ( i.e. , enlargement of the anterior arch length ) seems well predictable . The initial ClinCheck ® models provided high accuracy compared to the initial casts . The achieved tooth movement was in concordance with the predicted movement for all parameters , except for the overbite Clear aligners provide a convenient model to measure orthodontic tooth movement ( OTM ) . We examined the role of in vivo aligner material fatigue and subject-specific factors in tooth movement . Fifteen subjects seeking orthodontic treatment at the University of Florida were enrolled . Results were compared with data previously collected from 37 subjects enrolled in a similar protocol . Subjects were followed prospect ively for eight weeks . An upper central incisor was programmed to move 0.5 mm . every two weeks using clear aligners . A duplicate aligner was provided for the second week of each cycle . Weekly polyvinyl siloxane ( PVS ) impressions were taken , and digital models were fabricated to measure OTM . Initial and final cone beam computed tomography ( CBCT ) images were obtained to characterize OTM . Results were compared to data from a similar protocol , where subjects received a new aligner biweekly . No significant difference was found in the amount of OTM between the two groups , with mean total OTM of 1.11 mm . ( st and ard deviation ( SD ) 0.30 ) and 1.07 mm . ( SD 0.33 ) for the weekly aligner and biweekly control groups , respectively ( P = 0.72 ) . Over eight weeks , in two-week intervals , material fatigue does not play a significant role in the rate or amount of tooth movement Fifty-one patients were enrolled in this study to explore the treatment effects of material stiffness and frequency of appliance change when using clear , sequential , removable appliances ( aligners ) . Patients were stratified based on pretreatment peer assessment rating ( PAR ) scores and need for extraction s. They were r and omized into 4 treatment protocol s : 1-week activation with soft material , 1-week activation with hard material , 2-week activation with soft material , and 2-week activation with hard material . Patients continued with their protocol s until either the series of aligners was completed , or until it was determined that the aligner was not fitting well ( study end point ) . Weighted PAR score and average incisor irregularity ( AII ) indexes were used to measure pretreatment and end-point study models , and average improvement was compared among the 4 groups . In addition to the evaluation of the 4 treatment groups , comparisons were made of the individual components of the PAR score to determine which occlusal components experienced the most correction with the aligners . The percentages and absolute extraction space closures were evaluated , and papillary bleeding scores before and during treatment were compared . Although no statistical difference was observed between the 4 treatment groups , a trend was noted with the 2-week frequency having a larger percentage of reduction in weighted PAR and AII scores , and greater extraction space closure . Anterior alignment was the most improved component , and buccal occlusion was the least improved . When analyzed by type of extraction , incisor extraction sites had a significantly greater percentage of closure than either maxillary or m and ibular premolar extraction sites . A statistically significant decrease in mean average papillary bleeding score was found during treatment when compared with pretreatment scores , although this difference was not clinical ly significant The purpose of this study was to compare the efficacy of overbite correction achieved by a conventional continuous arch wire technique and the segmented arch technique as recommended by Burstone . The sample comprised 50 adult patients ( age 18 to 40 years ) with deep bites . Twenty-five patients were treated with a continuous arch wire technique ( CAW ) ; in the second half of the sample , the segmented arch technique ( Burstone ) was used for correction of the vertical malocclusion . Lateral cephalograms and plaster cast models taken before and immediately after treatment were evaluated . Statistical analysis was performed on the collected data . The results showed that both techniques produced a highly significant overbite reduction ( CAW : -3.17 mm , p < 0.001 ; Burstone : -3.56 mm , p < 0.001 ) . The CAW group showed an extrusion in the molar area with subsequent posterior rotation of the m and ible ( 6occl-ML : + 1.30 mm ; 6occl-NSL : + 1.63 mm ; ML/NSL : + 1.94 degrees , all p < 0.001 ) . The Burstone group , however , showed overbite reduction by incisor intrusion without any substantial extrusion of posterior teeth ( upper 1-NSL : -1.50 mm ; lower 1-ML : -1.72 mm ; both p < 0.001 ) . As a consequence , no significant posterior rotation of the m and ible took place ( ML/NSL : + 0.52 degrees , n.s . ) . It is concluded that in adult patients the segmented arch technique ( Burstone ) can be considered as being superior to a conventional continuous arch wire technique if arch leveling by incisor intrusion is indicated
Output:
| Extrusion was the most difficult movement to control ( 30 % of accuracy ) , followed by rotation .
CAT aligns and levels the arches ; it is effective in controlling anterior intrusion but not anterior extrusion ; it is effective in controlling posterior buccolingual inclination but not anterior buccolingual inclination ; it is effective in controlling upper molar bodily movements of about 1.5 mm ; and it is not effective in controlling rotation of rounded teeth in particular . |
MS211221 | ***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 Pakistan has high maternal mortality , particularly in the rural areas . The delay in decision making to seek medical care during obstetric emergencies remains a significant factor in maternal mortality . Methods We present results from an experimental study in rural Pakistan . Village clusters were r and omly assigned to intervention and control arms ( 16 clusters each ) . In the intervention clusters , women were provided information on safe motherhood through pictorial booklets and audiocassettes ; traditional birth attendants were trained in clean delivery and recognition of obstetric and newborn complications ; and emergency transportation systems were set up . In eight of the 16 intervention clusters , husb and s also received specially design ed education material s on safe motherhood and family planning . Pre- and post-intervention surveys on selected maternal and neonatal health indicators were conducted in all 32 clusters . A district-wide survey was conducted two years after project completion to measure any residual impact of the interventions . Results Pregnant women in intervention clusters received prenatal care and prophylactic iron therapy more frequently than pregnant women in control clusters . Providing safe motherhood education to husb and s result ed in further improvement of some indicators . There was a small but significant increase in percent of hospital deliveries but no impact on the use of skilled birth attendants . Perinatal mortality reduced significantly in clusters where only wives received information and education in safe motherhood . The survey to assess residual impact showed similar results . Conclusions We conclude that providing safe motherhood education increased the probability of pregnant women having prenatal care and utilization of health services for obstetric complications Abstract Objective To evaluate whether routine administration of sublingual misoprostol 600 μg after delivery reduces postpartum haemorrhage . Design R and omised double blind placebo controlled trial . Setting Primary health centre in Bissau , Guinea-Bissau , West Africa . Participants 661 women undergoing vaginal delivery . Intervention Misoprostol 600 μg or placebo administered sublingually immediately after delivery . Main outcome measures Postpartum haemorrhage , defined as a loss of ≥ 500 ml and decrease in haemoglobin concentration after delivery . Results The incidence of postpartum haemorrhage was not significantly different between the two groups , the relative risk being 0.89 ( 95 % confidence interval 0.76 to 1.04 ) in the misoprostol group compared with the placebo group . Mean blood loss was 10.5 % ( −0.5 % to 20.4 % ) lower in the misoprostol group than in the control group . Severe postpartum haemorrhage of ≥ 1000 ml or ≥1500 ml occurred in 17 % ( 56 ) and 8 % ( 25 ) in the placebo group and 11 % ( 37 ) and 2 % ( 7 ) in the misoprostol group . Significantly fewer women in the misoprostol group experienced a loss of ≥1000 ml ( 0.66 , 0.45 to 0.98 ) or ≥ 1500 ml ( 0.28 , 0.12 to 0.64 ) . The decrease in haemoglobin concentration tended to be less in the misoprostol group , the mean difference between the two groups being 0.16 mmol/l ( −0.01 mmol/l to 0.32 mmol/l ) . Conclusion Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage David Osrin and colleagues report findings from a cluster-r and omized trial conducted in Mumbai slums ; the trial aim ed to evaluate whether facilitator-supported women 's groups could improve perinatal outcomes WHO recommends that anthelmintic treatment be included in strategies to improve maternal nutrition in areas where hookworms are endemic and anaemia is prevalent . At present , few countries have adopted this recommendation , partly owing to the lack of data to support the adverse effects of hookworms on maternal health . A longitudinal study was conducted on 125 women in Sierra Leone ( in 1995/96 ) to measure the impact of single-dose albendazole ( 400 mg ) and daily iron-folate supplements ( 36 mg iron and 5 mg folate ) on haemoglobin and serum ferritin concentration during pregnancy . Women who received both albendazole and iron-folate supplements experienced no significant change ( P > 0.05 ) in the prevalence of anaemia and iron-deficiency anaemia between the first and third trimesters . These prevalence levels significantly increased ( P < 0.05 ) in women who received either albendazole or iron-folate supplements or neither . After controlling for baseline haemoglobin concentration and season , the mean decline in haemoglobin concentration between the first and third trimester in women who received albendazole was 6.6 g/L less than in women who received the control ( P = 0.0034 ) . The corresponding value for iron-folate supplements was 13.7 g/L haemoglobin ( P < 0.001 ) . The effects of albendazole and iron-folate supplements were additive . These findings lend support to WHO 's recommendation for anthelmintic treatment during pregnancy BACKGROUND More than 95 % of neonatal deaths occur in developing countries , approximately 50 % at home . Few data are available on the impact of h and -washing practice s by birth attendants or caretakers on neonatal mortality . OBJECTIVE To evaluate the relationship between birth attendant and maternal h and -washing practice s and neonatal mortality in rural Nepal . DESIGN Observational prospect i ve cohort study . SETTING Sarlahi District in rural southern Nepal . PARTICIPANTS Newborn infants were originally enrolled in a community-based trial assessing the effect of skin and /or umbilical cord cleansing with chlorhexidine on neonatal mortality in southern Nepal . A total of 23,662 newborns were enrolled and observed through 28 days of life . MAIN EXPOSURES Question naires were administered to mothers on days 1 and 14 after delivery to identify care practice s and risk factors for mortality and infection . Three h and -washing categories were defined : ( 1 ) birth attendant h and washing with soap and water before assisting with delivery , ( 2 ) maternal h and washing with soap and water or antiseptic before h and ling the baby , and ( 3 ) combined birth attendant and maternal h and washing . OUTCOME MEASURES Mortality within the neonatal period . RESULTS Birth attendant h and washing was related to a statistically significant lower mortality rate among neonates ( adjusted relative risk [ RR ] = 0.81 ; 95 % confidence interval [ CI ] , 0.66 - 0.99 ) , as was maternal h and washing ( adjusted RR = 0.56 ; 95 % CI , 0.38 - 0.82 ) . There was a 41 % lower mortality rate among neonates exposed to both h and -washing practice s ( adjusted RR = 0.59 ; 95 % CI , 0.37 - 0.94 ) . CONCLUSIONS Birth attendant and maternal h and washing with soap and water were associated with significantly lower rates of neonatal mortality . Measures to improve or promote birth attendant and maternal h and washing could improve neonatal survival rates OBJECTIVES To determine the effectiveness of birth plans in increasing use of skilled care at delivery and in the postnatal period among antenatal care ( ANC ) attendees in a rural district with low occupancy of health units for delivery but high antenatal care uptake in northern Tanzania . METHODS Cluster r and omised trial in Ngorongoro district , Arusha region , involving 16 health units ( 8 per arm ) . Nine hundred and five pregnant women at 24 weeks of gestation and above ( 404 in the intervention arm ) were recruited and followed up to at least 1 month postpartum . RESULTS Skilled delivery care uptake was 16.8 % higher in the intervention units than in the control [ 95 % CI 2.6 - 31.0 ; P = 0.02 ] . Postnatal care utilisation in the first month of delivery was higher ( difference in proportions : 30.0 % [ 95 % CI 1.3 - 47.7 ; P < 0.01 ] ) and also initiated earlier ( mean duration 6.6 ± 1.7 days vs. 20.9 ± 4.4 days , P < 0.01 ) in the intervention than in the control arm . Women 's and providers ' reports of care satisfaction ( received or provided ) did not differ greatly between the two arms of the study ( difference in proportion : 12.1 % [ 95 % CI -6.3 - 30.5 ] P = 0.17 and 6.9 % [ 95 % CI -3.2 - 17.1 ] P = 0.15 , respectively ) . CONCLUSION Implementation of birth plans during ANC can increase the uptake of skilled delivery and post delivery care in the study district without negatively affecting women 's and providers ' satisfaction with available ANC services . Birth plans should be considered along with the range of other recommended interventions as a strategy to improve the uptake of maternal health services BACKGROUND Most mothers breastfeed in Bangladesh , but they rarely practise exclusive breastfeeding . Hospital-based strategies for breastfeeding promotion can not reach them because about 95 % have home deliveries . We postulated that with the intervention of trained peer counsellors , mothers could be enabled to breastfeed exclusively for the recommended duration of 5 months . METHODS 40 adjacent zones in Dhaka were r and omised to intervention or control groups . Women were enrolled during the last trimester of pregnancy between February and December , 1996 . In the intervention group , 15 home-based counselling visits were scheduled , with two visits in the last trimester , three early postpartum ( within 48 h , on day 5 , between days 10 and 14 ) , and fortnightly thereafter until the infant was 5 months old . Peer counsellors were local mothers who received 10 days ' training . FINDINGS 363 women were enrolled in each group . Peer counselling significantly improved breastfeeding practice s. For the primary outcome , the prevalence of exclusive breastfeeding at 5 months was 202/228 ( 70 % ) for the intervention group and 17/285 ( 6 % ) for the control group ( difference=64 % ; 95 % CI 57%-71 % , p>0.0001 ) . For the secondary outcomes , mothers in the intervention group initiated breastfeeding earlier than control mothers and were less likely to give prelacteal and postlacteal foods . At day 4 , significantly more mothers in the intervention group breastfed exclusively than controls . INTERPRETATION Peer counsellors can effectively increase the initiation and duration of exclusive breastfeeding . We recommend incorporation of peer counsellors in mother and child health programmes in developing countries Background In the global context of a reduction of under-five mortality , neonatal mortality is an increasingly relevant component of this mortality . Malaria in pregnancy may affect neonatal survival , though no strong evidence exists to support this association . Methods In the context of a r and omised , placebo-controlled trial of intermittent preventive treatment ( IPTp ) with sulphadoxine-pyrimethamine ( SP ) in 1030 Mozambican pregnant women , 997 newborns were followed up until 12 months of age . There were 500 live borns to women who received placebo and 497 to those who received SP . Findings There were 58 infant deaths ; 60.4 % occurred in children born to women who received placebo and 39.6 % to women who received IPTp ( p = 0.136 ) . There were 25 neonatal deaths ; 72 % occurred in the placebo group and 28 % in the IPTp group ( p = 0.041 ) . Of the 20 deaths that occurred in the first week of life , 75 % were babies born to women in the placebo group and 25 % to those in the IPTp group ( p = 0.039 ) . IPTp reduced neonatal mortality by 61.3 % ( 95 % CI 7.4 % , 83.8 % ) ; p = 0.024 ] . Conclusions Malaria prevention with SP in pregnancy can reduce neonatal mortality . Mechanisms associated with increased malaria infection at the end of pregnancy may explain the excess mortality in the malaria less protected group . Alternatively , SP may have reduced the risk of neonatal infections . These findings are of relevance to promote the implementation of IPTp with SP , and provide insights into the underst and ing of the pathophysiological mechanisms through which maternal malaria affects fetal and neonatal health . Trial Registration Clinical Trials.gov Background To evaluate a delivery strategy for newborn interventions in rural Bangladesh . Methods A cluster-r and omized controlled trial was conducted in Mirzapur , Bangladesh . Twelve unions were r and omized to intervention or comparison arm . All women of reproductive age were eligible to participate . In the intervention arm , community health workers identified pregnant women ; made two antenatal home visits to promote birth and newborn care preparedness ; made four postnatal home visits to negotiate preventive care practice s and to assess newborns for illness ; and referred sick neonates to a hospital and facilitated compliance . Primary outcome measures were antenatal and immediate newborn care behaviours , knowledge of danger signs , care seeking for neonatal complications , and neonatal mortality . Findings A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm
Output:
| RESULTS In the aggregate , achieving high effective coverage for this set of interventions would very substantially reduce risk for our outcomes of interest and reduce outcome inequities .
Behavioral interventions targeting practice s at birth and in the hours that follow can have substantial impact in setting s where many births happen at home : in such circumstances early initiation of breastfeeding can reduce risk of newborn death by up to 20 % ; good thermal care practice s can reduce mortality risk by a similar order of magnitude .
Simple interventions delivered during pregnancy have considerable potential impact on important mortality outcomes . |
MS211222 | ***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: Therapeutic hypothermia holds promise as a rescue neuroprotective strategy for hypoxic-ischemic injury , but the incidence of severe neurologic sequelae with hypothermia is unknown in encephalopathic neonates who present shortly after birth . This study reports a multicenter , r and omized , controlled , pilot trial of moderate systemic hypothermia ( 33 degrees C ) vs normothermia ( 37 degrees C ) for 48 hours in neonates initiated within 6 hours of birth or hypoxic-ischemic event . The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers , and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vinel and tests between normothermic and hypothermic groups . Thirty-two hypothermic and 33 normothermic neonates were enrolled . The entry criteria selected a severely affected group of neonates , with 77 % Sarnat stage III . Ten hypothermia ( 10/32 , 31 % ) and 14 normothermia ( 14/33 , 42 % ) patients expired . Controlling for treatment group , outborn infants were significantly more likely to die than hypoxic-ischemic infants born in participating tertiary care centers ( odds ratio 10.7 , 95 % confidence interval 1.3 - 90 ) . Severely abnormal motor scores ( Psychomotor Development Index < 70 ) were recorded in 64 % of normothermia patients and in 24 % of hypothermia patients . The combined outcome of death or severe motor scores yielded fewer bad outcomes in the hypothermia group ( 52 % ) than the normothermia group ( 84 % ) ( P = 0.019 ) . Although these results need to be vali date d in a large clinical trial , this pilot trial provides important data for clinical trial design of hypothermia treatment in neonatal hypoxic-ischemic injury Composite outcomes , in which multiple end points are combined , are frequently used as primary outcome measures in r and omized trials and are often associated with increased statistical efficiency . However , such measures may prove challenging for the interpretation of results . In this article , we examine the use of composite outcomes in major clinical trials , assess the arguments for and against them , and provide guidance on their application and reporting . To assess incidence and quality of reporting , we systematic ally review ed the use of composite end points in clinical trials in Annals of Internal Medicine , BMJ , Circulation , Clinical Infectious Diseases , Journal of the American College of Cardiology , JAMA , Lancet , New Engl and Journal of Medicine , and Stroke from 1997 through 2001 using a sensitive search strategy . We selected for review 167 original reports of r and omized trials ( with a total of 300 276 patients ) that included a composite primary outcome that incorporated all-cause mortality . Sixty-three trials ( 38 % ) were neutral both for the primary end point and the mortality component . Sixty trials ( 36 % ) reported significant results for the primary outcome measure but not for the mortality component . Only 6 trials ( 4 % ) were significant for the mortality component but not for the primary composite outcome , whereas 19 trials ( 11 % ) were significant for both . Twenty-two trials ( 13 % ) were inadequately reported . Our review suggests that reporting of composite outcomes is generally inadequate , implying that the results apply to the individual components of the composite outcome rather than only to the overall composite . Current guidelines for the undertaking and reporting of clinical trials could be revised to reflect the common use of composite outcomes in clinical trials OBJECTIVE To assess the safety of selective head cooling in birth-asphyxiated term newborn infants while maintaining the rectal temperature at 35.0 degrees C or 34.5 degrees C. METHODS Twenty-six term infants with Apgar < or=6 at 5 minutes or cord/first arterial pH < 7.1 , plus evidence of encephalopathy , were studied . After parental consent had been obtained , 13 infants received selective head cooling with the rectal temperature maintained at 35.0 degrees C in 6 infants and at 34.5 degrees C in 7 infants . The remaining 13 infants were normothermic . Cooling was achieved by circulating water at 10 degrees C through a cap placed around the head . Rectal , fontanelle , and nasopharyngeal temperatures were monitored . RESULTS One cooled infant died 2 days after rewarming , and 3 control infants died . Seizures occurred in 9 (69%)of 13 cooled infants and 5 ( 38 % ) of 13 control infants . Respiratory support within the first 72 hours of life was required in 10 of 13 infants in both the cooled and control groups . Three cooled infants and 1 control infant received nitric oxide for persistent pulmonary hypertension . During the same interval , 6 of the cooled infants and 4 of the control infants had episodes in which their blood pressure fell to < 40 mm Hg ; in 2 infants in each group , the lowest blood pressure was below 35 mm Hg . No requirement for volume expansion or increased inotropic support was seen in any infant during stepwise rewarming . All of the cooled infants demonstrated a fall in heart rate during cooling , but the rate was < 80/min in only 2 cases and no infant had a rate < 70/min . No infant demonstrated an abnormal rhythm or was clinical ly compromised by the change in heart rate . One infant cooled to a rectal temperature of 34.5 degrees C had a prolonged QT interval of 570 ms associated with a heart rate of 85/min on electrocardiogram aged 34 hours . This returned to normal after rewarming . Platelet counts below 150 x 10(9)/L , hypoglycemia below 2.6 mmol/L , and highest creatinine were not statistically different between cooled and control infants . Positive precooling blood cultures were found in 1 cooled and 1 control infant . The mean cap water input temperature used during cooling was 10 + /- 1 degrees C. During active cooling , the mean difference between rectal and nasopharyngeal temperature was 1.4 degrees C in the infants who were not receiving respiratory support , but this gradient could not be measured in those who were receiving respiratory support that involved delivery of warmed gases to the nasopharynx . CONCLUSIONS This study suggests that selective head cooling combined with mild systemic hypothermia of 34.4 degrees C or 35.0 degrees C is a stable , well-tolerated method of reducing cerebral temperature in term newborn infants after perinatal asphyxia OBJECTIVE . The goal of this study was to evaluate the role of factors that may determine the efficacy of treatment with delayed head cooling and mild systemic hypothermia for neonatal encephalopathy . METHODS . A total of 218 term infants with moderate to severe neonatal encephalopathy plus abnormal amplitude-integrated electroencephalographic recordings , assigned r and omly to head cooling for 72 hours , starting within 6 hours after birth ( with the rectal temperature maintained at 34.5 ± 0.5 ° C ) , or conventional care , were studied . Death or severe disability at 18 months of age was assessed in a multicenter , r and omized , controlled study ( the CoolCap trial ) . RESULTS . Treatment , lower encephalopathy grade , lower birth weight , greater amplitude-integrated electroencephalographic amplitude , absence of seizures , and higher Apgar score , but not gender or gestational age , were associated significantly with better outcomes . In a multivariate analysis , each of the individually predictive factors except for Apgar score remained predictive . There was a significant interaction between treatment and birth weight , categorized as ≥25th or < 25th percentile for term , such that larger infants showed a lower frequency of favorable outcomes in the control group but greater improvement with cooling . For larger infants , the number needed to treat was 3.8 . Pyrexia ( ≥38 ° C ) in control infants was associated with adverse outcomes . Although there was a small correlation with birth weight , the adverse effect of greater birth weight in control infants remained significant after adjustment for pyrexia and severity of encephalopathy . CONCLUSIONS . Outcomes after hypothermic treatment were strongly influenced by the severity of neonatal encephalopathy . The protective effect of hypothermia was greater in larger infants Hypoxic-ischemic encephalopathy ( HIE ) remains one of the most important neurologic complications in the newborn . Several experimental and clinical studies have shown that hypothermia is the most effective means known for protecting the brain against hypoxic-ischemic brain damage . Furthermore , recent data have suggested that platelet-activating factor ( PAF ) could play a pathophysiologically important role in the progression of hypoxic-ischemic brain injury . The aim of the present study was to investigate the role of head cooling combined with minimal hypothermia in short-term outcome of infants with perinatal asphyxia . In addition , we have examined the effect of head cooling combined with minimal hypothermia on PAF concentrations in cerebrospinal fluid ( CSF ) after hypoxic-ischemic brain injury . The group of asphyxiated infants ( Group 1 ) consisted of 21 full-term ( gestational age > 37 weeks ) . These infants were r and omized and divided into either a st and ard therapy group ( Group 1a ; n=10 ) or cooling group ( Group 1b ; n=11 ) . Head cooling combined with minimal hypothermia ( rectal temperature 36.5 - 36 degrees C ) was started as soon as practicable after birth . The infants were cooled for 72h and then were rewarmed at 0.5 degrees C/h . The control group ( Group 2 ) consisted of seven full-term infants and none of these infants showed any sign of asphyxia . To measure PAF concentration in CSF , CSF with lumbar puncture was collected into tubes immediately before the cooling ( 1 - 3h after birth ) and again after 36h . We had no evidence of severe adverse events related to hypothermia . In Group 1a , two infants died after 72h of life ; however , all newborn infants in Group 1b survived . Convulsion required treatment in three infants of st and ard therapy group ( 1a ) ; none of the infants in Group 1b had clinical seizure activity . Abnormal EEG patterns were found in four infants of Group 1a ; no EEG abnormalities were noted in Group 1b ( P<0.05 ) . On admission ( before cooling ) , PAF concentration in CSF of asphyxiated infants was found to be significantly higher when compared with that of control ( P<0.001 ) . Mean PAF concentration before initiation of the study was similar in the two asphyxiated groups ( Group 1a vs. 1b ) ( P>0.05 ) . Obtained PAF level in CSF after 36h , showed a profound decline in cooling group of infants compared to Group 1a infants ( P<0.01 ) . In conclusion , the present study suggests that cerebral cooling with minimal hypothermia started soon after birth has no severe adverse effects during 72-h cooling period and that short-term outcome of infants are encouraging . Our results also support the hypothesis PAF an important mediator in hypoxic-ischemic brain injury and demonstrate that head cooling combined with minimal hypothermia reduces the normal increase in PAF following hypoxic-ischemic brain injury in full-term infants School performance testing was completed at 8 years of age on 145 children who had had neonatal encephalopathy associated with birth asphyxia as term infants and on a comparison peer group of 155 children . The prospect ively identified clinical categories of encephalopathy for the neonates were 56 mild ( hyperalertness , hyperexcitability ) , 84 moderate ( lethargy , hypotonia , suppressed primitive reflexes ) , and 5 severe ( stupor , flaccidity , absent primitive reflexes ) . The mortality rate to 8 years of age was 13 % . The incidence of impairment , which included cerebral palsy , blindness , cognitive delay , convulsive disorder , and severe hearing loss , was 16 % among those assessed at 8 years ( 75 % of survivors ) . Intellectual , visual-motor integration , and receptive vocabulary scores , as well as reading , spelling , and arithmetic grade levels for those with moderate or severe encephalopathy , were significantly below ( p less than 0.01 ) those in the mild encephalopathy or peer comparison groups . Predictors of reading performance for the study group included category of encephalopathy , birth weight for gestational age , native language , and mother 's educational level ( multiple R = 0.58 ) . Nonimpaired survivors of moderate encephalopathy were more likely to be more than one grade level delayed than were children from the peer group ( reading 35 % vs 15 % , spelling 18 % vs 8 % , arithmetic 20 % vs 12 % , p less than 0.01 ) . Thus children who had moderate and severe neonatal encephalopathy are at risk for physical and mental impairment and reduced school performance . Children with mild encephalopathy had school performance scores similar to those of their peers BACKGROUND Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia . We did a multicentre r and omised controlled trial to find out if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy . METHODS 234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroence
Output:
| Conclusion In general , therapeutic hypothermia seems to have a beneficial effect on the outcome of term neonates with moderate to severe hypoxic ischemic encephalopathy . |
MS211223 | ***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 In developed countries hepatitis C is prevalently transmitted by intravenous drug users ( IDUs ) . The problems associated with management of HCV hepatitis in these patients have , in the past , discouraged treatment . AIM To evaluate efficacy , safety and tolerability of a st and ard Peginterferon ( Peg-IFN ) alpha-2b or alpha-2a plus Ribavirin treatment in IDUs who were receiving methadone or buprenorphine . METHODS A multi-centre prospect i ve observational study performed from September 2003 to September 2006 in Central Italy ( Umbria and Marches regions ) . A shared care model of HCV management was used which integrated a multidimensional , multidisciplinary approach . RESULTS Sixty-five subjects were evaluated and 52 satisfied inclusion criteria . Forty-five completed treatment ( 25 with Peg-IFN alpha-2b , 20 with Peg-IFN alpha-2a ) , a total of 37 showed a biochemical/virological response at the end of treatment ( ITT 71.1 % ) , 26 had a sustained virological response ( ITT 50 % ; 38.4 % of cases genotype 1 - 4 , 61.6 % genotype 3 - 2 ) . CONCLUSIONS The results indicate that patients on maintenance treatment with methadone/buprenorphine can be treated for HCV . The success rate was fairly good ; tolerability and side effects were similar to those reported in non-IDU patients . Close cooperation with specialists in drug addiction and psychiatrists is however essential for success AIM To evaluate the effect of a multi-disciplinary st and ardized management model on the efficacy of pegylated (Peg)-interferon alpha-2b plus ribavirin treatment of chronic hepatitis C in drug addicts undergoing substitutive or antagonist therapy . DESIGN Observational prospect i ve multi-centre study . SETTING Six clinical infectious disease centres in collaboration with 11 drug dependency units ( DDU ) in five Italian regions . PARTICIPANTS Intravenous drug users affected by chronic hepatitis C engaged in detoxification programmes . METHODS Application of a multi-disciplinary st and ardized management model for HCV treatment involving DDU operators , psychologists or psychiatrists and infectious disease specialists . MEASUREMENTS Very early , early , end-of-treatment and sustained virological response to Peg-interferon alpha-2b plus ribavirin . FINDINGS Fifty-three subjects were studied [ 43.4 % with hepatitis C virus ( HCV ) genotypes 1 or 4 ] . Intent-to-treat analysis showed an end-of-treatment virological response in 58.5 % of patients ( 39.1 % genotypes 1 or 4 ; 73.4 % genotype 3 ) and a sustained virological response in 54.7 % ( 34.8 % genotypes 1 or 4 ; 70.0 % genotype 3 ) . There were 19 ( 35.8 % ) dropouts and three ( 5.7 % ) non-responders : one genotype 1 and two genotype 4 . Two ( 3.8 % ) patients relapsed : genotypes 1 and 3 . On-treatment analysis showed negative HCV-RNA in 40 ( 93.1 % ) of 43 subjects who completed the first 12 treatment weeks and in 35 who completed the first 24 treatment weeks . All subjects with an end-of-treatment response , except one with genotype 3 infection , had a sustained response . CONCLUSIONS Our data show that antiviral treatment in the context of a multi-disciplinary st and ardized management model helps many HCV-positive drug addicts achieve a good virological response BACKGROUND / AIMS Treatment with interferon-alpha ( IFN-alpha ) may eradicate HCV in most acute hepatitis C patients , thus preventing chronic hepatitis and avoiding less efficacious combination therapy . METHODS In a prospect i ve study , we evaluated the impact of barriers to successful start and completion of treatment of acute and subacute ( < 12 months from infection ) hepatitis C with pegylated IFN-alpha2b , 1.5 microg/kg , QW , for 24 weeks . RESULTS Out of 27 patients ( 22 were active intravenous drug users [ IVDU ] ) , 5 cleared HCV spontaneously . Antiviral treatment was indicated in 22 patients : six refused therapy for fear of side effects , whereas two others were lost to observation . Eight patients completed the treatment or received > 80 % of the scheduled drug : seven ( 88 % ) were sustained virological responders 24 weeks after the end of treatment . Six patients ( all IVDU ) stopped prematurely due to side effects : only one had a sustained virological response . Based on an intent-to-treat analysis , and considering all 14 patients in whom at least one dose of drug was administered , only 8 ( 57 % ) became sustained virological responders . CONCLUSIONS Treatment of acute hepatitis C with pegylated IFN-alpha is highly beneficial , but its effectiveness is affected by a poor rate of acceptance and /or adherence to currently available regimens , especially in IVDU and women BACKGROUND A sustained virological response ( SVR ) rate of 41 % has been achieved with interferon alfa-2b plus ribavirin therapy of chronic hepatitis C. In this r and omised trial , peginterferon alfa-2b plus ribavirin was compared with interferon alfa-2b plus ribavirin . METHODS 1530 patients with chronic hepatitis C were assigned interferon alfa-2b ( 3 MU subcutaneously three times per week ) plus ribavirin 1000 - 1200 mg/day orally , peginterferon alfa-2b 1.5 microg/kg each week plus 800 mg/day ribavirin , or peginterferon alfa-2b 1.5 microg/kg per week for 4 weeks then 0.5 microg/kg per week plus ribavirin 1000 - 1200 mg/day for 48 weeks . The primary endpoint was the SVR rate ( undetectable hepatitis C virus [ HCV ] RNA in serum at 24-week follow-up ) . Analyses were based on patients who received at least one dose of study medication . FINDINGS The SVR rate was significantly higher ( p=0.01 for both comparisons ) in the higher-dose peginterferon group ( 274/511 [ 54 % ] ) than in the lower-dose peginterferon ( 244/514 [ 47 % ] ) or interferon ( 235/505 [ 47 % ] ) groups . Among patients with HCV genotype 1 infection , the corresponding SVR rates were 42 % ( 145/348 ) , 34 % ( 118/349 ) , and 33 % ( 114/343 ) . The rate for patients with genotype 2 and 3 infections was about 80 % for all treatment groups . Secondary analyses identified bodyweight as an important predictor of SVR , prompting comparison of the interferon regimens after adjusting ribavirin for bodyweight ( mg/kg ) . Side-effect profiles were similar between the treatment groups . INTERPRETATION In patients with chronic hepatitis C , the most effective therapy is the combination of peginterferon alfa-2b 1.5 microg/kg per week plus ribavirin . The benefit is mostly achieved in patients with HCV genotype 1 infections Background : Though patients in opiate substitution programs are commonly infected with HCV , due to safety and efficacy concerns , they are rarely treated with interferon and ribavirin . Methods : In a multicenter study , HCV-infected patients in opiate maintenance treatment programs received 180 μg pegylated interferon-alfa-2a once weekly , plus daily ribavirin for 24 weeks ( genotypes 2 , 3 ) , or 48 weeks ( genotypes 1 , 4 ) . Results : Of the 67 patients enrolled , 31 ( 46 % ) had HCV genotypes 1 or 4 , and 36 ( 54 % ) had genotypes 2 or 3 . Intent-to-treat analysis showed end-of-treatment virologic response in 75 % of patients ( 81 % of genotypes 2 or 3 ; 65 % of genotypes 1 or 4 ) , and a sustained virologic response in 61 % of patients ( 72 % of genotypes 2 or 3 ; 48 % of genotypes 1 or 4 ) . Fifteen patients ( 22 % ) did not complete the study , in 5 ( 8 % ) cases because of severe adverse events . Conclusions : Drug users with chronic HCV infection , regularly attending an opiate maintenance program in which close collaboration between hepatologists/internists and addiction specialists is assured , can be treated effectively and safely with pegylated interferon-alfa-2a and ribavirin . Treatment results are very similar to those in other patient groups , and thus therapy should also be considered for this population BACKGROUND A minority of HIV/HCV coinfected patients with opiate addiction undergo HCV treatment . HCV therapy for HCV-monoinfected methadone maintenance ( MM ) recipients is safe and effective . We evaluated treatment efficacy and adherence to pegylated interferon ( pegIFN ) among HIV/HCV coinfected MM recipients . METHODS HCV treatment-naïve , HIV-infected persons 18 - 65 years with chronic HCV genotype 1 on MM were prospect ively enrolled in an HCV treatment study at two HIV clinics . At weekly visits pegIFN alfa-2a injections were directly administered . Daily MM recipients had morning ribavirin delivered with methadone at off-site methadone clinics . Weekly take-home MM recipients took ribavirin unsupervised . Target enrollment was 30 participants . RESULTS During 18 recruitment months , 11 participants were enrolled , 6 of whom received daily methadone . Mean age was 46 , 64 % were female , 5 were Caucasian , 4 Black and 2 Hispanic . At baseline , 82 % had high HCV RNA and 55 % had stage 2 fibrosis or greater . The majority ( 91 % ) were on HAART , and 82 % had undetectable HIV RNA with a median CD4(+ ) of 508cells/μL. All had polysubstance use history , non-substance-based psychiatric diagnoses and were on psychotropic medications pre-enrollment . Two ( 18 % ) participants achieved a Sustained Virologic Response ( SVR ) . Two completed 48 treatment weeks , 5 were withdrawn due to adverse events , 2 dropped out prematurely and 2 had treatment discontinued for virologic non-response . Of on-treatment weeks , adherence to pegIFN was > 99 % . CONCLUSIONS SVR rate was comparable to historic controls for coinfected genotype 1 patients , with optimal pegIFN adherence . Adverse effects often prevented therapy completion in this population BACKGROUND : Adherence to chronic hepatitis C ( CHC ) treatment may be particularly challenging in methadone maintenance patients . We assessed the safety , tolerability , and efficacy of peginterferon alfa-2a/ribavirin treatment in methadone maintenance patients previously untreated for CHC . METHODS : Patients were r and omized 1:1 to direct observed therapy ( DOT ) or self-administration ( SA ) of peginterferon alfa-2a . DOT patients were seen weekly at methadone clinics ; SA patients were seen less frequently , only at investigative sites . Genotype 1-infected patients were treated for 48 wk with peginterferon alfa-2a ( 180 μg/wk)/ribavirin ( 1,000/1,200 mg/day ) ; genotypes 2- and 3-infected patients were treated for 24 wk with peginterferon alfa-2a ( 180 μg/wk)/ribavirin ( 800 mg/day ) . RESULTS : Based on defined efficacy stopping rules , 77 % ( 37/48 ) completed their targeted length of treatment , and 44 % ( 21/48 ) achieved sustained virologic response ( SVR ) . Two DOT and 3 SA patients were withdrawn for safety reasons and 6 and 9 , respectively , for nonsafety reasons . Over 60 % and 50 % of each group were > 80 % compliant with the planned cumulative doses of peginterferon alfa-2a and ribavirin , respectively , and over 60 % with overall treatment duration . SVR rates were 54 % ( 13/24 ) for DOT and 33 % ( 8/24 ) for SA ; 23 % ( 3/13 ) and 38 % ( 6/16 ) , respectively , for genotype 1 and 91 % ( 10/11 ) and 25 % ( 2/8 ) , respectively , for genotypes 2 and 3 . Stepwise logistic regression analysis , showed that DOT ( vs SA ; OR 3.27 , 95 % CI 0.90–11.91 , P= 0.073 ) and Caucasian race ( vs Other
Output:
| Treatment of addiction during HCV therapy results in higher treatment completion .
Our pooled SVR rate is similar to that obtained in registration trials in the general population . |
MS211224 | ***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: This article evaluates the effects and use of adjuncts to a televised smoking cessation program , based on the American Lung Association 's " Freedom From Smoking in 20 Days . " Subjects were r and omized to maintenance and control conditions . The maintenance condition received newsletters with information and support addressing different stages in the cessation process and information about a telephone hotline . The maintenance condition did not increase cessation at any wave of interviewing , assessed by multiple point or point prevalence of abstinence . Those abstinent at 6 months and those who had made an attempt to stop smoking by that time were more likely to have used the newsletters and were more likely to have used the sections relevant to their cessation stage . Rates of use of the telephone hotline were low . The newsletters appear to be useful to smokers who are predisposed to use written material OBJECTIVE To evaluate the effect of the middle and junior high school Drug Abuse Resistance Education ( D.A.R.E. ) and D.A.R.E. Plus programs on drug use and violence . DESIGN R and omized controlled trial of 24 schools , with 3 conditions : D.A.R.E. only , D.A.R.E. Plus , and delayed program control . SETTING Schools and neighborhoods , primarily in Minneapolis-St Paul . PARTICIPANTS All seventh- grade students in 24 schools in the academic year 1999 - 2000 ( N = 6237 at baseline , 67.3 % were white , and there was 84.0 % retention at final follow-up ) . INTERVENTIONS The middle and junior high school D.A.R.E. curriculum in the 16 schools that received D.A.R.E. only and D.A.R.E. Plus . In the 8 schoolts that received D.A.R.E. Plus , additional components included a peer-led parental involvement classroom program called " On the VERGE , " youth-led extracurricular activities , community adult action teams , and postcard mailings to parents . The interventions were implemented during 2 school years , when the cohort was in the seventh and eighth grade s. MAIN OUTCOME MEASURES Self-reported tobacco , alcohol , and marijuana use ; multidrug use ; violence ; and victimization , assessed at the beginning and end of seventh grade and at the end of eighth grade . Growth curve analytic methods were used to assess changes over time by condition . RESULTS There were no significant differences between D.A.R.E. only and the controls ; significant differences among boys between D.A.R.E. Plus and controls for tobacco , alcohol , and multidrug use and victimization ; significant differences among boys between D.A.R.E. Plus and D.A.R.E. only in tobacco use and violence ; and no significant behavioral differences among girls . CONCLUSION D.A.R.E. Plus significantly enhanced the effectiveness of the D.A.R.E. curriculum among boys and was more effective than the delayed program controls , underscoring the potential for multiyear , multicomponent prevention programs and demonstrating sex differences in response to intervention programs A population -based , r and omized universal classroom intervention trial for the prevention of disruptive behavior ( i.e. , attention-deficit/hyperactivity problems , oppositional defiant problems , and conduct problems ) is described . Impact on developmental trajectories in young elementary schoolchildren was studied . Three trajectories were identified in children with high , intermediate , or low levels of problems on all 3 disruptive behaviors at baseline . The intervention had a positive impact on the development of all disruptive behavior problems in children with intermediate levels of these problems at baseline . Effect sizes of mean difference at outcome were medium or small . In children with the highest levels of disruptive behavior at baseline , a positive impact of the intervention was found for conduct problems This study evaluates a youth subject-directed smoking prevention and cessation program titled Breathe Easy ! The program was delivered at two sites and a control group was recruited from two additional sites . Surveys were administered prior to the program and either 1 month or 6 months after completion at the exposure sites . The same survey administration procedure was used as the control . After controlling for invalid responses and including only those that completed both surveys , 251 exposure subjects and 159 control subjects remained for analysis . At sites with 1-month follow-up , no significant difference was noted between intervention and control groups . At the sites with 6-month follow-up , prevalence dropped from 18.7 % to 8.9 % , which is statistically significant , while at the control site prevalence changed from 14.1 % to 9.4 % , which is not significant . Additional outcomes examined in the exposed group showed trends toward smoking cessation and prevention at higher rates than those of the unexposed group BACKGROUND No long-term impact has yet been observed with the use of the social-influences approach to school-based smoking prevention for youth . However , whether this lack of impact is due to method ologic problems with the studies or to the failure of the interventions is unclear . The Hutchinson Smoking Prevention Project ( HSPP ) , conducted from September 1984 through August 1999 , aim ed to attain the most rigorous r and omized trial possible to determine the long-term impact of a theory-based , social-influences , grade 3 - 12 intervention on smoking prevalence among youth . METHODS Forty Washington school districts were r and omly assigned to the intervention or to the control condition . Study participants were children enrolled in two consecutive 3rd grade s in the 40 districts ( n = 8388 ) ; they were followed to 2 years after high school . The trial achieved high implementation fidelity and 94 % follow-up . Data were analyzed with the use of group-permutation methods , and all statistical tests were two-sided . RESULTS No significant difference in prevalence of daily smoking was found between students in the control and experimental districts , either at grade 12 ( difference [ Delta ] = 0.2 % , 95 % confidence interval [ CI ] = -4.6 % to 4.4 % , and P = .91 for girls ; Delta = 0.3 % , 95 % CI = -5.0 % to 5.5 % , and P = .89 for boys ) or at 2 years after high school ( Delta = -1.4 % , 95 % CI = -5.0 % to 1.6 % , and P = .38 for girls ; Delta = 2.6 % , 95 % CI = -2.5 % to 7.7 % , and P = .30 for boys ) . Moreover , no intervention impact was observed for other smoking outcomes , such as extent of current smoking or cumulative amount smoked , or in subgroups that differ in a priori specified variables , such as family risk for smoking . CONCLUSION The rigor of the HSPP trial suggests high credence for the intervention impact results . Consistent with previous trials , there is no evidence from this trial that a school-based social-influences approach is effective in the long-term deterrence of smoking among youth This study examined the effects of the Iowa Strengthening Families Program ( ISFP ) and the Preparing for the Drug-Free Years program ( PDFY ) on young adolescent transitions from nonuse of substances to initiation and progression of substance use . Analyses incorporated 3 waves of data collected over a 2.5-year period from 329 rural young adolescents . Outcomes were analyzed by using log-linear models that incorporated substance use status frequencies derived from latent transition analyses . Effects on delayed substance use initiation were shown for both the ISFP and the PDFY at a 2-year follow-up . Also at this follow-up , the PDFY showed effects on delayed progression of use among those previously reporting initiation Recent studies have suggested that a prevention program that addresses the social influences that encourage smoking can be effective in deterring cigarette use by adolescents . This study presents 1- , 2- , and 3-year follow-up results from two studies which evaluated three variations of the social influences curriculum and compared them to a health consequences program and a usual-care comparison group . These results suggest that a peer-led , social influences program can restrain smoking among both baseline nonsmokers and baseline experimental smokers at 2 years postintervention . Analyses of attrition data suggest no evidence to threaten the internal validity of these findings , although their generalizability to baseline smokers may be limited This study reports the evaluation of an intervention design edto reinforcetobacco abstinence amongelementary schoolchildren in a school transition period . This intervention was developed according to the principles of Intervention Mapping . A total of 765 grade 5 students ( ages 10 - 12 ) was recruited in 32 elementary schools . A quasi-experimental longitudinal design was used to evaluate the outcomes . Results observed 2 and 8 months postintervention are reported here . It is shown that although the behavior remained largely unchanged by the intervention , some of its determinants were modified . Behavioral intention , behavioral and normative beliefs , perceived self-efficacy , and role beliefs were changed at one or both postintervention measures . An interesting feature of these results relates to the fact that the most positive outcomes were seen among at-risk children . Discussion considers the advisability to develop , implement , and evaluate evidence -based interventions targeting the psychosocial factors underlying maintenance of tobacco smoking abstinence in elementary school Most school-based smoking prevention studies employ design s in which schools or classrooms are assigned to different treatment conditions while observations are made on individual students . This design requires that the treatment effect be assessed against the between-school variance . However , the between-school variance is usually larger than the variance that would be obtained if students were individually r and omized to different conditions . Consequently , the power of the test for a treatment effect is reduced , and it becomes difficult to detect important treatment effects . To assess the potential loss of power or to calculate appropriate sample sizes , investigators need good estimates of the intraclass correlations for the variables of interest . The authors calculated intraclass correlations for some common outcome variables in a school-based smoking prevention study , using a three-level model-i.e . , students nested within classrooms and classrooms nested within schools . The authors present the intraclass correlation estimates for the entire data set , as well as separately by sex and ethnicity . They also illustrate the use of these estimates in the planning of future studies Outcome research has shown that drug prevention programs based on theories of social influence often prevent the onset of adolescent drug use . However , little is known empirically about the processes through which they have their effects . The purpose of the present study was to evaluate intervening mechanism theories of two program models for preventing the onset of adolescent drug use . Analyses based on a total of 3077 fifth grade rs participating in the Adolescent Alcohol Prevention Trial revealed that both normative education and resistance training activated the causal processes they targeted . While beliefs about prevalence and acceptability significantly mediated the effects of normative education on subsequent adolescent drug use , resistance skills did not significantly predict subsequent drug use . More impressively , this pattern of results was virtually the same across sex , ethnicity , context ( public versus private school students ) , drugs ( alcohol , cigarettes , and marijuana ) and levels of risk and was durable across time . These findings strongly suggest that successful social influence-based prevention programs may be driven primarily by their ability to foster social norms that reduce an adolescent 's social motivation to begin using alcohol , cigarettes , and marijuana BACKGROUND Physicians ' advice to help pregnant women quit smoking during prenatal care has had mixed results . Training and prompting physicians to provide consistent advice and referral to on-site support might improve cessation rates . METHODS Pregnant women who smoked were r and omly assigned to receive structured advice from their physician and referral to individual behavior change counseling during prenatal care or to receive brief advice to stop smoking and a quit smoking booklet at their first visit . Smoking status was measured by self-report , exhaled carbon monoxide , and urinary cotinine . RESULTS Compared with usual care , greater proportions of intervention group women reported not smoking at the 36th-week visit ( 14 % vs 10 % ) and at 1 year postpartum ( 18 % vs 11 % ) , but these differences were not significant . However , significantly greater proportions of intervention group women reported either not smoking or reducing their cigarette consumption by 50 % or more at their second visit ( 43 % vs 29 % , P = 0.02 ) , at their 36th-week visit ( 40 % vs 25 % , P < 0.01 ) , and at 1 year postpartum ( 26 % vs 14 % , P = 0.02 ) . CONCLUSIONS Physician training on how to gain a pregnant smoker 's commitment to change her smoking behavior , an office prompt system , and individualized smoking behavior change counseling show promise in reducing smoking during pregnancy and postpartum , but practical methods to assist pregnant smokers between regular prenatal visits , as they attempt to quit , need to be developed This article review s major risk factors for cigarette smoking , alcohol , and other drug abuse and promising community-based approaches to primary prevention . In a longitudinal experimental study , 8 representative Kansas City communities were assigned r and omly to program ( school , parent , mass media , and community organization ) and control ( mass media and community organization only ) conditions . Programs were delivered at either 6th or 7th grade , and panels were followed through Grade 9 or 10 . The primary findings were ( a ) significant reductions at 3 years in tobacco and marijuana use and ( b ) equivalent reductions for youth at different levels of risk . This study provides evidence that a comprehensive community program-based approach can prevent the onset of substance abuse and that the benefits are experienced equally by youth at high and low risk OBJECTIVES Our study tested the effectiveness of network methods for identifying opinion leaders and for constructing groups . METHODS Three conditions-r and om , teacher , and network -- ere r and omly assigned to 84 6th- grade classrooms within 16 schools . Pre- and postcurriculum data on mediators of tobacco use were collected
Output:
| There was a lack of high quality evidence about the effectiveness of combinations of social influences and social competence approaches .
There is one rigorous test of the effects of information-giving about smoking . |
MS211225 | ***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 Motivating adolescents to adopt proper nutrition and physical activity behaviors is important in this nation 's fight to prevent obesity and chronic diseases . This study was conducted to determine which health education delivery method would elicit a greater behavior change . METHOD The intervention was conducted in three schools ( control , computer-based , and traditional education ) . RESULTS Students who received the computer-based intervention showed increased knowledge ( p<0.001 ) , physical activity ( p=0.001 ) , self-efficacy ( p<0.001 ) , and social support ( p<0.001 ) , and decreased meals skipped ( p<0.001 ) . CONCLUSION The computer-based group showed more positive behavior changes . However , future programs may be enhanced by including group discussion and individual feedback PURPOSE To examine the feasibility and efficacy of a theory-driven and family-based program delivered online to promote healthy lifestyles and weights in Chinese American adolescents . METHODS A r and omized controlled study of a web-based intervention was developed and conducted in 54 Chinese American adolescents ( ages , 12 - 15 years ) and their families . Data on anthropometry , blood pressure , dietary intake , physical activity , and knowledge and self-efficacy regarding physical activity and nutrition were collected at baseline and 2 , 6 , and 8 months after the baseline assessment . Data were analyzed using linear mixed modeling . RESULTS The intervention result ed in significant decreases in waist-to-hip ratio and diastolic blood pressure and increases in vegetable and fruit intake , level of physical activity , and knowledge about physical activity and nutrition . CONCLUSION This web-based behavior program for Chinese American adolescents and their families seems feasible and effective in the short-term . Long-term effects remain to be determined . This type of program can be adapted for other minority ethnic groups who are at high-risk for overweight and obesity and have limited access to programs that promote healthy lifestyles PURPOSE To compare the effectiveness of two school-based internet obesity prevention programs for diverse adolescents on body mass index ( BMI ) , health behaviors , and self-efficacy , and to explore moderators of program efficacy . It was hypothesized that the addition of coping skills training to a health education and behavioral support program would further enhance health outcomes . METHODS A r and omized clinical trial with cluster r and omization by class and repeated measures with follow-up at 3 and 6 months was conducted ( n = 384 ) . BMI was assessed by use of st and ard procedures . Sedentary behavior , physical activity , nutrition behavior , self-efficacy , and satisfaction were assessed with self-report measures . Data analysis consisted of mixed model analyses with autoregressive covariance structure for repeated data by use of intent-to-treat procedures . RESULTS The mean age of students was 15.31 years ( ±0.69 ) , with a mean BMI of 24.69 ( ±5.58 ) . The majority were girls ( 62 % ) and of diverse race/ethnicity ( 65 % non-white ) . There were no significant differences between groups on any outcomes and no change in BMI over time . There were significant improvements in health behaviors ( sedentary behavior , moderate and vigorous physical activity , healthy eating , fruit and vegetable intake , sugar beverages , and junk food intake ) and self-efficacy . Gender and lesson completion moderated select health outcomes . There was excellent participation and high satisfaction with the programs . CONCLUSIONS School-based internet obesity prevention programs are appealing to adolescents and improve health behaviors . The differential effect of coping skills training may require longer follow-up Background : The positive effects of computer-tailored dietary fat intake interventions have been demonstrated in adults , but few studies have investigated the impact on adolescents . Purpose : The purpose is to evaluate the acceptability , feasibility and effectiveness of a computer-tailored dietary fat intake education program for adolescents . Methods : A r and om sample of 10 schools , 5 with general and 5 with technical-vocational education programs , were selected to participate . In each of the 10 schools , 2 classes of 7th grade rs were r and omly assigned to the intervention ( n=153 ) or control ( no-intervention , n=151 ) condition . Students were exposed once in class to a 50-min theory-based computer-tailored dietary fat intake intervention . Question naires were completed 1 week before ( food frequency question naire for dietary fat intake + psychosocial determinants ) and 3 months after ( process evaluation + food frequency question naire for dietary fat intake + psychosocial determinants ) the intervention . Results : About one in three students evaluated the intervention as interesting ( 34 % ) , novel ( 38 % ) , personally relevant ( 26 % ) , credible ( 34 % ) , and correct ( 38 % ) . Half of the students evaluated the intervention messages to be too long , and one fourth did not read the intervention messages . A decrease in dietary fat consumption was shown in girls enrolled in technical-vocational schools ( F=3.5 , p≤.05 ) and in boys and girls undertaking general education who reported to have read the intervention messages ( F=3.6 , p≤.05 ) ; however , no intervention effects were detected for the total sample . Conclusions : Further improvements to the intervention for use in adolescents should be evaluated . Given that a positive impact was shown in most adolescents and that a computer-tailored dietary fat intake education program has the capability of reaching large groups at low cost , this study shows that using such interventions in adolescents has potential OBJECTIVE To evaluate the impact of a school-based health behavior intervention known as Planet Health on obesity among boys and girls in grade s 6 to 8 . DESIGN R and omized , controlled field trial with 5 intervention and 5 control schools . Outcomes were assessed using preintervention ( fall 1995 ) and follow-up measures ( spring 1997 ) , including prevalence , incidence , and remission of obesity . PARTICIPANTS A group of 1295 ethnically diverse grade 6 and 7 students from public schools in 4 Massachusetts communities . INTERVENTION Students participated in a school-based interdisciplinary intervention over 2 school years . Planet Health sessions were included within existing curricula using classroom teachers in 4 major subjects and physical education . Sessions focused on decreasing television viewing , decreasing consumption of high-fat foods , increasing fruit and vegetable intake , and increasing moderate and vigorous physical activity . MAIN OUTCOME MEASURES Obesity was defined as a composite indicator based on both a body mass index and a triceps skinfold value greater than or equal to age- and sex-specific 85th percentiles . Because schools were r and omized , rather than students , the generalized estimating equation method was used to adjust for individual-level covariates under cluster r and omization . RESULTS The prevalence of obesity among girls in intervention schools was reduced compared with controls , controlling for baseline obesity ( odds ratio , 0.47 ; 95 % confidence interval , 0.24 - 0.93 ; P = .03 ) , with no differences found among boys . There was greater remission of obesity among intervention girls vs. control girls ( odds ratio , 2.16 ; 95 % confidence interval , 1.07 - 4.35 ; P = .04 ) . The intervention reduced television hours among both girls and boys , and increased fruit and vegetable consumption and result ed in a smaller increment in total energy intake among girls . Reductions in television viewing predicted obesity change and mediated the intervention effect . Among girls , each hour of reduction in television viewing predicted reduced obesity prevalence ( odds ratio , 0.85 ; 95 % confidence interval , 0.75 - 0.97 ; P = .02 ) . CONCLUSION Planet Health decreased obesity among female students , indicating a promising school-based approach to reducing obesity among youth BACKGROUND Consumption of liquid calories from beverages has increased in parallel with the obesity epidemic in the US population , but their causal relation remains unclear . OBJECTIVE The objective of this study was to examine how changes in beverage consumption affect weight change among adults . DESIGN This was a prospect i ve study of 810 adults participating in the PREMIER trial , an 18-mo r and omized , controlled , behavioral intervention trial . Measurements ( weight , height , and 24-h dietary recall ) were made at baseline , 6 mo , and 18 mo . RESULTS Baseline mean intake of liquid calories was 356 kcal/d ( 19 % of total energy intake ) . After potential confounders and intervention assignment were controlled for , a reduction in liquid calorie intake of 100 kcal/d was associated with a weight loss of 0.25 kg ( 95 % CI : 0.11 , 0.39 ; P < 0.001 ) at 6 mo and of 0.24 kg ( 95 % CI : 0.06 , 0.41 ; P = 0.008 ) at 18 mo . A reduction in liquid calorie intake had a stronger effect than did a reduction in solid calorie intake on weight loss . Of the individual beverages , only intake of sugar-sweetened beverages ( SSBs ) was significantly associated with weight change . A reduction in SSB intake of 1 serving/d was associated with a weight loss of 0.49 kg ( 95 % CI : 0.11 , 0.82 ; P = 0.006 ) at 6 mo and of 0.65 kg ( 95 % CI : 0.22 , 1.09 ; P = 0.003 ) at 18 mo . CONCLUSIONS These data support recommendations to limit liquid calorie intake among adults and to reduce SSB consumption as a means to accomplish weight loss or avoid excess weight gain . This trial was registered at clinical trials.gov as NCT00000616 OBJECTIVE A r and omized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for African-American girls over a 2-year period of intervention . RESEARCH METHODS AND PROCEDURES Fifty-seven overweight ( mean BMI percentile , 98.3 ) African-American girls ( mean age , 13.2 years ) were r and omly assigned to an interactive behavioral internet program or an internet health education program , the control condition . Overweight parents were also participants in the study . Forty adolescent-parent dyads ( 70 % ) completed the 2-year trial . Outcome data including BMI , body weight , body composition , and weight loss behaviors were collected at baseline and at 6-month intervals . A computer server tracked use of the web sites . RESULTS An intention-to-treat statistical approach was used , with the last observation carried forward . In comparison with the control condition , adolescents in the behavioral program lost more mean body fat ( BF ) ( -1.12 + /- 0.47 % vs. 0.43 + /- 0.47 % BF , p < 0.05 ) , and parents in the behavioral program lost significantly more mean body weight ( -2.43 + /- 0.66 vs. -0.35 + /- 0.64 kg , p < 0.05 ) during the first 6 months . This weight loss was regained over the next 18 months . After 2 years , differences in fat for adolescents ( -0.08 + /- 0.71 % vs. 0.84 + /- 0.72 % BF ) and weight for parents ( -1.1 + /- 0.91 vs. -0.60 + /- 0.89 kg ) did not differ between the behavioral and control programs . DISCUSSION An internet-based weight management program for African-American adolescent girls and their parents result ed in weight loss during the first 6 months but did not yield long-term loss due to reduced use of the web site over time OBJECTIVE . This study examined the efficacy of an Internet-facilitated intervention for weight maintenance and binge eating in adolescents . METHODS . A total of 105 adolescent male and female high school students at risk for overweight ( mean age : 15.1 ± 1.0 years ) were r and omly assigned to a 16-week online intervention , StudentBodies2-BED ( n = 52 ) , or the wait-list control group ( n = 53 ) . RESULTS . Participants in the StudentBodies2-BED group had significantly lower BMI z scores and BMI from baseline assessment to follow-up assessment , compared with the wait-list control group . In addition , significant reductions in objective binge episodes and subjective binge episodes from baseline assessment to posttreatment assessment and from baseline assessment to follow-up assessment were observed among StudentBodies2-BED participants . The StudentBodies2-BED group also reported significantly reduced weight and shape concerns from posttreatment assessment to follow-up assessment and from baseline assessment to follow-up assessment . Participants in the StudentBodies2-BED group who engaged in objective overeating or binge eating episodes at baseline assessment experienced a significantly greater reduction in BMI at follow-up assessment , compared with the wait-list control group . CONCLUSIONS . Results suggest that an Internet-facilitated intervention is moderately effective in short-term weight loss and weight maintenance and yields a large reduction in binge eating . This study also demonstrates that weight management and reduction of eating disorder psychopathological features can be achieved simultaneously by using an easily disseminated , Internet-facilitated program OBJECTIVE This study was undertaken to evaluate the efficacy of a skills-based CD-ROM intervention , with and without a parent component , to reduce alcohol use among urban youth at 6-year follow-up . METHOD At recruitment , 513 youths with a mean age of 10.8 years were r and omly assigned to
Output:
| Small changes in diet , physical activity , knowledge , and self-efficacy were shown ; however , few results were sustained long term .
With further research and evidentiary support , this approach to obesity-related nutrition education has the potential to be successful |
MS211226 | ***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 Infantile Pompe disease ( glycogen storage disease type 2 ) is a fatal disorder caused by deficiency of acid α-glucosidase . This deficiency results in glycogen accumulation in the lysosomes of many tissues including cardiac muscle . The disease is characterized by profound hypotonia , poor growth , organomegaly , and cardiomegaly . Severe hypertrophic cardiomyopathy often is present in early infancy , and most patients die of cardiac or respiratory failure in the first year of life . This report describes the cardiac response of infants with Pompe disease to a phase 2 trial of enzyme replacement therapy ( ERT ) . Methods Eight patients with classical infantile Pompe disease were given intravenous recombinant human GAA ( rhGAA ) for 1 year . Cardiac monitoring included echocardiography , electrocardiograms ( ECGs ) , chest radiographs , and clinical cardiac evaluation at 4 , 8 , 12 , 24 , 36 , and 52 weeks . At 52 weeks , 6 patients were alive . Results Most of the treated patients had rapid regression of ventricular hypertrophy in response to ERT , with near normalization of posterior wall thickness , ventricular mass , and ventricular size . Systolic ventricular function was preserved despite rapid changes in ventricular mass and size . Concomitantly , ECGs documented lengthening of the PR interval and decreased ventricular voltages , whereas chest radiographs documented a decreased cardiothoracic ratio . Symptoms of pulmonary congestion were diminished , and survival was improved . Conclusion The cardiovascular system responds quickly and strikingly to ERT with rhGAA , suggesting rapid reversal of excessive glycogen storage in cardiac muscle cells . Changes in ventricular mass and function are maintained throughout 1 year of follow-up evaluation and associated with decreased morbidity and prolonged survival Deficiency of acid alpha glucosidase ( GAA ) causes Pompe disease , which is usually fatal if onset occurs in infancy . Patients synthesize a non-functional form of GAA or are unable to form native enzyme . Enzyme replacement therapy with recombinant human GAA ( rhGAA ) prolongs survival in infantile Pompe patients but may be less effective in cross-reactive immunologic material (CRIM)-negative patients . We retrospectively analyzed the influence of CRIM status on outcome in 21 CRIM-positive and 11 CRIM-negative infantile Pompe patients receiving rhGAA . Patients were from the clinical setting and from clinical trials of rhGAA , were 6 months of age , were not invasively ventilated , and were treated with IV rhGAA at a cumulative or total dose of 20 or 40 mg/kg/2 weeks . Outcome measures included survival , invasive ventilator-free survival , cardiac status , gross motor development , development of antibodies to rhGAA , and levels of urinary Glc(4 ) . Following 52 weeks of treatment , 6/11 ( 54.5 % ) CRIM-negative and 1/21 ( 4.8 % ) CRIM-positive patients were deceased or invasively ventilated ( p<0.0001 ) . By age 27.1 months , all CRIM-negative patients and 4/21 ( 19.0 % ) CRIM-positive patients were deceased or invasively ventilated . Cardiac function and gross motor development improved significantly more in the CRIM-positive group . IgG antibodies to rhGAA developed earlier and serotiters were higher and more sustained in the CRIM-negative group . CRIM-negative status predicted reduced overall survival and invasive ventilator-free survival and poorer clinical outcomes in infants with Pompe disease treated with rhGAA . The effect of CRIM status on outcome appears to be mediated by antibody responses to the exogenous protein Emerging phenotypes in long-term survivors with Pompe disease on st and ard enzyme replacement therapy ( ERT ) ( alglucosidase alfa 20 mg/kg/2 weeks ) can include patients with worsening motor function . Whether higher doses of ERT improve skeletal function in these patients has not been systematic ally studied . This exploratory , r and omized , open-label , 52-week study examined the safety and efficacy of 2 ERT regimens of alglucosidase alfa ( 20 mg/kg/week or 40 mg/kg/2 weeks ) in 13 patients with Pompe disease and clinical decline or a lack of improvement on st and ard ERT : late-onset ( n = 4 ) , infantile-onset ( n = 9 ) . Cross-reactive immunologic material assay-negative patients were excluded . Eleven of 13 patients completed the study . Trends for improvement were seen in total gross motor function , but not mobility ; however , 6 ( late-onset , 2 ; infantile-onset , 4 ) of 11 patients ( 55 % ) who met the entry criteria of motor decline ( late-onset , 4 ; infantile-onset , 7 ) showed improvement in motor and /or mobility skills . No between-regimen differences in efficacy emerged . Two case studies highlight the benefits of increased ERT dose in patients with Pompe disease experiencing clinical decline . Both alternative regimens were generally well tolerated . This study was limited by the small sample size , which is not uncommon for small clinical studies of rare diseases . Additionally , the study did not include direct assessment of muscle pathology , which may have identified potential causes of decreased response to ERT . Results were inconclusive but suggest that increased ERT dose may be beneficial in some patients with Pompe disease experiencing motor decline . Controlled studies are needed to clarify the benefits and risks of this strategy Purpose : A clinical trial was conducted to evaluate the safety and efficacy of alglucosidase alfa in infants and children with advanced Pompe disease . Methods : Open-label , multicenter study of IV alglucosidase alfa treatment in 21 infants 3–43 months old ( median 13 months ) with minimal acid α-glucosidase activity and abnormal left ventricular mass index by echocardiography . Patients received IV alglucosidase alfa every 2 weeks for up to 168 weeks ( median 120 weeks ) . Survival results were compared with an untreated reference cohort . Results : At study end , 71 % ( 15/21 ) of patients were alive and 44 % ( 7/16 ) of invasive-ventilator free patients remained so . Compared with the untreated reference cohort , alglucosidase alfa reduced the risk of death by 79 % ( P < 0.001 ) and the risk of invasive ventilation by 58 % ( P = 0.02 ) . Left ventricular mass index improved or remained normal in all patients evaluated beyond 12 weeks ; 62 % ( 13/21 ) achieved new motor milestones . Five patients were walking independently at the end of the study and 86 % ( 18/21 ) gained functional independence skills . Overall , 52 % ( 11/21 ) of patients experienced infusion-associated reactions ; 95 % ( 19/20 ) developed IgG antibodies to recombinant human lysosomal acid α-glucosidase ; no patients withdrew from the study because of safety concerns . Conclusions : In this population of infants with advanced disease , biweekly infusions with alglucosidase alfa prolonged survival and invasive ventilation-free survival . Treatment also improved indices of cardiomyopathy , motor skills , and functional independence OBJECTIVE To conduct an open-label , multinational , multicenter study examining the safety and efficacy of recombinant human acid alpha-glucosidase ( rhGAA ) in treatment of infantile-onset Pompe disease . STUDY DESIGN We enrolled 8 infant patients who had Pompe disease with GAA activity < 1 % of normal , cardiomyopathy , and hypotonia . In the 52-week initial phase , rhGAA was infused intravenously at 10 mg/kg weekly ; an extension phase continued survivors ' treatment with 10 to 20 mg/kg of rhGAA weekly or 20 mg/kg every 2 weeks for as long as 153 weeks . Safety measurements included adverse events , laboratory tests , and anti-rhGAA antibody titers . Efficacy evaluations included survival , ventilator use , echocardiograms , growth , and motor and cognitive function . RESULT After 52 weeks of treatment , 6 of 8 patients were alive , and 5 patients were free of invasive ventilator support . Clinical improvements included ameliorated cardiomyopathy and improved growth and cognition . Five patients acquired new motor milestones ; 3 patients walked independently . Four patients died after the initial study phase ; the median age at death or treatment withdrawal for all patients was 21.7 months , significantly later than expected for patients who were not treated . Treatment was safe and well tolerated ; no death was drug-related . CONCLUSION rhGAA improved ventilator-free survival , cardiomyopathy , growth , and motor function in patients with infantile-onset Pompe disease compared with outcomes expected for patients without treatment Pompe disease is an autosomal recessive muscle-wasting disorder caused by the deficiency of the lysosomal enzyme acid alpha-glucosidase . Due to virtual absence of acid alpha-glucosidase , patients with classical infantile Pompe disease develop progressive cardiomyopathy , skeletal muscle weakness and respiratory insufficiency leading to death in early infancy . We report on the results of a phase II clinical trial including two patients with classical infantile Pompe disease receiving enzyme replacement therapy over a period of 48 weeks by weekly infusions . Recombinant acid alpha-glucosidase was derived from the milk of transgenic rabbits . Safety was evaluated by recording adverse events while clinical efficacy was evaluated by ventilator-free survival , left ventricular mass index , motor development as well as histologic and biochemical analysis of muscle biopsies . This therapy was in general well-tolerated . There was an overall improvement in left ventricular mass , cardiac function , skeletal muscle function and histological appearance of skeletal muscle
Output:
| Long-term alglucosidase alfa treatment markedly extended survival as well as ventilation-free survival and improved cardiomyopathy ( low- quality evidence ) .
One small r and omized controlled trial provided no robust evidence for which dosing schedule of alglucosidase alfa was more effective to treat infantile-onset Pompe disease . |
MS211227 | ***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 Odour baits can attract host-seeking Anopheles mosquitoes indoors and outdoors . We assessed the effects of mass deployment of odour-baited traps on malaria transmission and disease burden . METHODS We installed solar-powered odour-baited mosquito trapping systems ( SMoTS ) to households on Rusinga Isl and , Lake Victoria , western Kenya ( mean population 24 879 ) , in a stepped-wedge cluster-r and omised trial . All residents in the completed health and demographic surveillance system were eligible to participate . We used the travelling salesman algorithm to assign all households to a cluster ( 50 or 51 geographically contiguous households ) ; nine contiguous clusters formed a metacluster . Initially , no cluster had SMoTS ( non-intervened ) . During the course of the intervention roll-out SMoTS were gradually installed cluster by cluster until all clusters had SMoTS installed ( intervened ) . We generated 27 cluster r and omisations , with the cluster as unit of r and omisation , to establish the order to install the traps in the clusters until all had a SMoTS installed . Field workers and participants were not masked to group allocation . The primary outcome of clinical malaria was monitored through repeated household visits covering the entire population , once before roll-out ( baseline ) and five times throughout the 2-year roll-out . We measured clinical malaria as fever plus a positive result with a rapid diagnostic test . The SolarMal project was registered on the Dutch Trial Register ( NTR 3496 ) . FINDINGS We enrolled 34 041 participants between April 25 , 2012 , and March 23 , 2015 , to 81 clusters and nine metaclusters . 4358 households were provided with SMoTS during roll-out between June 3 , 2013 , and May 16 , 2015 . 23 clinical malaria episodes were recorded in intervened clusters and 33 episodes in non-intervened clusters ( adjusted effectiveness 40·8 % [ 95 % CI -172·8 to 87·1 ] , p=0·5 ) during the roll-out . Malaria prevalence measured by rapid diagnostic test was 29·8 % ( 95 % CI 20·9 - 38·0 ) lower in SMoTS clusters ( prevalence 23·7 % ; 1552 of 6550 people ) than in non-intervened clusters ( prevalence 34·5 % ; 2002 of 5795 people ) . INTERPRETATION The unexpectedly low clinical incidence of malaria during roll-out led to an imprecise estimate of effectiveness from the clinical incidence data . The substantial effect on malaria prevalence is explained by reduction in densities of Anopheles funestus . Odour-baited traps might be an effective malaria intervention . FUNDING COmON Foundation A r and omized , double-blinded , placebo-controlled study was conducted to examine the effect of spatial repellent ( SR ) in households at risk of malaria in Indonesia . Following presumptive radical cure for malaria in 180 adult men representing sentinels of new infection in four clusters within two villages , all households were given either metofluthrin or placebo mosquito coils . Weekly blood smear screening and human-l and ing mosquito catches were done throughout the 6 months intervention . Malaria infections occurred in 61 subjects living in placebo households and 31 subjects living in SR coil households , suggesting a 52 % protective effect of SR . Likewise , anopheles indoor human l and ing rates were 32 % lower in homes receiving SR coils . Differences in the malaria attack rate between SR- and placebo-treated homes was significant when not accounting for the effects of clustering . When the analysis was adjusted for intra-cluster correlation , the differences between SR- and placebo-treated homes were not statistically significant . The findings provide evidence of SR public health benefit and support a larger trial statistically powered to detect those effects Background Mosquito coils are the most commonly used household insecticidal product in the world with sales exceeding 50 billion coils , used by two billion people worldwide annually . Despite strong evidence that coils prevent mosquito bites a systematic review concluded that there is no evidence that burning mosquito coils prevents malaria acquisition . Therefore , the current trial was design ed to measure and compare prevention of malaria infection by mosquito coils or long-lasting insecticidal net ( LLIN ) or a combination of the two in Yunnan , China in the Greater Mekong sub-region . Methods A four-arm single blind household-r and omized design was chosen as coils emanate insecticide throughout the household . Households enrolled at baseline were r and omly allocated by the lottery method to one of the four intervention arms : ( i ) nothing , ( ii ) 0.03 % transfluthrin coils alone , ( iii ) deltamethrin long-lasting insecticide treated nets , ( LLINs ) alone or ( iv ) a combination of transfluthrin coils and deltamethrin LLINs . All household members were recruited to the study , with only those households excluded with pregnant or breastfeeding mothers , members with chest complaints or allergies or members that regularly slept away from home . The main outcome of interest was Plasmodium falciparum malaria prevalence detected by rapid diagnostic tests ( RDTs ) during six repeated monthly cross-sectional surveys . The secondary outcome of interest was the effect on Plasmodium vivax prevalence detected in the same way . Results A total of 2,052 households were recruited into the study , comprising 7,341 individuals The odds ratios of testing positive by RDT with P. falciparum or P. vivax were > 75 % lower for all intervention arms compared with the control arm . Coils alone provided 77 % protection ( 95 % CI : 50%-89 % ) , LLINs provided 91 % protection ( 95 % CI : 72%-97 % ) and the combination of coils and LLINs provided 94 % protection ( 95 % CI : 77%-99 % ) against P. falciparum compared with the control arm . There was no statistically significant difference between the protective efficacies of the different interventions . Conclusions This is the first robust clinical evaluation of transfluthrin mosquito coils as a means to reduce malaria and the high degree of infection prevented would indicate they represent a potentially highly effective tool , which could be integrated into larger vector control programmes . Trial registration Clinical Trials.gov Identifier : NCT00442442 , March 2007 BACKGROUND House screening should protect people against malaria . We assessed whether two types of house screening -- full screening of windows , doors , and closing eaves , or installation of screened ceilings -- could reduce house entry of malaria vectors and frequency of anaemia in children in an area of seasonal malaria transmission . METHODS During 2006 and 2007 , 500 occupied houses in and near Farafenni town in The Gambia , an area with low use of insecticide-treated bednets , were r and omly assigned to receive full screening , screened ceilings , or no screening ( control ) . R and omisation was done by computer-generated list , in permuted blocks of five houses in the ratio 2:2:1 . Screening was not treated with insecticide . Exposure to mosquitoes indoors was assessed by fortnightly light trap collection s during the transmission season . Primary endpoints included the number of female Anopheles gambiae sensu lato mosquitoes collected per trap per night . Secondary endpoints included frequency of anaemia ( haemoglobin concentration < 80 g/L ) and parasitaemia at the end of the transmission season in children ( aged 6 months to 10 years ) who were living in the study houses . Analysis was by modified intention to treat ( ITT ) , including all r and omised houses for which there were some outcome data and all children from those houses who were sample d for haemoglobin and parasitaemia . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N51184253 . FINDINGS 462 houses were included in the modified ITT analysis ( full screening , n=188 ; screened ceilings , n=178 ; control , n=96 ) . The mean number of A gambiae caught in houses without screening was 37.5 per trap per night ( 95 % CI 31.6 - 43.3 ) , compared with 15.2 ( 12.9 - 17.4 ) in houses with full screening ( ratio of means 0.41 , 95 % CI 0.31 - 0.54 ; p<0.0001 ) and 19.1 ( 16.1 - 22.1 ) in houses with screened ceilings ( ratio 0.53 , 0.40 - 0.70 ; p<0.0001 ) . 755 children completed the study , of whom 731 had complete clinical and covariate data and were used in the analysis of clinical outcomes . 30 ( 19 % ) of 158 children from control houses had anaemia , compared with 38 ( 12 % ) of 309 from houses with full screening ( adjusted odds ratio [ OR ] 0.53 , 95 % CI 0.29 - 0.97 ; p=0.04 ) , and 31 ( 12 % ) of 264 from houses with screened ceilings ( OR 0.51 , 0.27 - 0.96 ; p=0.04 ) . Frequency of parasitaemia did not differ between intervention and control groups . INTERPRETATION House screening substantially reduced the number of mosquitoes inside houses and could contribute to prevention of anaemia in children . FUNDING Medical Research Council Background In malaria-endemic areas , residents of modern houses have less malaria than those living in traditional houses . This study will determine if modern housing provides incremental protection against clinical malaria over the current best practice of long-lasting insecticidal nets ( LLINs ) and prompt treatment in The Gambia , determine the incremental cost-effectiveness of the interventions , and analyze the housing market in The Gambia . Methods / design A two-armed , household , cluster-r and omized , controlled study will be conducted to assess whether improved housing and LLINs combine to provide better protection against clinical malaria in children than LLINs alone in The Gambia . The unit of r and omization will be the household , defined as a house and its occupants . A total of 800 households will be enrolled and will receive LLINs , and 400 will receive improved housing before clinical follow-up . One child aged 6 months to 13 years will be enrolled from each household and followed for clinical malaria using active case detection to estimate malaria incidence for two malaria transmission seasons . Episodes of clinical malaria will be the primary endpoint . Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection , parasite density , and the prevalence of anemia . Exposure to malaria parasites will be assessed using light traps , followed by detection of Anopheles gambiae species and sporozoite infection . Ancillary economic and social science studies will undertake a cost-effectiveness analysis and use qualitative and participatory methods to explore the acceptability of the housing modifications and to design strategies for scaling-up housing interventions . Discussion The study is the first of its kind to measure the efficacy of housing on reducing clinical malaria , assess the incremental cost-effectiveness of improved housing , and identify mechanisms for scaling up housing interventions . Trial findings will help inform policy makers on improved housing for malaria control in sub-Saharan Africa . Trial registration IS RCT N Registry , IS RCT N02622179 . Registered on 23 September 2014 Background In Vietnam , malaria remains a problem in some remote areas located along its international borders and in the central highl and s , partly due to the bionomics of the local vector , mainly found in forested areas and less vulnerable to st and ard control measures . Long Lasting Insecticidal Hammocks ( LLIH ) , a tailored and user-friendly tool for forest workers , may further contribute in reducing the malaria burden . Their effectiveness was tested in a large community-based intervention trial carried out in Ninh Thuan province in Central Vietnam . Methods and Findings Thirty villages ( population 18,646 ) were assembled in 20 clusters ( 1,000 individuals per cluster ) that were r and omly allocated to either the intervention or control group ( no LLIH ) after stratification according to the pre-intervention P. falciparum antibody prevalence ( < 30 % ; ≥30 % ) . LLIH were distributed to the intervention group in December 2004 . For the following 2 years , the incidence of clinical malaria and the prevalence of infection were determined by passive case detection at community level and by bi-annual malariometric surveys . A 2-fold larger effect on malaria incidence in the intervention as compared to the control group was observed . Similarly , malaria prevalence decreased more substantially in the intervention ( 1.6-fold greater reduction ) than in the control group . Both for incidence and prevalence , a stronger and earlier effect of the intervention was observed in the high endemicity stratum . The number of malaria cases and infections averted by the intervention overall was estimated at 10.5 per 1,000 persons and 5.6/100 individuals , respectively , for the last half of 2006 . In the high endemicity stratum , the impact was much higher , i.e. 29/1000 malaria cases and 15.7 infections/100 individuals averted . Conclusions LLIH reduced malaria incidence and prevalence in this remote and forested area of Central Vietnam . As the targets of the newly-launched Global Malaria Action Plan include
Output:
| Overall the quality of the evidence base remains greatest for LSM and topical repellents , relative to the other VCTs evaluated , although existing evidence indicates that topical repellents are unlikely to provide effective population -level protection against malaria . |
MS211228 | ***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: This study reports the effect of the Fruits and Vegetables Make the Marks intervention , a school-based fruit and vegetable intervention consisting of a home economics classroom component and parental involvement and encouraged participation in the Norwegian School Fruit Programme , all delivered during the school year of 2001 - 02 . Nine r and omly chosen schools received the intervention and 10 schools served as control schools . Participating pupils completed question naires at baseline ( September 2001 ) , at Follow-up 1 ( May-June 2002 ) and at Follow-up 2 ( May 2003 ) . A total of 369 pupils ( 69 % ; mean age , 11.3 years at baseline ) participated in all three surveys . No effect of the intervention was found for intake of fruit and vegetables eaten at school or all day , neither at Follow-up 1 nor at Follow-up 2 . On analysing the effects on potential mediators , significant differences between intervention and control groups were found for Awareness of the five-a-day recommendations only . The intervention programme was rated as very good by the teachers , and the pupils reported that they enjoyed it . However , the intervention failed to change fruit and vegetable intake , probably because it did not succeed in changing the pupils ' preferences for or the accessibility of fruit and vegetables -- the two strongest correlates of children 's fruit and vegetable intake Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design OBJECTIVE To measure the effect of a school fruit and vegetable subscription on children 's intake of fruit and vegetables after 5 weeks of intervention . SETTING Seven primary schools in Denmark . DESIGN AND METHODS Intervention schools ( n=4 ) were offered a fruit and vegetable subscription comprising one piece per day . Control schools situated in another municipality were not offered the subscription . Intake of fruit and vegetables was measured at baseline and 5 weeks after the start of the subscription . Two methods were used for dietary assessment : a pre-coded 24-hour recall form including total food intake and a food-frequency question naire ( FFQ ) including only fruit and vegetables . SUBJECTS Children aged 6 - 10 years ( n=804 from intervention schools and n=689 from control schools ) . Response rate in the dietary assessment was 31 % . RESULTS At intervention schools 45 % of the children enrolled in the subscription . After 5 weeks of intervention , both subscribers and non-subscribers had increased their intake of fruit by 0.4 ( P=0.019 ) and 0.3 ( P=0.008 ) pieces per school day , respectively , but no change was observed in vegetable intake . Total intake increased only for non-subscribers by 0.4 piece/school day ( P=0.008 ) mainly due to the consistent increase in fruit intake . No change in intake was measured at control schools . Only the 24-hour recall question naire was sensitive enough to pick up the changes of the subscription , whereas the FFQ was not . CONCLUSION Five weeks with the subscription affected both subscribers and non-subscribers to increase intake of fruit . This may indicate that the subscription had an additional effect of stimulating parents of non-subscribers to supply their children with fruit . The results stress the importance of evaluating the effect of this type of programme , and the carefulness needed in design ing the evaluation study OBJECTIVE To assess the impact of a school-based nutrition education intervention aim ed at increasing the consumption of fruits and vegetables . DESIGN The intervention programme increased the provision of fruits and vegetables in schools and provided a range of point-of-purchase marketing material s , newsletters for children and parents , and teacher information . Curriculum material s at age 6 - 7 and 10 - 11 years were also developed and utilised . Evaluation was undertaken with groups of younger ( aged 6 - 7 years ) and older ( aged 10 - 11 years ) children . Methods included 3-day dietary records with interview and cognitive and attitudinal measures at baseline , with follow-up at 9 months , in intervention and control schools . SETTING The work was undertaken in primary schools in Dundee , Scotl and . SUBJECTS Subjects comprised 511 children in two intervention schools with a further 464 children from two schools acting as controls . RESULTS Children ( n=64 ) in the intervention schools had an average increase in fruit intake ( 133+/-1.9 to 183+/-17.0 g day(-1 ) ) that was significantly ( P<0.05 ) greater than the increase ( 100+/-11.7 to 107+/-14.2 g day(-1 ) ) estimated in children ( n=65 ) in control schools . No other changes in food or nutrient intake were detected . Increases in scores for variables relating to knowledge about fruits and vegetables and subjective norms were also greater in the intervention than in the control group , although taste preferences for fruits and vegetables were unchanged . CONCLUSIONS It is concluded that a whole school approach to increasing intakes of fruits and vegetables has a modest but significant effect on cognitive and attitudinal variables and on fruit intake BACKGROUND Secondary school students often do not drink sufficient quantities of water during the school day to prevent dehydration , promote learning and good health . The study aim ed to measure the effect of health promotion and the free provision of cooled filtered water on the consumption of water and soft drinks . It also aim ed to explore students ' views of drinking water provision . METHODS A study was conducted with three secondary schools in North Tyneside . Over a 3 month period one school was given cooled filtered water and active promotion ( W + P ) , another had water only ( W ) . The control school ( C ) took part in post-intervention focus group work . RESULTS The average volume of water drunk by students , in school ' W + P ' was greater ( P = 0.05 ) than that drunk in school ' W ' and control school ' C ' . The volume of soft drinks purchased by students in all three schools before and during the intervention remained static . Focus group data revealed that students viewed their existing water provision as poor and wanted sufficient supplies of cooled filtered water in school . CONCLUSIONS This pilot study indicates that active promotion of water drinking increased consumption of water by secondary school students . Further developments of the project are suggested CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs Background : The positive effects of computer-tailored dietary fat intake interventions have been demonstrated in adults , but few studies have investigated the impact on adolescents . Purpose : The purpose is to evaluate the acceptability , feasibility and effectiveness of a computer-tailored dietary fat intake education program for adolescents . Methods : A r and om sample of 10 schools , 5 with general and 5 with technical-vocational education programs , were selected to participate . In each of the 10 schools , 2 classes of 7th grade rs were r and omly assigned to the intervention ( n=153 ) or control ( no-intervention , n=151 ) condition . Students were exposed once in class to a 50-min theory-based computer-tailored dietary fat intake intervention . Question naires were completed 1 week before ( food frequency question naire for dietary fat intake + psychosocial determinants ) and 3 months after ( process evaluation + food frequency question naire for dietary fat intake + psychosocial determinants ) the intervention . Results : About one in three students evaluated the intervention as interesting ( 34 % ) , novel ( 38 % ) , personally relevant ( 26 % ) , credible ( 34 % ) , and correct ( 38 % ) . Half of the students evaluated the intervention messages to be too long , and one fourth did not read the intervention messages . A decrease in dietary fat consumption was shown in girls enrolled in technical-vocational schools ( F=3.5 , p≤.05 ) and in boys and girls undertaking general education who reported to have read the intervention messages ( F=3.6 , p≤.05 ) ; however , no intervention effects were detected for the total sample . Conclusions : Further improvements to the intervention for use in adolescents should be evaluated . Given that a positive impact was shown in most adolescents and that a computer-tailored dietary fat intake education program has the capability of reaching large groups at low cost , this study shows that using such interventions in adolescents has potential OBJECTIVE To measure the effects of two school-based interventions on children 's intake of fruit and vegetables ( F&V ) . DESIGN AND METHODS A total of six primary schools were r and omly assigned to ( 1 ) a free F&V distribution programme , or ( 2 ) a multicomponent programme , consisting of a classroom curriculum and parental involvement . The two interventions were evaluated on their effects and compared with six control schools in a pre-test-post-test design . Two methods were used for dietary assessment : a pre-structured food recall and a food-frequency question naire including only F&V. SUBJECTS A total of 939 parents of children aged 4 - 12 years filled out the question naire at both pre-test and post-test . The response rate was 54 % . RESULTS Multilevel analyses showed that both programmes were equally effective in increasing children 's fruit consumption by 0.2 portions per day . The free F&V distribution increased vegetable intake among non-native children and the oldest age group , and the multicomponent programme among the oldest children and girls . The distribution also caused an increased 24 h fruit , juice and vegetable intake among the youngest and the oldest age groups , and the multicomponent programme among all children . CONCLUSION The results of this study indicate that both interventions were shown to be effective for different subgroups regarding age , gender and ethnicity . When comparing both interventions , the distribution programme was shown to be more effective , especially in increasing vegetable consumption . An important next step will be to investigate which intervention has the greatest potential to be implemented in primary schools This study reports the effect of a school-r and omized fruit and vegetable intervention consisting of a subscription to the Norwegian School Fruit Programme at no parental cost , and the Fruit and Vegetables Make the Marks ( FVMM ) educational programme , both delivered in the school year of 2001 - 02 . Nine r and omly chosen schools received the intervention and 10 schools served as control schools . Participating pupils completed question naires at baseline ( September 2001 ) , at Follow-up 1 ( May-June 2002 ) and at Follow-up 2 ( May 2003 ) . A total of 517 pupils ( 84 % ; mean age , 11.3 years at baseline ) participated in all three surveys . At both Follow-up 1 and Follow-up 2 , strong intervention effects were observed for all-day fruit and vegetable intake ( effect sizes were 0.6 and 0.5 portions , respectively ) . The sustained effect at Follow-up 2 , 1 year after the end of the intervention , can partly be explained by greater participation rates in the School Fruit Programme ( st and ard paid subscription ) . We conclude that the effects observed are most likely due to the no-cost subscription and not due to the FVMM educational programme , and that providing pupils with a piece of fruit or a vegetable at school at no cost for the parents is an effective strategy to increase school children 's intake of fruit and vegetables . The effect is also sustained 1 year after the end of the no-cost subscription , providing increased health benefits The aim of this study was to examine the fidelity and
Output:
| In children , strong evidence of effect was found for multicomponent interventions on fruit and vegetable intakes .
Limited evidence of effect was found for educational interventions on behaviour , and for environmental interventions on fruit and vegetable intakes .
Interventions that specifically targeted children from lower socio-economic status groups showed limited evidence of effect on behaviour .
In adolescents , moderate evidence of effect was found for educational interventions on behaviour and limited evidence of effect for multicomponent programmes on behaviour .
To conclude , evidence was found for the effectiveness of especially multicomponent interventions promoting a healthy diet in school-aged children in European Union countries on self-reported dietary behaviour . |
MS211229 | ***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 Green tea polyphenols ( GTPs ) have significant antioxidant and antiinflammatory activities , and prior short‐term studies suggest that these compounds may improve photoaging skin . OBJECTIVES To evaluate the long‐term effects of oral GTPs on the clinical and histologic characteristics of photoaging skin . MATERIAL S AND METHODS Double‐blind , placebo‐controlled trial of 56 women aged 25 to 75 r and omized to 250 mg GTPs or placebo twice daily for 2 years . A blinded dermatologist scored the appearance of photodamaged facial skin at 0 , 6 , 12 , and 24 months . A blinded dermatopathologist scored the histologic characteristics of sun‐exposed arm skin at 0 and 24 months . RESULTS Clinical assessment of facial skin revealed that the GTP group had significant improvement in overall solar damage at 6 months ( p=.02 ) and significant improvement in erythema and telangiectasias at 12 months ( p=.02 ) . The placebo group did not have significant improvements in these parameters at 6 months or 12 months . There were no statistically significant differences in other photoaging parameters at 6 , 12 , or 24 months in the GTP or placebo groups . Histopathologic analysis of sunexposed arm skin showed no statistically significant difference in photoaging parameters in the GTP group or the placebo group at 24 months . CONCLUSIONS Long‐term supplementation with oral GTPs was not superior to placebo in improving clinical or histologic photoaging parameters after 24 months of use . Funding and material s for this study were provided by Nu Skin , Provo , Utah . Dale Kern is an employee of Nu Skin International To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results A double-blind , placebo-controlled trial was conducted to clinical ly evaluate the effect of soy isoflavone aglycone on the aged skin of middle-aged women . Twenty-six women volunteers in their late 30s and early 40s were r and omly assigned to receive either a test food ( 13 women , the test food group ) or a placebo food ( 13 women , the control group ) . These groups were given the test food ( 40 mg of soy isoflavone aglycone per day ) and placebo , respectively , for 12 wk . The extent of linear and fine wrinkles at the lateral angle of the eyes was selected as the major evaluation criterion to assess the effects of foods , and the wrinkles ' area ratio was used as the evaluation parameter . The extent of skin microrelief at the lateral angle of eyes and that of malar skin elasticity were used as secondary evaluation criteria , and the skin microrelief 's area ratio and recovery of skin elasticity were used as the respective evaluation parameters . These parameters were assessed 4 , 8 , and 12 wk after the start of the test food or placebo intake . The test food group showed a statistically significant improvement of fine wrinkles at week 12 ( p<0.05 ) and of malar skin elasticity at week 8 ( p<0.05 ) , compared with the control group . Although there was no significant difference between the test food group and the control group regarding effects on skin microrelief at lateral angle of the eyes , a significant intragroup improvement was observed at week 8 in the test food group ( p<0.05 ) . As for the test food safety , none of the subjects presented adverse symptoms during the study period or discontinued the intake of the test food . These data indicate that the oral intake of 40 mg soy isoflavone aglycones per day improves the aged skin of middle-aged women This study evaluates the efficacy and tolerability of an investigational study cream composed of 3 ingredients ( green and white teas , mangosteen , and pomegranate extract ) , Vitaphenol Skin Cream ( La Jolla Spa MD , La Jolla CA ) , as compared to a placebo cream in rejuvenating facial skin . Twenty healthy females between the ages of 35 and 65 with demonstrable facial wrinkling , achieving a Rao-Goldman wrinkle scale score of 2 or above , applied either Vitaphenol Skin Cream or placebo cream to a r and omized half of their face twice daily for 60 days and returned for follow-up after 2 weeks . Twice as many subjects indicated an enhancement of skin texture ( eg , reduction in pore size , roughness , and touch ) with the usage of Vitaphenol versus placebo . In all , 41 % of the study subjects preferred the half of their face that had been receiving Vitaphenol , while only 0.06 % of the subjects favored the placebo side . PRIMOS images from periorbital skin treated with Vitaphenol demonstrated an average improvement in skin smoothness of 1 mm3 , whereas skin treated with placebo showed an average decrease in smoothness or an increase in skin roughness of 0.9 mm3 . The addition of 3 antioxidants , green and white teas , mangosteen , and pomegranate , have an additive effect to enhance the improvement of age-related changes in the skin BACKGROUND Green tea extracts have gained popularity as ingredients in topical skin care preparations to treat aging skin . Green tea polyphenolic compounds have significant antioxidant and anti-inflammatory activities , and studies suggest that these extracts help mediate ultraviolet radiation damage . OBJECTIVE To evaluate the effects of a combination regimen of topical and oral green tea supplementation on the clinical and histologic characteristics of photoaging . METHODS Forty women with moderate photoaging were r and omized to either a combination regimen of 10 % green tea cream and 300 mg twice-daily green tea oral supplementation or a placebo regimen for 8 weeks . RESULTS No significant differences in clinical grading were found between the green tea-treated and placebo groups , other than higher subjective scores of irritation in the green tea-treated group . Histologic grading of skin biopsies did show significant improvement in the elastic tissue content of treated specimens ( p<.05 ) . CONCLUSION Participants treated with a combination regimen of topical and oral green tea showed histologic improvement in elastic tissue content . Green tea polyphenols have been postulated to protect human skin from the cutaneous signs of photoaging , but clinical ly significant changes could not be detected . Longer supplementation may be required for clinical ly observable improvements Hormones play a central role in skin appearance and are implicated in skin aging . Recently , along with the remarkable increase in interest in natural products , the application of phytohormones in antiaging products has become very important . In this context , we developed date palm kernel extract . Date palm kernel is rich in phytohormones and we investigated the antiaging properties of date palm kernel in this in vivo study on wrinkles . Ten healthy women volunteers , between the ages of 46 and 58 years , applied the cream formula with 5 % date palm kernel or placebo on the eye area twice a day for 5 weeks . The evaluation was made both clinical ly and by silicon replica analysis followed by statistical analysis using the Wilcoxon test . Silicon replica results showed that topical application of date palm kernel reduced the total surface of wrinkles by 27.6 % ( p = 0.038 ) . Moreover , date palm kernel reduced the depth of wrinkles by 3.52 % ( p = 0.0231 ) . These results are statistically significant and were clinical ly confirmed where visual improvement was seen in 60 % of the volunteers treated . This in vivo study demonstrates that date palm kernel exhibits a significant antiwrinkle effect and is therefore of interest in antiaging skin care products Recently , it has become indispensable for anti-aging active ingredients to provide a visible and immediate smoothing antiwrinkle effect . In Quercus suber , suberin is the most important structural component of cork cell walls . Studies have shown that suberin is made up mostly of hydroxycarboxylic acids and that it is endowed with many special mechanical and chemical properties that evoke a possible smoothing effect on the surface of the skin . Therefore , we were interested in investigating the effect of this cork extract on the skin 's surface in a double-blind clinical study . The study was conducted in 15 healthy volunteers , aged 22 to 52 years . The volunteers applied a gel formula with 3 % of cork extract , or placebo gel , on each forearm . Skin surface roughness was evaluated visually by pictures and by silicone replicas 1 and 2 h after application , followed by statistical analysis using the matched-pairs McNemar statistical test . McNemar analysis of the pictures revealed that application of cork extract on the skin result ed in a highly significant reduction of roughness 1 h after application . This effect was observed in 73.3 % of volunteers . Two hours after cork extract application , a highly significant improvement of skin roughness was found in 78.6 % of volunteers . Moreover , silicone replica treatment confirmed significant improvement in average of roughness at 2 h. These results demonstrate that cork extract provides a remarkable and highly significant tensor and smoothing effect on the skin , which could be of great use in anti-aging skin care products R and omized , controlled trials ( RCTs ) of herbal interventions often inadequately describe important aspects of their methods ( 1 - 4 ) . Although the quality of reporting of these trials may be improving with time , many still lack important information , particularly about the composition of the herbal intervention ( 4 , 5 ) . Crude herbal drugs are natural products and their chemical composition varies depending on several factors , such as geographic source of the plant material , climate in which it was grown , and time of harvest . Commercially available herbal medicinal products also vary in their content and concentration of chemical constituents from batch to batch and when products containing the same herbal ingredient are compared among manufacturers ( 6 - 14 ) . Even when herbal products are st and ardized for content of known active or marker compounds to achieve more consistent pharmaceutical quality , there is variation in the concentrations of other constituents . These variations can result in differences in pharmacologic activity in vitro ( 15 ) and in bioavailability in humans ( 16 ) . Mindful of these issues , we elaborated on the 22-item checklist of the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement ( 17 ) to help authors and editors improve reporting of RCTs of herbal interventions . Methods We developed these reporting recommendations in 3 phases that included premeeting item generation , a consensus meeting , and postmeeting feedback . The individuals who participated are listed in the Appendix . To generate items , 1 investigator conducted telephone interviews of 16 participants with expertise in the method and reporting of RCTs ( 5 participants ) , pharmacognosy ( 4 participants ) , herbal medicinal products ( 5 participants ) , medical statistics ( 1 participant ) , and herbal product manufacturing ( 1 participant ) . The investigator asked participants to suggest revisions to existing CONSORT checklist items and also to additional items required for reporting trials of herbal interventions . He asked participants to nominate revisions or new items on the basis of empirical evidence that not reporting the item would bias estimates of treatment effect . When no empirical evidence was available , commonsense reasoning was acceptable . After completing all telephone calls , the investigator thematically grouped items and circulated them by e-mail to each participant for review . Fourteen participants attended the consensus meeting . The meeting began with a review of the premeeting checklist item suggestions . We emphasized minimizing item elaborations and additions and basing elaborations on evidence whenever possible . Each item suggestion was presented and followed by debate for its inclusion , deletion , or modification . This process was repeated until all items were review ed and a consensus emerged . After the consensus meeting , we circulated a draft summary report to all participants to ensure that it accurately represented decisions made during the consensus meeting . We then circulated the report to the wider CONSORT Group for input and revised it on the basis of their suggestions . Ethical approval was obtained from The University of Toronto Health Sciences Ethics Review Committee on 23 January 2004 . Financial support for the consensus meeting was provided by the Canadian Institutes of Health Research . The funding body had no role in the design , conduct , or analysis of this study and did not influence the decision to su bmi t the manuscript for publication . All research ers are independent of the funders . Results The group did not recommend any new CONSORT checklist items or modifications in the CONSORT flow diagram . We did , however , elaborate on 9 of the 22 CONSORT checklist items to enhance their relevance to trials of herbal interventions ( Table , Figure ; Appendix Table ) , including minor recommendations for 8 items ( item 1 [ title and abstract ] , item 2 [ background ] , item 3 [ participants ] , item 6 [ outcomes ] , item 15 [ baseline data ] , item 20 [ interpretation ] , item 2
Output:
| In summary , there is some weak evidence to suggest that several botanical extracts may be effective in reducing the appearance of skin aging but no evidence that this effect is enduring . |
MS211230 | ***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 Abacavir , a nucleoside analogue , has demonstrated suppression of human immunodeficiency virus ( HIV ) replication alone and in combination therapy . However , the role of abacavir in a triple nucleoside combination regimen has not been evaluated against a st and ard protease inhibitor-containing regimen for initial antiretroviral treatment . OBJECTIVE To evaluate antiretroviral equivalence and safety of an abacavir-lamivudine-zidovudine regimen compared with an indinavir-lamivudine-zidovudine regimen . DESIGN AND SETTING A multicenter , phase 3 , r and omized , double-blind trial with an enrollment period from August 1997 to June 1998 , with follow-up through 48 weeks at 73 clinical research units in the United States , Canada , Australia , and Europe . PATIENTS Five hundred sixty-two antiretroviral-naive , HIV-infected adults with a plasma HIV RNA level of at least 10 000 copies/mL and a CD4 cell count of at least 100 x 10(6)/L. INTERVENTIONS Patients were stratified by baseline HIV RNA level and r and omly assigned to receive a combination tablet containing 150 mg of lamivudine and 300 mg of zidovudine twice daily plus either 300 mg of abacavir twice daily and indinavir placebo or 800 mg of indinavir every 8 hours daily plus abacavir placebo . After 16 weeks , patients with confirmed HIV RNA levels greater than 400 copies/mL were eligible to continue receiving r and omized treatment or receive open-label therapy . MAIN OUTCOME MEASURE Virologic suppression , defined as HIV RNA concentration of 400 copies/mL or less at week 48 . RESULTS The proportion of patients who met the end point of having an HIV RNA level of 400 copies/mL or less at week 48 was equivalent in the abacavir group ( 51 % [ 133/262 ] ) and in the indinavir group ( 51 % [ 136/265 ] ) with a treatment difference of -0.6 % ( 95 % confidence interval [ CI ] , -9 % to 8 % ) . In patients with baseline HIV RNA levels greater than 100 000 copies/mL , the proportion of patients achieving less than 50 copies/mL was greater in the indinavir group than in the abacavir group with 45 % ( 45/100 ) vs 31 % ( 30/96 ) and a treatment diference of -14 % ( 95 % CI , -27 % to 0 % ) . The 2 treatments were comparable with respect to their effects on CD4 cell count . There was no difference between groups in the frequency of treatment-limiting adverse events or laboratory abnormalities . One death in the abacavir group was attributed to hypersensitivity reaction , which occurred following rechallenge with abacavir , approximately 3 weeks after initiating study treatment . CONCLUSIONS In this study of antiretroviral-naive HIV-infected adults , the triple nucleoside regimen of abacavir-lamivudine-zidovudine was equivalent to the regimen of indinavir-lamivudine-zidovudine in achieving a plasma HIV RNA level of less than 400 copies/mL at 48 weeks Patients with sustained virological suppression on protease inhibitor (PI)-based therapy were r and omly assigned to switch the PI to nevirapine ( n = 155 ) , efavirenz ( n = 156 ) , or abacavir ( n = 149 ) and were followed for at least 3 years regardless of the discontinuation of assigned therapy . There was a higher probability of maintaining virological suppression after 3 years of follow-up with nevirapine or efavirenz than with abacavir . In contrast , abacavir showed a lower incidence of adverse effects leading to drug discontinuation BACKGROUND Evidence from r and omized controlled trials supports the use of triple therapy . Research is required on the effectiveness of quadruple therapy in comparison to this and the relative effectiveness of specific highly active antiretroviral therapy ( HAART ) combinations . METHODS Antiretroviral-naive individuals ( n = 53 ) with an HIV-1 viral load > 100 000 copies/mL were r and omized to receive three-drug HAART with zidovudine/lamivudine ( Combivir ) and efavirenz or quadruple therapy with zidovudine/lamivudine/abacavir ( Trizivir ) and efavirenz ( quad regimen ) . Patients continued on HAART for 48 weeks with regular clinical and immunological assessment . St and ard and ultrasensitive ( < 5 copies/mL ) viral load testing was carried out . RESULTS A DAVG ( difference in averages ) analysis of the fall in viral load and increase in CD4 count showed no significant differences between regimens . Triple therapy result ed in a -4.17 log change ( 95 % CI , -4.48 to -3.85 ) and quadruple therapy in a -4.36 log change ( 95 % CI , -4.68 to -4.03 ) in viral load . For CD4 counts , the triple therapy arm increased by 164 cells/mm(3 ) ( 95 % CI 112 - 217 ) and the quadruple arm by 185 ( 95 % CI , 133 - 237 ) . In an intent-to-treat analysis , 77 % of patients in the triple therapy group reached an undetectable viral load ( < 50 copies/mL ) compared with 84.2 % of the quadruple therapy group . For ultrasensitive viral load testing , 23 % and 18 % of each group , respectively , reached undetectable viral loads . The hazard ratio for attaining a viral load of < 5 copies/mL was 0.59 ( 95 % CI , 0.26 - 1.33 ) for quadruple versus triple therapy . Three individuals in the triple therapy arm and nine in the quadruple therapy arm discontinued treatment . CONCLUSIONS No differences in any analyses were observed between a st and ard of care regimen ( zidovudine/lamivudine and efavirenz ) and the quad regimen ( zidovudine/lamivudine/abacavir and efavirenz ) Background : The OK04 trial has shown that 48 weeks of lopinavir-ritonavir monotherapy with re introduction of nucleosides as needed was noninferior to continuation of triple therapy with 2 nucleosides and lopinavir-ritonavir in patients with prior stable suppression . However , it is still uncertain if this experimental strategy can maintain suppression in the long term . Methods : Patients entered this noninferiority trial ( upper limit 95 % confidence interval : + 12 % ) with no history of virological failure while receiving a protease inhibitor and receiving 2 nucleosides plus lopinavir/ritonavir , with HIV RNA < 50 copies per milliliter for more than 6 months . Primary end point was percent of patients without therapeutic failure , defined as confirmed HIV RNA > 500 copies per milliliter with exclusion of monotherapy patients who resuppressed to < 50 copies per milliliter after resuming baseline nucleosides , or loss to follow-up , or change of r and omized therapy other than reinduction . Results : Through 96 weeks , percentage of patient without therapeutic failure was 87 % ( monotherapy , n = 100 ) vs. 78 % ( triple therapy , n = 98 ; 95 % confidence interval : −20 % to + 1.2 % ) . Percentage with HIV RNA < 50 copies per milliliter ( intention to treat , missing = failure , reinduction = failure ) : 77 % ( monotherapy ) vs. 78 % ( triple therapy ) . Low-level viral rebound was more frequent in the monotherapy group . Twelve patients in the monotherapy group ( 12 % ) needed reinduction with nucleosides . Discontinuations due to adverse events were significantly more frequent in the triple therapy group ( 8 % ) than in the monotherapy group ( 0 % ) ; P = 0.003 . Conclusions : At 96-week lopinavir/ritonavir monotherapy with re introduction of nucleosides as needed was noninferior to continuation of triple therapy . Incidence of adverse events leading to treatment discontinuation was significantly lower with monotherapy . ( Clinical Trials.gov number , NCT00114933 ) Background : The NEFA Study was a r and omized study comparing nevirapine ( NVP ) , efavirenz ( EFV ) or abacavir ( ABC ) as substitutes for protease inhibitors in a large group of HIV-1-infected patients successfully treated with antiretroviral regimens containing protease inhibitors . Objective : To evaluate genotype and phenotype resistance patterns among patients who have experienced virological failure under one of the three study arms . Methods : Patients with virological failure , defined as two consecutive determinations of HIV-1 RNA > 200 copies/ml , were analysed for phenotypic susceptibility and HIV-1 mutations . Results : Of the 460 patients included in the study , 51 ( 11 % ) experienced virological failure after 24 months of follow-up while on assigned study medication . A higher proportion of patients in the ABC [ 25 ( 17 % ) ] than in the NVP [ 14 ( 9 % ) ] or EFV [ 12 ( 8 % ) ] arms selected resistance to the study drug ( P = 0.04 ) . Moreover , a much higher number of resistance mutations to one or more of the backbone nucleoside reverse transcriptase inhibitor drugs contained in the failing regimen were observed in the ABC than in the EFV or NVP arms . In general , there was a good concordance among genotype and phenotype resistance testing , except for ABC , stavudine and didanosine , where phenotypic resistance testing added valuable information ( fold change in the median inhibitory concentration ) . Conclusions : Cross-resistance involving nucleoside reverse transcriptase inhibitor drugs might explain the higher risk of virological failure in patients switched to ABC-containing antiretroviral therapy . Phenotypic resistance testing may be helpful in interpreting unclear genotypic results BACKGROUND Hypersensitivity reaction to abacavir is strongly associated with the presence of the HLA-B*5701 allele . This study was design ed to establish the effectiveness of prospect i ve HLA-B*5701 screening to prevent the hypersensitivity reaction to abacavir . METHODS This double-blind , prospect i ve , r and omized study involved 1956 patients from 19 countries , who were infected with human immunodeficiency virus type 1 and who had not previously received abacavir . We r and omly assigned patients to undergo prospect i ve HLA-B*5701 screening , with exclusion of HLA-B*5701-positive patients from abacavir treatment ( prospect ive-screening group ) , or to undergo a st and ard-of-care approach of abacavir use without prospect i ve HLA-B*5701 screening ( control group ) . All patients who started abacavir were observed for 6 weeks . To immunologically confirm , and enhance the specificity of , the clinical diagnosis of hypersensitivity reaction to abacavir , we performed epicutaneous patch testing with the use of abacavir . RESULTS The prevalence of HLA-B*5701 was 5.6 % ( 109 of 1956 patients ) . Of the patients receiving abacavir , 72 % were men , 84 % were white , and 18 % had not previously received antiretroviral therapy . Screening eliminated immunologically confirmed hypersensitivity reaction ( 0 % in the prospect ive-screening group vs. 2.7 % in the control group , P<0.001 ) , with a negative predictive value of 100 % and a positive predictive value of 47.9 % . Hypersensitivity reaction was clinical ly diagnosed in 93 patients , with a significantly lower incidence in the prospect ive-screening group ( 3.4 % ) than in the control group ( 7.8 % ) ( P<0.001 ) . CONCLUSIONS HLA-B*5701 screening reduced the risk of hypersensitivity reaction to abacavir . In predominantly white population s , similar to the one in this study , 94 % of patients do not carry the HLA-B*5701 allele and are at low risk for hypersensitivity reaction to abacavir . Our results show that a pharmacogenetic test can be used to prevent a specific toxic effect of a drug . ( Clinical Trials.gov number , NCT00340080 . Background : Darunavir/ritonavir ( darunavir/r ) maintenance strategy , in patients with suppressed HIV RNA viremia , is a potential long-term strategy to avoid nucleoside analogue toxicities and to reduce costs . Methods : MONOtherapy Inhibitor protease is a prospect i ve , open-label , noninferiority , 96-week safety and efficacy trial in virologically suppressed patients on triple therapy who were r and omized to a darunavir/r triple drug regimen or darunavir/r monotherapy . The primary endpoint was the proportion of patients with HIV
Output:
| For the outcomes discontinuation for adverse events and virologic failures , the RRs were not significant , albeit being not far from the alpha level of 0.05 , thus suggesting a weak evidence of lower incidence of side effects and an higher incidence of virologic failure in the 3NRTI group compared to controls .
The strategy of switching to triple nucleoside regimens shows weak evidence of lower incidence of side effects and a higher incidence of virologic failure in the 3NRTI group compared to controls .
Simplification with 3NRTI holds the advantages of preserving other classes of antiretroviral drugs , to lower blood lipids , and to be cost effective and simple to administer . |
MS211231 | ***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 : Numerous dietary factors elevate serum levels of insulin and insulin-like growth factor I ( IGF-I ) , both potent prostate cancer mitogens . We tested whether varying dietary carbohydrate and fat , without energy restriction relative to comparison diets , would slow tumor growth and reduce serum insulin , IGF-I , and other molecular mediators of prostate cancer in a xenograft model . Experimental Design : Individually caged male severe combined immunodeficient mice ( n = 130 ) were r and omly assigned to one of three diets ( described as percent total calories ) : very high-fat/no-carbohydrate ketogenic diet ( NCKD : 83 % fat , 0 % carbohydrate , 17 % protein ) , low-fat/high-carbohydrate diet ( LFD : 12 % fat , 71 % carbohydrate , 17 % protein ) , or high-fat/moderate-carbohydrate diet ( MCD : 40 % fat , 43 % carbohydrate , 17 % protein ) . Mice were fed to maintain similar average body weights among groups . Following a preliminary feeding period , mice were injected with 1 × 106 LNCaP cells ( day 0 ) and sacrificed when tumors were ≥1,000 mm3 . Results : Two days before tumor injection , median NCKD body weight was 2.4 g ( 10 % ) and 2.1 g ( 8 % ) greater than the LFD and MCD groups , respectively ( P < 0.0001 ) . Diet was significantly associated with overall survival ( log-rank P = 0.004 ) . Relative to MCD , survival was significantly prolonged for the LFD ( hazard ratio , 0.49 ; 95 % confidence interval , 0.29 - 0.79 ; P = 0.004 ) and NCKD groups ( hazard ratio , 0.59 ; 95 % confidence interval , 0.37 - 0.93 ; P = 0.02 ) . Median serum insulin , IGF-I , IGF-I/IGF binding protein-1 ratio , and IGF-I/IGF binding protein-3 ratio were significantly reduced in NCKD relative to MCD mice . Phospho-AKT/total AKT ratio and pathways associated with antiapoptosis , inflammation , insulin resistance , and obesity were also significantly reduced in NCKD relative to MCD tumors . Conclusions : These results support further pre clinical exploration of carbohydrate restriction in prostate cancer and possibly warrant pilot or feasibility testing in humans Abstract Background : Calcium , phosphorus , fructose , and animal protein are hypothesized to be associated with prostate cancer risk , potentially via their influence on 1,25-dihydroxyvitamin D3 . We examined these nutrients and overall diet and prostate cancer risk in the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study ( ATBC Study ) . Material s and methods : The ATBC Study was a r and omized 2 × 2 trial of alpha-tocopherol and beta-carotene on lung cancer incidence conducted among Finnish male smokers ; 27,062 of the men completed a food-use question naire at baseline , and comprise the current study population . There were 184 incident clinical ( stage 2–4 ) prostate cancer cases diagnosed between 1985 and 1993 . We used Cox proportional hazards models to examine associations between dietary intakes and prostate cancer . Results : We did not observe significant independent associations for calcium and phosphorus and prostate cancer risk . However , men with lower calcium and higher phosphorus intake had a multivariate relative risk of 0.6 ( 95 % CI 0.3–1.0 ) compared to men with lower intakes of both nutrients , adjusting for age , smoking , body mass index , total energy , education , and supplementation group . Of the other foods and nutrients examined , none was significantly associated with risk . Discussion : This study provides , at best , only weak evidence for the hypothesis that calcium and phosphorus are independently associated with prostate cancer risk , but suggests that there may be an interaction between these nutrients Background Control of body weight by balancing energy intake and energy expenditure is of major importance for the prevention of type 2 diabetes , but the role of specific dietary factors in the etiology of type 2 diabetes is less well established . We evaluated intakes of whole grain , bran , and germ in relation to risk of type 2 diabetes in prospect i ve cohort studies . Methods and Findings We followed 161,737 US women of the Nurses ' Health Studies ( NHSs ) I and II , without history of diabetes , cardiovascular disease , or cancer at baseline . The age at baseline was 37–65 y for NHSI and 26–46 y for NHSII . Dietary intakes and potential confounders were assessed with regularly administered question naires . We documented 6,486 cases of type 2 diabetes during 12–18 y of follow-up . Other prospect i ve cohort studies on whole grain intake and risk of type 2 diabetes were identified in search es of MEDLINE and EMBASE up to January 2007 , and data were independently extracted by two review ers . The median whole grain intake in the lowest and highest quintile of intake was , respectively , 3.7 and 31.2 g/d for NHSI and 6.2 and 39.9 g/d for NHSII . After adjustment for potential confounders , the relative risks ( RRs ) for the highest as compared with the lowest quintile of whole grain intake was 0.63 ( 95 % confidence interval [ CI ] 0.57–0.69 ) for NHSI and 0.68 ( 95 % CI 0.57–0.81 ) for NHSII ( both : p-value , test for trend < 0.001 ) . After further adjustment for body mass index ( BMI ) , these RRs were 0.75 ( 95 % CI 0.68–0.83 ; p-value , test for trend < 0.001 ) and 0.86 ( 95 % CI 0.72–1.02 ; p-value , test for trend 0.03 ) respectively . Associations for bran intake were similar to those for total whole grain intake , whereas no significant association was observed for germ intake after adjustment for bran . Based on pooled data for six cohort studies including 286,125 participants and 10,944 cases of type 2 diabetes , a two-serving-per-day increment in whole grain consumption was associated with a 21 % ( 95 % CI 13%–28 % ) decrease in risk of type 2 diabetes after adjustment for potential confounders and BMI . Conclusions Whole grain intake is inversely associated with risk of type 2 diabetes , and this association is stronger for bran than for germ . Findings from prospect i ve cohort studies consistently support increasing whole grain consumption for the prevention of type 2 diabetes BACKGROUND Dietary fiber may reduce the risk of prostate cancer , possibly by increasing circulating concentrations of sex hormone-binding globulin and improving insulin sensitivity . However , results from previous epidemiologic studies of fiber intake and prostate cancer are inconsistent , and to our knowledge , no study has comprehensively evaluated the effects of soluble and insoluble fiber on prostate cancer in Asia . OBJECTIVE The objective was to examine the association between fiber intake and prostate cancer in Japanese men . DESIGN We conducted a population -based prospect i ve study in 43,435 Japanese men aged 45 - 74 y. Participants responded to a vali date d question naire , which included 138 food items . Follow-up was from 1995 through 2009 . HRs and 95 % CIs of incidence were calculated according to quartiles of fiber intake . RESULTS During the 11.6-y follow-up , of the 825 men newly diagnosed with prostate cancer , 213 had advanced-stage cancer , 582 had organ-localized disease , and 30 had an undetermined stage of disease . Among them , 217 cases were detected by subjective symptoms . Total fiber was not associated with total or advanced prostate cancer , with respective multivariable HRs for the highest and lowest quartiles of 1.00 ( 95 % CI : 0.77 , 1.29 ; P-trend = 0.97 ) and 0.67 ( 95 % CI : 0.42 , 1.07 ; P-trend = 0.30 ) . Total fiber and insoluble fiber intake were associated with a decreased risk of advanced cancers detected by subjective symptoms , with multivariate HRs ( 95 % CIs ) across increasing quartiles of 1.00 , 0.58 , 0.62 , and 0.44 ( 0.21 , 0.92 ; P-trend = 0.05 ) for total fiber and 1.00 , 0.60 , 0.52 , and 0.46 ( 0.22 , 0.93 ; P-trend = 0.04 ) for insoluble fiber . Soluble fiber intake showed no association with prostate cancer . CONCLUSIONS Dietary fiber is inversely associated with advanced prostate cancer detected by subjective symptoms even among population s with relatively low intake , such as Japanese . These results suggest that a very low intake of dietary fiber is associated with an increased risk of prostate cancer Epidemiological data on most cancer sites suggest that consumption of plant foods , which contain high levels of antioxidants , might slow or prevent the appearance of cancer . We used data from three case-control studies to test this hypothesis . The total study population consisted of 617 incident cases of prostate cancer and 636 population controls from Ontario , Quebec , and British Columbia . Dietary information was collected by an in-person interview with a detailed quantitative dietary history . Unconditional logistic regression analyses were performed to estimate odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) . A decreasing , statistically significant association was found with increasing intakes of green vegetables ( OR = 0.54 , 95 % CI = 0.40 - 0.71 for 4th quartile ) , tomatoes ( OR = 0.64 , 95 % CI = 0.45 - 0.91 ) , beans/lentils/nuts ( OR = 0.69 , 95 % CI = 0.53 - 0.91 ) , and cruciferous vegetables ( OR = 0.69 , 95 % CI = 0.52 - 0.91 for 3rd quartile ) . Higher intakes of fruit were associated with higher ORs ( OR = 1.51 , 95 % CI = 1.14 - 2.01 for 4th quartile ) , an effect that was seen for total fruit and citrus fruit , as well as for all other noncitrus fruits . Among the grains , refined-grain bread intake was associated with a decrease in risk ( OR = 0.65 for 4th quartile ) , whereas whole-grain breakfast cereals were associated with a higher risk for prostate cancer . Of all the antioxidant nutrients studied , the ORs were higher with higher intakes of cryptoxanthin ( OR = 1.44 , 95 % CI = 1.09 - 1.89 for 4th quartile ) . Exposure to certain dietary components of plant origin , which are potentially modifiable , indicates the theoretical scope for reducing the risk from prostate cancer . Future experimental studies or trials are warranted for further underst and ing Objective To evaluate the associations between dietary carbohydrate , glycemic index ( GI ) , glycemic load ( GL ) , and incident prostate cancer in the Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial ( PLCO ) cohort . Methods Between September 1993 and September 2000 , 38,343 men were r and omized to the screening arm of the trial at one of 10 PLCO centers . A food frequency question naire administered at baseline assessed usual dietary intake over the preceding 12 months . Prostate cancer was ascertained by medical follow-up of suspicious screening results and annual mailed question naires and confirmed with medical records . Cox proportional hazards regression was used to model the associations of carbohydrate , GI , and GL with prostate cancer risk . Results During follow-up ( median = 9.2 years ) , 2,436 incident prostate cancers were identified among 30,482 eligible participants . Overall , there were no associations of baseline carbohydrate , GI , or GL with incident prostate cancer in minimally or fully adjusted models . There were no associations when the 228 advanced and 2,208 non-advanced cancers were analyzed separately . Conclusions Dietary carbohydrate , GI , and GL were not associated with incident prostate cancer in PLCO . The narrow range of GI in this cohort may have limited our ability to detect associations , an issue that future studies should address Objective High intake of whole-grain products may protect against prostate cancer , but overall evidence is limited and inconclusive . The aim of the present study was to investigate the relationship between the intake of whole-grain products and risk of prostate cancer in a large prospect i ve cohort . Methods A total of 26,691 men aged 50–64 years participated in the Diet , Cancer and Health cohort study and provided information about diet and potential prostate cancer risk factors . During a median follow-up of 12.4 years , we identified 1,081 prostate cancer cases . Associations between
Output:
| The findings of this meta- analysis indicate that , based on available information , dietary fiber , whole grains , carbohydrate , GI , and GL are not associated with the risk of prostate cancer |
MS211232 | ***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: This study compares patient compliance with once- and twice-daily formulations of 5-isosorbide mononitrate . A total of 31 patients ( 20 men and 11 women ) with stable angina pectoris were r and omized to receive either 60 mg 5-isosorbide mononitrate in a controlled release formulation once daily , or 20 mg 5-isosorbide mononitrate twice daily . The results indicated that compliance assessed using the electronic Medication Event Monitoring System ( MEMS ® ) was better with the once-daily than with the twice-daily formulation ; patients on the once-daily regimen performed better with respect to the total number of bottle openings , the number of openings per day , the timing of openings and the intervals between openings . The apparently superior compliance with the once-daily regimen appeared to be reflected in better efficacy ; patients on the once-daily regimen experienced fewer angina attacks ( a mean of 1.7 per 7 days , compared with 3.3 per 7 days for patients on the twice-daily regimen ) and used fewer nitroglycerin tablets than those on the twice-daily regimen PURPOSE We conducted a prospect i ve study to determine the effects of nonadherence with mesalamine among patients with quiescent ulcerative colitis . METHODS We followed a cohort of 99 consecutive patients who had ulcerative colitis in remission for more than 6 months and who were taking maintenance mesalamine . Medication adherence rates were calculated based on pharmacy records and a vali date d formula . Nonadherence was defined as refilling less than 80 % of prescribed medication . Patients were followed prospect ively and evaluated either in clinic or via telephone at 6 , 12 , and 24 months . The primary outcome was clinical recurrence of ulcerative colitis . Proportional hazards models were used to adjust for confounders . RESULTS At 6 months , 12 patients ( 12 % ) had clinical recurrence of disease symptoms , all of whom were nonadherent with medication . At 12 months , 19 of 86 patients had recurrent disease , 13 ( 68 % ) of whom were nonadherent . Patients who were not adherent with medication had more than a fivefold greater risk of recurrence than adherent patients ( hazard ratio = 5.5 ; 95 % confidence interval : 2.3 to 13 ; P < 0.001 ) . CONCLUSION Nonadherence with medication increases the risk of clinical relapse among patients with quiescent ulcerative colitis . Future research should be directed at behavioral interventions to improve adherence BACKGROUND & AIMS This study was conducted to assess , in a small sample , the short-term outcomes of once-daily mesalamine versus conventional dosing in maintaining quiescent ulcerative colitis ( UC ) and to assess adherence rates with both regimens . METHODS Consecutive patients were r and omly assigned to either a once-daily regimen , or they continued current conventional regimen ( twice daily or 3 times daily ) . Patients were assessed at 3 months and 6 months . At each point , a clinical symptom disease score was obtained using patient question naires , and medication rates via pharmacy data . Adherence was defined as consumption of > 80 % of prescribed medication . Information was collected by an investigator blinded to treatment regimen . RESULTS Twenty-two patients were enrolled in the study , 12 in the once-daily group ( QD ) and 10 in the conventional group ( CD ) . At 3 months , no patients had experienced a relapse . All of the patients in the QD group and 70 % of patients in the CD group were adherent ( P = 0.04 ) . The average amount of medication consumed in the QD group was significantly higher than in the CD group ( 90 % vs. 75 % , P = 0.02 ) . At 6 months , 2 patients ( 1 patient from each group ) experienced a clinical relapse ( P = 0.76 ) . Seventy-five percent vs. 70 % of patients were adherent ( P = 0.8 ) ; the amount of medication taken approached significance ( 90 % vs. 76 % , P = 0.07 ) . All patients in the QD group reported being either " very satisfied " or " satisfied " with their regimen . CONCLUSIONS In this r and omized pilot trial , patients taking once-daily mesalamine had outcomes similar to those for patients on conventional regimens . A larger trial is warranted to assess whether true differences between regimens exist A large , Internet‐based survey of a r and om sample of members of the Crohn 's and Colitis Foundation of America was undertaken to gain knowledge and underst and ing of patients ' experiences with ulcerative colitis and first‐line therapies . From 49,410 invitations to participate , 1,595 usable responses were received from patients with ulcerative colitis . Patients were prescribed a range of aminosalicylates for their ulcerative colitis . Treatments with the highest proportion of satisfied patients were associated with highest remission rates . Forty‐three percent of patients considered their disease to be in remission ; however , 74 % reported disease relapse during the previous 12 months . Over 60 % of patients reported that they were noncompliant with prescribed aminosalicylate dosing schedules , with reasons attributed to frequency of dosing , the number of pills , and the inconvenience of the medication . Many respondents reported that they had made significant lifestyle changes because of their ulcerative colitis , including spending more time at home ( 46 % ) and participating in fewer social activities ( 37 % ) . When asked to describe their ideal treatment , patients considered high efficacy ( 97 % ) , lack of side effects ( 74 % ) , nonparenteral dosing ( 46 % ) , nonrectal dosing ( 36 % ) , low cost ( 23 % ) , fewer pills ( 23 % ) , and less frequent dosing ( 23 % ) as “ very important . ” This study demonstrates that continuous symptomatic remission is central to patient satisfaction and that patients find currently available aminosalicylates to be inconvenient . Patients ' ideal therapy would be an effective , oral formulation with fewer tablets , less frequent dosing , and minimal side effects . Development of such a therapy would , therefore , potentially improve both patient compliance and overall treatment success OBJECTIVE : The aim of this study was to identify determinants of nonadherence to medication in out patients with established inflammatory bowel disease ( IBD ) . METHODS : Ten gastroenterologists and 153 of their IBD patients participated in this prospect i ve study . Demographic , clinical , and psychosocial characteristics , as well as patient-physician discordance , were assessed at an office visit . Nonadherence to medication was assessed 2 wk later . Separate generalized estimating equations were used to identify determinants of nonadherence . RESULTS : Physicians averaged 47.9 yr in age ( range 30.1–57.5 yr ) , and 90 % were male . Patients averaged 37.0 yr ( SD = 15.1 ) , and 87 ( 56.9 % ) were female . In all , 63 patients ( 41.2 % ) were nonadherent to medication ; of these , 51 ( 81.0 % ) indicated unintentional nonadherence , 23 ( 36.5 % ) intentional nonadherence , and 11 ( 17.5 % ) both . Overall nonadherence was predicted by disease activity ( OR = 0.55 , p = 0.0022 ) , new patient status ( OR = 2.14 , p = 0.0394 ) , disease duration ( OR = 0.50 , p = 0.0001 ) , and scheduling a follow-up appointment ( OR = 0.30 , p = 0.0059 ) , whereas higher discordance on well-being was predictive only in psychologically nondistressed patients ( p = 0.0026 for interaction ) . Unintentional nonadherence was predicted by age ( OR = 0.97 , p = 0.0072 ) , new patient status ( OR = 2.80 , p = 0239 ) , and higher discordance on well-being in psychologically nondistressed patients ( p = 0.0504 ) . Intentional nonadherence was predicted by disease duration ( OR = 0.55 , p = 0032 ) , scheduling a follow-up appointment ( OR = 0.12 , p = 0.0001 ) , certainty that medication would be helpful ( OR = 0.99 , p = 0.0409 ) , and total patient-physician discordance ( OR = 1.59 , p = .0120 ) . CONCLUSIONS : These findings suggest that the therapeutic relationship , as well as individual clinical and psychosocial characteristics , influence adherence to medication The objective of this study was to determine the relationship between prescribed daily dose frequency and patient medication compliance . The medication compliance of 105 patients receiving antihypertensive medications was monitored by analyzing data obtained from special pill containers that electronically record the date and time of medication removal . Inaccurate compliance estimates derived using the simple pill count method were thereby avoided . Compliance was defined as the percent of days during which the prescribed number of doses were removed . Compliance improved from 59.0 % on a three-time daily regimen to 83.6 % on a once-daily regimen . Thus , compliance improves dramatically as prescribed dose frequency decreases . Probably the single most important action that health care providers can take to improve compliance is to select medications that permit the lowest daily prescribed dose frequency Recent studies have shown a low adherence rate to maintenance treatment in patients with inflammatory bowel disease ( IBD ) . We sought to assess the medication-taking behavior in a cohort of patients with IBD . We prospect ively included IBD patients from the outpatient clinic who agreed to answer a question naire about prescribed treatment and adherence . Physicians registered clinical data including prescribed medications . Two hundred fourteen patients ( 115 Crohn 's disease/99 ulcerative colitis ) were included . The most prescribed medications were oral mesalazine ( 56.5 % ) and immunomodulators ( 41.1 % ) . Forty-three percent of patients admitted to occasionally forgetting to take their medication but only 7.5 % of them did it voluntary . Oral mesalazine and azathioprine were the drugs with the poorest compliance , with nonadherence rates of 45 % and 25 % of the total prescribed doses , respectively . The only factor associated with a better adherence was a more complicated course of the disease — steroid dependency , steroid refractoriness , need for infliximab treatment , hospitalization , or surgery ( P=.02 ) . Twenty percent of patients admitted to self-medicating . An important proportion of patients with IBD admit to forget some doses of the prescribed medication in the setting of a specialized unit of a referral centre BACKGROUND Patients with inflammatory bowel disease ( IBD ) suffer physical dysfunction and impaired quality of life ( QOL ) , and need frequent health care . They often lack knowledge about their disease and desire more education . Educational interventions for other chronic diseases have demonstrated reduced health care use and increased knowledge , medication adherence and QOL . METHOD Sixty-nine participants were r and omly assigned to formal IBD education and st and ard of care ( pamphlets and ad hoc physician education ) or st and ard of care alone . Assessment of IBD knowledge and QOL occurred at baseline , immediately posteducation and eight weeks posteducation . Participants documented medication adherence and health care use in diaries . Patient satisfaction was assessed at the end of the study . RESULTS The education group had higher knowledge scores ( P=0.000 ) , perceived knowledge ratings ( P=0.01 ) and patient satisfaction ( P=0.001 ) . There was a lower rate of medication nonadherence and health care use for the education group , but the differences were not significant . QOL indices did not change . Significant correlations were found for increased health care use in patients with poorer medication adherence ( P=0.01 ) and lower perceived health ( P=0.05 ) . CONCLUSION Formal IBD patient education improves knowledge , perceived knowledge and patient satisfaction . Further study of long-term effects may better demonstrate potential benefits for QOL , medication adherence and health care use
Output:
| A substantial proportion of UC flares and medical costs of UC are attributable to 5-ASA non-adherence . |
MS211233 | ***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 goal of our study was to compare a prospect i ve triggering ( PT ) CT technique with retrospectively gated ( RG ) CT techniques in coronary computed tomographic angiograms ( CCTA ) with respect to image quality and radiation dose . Sixty consecutive patients were enrolled . CCTAs using the RG technique were obtained with a dual- source 64-slice CT system in 40 patients , using ECG-triggered tube current modulation , with either a broad pulsing window at 30–80 % of the RR interval ( group RGb , 20 patients , heart rate > 70 bpm ) or a small pulsing window at 70 % ( group RGs , 20 patients , heart rate < 70 bpm ) . The other 20 patients underwent CCTA using the PT technique on a 128-slice CT system ( group PT , heart rate < 70 bpm ) . All images were evaluated by two observers for quality on a three-point scale , with 1 being excellent and 3 being insufficient . The effective radiation dose was calculated for each patient . The average image quality score was 1.5 ± 0.6 for PT , 1.35 ± 0.5 for RGs and 1.65 ± 0.5 for RGb . The mean effective dose for RGb was 9 ± 4 mSv , for RGs 7 ± 3 mSv and for PT 3 ± 1 mSv . This represents a 57 % dose reduction for PT compared with RGs and a 67 % dose reduction for PT compared with RGb . In conclusion , in selected patients CCTA with the PT technique offers adequate image quality with a significantly lower radiation dose compared with CCTA using RG techniques OBJECTIVE To compare , in patients with suspicion of coronary artery disease ( CAD ) and low heart rates , image quality , diagnostic performance , and radiation dose values of prospect ively and retrospectively electrocardiography (ECG)-gated dual- source computed tomography coronary angiography ( CTCA ) for the diagnosis of significant coronary stenoses . MATERIAL S AND METHODS Two-hundred consecutive patients with heart rates ≤70 bpm were retrospectively enrolled ; 100 patients undergoing prospect ively ECG-gated CTCA ( group 1 ) and 100 patients undergoing retrospectively-gated CTCA ( group 2 ) . Coronary artery segments were assessed for image quality and significant luminal diameter narrowing . Sensitivity , specificity , positive predictive values ( PPV ) , negative predictive values ( NPV ) , and accuracy of both CTCA groups were determined using conventional catheter angiography ( CCA ) as reference st and ard . Radiation dose values were calculated . RESULTS Both groups were comparable regarding gender , body weight , cardiovascular risk profile , severity of CAD , mean heart rate , heart rate variability , and Agatston score ( all p>0.05 ) . There was no significant difference in the rate of non-assessable coronary segments between group 1 ( 1.6 % , 24/1404 ) and group 2 ( 1.4 % , 19/1385 ; p=0.77 ) ; non-diagnostic image quality was significantly ( p<0.001 ) more often attributed to stair step artifacts in group 1 . Segment-based sensitivity , specificity , PPV , NPV , and accuracy were 98 % , 98 % , 88 % , 100 % , and 100 % among group 1 ; 96 % , 99 % , 90 % , 100 % , and 98 % among group 2 , respectively . Parameters of diagnostic performance were similar ( all p>0.05 ) . Mean effective radiation dose of prospect ively ECG-gated CTCA ( 2.2±0.4 mSv ) was significantly ( p<0.0001 ) smaller than that of retrospectively ECG-gated CTCA ( 8.1±0.6 mSv ) . CONCLUSION Prospect ively ECG-gated CTCA yields similar image quality , performs as accurately as retrospectively ECG-gated CTCA in patients having heart rates ≤70 bpm while being associated with a lower mean effective radiation dose BACKGROUND Prospect ively gated coronary computed tomographic angiography ( CCTA ) with dual- source CT allows substantial reduction of radiation exposure but requires prospect i ve single-phase selection and assessment of likelihood of adequate image quality . OBJECTIVE We developed and tested the model for predicting success of prospect ively gated CCTA . METHODS Retrospectively gated CCTA was acquired with dual- source CT in 162 patients . Two cardiologists assessed by consensus whether diagnostic quality images could have been obtained in a single predefined phase , 70 % of R-R interval ( 70P ) , thereby identifying patients in whom a prospect ively gated scan at 70P would have been successful . Logistic regression models were built with and without a coronary calcium scan . The obtained criteria were applied on 42 additional patients . RESULTS By logistic regression , heart rate before CCTA of > or=70 beats/min , maximal heart rate variation before CCTA of > or=10 beats/min , coronary calcium score > or= 400 U , and body mass index ( in kg/m(2 ) ) > or= 30 were independent predictors of unsuccessful prospect ively gated CCTA using 70P . Excluding coronary calcium score from the model , these same variables in addition to age > 65 years were found to be predictors of unsuccessful prospect ively gated CCTA . Applying this model to 42 additional patients , using prospect i ve gating , only 5 segments in 4 patients were nondiagnostic . Mean radiation dose for prospect ively gated CCTA was 2.2 + /- 0.8 mSv . CONCLUSION Prospect ively gated CCTA with dual- source CT can be successfully implemented with consideration of prescan heart rate , heart rate variability , body mass index , and coronary calcium score OBJECTIVES The aim of this study was to compare the diagnostic performance of multidetector computed tomography ( MDCT ) with prospect i ve electrocardiogram ( ECG ) triggering versus retrospective ECG triggering . BACKGROUND MDCT allows the noninvasive visualization of the coronary arteries . However , radiation exposure is a reason for concern . METHODS One hundred eighty consecutive patients scheduled for invasive coronary angiography were enrolled in this study . Twenty patients were excluded due to contraindications to sustain MDCT . Of the 160 remaining patients , 80 were studied with MDCT with prospect i ve ECG triggering ( Group 1 ) and 80 with a retrospective ECG triggering ( Group 2 ) . The individual radiation dose exposure was estimated . RESULTS In nonstented segments , the evaluability of Groups 1 and 2 was 96 % versus 97 % , respectively ( p = 0.05 ) , the accuracy in segment-based model was 93 % versus 96 % , respectively ( p < 0.05 ) including diagnostic segments and 91 % versus 94 % , respectively ( p < 0.01 ) including all segments , whereas the accuracy in a patient-based model was 98 % in both groups . In stented segments the evaluability in Groups 1 and 2 was 92 % versus 94 % , respectively , and the accuracy was 93 % versus 92 % , respectively , including diagnostic stented segments and 90 % versus 89 % , respectively , including all stented segments . Group 1 presented lower radiation dose compared with Group 2 ( 5.7 + /- 1.5 mSv vs. 20.5 + /- 4.3 mSv , p < 0.01 ) . CONCLUSIONS Prospect i ve ECG-triggering computed tomography allows an accurate detection of coronary stenosis , despite a slight reduction of diagnostic performance , with a low radiation dose With the advent of multislice CT more than a decade ago , multislice CT angiography has demonstrated a huge potential in the less invasive imaging of cardiovascular disease , especially in the diagnosis of coronary artery disease . The diagnostic accuracy of multislice CT angiography has been significantly augmented with the rapid technical developments ranging from the initial 4-slice , to the current 64-slice and 256 and 320-slice CT scanners . This is mainly demonstrated by the improved spatial and temporal resolution when compared to the earlier type of CT scanners . Traditionally , multislice CT angiography is acquired with retrospective ECG-gating with acquisition of volume data at the expense of increased radiation dose , since data is acquired at the entire cardiac cycle , although not all of them are used for postprocessing or reconstructions . Recently , there is an increasing trend of utilising prospect i ve ECG-gating in cardiac imaging with latest multislice CT scanners ( 64 or more slices ) with significant reduction of radiation dose when compared to retrospective ECG-gating method . However , there is some debate as to the diagnostic value of prospect i ve ECG-gating in the diagnosis of coronary artery disease , despite its attractive ability to reduce radiation dose . This article will review the performance of retrospective ECG-gating in the diagnostic value of coronary artery disease , highlight the potential applications of prospect i ve ECG-gating , and explore the future directions of multislice CT angiography in cardiac imaging PURPOSE To evaluate the effect of a small field of view ( FOV ) for step- and -shoot coronary computed tomography angiography ( CCTA ) on craniocaudal z-coverage per scan step , image quality , and radiation exposure . METHODS 53 patients underwent prospect ively ECG-gated CCTA on a 256-slice MDCT scanner using either a FOV > 250 mm ( group 1 , n = 29 ) or a FOV ≤ 250 mm ( group 2 , n = 24 ) . Craniocaudal z-coverage was determined on coronal multiplanar reformations . Image noise , signal-to-noise ratio , contrast-to-noise ratio , and qualitative image parameters were assessed . Radiation dose was estimated from the dose length product and was st and ardized for a scan range from the main pulmonary artery to the diaphragm in order to make both groups comparable . RESULTS Diagnostic image quality was achieved in 91.3 % of the coronary artery segments of group 1 and 89.9 % in group 2 ( p = 0.201 ) . There were no major differences in image noise , SNR , and CNR between both groups . A smaller FOV leads to an increase of craniocaudal coverage of a single CT scan step ( r = -0.879 ; p ≤ 0.001 ) . There was an increase of 23.8 % of the mean z-coverage per scanned subvolume in group 2 ( 59.9 mm vs. 48.8 mm ) . Radiation dose was significantly lower in group 2 ( 229 vs. 285 mGy cm , respectively ) . CONCLUSION The use of a small transverse FOV for step- and -shoot CCTA at a wide detector CT scanner leads to an increased z-coverage . 2 scan volumes are enough to image the cardiac anatomy . Radiation dose is decreased without negative impact on image quality Background — Surveillance conventional coronary angiography ( CCA ) is recommended 2 to 6 months after stent-supported left main coronary artery ( LMCA ) percutaneous coronary intervention due to the unpredictable occurrence of in-stent restenosis ( ISR ) , with its attendant risks . Multislice computed tomography ( MSCT ) is a promising technique for noninvasive coronary evaluation . We evaluated the diagnostic performance of high-resolution MSCT to detect ISR after stenting of the LMCA . Methods and Results — Seventy-four patients were prospect ively identified from a consecutive patient population scheduled for follow-up CCA after LMCA stenting and underwent MSCT before CCA . Until August 2004 , a 16-slice scanner was used ( n=27 ) , but we switched to the 64-slice scanner after that period ( n=43 ) . Patients with initial heart rates > 65 bpm received β-blockers , which result ed in a mean periscan heart rate of 57±7 bpm . Among patients with technically adequate scans ( n=70 ) , MSCT correctly identified all patients with ISR ( 10 of 70 ) but misclassified 5 patients without ISR ( false-positives ) . Overall , the accuracy of MSCT for detection of angiographic ISR was 93 % . The sensitivity , specificity , and positive and negative predictive values were 100 % , 91 % , 67 % , and 100 % , respectively . When analysis was restricted to patients with stenting of the LMCA with or without extension into a single major side branch , accuracy was 98 % . When both branches of the LMCA bifurcation were stented , accuracy was 83 % . For the assessment of stent diameter and area , MSCT showed good correlation with intravascular ultrasound ( r=0.78 and 0.73 , respectively ) . An intravascular ultrasound threshold value ≥1 mm was identified to reliably detect in-stent neointima hyperplasia with MSCT . Conclusions — Current MSCT technology , in combination with optimal heart rate control , allows reliable noninvasive evaluation of selected patients after LMCA stenting . MSCT is safe to exclude left main ISR and may therefore be an acceptable first-line alternative to CCA We sought to determine the cut-off point of the average heart rate ( HR ) and HR differences in obtaining diagnostic image quality using prospect i ve electrocardiographically-triggered ( PT ) coronary computed tomographic angiography ( CCTA ) and to compare image quality and radiation dose for CCTA obtained with PT CCTA and retrospective electrocardiographically-gated ( RG ) CCTA . A total
Output:
| The pooled estimates of diagnostic values were more than 90 % for patient- , vessel- and segment-based assessment s. Prospect i ve ECG-triggered CCTA results in high diagnostic accuracy and image quality , with a significantly low radiation dose |
MS211234 | ***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 : Hypothermia during and after major abdominal surgery decreases host defenses , increases the incidence of coagulopathy and may alter blood pressure , cardiac contractility and myocardial stability . Methods : We design ed a prospect i ve r and omized study to compare the benefits of a forced air warming system with warm blanket treatments in minimizing the effects of hypothermia on 64 morbidly obese patients undergoing Roux-en-Y gastric bypass . Results : Patients in the forced air warming group ( n = 32 ) had significantly higher perioperative body core temperature , lower central venous pressure and blood pressure readings , lower incidence of shivering , less blood loss intraoperatively and achieved a higher post anesthesia Aldrete Score than those patients in the warmed blanket group ( n = 32 ) . Conclusion : The forced air warming system is safe , cost effective and beneficial in minimizing the undesirable consequences of hypothermia in morbidly obese patients undergoing Roux-en-Y gastric bypass BACKGROUND The magnitude of the systemic stress response is proportional to the degree of operative trauma . We hypothesized that laparoscopic gastric bypass ( GBP ) is associated with reduced operative trauma compared with open GBP , result ing in a lower systemic stress response . STUDY DESIGN Forty-eight patients with a body mass index of 40 to 60 were r and omly assigned to laparoscopic ( n = 26 ) or open ( n = 22 ) GBP Blood sample s were measured at baseline and at 1 , 24 , 48 , and 72 hours postoperatively . Metabolic ( insulin , glucose , epinephrine , norepinephrine , dopamine , ACTH , cortisol ) , acute phase ( C-reactive protein ) , and cytokine ( interleukin [IL]-6 , IL-8 , tumor necrosis factor [TNF]-alpha ) responses were measured . Catabolic response was also measured by calculating the nitrogen balance at 24 and 48 hours postoperatively . RESULTS The two groups of patients were similar in terms of age , gender , and preoperative body mass index . The mean operative time was longer for laparoscopic GBP than for open GBP ( 229 + /- 50 versus 207 43 minutes ) . After laparoscopic and open GBP , plasma concentrations of insulin , glucose , epinephrine , dopamine , and cortisol increased ; IL-8 and TNF-alpha remained unchanged ; and negative nitrogen balances occurred at 24 and 48 hours . There was no significant difference in these parameters between groups . Concentrations of norepinephrine , ACTH , C-reactive protein , and IL-6 levels also increased , but these levels were significantly lower after laparoscopic GBP than after open GBP ( p < 0.05 ) . CONCLUSIONS Systemic stress response after laparoscopic GBP is similar to that after open GBP , except that concentrations of norepinephrine , ACTH , C-reactive protein , and IL-6 are lower after laparoscopic than after open GBP . These findings may suggest a lower degree of operative injury after laparoscopic GBP The benefits of laparoscopic appendectomy appear to be controversial . Since 1994 , several abdominal procedures have been completed by using the needlescopic technique , but there appear to be no prospect i ve studies to demonstrate the perceived benefits of needlescopic appendectomy . The authors compared open , laparoscopic , and needlescopic appendectomy in a r and omized fashion with regard to duration of surgery , length of hospitalization , analgesic dosage , and surgery-associated complications . From March to July 1998 , 75 patients admitted at the emergency station of the authors ' hospital with a final diagnosis of acute appendicitis without tumor formation were r and omized to receive one of the three treatment categories : open ( OA ) , laparoscopic ( LA ) , and needlescopic ( nLA ) appendectomy . Laparoscopic and needlescopic appendectomy were performed by using a three-port technique , although the size of the trocar used varied . There were 26 patients in the OA group , 23 in the LA group , and 26 in the nLA group . The mean operation duration s for the OA , LA , and nLA groups were 55.4 ± 28.0 minutes , 69.1 ± 48.8 minutes , and 62.3 ± 26.3 minutes , respectively , and these were not significantly different from one another . The mean number of the analgesic doses ( Pethidine 1 mg/kg ) required was 1.3 ± 1.2 mg/kg , 0.5 ± 0.8 mg/kg , and 0.2 ± 0.6 mg/kg , respectively . Significant differences were noted when comparing the OA with the LA or nLA groups ( OA vs. LA , P = 0.02 ; OA vs. nLA , P = 0.0002 ; LA vs. nLA , P = 0.06 ) . The mean oral intake duration s were 32.2 ± 16.9 hours , 21.0 ± 14.6 hours , and 20.8 ± 16.4 hours , respectively , after surgery for the OA , LA , and nLA groups , and the between-group differences were statistically significant for the OA versus LA group ( P = 0.004 ) and for the OA versus nLA group ( P = 0.003 ) . The mean duration s of hospitalization for the OA , LA , and nLA groups were 3.6 ±1.8 days , 2.8 ± 1.4 days , and 2.4 ± 0.9 days , and difference was detected between the OA and the nLA groups ( P = 0.02 ) . The OA group rendered a greater wound-complication rate and ileus than did the other two groups , but the differences were not detected between the three categories ( P = 0.065 , 0.6935 ) . The result of the current study confirmed that the nLA procedure is a feasible and safe one . The nLA procedure provided substantial advantages over the OA procedure in the context s of diminished postoperative pain and shorter hospital stay without significant increases in postoperative complication rate or surgical time HYPOTHESIS Laparoscopic gastric bypass ( GBP ) induces a postoperative hypercoagulable state that is similar or reduced compared with open GBP . SETTING University hospital . PATIENTS Between May 1999 and June 2000 , 70 patients were r and omly assigned to laparoscopic ( n = 36 ) or open ( n = 34 ) GBP . Deep venous thrombosis ( DVT ) prophylaxis consisted of antiembolism stockings and sequential pneumatic compression devices . MAIN OUTCOME MEASURES Plasminogen , thrombin-antithrombin complex ( TAT ) , prothrombin fragment 1.2 ( F1.2 ) , fibrinogen , D-dimer , antithrombin III ( AT ) , and protein C levels were measured at baseline and at 1 , 24 , 48 , and 72 hours postoperatively . A venous duplex examination of both lower extremities was performed preoperatively and between the third and fifth day postoperatively . RESULTS The 2 groups were similar in age , weight , and body mass index . Plasminogen levels decreased , and TAT , F1.2 , and fibrinogen levels increased after laparoscopic and open GBP . There was no significant difference in these levels between groups . D-dimer levels increased in both groups , but the levels were significantly higher after open GBP than after laparoscopic GBP ( P<.01 ) . Antithrombin III and protein C levels decreased in both groups . The reduction of AT ( at 1 hour ) and protein C ( at 72 hours ) was significantly less after laparoscopic GBP than after open GBP ( P<.05 ) . Postoperative venous duplex examination revealed DVT in 1 ( 2.9 % ) of 34 patients after open GBP but in none of 36 patients after laparoscopic GBP . One patient developed pulmonary embolism after open GBP . CONCLUSIONS Laparoscopic GBP induces a hypercoagulable state similar to that of open GBP . Our findings suggest that DVT prophylaxis should be used during laparoscopic GBP as in open GBP BACKGROUND Impairment of pulmonary function is common after upper abdominal operations . The purpose of this study was to compare postoperative pulmonary function and analgesic requirements in patients undergoing either laparoscopic or open Roux-en-Y gastric bypass ( GBP ) . STUDY DESIGN Seventy patients with a body mass index of 40 to 60 kg/m2 were r and omly assigned to undergo laparoscopic ( n = 36 ) or open ( n = 34 ) GBP . The two groups were similar in age , gender , body mass index , pulmonary history , and baseline pulmonary function . Pulmonary function studies were performed preoperatively and on postoperative days 1 , 2 , 3 , and 7 . Oxygen saturation and chest radiographs were performed on both groups preoperatively and on postoperative day 1 . Postoperative pain was evaluated using a visual analog scale and the amount of narcotic consumed was recorded . Data are presented as mean + /- st and ard deviation . RESULTS Laparoscopic GBP patients had significantly less impairment of pulmonary function than open GBP patients on the first three postoperative days ( p < 0.05 ) . By the 7th postoperative day , all pulmonary function parameters in the laparoscopic GBP group had returned to within preoperative levels , but only one parameter ( peak expiratory flow ) had returned to preoperative levels in the open GBP group . On the first postoperative day , laparoscopic GBP patients used less morphine than open GBP patients ( 46 + /- 31 mg versus 76 + /- 39 mg , respectively , p < 0.001 ) , and visual analog scale pain scores at rest and during mobilization were lower after laparoscopic GBP than after open GBP ( p < 0.05 ) . Fewer patients after laparoscopic GBP than after open GBP developed hypoxemia ( 31 % versus 76 % , p < 0.001 ) and segmental atelectasis ( 6 % versus 55 % , p = 0.003 ) . CONCLUSION Laparoscopic gastric bypass result ed in less postoperative suppression of pulmonary function , decreased pain , improved oxygenation , and less atelectasis than open gastric bypass BACKGROUND To perform a prospect i ve , r and omized comparison of laparoscopic adjustable gastric b and ing ( LAGB ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . METHODS LAGB , using the pars flaccida technique , and st and ard LRYGB were performed . From January 2000 to November 2000 , 51 patients ( mean age 34.0 + /- 8.9 years , range 20 - 49 ) were r and omly allocated to undergo either LAGB ( n = 27 , 5 men and 22 women , mean age 33.3 years , mean weight 120 kg , mean body mass index [ BMI ] 43.4 kg/m(2 ) ; percentage of excess weight loss 83.8 % ) or LRYGB ( n = 24 , 4 men and 20 women , mean age 34.7 , mean weight 120 kg , mean BMI 43.8 kg/m(2 ) , percentage of excess weight loss 83.3 ) . Data on the operative time , complications , reoperations with hospital stay , weight , BMI , percentage of excess weight loss , and co-morbidities were collected yearly . Failure was considered a BMI of > 35 at 5 years postoperatively . The data were analyzed using Student 's t test and Fisher 's exact test , with P < .05 considered significant . RESULTS The mean operative time was 60 + /- 20 minutes for the LAGB group and 220 + /- 100 minutes for the LRYGB group ( P < .001 ) . One patient in the LAGB group was lost to follow-up . No patient died . Conversion to laparotomy was performed in 1 ( 4.2 % ) of 24 LRYGB patients because of a posterior leak of the gastrojejunal anastomosis . Reoperations were required in 4 ( 15.2 % ) of 26 LAGB patients , 2 because of gastric pouch dilation and 2 because of unsatisfactory weight loss . One of these patients required conversion to biliopancreatic diversion ; the remaining 3 patients were on the waiting list for LRYGB . Reoperations were required in 3 ( 12.5 % ) of the 24 LRYGB patients , and each was because of a potentially lethal complication . No LAGB patient required reoperation because of an early complication . Of the 27 LAGB patients , 3 had hypertension and 1 had sleep apnea . Of the 24 LRYGB patients , 2 had hyperlipemia , 1 had hypertension , and 1 had type 2 diabetes . Five years after surgery , the diabetes , sleep apnea , and hyperlipemia had resolved . At the 5-year ( range 60 - 66 months ) follow-up visit , the LRYGB patients had significantly lower weight and BMI and a greater percentage of excess weight loss than did the LAGB patients . Weight loss failure ( BMI > 35 kg/m(2 ) at 5 yr ) was observed in 9 ( 34.6 % ) of 26 LAGB patients and in 1 ( 4
Output:
| Recent r and omized trials have demonstrated that laparoscopic gastric and colorectal cancer resection are safe and oncologically correct procedures .
However , evidence -based medicine has failed to show major advantages in SILS , and the disadvantage of robotic surgery is the high costs related to purchase and maintenance of technology . |
MS211235 | ***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 Accurate children 's weight estimation is necessary and important for emergency pediatric care , particularly for drug dosages , electrical therapy , or equipment sizes . Children 's weight is difficult to measure in critically ill patients . Several methods were developed to estimate children 's accurate weight . Most methods were developed from western countries . The methods used currently might not work with Thai children . OBJECTIVE To determine the accuracy of the Broselow tape , family member estimation and the 50th percentile of national weight for height correlation graph for Thai children 's weight estimation . MATERIAL AND METHOD The authors carried out a prospect i ve study . Children from neonate to 12 years old who presented to the emergency department and general outpatient pediatric clinic were included . The patients were studied in both overall and subgroup analysis ( less than 10 kg , 10 to 25 kg , 25 to 40 kg , and over 40 kg ) . The primary outcome was the accuracy within 10 % error of the measured weight and the mean difference of the weight . RESULTS Five hundred ninety five patients were included in the present study . There were 333 ( 55.97 % ) boys and 262 ( 44.03 % ) girls . Family member estimation was the most accurate method with the accuracy within 10 % error 85.21 % and had the lowest mean difference ( -0.262 kg ) . Family members could estimate weight accurately for all weight subgroups . The Broselow tape was the second most accurate method with the accuracy within 10 % error 56.13 % and the low mean difference ( -0.485 kg ) . The accuracy within 10 % error of the 50th percentile of national weight for height correlation graph was 51.43 % and the mean difference was -0.648 kg . Every method had the best estimation in the weight subgroup 10 to 25 kg except the Broselow tape . CONCLUSION Family member estimation was the most accurate method in the present study . The family member could estimate the children 's weight within 10 % error of the measured weight about 85 % of cases . In case where family member estimation was not available , the Broselow tape was the next accurate alternative method Background The Broselow tape ( BT ) has been shown to estimate weight poorly primarily because of variations in body habitus . The manufacturers have suggested that a visual assessment of habitus may be used to increase its performance . This study evaluated the ability of habitus-modified models to improve the accuracy thereof . Methods A post hoc analysis of prospect ively collected data from four hospitals in Johannesburg , South Africa , on a population of 1,085 children . Sixteen a priori models generated a modified weight estimation or drug dose based on the BT weight and a gestalt assessment of habitus . Results The habitus-modified method suggested by the manufacturer did not improve the accuracy of the BT . Five dosing and four weight-estimation models were identified that markedly improved dosing and weight estimation accuracy , respectively . The best dosing model improved dosing accuracy ( doses within 10 % of correct dose ) from 52.0 to 69.6 % and reduced critical dosing errors from 16.5 to 4.3 % . The best weight-estimation model improved accuracy from 59.4 to 81.9 % and reduced critical errors from 11.8 to 1.9 % . Conclusion The accuracy of the BT as a drug-dosing and weight-estimation device can be substantially improved by including an appraisal of body habitus in the methodology Objective Obtaining an accurate weight is crucial during pediatric trauma/medical resuscitation . Currently , length-based weight estimations are used . Study objective was to assess feasibility of obtaining actual weights of children during trauma resuscitation and study its concordance with length-based estimated weight using the Broselow Pediatric Emergency Tape . Methods Pediatric trauma patients 0 to 14 years old presenting to a tertiary care pediatric trauma center between November 2008 and October 2009 were enrolled prospect ively . Length-based weight estimation was done on patient arrival using the Broselow tape ; in addition , an actual patient weight was recorded using the trauma stretcher integrated weighing scale . Results Two hundred thirty-one patients were eligible and enrolled . Weights were recorded in 145 children ( 63.2 % ) . In 27 patients ( 18.6 % ) whose body length exceeded Broselow tape range , weight was measured using stretcher scale only . The remaining 118 patients ( mean age , 5.0 [ SE ± 0.3 ] years ; 67 % male ) were used for correlation analysis . There was good correlation ( Pearson correlation coefficient , r = 0.86 ) between estimated weight and measured weight . However , Bl and -Altman analysis showed mean bias + 2.6 kg ( 95 % confidence interval [ CI ] , 1.6–3.6 kg ) ; lower/upper limits of agreement were −8.3 kg ( CI , −10.0 to −6.6 kg ) and 13.5 kg ( CI , 11.7–15.2 kg ) . Conclusions It is possible to obtain an actual patient weight during pediatric trauma resuscitation . Length-based estimated weight using Broselow tape underestimated weight by 2.6 kg ; the mean error was greatest in the highest weight category Background In paediatric resuscitation , for a rapid and accurate estimate of children 's weight , the Broselow tape can be used in children who are 46–144 cm tall . The Broselow tape has previously been found to provide the most accurate estimate of children 's weight internationally , but it is not known how many fall outside the range of the tape , or whether such children can be assumed to be of adult weight , or how otherwise to estimate the weight of these children . Objectives To determine what proportion of children in different age groups falls outside the limits of the Broselow tape , how their weight compares with that of the adults and what correlates most strongly with weight in these children . Methods This was a population -based prospect i ve observational study of Chinese children up to 12 years old , from schools in Hong Kong . Weight was measured to the nearest 0.2 kg , and the height , foot-length and mid-arm circumference ( MAC ) were measured to the nearest 0.1 cm . Results 40 % of 10-year olds and 70 % of 11-year olds were too tall for the tape . Their median weight was 41.9 kg . This was significantly less than the median weight of 18-year olds ( 55 kg , p<0.0001 ) in Hong Kong . The strongest correlate with weight in these children was MAC . Conclusions The Broselow tape is inappropriate for use in most children over 10 years old . Children too tall for the tape can not be assumed to be of adult weight ; to do so would imply an average overestimate of 30 % . Weight estimates in older children could be based on MAC OBJECTIVES . The purpose of this study was to compare the predictive accuracy of 3 methods ( Broselow tape , Leffler formula , and Theron formula ) for pediatric weight estimation to identify factors that can influence weight estimation , and to derive alternative models for such estimation if indicated . METHODS . This was a prospect i ve , nonblinded observational study . Every patient in the cohort was ≤10 years of age . The patients ’ age and height were used to estimate their weight by using the 3 previously mentioned methods . These estimated weights were compared with the patients ’ actual weight by using the modified Bl and -Altman method . RESULTS . One thous and eleven subjects were included . Percent differences between predicted and actual weight were significantly less using the Broselow tape compared with other methods for patients weighing < 10 or 10 to 25 kg and for the Theron formula compared with other methods for patients weighing > 40 kg . For patients weighing 25.1 to 40 kg , performance of the Broselow tape and Leffler method were similar , and both were superior to the Theron formula . Three weight predictors ( age , gender , and ethnicity ) were identified , and 2 new weight-estimation models were derived from the cohort . CONCLUSIONS . The Broselow tape is accurate for weight estimation in children ≤25 kg , but the Theron formula performs better with patients weighing > 40 kg . The Broselow tape was not statistically superior to the Leffler formula in subjects weighing 25.1 to 40 kg . A separate cohort is needed to evaluate the validity of the alternative predictive formulae Objective . Significant attention has been paid to weight estimation in setting s where scales are impractical or unavailable ; however , no studies have evaluated the performance of published weight estimation methods in children with Down syndrome . This study was design ed to evaluate the predictive performance of various methods in this population with well-established differences in height and weight for age . Methods . This was a prospect i ve study of children aged 0 to 18 years with Down syndrome . Anthropometric measurements including height , weight , humeral length , and mid-upper arm circumference were collected and applied to 4 distinct weight estimation strategies based on age ( APLS ) , length ( Broselow ) , habitus ( Cattermole ) , and length plus habitus ( Mercy ) . Predictive performance was evaluated by examining residual error ( RE ) , percentage error ( PE ) , root mean square error ( RMSE ) , limits of agreement , and intraclass correlation coefficients . Results . A total of 318 children distributed across age , gender , and body mass index percentile were enrolled . APLS and Mercy showed the smallest degree of bias ( PE = 7.8 ± 24.5 % and −3.9 ± 12.4 % , respectively ) . Broselow suffered the most extreme underestimation ( −63 % ) , whereas the APLS suffered the greatest degree of overestimation ( 107 % ) . Mercy demonstrated the highest intraclass correlation coefficient ( 0.987 vs 0.867 - 0.885 ) and predicted weight within 20 % of actual in the largest proportion of participants ( 88 % vs 40 % to 76 % ) . All methods were less robust in children with Down syndrome than reported for unaffected children . Conclusions . Mercy offered the best option for weight estimation in children with Down syndrome . Additional anthropometric data collected in this special population would allow investigators to refine existing weight estimation strategies specifically for these children Objectives The aims of the study were to examine the predictive accuracy of Broselow tape ( BT ) weight estimation and body mass index – based weight categorization in overweight and obese pediatric patients and to develop an adjustment factor that improves the BT weight estimate in overweight and obese pediatric patients . Methods A prospect i ve observational study was conducted . We enrolled noncritical pediatric patients presenting to a tertiary care pediatric emergency department with nonurgent complaints . Patients had their weights , heights , abdominal circumferences , and actual BT measurements documented by research staff . Results One hundred seventy-eight patients aged 2 to 18 years were enrolled . Using the Centers for Disease Control and Prevention 's definition of body mass index classification , 71 patients ( 39.89 % ) had normal BMI , 43 patients ( 24.16 % ) were overweight , and 64 patients ( 35.96 % ) were obese . The accuracy of the BT-estimated weight range , compared with the actual weight , is 40.5 % in our study population . When stratified by BMI classification , the accuracy proportions were the following : 71.8 % for normal , 41.9 % for overweight , and 4.7 % for obese patients . The adjustment formula ( [ 0.014 × waistline in cm + 0.3 ] × BT weight ) improved overall weight estimation from 40.5 % to 65.2 % . The greatest improvement was noted in obese children , where the BT accuracy improved from 4.7 % to 59.4 % . Conclusions The growing pediatric obesity epidemic has challenged the BT 's ability to accurately estimate the weights in overweight and obese pediatric patients . Our study demonstrated inverse relationship between the accuracy of BT and body weight . An adjustment factor significantly improved BT accuracy in obese children OBJECTIVE The Broselow Pediatric Emergency Tape ( Armstrong Medical Industries , Inc. , Lincolnshire , IL ) ( BT ) is a well-established length-based tool for estimation of body weight for children during resuscitation . In view of p and emic childhood obesity , the BT may no longer accurately estimate weight . We therefore studied the BT in children from Ontario in a large recent patient cohort . METHODS Actual height and weight were obtained from an urban and a rural setting . Children were prospect ively recruited between April 2007 and July 2008 from the emergency department and outpatient clinics at the London Health Science Centre . Rural children from junior kindergarten to grade 4 were also recruited in the spring of 2008 from the Avon Maitl and District School Board . Data for preschool children were obtained from three daycare centres and the electronic medical record from the Maitl and Valley Medical Centre . The predicted weight from the BT was compared to the actual weight using Spearman rank correlation ; agreement and percent error ( PE ) were also calculated . RESULTS A total of 6,361 children ( 46.2 % female ) were included in the study . The median age was 3.9 years ( interquartile range [ IQR ] 1.56 - 7.67 years ) , weight was 17.2 kg ( IQR 11.6 - 25.4 kg ) , and height was 103.5 cm ( IQR 82 - 124.4 cm ) . Although the BT weight estimate correlated with the actual weight ( r = 0.95577 , p < 0.0001 ) , the BT underestimated the actual weight by 1.62 kg ( 7.1 % ± 16.9 % SD , 95 % CI -26.0 - 40.2 ) . The BT had an ≥ 10 % PE 43.7 % of the time . CONCLUSIONS
Output:
| MAIN RESULTS The tape has undergone substantial changes over the years , but there was no evidence to show that the changes have improved weight-estimation performance .
The overestimation of weight in low- and middle-income countries was often extreme .
This indicated a significant potential for potentially harmful medication errors .
The limited available evidence on the value of the tape as a drug-dosing guide indicated that the tape was frequently used incorrectly and contained insufficient information to function without additional re sources .
The Broselow tape lacked sufficient accuracy as a weight estimation and drug-dosing tool when compared to other available techniques .
In addition , the Broselow tape contains insufficient drug-dosing information to function as a complete resuscitation aid without additional material . |
MS211236 | ***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: Introduction The field of laparoscopic rectal cancer surgery is exp and ing . We compare short-term and early oncological outcomes after laparoscopic versus open resection in carefully matched rectal cancer patients . Methods All consecutive patients undergoing elective laparoscopic resection for rectal cancer were review ed . Laparoscopic resections were matched 1:1 to open resections by age , gender , American Society of Anesthesiologists class , body mass index , neoadjuvant chemoradiation , and type of surgery . Data were analyzed using Fisher ’s exact , chi-square , Wilcoxon rank-sum tests , and Kaplan – Meier estimates . P-value < 0.05 was considered statistically significant . Results Ninety-one rectal cancer patients with laparoscopic resection were included , 59 % were male , and median age was 62 years . Conversion rate was 18.7 % . Laparoscopic and open surgery had similar 30-day morbidity and mortality except wound infection , which was lower for the laparoscopic group ( p = 0.02 ) . Laparoscopic surgery had similar 30-day readmissions but shorter total length of hospital stay ( 5 versus 7 days , p < 0.01 ) , time to first flatus ( 3 versus 4.5 days , p = 0.001 ) , and time to first bowel movement ( 4 versus 5 days , p = 0.05 ) when compared with open surgery . The 3-year disease-free survival , local recurrence , and distant recurrence rates were also similar between the two groups . Conclusion Laparoscopic surgery can be safely performed for rectal cancer , with better postoperative recovery and acceptable early oncological outcomes . Results from large ongoing r and omized trials with longer follow-up time are pending to better define oncologic outcomes OBJECTIVE To assess the advantage and disadvantage of laparoscopic abdomino-perineal resection and open abdominoperineal resection for low rectal cancer . METHODS Patients with low rectal cancer , collected from July 2003 to April 2006 , were r and omly divided into laparoscopic abdominoperineal resection group ( 37 cases ) and open abdominoperineal resection group ( 37 cases ) . Operation time , number of lymph node removed , intra-operative blood loss , time to pass flatus , time to ambulate , time to discharge , complications , early recurrence , and economical cost were compared between the 2 groups . RESULTS All patients were performed successfully . For the first 10 patients , operation time of laparoscopic group was significantly longer than that of open group , but there was no significant difference between the 2 groups . Intra-operative blood loss of laparoscopic group was significantly less than that of open group , but it was reverse for the first 10 patients . There was no significant difference in time to pass flatus between the 2 groups . Time to ambulate in laparoscopic group was significantly earlier than that in open group . There was no significant difference in time to discharge between the 2 groups , but it was earlier for perineum closure in laparoscopic group . Relative complications of laparoscopic group , including pulmonary infection , abdominal wound infection or split , were significantly less than those of open group . There was no significant difference in number of lymph nodes removed , early recurrence between the 2 groups . Operation cost of laparoscopic group was significantly higher than that of open group , but there was no significant difference . CONCLUSION Advantages of laparoscopic abdominoperineal resection were characterized for not only minimal invasion and good cosmetic outcome but also less blood loss , complications , and earlier postoperative recovery . The operation time , total costs and oncological clearance of laparoscopic abdominoperineal resection patients were comparable with those of open procedure patients BACKGROUND Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe . The aim in the COlorectal cancer Laparoscopic or Open Resection ( COLOR II ) trial was to compare laparoscopic and open surgery in patients with rectal cancer . METHODS A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries . Patients ( aged ≥18 years ) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were r and omly assigned to either laparoscopic or open surgery in a 2:1 ratio , stratified by centre , location of tumour , and preoperative radiotherapy . The study was not masked . Secondary ( short-term ) outcomes -including operative findings , complications , mortality , and results at pathological examination-are reported here . Analysis was by modified intention to treat , excluding those patients with post-r and omisation exclusion criteria and for whom data were not available . This study is registered with Clinical Trials.gov , number NCT00297791 . FINDINGS The study was undertaken between Jan 20 , 2004 , and May 4 , 2010 . 1103 patients were r and omly assigned to the laparoscopic ( n=739 ) and open surgery groups ( n=364 ) , and 1044 were eligible for analyses ( 699 and 345 , respectively ) . Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group ( median 200 mL [ IQR 100 - 400 ] vs 400 mL [ 200 - 700 ] , p<0·0001 ) ; however , laparoscopic procedures took longer ( 240 min [ 184 - 300 ] vs 188 min [ 150 - 240 ] ; p<0·0001 ) . In the laparoscopic surgery group , bowel function returned sooner ( 2·0 days [ 1·0 - 3·0 ] vs 3·0 days [ 2·0 - 4·0 ] ; p<0·0001 ) and hospital stay was shorter ( 8·0 days [ 6·0 - 13·0 ] vs 9·0 days [ 7·0 - 14·0 ] ; p=0·036 ) . Macroscopically , completeness of the resection was not different between groups ( 589 [ 88 % ] of 666 vs 303 [ 92 % ] of 331 ; p=0·250 ) . Positive circumferential resection margin ( < 2 mm ) was noted in 56 ( 10 % ) of 588 patients in the laparoscopic surgery group and 30 ( 10 % ) of 300 in the open surgery group ( p=0·850 ) . Median tumour distance to distal resection margin did not differ significantly between the groups ( 3·0 cm [ IQR 2·0 - 4·8 ] vs 3·0 cm [ 1·8 - 5·0 ] , respectively ; p=0·676 ) . In the laparoscopic and open surgery groups , morbidity ( 278 [ 40 % ] of 697 vs 128 [ 37 % ] of 345 , respectively ; p=0·424 ) and mortality ( eight [ 1 % ] of 699 vs six [ 2 % ] of 345 , respectively ; p=0·409 ) within 28 days after surgery were similar . INTERPRETATION In selected patients with rectal cancer treated by skilled surgeons , laparoscopic surgery result ed in similar safety , resection margins , and completeness of resection to that of open surgery , and recovery was improved after laparoscopic surgery . Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013 . FUNDING Ethicon Endo-Surgery Europe , Swedish Cancer Foundation , West Gothia Region , Sahlgrenska University Hospital OBJECTIVE The aims of this study were to evaluate the safety and efficacy of laparoscopic abdominoperineal resection compared to conventional approach for surgical treatment of patients with distal rectal cancer presenting with incomplete response after chemoradiation . METHOD Twenty eight patients with distal rectal adenocarcinoma were r and omized to undergo surgical treatment by laparoscopic abdominoperineal resection or conventional approach and evaluated prospect ively . Thirteen underwent laparoscopic abdominoperineal resection and 15 conventional approach . RESULTS There was no significant difference ( p<0,05 ) between the two studied groups regarding : gender , age , body mass index , patients with previous abdominal surgeries , intra and post operative complications , need for blood transfusion , hospital stay after surgery , length of resected segment and pathological staging . Mean operation time was 228 minutes for the laparoscopic abdominoperineal resection versus 284 minutes for the conventional approach ( p=0.04 ) . Mean anesthesia duration was shorter ( p=0.03 ) for laparoscopic abdominoperineal resection when compared to conventional approach : 304 and 362 minutes , respectively . There was no need for conversion to open approach in this series . After a mean follow-up of 47.2 months and with the exclusion of two patients in the conventional abdominoperineal resection who presented with unsuspected synchronic metastasis during surgery , local recurrence was observed in two patients in the conventional group and in none in the laparoscopic group . CONCLUSIONS We conclude that laparoscopic abdominoperineal resection is feasible , similar to conventional approach concerning surgery duration , intra operative morbidity , blood requirements and post operative morbidity . Larger number of cases and an extended follow-up are required to adequate evaluation of oncological results for patients undergoing laparoscopic abdominoperineal resection after chemoradiation for radical treatment of distal rectal cancer Purpose Laparoscopic surgery of colon cancer has been accepted to be oncologically adequate compared with open resection . However , the situation in rectal cancer remains unclear , because anatomy and complex surgical procedures might specifically influence the long-term outcome . This study was design ed to analyze perioperative and long-term outcome of patients with rectal cancer after laparoscopic vs. open access surgery . Methods A total of 389 patients ( 1998–2005 ) were prospect ively analyzed ; 114 patients had laparoscopic beginning , and 25 patients had conversion and were separately analyzed . Eighty-nine patients remained in the laparoscopic group and 275 had open access surgery . Results Both groups were comparable regarding age , gender , tumor localization , stage , and complications . Differences were found in harvested lymph nodes ( laparoscopic 13.5/open access 16.9 ; P = 0.001 ) and hospitalization ( 15.1/18.7 days ; P = 0.037 ) . Local recurrence rate and metachronous metastasis were comparable . In patients with deep anterior resection with total mesenteric excision , favorable long-term survival in the laparoscopic group was found ( P = 0.035 , log-rank ) . Conclusions Minimally invasive surgery is equivalent in the treatment of rectal cancer and shows advantages of shorter hospitalization and faster recovery . Especially in patients with low rectal cancer , minimally invasive surgery with exact preparation of the total mesenteric excision seems to be favorable compared with open access surgery Purpose This study was design ed to evaluate the impact of laparoscopic rectal resection on short-term postoperative morbidity and costs . Methods A total of 168 patients with rectal cancer were r and omly assigned to laparoscopic ( n = 83 ) or open ( n = 85 ) resection . Outcome parameters were : postoperative morbidity , length of hospital stay , quality of life , long-term survival , and local recurrences . The mean follow-up period was 53.6 months . Cost-benefit analysis was based on hospital costs . Results Operative time was 53 minutes longer in the laparoscopic group ( P < 0.0001 ) . Postoperative morbidity rate was 28.9 percent in the laparoscopic vs. 40 percent in the open group ( P = 0.18 ) . The mean length of hospital stay was 10 ( 4.9 ) days in the laparoscopic group and 13.6 ( 10 ) days in the open group ( P = 0.004 ) . Local recurrence rate and five-year survival were similar in both groups ; however , the limited number of patients does not allow firm conclusions . Quality of life was better in the laparoscopic group only in the first year after surgery ( P < 0.0001 ) . The additional charge in the laparoscopic group was $ 1,748 per patient r and omized ( $ 1,194 the result of surgical instruments and $ 554 the result of longer operative time ) . The saving in the laparoscopic group was $ 1,396 per patient r and omized ( $ 647 the result of shorter length of hospital stay and $ 749 the result of the lower cost of postoperative complications ) . The net balance result ed in $ 351 extra cost per patient r and omly allocated to the laparoscopic group . Conclusions Short-term postoperative morbidity was similar in the two groups . Laparoscopic resection reduced length of hospital stay , improved first-year quality of life , and slightly increased hospital costs A r and omized controlled trial was started in Japan to evaluate whether laparoscopic surgery is the optimal treatment for colorectal cancer . Patients with T3 or deeper carcinoma in the colorectum without transverse and descending colons are pre-operatively r and omized to either open or laparoscopic colorectal resection . Surgeons in 24 specialized institutions will recruit
Output:
| Laparoscopic surgery was associated with significantly lower intraoperative blood loss , earlier return of bowel movement and reduced length of hospital stay as compared to open surgery , although with increased operative time .
It also showed an obvious advantage for minimizing late complications of adhesion-related bowel obstruction .
On the basis of this meta- analysis we conclude that laparoscopic surgery has advantages of earlier postoperative recovery , less blood loss and lower rates of adhesion-related bowel obstruction .
In addition , oncological outcome is comparable after laparoscopic and open resection for rectal cancer |
MS211237 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Little is known about the involvement of saliva in gingival overgrowth ( GO ) . It was hypothesized that , in this situation , the composition of saliva is altered . Thus , proteins , albumin , cytokines , and growth factors in whole and gl and ular saliva were investigated . Differences between gl and ular and gingival contributions to the composition of saliva were explored in patients medicated with cyclosporin who exhibited GO ( responders ) , those without GO ( non-responders ) , and non-medicated subjects ( controls ) . In whole saliva , interleukin-1α ( IL-1α ) , IL-6 , IL-8 , epidermal growth factor ( EGF ) , nerve growth factor ( NGF ) , and albumin were detected , but in gl and ular saliva only EGF and NGF were identified . Albumin and IL-6 differed significantly between responders and controls , although the overall profile of salivary proteins remained unchanged . Thus , inflammatory cytokines and albumin are confined to whole saliva and are associated with GO , whereas its content of EGF and NGF appears unaffected by cyclosporin Transforming growth factor-beta 1 ( TGF-beta 1 ) plays an important role in the modulation of cellular growth and differentiation and the production and degradation of the extracellular matrix . A number of experimental results suggest that TGF-beta 1 may be involved in cardiovascular physiopathology . In the present study , we assessed whether the TGF-beta 1 gene is a c and i date gene for coronary heart disease or hypertension . We screened the coding region and 2181 bp upstream of the TGF-beta gene for polymorphisms and identified seven polymorphisms : 3 in the upstream region of the gene at positions -988 , -800 , and -509 from the first transcribed nucleotide ; 1 in a nontranslated region at position + 72 ; 2 in the signal peptide sequence Leu10 - ->Pro , Arg25 - ->Pro ; and 1 in the region of the gene coding for the precursor part of the protein not present in the active form , Thr263 - ->Ile . We analyzed these TGF-beta 1 polymorphisms in 563 patients with myocardial infa rct ion and 629 control subjects from four regions in Northern Irel and and France . The Pro25 allele was more frequent in patients than in control subjects in Belfast ( P < .01 ) and Strasbourg ( P < .05 ) . The TGF-beta 1 polymorphisms were not associated with the degree of angiographically assessed coronary artery disease in patients . The presence of a Pro25 allele was associated with a lower systolic pressure in the four control groups ( P < .002 ) , and a history of hypertension was significantly less frequent in homozygotes or heterozygotes for Pro25 than in hormozygotes for Arg25 ( odds ratio , 0.43 , 95 % confidence interval , 0.19 to 0.92 ; P < .03 ) . Since the Pro25 allele was associated with an increased risk of myocardial infa rct ion and a reduced risk of hypertension , we favor a cautious interpretation of these apparently inconsistent results . Other studies will need to verify whether these associations are real
Output:
| Our meta- analysis has found the haplotype of TGFB1 codon 10/25 T/T G/G and T/C G/G genotypes , associated with increased production of TGF-β1 , was linked with CAD risk following kidney transplantation .
Moreover , no significant difference was found between TGFB1 codon 10 or codon 25 and the development of CAD |
MS211238 | ***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: To compare the efficacy and safety of new insulin glargine 300 U/ml ( Gla‐300 ) with insulin glargine 100 U/ml ( Gla‐100 ) over 12 months of treatment in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs ( OADs ) AIM To explore if efficacy and safety findings for insulin glargine 300U/mL ( Gla-300 ) versus insulin glargine 100U/mL ( Gla-100 ) , observed over 6 months in insulin-naïve people with type 2 diabetes , are maintained after 12 months . METHODS EDITION 3 was a phase 3a , r and omized , multicentre , open-label , parallel-group , treat-to-target study of once-daily Gla-300 versus Gla-100 ( target fasting self-monitored plasma glucose , 4.4 - 5.6mmol/L [ 80 - 100mg/dL ] ) . Participants completing the initial 6-month treatment phase continued their previously allocated basal insulin . RESULTS Of 878 participants r and omized , 337/439 ( 77 % ) and 314/439 ( 72 % ) assigned to Gla-300 and Gla-100 , respectively , completed 12 months of treatment . Improved glycaemic control was sustained until 12 months in both treatment groups , with similar reductions in HbA1c from baseline to month 12 ( difference : -0.08 [ 95 % confidence interval ( CI ) : -0.23 to 0.07 ] % or -0.9 [ -2.5 to 0.8 ] mmol/mol ) . Relative risk of experiencing≥1 confirmed ( ≤3.9mmol/L [ ≤70mg/dL ] ) or severe hypoglycaemic event with Gla-300 versus Gla-100 was 0.86 ( 95 % CI : 0.69 to 1.07 ) at night and 0.92 ( 0.82 to 1.03 ) at any time of day . For events with a glycaemic threshold of<3.0mmol/L ( < 54mg/dL ) these numbers were 0.76 ( 0.49 to 1.19 ) and 0.66 ( 0.50 to 0.88 ) . A similar pattern was seen for documented symptomatic events . No between-group differences in adverse events were identified . CONCLUSION Over 12 months , Gla-300 treatment was as effective as Gla-100 in reducing HbA1c in insulin-naïve people with type 2 diabetes , with lower overall risk of hypoglycaemia at the<3.0mmol/L threshold Aims To evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml ( Gla-300 ) versus glargine 100 U/ml ( Gla-100 ) in people with type 2 diabetes mellitus ( T2DM ) using basal plus meal-time insulin for 12 months in the EDITION 1 trial . Methods EDITION 1 was a multicentre , r and omized , open-label , two-arm , phase IIIa study . Participants completing the initial 6-month treatment period continued to receive Gla-300 or Gla-100 , as previously r and omized , once daily for a further 6-month open-label extension phase . Changes in glycated haemoglobin ( HbA1c ) and fasting plasma glucose concentrations , insulin dose , hypoglycaemic events and body weight were assessed . Results Of 807 participants enrolled in the initial phase , 89 % ( 359/404 ) assigned to Gla-300 and 88 % ( 355/403 ) assigned to Gla-100 completed 12 months . Glycaemic control was sustained in both groups ( mean HbA1c : Gla-300 , 7.24 % ; Gla-100 , 7.42 % ) , with more sustained HbA1c reduction for Gla-300 at 12 months : least squares mean difference Gla-300 vs Gla-100 : HbA1c −0.17 [ 95 % confidence interval ( CI ) −0.30 to −0.05]% . The mean daily basal insulin dose at 12 months was 1.03 U/kg for Gla-300 and 0.90 U/kg for Gla-100 . Lower percentages of participants had ≥1 confirmed [ ≤3.9 mmol/l ( ≤70 mg/dl ) ] or severe hypoglycaemic event with Gla-300 than Gla-100 at any time of day [ 24 h ; 86 vs 92 % ; relative risk 0.94 ( 95 % CI 0.89–0.99 ) ] and during the night [ 54 vs 65 % ; relative risk 0.84 ( 95 % CI 0.75–0.94 ) ] , while the annualized rates of such hypoglycaemic events were similar . No between-treatment differences in adverse events were apparent . Conclusion During 12 months of treatment of T2DM requiring basal and meal-time insulin , glycaemic control was better sustained and fewer individuals reported hypoglycaemia with Gla-300 than with Gla-100 . The mean basal insulin dose was higher with Gla-300 compared with Gla-100 , but total numbers of hypoglycaemic events and overall tolerability did not differ between treatments Abstract Introduction New insulin glargine 300 U mL−1 ( Gla-300 ) is a basal insulin that shows more stable and prolonged pharmacokinetic and pharmacodynamic profiles than insulin glargine 100 U mL−1 ( Gla-100 ) . This study used continuous glucose monitoring ( CGM ) to compare 24-h glucose profiles in a Japanese population using Gla-300 versus Gla-100 . Methods This was an exploratory 8.4-week , single-center , 2-sequence , 2-period , open-label crossover study . Japanese adults with type 1 diabetes mellitus ( T1DM ) treated with basal – bolus insulin , with glycated hemoglobin ( HbA1c ) 6.5–10.0 % and median fasting self-monitored plasma glucose concentration ≤13 mmol L−1 , were r and omized to Gla-300 followed by Gla-100 ( subgroup 1 ) or vice versa ( subgroup 2 ) , with no washout period . CGM was performed on the last 3 days of the screening period and each treatment period . Primary endpoint was comparison of 24-h glucose variability ( area under the curve [AUC]mean_24 h ) on the second day of each CGM measurement with Gla-300 versus Gla-100 . Baseline and end of treatment period values for HbA1c , fasting plasma glucose ( FPG ) and daily basal/mealtime insulin doses were recorded . Hypoglycemia and adverse events ( AEs ) were recorded . Results Twenty participants were r and omized ( 10 to subgroup 1 and 10 to subgroup 2 ) . Participants showed comparable glucose variability over 24 h ( AUCmean_24 h during treatment with Gla-300 or Gla-100 ( treatment ratio 0.96 ; 90 % confidence interval 0.79 , 1.16 ) . HbA1c and FPG were generally stable across both treatment periods . There was a trend towards fewer participants experiencing ≥1 hypoglycemia event at any time ( 24 h ) and at night ( 00:00–05:59 h ) with Gla-300 versus Gla-100 . Treatment-emergent AEs , reported by 9/20 ( 45 % ) and 4/20 ( 20 % ) participants during Gla-300 and Gla-100 treatment , respectively , were unrelated to study medication . Conclusions In this cohort of Japanese people with T1DM , no between-treatment difference was observed in glucose variability with Gla-300 versus Gla-100 , as measured by CGM . There was a trend for less hypoglycemia with Gla-300 , particularly at night , versus Gla-100 . Both treatments were well tolerated . Funding Sanofi , Tokyo , Japan . Clinical trial registration : NCT01676233 , Clinical Trials.gov 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 Aims Two single-dose studies were conducted in Japan and Europe to compare the pharmacokinetic ( PK ) and pharmacodynamic ( PD ) profiles of new insulin glargine 300 U/ml ( Gla-300 ) and insulin glargine 100 U/ml ( Gla-100 ) in people with type 1 diabetes mellitus . Methods In two double-blind , r and omized , crossover studies , 18 Japanese participants ( aged 20–65 years ) and 24 European participants ( aged 18–65 years ) with glycated haemoglobin levels ≤9.0 % ( ≤75 mmol/mol ) received single subcutaneous doses of Gla-300 , 0.4 , 0.6 and 0.9 U/kg ( 0.9 U/kg in the European study only ) , and Gla-100 , 0.4 U/kg . A 36-h euglycaemic clamp procedure was performed after each dosing . Results The serum insulin glargine concentration ( INS ) and glucose infusion rate ( GIR ) developed more gradually into more constant and prolonged profiles with Gla-300 than with Gla-100 . In support of this , the times to 50 % of glargine exposure and insulin activity were longer for all Gla-300 doses than for Gla-100 during the 36-h clamp period , indicating a more evenly distributed exposure and metabolic effect beyond 24 h. Exposure to insulin glargine and glucose utilization were lower with the 0.4 and 0.6 U/ml Gla-300 doses in both studies compared with the 0.4 U/ml Gla-100 dose . Glucose-lowering activity was detected for up to 36 h with all doses of Gla-300 . Conclusions Single-dose injections of Gla-300 present more constant and prolonged PK and PD profiles compared with Gla-100 , maintaining blood glucose control for up to 36 h in euglycaemic clamp setting s in Japanese and European participants with type 1 diabetes AIMS Data on the impact of hypoglycaemia on patients ' daily lives and diabetes self-management , particularly in developing countries , are lacking . The aim of this study was to assess fear of , and responses to , hypoglycaemia experienced by patients globally . MATERIAL S AND METHODS This non-interventional , multicentre , 4-week prospect i ve study using self- assessment question naires and patient diaries consisted of 27,585 patients , ≥18years , with type 1 diabetes ( n=8022 ) or type 2 diabetes ( n=19,563 ) treated with insulin for > 12months , at 2004 sites in 24 countries worldwide . RESULTS Increased blood glucose monitoring ( 69.7 % ) and seeking medical assistance ( 62.0 % ) were the most common responses in the 4weeks following hypoglycaemic events for patients with type 1 diabetes and type 2 diabetes , respectively . Approximately 44 % of patients with type 1 diabetes or type 2 diabetes increased calorie intake in response to a hypoglycaemic episode . Following hypoglycaemia , 3.9 % ( type 1 diabetes ) and 6.2 % ( type 2 diabetes ) of patients took leave from work or study . Regional differences in fear of , and responses to , hypoglycaemia were evident - in particular , a lower level of hypoglycaemic fear and utilisation of healthcare re sources in Northern Europe and Canada . CONCLUSIONS Hypoglycaemia has a major impact on patients and their behaviour . These global data for the first time reveal regional variations in response to hypoglycaemia and highlight the importance of patient education and management strategies Aims Insulin glargine 300 U/mL ( Gla‐300 ) offers a flatter pharmacodynamic profile than insulin glargine 100 U/mL ( Gla‐100 ) . We have compared these insulins over 1 year in people with type 1 diabetes ( T1DM ) . Methods EDITION 4 was a 6‐month , multicentre , r and omized , open‐label phase 3 study . People with T1DM who completed the 6 months continued r and omized Gla‐300 or Gla‐100 once daily , morning or evening , for a further 6 months . Results Among 549 participants r and omized , 444 completed the 12‐month study period ( Gla‐300 , 80 % ; Gla‐100 , 82 % ) . Mean HbA1c decreased similarly from baseline to month 12 in the 2 treatment groups ( difference , 0.02 [ 95 % CI , −0.13 to 0.17 ] ) % ‐units [ 0.2 ( −
Output:
| Conclusions The best current evidence indicates that Gla-300 reduces the incidence of nocturnal hypoglycemia with slight improvements in glycemic control compared with Gla-100 in both type 1 and type 2 diabetes adult patients |
MS211239 | ***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 There has been limited study of yoga training as a complementary exercise strategy to manage the symptom of dyspnea in patients with chronic obstructive pulmonary disease ( COPD ) . PURPOSE The primary purpose of this pilot study was to evaluate a yoga program for its safety , feasibility , and efficacy for decreasing dyspnea intensity ( DI ) and dyspnea-related distress ( DD ) in older adults with COPD . METHODS Clinical ly stable patients with COPD ( n = 29 ; age 69.9 + /- 9.5 ; forced expiratory volume in 1 second ( FEV(1 ) ) 47.7 + /- 15.6 % predicted ; female = 21 ) were r and omized to a 12-week yoga program specifically design ed for people with COPD or usual-care control ( UC ) . The twice-weekly yoga program included asanas ( yoga postures ) and visama vritti pranayama ( timed breathing ) . Safety measure outcomes included heart rate , oxygen saturation , dyspnea , and pain . Feasibility was measured by patient-reported enjoyment , difficulty , and adherence to yoga sessions . At baseline and at 12 weeks , DI and DD were measured during incremental cycle ergometry and a 6-minute walk ( 6MW ) test . Secondary efficacy outcomes included physical performance , psychologic well-being , and health-related quality of life ( HRQoL ) . RESULTS Yoga training was safe and feasible for patients with COPD . While yoga training had only small effects on DI after the 6MW test ( effect size [ ES ] , 0.20 ; p = 0.60 ) , there were greater reductions in DD in the yoga group compared to UC ( ES , 0.67 ; p = 0.08 ) . Yoga training also improved 6MW distance ( + 71.7 + /- 21.8 feet versus -27.6 + /- 36.2 feet ; ES = 0.78 , p = 0.04 ) and self-reported functional performance ( ES = 0.79 , p = 0.04 ) compared to UC . There were small positive changes in muscle strength and HRQoL. CONCLUSIONS Elderly patients with COPD participated safely in a 12-week yoga program especially design ed for patients with this chronic illness . After the program , the subjects tolerated more activity with less DD and improved their functional performance . These findings need to be confirmed in a larger , more sufficiently powered efficacy study BACKGROUND Heart failure ( HF ) is a major public health problem . Case management by nurses using telephone follow-up has been suggested as a convenient and effective mechanism to promote the self-management of HF . Similarly , a patient empowerment approach to the management of chronic disease has been suggested as one that may nurture self-management in individuals with chronic illness . OBJECTIVE The purpose of this study was to examine the effects of a telephone-delivered empowerment intervention ( EI ) on clinical ly and theoretically relevant outcomes in patients with HF , including purpose ful participation in goal attainment , self-management of HF , and perception of functional health . The EI was guided by Rogers ' Science of Unitary Human Beings person-environment process . METHODS A convenience sample of men and women aged 21 years and older with a clinical diagnosis of HF was obtained from a metropolitan hospital located in the southwestern United States . The participants were r and omly assigned to the control group ( n = 45 ) or EI group ( n = 45 ) . All participants received st and ardized HF patient education ; the intervention group also received an EI delivered through telephone follow-up calls from a registered nurse . Repeated- measures analysis of variance was used to evaluate intervention effects . RESULTS The telephone-delivered EI facilitated self-management of HF through self-care activities in EI group members . CONCLUSION The knowledge gained from this study provides a beginning underst and ing of strategies to enhance health care providers ' ability to facilitate self-management of HF among patients diagnosed with HF Objectives To assess benefits of telephone-delivered health mentoring in community-based chronic obstructive pulmonary disease ( COPD ) . Design Cluster r and omised controlled trial . Setting Tasmanian general practice s : capital city ( 11 ) , large rural ( 3 ) , medium rural ( 1 ) and small rural ( 16 ) . Participants Patients were invited ( 1207 ) from general practitioner ( GP ) data bases with COPD diagnosis and /or tiotropium prescription , response rate 49 % ( 586 ) , refused ( 176 ) and excluded ( criteria : smoking history or previous study , 68 ) . Spirometry testing ( 342 ) confirmed moderate or severe COPD in 182 ( 53 % ) patients . R and omisation By r and om numbers code , block stratified on location , allocation by sequentially numbered , opaque and sealed envelopes . Intervention Health mentor ( HM ) group received regular calls to manage illness issues and health behaviours from trained community health nurses using negotiated goal setting : problem solving , decision-making and action planning . Control : usual care ( UC ) group received GP care plus non-interventional brief phone calls . Outcomes Measured at 0 , 6 and 12 months , the Short Form 36 ( SF-36 ) and St George ’s Respiratory Question naire ( SGRQ , primary ) ; Partners In Health ( PIH ) Scale for self-management capacity , Hospital Anxiety and Depression Scale ( HADS ) , Center for Epidemiologic Studies -Depression ( CES-D ) question naire , Post-Traumatic Stress Disorder Checklist , Satisfaction with life and hospital admissions ( secondary ) . Results 182 participants with COPD ( age 68±8 years , 62 % moderate COPD and 53 % men ) were r and omised ( HM=90 and UC=92 ) . Mixed model regression analysis accounting for clustering , adjusting for age , gender , smoking status and airflow limitation assessed efficacy ( regression coefficient , β , reported per 6-month visit ) . There was no difference in quality of life between groups , but self-management capacity increased in the HM group ( PIH overall 0.15 , 95 % CI 0.03 to 0.29 ; knowledge domain 0.25 , 95 % CI 0.00 to 0.50 ) . Anxiety decreased in both groups ( HADS A 0.35 ; 95 % CI −0.65 to −0.04 ) and coping capacity improved ( PIH coping 0.15 ; 95 % CI 0.04 to 0.26 ) . Conclusions Health mentoring improved self-management capacity but not quality of life compared to regular phone contact , which itself had positive effects where decline is generally expected OBJECTIVE Women with gynecological cancers have reported poor health-related quality of life ( QOL ) , with complex physical and psychological needs post-surgery and during chemotherapy treatment . There are no studies reporting interventions addressing these needs post-hospital discharge in this population . METHODS Patients were r and omized into two groups . The intervention group received 6 months of specialized care by an Advanced Practice Nurse ( APN ) ; in addition , women with high distress were evaluated and monitored by a psychiatric consultation-liaison nurse ( PCLN ) . The attention control group was assisted with symptom management by a research assistant . The effects of the 6-month intervention were evaluated using self-report question naires at baseline ( 24 - 48 h after surgery ) , 1 , 3 , and 6 months post- surgery . QOL assessment s included the Center for Epidemiological Studies -Depression Scale , the ambiguity subscale of the Mishel Uncertainty in Illness Scale , the Symptom Distress Scale , and the Short-Form Health Survey ( SF-12 ) . The sample for the longitudinal analysis included 123 who completed QOL outcome measures across three occasions post-surgery . RESULTS The APN intervention result ed in significantly less uncertainty than the attention control intervention 6 months after surgery . When the sub-group who received the APN plus PCLN intervention was compared with the total attention control group , the sub-group had significantly less uncertainty , less symptom distress , and better SF-12 mental and physical QOL over time . CONCLUSION Nurse tailored interventions that target both physical and psychological aspects of QOL in women recovering from cancer surgery and undergoing chemotherapy produce stronger outcomes than interventions that target solely one QOL aspect Aim To examine the effects of a nurse-led case management programme for hospital-discharged older adults with co-morbidities . Background The most significant chronic conditions today involve diseases of the cardiovascular , respiratory , endocrine and renal systems . Previous studies have suggested that a nurse-led case management approach using either telephone follow-ups or home visits was able to improve clinical and patient outcomes for patients having a single , chronic disease , while the effects for older patients having at least two long-term conditions are unknown . A self-help programme using motivation and empowerment approaches is the framework of care in the study . Design R and omized controlled trial . Method The study was conducted from 2010–2012 . Older patients having at least two chronic diseases were included for analysis . The participants were r and omized into three arms : two study groups and one control group . Data were collected at baseline and at 4 and 12 weeks later . Results Two hundred and eighty-one patients completed the study . The interventions demonstrated significant differences in hospital readmission rates within 84 days post discharge . The two intervention groups had lower readmission rates than the control group . Patients in the two study arms had significantly better self-rated health and self-efficacy . There was significant difference between the groups in the physical composite score , but no significant difference in mental component score in SF-36 scale . Conclusion The postdischarge interventions led by the nurse case managers on self-management of disease using the empowerment approach were able to provide effective clinical and patient outcomes for older patients having co-morbidities Context Few studies have evaluated whether health care assistants can improve care for depressed patients . Contribution Patients who were r and omly assigned to receive telephone case management by health care assistants reported slightly greater improvements in depression symptoms , better adherence to antidepressant therapies , and more favorable assessment s of the quality of their care than did patients r and omly assigned to receive usual care . Implication Telephone case management facilitated by health care assistants may be a feasible mechanism for small primary care practice s to improve care of their patients with depression . The Editors Depression causes a substantial disease burden ( 1 ) and is responsible for annual health care costs of about $ 83.1 billion in the United States ( 2 , 3 ) . Most patients with depression are treated in primary care ( 46 ) . Collaborative care can improve depression outcomes by providing decision support and clinical information for family physicians , as well as self-management support and follow-up for patients . However , evidence regarding collaborative depression care stems mostly from academic or managed care setting s in the United States ( 711 ) . In these trials , family physicians generally relied on mental health case managers and decision support from mental health specialists ( 12 ) . Case management is a patient-centered element of collaborative care that may be effective in primary care ( 13 ) . It comprises systematic tracking of patients , support for continuing the treatment , and taking action in the case of nonadherence or lack of improvement ( 14 ) . Collaborative depression care has generally yielded positive results in diverse primary care setting s ( 7 ) . The IMPACT ( Improving MoodPromoting Access to Collaborative Treatment ) trial found that care managers who were supervised by psychiatrists and who provided education and support for medication adherence reduced depression symptoms in older patients ( 15 ) . Dietrich and colleagues ( 16 ) found that telephone support , provided by a trained , central ly based mental health care manager who was supervised by a psychiatrist , improved depression symptoms . Dobscha and colleagues ( 17 ) evaluated a primary care decision-support team for depression ( comprising a psychiatrist and a mental health nurse ) and found improved care processes but no differences in depression symptoms ( 17 ) , possibly because of less intensive follow-up of patients . Small , isolated primary care setting s often have limited re sources ( 18 ) . In the United States , 26 % of primary care practice s are solo practice s or 2-person partnerships , in which extensive collaborative models would be difficult to implement , and 22 % are located in rural areas with limited access to mental health specialists ( 19 ) . Health care assistants are established professionals in primary care setting s. They have less training than U.S. physician assistants or nurse practitioners , who provide first-contact care , and need not be college graduates ( 20 ) . In Germany , health care assistants have 3 years of on-the-job training . They are mainly responsible for administrative tasks in general practice but provide basic clinical procedures ( 21 ) . Health care assistants are a potentially important re source for enhancing patient care in primary care setting s ( 20 ) . Our aim was to evaluate whether case management by a practice -based health care assistant can reduce depression symptoms and improve the process of care for patients with major depression in small primary care practice s. Methods We design ed a pragmatic , cluster r and omized , controlled trial that used practice as the unit of r and omization to avoid contamination ( 22 ) . The institutional review board of Goethe University Frankfurt am Main , Frankfurt am Main , Germany , approved the study protocol on 25 April 2005 ( 23 ) . We used written consent procedures for family physicians and patients . We recruited practice s between February 2005 and May 2005 and patients between May 2005 and July 2006 . We carried out the intervention between June 2005 and August 2007 . We completed the last follow-up for study patients in September 2007 . Setting and Participants After calculating the sample size ( 24 ) , we informed all 1600
Output:
| This improvement on HRQoL was associated to interventions on " Case Management " and " Treatments and Procedures " , which were based on a theory , were of shorter duration , and had a follow-up period .
Interventions targeting people with chronic diseases result ed in a slight increase in the HRQoL that was not always significant , which suggests that there is a need for their continuous improvement |
MS211240 | ***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 To evaluate granulocyte colony-stimulating factor ( G-CSF ) efficacy in accelerating bone regeneration following opening-wedge high tibial valgus osteotomy for genu varum . Methods A phase II trial was conducted for evaluating the preoperative administration of G-CSF given at 10 μg/kg/day for 3 consecutive days with an additional half-dose 4 h before the opening-wedge high tibial valgus osteotomy . Overall , 12 patients ( Group A ) received G-CSF treatment , and the subsequent 12 patients ( Group B ) underwent surgery without G-CSF . The osteotomy gap was filled by a bone graft substitute . Bone marrow cell ( BMC ) mobilization was monitored by CD34+ve cell and clonogenic progenitor cell analysis . All patients underwent a clinical ( Lysholm Knee Scale and SF-36 ) and radiographic evaluation preoperatively , as well as at given intervals postsurgery . Results All patients completed the treatment program without major side effects ; G-CSF was well tolerated . BMC mobilization occurred in all Group A patients , with median peak values of circulating CD34+ve cells of 110/μL ( range 29–256 ) . Circulating clonogenic progenitors paralleled CD34+ve cell levels . A significant improvement in Lysholm Knee Scale was recorded at follow-up in Group A compared to Group B. At the radiographic evaluation , there was a significant increase in osseointegration at the bone-graft junction in Group A at 1 , 2 , 3 and 6 months postsurgery compared to Group B. The computerized tomography scan of the grafted area at 2 months postsurgery showed no significant difference in the quality of the newly formed bone between the two Groups . Conclusions Although the limited number of patients does not allow firm conclusions , the study suggests that G-CSF can be safely administered preoperatively in subjects undergoing opening-wedge high tibial valgus osteotomy ; in addition , the clinical , radiographic and CT monitoring indicate that G-CSF and /or mobilized BMC s may hasten bone graft substitute osseointegration . Level of evidence Purpose Early knee OA is a significant problem that can be disabling . The purpose of this study was to underst and the symptomatic profile of patients with early knee OA when compared to those with end-stage knee OA . Methods A cross-sectional case control study design was used to compare those with early structural change to those with advanced structural change . In total , 100 consecutive patients with early radiographic knee OA presenting to the knee service outpatient clinic from December 2010 to August 2011 were prospect ively identified on the basis of their radiographic changes . All met the symptomatic and radiological diagnostic criteria of early knee OA as defined by Luyten et al. They were compared with 200 knees with full thickness anteromedial knee OA and 200 knees with full thickness tricompartmental knee OA for their demographic , pain and functional profile . Results Patients with early knee OA were younger than those with full thickness disease . However , 78 % of individual patients with early radiographic OA had pain and function scores equal to individual patients presenting for UKA , whilst 74 % of individual patients with early radiographic OA had pain and function scores that are equal to or worse than individual patients presenting for TKA . Conclusions Patients with early radiographic knee OA demonstrate considerable overlap in the severity of their symptoms with those demonstrating end-stage structural changes within the knee . Patients with early structural changes of arthritis should not be assumed by clinicians to have mild disease . In many cases , their symptoms are as bad as those with end-stage structural changes . This work will help clinicians to identify and categorise those with early arthritis and thereby assist in guiding appropriate treatments In this prospect i ve r and omised study two treatments after non-traumatic medial meniscal tear diagnosed with radiological examination and magnetic resonance imaging were compared ; arthroscopic partial meniscectomy followed by supervised exercise or supervised exercise alone . The aim was to evaluate knee function and physical activity . Ninety patients ( mean age 56 years ) were evaluated using the Knee Injury and Osteoarthritis Outcome Score , the Lysholm Knee Scoring Scale , the Tegner Activity Scale and a Visual Analogue Scale for knee pain prior to the intervention , after 8 weeks of exercise and after 6 months . According to the outcome scores arthroscopic partial medial meniscectomy combined with exercise did not lead to greater improvement than exercise alone . After the intervention both groups reported decreased knee pain , improved knee function and a high satisfaction ( P < 0.0001 ) . Forty-one per cent of the patients returned to their pre-injury activity level after 6 months . In conclusion , when evaluated with outcome scores , arthroscopic partial medial meniscectomy followed by supervised exercise was not superior to supervised exercise alone in terms of reduced knee pain , improved knee function and improved quality of life Purpose We compared the effectiveness of mechanical debridement ( MD ) and bipolar radiofrequency chondroplasty ( RF ) with regard to clinical outcome , rate of revision , and progression of knee osteoarthritis . Methods Sixty patients with MRI-detected grade III cartilage lesions on the medial femoral condyle were considered for the study . For MD ( group 1 ; n = 30 ) , each lesion was debrided using a mechanical shaver . For RF ( group 2 ; n = 30 ) , each lesion was smoothed using a temperature-controlled RF probe set at 50 ° C . Results The 10-year follow-up was available for 47 patients ( 78.3 % ) . Sixty per cent of group 1 ( n = 18 ) underwent revision during the follow-up period . In contrast , the revision rate in group 2 was 23.3 % ( n = 7 ; p = 0.061 ) . The mean survival was 94.1 months ( 95 % CI 77.1–111.3 ) and 62.5 months ( 95 % CI 45.9–79.2 ) for group 2 and group 1 , respectively . Patients who did not require revision ( group 1 , n = 9 ; group 2 , n = 13 ) were assessed before surgery and 1 , 4 , and 10 years after surgery using the knee injury and osteoarthritis outcome score ( KOOS ) . At follow-up , the KOOS was higher for group 2 than group 1 . At the time of surgery , no patient showed any radiological signs of osteoarthritis . The width of the medial joint was 5.4 mm ( 95 % CI 4.3–6.5 ) and 5.6 mm ( 95 % CI 4.9–6.3 ) in the MD and RF groups , respectively ( n.s . ) . During the follow-up period , the joint space width narrowed continuously in both groups ( p < 0.001 ) , but more rapidly in the group 1 ( n.s ) . Conclusion Compared to conventional MD , 50 ° RF treatment appears to be a superior method based on short- and medium-term clinical outcomes and the progression of knee osteoarthritis . Clear predictors for the indications of different cartilage treatments and more r and omized clinical trials are needed . Level of evidence Objective Compare arthroscopic partial meniscectomy to a true sham intervention . Methods Sham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35–55 years with persistent knee pain and an MRI-confirmed medial meniscus lesion . A computer-generated table of r and om numbers generated two comparison groups . Participants and outcome assessors were blinded to group allocation . Exclusions were locking knees , high-energy trauma or severe osteoarthritis . Outcomes were collected at baseline , 3 and 24 months . We hypothesised no difference between groups . The primary outcome was the between-group difference in change from baseline to 2 years in the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score ( KOOS ) subscales ( KOOS5 ) . Results Forty-four patients ( of the estimated 72 ) underwent r and omisation ; 22 in each group . Sixteen participants ( 36 % ) were non-blinded and eight participants ( 36 % ) from the sham group crossed over to the surgery group prior to the 2-year follow-up . At 2 years , both groups reported clinical ly relevant improvements ( surgery 21.8 , skin incisions only 13.6 ) , the mean difference between groups was 8.2 in favour of surgery , which is slightly less than the cut-off of 10 prespecified to represent a clinical ly relevant difference ; judged by the 95 % CI ( −3.4 to 19.8 ) , a possibility of clinical ly relevant difference could not be excluded . In total , nine participants experienced 11 adverse events ; six in the surgery group and three in the skin-incisions-only group . Conclusion We found greater improvement from arthroscopic partial meniscectomy compared with skin incisions only at 2 years , with the statistical uncertainty of the between-group difference including what could be considered clinical ly relevant . Because of the study being underpowered , nearly half in the sham group being non-blinded and one-third crossing over to surgery , the results can not be generalised to the greater patient population . Trial registration number NCT01264991 Background : The optimal treatment for middle-aged patients with knee pain and meniscal lesions has been extensively debated . Most previous studies have revealed only short-term beneficial results of knee arthroscopic surgery . The authors have previously shown a positive benefit of knee arthroscopic surgery and an exercise program after 1 year when compared with an exercise program alone . Purpose : To evaluate if knee arthroscopic surgery combined with an exercise program provided an additional long-term benefit after 3 years compared with an exercise program alone in middle-aged patients with meniscal symptoms . Study Design : R and omized controlled trial ; Level of evidence , 1 . Methods : Of 179 eligible patients , aged 45 to 64 years , 150 were r and omized to ( 1 ) a 3-month exercise program ( nonsurgery group ) or ( 2 ) the same as group 1 plus knee arthroscopic surgery within 4 weeks ( surgery group ) . The primary outcome was the change in the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) subscore of pain between baseline and the 3-year follow-up . Results from the 1-year follow-up have been published previously . Results : Both treatment groups improved significantly in the KOOS pain subscore at 3 years ’ follow-up in the intention-to-treat and as-treated analyses ( P < .001 ) . The between-group difference for the change in the KOOS pain subscore between baseline and the 3-year follow-up was no longer statistically significant , neither in the intention-to-treat analysis ( 7.6 points ; 95 % CI , –0.6 to 15.9 ; P = .068 ) nor in the as-treated analysis ( 5.3 points ; 95 % CI , –3.1 to 13.8 ; P = .216 ) . The factorial analysis of the effect of the intervention and age , onset of pain , and mechanical symptoms indicated that older patients improved more , regardless of treatment , and surgery may be more beneficial for patients without mechanical symptoms ( as-treated analysis ) . The effect of the predictive factors on the KOOS pain subscore was uncertain because of the small sample size in the subgroup analyses . Conclusion : The benefit of knee arthroscopic surgery , seen at 1 year in middle-aged patients with meniscal symptoms , was diminished at 3 years and was no longer statistically significant . Clinical Relevance : Knee arthroscopic surgery may be beneficial for middle-aged patients with meniscal symptoms in addition to an exercise program . Older age and absence of mechanical symptoms should not be contraindications to surgery . Registration : NCT01288768 ( Clinical Trials.gov identifier BACKGROUND Few studies have examined whether chondral lesions encountered in patients undergoing meniscectomy should be surgically treated . The primary aim of the ChAMP ( Chondral Lesions And Meniscus Procedures ) Trial is to determine whether there is a difference in knee pain between patients undergoing debridement versus observation of chondral lesions encountered during arthroscopic meniscectomy . This paper describes the rationale and study design for the ChAMP Trial . METHODS / DESIGN The ChAMP Trial is a r and omized controlled trial of patients aged 30 and older undergoing partial meniscectomy and r and omly allocated to debridement ( CL-Deb , N=98 ) or observation ( CL-Obs , N=92 ) of chondral lesions identified during surgery and deemed to be significant ( Outerbridge Grade II-IV ) . Patients and data collectors were unaware of treatment allocation until completion of the study . Patients with surgically insignificant ( Outerbridge Grade I ) chondral lesions or no chondral lesions were included as a third non-r and omized comparison group ( NoCL , N=76 ) . The primary outcome is the difference in knee pain assessed by WOMAC ( Western Ontario and McMaster Universities Arthritis Index ) between the CL-Deb and CL-Obs groups at 1-year after surgery . Secondary outcomes include 1-year differences in additional measures of knee pain , function , symptoms , activity , and quality of life assessed by the WOMAC , KOOS ( Knee Injury and Osteoarthritis Outcome Score ) , visual analog pain scale , and physical exam ; as well as general health assessed with the SF-36 ( Short-form Health Survey ) . Increased intraoperative costs associated
Output:
| Low- quality evidence suggests there may be little difference in pain and function at 12 months follow-up in people who have arthroscopic partial meniscectomy and those who have physical therapy .
Due to very low quality evidence , we are uncertain if surgery is associated with an increased risk of serious adverse events , incidence of total knee replacement or withdrawal rates .
Similarly , low- quality evidence from a few small trials indicates there may not be any benefit of arthroscopic surgery over other non-surgical treatments including saline irrigation and hyaluronic acid injection , or one type of surgery over another .
We are uncertain of the risk of adverse events or of progressing to total knee replacement due to very small event rates . |
MS211241 | ***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 present study investigated the effects of propofol , desflurane , and sevoflurane on recovery of myocardial function in high-risk coronary surgery patients . High-risk patients were defined as those older than 70 yr with three-vessel disease and an ejection fraction less than 50 % with impaired length-dependent regulation of myocardial function . Methods Coronary surgery patients ( n = 45 ) were r and omly assigned to receive either target-controlled infusion of propofol or inhalational anesthesia with desflurane or sevoflurane . Cardiac function was assessed perioperatively and during 24 h postoperatively using a Swan-Ganz catheter . Perioperatively , a high-fidelity pressure catheter was positioned in the left and right atrium and ventricle . Response to increased cardiac load , obtained by leg elevation , was assessed before and after cardiopulmonary bypass ( CPB ) . Effects on contraction were evaluated by analysis of changes in dP/dtmax . Effects on relaxation were assessed by analysis of the load-dependence of myocardial relaxation . Postoperative levels of cardiac troponin I were followed for 36 h. Results After CPB , cardiac index and dP/dtmax were significantly lower in patients under propofol anesthesia . Post-CPB , leg elevation result ed in a significantly greater decrease in dP/dtmax in the propofol group , whereas the responses in the desflurane and sevoflurane groups were comparable with the responses before CPB . After CPB , load dependence of left ventricular pressure drop was significantly higher in the propofol group than in the desflurane and sevoflurane group . Troponin I levels were significantly higher in the propofol group . Conclusions Sevoflurane and desflurane but not propofol preserved left ventricular function after CPB in high-risk coronary surgery patients with less evidence of myocardial damage postoperatively BACKGROUND Whether remote ischemic preconditioning ( transient ischemia and reperfusion of the arm ) can improve clinical outcomes in patients undergoing coronary-artery bypass graft ( CABG ) surgery is not known . We investigated this question in a r and omized trial . METHODS We conducted a multicenter , sham-controlled trial involving adults at increased surgical risk who were undergoing on-pump CABG ( with or without valve surgery ) with blood cardioplegia . After anesthesia induction and before surgical incision , patients were r and omly assigned to remote ischemic preconditioning ( four 5-minute inflations and deflations of a st and ard blood-pressure cuff on the upper arm ) or sham conditioning ( control group ) . Anesthetic management and perioperative care were not st and ardized . The combined primary end point was death from cardiovascular causes , nonfatal myocardial infa rct ion , coronary revascularization , or stroke , assessed 12 months after r and omization . RESULTS We enrolled a total of 1612 patients ( 811 in the control group and 801 in the ischemic-preconditioning group ) at 30 cardiac surgery centers in the United Kingdom . There was no significant difference in the cumulative incidence of the primary end point at 12 months between the patients in the remote ischemic preconditioning group and those in the control group ( 212 patients [ 26.5 % ] and 225 patients [ 27.7 % ] , respectively ; hazard ratio with ischemic preconditioning , 0.95 ; 95 % confidence interval , 0.79 to 1.15 ; P=0.58 ) . Furthermore , there were no significant between-group differences in either adverse events or the secondary end points of perioperative myocardial injury ( assessed on the basis of the area under the curve for the high-sensitivity assay of serum troponin T at 72 hours ) , inotrope score ( calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery ) , acute kidney injury , duration of stay in the intensive care unit and hospital , distance on the 6-minute walk test , and quality of life . CONCLUSIONS Remote ischemic preconditioning did not improve clinical outcomes in patients undergoing elective on-pump CABG with or without valve surgery . ( Funded by the Efficacy and Mechanism Evaluation Program [ a Medical Research Council and National Institute of Health Research partnership ] and the British Heart Foundation ; ERICCA Clinical Trials.gov number , NCT01247545 . ) BACKGROUND Remote ischemic preconditioning ( RIPC ) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery , but uncertainty about clinical outcomes remains . METHODS We conducted a prospect i ve , double-blind , multicenter , r and omized , controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol . The trial compared upper-limb RIPC with a sham intervention . The primary end point was a composite of death , myocardial infa rct ion , stroke , or acute renal failure up to the time of hospital discharge . Secondary end points included the occurrence of any individual component of the primary end point by day 90 . RESULTS A total of 1403 patients underwent r and omization . The full analysis set comprised 1385 patients ( 692 in the RIPC group and 693 in the sham-RIPC group ) . There was no significant between-group difference in the rate of the composite primary end point ( 99 patients [ 14.3 % ] in the RIPC group and 101 [ 14.6 % ] in the sham-RIPC group , P=0.89 ) or of any of the individual components : death ( 9 patients [ 1.3 % ] and 4 [ 0.6 % ] , respectively ; P=0.21 ) , myocardial infa rct ion ( 47 [ 6.8 % ] and 63 [ 9.1 % ] , P=0.12 ) , stroke ( 14 [ 2.0 % ] and 15 [ 2.2 % ] , P=0.79 ) , and acute renal failure ( 42 [ 6.1 % ] and 35 [ 5.1 % ] , P=0.45 ) . The results were similar in the per- protocol analysis . No treatment effect was found in any subgroup analysis . No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release , the duration of mechanical ventilation , the length of stay in the intensive care unit or the hospital , new onset of atrial fibrillation , and the incidence of postoperative delirium . No RIPC-related adverse events were observed . CONCLUSIONS Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery . ( Funded by the German Research Foundation ; RIPHeart Clinical Trials.gov number , NCT01067703 . ) Background : Experimental studies have related the cardioprotective effects of sevoflurane both to preconditioning properties and to beneficial effects during reperfusion . In clinical studies , the cardioprotective effects of volatile agents seem more important when administered throughout the procedure than when used only in the preconditioning period . The authors hypothesized that the cardioprotective effects of sevoflurane observed in patients undergoing coronary surgery with cardiopulmonary bypass are related to timing and duration of its administration . Methods : Elective coronary surgery patients were r and omly assigned to four different anesthetic protocol s ( n = 50 each ) . In a first group , patients received a propofol based intravenous regimen ( propofol group ) . In a second group , propofol was replaced by sevoflurane from sternotomy until the start of cardiopulmonary bypass ( SEVO pre group ) . In a third group , propofol was replaced by sevoflurane after completion of the coronary anastomoses ( SEVO post group ) . In a fourth group , propofol was administered until sternotomy and then replaced by sevoflurane for the remaining of the operation ( SEVO all group ) . Postoperative concentrations of cardiac troponin I were followed during 48 h. Cardiac function was assessed perioperatively and during 24 h postoperatively . Results : Postoperative troponin I concentrations in the SEVO all group were lower than in the propofol group . Stroke volume decreased transiently after cardiopulmonary bypass in the propofol group but remained unchanged throughout in the SEVO all group . In the SEVO pre and SEVO post groups , stroke volume also decreased after cardiopulmonary bypass but returned earlier to baseline values than in the propofol group . Duration of stay in the intensive care unit was lower in the SEVO all group than in the propofol group . Conclusion : In patients undergoing coronary artery surgery with cardiopulmonary bypass , the cardioprotective effects of sevoflurane were clinical ly most apparent when it was administered throughout the operation OBJECTIVE Minimally invasive mitral valve repair may be associated with prolonged cardioplegic arrest times and ischemic reperfusion injury . Intravenous ( propofol ) and volatile ( sevoflurane ) anesthesia are used routinely during cardiac surgery and are thought to provide cardioprotection ; however , the individual contribution of each regimen to cardioprotection is unknown . Therefore , the authors sought to compare the cardioprotective effects of propofol and sevoflurane anesthesia in patients undergoing minimally invasive mitral valve repair . DESIGN A single-center single-blind r and omized controlled trial . SETTING A specialized regional cardiac surgery center in Italy . PARTICIPANTS The study enrolled 62 adults undergoing elective isolated minimally invasive mitral valve repair for degenerative disease . Exclusion criteria included secondary mitral regurgitation , previously treated coronary artery disease , diabetes mellitus , chronic renal failure requiring dialysis , atrial fibrillation , and documented allergy to either propofol or sevoflurane . INTERVENTIONS All patients received video-assisted minimally invasive right minithoracotomy . Patients were r and omized to receive propofol or sevoflurane anesthesia in a 1:1 ratio . MEASUREMENTS AND MAIN RESULTS Cardiac troponin I release was measured over the first 72 hours postoperatively . Operative , cross-clamp , and total bypass times were similar between groups . Cardiac troponin I release was reduced nonsignificantly in the propofol group ( p = 0.62 ) , and peak troponin I release was correlated with cross-clamp time in both groups . There were no differences in terms of intraoperative lactate release and blood pH between groups . CONCLUSION Propofol and sevoflurane anesthesia were associated with similar degrees of myocardial injury , indicating comparable cardioprotection . Myocardial injury was related directly to the duration of cardioplegic arrest Background Sevoflurane has been shown to protect against myocardial ischemia and reperfusion injury in animals . The present study investigated whether these effects were clinical ly relevant and would protect left ventricular ( LV ) function during coronary surgery . Methods Twenty coronary surgery patients were r and omly assigned to receive either target-controlled infusion of propofol or inhalational anesthesia with sevoflurane . Except for this , anesthetic and surgical management was the same in all patients . A high-fidelity pressure catheter was positioned in the left ventricle and the left atrium . LV response to increased cardiac load , obtained by leg elevation , was assessed before and after cardiopulmonary bypass ( CPB ) . Effects on contraction were evaluated by analysis of changes in dP/dtmax . Effects on relaxation were assessed by analysis of the load dependence of myocardial relaxation ( R = slope of the relation between time constant & tgr ; of isovolumic relaxation and end-systolic pressure ) . Postoperative concentrations of cardiac troponin I were followed during 36 h. Results Before CPB , leg elevation slightly increased dP/dtmax in the sevoflurane group ( 5 ± 3 % ) , whereas it remained unchanged in the propofol group ( 1 ± 6 % ) . After CPB , leg elevation result ed in a decrease in dP/dtmax in the propofol group ( −5 ± 4 % ) , whereas the response in the sevoflurane group was comparable to the response before CPB ( 5 ± 4 % ) . Load dependence of LV pressure fall ( R ) was similar in both groups before CPB . After CPB , R was increased in the propofol group but not in the sevoflurane group . Troponin I concentrations were significantly lower in the sevoflurane than in the propofol group . Conclusions Sevoflurane preserved LV function after CPB with less evidence of myocardial damage in the first 36 h postoperatively . These data suggest a cardioprotective effect of sevoflurane during coronary artery surgery OBJECTIVE The purpose of this study was to compare the effects of a total intravenous and a volatile anesthetic regimen on biochemical markers of hepatic and renal dysfunction after coronary artery surgery . DESIGN Prospect i ve , double-blind , r and omized clinical study . SETTING University hospital , single institutional . PARTICIPANTS Three hundred twenty patients undergoing elective coronary artery surgery were divided into 2 different anesthetic protocol s : propofol group ( n = 160 ) and sevoflurane group ( n = 160 ) . INTERVENTIONS Hemodynamic data were registered before the start of surgery , before the start of CP
Output:
| Conclusions : In adults undergoing cardiac surgery with cardiopulmonary bypass , the class of volatile anesthetics was superior to propofol with regard to long-term mortality , as well as to many secondary outcomes indicating myocardial protection .
Although early postoperative mortality did not differ significantly between the anesthetic groups , 1-yr mortality was significantly lower in the patients who received volatile anesthetics .
Additionally patients in the volatile anesthetic group had significantly lower occurrence of perioperative myocardial infa rct ion and troponin release and had higher postoperative cardiac index . |
MS211242 | ***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 —Tai Chi Chuan ( TTC ) exercise has beneficial effects on the components of physical condition and can produce a substantial reduction in the risk of multiple falls . Previous studies have shown that short term TCC exercise did not improve the scores in the single leg stance test with eyes closed and the sit and reach test . There has apparently been no research into the effects of TCC on total body rotation flexibility and heart rate responses at rest and after a three minute step test . Methods —In this cross sectional study , 28 male TCC practitioners with an average age of 67.5 years old and 13.2 years of TCC exercise experience were recruited to form the TCC group . Another 30 sedentary men aged 66.2 were selected to serve as the control group . Measurements included resting heart rate , left and right single leg stance with eyes closed , modified sit and reach test , total body rotation test ( left and right ) , and a three minute step test . Results —Compared with the sedentary group , the TCC group had significantly better scores in resting heart rate , three minute step test heart rate , modified sit and reach , total body rotation test on both right and left side ( p<0.01 ) , and both right and left leg st and ing with eyes closed ( p<0.05 ) . According to the American Fitness St and ards , the TCC group attained the 90th percentile rank for sit and reach and total body rotation test , right and left . Conclusion —Long term regular TCC exercise has favourable effects on the promotion of balance control , flexibility , and cardiovascular fitness in older adults Physical exercise has been shown to increase brain volume and improve cognition in r and omized trials of non-demented elderly . Although greater social engagement was found to reduce dementia risk in observational studies , r and omized trials of social interventions have not been reported . A representative sample of 120 elderly from Shanghai , China was r and omized to four groups ( Tai Chi , Walking , Social Interaction , No Intervention ) for 40 weeks . Two MRIs were obtained , one before the intervention period , the other after . A neuropsychological battery was administered at baseline , 20 weeks , and 40 weeks . Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests . Time-intervention group interactions for neuropsychological measures were evaluated with repeated- measures mixed models . Compared to the No Intervention group , significant increases in brain volume were seen in the Tai Chi and Social Intervention groups ( p < 0.05 ) . Improvements also were observed in several neuropsychological measures in the Tai Chi group , including the Mattis Dementia Rating Scale score ( p = 0.004 ) , the Trailmaking Test A ( p = 0.002 ) and B ( p = 0.0002 ) , the Auditory Verbal Learning Test ( p = 0.009 ) , and verbal fluency for animals ( p = 0.01 ) . The Social Interaction group showed improvement on some , but fewer neuropsychological indices . No differences were observed between the Walking and No Intervention groups . The findings differ from previous clinical trials in showing increases in brain volume and improvements in cognition with a largely non-aerobic exercise ( Tai Chi ) . In addition , intellectual stimulation through social interaction was associated with increases in brain volume as well as with some cognitive improvements Background . Effects of Tai Chi ( TC ) on specific cognitive function and mechanisms by which TC may improve cognition in older adults with amnestic mild cognitive impairment ( a-MCI ) remain unknown . Objective . To examine the effects of TC on cognitive functions and plasma biomarkers ( brain-derived neurotrophic factor [ BDNF ] , tumor necrosis factor-α [ TNF-α ] , and interleukin-10 [ IL-10 ] ) in a-MCI . Methods . A total of 66 older adults with a-MCI ( mean age = 67.9 years ) were r and omized to either a TC ( n = 33 ) or a control group ( n = 33 ) . Participants in the TC group learned TC with a certified instructor and then practice d at home for 50 min/session , 3 times/wk for 6 months . The control group received educational material that covered information related to cognition . The primary outcome was cognitive performance , including Logical Memory ( LM ) delayed recall , Block Design , Digit Span , and Trail Making Test B minus A ( TMT B-A ) . The secondary outcomes were plasma biomarkers , including BDNF , TNF-α , and IL-10 . Results . At the end of the trial , performance on the LM and TMT B-A was significantly better in the TC group compared with the control group after adjusting for age , gender , and education ( P < .05 ) . Plasma BDNF level was significantly increased for the TC group , whereas the other outcome measures were similar between the 2 groups after adjusting for age and gender ( P < .05 ) . Conclusions . TC training significantly improved memory and the mental switching component of executive function in older adults with a-MCI , possibly via an upregulation of BDNF BACKGROUND Nearly two-thirds of elderly patients treated for depression fail to achieve symptomatic remission and functional recovery with first-line pharmacotherapy . In this study , we ask whether a mind-body exercise , Tai Chi Chih ( TCC ) , added to escitalopram will augment the treatment of geriatric depression design ed to achieve symptomatic remission and improvements in health functioning and cognitive performance . METHODS : One hundred twelve older adults with major depression age 60 years and older were recruited and treated with escitalopram for approximately 4 weeks . Seventy-three partial responders to escitalopram continued to receive escitalopram daily and were r and omly assigned to 10 weeks of adjunct use of either 1 ) TCC for 2 hours per week or 2 ) health education ( HE ) for 2 hours per week . All participants underwent evaluations of depression , anxiety , resilience , health-related quality of life , cognition , and inflammation at baseline and during 14-week follow-up . RESULTS Subjects in the escitalopram and TCC condition were more likely to show greater reduction of depressive symptoms and to achieve a depression remission as compared with those receiving escitalopram and HE . Subjects in the escitalopram and TCC condition also showed significantly greater improvements in 36-Item Short Form Health Survey physical functioning and cognitive tests and a decline in the inflammatory marker , C-reactive protein , compared with the control group . CONCLUSION : Complementary use of a mind-body exercise , such as TCC , may provide additional improvements of clinical outcomes in the pharmacologic treatment of geriatric depression OBJECTIVES We reported the interim findings of a r and omized controlled trial ( RCT ) to examine the effects of a mind body physical exercise ( Tai Chi ) on cognitive function in Chinese subjects at risk of cognitive decline . SUBJECTS 389 Chinese older persons with either a Clinical Dementia Rating ( CDR 0.5 ) or amnestic-MCI participated in an exercise program . The exercise intervention lasted for 1 year ; 171 subjects were trained with 24 forms simplified Tai Chi ( Intervention , I ) and 218 were trained with stretching and toning exercise ( Control , C ) . The exercise comprised of advised exercise sessions of at least three times per week . RESULTS At 5th months ( 2 months after completion of training ) , both I and C subjects showed an improvement in global cognitive function , delayed recall and subjective cognitive complaints ( paired t-tests , p < 0.05 ) . Improvements in visual spans and CDR sum of boxes scores were observed in I group ( paired t-tests , p < 0.001 ) . Three ( 2.2 % ) and 21(10.8 % ) subjects from the I and C groups progressed to dementia ( Pearson chi square = 8.71 , OR = 5.34 , 95 % CI 1.56 - 18.29 ) . Logistic regression analysis controlled for baseline group differences in education and cognitive function suggested I group was associated with stable CDR ( OR = 0.14 , 95%CI = 0.03 - 0.71 , p = 0.02 ) . CONCLUSIONS Our interim findings showed that Chinese style mind body ( Tai Chi ) exercise may offer specific benefits to cognition , potential clinical interests should be further explored with longer observation period OBJECTIVE It was hypothesized that a combined Taoist Tai Chi ( TTC ) and a memory intervention program ( MIP ) would be superior to a MIP alone in improving everyday memory behaviors in individuals with amnestic mild cognitive impairment ( aMCI ) . A secondary hypothesis was that TTC would improve cognition , self-reported health status , gait , and balance . METHOD A total of 48 individuals were r and omly assigned to take part in MIP + TTC or MIP alone . The TTC intervention consisted of twenty 90 min sessions . Outcome measures were given at baseline , and after 10 and 22 weeks . RESULTS Both groups significantly increased their memory strategy knowledge and use , ratings of physical health , processing speed , everyday memory , and visual attention . No preferential benefit was found for individuals in the MIP + TTC group on cognition , gait , or balance measures . CONCLUSIONS Contrary to expectations , TTC exercise did not specifically improve cognition or physical mobility . Explanations for null findings are explored Objective To evaluate the effects of Tai chi exercise on balance , sleep quality , and cognitive performance in community-dwelling elderly in Vinh city , Vietnam . Design A r and omized controlled trial . Participants One hundred two subjects were recruited . Intervention Subjects were divided r and omly into two groups . The Tai chi group was assigned 6 months ’ Tai chi training . The control group was instructed to maintain their routine daily activities . Outcome measures The Falls Efficacy Scale ( FES ) , Pittsburgh Sleep Quality Index ( PSQI ) , and Trail Making Test ( TMT ) were used as primary outcome measures . Results Participants in the Tai chi group reported significant improvement in TMT ( part A ) ( F [ 1 , 71 ] = 78.37 , P < 0.001 ) and in TMT ( part B ) , ( F [ 1 , 71 ] = 175.00 , P < 0.001 ) in comparison with the control group . Tai chi participants also reported better scores in FES ( F [ 1 , 71 ] = 96.90 , P < 0.001 ) and in PSQI ( F [ 1,71 ] = 43.69 , P = 0.001 ) than the control group . Conclusion Tai chi is beneficial to improve balance , sleep quality , and cognitive performance of the elderly [ Purpose ] To investigate the effect of Tai Chi on cognitive and physical function in the elderly . [ Subjects and Methods ] A r and omized trial design was used . A total 150 subjects were enrolled and were divided into Tai Chi and control groups . Subjects in the Tai Chi group participated Tai Chi for 6 months , and subjects in the control group participated in other non-athletic activities . [ Results ] There were no differences between the groups in the one leg st and ing time with eyes open , left grip strength , or the Frontal Assessment Battery at bedside after 3 and 6 months of intervention . The Mini-Mental State Examination scores after 3 and 6 months were higher in the Tai Chi group than in the control group . The right grip strength after 3 months increased more in the Tai Chi group than in the control group . Both the 5-m high walking speed and 10-m normal walking speed were significantly lower after 3 and 6 months of Tai Chi practice . [ Conclusion ] These results suggest that regular Tai Chi practice may improve cognitive and physical function in the elderly This one-arm pilot study investigated the effect of tai chi on cognition in elders with cognitive impairment . Although no significant difference existed between pre- and post-test performance on all cognition measures , a dose-response relationship was demonstrated between attendance and some cognition measures OBJECTIVES To examine whether combined center- and home-based Tai Chi training can improve cognitive ability and reduce physiological fall risk in older adults with amnestic mild cognitive impairment ( a-MCI ) . DESIGN R and omized controlled trial . SETTING Chiang Mai , Thail and . PARTICIPANTS Adults aged 60 and older who met Petersen 's criteria for multiple-domain a-MCI ( N = 66 ) . INTERVENTION Three weeks center-based and 12 weeks home-based Tai Chi ( 50 minutes per session , 3 times per week ) . MEASUREMENTS Cognitive tests , including Logical Memory ( LM ) delayed recall , Block Design , Digit Span forward and backward , and Trail-Making Test Part B-A ( TMT B-A ) , and fall risk index using the Physiological Profile Assessment ( PPA ) . RESULTS At the end of the trial , performance on LM , Block Design , and TMT B-A were significantly better for the Tai Chi group than the control group after adjusting for baseline test performance . The Tai Chi group also had significantly better composite PPA score and PPA parameter scores : knee extension strength , reaction time , postural sway , and lower limb proprioception . CONCLUSION Combined center- and home-based Tai Chi training three times per week for 15 weeks significantly improved cognitive function and moderately reduced physiological fall risk in older adults with multiple-domain a-MCI . Tai Chi may be particularly beneficial to older adults with this condition OBJECTIVES To compare the effectiveness of Chinese-style mind-body exercise ( 24 forms simplified Tai Chi ) versus stretching and toning exercise in the maintenance of cognitive abilities in Chinese elders at risk of cognitive decline . DESIGN A 1-year single-blind cluster r and omized controlled trial . SETTING S Community centers and residential homes for elders in Hong Kong . PARTICIPANTS A total of 389 subjects at risk of cognitive decline ( Clinical Dementia Rating , CDR 0.5 or amnestic-MCI ) participated in an exercise intervention program . INTERVENTION A total of 171 subjects were trained with Tai
Output:
| The meta- analysis revealed that Tai Chi could significantly improve global cognitive function ; memory and learning ; mental speed and attention ; ideas , abstract ion , figural creations , and mental flexibility ; and visuospatial perception .
The present review adds to the evidence showing that Tai Chi is potentially beneficial in improving cognitive functions among elderly people with MCI . |
MS211243 | ***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: Rizatriptan is a potent , oral , 5-HT1B/1D agonist with more rapid absorption and higher bioavailability than oral sumatriptan . It was postulated that this would result in more rapid onset of effect . This r and omized , double-blind , triple-dummy , parallel-groups study compared rizatriptan 5 mg , rizatriptan 10 mg , sumatriptan 100 mg , and placebo in 1268 out patients treating a single migraine attack . Headache relief rates after rizatriptan 10 mg were consistently higher than sumatriptan at all time points up to 2 hours , with significance at 1 hour ( 37 % versus 28 % , P = 0.010 ) . All active agents were significantly superior to placebo with regard to headache relief and pain freedom at 2 hours ( P < or = 0.001 ) . The primary efficacy endpoint of time to pain relief through 2 hours demonstrated that , after adjustment for age imbalance , rizatriptan 10 mg had earlier onset than sumatriptan 100 mg ( P = 0.032 ; hazard ratio 1.21 ) . Rizatriptan 10 mg was also superior to sumatriptan on pain-free response ( P = 0.032 ) , reduction in functional disability ( P = 0.015 ) , and relief of nausea at 2 hours ( P = 0.010 ) . Significantly fewer drug-related clinical adverse events were reported after rizatriptan 10 mg ( 33 % , P = 0.014 ) compared with sumatriptan 100 mg ( 41 % ) . We conclude that rizatriptan 10 mg has a rapid onset of action and relieves headache and associated symptoms more effectively than sumatriptan 100 mg OBJECTIVE To evaluate the impact of sumatriptan succinate injection compared with placebo on productivity loss during a migraine attack in the workplace . DESIGN R and omized , double-blind , placebo-controlled , parallel-group clinical trial . SETTING Fifteen clinical centers in the United States . PATIENTS One hundred thirty-five patients 18 years and older diagnosed as having migraine according to International Headache Society criteria . INTERVENTIONS Patients self-administered sumatriptan injection ( 6 mg ) or matching placebo to treat a moderate or severe migraine occurring within the first 4 hours of a minimum 8-hour work shift . MAIN OUTCOME MEASURES Mean productivity loss 2 hours after dosing and across the work shift ; percentages of patients returning to normal work performance within 2 hours after dosing and across the work shift ; percentages of patients experiencing headache relief ( reduction of moderate or severe predose pain to mild or no pain ) 1 and 2 hours after dosing . RESULTS Mean productivity loss was significantly ( P < or = .002 ) lower in the sumatriptan group compared with the placebo group both during the 2-hour postdose period ( sumatriptan , 39 minutes ; placebo , 54 minutes ) and across the work shift ( sumatriptan , 86 minutes ; placebo , 168 minutes ) . Significantly ( P<.001 ) greater percentages of patients in the sumatriptan group compared with the placebo group returned to normal work performance by 2 hours after dosing ( sumatriptan , 52 % ; placebo , 9 % ) and across the work shift ( sumatriptan , 66 % ; placebo , 18 % ) . Significantly ( P < or = .001 ) greater percentages of patients in the sumatriptan group compared with the placebo group experienced headache relief 1 hour after dosing ( sumatriptan , 69 % ; placebo , 18 % ) and 2 hours after dosing ( sumatriptan , 79 % ; placebo , 32 % ) . CONCLUSION Sumatriptan reduced migraine-associated productivity loss during a minimum 8-hour work shift by approximately 50 % compared with placebo and alleviated headache in more than three fourths of patients Overemphasis on hypothesis testing-- and the use of P values to dichotomise significant or non-significant results --has detracted from more useful approaches to interpreting study results , such as estimation and confidence intervals . In medical studies investigators are usually interested in determining the size of difference of a measured outcome between groups , rather than a simple indication of whether or not it is statistically significant . Confidence intervals present a range of values , on the basis of the sample data , in which the population value for such a difference may lie . Some methods of calculating confidence intervals for means and differences between means are given , with similar information for proportions . The paper also gives suggestions for graphical display . Confidence intervals , if appropriate to the type of study , should be used for major findings in both the main text of a paper and its abstract Rizatriptan wafer is a 5HT1B/1D agonist for use in the acute treatment of migraine . It is a freeze-fried formulation , approved for oral administration , which dissolves on the tongue and is swallowed with saliva . In this study the efficacy of sublingually administered rizatriptan 10-mg wafer was evaluated in a r and omized , double-blind , placebo-controlled , out-patient study involving 39 migraineurs . Patients were instructed to treat a migraine at the onset of pain in order to evaluate time of onset of pain relief and pain relief at 1 h. The average time to onset of relief was 25 min for patients treated with rizatriptan wafer and 27 min for patients treated with placebo . At 1 h , 50 % of the patients receiving rizatriptan wafer and 50 % of the patients receiving placebo experienced significant relief . Implication s and potential reasons for a high placebo response are discussed We assessed the quality of assessment and reporting of adverse effects in r and omized , double-blind clinical trials of single-dose acetaminophen or ibuprofen compared with placebo in moderate to severe postoperative pain . Reports were identified by systematic search ing of a number of bibliographic data bases ( e.g. , MEDLINE ) . Information on adverse effect assessment , severity and reporting , patient withdrawals , and anesthetic used was extracted . Compliance with former guidelines for adverse effect reporting was noted . Fifty-two studies were included ; two made no mention of adverse effects . No method of assessment was given in 19 studies . Twenty trials failed to report the type of anesthetic used , eight made no mention of patient withdrawals , and nine did not state the severity of reported adverse effects . Only two studies described the method of assessment of adverse effect severity . When all adverse effect data were pooled , significantly more adverse effects were reported with active treatment than with placebo . For individual adverse effects , there was no difference between active ( acetaminophen 1000 mg or ibuprofen 400 mg ) and placebo ; the exception was significantly more somnolence/drowsiness with ibuprofen 400 mg . Ninety percent of trials reporting somnolence/drowsiness with ibuprofen 400 mg were in dental pain . All studies published after 1994 complied with former guidelines for adverse effect reporting . Different methods of assessing adverse effects produce different reported incidence : patient diaries yielded significantly more adverse effects than other forms of assessment . We recommend guidelines for reporting adverse effect information in clinical trials MK-462 is a potent , selective 5HT1D receptor agonist which may be useful in treating acute migraine . We conducted a double-blind placebo-controlled inpatient study to assess the preliminary efficacy and safety of oral doses of MK-462 20 mg ( n = 8) and 40 mg ( n = 36 ) vs placebo ( n = 21 ) , administered to 65 male and post-menopausal female migraine patients aged 22–51 with moderate or severe migraine headache . Headache severity and functional disability were measured at 0.5 , 1 , 1.5 , and 2 h post-dose . The 20 mg dose was well tolerated and 4/8 patients obtained relief in headache severity at the 2 h time point . The 40 mg dose was well tolerated and was significantly ( p < 0.05 ) superior to placebo at the 1.5 and 2 h time points ( with 27/36 or 75 % obtaining relief at 2 h compared to 7/21 or 33 % for placebo ) . Adverse events occurred in 50 % of patients on 20 mg MK-462 , 72 % of those on 40 mg MK-462 , and in 52 % of placebo-treated subjects . The most common adverse events associated with MK-462 were drowsiness ( 20 mg 12 % ; 40 mg 44 % ; placebo 24 % ) , dry mouth ( 10 mg 36 % ; placebo 19 % ) , and lightheadedness/dizziness ( 40 mg 17 % ; placebo 10 % ) . Based on these preliminary results , MK-462 appears worthy of continued study for the treatment of acute migraine The efficacy and tolerability of rizatriptan ( MAXALT ™ ) and zolmitriptan ( ZOMIG ™ ) were compared in a r and omized , double – blind , double – dummy , stratified ( on prior use of rizatriptan and /or zolmitriptan ) , placebo – controlled , single attack study in 766 patients . Rizatriptan tended to provide freedom from pain sooner than zolmitriptan ( hazard ratio 1.26 , P = 0.075 ) , acting within 60 min following dosing . More patients were pain free at 2 h on rizatriptan than on zolmitriptan ( 43.2 % vs. 35.6 % , P = 0.041 ) , while headache relief at 2 h was similar ( 70.5 % vs. 66.8 % ) . At 2 h , fewer patients on rizatriptan had symptoms of photophobia ( 35.6 % vs. 43.5 % , P = 0.029 ) and nausea ( 25.2 % vs. 32.5 % , P = 0.046 ) , and more patients on rizatriptan had normal function ( 45.4 % vs. 37.0 % , P = 0.025 ) than zolmitriptan . Headache recurred in 28 % of patients taking rizatriptan , 29 % taking zolmitriptan and 26 % taking placebo . Both active treatments were effective compared to placebo and were well tolerated . The most common side – effects with rizatriptan were asthenia/fatigue , somnolence and dizziness , while the most common side – effects with zolmitriptan were asthenia/fatigue and dizziness Rizatriptan ( MAXALTTM , a registered trademark of Merck & Co. Inc. ) is a selective 5-HT1B/1D receptor agonist with rapid oral absorption and early onset of action in the acute treatment of migraine . This r and omized , open-label , crossover outpatient study assessed the preference of 481 patients for rizatriptan 10-mg rapidly disintegrating tablets versus sumatriptan ( IMIGRANTM , a registered trademark of GlaxoWellcome PLC ) 50-mg tablets in the treatment of a single migraine attack with each therapy . Almost twice as many patients preferred rizatriptan 10-mg rapidly disintegrating tablet to sumatriptan 50-mg tablet ( 64.3 vs. 35.7 % , p ≤ 0.001 ) . Faster relief of headache pain was the most important reason for the preference , cited by 46.9 % of patients preferring rizatriptan and 43.4 % of patients who preferred sumatriptan . Headache relief at 2 h was 75.9 % with rizatriptan and 66.6 % with sumatriptan ( p ≤ 0.001 ) , with rizatriptan being superior to sumatriptan within 30 min of dosing . Fifty-five percent of patients were pain free 2 h after rizatriptan , compared with 42.1 % treated with sumatriptan ( p ≤ 0.001 ) , rizatriptan being superior within 1 h of treatment . Forty-one percent of patients taking rizatriptan were pain free at 2 h and had no recurrence or need for additional medication , compared to 32.3 % of patients on sumatriptan . Rizatriptan was also superior to sumatriptan in terms of the proportions of patients with no nausea , phonophobia or photophobia , and patients with normal function 2 h after treatment intake ( p < 0.05 ) . More patients were ( completely , very or somewhat ) satisfied 2 h after treatment with rizatriptan ( 73.3 % ) than 2 h after treatment with sumatriptan ( 59.0 % ) ( p ≤ 0.001 ) . Additionally , 2 h after the dose , more patients found rizatriptan to be very convenient , convenient or somewhat convenient ( 87.2 % ) than they did sumatriptan ( 76.3 % ) ( p ≤ 0.001 ) . Both active treatments were well tolerated . The most common side effects with rizatriptan and sumatriptan were nausea ( 6.6 and 6.9 % of patients , respectively ) , dizziness ( 6.1 and 5.8 % ) and somnolence ( 7.4 and 6.7 % ) A vali date d migraine-specific question naire ( 24-h Migraine Quality of Life Question na
Output:
| A dose response was seen for the main outcomes .
REVIEW ER 'S CONCLUSIONS Rizatriptan 5 mg and 10 mg are effective in treating acute migraine , with a dose-related increase in efficacy |
MS211244 | ***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 Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review BACKGROUND The aim of this prospect i ve study is to evaluate the prevalence of mucositis , peri-implantitis , implant success , and survival in partially edentulous patients treated for generalized aggressive periodontitis ( GAgP ) and in periodontally healthy individuals . METHODS Thirty-five patients treated for GAgP and 18 periodontally healthy patients orally rehabilitated with osseointegrated implants participated in the study . They were first examined 2 to 4 weeks before extraction of the non-retainable teeth ( baseline ) and 3 weeks after insertion of the final abutments . Additional examinations were performed during a 3-month recall schedule over a 5- to 16-year period ( mean , 8.25 years ) . At every session , clinical parameters were recorded . At 1 , 3 , 5 , 10 , and 15 years after insertion of the superstructure , a microbiological and radiographic examination was performed . RESULTS The results show implant survival rates of 100 % in periodontally healthy individuals versus 96 % in GAgP patients . The implant success rate was 33 % in GAgP patients and 50 % in periodontally healthy individuals . In GAgP patients , mucositis was present in 56 % and peri-implantitis in 26 % of the implants . In periodontally healthy individuals , 40 % of the implants showed mucositis and 10 % peri-implantitis . GAgP patients had a five times greater risk of implant failure , a three times greater risk of mucositis , and a 14 times greater risk of peri-implantitis . CONCLUSION These results suggest that patients with treated GAgP are more susceptible to mucositis and peri-implantitis , with lower implant survival and success rates OBJECTIVE To monitor clinical , microbiological and host-derived alterations occurring around teeth and titanium implants during the development of experimental gingivitis/mucositis and their respective healing sequence in humans . MATERIAL AND METHODS Fifteen subjects with healthy or treated periodontal conditions and restored with dental implants underwent an experimental 3-week period of undisturbed plaque accumulation in the m and ible . Subsequently , a 3-week period with optimal plaque control was instituted . At Days 0 , 7 , 14 , 21 , 28 , 35 and 42 , the presence/absence of plaque deposits around teeth and implants was assessed , ( plaque index [ PlI ] ) and the gingival/mucosal conditions were evaluated ( gingival index[GI ] ) . Subgingival/submucosal plaque sample s and gingival/mucosal crevicular fluid ( CF ) sample s were collected from two pre-determined sites around each experimental unit . CF sample s were analyzed for matrix-metalloproteinase-8 ( MMP-8 ) and interleukin-1beta ( IL-1β ) . Microbial sample s were analyzed using DNA-DNA hybridization for 40 species . RESULTS During 3 weeks of plaque accumulation , the median PlI and GI increased significantly at implants and teeth . Implant sites yielded a greater increase in the median GI compared with tooth sites . Over the 6-week experimental period , the CF levels of MMP-8 were statistically significantly higher at implants compared with teeth ( P<0.05 ) . The CF IL-1β levels did not differ statistically significantly between teeth and implants ( P>0.05 ) . No differences in the total DNA counts between implant and tooth sites were found at any time points . No differences in the detection frequency were found for putative periodontal pathogens between implant and tooth sites . CONCLUSION Peri-implant soft tissues developed a stronger inflammatory response to experimental plaque accumulation when compared with that of their gingival counterparts . Experimental gingivitis and peri-implant mucositis were reversible at the biomarker level . Clinical ly , however , 3 weeks of resumed plaque control did not yield pre-experimental levels of gingival and peri-implant mucosal health indicating that longer healing periods are needed Dental implants have become an often used alternative to replace missing teeth , result ing in an increasing percentage of the adult population with implant supported prosthesis . Although favourable long-term results of implant therapy have been reported , infections occur . Until recently few reports included data on peri-implant infections , possibly underestimating this complication of implant treatment . It is possible that some infections around implants develop slowly and that with time peri-implantitis will be a common complication to implant therapy as an increasing number of patients have had their implants for a long time ( > 10 years ) . Data on treatment of peri-implant lesions are scarce leaving the clinician with limited guidance regarding choice of treatment . The aim of this thesis was to study the frequency of implant loss and presence of peri-implant lesions in a group of patients supplied with Brånemark implants 9 - 14 years ago , and to relate these events to patient and site specific characteristics . Moreover three surgical treatment modalities for peri-implantitis were evaluated . The thesis is based on six studies ; Studies I-III included 218 patients and 1057 implants followed for 9 - 14 years evaluating prevalence of , and factors related to implant loss ( Paper I ) and prevalence of peri-implant infections and related factors ( Paper I-III ) . Study IV is a review describing different treatment modalities of peri-implant infections . Study V is a prospect i ve cohort study involving 36 patients and 65 implants , evaluating the use of a bone substitute with or without the use of a resorbable membrane . Study VI is a case series with 12 patients and 16 implants , evaluating a bone substitute in combination with a resorbable membrane and submerged healing . This thesis demonstrated that : After 9 - 14 years the survival rates of dental implants are high ( 95.7 % ) . Implant loss seems to cluster within patients and are related to periodontitis evidence d as bone loss on radiographs at remaining teeth before implant placement . ( Paper I ) Peri-implantitis is a common clinical entity after 9 - 14 years . ( Paper II ) Using the implant as the statistical unit the level of keratinized mucosa and pus were explanatory for a bone level at > or =3 threads ( 1.8 mm ) . When the patient was used as a statistical unit a history of periodontitis and smoking were explanatory for peri-implantitis . ( Paper III ) Animal research has demonstrated that re-osseointegration can occur . The majority of human studies were found to be case reports . Using submerged healing and bone transplants , bone fill can occur in peri-implant defects . ( Paper IV ) Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane result ed in similar pocket depth reduction , attachment gain and defect fill . ( Paper V ) Bone substitute in combination with a resorbable membrane and a submerged healing result ed in defect fill > or = 2 threads ( 1.2 mm ) in 81 % of the implants . ( Paper VI ) In conclusion : 9 - 14 years after implant installation peri-implant lesions are a common clinical entity . Smokers and patients with a history of periodontal disease are at higher risk to develop peri-implantitis . Clinical improvements and defect fill can be obtained with various surgical techniques using a bone substitute AIM To determine the incidence of peri-implantitis in individuals with mucositis in a 5-year follow-up study . MATERIAL AND METHODS A sample of 212 partially edentulous individuals , rehabilitated with dental implants , underwent periodontal and peri-implant clinical examinations in 2005 ( baseline ) . Five years later , 80 individuals who had been diagnosed with mucositis in the baseline examination were re-examined . These individuals were divided into two groups : one group with preventive maintenance during the study period ( GTP ; n = 39 ) , and another group without preventive maintenance ( GNTP ; n = 41 ) . The following parameters were clinical ly evaluated : plaque index , bleeding on periodontal and peri-implant probing , periodontal and peri-implant probing depth , suppuration and peri-implant bone loss . The influence of biological and behavioural risk variables associated with the occurrence of peri-implantitis was analysed using univariate and multivariate logistic regression analyses . RESULTS The incidence of peri-implantitis in the global sample was 31.2 % ( GNTP = 43.9 % and GTP = 18.0 % ) . CONCLUSION The absence of preventive maintenance in individuals with pre-existing peri-implant mucositis was associated with a high incidence of peri-implantitis . Clinical parameters , such as bleeding on peri-implant probing , periodontal probing depth and the presence of periodontitis were associated with a higher risk of developing peri-implantitis AIM The aim of the present study was to analyze tissue reactions to plaque formation following ligature removal at commercially available implants exposed to experimental peri-implantitis . MATERIAL AND METHODS Six Labrador dogs about 1 year old were used . All m and ibular premolars and the three anterior premolars in both sides of the maxilla were extracted . After 3 months four implants representing four different implant systems with different surface characteristics -- implant group A ( turned ) , B ( TiOblast ) , C ( s and blasted acid-etched ; SLA ) and D (TiUnite)--were placed in a r and omized order in the right side of the m and ible . Three months after implant installation experimental peri-implantitis was initiated by placement of ligatures in a submarginal position and plaque accumulation . At week 12 , when about 40 - 50 % of the supporting bone was lost , the ligatures were removed . During the subsequent 24-week period plaque accumulation continued . Radiographic and clinical examinations were performed during the ' active breakdown ' period ( plaque accumulation and ligatures ) and the plaque accumulation period after ligature removal . The experiment was terminated at week 36 . RESULTS The bone loss that took place during the ' active breakdown ' period varied between 3.5 and 4.6 mm . The additional bone loss that occurred during the plaque accumulation period after ligature removal was 1.84 ( A ) , 1.72 ( B ) , 1.55 ( C ) and 2.78 mm ( D ) . CONCLUSION Spontaneous progression of experimentally induced peri-implantitis occurred at implants with different geometry and surface characteristics . Progression was most pronounced at implants of type D ( TiUnite surface ) A clinical trial was performed to study the result of periodontal treatment following different modes of periodontal surgery in patients not recalled for maintenance care . The material consisted of 25 patients distributed into 5 groups . Following an initial examination , all patients underwent presurgical treatment including case presentation and instruction in oral hygiene measures . This instruction was given once . The various patient groups were then subjected to one of the following surgical procedures : 1 ) the apically repositioned flap operation including elimination of bony defects 2 ) the apically repositioned flap operation including curettage of bony defects but without removal of bone 3 ) the " Widman flap " technique including elimination of bony defects 4 ) the " Widman flap " technique including curettage of bony defects but without removal of bone 5 ) gingivectomy including curettage of bony defects but without removal of bone . Six , 12 and 24 months after completion of the treatment , the patients were recalled for assessment of their oral hygiene st and ard and periodontal conditions . The results showed that case presentation and oral hygiene instruction given once , only temporarily improved the patient 's oral hygiene habits . Renewed accumulation of plaque in the operated areas result ed in recurrence of periodontal disease including a significant further loss of attachment . All five different techniques for surgical pocket elimination were equally ineffective in preventing recurrence of destructive periodontitis A
Output:
| Similarly , significant effects of history of periodontal disease were obtained for peri-implantitis for both implant and patient levels .
Furthermore , mean PIMT interval was demonstrated to influence the incidence of peri-implantitis at implant but not patient level .
PIMT interval showed significance at both levels .
Within the limitations of the present systematic review , it can be concluded that implant therapy must not be limited to the placement and restoration of dental implants but to the implementation of PIMT to potentially prevent biologic complications and hence to heighten the long-term success rate . |
MS211245 | ***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 ovarian volume of World Health Organization II anovulatory patients in the early follicular phase predicts the response to ovulation induction with gonadotropins . DESIGN Retrospective data analysis of two prospect i ve , r and omized , multicenter studies . SETTING Clinical development unit of biotechnology company . PATIENT(S ) Four hundred sixty-five World Health Organization II anovulatory patients undergoing ovulation induction . MAIN OUTCOME MEASURE(S ) Ovarian response to stimulation , ovulation ( mid-luteal serum progesterone > 30 nmol/L ) , cancellation rate , pregnancy rate , and incidence of the ovarian hyperstimulation syndrome ( OHSS ) according to baseline ovarian volume ( day 2 - 5 ) before stimulation . RESULT ( S ) Mean ovarian volume was 11.55 + /- 6.0 cm(3 ) ( range , 0.8 - 49.3 cm(3 ) ) . Small ovarian volume was associated with lower rates of cycle cancellation owing to risk for OHSS ( 3 vs. 29 patients [ 2.8 % vs. 9 % ] ) . Patients with small ovarian volume ( < 7.25 cm(3 ) ) required fewer ampules of FSH ( 1373 IU vs. 1629 IU ) and shorter duration of stimulation ( 16 vs. 18.1 days ) and had higher ovulation rate than did patients with mid-range and larger ovarian volume ( 84.3 % vs. 69.1 % and 68.8 % , respectively ) . The clinical pregnancy rate per cycle of hCG administration was similar in the three groups ( 25.8 % , 28.1 % , and 27.5 % ) . CONCLUSIONS World Health Organization II anovulatory women with medium-sized or large ovaries who are undergoing low-dose gonadotropin stimulation for ovulation induction may have higher risk for OHSS than do women with small ovaries . Women with small ovaries who meet criteria for administration of hCG respond better to ovulation induction and have a similar likelihood of conceiving compared with women with larger ovaries We previously tested a combined regimen based on the administration of gonadotropin in the early follicular phase followed by pulsatile gonadotropin-releasing hormone ( GnRH ) until complete follicular maturation in patients suffering from polycystic ovarian disease . Despite good clinical results , a high rate of premature luteinization was observed with this approach . We therefore evaluated in this study whether starting pulsatile GnRH therapy before gonadotropin administration might reduce premature luteinization . Eight women underwent induction of ovulation with both combined therapy and pure exogenous follicle-stimulating hormone alone using a crossover scheme . No premature luteinization and a single follicular growth were recorded with the modified combined regimen . Clinical results ( 8/8 versus 3/7 ovulatory cycles ; 3/8 versus 1/7 pregnancies ) favor the combined approach over gonadotropin alone A low dose step-up and step-down regimen for induction of ovulation using urinary FSH was compared in a prospect i ve r and omized fashion in 37 normogonadotropic clomiphene-resistant oligo- or amenorrheic infertile women . The objectives was to assess potential differences in duration of treatment , ovarian stimulation ( serum FSH levels ) , and response [ serum estradiol ( E2 ) levels and number and size of follicles ] . Monitoring ( blood sampling and transvaginal sonography ) took place on the day of initiation of treatment , the first day of ovarian response as assessed by ultrasound ( i.e. the first day a follicle > or = 10 mm could be recognized ) , the day of hCG administration to induce ovulation , and 3 days thereafter . The median duration of treatment in the low dose step-up group was 18 ( range , 7 - 41 ) days compared to 9 ( range , 4 - 16 ) days in the step-down group ( P = 0.003 ) , and the total numbers of ampules administered were 20 ( range , 7 - 69 ) and 14 ( range , 7 - 33 ) , respectively ( P = NS ) . Serum FSH levels from the first day of sonographic ovarian response until the administration of hCG were constant ( median increase , 2%/day ) in patients receiving the low dose step-up protocol , but showed a decrease ( median , 5%/day ) in step-down cycles ( P < 0.001 ) . Monofollicular growth , defined as not more than one follicle 16 mm or larger on the day of hCG administration , was observed in 56 % of low dose step-up and 88 % of step-down cycles ( P = 0.04 ) . The percentage of patients with normal range periovulatory E2 serum levels ( 500 - 1500 pmol/L ) was 33 % in the low dose step-up group vs. 71 % in the step-down group ( P = 0.03 ) . We conclude that a step-down protocol for gonadotropin induction of ovulation exhibits a more physiological , late follicular phase FSH serum profile than a low dose step-up protocol . This results in a shorter duration of treatment , a greater number of monofollicular cycles , and more cycles with periovulatory E2 levels within the normal range in the step-down protocol BACKGROUND This study revisited the ultrasonographic diagnostic criteria of polycystic ovary syndrome ( PCOS ) and studied the relationship between the major hormonal and metabolic features of PCOS and the follicle number per ovary ( FNPO ) . METHODS This prospect i ve study included 214 women with PCOS compared with 112 women with normal ovaries . Main clinical , biological and ultrasonographic markers of PCOS were assessed during the early follicular phase . RESULTS The mean FNPO of follicles 2 - 5 mm in size was significantly higher in polycystic ovaries than in controls , while it was similar within the 6 - 9 mm range . Setting the threshold at 12 for the 2 - 9 mm FNPO offered the best compromise between specificity ( 99 % ) and sensitivity ( 75 % ) . Within the 2 - 5 mm follicular range , we found significant positive relationships between the FNPO and and rogens . The FNPO within the 6 - 9 mm range was significantly and negatively related to body mass index and fasting insulin serum level . CONCLUSIONS We propose to modify the definition of polycystic ovaries by adding the presence of > or = 12 follicles measuring 2 - 9 mm in diameter ( mean of both ovaries ) . Also , our findings strengthen the hypothesis that the intra-ovarian hyper and rogenism promotes excessive early follicular growth and that further progression can not proceed normally because of hyperinsulinism and /or other metabolic influence linked to obesity In order to determine which factors influence the large variations in sensitivity to gonadotrophins witnessed in women with polycystic ovary syndrome ( PCOS ) , a prospect i ve study was conducted of the correlation between basal clinical and endocrinological features and gonadotrophin requirements of 20 women with clomiphene-resistant PCOS undergoing ovulation induction . Baseline evaluation of serum concentrations of luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , testosterone , fasting insulin , insulin-like growth factor-1 ( IGF-1 ) , IGF binding protein-1 ( IGFBP-1 ) and sex hormone-binding globulin ( SHBG ) were performed before administering gonadotrophin-releasing hormone agonist ( GnRHa ) . Two weeks later , human menopausal gonadotrophin ( HMG ) was given in a st and ard individualized protocol according to ovarian response , until human chorionic gonadotrophin ( HCG ) was given . Serum concentrations of insulin , IGF-1 , and IGFBP-1 were unaffected by GnRHa . The BMI correlated positively with insulin and inversely with IGFBP-1 serum concentrations and insulin and IGFBP-1 were inversely correlated . The amount of HMG required correlated positively with BMI and insulin concentrations and inversely with IGFBP-1 in the whole group and these correlations were maintained in the sub-group of lean women . No correlation was observed between HMG requirements and IGF-1 or other hormones . Women with hyperinsulinaemia and low IGFBP-1 concentrations required significantly more HMG . Multiple regression analysis revealed that insulin concentration is the most significant determinant of HMG requirement even when dissociated from BMI . We concluded that requirements of HMG in PCOS is not merely determined by obesity but by a cardinal role of insulin concentrations which , when high , induce , hypothetically , a hyper and rogenic intrafollicular milieu In 20 patients with clinical ly , sonographically and endocrinologically proven polycystic ovary syndrome , ovulation induction with low doses of follicle stimulating hormone ( FSH ) was attempted by administration for 27 menstrual cycles . One ampule FSH was administered from day 3 onwards . If the ovarian response was inadequate after days 10 - 12 , the daily FSH dose was increased by half an ampule until ovulation induction . Of the cycles , 55.5 % were monofollicular , whereas 4 cycles had to be cancelled due to a multifollicular response or failure of ovarian stimulation . On average , 14.4 ampules was used , and human chorionic gonadotropin was given on day 16 . Seven pregnancies were established , with all of them ongoing at this writing . One twin pregnancy and one triplet pregnancy occurred . Even in polycystic ovary syndrome patients , low-dose administration of FSH allows safe stimulation , with a low incidence of ovarian hyperstimulation , a high pregnancy rate and an acceptably low risk of multiple pregnancies OBJECTIVE To compare the efficacy and safety of urinary FSH and recombinant FSH for ovulation induction in patients with clomiphene citrate-resistant , normogonadotropic , chronic anovulation . DESIGN Prospect i ve , r and omized trial . SETTING University-based infertility clinic . PATIENT(S ) Fifty-one women . INTERVENTION(S ) Subjects were r and omized to receive either urinary FSH ( 35 patients , 64 cycles ) or recombinant FSH ( 16 patients , 32 cycles ) . A maximum of three cycles using the low-dose step-up protocol with the same gonadotropin were undertaken . MAIN OUTCOME MEASURE(S ) Cumulative ovulation and pregnancy rates after three cycles , total gonadotropin dose , duration of stimulation , and single follicle development rate . RESULT ( S ) Cumulative ovulation rates were 89.3 % and 93.1 % for the urinary FSH and recombinant FSH groups , respectively . The threshold and total doses of FSH and the duration of stimulation were similar between the two groups . Significantly more single follicle development was noted in the recombinant FSH group . The respective clinical pregnancy rates per noncanceled cycles in the urinary FSH and recombinant FSH groups were 23.2 % and 27.6 % . There were three sets of twins in the urinary FSH group . No case of ovarian hyperstimulation syndrome was encountered . CONCLUSION ( S ) Urinary FSH and recombinant FSH are both efficient and safe for inducing ovulation with the low-dose step-up protocol Abstract Purpose : Our goal was to investigate the safety , effectiveness , and feasibility for the practicing physician of stepwise and low-dose administration of FSH in WHO group II anovulatory infertile women . Methods : Infertile female patients ( n=234 ) suffering from WHO group II anovulation , and who failed to became pregnant with clomiphene citrate , were included in a multicenter , prospect i ve , clinical study of treatment with a protocol of chronic low-dose and small incremental rises with urinary purified or highly purified FSH . Follicular development was monitored with ultrasonographic scans . Results : The 234 patients received a total of 534 cycles of treatment , for a mean number of 2.3 treated cycles per patient . hCG was withheld in 65 ( 12.2 % ) cyles because of no response and in 28 ( 5.2 % ) cycles because of hyperresponse . Of the remaining 441 cycles , 419 ( 95 % ) were ovulatory , and in 198 ( 47.3 % ) of these cycles a single dominant follicle developed . There were 93 pregnancies ( 39.7 % per patient ) , for a cycle fecundity rate of 17.4 % . Cumulative conception rate after two treated cycles was 33.5 % . There were 14 ( 15 % ) pairs of twins and 10 ( 10.8 % ) spontaneous miscarriages . The prevalence of complications was low with no cases of severe OHSS . Basal LH/FSH ratio was significantly higher in the pregnant group of patients than in nonpregnant women . Conclusions : Stepwise and chronic low-dose administration of FSH is a safe and effective method for treatment of WHO group II anovulatory infertility , mainly in those patients having high LH/FSH ratios Treatment with low-dose follicle-stimulating hormone ( FSH ) is associated with a high rate of ovulation in anovulatory women with polycystic ovarian syndrome ( PCOS ) , but it is not clear whether the
Output:
| Finally , pooled analysis did not find a significant association between testosterone and pregnancy rate .
In conclusion , the best available evidence , though limited , suggests that the most clinical ly useful predictors of gonadotrophin ovulation induction outcome in normogonadotrophic women are obesity and insulin resistance |
MS211246 | ***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 Several studies have shown the efficacy , tolerability , and ease of administration of pemetrexed-an antifolate antineoplastic agent-in patients with advanced non-small-cell lung cancer . We assessed pemetrexed as maintenance therapy in patients with this disease . METHODS This r and omised double-blind study was undertaken in 83 centres in 20 countries . 663 patients with stage IIIB or IV disease who had not progressed on four cycles of platinum-based chemotherapy were r and omly assigned ( 2:1 ratio ) to receive pemetrexed ( 500 mg/m(2 ) , day 1 ) plus best supportive care ( n=441 ) or placebo plus best supportive care ( n=222 ) in 21-day cycles until disease progression . Treatment was r and omised with the Simon and Pocock minimisation method . Patients and investigators were masked to treatment . All patients received vitamin B(12 ) , folic acid , and dexamethasone . The primary endpoint of progression-free survival and the secondary endpoint of overall survival were analysed by intention to treat . This study is registered with Clinical Trials.gov , number NCT00102804 . FINDINGS All r and omly assigned participants were analysed . Pemetrexed significantly improved progression-free survival ( 4.3 months [ 95 % CI 4.1 - 4.7 ] vs 2.6 months [ 1.7 - 2.8 ] ; hazard ratio [ HR ] 0.50 , 95 % CI 0.42 - 0.61 , p<0.0001 ) and overall survival ( 13.4 months [ 11.9 - 15.9 ] vs 10.6 months [ 8.7 - 12.0 ] ; HR 0.79 , 0.65 - 0.95 , p=0.012 ) compared with placebo . Treatment discontinuations due to drug-related toxic effects were higher in the pemetrexed group than in the placebo group ( 21 [ 5 % ] vs three [ 1 % ] ) . Drug-related grade three or higher toxic effects were higher with pemetrexed than with placebo ( 70 [ 16 % ] vs nine [ 4 % ] ; p<0.0001 ) , specifically fatigue ( 22 [ 5 % ] vs one [ 1 % ] , p=0.001 ) and neutropenia ( 13 [ 3 % ] vs 0 , p=0.006 ) . No pemetrexed-related deaths occurred . Relatively fewer patients in the pemetrexed group than in the placebo group received systemic post-discontinuation therapy ( 227 [ 51 % ] vs 149 [ 67 % ] ; p=0.0001 ) . INTERPRETATION Maintenance therapy with pemetrexed is well tolerated and offers improved progression-free and overall survival compared with placebo in patients with advanced non-small-cell lung cancer . FUNDING Eli Lilly BACKGROUND We conducted a r and omized , placebo-controlled , double-blind trial to determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival in non-small-cell lung cancer after the failure of first-line or second-line chemotherapy . METHODS Patients with stage IIIB or IV non-small-cell lung cancer , with performance status from 0 to 3 , were eligible if they had received one or two prior chemotherapy regimens . The patients were stratified according to center , performance status , response to prior chemotherapy , number of prior regimens , and prior platinum-based therapy and were r and omly assigned in a 2:1 ratio to receive oral erlotinib , at a dose of 150 mg daily , or placebo . RESULTS The median age of the 731 patients who underwent r and omization was 61.4 years ; 49 percent had received two prior chemotherapy regimens , and 93 percent had received platinum-based chemotherapy . The response rate was 8.9 percent in the erlotinib group and less than 1 percent in the placebo group ( P<0.001 ) ; the median duration of the response was 7.9 months and 3.7 months , respectively . Progression-free survival was 2.2 months and 1.8 months , respectively ( hazard ratio , 0.61 , adjusted for stratification categories ; P<0.001 ) . Overall survival was 6.7 months and 4.7 months , respectively ( hazard ratio , 0.70 ; P<0.001 ) , in favor of erlotinib . Five percent of patients discontinued erlotinib because of toxic effects . CONCLUSIONS Erlotinib can prolong survival in patients with non-small-cell lung cancer after first-line or second-line chemotherapy Background Overexpression of RRM1 and RRM2 has been associated with gemcitabine resistance . BRCA1 overexpression increases sensitivity to paclitaxel and docetaxel . We have retrospectively examined the effect of RRM1 , RRM2 and BRCA1 expression on outcome to gemcitabine plus docetaxel in advanced non-small-cell lung cancer ( NSCLC ) patients . Methodology and Principal Findings Tumor sample s were collected from 102 chemotherapy-naïve advanced NSCLC patients treated with gemcitabine plus docetaxel as part of a r and omized trial . RRM1 , RRM2 and BRCA1 mRNA levels were assessed by quantitative PCR and correlated with response , time to progression and survival . As BRCA1 levels increased , the probability of response increased ( Odds Ratio [ OR ] , 1.09 : p = 0.01 ) and the risk of progression decreased ( hazard ratio [ HR ] , 0.99 ; p = 0.36 ) . As RRM1 and RRM2 levels increased , the probability of response decreased ( RRM1 : OR , 0.97 ; p = 0.82 ; RRM2 : OR , 0.94 ; p<0.0001 ) and the risk of progression increased ( RRM1 : HR , 1.02 ; p = 0.001 ; RRM2 : HR , 1.005 ; p = 0.01 ) . An interaction observed between BRCA1 and RRM1 allowed patients to be classified in three risk groups according to combinations of gene expression levels , with times to progression of 10.13 , 4.17 and 2.30 months ( p = 0.001 ) . Low BRCA1 expression was the only factor significantly associated with longer time to progression in 31 patients receiving cisplatin-based second-line therapy . Conclusions The mRNA expression of BRCA1 , RRM1 and RRM2 is potentially a useful tool for selecting NSCLC patients for individualized chemotherapy and warrants further investigation in prospect i ve studies Purpose : No chemotherapy regimen , including the widely used combination of gemcitabine/cisplatin , confers significantly improved survival over any other in metastatic non-small cell lung cancer ( NSCLC ) ; however , the selection of patients according to key genetic characteristics can help to tailor chemotherapy . Ribonucleotide reductase subunit M1 ( RRM1 ) is involved in DNA synthesis and repair and in gemcitabine metabolism , and the excision repair cross-complementing group 1 ( ERCC1 ) gene has been related to cisplatin activity . Experimental Design : Patients were part of a large r and omized trial carried out from September 1998 to July 2000 , comparing gemcitabine/cisplatin versus gemcitabine/cisplatin/vinorelbine versus gemcitabine/vinorelbine followed by vinorelbine/ifosfamide . We analyzed RRM1 and ERCC1 mRNA expression in paraffin-embedded sample s obtained from bronchoscopy by real-time quantitative reverse transcription-PCR . Results were correlated with survival using the Kaplan-Meier method . Results : A total of 100 patients were assessed . There was a strong correlation between RRM1 and ERCC1 mRNA expression levels ( Spearman r = 0.410 ; P < 0.001 ) . In the gemcitabine/cisplatin arm , patients with low RRM1 mRNA expression levels had significantly longer median survival than those with high levels [ 13.7 versus 3.6 months ; 95 % confidence interval ( CI ) , 9.6–17.8 months ; P = 0.009 ] . Median survival was also significantly longer among patients with low mRNA expression levels of both RRM1 and ERCC1 ( not reached ) , than among those with high levels of both genes ( 6.8 months ; 95 % CI , 2.6–11.1 months ; P = 0.016 ) . Conclusions : RRM1 mRNA expression is a crucial predictive marker of survival in gemcitabine/cisplatin-treated patients . Genetic testing of RRM1 mRNA expression levels can and should be used to personalize chemotherapy PURPOSE V and etanib is a once-daily oral inhibitor of vascular endothelial growth factor receptor ( VEGFR ) and epidermal growth factor receptor ( EGFR ) signaling . In this two-part phase II study , the efficacy and safety of v and etanib was compared with that of gefitinib , an inhibitor of EGFR signaling . PATIENTS AND METHODS Patients ( N = 168 ) with locally advanced or metastatic ( stage IIIB/IV ) non-small-cell lung cancer ( NSCLC ) , after failure of first-line with or without second-line platinum-based chemotherapy , received once-daily v and etanib 300 mg ( n = 83 ) or gefitinib 250 mg ( n = 85 ) until disease progression or evidence of toxicity ( part A ) . After a 4-week washout period , eligible patients had the option to switch to the alternative treatment ( part B ) . Progression-free survival ( PFS ) was the primary efficacy assessment in part A , which was design ed to have a higher than 75 % power to detect a 33 % prolongation of PFS at a one-sided significance level of .2 . RESULTS In part A , v and etanib prolonged PFS compared with gefitinib ( hazard ratio = 0.69 ; 95 % CI , 0.50 to 0.96 ; one-sided P = .013 ) . Patients receiving v and etanib experienced adverse events that were manageable and generally consistent with inhibition of EGFR and VEGFR signaling , including diarrhea , rash , and hypertension . There were no unexpected safety findings with gefitinib . Overall survival , a secondary assessment , was not significantly different between patients initially r and omly assigned to either v and etanib or gefitinib . CONCLUSION The primary efficacy objective was achieved , with v and etanib demonstrating a significant prolongation of PFS versus gefitinib . V and etanib 300 mg/d is currently being evaluated as a monotherapy in two r and omized phase III studies in advanced NSCLC PURPOSE To confirm the promising phase II results of docetaxel monotherapy , this phase III trial was conducted of chemotherapy for patients with advanced non-small-cell lung cancer ( NSCLC ) who had previously failed platinum-containing chemotherapy . PATIENTS AND METHODS A total of 373 patients were r and omized to receive either docetaxel 100 mg/m(2 ) ( D100 ) or 75 mg/m(2 ) ( D75 ) versus a control regimen of vinorelbine or ifosfamide ( V/I ) . The three treatment groups were well-balanced for key patient characteristics . RESULTS Overall response rates were 10.8 % with D100 and 6.7 % with D75 , each significantly higher than the 0.8 % response with V/I ( P = .001 and P = .036 , respectively ) . Patients who received docetaxel had a longer time to progression ( P = .046 , by log-rank test ) and a greater progression-free survival at 26 weeks ( P = .005 , by chi(2 ) test ) . Although overall survival was not significantly different between the three groups , the 1-year survival was significantly greater with D75 than with the control treatment ( 32 % v 19 % ; P = .025 , by chi(2 ) test ) . Prior exposure to paclitaxel did not decrease the likelihood of response to docetaxel , nor did it impact survival . There was a trend toward greater efficacy in patients whose disease was platinum-resistant rather than platinum-refractory and in patients with performance status of 0 or 1 versus 2 . Toxicity was greatest with D100 , but the D75 arm was well-tolerated . CONCLUSION This first r and omized trial in this setting demonstrates that D75 every 3 weeks can offer clinical ly meaningful benefit to patients with advanced NSCLC whose disease has relapsed or progressed after platinum-based chemotherapy PURPOSE To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy . Secondary end points included assessment of response ( docetaxel arm only ) , toxicity , and quality of life . PATIENTS AND METHODS Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and
Output:
| There is some evidence that histology is prognostic for survival .
There is evidence from multiple r and omized clinical trials to recommend the following : histologic subtype is predictive of treatment efficacy and for some agents toxicity .
Clinical data on K-RAS mutations are inconsistent , therefore testing is not recommended .
There is insufficient evidence to recommend other biomarker testing .
No biomarkers to date reliably predict improved efficacy for anti-VEGF therapy . |
MS211247 | ***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: Medical treatment and chemotherapy are seldom successful in achieving objective tumour reduction in patients with metastatic neuroendocrine tumours . Treatment with the radiolabelled somatostatin analogue [90Y-DOTA0,Tyr3]octreotide may result in partial remissions in 10–25 % of patients . The newer analogue [DOTA0,Tyr3]octreotate ( octreotate ) has a ninefold higher affinity for the somatostatin receptor subtype 2 as compared with [DOTA0,Tyr3]octreotide . Also , labelled with the beta- and gamma-emitting radionuclide 177Lu , it has proved very successful in achieving tumour regression in animal models . The effects of 177Lu-octreotate therapy were studied in 35 patients with neuroendocrine gastro-entero-pancreatic ( GEP ) tumours who underwent follow-up for 3–6 months after receiving their final dose . Patients were treated with doses of 100 , 150 or 200 mCi 177Lu-octreotate , to a final cumulative dose of 600–800 mCi , with treatment intervals of 6–9 weeks . Nausea and vomiting within the first 24 h after administration were present in 30 % and 14 % of the administrations , respectively . WHO toxicity grade 3 anaemia , leucocytopenia and thrombocytopenia occurred after 0 % , 1 % and 1 % of the administrations , respectively . Serum creatinine and creatinine clearance did not change significantly . The effects of the therapy on tumour size were evaluable in 34 patients . Three months after the final administration , complete remission was found in one patient ( 3 % ) , partial remission in 12 ( 35 % ) , stable disease in 14 ( 41 % ) and progressive disease in seven ( 21 % ) , including three patients who died during the treatment period . Tumour response was positively correlated with a high uptake on the octreoscan , limited hepatic tumour mass and a high Karnofsky Performance Score . Because of the limited efficacy of alternative therapies , many physicians currently adopt an expectant attitude when dealing with patients with metastatic GEP tumours . However , in view of the high success rate of therapy with 177Lu-octreotate and the absence of serious side-effects , we advocate its use in patients with GEP tumours without waiting for tumour progression Objective Everolimus , an inhibitor of the mammalian target of rapamycin , has recently demonstrated efficacy and safety in a Phase III , double-blind , r and omized trial ( RADIANT-3 ) in 410 patients with low- or intermediate- grade advanced pancreatic neuroendocrine tumours . Everolimus 10 mg/day provided a 2.4-fold improvement compared with placebo in progression-free survival , representing a 65 % risk reduction for progression . The purpose of this analysis was to investigate the efficacy and safety of everolimus in the Japanese subgroup enrolled in the RADIANT-3 study . Methods Subgroup analysis of the Japanese patients was performed comparing efficacy and safety between everolimus 10 mg/day orally ( n = 23 ) and matching placebo ( n = 17 ) . The primary endpoint was progression-free survival . Safety was evaluated on the basis of the incidence of adverse drug reactions . Results Progression-free survival was significantly prolonged with everolimus compared with placebo . The median progression-free survival was 19.45 months ( 95 % confidence interval , 8.31–not available ) with everolimus vs 2.83 months ( 95 % confidence interval , 2.46–8.34 ) with placebo , result ing in an 81 % risk reduction in progression ( hazard ratio , 0.19 ; 95 % confidence interval , 0.08–0.48 ; P < 0.001 ) . Adverse drug reactions occurred in all 23 ( 100 % ) Japanese patients receiving everolimus and in 13 ( 77 % ) patients receiving placebo ; most were grade 1/2 in severity . The most common adverse drug reactions in the everolimus group were rash ( n = 20 ; 87 % ) , stomatitis ( n = 17 ; 74 % ) , infections ( n = 15 ; 65 % ) , nail disorders ( n = 12 ; 52 % ) , epistaxis ( n = 10 ; 44 % ) and pneumonitis ( n = 10 ; 44 % ) . Conclusions These results support the use of everolimus as a valuable treatment option for Japanese patients with advanced pancreatic neuroendocrine tumours BACKGROUND Gastric carcinoid tumours type 1 ( GCA1 ) originate from hyperplastic enterochromaffin-like ( ECL ) cells secondary to hypergastrinaemia . Treatment with somatostatin analogues ( SSA ) might impede ECL-cell hyperplasia by suppressing gastrin secretion and /or by a direct anti-proliferative effect on ECL cells . We conducted a multicentre prospect i ve study to assess the effects of long-acting SSA on hypergastrinaemia and ECL-cell proliferation in patients with GCA1 . METHODS We studied 15 patients with GCA1 treated with monthly long-acting release octreotide ( LAR ) ( 20 - 30 mg ; n=14 ) or Lanreotide 90 mg ( n=1 ) for at least 6 months . Patients had serum gastrin and chromogranin A measurements performed and biopsies taken from both tumours and surrounding mucosa before , and every 6 - 12 months following treatment . Sections were immunostained for neuroendocrine markers . The cell proliferation index Ki-67 , intensity of staining before and after treatment and the degree of gastric wall invasion were also assessed . RESULTS All patients tolerated treatment well ( mean follow-up of 18 months ) . In 11 patients ( 73 % ) , a complete disappearance of the tumours at 1 year of treatment was observed on endoscopy , while in three patients ( 20 % ) , the tumours decreased significantly in number and size . Gastrin levels normalized in 25 % of patients , and were reduced by more than 80 % in the remaining 75 % . CONCLUSIONS Treatment with SSAs in GCA1 leads to a substantial tumour load reduction , with a concomitant decrease of serum gastrin levels . Our data indicate an important anti-proliferative effect of SSA on ECL cells , providing clinical benefit and obviating , at least temporarily , the need for invasive therapies for GCA1 4008 Background : In a double-blind phase 3 trial , SU improved PFS vs PBO ( 11.4 vs 5.5 months ; HR 0.418 , 95 % CI 0.263 , 0.662 ; p=0.0001 ) and was well tolerated in pts with advanced well-differentiated , unresectable NET that had progressed in ≤12 months ( NEJM , Feb 2011 ) . Initial OS showed a benefit for SU over PBO , but median OS was not reached ( NR ) . Here we report up date d results of median OS and also PFS assessed by BICR to correct for potential unblinding due to identifiable adverse events ( AE ) . METHODS Pts were r and omized 1:1 to SU 37.5 mg as a continuous daily dose or PBO , each with best supportive care . Primary endpoint was PFS ; secondary endpoint was OS . Median OS and HR were estimated using Kaplan-Meier ( K-M ) methods and Cox proportional hazards models . Baseline and on- study CT/MRI scans were evaluated by a 2-reader , 2-time point lock , followed by a sequential locked-read , batch-mode paradigm by blinded , third-party radiologists . RESULTS 171 pts were r and omized ( SU , n=86 ; PBO , n=85 ) from 6/2007 to 4/2009 . The trial ended early when an independent data monitoring committee noted efficacy favoring SU and more serious AEs and deaths with PBO . The study was unblinded at closure , and pts were offered open-label SU . At study end , there were 9 and 21 deaths in SU and PBO arms , respectively ; HR of 0.409 ( 95 % CI 0.187 , 0.894 ; p=0.0204 ) favoring SU . By 6/2010 , there were 34 and 39 deaths , respectively ; median OS was 30.5 ( 95 % CI 20.6 , NR ) and 24.4 ( 95 % CI : 16.3 , NR ) months , respectively . The HR of 0.737 ( 95 % CI 0.465 , 1.168 ; p=0.1926 ) continued to favor SU ; a K-M plot showed early/persistent separation of curves . For BICR analysis , scans were collected for 170 ( 99.4 % ) pts , with 160 ( 93.6 % ) having complete scan sets/time points . Median PFS by BICR was 12.6 vs 5.8 months for SU and PBO ( HR 0.315 [ 95 % CI 0.181 , 0.546 ; p=0.000015 ] ) . CONCLUSIONS SU led to a 6.1-month improvement in median OS vs PBO , and BICR analysis confirmed the investigator-assessed PFS benefit of SU . These up date d results support the robustness of the initial findings and the clinical benefit of treatment with sunitinib PURPOSE Effective systemic therapy for advanced carcinoid is lacking . The combination of bevacizumab ( BEV ) and pegylated ( PEG ) interferon alpha-2b was evaluated among patients with metastatic or unresectable carcinoid tumors . PATIENTS AND METHODS Forty-four patients on stable doses of octreotide were r and omly assigned to 18 weeks of treatment with bevacizumab or PEG interferon alpha-2b . At disease progression ( PD ) or at the end of 18 weeks ( whichever occurred earlier ) , patients received bevacizumab plus PEG interferon until progression . Functional computer tomography ( CT ) scans were performed to measure effect on tumor blood flow . RESULTS In the bevacizumab arm , four patients ( 18 % ) achieved confirmed partial response ( PR ) , 17 patients ( 77 % ) had stable disease ( SD ) , and one patient ( 5 % ) had PD . In the PEG interferon arm , 15 patients ( 68 % ) had SD and six patients ( 27 % ) had PD . Progression-free survival ( PFS ) rates after 18 weeks of monotherapy were 95 % in bevacizumab versus 68 % on the PEG interferon arm . The overall median PFS for all 44 patients is 63 weeks . Compared with paired baseline measurements on functional CT scans , we observed a 49 % ( P < .01 ) and 28 % ( P < .01 ) decrease in tumor blood flow at day 2 and week 18 among patients treated with bevacizumab . No significant changes in tumor blood flow were observed following PEG interferon . PEG interferon alpha-2b treatment was associated with decrease in plasma basic fibroblast growth factor ( bFGF ; P = .04 ) and increase in plasma interleukin-18 ( IL-18 ; P < .01 ) . No significant changes in bFGF or IL-18 following treatment with bevacizumab were observed . CONCLUSION Bevacizumab therapy result ed in objective responses , reduction of tumor blood flow , and longer PFS in patients with carcinoid than PEG interferon treatment PURPOSE Optimal treatments for metastatic carcinoid tumor remain undefined , and the role of chemotherapy for symptomatic patients with progressive disease is uncertain . PATIENTS AND METHODS Two hundred forty-nine patients with advanced carcinoid tumors were r and omized to either doxorubicin with fluorouracil ( FU/DOX ) or streptozocin with fluorouracil ( FU/STZ ) . Patients crossed over to the dacarbazine ( DTIC ) treatment after disease progression following first-line treatment ( either FU/DOX or FU/STZ ) , and 73 patients were assigned to one of these three treatments based on their previous treatment or on abnormal baseline cardiac or renal function . RESULTS In the r and omized group , there was no difference between FU/DOX and FU/STZ in response rates ( 15.9 % v 16 % ) and progression-free survival ( 4.5 v 5.3 months ) . FU/STZ ( 24.3 months ) was superior to FU/DOX ( 15.7 months ; P = .0267 ) in median survival . The response rate of crossover DTIC treatment was 8.2 % , with a median survival of 11.9 months . Hematologic toxicities were the major treatment-related toxicities for both FU/DOX and FU/STZ , and mild to moderate renal toxicity was reported in 40 ( 34.8 % ) of 115 patients in the FU/STZ arm . CONCLUSION Response to all three treatment regimens were modest . FU/STZ improved survival compared with the doxorubicin-based regimen , suggesting that the combination should be considered to be an active regimen of therapy when chemotherapy is judged to be an option for selected patients with car
Output:
| The pNETs trials consistently found that the interventions improved PFS and overall survival ( OS ) compared with BSC .
Our indirect comparison found no significant difference in PFS between everolimus and sunitinib .
After adjustment , our indirect comparison suggested a lower , but non-significant , hazard of death for sunitinib compared with everolimus .
In GI and lung NETs , everolimus significantly improved PFS compared with BSC and showed a non-significant trend towards improved OS compared with BSC .
Adverse events were more commonly reported following treatment with targeted interventions than after treatment with BSC .
Given NICE 's current stated range of £ 20,000 - 30,000 per QALY for the cost-effectiveness threshold , based on list prices , only sunitinib might be considered good value for money in Engl and and Wales . |
MS211248 | ***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: AIM To evaluate the protocol -specified final analysis of overall survival ( OS ) in the KEYNOTE-002 study ( NCT01704287 ) of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory , advanced melanoma . METHODS In this r and omised , phase II study , eligible patients had advanced melanoma with documented progression after two or more ipilimumab doses , previous BRAF or MEK inhibitor or both , if BRAFV600 mutant-positive . Patients were r and omised to pembrolizumab 2 mg/kg or 10 mg/kg every 3 weeks or investigator-choice chemotherapy . Crossover to pembrolizumab was allowed following progression on chemotherapy . The protocol -specified final OS was performed in the intent-to-treat population . Survival was positive if p < 0.01 in one pembrolizumab arm . RESULTS A total of 180 patients were r and omised to pembrolizumab 2 mg/kg , 181 to pembrolizumab 10 mg/kg and 179 to chemotherapy . At a median follow-up of 28 months ( range 24.1 - 35.5 ) , 368 patients died and 98 ( 55 % ) crossed over to pembrolizumab . Pembrolizumab 2 mg/kg ( hazard ratio [ HR ] 0.86 , 95 % confidence interval [ CI ] 0.67 - 1.10 , p = 0.117 ) and 10 mg/kg ( 0.74 , 0.57 - 0.96 , p = 0.011 ) result ed in a non-statistically significant improvement in OS versus chemotherapy ; median OS was 13.4 ( 95 % CI 11.0 - 16.4 ) and 14.7 ( 95 % CI 11.3 - 19.5 ) , respectively , versus 11.0 months ( 95 % CI 8.9 - 13.8 ) , with limited improvement after censoring for crossover . Two-year survival rates were 36 % and 38 % , versus 30 % . Progression-free survival , objective response rate and duration of response improved with pembrolizumab versus chemotherapy , regardless of dose . Grade III-V treatment-related adverse events occurred in 24 ( 13.5 % ) , 30 ( 16.8 % ) and 45 ( 26.3 % ) patients , respectively . CONCLUSION Improvement in OS with pembrolizumab was not statistically significant at either dose versus chemotherapy 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 Nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , disrupts PD-1-mediated signaling and may restore antitumor immunity . METHODS In this r and omized , open-label , international phase 3 study , we assigned patients with nonsquamous non-small-cell lung cancer ( NSCLC ) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks . The primary end point was overall survival . RESULTS Overall survival was longer with nivolumab than with docetaxel . The median overall survival was 12.2 months ( 95 % confidence interval [ CI ] , 9.7 to 15.0 ) among 292 patients in the nivolumab group and 9.4 months ( 95 % CI , 8.1 to 10.7 ) among 290 patients in the docetaxel group ( hazard ratio for death , 0.73 ; 96 % CI , 0.59 to 0.89 ; P=0.002 ) . At 1 year , the overall survival rate was 51 % ( 95 % CI , 45 to 56 ) with nivolumab versus 39 % ( 95 % CI , 33 to 45 ) with docetaxel . With additional follow-up , the overall survival rate at 18 months was 39 % ( 95 % CI , 34 to 45 ) with nivolumab versus 23 % ( 95 % CI , 19 to 28 ) with docetaxel . The response rate was 19 % with nivolumab versus 12 % with docetaxel ( P=0.02 ) . Although progression-free survival did not favor nivolumab over docetaxel ( median , 2.3 months and 4.2 months , respectively ) , the rate of progression-free survival at 1 year was higher with nivolumab than with docetaxel ( 19 % and 8 % , respectively ) . Nivolumab was associated with even greater efficacy than docetaxel across all end points in subgroups defined according to prespecified levels of tumor-membrane expression ( ≥1 % , ≥5 % , and ≥10 % ) of the PD-1 lig and . Treatment-related adverse events of grade 3 or 4 were reported in 10 % of the patients in the nivolumab group , as compared with 54 % of those in the docetaxel group . CONCLUSIONS Among patients with advanced nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy , overall survival was longer with nivolumab than with docetaxel . ( Funded by Bristol-Myers Squibb ; CheckMate 057 Clinical Trials.gov number , NCT01673867 . ) BACKGROUND Nivolumab , a fully human IgG4 PD-1 immune checkpoint inhibitor antibody , can result in durable responses in patients with melanoma who have progressed after ipilimumab and BRAF inhibitors . We assessed the efficacy and safety of nivolumab compared with investigator 's choice of chemotherapy ( ICC ) as a second-line or later-line treatment in patients with advanced melanoma . METHODS In this r and omised , controlled , open-label , phase 3 trial , we recruited patients at 90 sites in 14 countries . Eligible patients were 18 years or older , had unresectable or metastatic melanoma , and progressed after ipilimumab , or ipilimumab and a BRAF inhibitor if they were BRAF(V 600 ) mutation-positive . Participating investigators r and omly assigned ( with an interactive voice response system ) patients 2:1 to receive an intravenous infusion of nivolumab 3 mg/kg every 2 weeks or ICC ( dacarbazine 1000 mg/m(2 ) every 3 weeks or paclitaxel 175 mg/m(2 ) combined with carboplatin area under the curve 6 every 3 weeks ) until progression or unacceptable toxic effects . We stratified r and omisation by BRAF mutation status , tumour expression of PD-L1 , and previous best overall response to ipilimumab . We used permuted blocks ( block size of six ) within each stratum . Primary endpoints were the proportion of patients who had an objective response and overall survival . Treatment was given open-label , but those doing tumour assessment s were masked to treatment assignment . We assessed objective responses per- protocol after 120 patients had been treated with nivolumab and had a minimum follow-up of 24 weeks , and safety in all patients who had had at least one dose of treatment . The trial is closed and this is the first interim analysis , reporting the objective response primary endpoint . This study is registered with Clinical Trials.gov , number NCT01721746 . FINDINGS Between Dec 21 , 2012 , and Jan 10 , 2014 , we screened 631 patients , r and omly allocating 272 patients to nivolumab and 133 to ICC . Confirmed objective responses were reported in 38 ( 31·7 % , 95 % CI 23·5 - 40·8 ) of the first 120 patients in the nivolumab group versus five ( 10·6 % , 3·5 - 23·1 ) of 47 patients in the ICC group . Grade 3 - 4 adverse events related to nivolumab included increased lipase ( three [ 1 % ] of 268 patients ) , increased alanine aminotransferase , anaemia , and fatigue ( two [ 1
Output:
| Conclusions The incidence of high- grade and all- grade pneumonitis is higher in anti-PD-1 therapy but not in anti-PD-L1 therapy when compared to traditional CTH regimens for NSCLC and melanoma .
High- grade adverse events were otherwise more common in the CTH arm .
Tumor response rate , PFS , and OS are all substantially improved with IMM over CTH . |
MS211249 | ***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 aim of this study is to compare the effectiveness of the 5-HT3 antagonist , ondansetron and a non-steroidal anti-inflammatory agent , diclofenac sodium , as a pain reliever in the treatment of acute ureteral colic . Sixty four patients with severe or moderate pain who were clinical ly diagnosed as having ureteral colic associated with microscopic or gross hematuria were included in the study . Thirty three patients were administered ondansetron and 31 patients were administered diclofenac sodium . Exclusion critera were known kidney or liver disease causing dysfunction , known hypersensitivity to ondansetron or diclofenac sodium , pregnancy , lactation , duodenal ulcer or bleeding . After pain assessment with a verbal scale and a visual analog scale ( VAS ) , we r and omized patients and administered 8 mg ondansetron intravenously to 33 patients and 75 mg diclofenac sodium intramuscularly to 31 patients and pain scores were recorded every 15 minutes . If significant pain relief was not achieved within 60 minutes , IV meperidine was given as rescue pain medication . Ondansetron was effective as a primary pain reliever in 14 ( 42.4 % ) patients , whereas 19 patients required additional medication . Diclofenac sodium was effective as a primary pain reliever in 24 ( 77.4 % ) patients , whereas 7 patients required additional medication . Ondansetron was not superior to diclofenac sodium in relieving pain in patients with acute ureteral colic Eighty-six patients with ureteral colic were included in a r and omised , prospect i ve , double-blind study of the analgesic efficacy and tolerance of ketoprofen versus diclofenac , both administered intramuscularly . There were no significant differences regarding pain-relief or side-effects The aim of this study was to assess the efficacy of desmopressin nasal spray compared with diclofenac given intramuscularly in patients with acute renal colic caused by urolithiasis . The study included 72 patients r and omized into three different groups : group A received desmopressin ( 40 mg , nasal spray ) , group B diclofenac ( 75 mg ) intramuscularly and group C , both desmopressin and diclofenac . Pain was assessed using a visual analogue scale at baseline , 10 , 30 min and 1 h after administering the treatments . Rescue analgesia was given at 30 min if needed . On admission , the pain level was the same in all three groups ( group A 85 ; and group B and C 90 each ) . At 10 min the pain decreased minimally in all the groups but more in group B and C ( group A 80 and group B and C 70 each ) . At 30 min pain scores were 75 , 37.5 and 40 for group A , B and C , respectively , indicating that there was no significant pain relief in desmopressin group . Rescue analgesic had to be given to all patients in group A and two patients in group B and three patients in group C. Pain relief in the desmopressin only group was significantly less at 1 h even after rescue analgesia ( pain scores of 27.5 , 15 and 20 for group A , B and C respectively ) . Intranasal desmopressin is not an effective analgesic in renal colic : exerts mild analgesic effect over a period of 30 min . It does not potentiate the effect of diclofenac Objective The aim of this study was to assess the efficacy and safety of a single intravenous ( i.v . ) bolus of dexketoprofen trometamol compared with an i.v . infusion of dipyrone in patients with moderate to severe pain due to renal colic . Methods A total of 308 patients with renal colic and visual analog scale ( VAS ) score ≥40 mm participated in a multicenter , r and omized , double blind , double-dummy , parallel , and active-controlled study and were r and omized to dexketoprofen 25 mg ( n = 101 ) , dexketoprofen 50 mg ( n = 104 ) , and dipyrone 2 g ( n = 103 ) . Results Mean [ ± st and ard deviation ( SD ) ] total pain relief ( TOTPAR ) scores were similar in the dexketoprofen 50 mg ( 15.3 ± 8.6 ) and dipyrone ( 15.5 ± 8.6 ) and slighly higher than in dexketoprofen 25 mg ( 13.5 ± 8.6 ) , although significant differences were not achieved . In the same way , patients in the dexketoprofen 50 mg and dipyrone groups showed higher scores in the sum of pain intensity differences ( SPID ) and the sum of analogue pain intensity differences ( SAPID ) than patients in the dexketoprofen 25 mg group , reaching statistical significance in comparison with dexketoprofen 25 mg and dipyrone for SPID and SAPID ( p < 0.05 ) . The time – effect course for pain intensity differences and pain relief showed significantly higher values for both doses of dexketoprofen during the first 30 min after drug administration ( p < 0.05 ) . Dexketoprofen 50 mg and dipyrone groups had 66 % and 70 % , respectively , of patients with at least 50 % of maximum obtainable TOTPAR in comparison with 56 % in the dexketoprofen 25 mg group . The study medications were well tolerated . Conclusions Dexketoprofen 50 mg administered as a single i.v . bolus was effective for the relief of moderate to severe pain in patients with renal colic , with a good safety profile and efficacy similar to i.v . dipyrone 2 g. Dexketoprofen produced analgesia that was faster in onset Intravenous indoprofen ( 400 mg ) , a cyclooxygenase inhibitor , was compared with intramuscular oxicodone hydrochloride (= oxicone 10 mg ) , a narcotic analgesic agent , in regard to efficacy and side effects in the treatment of renal colic . Oxicone was combined with papaverine ( 20 mg ) . Patients were r and omized to either treatment , and the drugs were given in double-dummy fashion , i.e. one injection of active drug plus one placebo injection . Pain intensity before and after treatment was registered by the patient ( visual analog scale ) and by a nurse , who also registered side effects . Oxicone was given to 46 patients and indoprofen to 48 . The groups did not differ in body weight , age , sex distribution , or pretreatment intensity of pain . More patients required additional treatment in the oxicone than in the indoprofen group ( 19 v. 10 ) . At 2 - 5 min after injection , pain reduction was greater with indoprofen , and more patients in this group had pain relief after 3 - 5 hours . Side effects were less frequent with indoprofen than with oxicone ( 1 v. 20 patients ) , in particular from the central nervous system . This difference probably was related to indoprofen 's slow and poor penetration of the blood-brain barrier . The study affirmed that non-narcotic cyclooxygenase inhibitors can replace narcotic analgesics for acute pain alleviation in renal colic . Indoprofen seems to be a useful alternative , with low risk of central nervous side effects Summary To investigate the combined analgesic and spasmolytic effect of dipyrone , 104 patients suffering from “ severe ” or “ excruciating ” colic pain due to a confirmed calculus in the upper urinary tract were r and omized to receive i.v . either 2.5 g dipyrone ( 36 patients ) , 100 mg tramadol ( 35 patients ) , or 20 mg butylscopolamine ( 33 patients ) in a multicentre , observer-blind , parallel-group study conducted in 8 German centres . The three treatment groups were homogeneous when analyzed by age , sex , height , and baseline pain intensity . Dipyrone was significantly more effective than tramadol in reducing pain for the primary endpoint , pain intensity differences ( PID ) at 20 , 30 , and 50 min after drug administration , and was significantly more effective than butylscopolamine at 30 and 50 min for the secondary efficacy endpoint , pain intensity differences on a categorical scale . Dipyrone had the highest SPID0–2 h of the three drugs ( P<0.05 ) . Only 5 patients receiving dipyrone needed “ rescue ” medication as compared with 13 patients given tramadol and 11 patients receiving butylscopolamine . Adverse events were observed in 4 patients receiving butylscopolamine and in 1 patient each given dipyrone and tramadol . “ Distinct ” pain relief as assessed on a visual analogue scale ( VAS ) is a reliable method of determining the onset of analgesic action in the colic pain model To determine the effects of indomethacin suppositories in the relief of acute colic and prevention of recurrent colic , we instituted a prospect i ve double-blind , placebo-controlled protocol . Patients were r and omized to receive either 50 mg . indomethacin or placebo suppositories every 8 hours and all patients received prescriptions for supplemental narcotics to be used on an as needed basis . Relief of colic was assessed by counting the total number of supplemental narcotics used by each patient per 24 hours during the study period , which was defined as until passage of the calculus or 5 days . There were 41 patients entered into the study protocol and complete followup was available for 26 . Mean calculus size was 3.4 mm . in the indomethacin group versus 3.1 mm . in the placebo group . All 13 patients in the control group had recurrent episodes of colic and 8 of these 13 had more than 1 recurrent episode . Five patients in the placebo group required admission to the hospital for control of pain . In contrast , only 4 of the 13 patients in the treatment group had colic and only 1 had more than 1 episode of colic . No patient in the active drug group required admission to the hospital for control of pain . Over-all the ratio of supplemental narcotic used by the placebo group versus the indomethacin group was 7.6:1 ( p less than 0.005 ) . The mean interval time to passage of the calculus was slightly lower in the indomethacin group ( 89 versus 82 hours ) but this difference was not statistically significant ( p greater than 0.10 ) . Our data strongly support the use of indomethacin suppositories in the prevention of recurrent colic secondary to ureteral calculi The effect of glucagon administered as a bolus ( 1 mg ) followed by a continuous infusion ( 2 mg/h ) for 8 h and a placebo was compared in 37 adults with urographically demonstrated ureteral calculi less than 6 mm . The bolus injection was given 20 min after start of intravenous urography , and the infusion was initiated immediately afterwards . No effect on pain relief or passage of calculi was found . Nausea and /or vomiting were recorded significantly more frequently in patients who had glucagon than in patients who had the placebo . It is concluded that glucagon is of no value in acute ureteral colic A comparative , r and omized , double-blind study of diclofenac sodium 75 mg i m versus Baralgin ( a combination drug composed of dipyrone and two spasmolytics ) 5 mL iv was performed on 57 patients with renal colic . Both groups were comparable as to age , sex , pain evolution time before treatment , and no treatment for renal colic in the six hours preceding trial drug administration . No significant differences were found between the two groups with respect to the evolution of pain after the first dose or in the frequency of administration of a second dose . Tolerability was good in both groups , but sweating and pain throughout the vein were observed in one patient in the Baralgin group . We concluded that diclofenac sodium constitutes an excellent alternative to pyrazolone analgesics , with the advantages of being monotherapy and having good tolerability , when used as intramuscular injection in ambulatory patients In an open investigation , ciramadol , a partial agonist opioid , was found to be a potent analgesic when given intravenously in patients experiencing renal colic . Single intravenous doses of 20 , 30 and 40 mg of ciramadol were given to 11 , 11 and 12 patients with renal colic , respectively , and good pain relief was obtained in 10 , 11 and 10 patients , respectively . Vomiting and nausea occurred in 9 patients , 4 in the 20 mg group , 2 in the 30 mg group and 3 in the 40 mg group . This adverse effect was related to st and ing and walking following the ciramadol injection PURPOSE To study the safety and efficacy of intranasal desmopressin and intramuscular tramadol versus pethidine for treatment of renal colic . MATERIAL S AND METHODS A total of 90 adult patients who presented with renal colic to the emergency wards were recruited in this study . The patients were r and omly assigned to receive 100 mg intramuscular tramadol , 40µ g intranasal desmopressin , or 40µ g intranasal desmopressin plus 100 mg intramuscular tramadol . The severity of the pain was assessed using Visual Analogue Scale . RESULTS The studied patients consisted of 49 men and 41 women with the mean age of 35.20 ± 13.26 years ( range , 16 to 82 years ) . There was no statistically significant difference regarding the mean age ( F [ 2
Output:
| Although due to variability in studies ( inclusion criteria , outcome variables and interventions ) and the evidence is not of highest quality , we still believe that NSAIDs are an effective treatment for renal colic when compared to placebo or antispasmodics .
The addition of antispasmodics to NSAIDS does not result in better pain control .
Major adverse effects are not reported in the literature for the use of NSAIDs for treatment of renal colic |
MS211250 | ***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 : Heart failure ( HF ) survival has improved , and nowadays , many patients with HF die of noncardiac causes , including cancer . Our aim was to investigate whether a causal relationship exists between HF and the development of cancer . Methods : HF was induced by inflicting large anterior myocardial infa rct ion in APCmin mice , which are prone to developing precancerous intestinal tumors , and tumor growth was measured . In addition , to rule out hemodynamic impairment , a heterotopic heart transplantation model was used in which an infa rct ed or sham-operated heart was transplanted into a recipient mouse while the native heart was left in situ . After 6 weeks , tumor number , volume , and proliferation were quantified . C and i date secreted proteins were selected because they were previously associated both with ( colon ) tumor growth and with myocardial production in post – myocardial infa rct ion proteomic studies . Myocardial gene expression levels of these selected c and i date s were analyzed , as well as their proliferative effects on HT-29 ( colon cancer ) cells . We vali date d these c and i date s by measuring them in plasma of healthy subjects and patients with HF . Finally , we associated the relation between cardiac specific and inflammatory biomarkers and new-onset cancer in a large , prospect i ve general population cohort . Results : The presence of failing hearts , both native and heterotopically transplanted , result ed in significantly increased intestinal tumor load of 2.4-fold in APCmin mice ( all P<0.0001 ) . The severity of left ventricular dysfunction and fibrotic scar strongly correlated with tumor growth ( P=0.002 and P=0.016 , respectively ) . We identified several proteins ( including serpinA3 and A1 , fibronectin , ceruloplasmin , and paraoxonase 1 ) that were elevated in human patients with chronic HF ( n=101 ) compared with healthy subjects ( n=180 ; P<0.001 ) . Functionally , serpinA3 result ed in marked proliferation effects in human colon cancer ( HT-29 ) cells , associated with Akt-S6 phosphorylation . Finally , elevated cardiac and inflammation biomarkers in apparently healthy humans ( n=8319 ) were predictive of new-onset cancer ( n=1124 ) independently of risk factors for cancer ( age , smoking status , and body mass index ) . Conclusions : We demonstrate that the presence of HF is associated with enhanced tumor growth and that this is independent of hemodynamic impairment and could be caused by cardiac excreted factors . A diagnosis of HF may therefore be considered a risk factor for incident cancer INTRODUCTION From a prospect i ve multicentre multicountry clinical trial , we developed and vali date d risk models to predict prospect i ve all-cause mortality and hospitalizations because of heart failure ( HF ) in patients with HF . METHODS AND RESULTS BIOSTAT-CHF is a research programme design ed to develop and externally vali date risk models to predict all-cause mortality and HF hospitalizations . The index cohort consisted of 2516 patients with HF from 69 centres in 11 European countries . The external validation cohort consisted of 1738 comparable patients from six centres in Scotl and , UK . Patients from the index cohort had a mean age of 69 years , 27 % were female , 83 % were in New York Heart Association ( NYHA ) class II-III and the mean left ventricular ejection fraction ( LVEF ) was 31 % . The full prediction models for mortality , hospitalization owing to HF , and the combined outcome , yielded c-statistic values of 0.73 , 0.69 , and 0.71 , respectively . Predictors of mortality and hospitalization owing to HF were remarkably different . The five strongest predictors of mortality were more advanced age , higher blood urea nitrogen and N-terminal pro-B-type natriuretic peptide , lower haemoglobin , and failure to prescribe a beta-blocker . The five strongest predictors of hospitalization owing to HF were more advanced age , previous hospitalization owing to HF , presence of oedema , lower systolic blood pressure and lower estimated glomerular filtration rate . Patients from the validation cohort were aged 74 years , 34 % were female , 85 % were in NYHA class II-III , and mean LVEF was 41 % ; c-statistic values for the full and compact model were comparable to the index cohort . CONCLUSION A small number of variables , which are usually readily available in the routine clinical setting , provide useful prognostic information for patients with HF . Predictors of mortality were remarkably different from predictors of hospitalization owing to HF BACKGROUND Several recent studies have suggested an increased cancer risk among patients with heart failure ( HF ) . However , these studies are constrained by limited size and follow-up , lack of comprehensive data on other health attributes , and adjudicated cancer outcomes . OBJECTIVES This study sought to determine whether HF is associated with cancer incidence and cancer-specific mortality . METHODS The study assembled a cohort from the Physicians ' Health Studies I and II , 2 r and omized controlled trials of aspirin and vitamin supplements conducted from 1982 to 1995 and from 1997 to 2011 , respectively , that included annual health evaluations and determination of cancer and HF diagnoses . In the primary analysis , the study excluded participants with cancer or HF at baseline and performed multivariable-adjusted Cox models to determine the relationship between HF and cancer , modeling HF as a time-varying exposure . In a complementary analysis , the study used the l and mark method and identified cancer-free participants at 70 years of age , distinguishing between those with and without HF , and likewise performed Cox regression . Sensitivity analyses were performed at 65 , 75 , and 80 years of age . RESULTS Among 28,341 Physicians ' Health Study participants , 1,420 developed HF . A total of 7,363 cancers developed during a median follow-up time of 19.9 years ( 25th to 75th percentile : 11.0 to 26.8 years ) . HF was not associated with cancer incidence in crude ( hazard ratio : 0.92 ; 95 % confidence interval : 0.80 to 1.08 ) or multivariable-adjusted analysis ( hazard ratio : 1.05 ; 95 % confidence interval : 0.86 to 1.29 ) . No association was found between HF and site-specific cancer incidence or cancer-specific mortality after multivariable adjustment . Results were similar when using the l and mark method at all l and mark ages . CONCLUSIONS HF is not associated with an increased risk of cancer among male physicians BACKGROUND Heart failure ( HF ) is associated with excess morbidity and mortality for which noncardiac causes are increasingly recognized . The authors previously described an increased risk of cancer among HF patients compared with community controls . OBJECTIVES This study examined whether HF was associated with an increased risk of subsequent cancer among a homogenous population of first myocardial infa rct ion ( MI ) survivors . METHODS A prospect i ve cohort study was conducted among Olmsted County , Minnesota , residents with incident MI from 2002 to 2010 . Patients with prior cancer or HF diagnoses were excluded . RESULTS A total of 1,081 participants ( mean age 64 ± 15 years ; 60 % male ) were followed for 5,327 person-years ( mean 4.9 ± 3.0 years ) . A total of 228 patients developed HF , and 98 patients developed cancer ( excluding nonmelanoma skin cancer ) . Incidence density rates for cancer diagnosis ( per 1,000 person-years ) were 33.7 for patients with HF and 15.6 for patients without HF ( p = 0.002 ) . The hazard ratio ( HR ) for cancer associated with HF was 2.16 ( 95 % confidence interval [ CI ] : 1.39 to 3.35 ) ; adjusted for age , sex , and Charlson comorbidity index ; HR : 1.71 ( 95 % CI : 1.07 to 2.73 ) . The HRs for mortality associated with cancer were 4.90 ( 95 % CI : 3.10 to 7.74 ) for HF-free and 3.91 ( 95 % CI : 1.88 to 8.12 ) for HF patients ( p for interaction = 0.76 ) . CONCLUSIONS Patients who develop HF after MI have an increased risk of cancer . This finding extends our previous report of an elevated cancer risk after HF compared with controls , and calls for a better underst and ing of shared risk factors and underlying mechanisms AIMS The prevalence of cardiovascular and non-cardiovascular co-morbidities and their relative importance for outcomes in heart failure with preserved ejection fraction ( HFPEF ) remain poorly characterized . This study aim ed to investigate this . METHODS AND RESULTS The Karolinska-Rennes ( KaRen ) Study was a multinational prospect i ve observational study design ed to characterize HFPEF . Inclusion required acute HF , defined by the Framingham criteria , LVEF ≥ 45 % , and NT-pro-BNP ≥ 300 ng/L or BNP ≥ 100 ng/L. Detailed clinical data were collected at baseline and patients were followed prospect ively for 18 months . Predictors of the primary ( HF hospitalization or all-cause mortality ) and secondary ( all-cause mortality ) outcomes were assessed with multivariable Cox regression . A total of 539 patients [ 56 % women ; median ( interquartile range ) age 79 ( 72 - 84 ) years ; NT-pro-BNP/BNP 2448 (1290 - 4790)/429 ( 229 - 805 ) ng/L ] were included . Known history of HF was present in 40 % . Co-morbidities included hypertension ( 78 % ) , atrial fibrillation/flutter ( 65 % ) , anaemia ( 51 % ) , renal dysfunction ( 46 % ) , CAD ( 33 % ) , diabetes ( 30 % ) , lung disease ( 25 % ) , and cancer ( 16 % ) . The primary outcome occurred in 268 patients [ 50 % ; 106 deaths ( 20 % ) and 162 HF hospitalizations ( 30 % ) ] . Important independent predictors of the primary and /or secondary outcomes were age , history of non-cardiovascular syncope , valve disease , anaemia , lower sodium , and higher potassium , but no cardiovascular co-morbidities . Renin-angiotensin system antagonist and mineralocorticoid receptor antagonist use predicted improved prognosis . CONCLUSION HFPEF was associated with higher age , female gender , hypertension , atrial fibrillation/flutter , and numerous non-cardiovascular co-morbidities . Prognosis was determined by non-cardiovascular co-morbidities , but use of conventional heart failure medications may still be associated with improved outcomes
Output:
| In this meta- analysis and systematic review , our results demonstrated that heart failure may increase the risk of incident cancer and that HF associated with cancer increases the risk of mortality |
MS211251 | ***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: Aim The aim of the present study was to compare threshold inspiratory muscle training ( IMT ) and expiratory muscle training ( EMT ) in elderly male patients with moderate degree of COPD . Material s and methods Forty male patients with moderate degree of COPD were recruited for this study . They were r and omly divided into two groups : the IMT group who received inspiratory training with an intensity ranging from 15 % to 60 % of their maximal inspiratory pressure , and the EMT group who received expiratory training with an equal intensity which was adjusted according to the maximal expiratory pressure . Both groups received training three times per week for 2 months , in addition to their prescribed medications . Results Both IMT and EMT groups showed a significant improvement in forced vital capacity , forced expiratory volume in the first second , forced expiratory volume in the first second% from the predicted values , and forced vital capacity% from the predicted value , with no difference between the groups . Both types of training result ed in a significant improvement in blood gases ( SaO2 % , PaO2 , PaCO2 , and HCO3 ) , with the inspiratory muscle group showing the best results . Both groups showed a significant improvement in the 6-min walking distance : an increase of about 25 % in the inspiratory muscle group and about 2.5 % in the expiratory muscle group . Conclusion Both IMT and EMT must be implemented in pulmonary rehabilitation programs in order to achieve improvements in pulmonary function test , respiratory muscle strength , blood oxygenation , and 6-min walking distance OBJECTIVE To determine the effects of a short- duration , combined ( inspiratory and expiratory ) , progressive resistance respiratory muscle training ( RMT ) protocol on respiratory muscle strength , fatigue , health-related quality of life , and functional performance in individuals with mild-to-moderate multiple sclerosis ( MS ) . DESIGN Quasi-experimental before-after trial . SETTING University rehabilitation research laboratory . PARTICIPANTS Volunteers with MS ( N=21 ) were divided into 2 groups : RMT ( n=11 ; 9 women , 2 men ; mean age ± SD , 50.9 ± 5.7y , mean Exp and ed Disability Status Scale score ± SD , 3.2 ± 1.9 ) and a control group that did not train ( n=10 ; 7 women , 3 men ; mean age ± SD , 56.2 ± 8.8y , mean Exp and ed Disability Status Scale score ± SD , 4.4 ± 2.1 ) . Exp and ed Disability Status Scale scores ranged from 1 to ≤6.5 . No patients withdrew from the study . INTERVENTION Training was a 5-week combined progressive resistance RMT program , 3d/wk , 30 minutes per session . MAIN OUTCOME MEASURES The primary outcome measures were maximal inspiratory pressure and expiratory pressure and the Modified Fatigue Impact Scale . All subjects completed secondary measures of pulmonary function , the six-minute walk test , the timed stair climb , the Multiple Sclerosis Self-Efficacy Scale , the Medical Outcomes Study 36-Item Short-Form Health Survey , and the Physical Activity Disability Scale . RESULTS Maximal inspiratory pressure and expiratory pressure ( mean ± SD ) increased 35 % ± 22 % ( P<.001 ) and 26 % ± 17 % ( P<.001 ) , respectively , whereas no changes were noted in the control group ( 12 % ± 23 % and -4 % ± 17 % , respectively ) . RMT improved fatigue ( Modified Fatigue Impact Scale , P<.029 ) , with no change or worsening in the control group . No changes were noted in the six-minute walk test , stair climb , Multiple Sclerosis Self-Efficacy Scale , or Physical Activity Disability Scale in the RMT group . The control group had decreases in emotional well-being and general health ( Medical Outcomes Study 36-Item Short-Form Health Survey ) . CONCLUSIONS A short- duration , combined RMT program improved inspiratory and expiratory muscle strength and reduced fatigue in patients with mild to moderate MS Objective : Dysphagia is the main cause of aspiration pneumonia and death in Parkinson disease ( PD ) with no established restorative behavioral treatment to date . Reduced swallow safety may be related to decreased elevation and excursion of the hyolaryngeal complex . Increased submental muscle force generation has been associated with expiratory muscle strength training ( EMST ) and subsequent increases in hyolaryngeal complex movement provide a strong rationale for its use as a dysphagia treatment . The current study 's objective was to test the treatment outcome of a 4-week device-driven EMST program on swallow safety and define the physiologic mechanisms through measures of swallow timing and hyoid displacement . Methods : This was a r and omized , blinded , sham-controlled EMST trial performed at an academic center . Sixty participants with PD completed EMST , 4 weeks , 5 days per week , for 20 minutes per day , using a calibrated or sham , h and held device . Measures of swallow function including judgments of swallow safety ( penetration – aspiration [ PA ] scale scores ) , swallow timing , and hyoid movement were made from videofluoroscopic images . Results : No pretreatment group differences existed . The active treatment ( EMST ) group demonstrated improved swallow safety compared to the sham group as evidence d by improved PA scores . The EMST group demonstrated improvement of hyolaryngeal function during swallowing , findings not evident for the sham group . Conclusions : EMST may be a restorative treatment for dysphagia in those with PD . The mechanism may be explained by improved hyolaryngeal complex movement . Classification of evidence : This intervention study provides Class I evidence that swallow safety as defined by PA score improved post EMST BACKGROUND Pulmonary and respiratory muscle function impairment are common in patients with Parkinson 's disease ( PD ) . Inspiratory muscle training may improve strength , dyspnea and functional capacity in healthy subjects and in those with chronic obstructive pulmonary disease . This study investigated the effect of specific inspiratory muscle training ( SIMT ) on pulmonary functions , inspiratory muscle performance , dyspnea and quality of life , in patients with PD . PATIENTS AND METHODS Twenty patients with PD ( stage II and III Hoehn and Yahr scale ) were recruited for the study and were divided into two groups : ( a ) ten patients who received SIMT and ( b ) ten patients who received sham training , for three months . Pulmonary functions , the respiratory muscle strength and endurance , the perception of dyspnea ( POD ) and the quality of life were studied before and within one week after the training period . All subjects trained daily , six times a week , each session consisting of 1/2 hour , for 12 weeks . RESULTS Following the training period , there was a significant improvement , in the training group but not in the control group , in the following parameters : inspiratory muscle strength , ( PImax , increased from 62.0 + /- 8.2 to 78.0 + /- 7.5 cm of H2O ( p < 0.05 ) , inspiratory muscle endurance ( increased from 20.0 + /- 2.8 to 29.0 + /- 3.0 cm of H2O ( p < 0.05 ) , and the POD ( decreased from 17.9 + /- 3.2 to 14.0 + /- 2.4 units ( p < 0.05 ) . There was a close correlation between the increase in the inspiratory muscle performance and the decrease in the POD . CONCLUSIONS The inspiratory muscle performance may be improved by SIMT in patients with PD . This improvement is associated with a significant decrease in their POD BACKGROUND Recently , resistance expiratory muscle strength training ( EMST ) has been reported as a remedial treatment for dysphagia . OBJECTIVE To investigate the effect of resistance EMST on the swallowing function in stroke patients with oropharyngeal dysphagia . METHODS Forty-two stroke patients with dysphagia were r and omly assigned to two groups : an experimental group ( n = 13 ) and a placebo group ( n = 13 ) . The experimental group performed EMST using a portable EMST device , while the placebo group performed EMST using a sham EMST device with no loading . The intervention was performed 5 days per week for 4weeks , in five sets of 5 breaths through the device for a total of 25 breaths per day . Both groups underwent conventional dysphagia treatment for 30 minutes/day , 5 days/week , for 4 weeks . Videofluoroscopic dysphagia scale ( VDS ) and penetration-aspiration scale ( PAS ) based on a videofluoroscopic swallowing study ( VFSS ) were assessed to analyze the oropharyngeal swallowing function . RESULTS The experimental group showed more improvement in pharyngeal phase of the VDS ( p = 0.018 and 0.006 , respectively ) and PAS compared to the placebo group ( p = 0.014 ) . CONCLUSIONS We suggest that EMST could improve the effects of dysphagia observed in post-stroke elderly patients based on swallowing function Objective : To compare the effects of an inspiratory versus and expiratory muscle-training program on voluntary and reflex peak cough flow in patients with Parkinson disease . Design : A r and omized controlled study . Setting : Home-based training program . Participants : In all , 40 participants with diagnosis of Parkinson ’s disease were initially recruited in the study and r and omly allocated to three study groups . Of them , 31 participants completed the study protocol ( control group , n = 10 ; inspiratory training group , n = 11 ; and expiratory training group , n = 10 ) Intervention : The inspiratory and expiratory group performed a home-based inspiratory and expiratory muscle-training program , respectively ( five sets of five repetitions ) . Both groups trained six times a week for two months using a progressively increased resistance . The control group performed expiratory muscle training using the same protocol and a fixed resistance . Main measures : Spirometric indices , maximum inspiratory pressure , maximum expiratory pressure , and peak cough flow during voluntary and reflex cough were assessed before and at two months after training . Results : The magnitude of increase in maximum expiratory pressure ( d = 1.40 ) and voluntary peak cough flow ( d = 0.89 ) was greater for the expiratory muscle-training group in comparison to the control group . Reflex peak cough flow had a moderate effect ( d = 0.27 ) in the expiratory group in comparison to the control group . Slow vital capacity ( d = 0.13 ) and forced vital capacity ( d = 0.02 ) had trivial effects in the expiratory versus the control group . Conclusions : Two months of expiratory muscle-training program was more beneficial than inspiratory muscle-training program for improving maximum expiratory pressure and voluntary peak cough flow in patients with Parkinson ’s disease Expiratory muscle strength training ( EMST ) involves forcible blowing as a means of generating high expiratory pressure , against adjustable resistance . EMST has recently been introduced as a potential treatment for dysphagia . This study was performed to investigate the effects of EMST on the activity of suprahyoid muscles , aspiration and dietary stages in stroke patients with dysphagia . Twenty-seven stroke patients with dysphagia were r and omly divided into two groups . The experimental group performed EMST with a 70 % threshold value of maximal expiratory pressure , using an EMST device , 5 days a week for 4 weeks . The placebo group trained with a sham device . The EMST regime involved 5 sets of 5 breaths through the EMST device for a total of 25 breaths per day . Activity in the suprahyoid muscle group was measured using surface electromyography ( sEMG ) . Further , the penetration-aspiration scale ( PAS ) was used to assess the results of the videofluoroscopic swallowing study ( VFSS ) . In addition , dietary stages were evaluated using the Functional Oral Intake Scale ( FOIS ) . The experimental group exhibited improved suprahyoid muscle group activity and PAS results , when compared to the placebo group . Following intervention , statistical analysis indicated significant differences in measured suprahyoid muscle activity ( P = 0·01 ) , liquid PAS outcomes ( P = 0·03 ) and FOIS results ( P = 0·06 ) , but not semisolid type PAS outcomes ( P = 0·32 ) , between the groups . This study confirms EMST as an effective treatment for the development of suprahyoid muscle activity in stroke patients with dysphagia . Additionally , improvements in aspiration and penetration outcomes were observed BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79
Output:
| Conclusions : Respiratory muscle training may be an effective alternative for improving respiratory muscle strength , swallowing function and phonatory parameters in subjects with Parkinson ’s disease . |
MS211252 | ***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: Evidence suggests that flavonoid-containing diets reduce cardiovascular risk , but the mechanisms responsible are unclear . In the present study , we sought to determine the effect of flavanol-rich cocoa on vascular function in individuals with CAD ( coronary artery disease ) . Forty subjects ( 61+/-8 years ; 30 male ) with CAD were recruited to a 6-week r and omized double-blind placebo-controlled study . Subjects consumed either a flavanol-rich chocolate bar and cocoa beverage daily ( total flavanols , 444 mg/day ) or matching isocaloric placebos daily ( total flavanols , 19.6 mg/day ) for 6 weeks . Brachial artery FMD ( flow-mediated dilation ) and SAC ( systemic arterial compliance ) were assessed at baseline , 90 min following the first beverage and after 3 and 6 weeks of daily consumption . Soluble cellular adhesion molecules and FBF ( forearm blood flow ) responses to ACh ( acetylcholine chloride ; 3 - 30 microg/min ) and SNP ( sodium nitroprusside ; 0.3 - 3 microg/min ) infusions , forearm ischaemia and isotonic forearm exercise were assessed at baseline and after 6 weeks . FMD , SAC and FBF responses did not differ between groups at baseline . No acute or chronic changes in FMD or SAC were seen in either group . No difference in soluble cellular adhesion molecules , FBF responses to ischaemia , exercise , SNP or ACh was seen in the group receiving flavanol-rich cocoa between baseline and 6 weeks . These data suggest that over a 6-week period , flavanol-rich cocoa does not modify vascular function in patients with established CAD Background Consumption of chocolate has been often hypothesized to reduce the risk of cardiovascular disease ( CVD ) due to chocolate 's high levels of stearic acid and antioxidant flavonoids . However , debate still lingers regarding the true long term beneficial cardiovascular effects of chocolate overall . Methods We review ed English- language MEDLINE publications from 1966 through January 2005 for experimental , observational , and clinical studies of relations between cocoa , cacao , chocolate , stearic acid , flavonoids ( including flavonols , flavanols , catechins , epicatechins , and procynadins ) and the risk of cardiovascular disease ( coronary heart disease ( CHD ) , stroke ) . A total of 136 publications were selected based on relevance , and quality of design and methods . An up date d meta- analysis of flavonoid intake and CHD mortality was also conducted . Results The body of short-term r and omized feeding trials suggests cocoa and chocolate may exert beneficial effects on cardiovascular risk via effects on lowering blood pressure , anti-inflammation , anti-platelet function , higher HDL , decreased LDL oxidation . Additionally , a large body of trials of stearic acid suggests it is indeed cholesterol-neutral . However , epidemiologic studies of serum and dietary stearic acid are inconclusive due to many method ologic limitations . Meanwhile , the large body of prospect i ve studies of flavonoids suggests the flavonoid content of chocolate may reduce risk of cardiovascular mortality . Our up date d meta- analysis indicates that intake of flavonoids may lower risk of CHD mortality , RR = 0.81 ( 95 % CI : 0.71–0.92 ) comparing highest and lowest tertiles . Conclusion Multiple lines of evidence from laboratory experiments and r and omized trials suggest stearic acid may be neutral , while flavonoids are likely protective against CHD mortality . The highest priority now is to conduct larger r and omized trials to definitively investigate the impact of chocolate consumption on long-term cardiovascular outcomes Consumption of flavanol-rich dark chocolate ( DC ) has been shown to decrease blood pressure ( BP ) and insulin resistance in healthy subjects , suggesting similar benefits in patients with essential hypertension ( EH ) . Therefore , we tested the effect of DC on 24-hour ambulatory BP , flow-mediated dilation ( FMD ) , and oral glucose tolerance tests ( OGTTs ) in patients with EH . After a 7-day chocolate-free run-in phase , 20 never-treated , grade I patients with EH ( 10 males ; 43.7±7.8 years ) were r and omized to receive either 100 g per day DC ( containing 88 mg flavanols ) or 90 g per day flavanol-free white chocolate ( WC ) in an isocaloric manner for 15 days . After a second 7-day chocolate-free period , patients were crossed over to the other treatment . Noninvasive 24-hour ambulatory BP , FMD , OGTT , serum cholesterol , and markers of vascular inflammation were evaluated at the end of each treatment . The homeostasis model assessment of insulin resistance ( HOMA-IR ) , quantitative insulin sensitivity check index ( QUICKI ) , and insulin sensitivity index ( ISI ) were calculated from OGTT values . Ambulatory BP decreased after DC ( 24-hour systolic BP −11.9±7.7 mm Hg , P<0.0001 ; 24-hour diastolic BP −8.5±5.0 mm Hg , P<0.0001 ) but not WC . DC but not WC decreased HOMA-IR ( P<0.0001 ) , but it improved QUICKI , ISI , and FMD . DC also decreased serum LDL cholesterol ( from 3.4±0.5 to 3.0±0.6 mmol/L ; P<0.05 ) . In summary , DC decreased BP and serum LDL cholesterol , improved FMD , and ameliorated insulin sensitivity in hypertensives . These results suggest that , while balancing total calorie intake , flavanols from cocoa products may provide some cardiovascular benefit if included as part of a healthy diet for patients with EH BACKGROUND Studies suggest cardioprotective benefits of dark chocolate containing cocoa . OBJECTIVE This study examines the acute effects of solid dark chocolate and liquid cocoa intake on endothelial function and blood pressure in overweight adults . DESIGN R and omized , placebo-controlled , single-blind crossover trial of 45 healthy adults [ mean age : 53 y ; mean body mass index ( in kg/m(2 ) ) : 30 ] . In phase 1 , subjects were r and omly assigned to consume a solid dark chocolate bar ( containing 22 g cocoa powder ) or a cocoa-free placebo bar ( containing 0 g cocoa powder ) . In phase 2 , subjects were r and omly assigned to consume sugar-free cocoa ( containing 22 g cocoa powder ) , sugared cocoa ( containing 22 g cocoa powder ) , or a placebo ( containing 0 g cocoa powder ) . RESULTS Solid dark chocolate and liquid cocoa ingestion improved endothelial function ( measured as flow-mediated dilatation ) compared with placebo ( dark chocolate : 4.3 + /- 3.4 % compared with -1.8 + /- 3.3 % ; P < 0.001 ; sugar-free and sugared cocoa : 5.7 + /- 2.6 % and 2.0 + /- 1.8 % compared with -1.5 + /- 2.8 % ; P < 0.001 ) . Blood pressure decreased after the ingestion of dark chocolate and sugar-free cocoa compared with placebo ( dark chocolate : systolic , -3.2 + /- 5.8 mm Hg compared with 2.7 + /- 6.6 mm Hg ; P < 0.001 ; and diastolic , -1.4 + /- 3.9 mm Hg compared with 2.7 + /- 6.4 mm Hg ; P = 0.01 ; sugar-free cocoa : systolic , -2.1 + /- 7.0 mm Hg compared with 3.2 + /- 5.6 mm Hg ; P < 0.001 ; and diastolic : -1.2 + /- 8.7 mm Hg compared with 2.8 + /- 5.6 mm Hg ; P = 0.014 ) . Endothelial function improved significantly more with sugar-free than with regular cocoa ( 5.7 + /- 2.6 % compared with 2.0 + /- 1.8 % ; P < 0.001 ) . CONCLUSIONS The acute ingestion of both solid dark chocolate and liquid cocoa improved endothelial function and lowered blood pressure in overweight adults . Sugar content may attenuate these effects , and sugar-free preparations may augment them BACKGROUND Numerous studies indicate that flavanols may exert significant vascular protection because of their antioxidant properties and increased nitric oxide bioavailability . In turn , nitric oxide bioavailability deeply influences insulin-stimulated glucose uptake and vascular tone . Thus , flavanols may also exert positive metabolic and pressor effects . OBJECTIVE The objective was to compare the effects of either dark or white chocolate bars on blood pressure and glucose and insulin responses to an oral-glucose-tolerance test in healthy subjects . DESIGN After a 7-d cocoa-free run-in phase , 15 healthy subjects were r and omly assigned to receive for 15 d either 100 g dark chocolate bars , which contained approximately 500 mg polyphenols , or 90 g white chocolate bars , which presumably contained no polyphenols . Successively , subjects entered a further cocoa-free washout phase of 7 d and then were crossed over to the other condition . Oral-glucose-tolerance tests were performed at the end of each period to calculate the homeostasis model assessment of insulin resistance ( HOMA-IR ) and the quantitative insulin sensitivity check index ( QUICKI ) ; blood pressure was measured daily . RESULTS HOMA-IR was significantly lower after dark than after white chocolate ingestion ( 0.94 + /- 0.42 compared with 1.72 + /- 0.62 ; P < 0.001 ) , and QUICKI was significantly higher after dark than after white chocolate ingestion ( 0.398 + /- 0.039 compared with 0356 + /- 0.023 ; P = 0.001 ) . Although within normal values , systolic blood pressure was lower after dark than after white chocolate ingestion ( 107.5 + /- 8.6 compared with 113.9 + /- 8.4 mm Hg ; P < 0.05 ) . CONCLUSION Dark , but not white , chocolate decreases blood pressure and improves insulin sensitivity in healthy persons Cocoa powder is rich in polyphenols , such as catechins and procyanidins , and has been shown in a variety of subject models to inhibit oxidized LDL and atherogenesis . Our study evaluated plasma LDL cholesterol and oxidized LDL concentrations following the intake of different levels of cocoa powder ( 13 , 19.5 , and 26 g/d ) in normocholesterolemic and mildly hypercholesterolemic humans . In this comparative , double-blind study , we examined 160 subjects who ingested either cocoa powder containing low-polyphenolic compounds ( placebo-cocoa group ) or 3 levels of cocoa powder containing high-polyphenolic compounds ( 13 , 19.5 , and 26 g/d for low- , middle- , and high-cocoa groups , respectively ) for 4 wk . The test powders were consumed as a beverage after the addition of hot water , twice each day . Blood sample s were collected at baseline and 4 wk after intake of the test beverages for the measurement of plasma lipids . Plasma oxidized LDL concentrations decreased in the low- , middle- , and high-cocoa groups compared with baseline . A stratified analysis was performed on 131 subjects who had a LDL cholesterol concentrations of > or = 3.23 mmol/L at baseline . In these subjects , plasma LDL cholesterol , oxidized LDL , and apo B concentrations decreased , and the plasma HDL cholesterol concentration increased , relative to baseline in the low- , middle- , and high-cocoa groups . The results suggest that polyphenolic substances derived from cocoa powder may contribute to a reduction in LDL cholesterol , an elevation in HDL cholesterol , and the suppression of oxidized LDL Flavanols from chocolate appear to increase nitric oxide bioavailability , protect vascular endothelium , and decrease cardiovascular disease ( CVD ) risk factors . We sought to test the effect of flavanol-rich dark chocolate ( FRDC ) on endothelial function , insulin sensitivity , beta-cell function , and blood pressure ( BP ) in hypertensive patients with impaired glucose tolerance ( IGT ) . After a run-in phase , 19 hypertensives with IGT ( 11 males , 8 females ; 44.8 + /- 8.0 y ) were r and omized to receive isocalorically either FRDC or flavanol-free white chocolate ( FFWC ) at 100 g/d for 15 d. After a wash-out period , patients were switched to the other treatment . Clinical and 24-h ambulatory BP was determined by sphygmometry and oscillometry , respectively , flow-mediated dilation ( FMD ) , oral glucose tolerance test , serum chol
Output:
| Chocolate or cocoa improved FMD regardless of the dose consumed , whereas doses > 50 mg epicatechin/d result ed in greater effects on systolic and diastolic BP .
GRADE ( Grading of Recommendations , Assessment , Development and Evaluation , a tool to assess quality of evidence and strength of recommendations ) suggested low- to moderate- quality evidence of beneficial effects , with no suggestion of negative effects .
We found consistent acute and chronic benefits of chocolate or cocoa on FMD and previously unreported promising effects on insulin and HOMA-IR . |
MS211253 | ***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: This functional magnetic resonance imaging study investigated the disgust- and fear-reactivity of patients suffering from obsessive-compulsive disorder ( OCD ) . Ten OCD patients were scanned while viewing blocks of pictures showing OCD triggers from their personal environment and OCD-irrelevant disgust-inducing , fear-inducing and neutral scenes . Afterwards , the patients rated the intensity of the induced disgust , fear and OCD symptoms . The responses were compared with those of 10 healthy control subjects . The disorder-relevant pictures provoked intense OCD symptoms in the clinical group associated with increased activation in the bilateral prefrontal cortex , the left insula , the right supramarginal gyrus , the left cau date nucleus and the right thalamus . The patients gave higher disgust and fear ratings than the controls for all aversive picture categories . Neural responses towards the disorder-irrelevant disgusting and fear-inducing material included more pronounced insula activation in patients than controls . Summarizing , photos of individual OCD-triggers are an effective means of symptom provocation and activation of the fronto-striato-thalamo-parietal network . The increased insular reactivity of OCD patients during all aversive picture conditions might mirror their susceptibility to experience negative somatic states In subjects with obsessive-compulsive disorder ( OCD ) , lower pre-treatment metabolism in the right orbitofrontal cortex ( OFC ) and anterior cingulate gyrus ( AC ) has been associated with a better response to clomipramine . We sought to determine pre-treatment metabolic predictors of response to behavioral therapy ( BT ) vs. pharmacotherapy in subjects with OCD . To do this , [18F]fluorodeoxyglucose positron emission tomography scans of the brain were obtained in subjects with OCD before treatment with either BT or fluoxetine . A Step-Wise Variable Selection was applied to normalized pre-treatment glucose metabolic rates in the OFC , AC , and cau date by treatment response ( change in Yale-Brown Obsessive-Compulsive Scale ) in the larger BT group . Left OFC metabolism ( normalized to the ipsilateral hemisphere ) alone was selected as predicting treatment response in the BT-treated group ( F = 6.07 , d.f . = 1,17 , P = 0.025 ) . Correlations between normalized left OFC metabolism and treatment response revealed that higher normalized metabolism in this region was associated with greater improvement in the BT-treated group ( tau = 0.35 , P = 0.04 ) , but worse outcome ( tau = -0.57 , P = 0.03 ) in the fluoxetine-treated group . These results suggest that subjects with differing patterns of metabolism preferentially respond to BT vs. medication BACKGROUND Cognitive behavioral therapy ( CBT ) with exposure and response prevention ( ERP ) is the psychotherapeutic treatment of choice for obsessive-compulsive disorder ( OCD ) . However , little is known about the impact of CBT on frontostriatal dysfunctioning , known to be the neuronal correlate of OCD . METHOD A probabilistic reversal learning ( RL ) task probing adaptive strategy switching capabilities was used in 10 unmedicated patients with OCD and 10 healthy controls during an event-related functional magnetic resonance imaging ( fMRI ) experiment . Patients were scanned before and after intensive CBT , controls twice at comparable intervals . RESULTS Strategy change within the RL task involved activity in a broad frontal network in patients and controls . No significant differences between the groups or in group by time interactions were detected in a whole-brain analysis corrected for multiple comparisons . However , a re analysis with a more lenient threshold revealed decreased responsiveness of the orbitofrontal cortex and right putamen during strategy change before treatment in patients compared with healthy subjects . A group by time effect was found in the cau date nucleus , demonstrating increased activity for patients over the course of time . Patients with greater clinical improvement , reflected by greater reductions in Yale-Brown Obsessive Compulsive Scale ( YBOCS ) scores , showed more stable activation in the pallidum . CONCLUSIONS Although these findings are preliminary and need to be replicated in larger sample s , they indicate a possible influence of psychotherapy on brain activity in core regions that have been shown to be directly involved both in acquisition of behavioral rules and stereotypes and in the pathophysiology of OCD , the cau date nucleus and the pallidum
Output:
| We found that functional abnormalities in OCD cluster within cortico-striatal thalamic circuits .
Within these circuits , the abnormalities identified showed significant dependence on the affective or non-affective nature of the tasks employed as circuit probes .
In studies using affective tasks , patients overactivated regions involved in salience , arousal and habitual responding ( anterior cingulate cortex , insula , cau date head and putamen ) and underactivated regions implicated in cognitive and behavioral control ( medial prefrontal cortex , posterior cau date ) .
In studies using non-affective cognitive tasks , patients overactivated regions involved in self-referential processing ( precuneus , posterior cingulate cortex ) and underactivated subcortical regions that support goal -directed cognition and motor control ( pallidum , ventral anterior thalamus , posterior cau date ) .
The overall pattern suggests that OCD-related brain dysfunction involves increased affective and self-referential processing , enhanced habitual responding and blunted cognitive control |
MS211254 | ***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: Moral distress is the knowledge of the ethically appropriate action to take but the inability to act upon it . This phenomenon is one experienced in the critical care setting . To help staff members cope with moral distress , a team conducted workshops at one facility to help the staff identify and cope with this distress . The workshop consisted of discussion s of distressing situations in the intensive care unit , didactic information on moral distress , formulation of an individual plan to reduce stress , and strategies to deal with moral distress in the intensive care unit . This article discusses the workshop and its effect on participants ' coping with moral distress Moral distress is described as the painful feelings and psychological disequilibrium when a person believes she knows the morally right action to take and is unable to carry it out because of external or internal constraints . It has been studied in intensive care unit ( ICU ) nurses , but to the best of our knowledge not in burn ICU nurses . A pilot study was performed to gather initial data on moral distress among nurses treating burn victims . Findings from an intervention aim ed at decreasing the level of moral distress in these nurses are reported . Nurses ( n = 13 ) were recruited from one U.S. burn ICU and were r and omized into two groups . A separate sample pretest post-test design was used . Group A completed the Moral Distress Scale-Revised ( MDS-R ) and Self-efficacy ( SE ) Scale before a 4-week educational intervention involving weekly 60-minute sessions , and Group B completed both scales afterward . Participants also completed written evaluations after each session . The MDS-R and SE Scale were readministered to both groups 6 weeks after the intervention was completed . Given the size and distribution of the sample , nonparametric data analyses were used . The MDS-R median score for Group B ( 92.0 ) was significantly different statistically from Group A ( 40.5 ) with P = .032 directly after the intervention was completed . No significant difference was found in the median SE scores between Group A ( 34.5 ) and Group B ( 34.0 ; P = .616 ) . The median for Group B was 69 and Group A was 60.5 ( P = .775 ) . At the 6-week follow up , the difference between the two groups was no longer observed . Defining and discussing moral distress may have contributed to increased awareness and higher levels of moral distress in Group B directly postintervention . The changes in moral distress levels postintervention and at the 6-week follow up highlight the need to examine the intervention in a larger sample Objective In this study , we tested an exp and ed model of Kanter ’s structural empowerment , which specified the relationships among structural and psychological empowerment , job strain , and work satisfaction . Background Strategies proposed in Kanter ’s empowerment theory have the potential to reduce job strain and improve employee work satisfaction and performance in current restructured healthcare setting s. The addition to the model of psychological empowerment as an outcome of structural empowerment provides an underst and ing of the intervening mechanisms between structural work conditions and important organizational outcomes . Methods A predictive , nonexperimental design was used to test the model in a r and om sample of 404 Canadian staff nurses . The Conditions of Work Effectiveness Question naire , the Psychological Empowerment Question naire , the Job Content Question naire , and the Global Satisfaction Scale were used to measure the major study variables . Results Structural equation modelling analyses revealed a good fit of the hypothesized model to the data based on various fit indices ( χ2 = 1140 , df = 545 , χ2/df ratio = 2.09 , CFI = 0.986 , RMSEA = 0.050 ) . The amount of variance accounted for in the model was 58 % . Staff nurses felt that structural empowerment in their workplace result ed in higher levels of psychological empowerment . These heightened feelings of psychological empowerment in turn strongly influenced job strain and work satisfaction . However , job strain did not have a direct effect on work satisfaction . Conclusions These results provide initial support for an exp and ed model of organizational empowerment and offer a broader underst and ing of the empowerment process We prospect ively studied the relationship between interdisciplinary collaboration and patient outcomes in the medical intensive care unit ( MICU ) using nurses ' and residents ' reports of amount of collaboration involved in making decisions about transferring patients from the MICU to a unit with a less intense level of care . Either readmission to the MICU or death was considered a negative patient outcome . Nurses ' reports of collaboration were significantly ( p = 0.02 ) and positively associated with patient outcome , controlling for severity of illness . Patient predicted risk of negative outcome decreased from 16 % , when the nurse reported no collaboration in decision making , to 5 % when the process was fully collaborative . There was an interaction of collaboration with availability of alternative choices in the transfer decision-making situation . When alternatives were available , collaboration was more strongly associated with patient outcome . There was no significant relationship between residents ' reports of collaboration and patient outcomes . The correlation between amount of collaboration reported by nurses and residents about the same decisions was quite low ( r = 0.10 ) Study purpose was to describe critical care nurses ' levels of moral distress and the effects of that distress on their professional practice environment . A descriptive , correlational , prospect i ve , survey design was used . The intensity of moral distress was inversely related to physician/nurse collegial relationships and the frequency of moral distress was inversely related to all aspects of the professional practice environment except foundations for quality of care . It is important to monitor the frequency of moral distress . Strategies to improve the nurse 's sense of control over practice , teamwork , communication , and autonomy need to be developed and tested in future research Moral distress is a phenomenon of increasing concern in nursing practice , education and research . Previous research has suggested that moral distress is associated with perceptions of ethical climate , which has implication s for nursing practice and patient outcomes . In this study , a r and omly selected sample of registered nurses was surveyed using Corley ’s Moral Distress Scale and Olson ’s Hospital Ethical Climate Survey ( HECS ) . The registered nurses reported moderate levels of moral distress intensity . Moral distress intensity and frequency were found to be inversely correlated with perceptions of ethical climate . Each of the HECS factors ( peers , patients , managers , hospitals and physicians ) was found to be significantly correlated with moral distress . Based on these findings , we highlight insights for practice and future research that are needed to enhance the development of strategies aim ed at improving the ethical climate of nurses ’ workplaces for the benefit of both nurses and patients The purpose of this study was to describe Finnish ICU nurses ' ( n=172 ) experiences of autonomy in their work . The research was carried out as part of a project concerned with empowerment in intensive care nursing . Viewed from a psychological perspective , empowerment is understood as referring to the ability to make goal -directed decisions and to take action towards meeting the goals set out . Autonomy , then , is seen as part of empowerment . The data were collected with a structured question naire specially design ed for this study . The r and om sample was drawn from 31 Finnish adult intensive care units . The respondents were registered nurses working in eight adult intensive care units . The data were analysed using statistical methods . Autonomy was defined as being composed of three bases : knowledge base ( independence , right and responsibility in decision-making ) , action base ( independence , right and responsibility in actions ) and value base ( independence , right and responsibility in values ) . The majority of the respondents felt they had more autonomy in decision-making and actions concerning patient care than in decision-making and actions concerning the intensive care unit as a whole . Autonomy usually increased with work experience . Work will be continued to study the autonomy of nurses in different health care organisations in Finl and
Output:
| Findings revealed that moral distress negatively affects clinicians ' wellbeing and job retention . |
MS211255 | ***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 a r and omized trial of a behavioral intervention among substance-using men who have sex with men , aim ed at reducing sexual risk behavior , Mansergh and colleagues fail to find evidence of a reduction in risk from the intervention Numerous herpesvirus infections are associated with clinical ly relevant outcomes as well as an accelerated HIV replication rate and subsequent disease progression . Stress management interventions mayimprovemarkersofcellularimmunecontroloverlatent herpesvirus infections and these changes appear to be mediated by perceptions of increased social support availability . We examined the effects ofagroup-based cognitive behavioral stress management ( CBSM ) intervention on distress , dysphoria , perceived socialsupport , and herpesvirus immunoglobulin G ( IgG ) antibody titers during the 6to 12 months following the intervention . Of those who were initially r and omized , 49 HIV-infected men were followed during the 6-to 12-month period after r and omization to either a 10-week CBSM intervention ( n=31 ) or amodified wait-list control condition ( n = 18 ) . Measures of distress , dysphoria , social support , and blood sample s for herpesvirus Ig Gtiters were taken at baseline , immediately following CBSM and at-6-to 12-month follow-up . Men in CBSM displayed maintenance of previously observed intervention effects on dysphoria , reliable alliance support , and herpesvirus IgG antibody titers ( i.e. , Epstein-Barr virus capsid antigen ; EBV-VCA ) . Intervention-related changes in EBV-VCA were unrelated to changes in lymphocyte subsets ( i.e. , CD4 + , CD8 + , and CD4+:CD8 + ) or changes in measures of dysphoria and social support during the investigation period . Data indicate that HIV-infected men participating in a CBS Mintervention maintain better psychosocial status and immunologic control of latent EBV infection up to 1 year after its conclusion 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 Background : Brief and low-burden HIV risk reduction counseling interventions are needed for population s at greatest risk for HIV infection . Purpose : This r and omized controlled trial tested a brief theory-based counseling intervention delivered entirely over the telephone for men who engage in unprotected intercourse with men . Methods : Participants received either risk reduction counseling that included information , motivational enhancement and behavior skills building , or brief HIV education counseling . A total of 319 participants completed follow-up assessment s over a 10-month period . Descriptive and r and om effects mixed models are used to evaluate findings . Results : Results demonstrate that a brief telephone intervention can reach and engage high-risk men in risk reduction counseling . Nearly one third of participants identified as men of color ; the median age was 33 years . Participants in both counseling conditions increased their motivation and behavioral skills to practice safer sex and reduced their number of sex partners and frequencies of engaging in unprotected anal sex over the study observation period . However , there were few differences between intervention conditions . Conclusions : The effects of repeated measurement reactivity and brief interpersonal consciousness raising may account for the lack of differences between counseling conditions and the decrease in risk for all participants over time BACKGROUND As many as one in three HIV-positive people continue unprotected sexual practice s after learning that they are HIV infected . This article reports the outcomes of a theory-based intervention to reduce risk of HIV transmission for people living with HIV infection . METHODS Men ( n=233 ) and women ( n=99 ) living with HIV-AIDS were r and omly assigned to receive either ( 1 ) a five-session group intervention focused on strategies for practicing safer sexual behavior , or ( 2 ) a five-session , contact-matched , health-maintenance support group ( st and ard-of-care comparison ) . Participants were followed for 6 months post-intervention . RESULTS The intervention to reduce risk of HIV transmission result ed in significantly less unprotected intercourse and greater condom use at follow-up . Transmission-risk behaviors with non-HIV-positive sexual partners and estimated HIV transmission rates over a 1-year horizon were also significantly lower for the behavioral risk-reduction intervention group . CONCLUSIONS This study is among the first to demonstrate successful HIV-transmission risk reduction result ing from a behavioral intervention tailored for HIV-positive men and women 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 Objective : To test the efficacy of brief , safer-sex counseling by medical providers of HIV-positive patients during medical visits . Setting : Six HIV clinics in California . Design : Clinics were r and omized to intervention arms evaluated with cohorts of r and omly selected patients measured before and after the intervention . Participants : Five-hundred and eighty-five HIV-positive persons , sexually active prior to enrollment . Interventions : Prevention counseling from medical providers supplemented with written information . Two clinics used a gain-framed approach ( positive consequences of safer-sex ) , two used a loss-frame approach ( negative consequences of unsafe sex ) , and two were attention-control clinics ( medication adherence ) . Interventions were given to all patients who attended the clinics . Outcome measure : Self-reported unprotected anal or vaginal intercourse ( UAV ) . Results : Among participants who had two or more sex partners at baseline , UAV was reduced 38 % ( P < 0.001 ) among those who received the loss-frame intervention . UAV at follow-up was significantly lower in the loss-frame arm [ odds ratio ( OR ) , 0.42 ; 95 % confidence interval ( CI ) , 0.19–0.91 ; P = 0.03 ] compared with the control arm . Using generalized estimating equations ( GEE ) to adjust for clustering did not change the conclusions ( OR , 0.34 ; 95 % CI , 0.24–0.49 ; P = 0.0001 ) . Similar results were obtained in participants with casual partners at baseline . No effects were seen in participants with only one partner or only a main partner at baseline . No significant changes were seen in the gain-frame arm . Conclusions : Brief provider counseling emphasizing the negative consequences of unsafe sex can reduce HIV transmission behaviors in HIV-positive patients presenting with risky behavioral profiles 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 There is an increasing interest in developing interventions for HIV and STD prevention that can be delivered on the Internet . However , we know little about what it takes to identify , recruit and retain participants in interventions so that we can test their efficacy and effectiveness . Objectives for this investigation were to evaluate rates of recruitment and retention in an Internet-based r and omized controlled trial ( RCT ) to increase sexually transmitted disease ( STD ) prevention among men who have sex with men ( MSM ) . The Smart Sex Quest study was a RCT conducted online . Eligible participants were MSM , at least 18 years old and US residents . After completing a baseline risk assessment , participants were exposed to tailored or control messages and asked to return to the site at three months for a follow-up interview . From January 2002 through June 2003 , 3,625 persons logged on as potential study participants ; of these , 563 were not eligible , while 1,286 left the site without filling out a baseline survey . Complete baseline data were available for 1,776 participants , all of whom were eligible to complete a follow-up . Complete follow-up data were available for 270 ( 15.2 % ) participants . While the Internet is a valuable tool for conducting research , conducting this longitudinal research online was severely affected by a loss to follow-up , and analyzing outcome data was hampered by significant differences between those who did and did not complete the study . Alternate ways to recruit for and evaluate online trials must be considered To the extent that men who have sex with men ( MSM ) use the Internet , it serves as a promising medium for behavioral intervention . The present study sought to investigate the efficacy of a web-based skills training and motivational intervention in a r and omized trial ( N = 112 ) conducted completely online . After a detailed assessment , MSM were r and omly assigned to an online intervention or a control website . The experimental intervention consisted of risk assessment and feedback , motivational exercises , skills training , and education while the control intervention focused on relaxation skills . Follow-up data were collected 3 months later and analyzed with repeated- measures MANOVA . Although both groups evidence d across-the-board reductions in unprotected sex , perhaps due to the detailed assessment , the experimental group showed greater reductions with the riskiest partners , those of positive or unknown serostatus . Thus , this study gives preliminary evidence that a brief web-based intervention offering cognitive behavioral skills training and motivational enhancement can effectively reduce sexual risk in MSM 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 Summary H
Output:
| Non-EBIs had multiple method ological limitations ; the most common was not finding a significant positive effect .
Compared to EBIs , non-EBIs were less likely to use peer intervention deliverers , include sexual communication in their interventions , and intervene at the community level . |
MS211256 | ***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 Carefully design ed controlled studies are essential in further evaluating the therapeutic efficacy of transcranial magnetic stimulation ( TMS ) in psychiatric disorders . A major method ological concern is the design of the " sham " control for TMS . An ideal sham would produce negligible cortical stimulation in conjunction with a scalp sensation akin to real treatment . Strategies employed so far include alterations in the position of the stimulating coil , but there has been little systematic study of their validity . In this study , we investigated the effects of different coil positions on cortical activation and scalp sensation . METHODS In nine normal subjects , single TMS pulses were administered at a range of intensities with a " figure eight " coil held in various positions over the left primary motor cortex . Responses were measured as motor-evoked potentials in the right first dorsal interosseus muscle . Scalp sensation to TMS with the coil in various positions over the prefrontal area was also assessed . RESULTS None of the coil positions studied met the criteria for an ideal sham . Arrangements associated with a higher likelihood of scalp sensation were also more likely to stimulate the cortex . CONCLUSIONS The choice of a sham for TMS involves a trade-off between effective blinding and truly inactive " stimulation . " Further research is needed to develop the best sham condition for a range of applications BACKGROUND Studies of repetitive transcranial magnetic stimulation ( rTMS ) in depression have mostly involved once-daily treatment , with positive but modest clinical results . This study tested the efficacy and safety of twice-daily rTMS over 2 weeks . METHOD Thirty-eight depressed subjects enrolled in a double-blind , sham-controlled trial of twice-daily rTMS ( left prefrontal cortex , 10 Hz , 110 % intensity , 1500 stimuli per session ) over 2 weeks . Mood and neuropsychological functioning were assessed weekly by blind raters , using the Montgomery-Asberg Depression Rating Scale ( MADRS ) as the primary outcome measure , plus the Hamilton Rating Scale for Depression ( HRSD ) and self-report measures . After the blind period , 22 subjects continued with once-daily rTMS to receive a total of 6 weeks of active rTMS . RESULTS Subjects were moderately treatment resistant . Active treatment result ed in significantly greater improvement than sham over the 2-week blind period on one outcome measure only ( MADRS p<0.05 ) . Subjects showed further improvement over the 6 weeks of active rTMS . Neuropsychological test scores did not change significantly . CONCLUSIONS rTMS given twice daily was effective and safe , with no adverse neuropsychological effects OBJECTIVE There is growing interest in neuropsychiatry for repetitive transcranial magnetic stimulation ( rTMS ) as a neuromodulatory treatment . However , there are limitations in interpreting rTMS effects as a real consequence of physiological brain changes or as placebo-mediated unspecific effects , which may be particularly strong in psychiatric patients . This is due to the fact that existing sham rTMS procedures are less than optimal . A new placebo tool is introduced here , called real electro-magnetic placebo ( REMP ) device , which can simulate the scalp sensation induced by the real TMS , while leaving both the visual impact and acoustic sensation of real TMS unaltered . METHODS Physical , neurophysiological and behavioural variables of monophasic and biphasic single-pulse TMS and biphasic 1Hz and 20Hz rTMS procedures ( at different intensities ) were tested in subjects who were expert or naïve of TMS . Results of the real TMS were compared with those induced by the REMP device and with two other currently used sham procedures , namely the commercially available Magstim sham coil and tilting the real coil by 90 degrees . RESULTS The REMP device , besides producing scalp sensations similar to the real TMS , attenuated the TMS-induced electric field ( as measured by a dipole probe ) to a biologically inactive level . Behaviourally , neither expert nor naïve TMS subjects identified the " coil at 90 degrees " or the " Magstim sham coil " as a real TMS intervention , whilst naïve subjects were significantly more likely to identify the REMP-attenuated TMS as real . CONCLUSIONS The " goodness of sham " of the REMP device is demonstrated by physical , neurophysiological , and behavioural results . SIGNIFICANCE Such placebo TMS is superior to the available sham procedures when applied on subjects naïve to TMS , as in case of patients undergoing a clinical rTMS trial OBJECTIVE High-frequency left-side repetitive transcranial magnetic stimulation ( rTMS ) and low-frequency stimulation to the right prefrontal cortex have both been shown to have antidepressant effects , but doubts remain about the magnitude of previously demonstrated treatment effects . The authors evaluated sequentially combined high-frequency left-side rTMS and low-frequency rTMS to the right prefrontal cortex for treatment-resistant depression . METHOD The authors conducted a 6-week double-blind , r and omized , sham-controlled trial in 50 patients with treatment-resistant depression . Three trains of low-frequency rTMS to the right prefrontal cortex of 140 seconds ' duration at 1 Hz were applied daily , followed immediately by 15 trains of 5 seconds ' duration of high-frequency left-side rTMS at 10 Hz . Sham stimulation was applied with the coil angled at 45 degrees from the scalp , resting on the side of one wing of the coil . The primary outcome variable was the score on the Montgomery-Asberg Depression Rating Scale . RESULTS There was a significantly greater response to active than sham stimulation at 2 weeks and across the full duration of the study . A significant proportion of the study group receiving active treatment met response ( 11 of 25 [ 44 % ] ) or remission ( nine of 25 [ 36 % ] ) criteria by study end compared to the sham stimulation group ( two of 25 [ 8 % ] and none of 25 respectively ) . CONCLUSIONS Sequentially applying both high-frequency left-side rTMS and low-frequency rTMS to the right prefrontal cortex , has substantial treatment efficacy in patients with treatment-resistant major depression . The treatment response accumulates to a clinical ly meaningful level over 4 to 6 weeks of active treatment BACKGROUND Repetitive transcranial magnetic stimulation ( TMS ) as a treatment for depression has shown statistically significant effects , but the clinical significance of these effects has been question ed . METHODS Patients with medication-resistant depression were r and omized to receive 15 sessions of active or sham repetitive TMS delivered to the left dorsolateral prefrontal cortex at 110 % the estimated prefrontal cortex threshold . Each session consisted of 32 trains of 10 Hz repetitive TMS delivered in 5-second trains . The primary end point was treatment response defined as a > or=50 % decrease in Hamilton Depression Rating Scale ( HDRS ) score at both 1 and 2 weeks following the final repetitive TMS treatment . Remission was defined as a HDRS score < 8 . RESULTS The response rate for the TMS group was 30.6 % ( 11/35 ) , significantly ( p = .008 ) greater than the 6.1 % ( 2/33 ) rate in the sham group . The remission rate for the TMS group was 20 % ( 7/35 ) , significantly ( p = .033 ) greater than the 3 % ( 1/33 ) rate in the sham group . The HDRS scores showed a significantly ( p < .002 ) greater decrease over time in the TMS group compared with the sham group . CONCLUSIONS Transcranial magnetic stimulation can produce statistically and clinical ly significant antidepressant effects in patients with medication-resistant major depression CONTEXT Daily left prefrontal repetitive transcranial magnetic stimulation ( rTMS ) has been studied as a potential treatment for depression , but previous work had mixed outcomes and did not adequately mask sham conditions . OBJECTIVE To test whether daily left prefrontal rTMS safely and effectively treats major depressive disorder . DESIGN Prospect i ve , multisite , r and omized , active sham-controlled ( 1:1 r and omization ) , duration -adaptive design with 3 weeks of daily weekday treatment ( fixed-dose phase ) followed by continued blinded treatment for up to another 3 weeks in improvers . SETTING Four US university hospital clinics . PATIENTS Approximately 860 out patients were screened , yielding 199 antidepressant drug-free patients with unipolar nonpsychotic major depressive disorder . INTERVENTION We delivered rTMS to the left prefrontal cortex at 120 % motor threshold ( 10 Hz , 4-second train duration , and 26-second intertrain interval ) for 37.5 minutes ( 3000 pulses per session ) using a figure-eight solid-core coil . Sham rTMS used a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations . MAIN OUTCOME MEASURE In the intention-to-treat sample ( n = 190 ) , remission rates were compared for the 2 treatment arms using logistic regression and controlling for site , treatment resistance , age , and duration of the current depressive episode . RESULTS Patients , treaters , and raters were effectively masked . Minimal adverse effects did not differ by treatment arm , with an 88 % retention rate ( 90 % sham and 86 % active ) . Primary efficacy analysis revealed a significant effect of treatment on the proportion of remitters ( 14.1 % active rTMS and 5.1 % sham ) ( P = .02 ) . The odds of attaining remission were 4.2 times greater with active rTMS than with sham ( 95 % confidence interval , 1.32 - 13.24 ) . The number needed to treat was 12 . Most remitters had low antidepressant treatment resistance . Almost 30 % of patients remitted in the open-label follow-up ( 30.2 % originally active and 29.6 % sham ) . CONCLUSION Daily left prefrontal rTMS as monotherapy produced statistically significant and clinical ly meaningful antidepressant therapeutic effects greater than sham . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00149838 Abstract Objectives . High frequency left-sided ( HFL ) and low frequency right-sided ( LFR ) unilateral repetitive transcranial magnetic stimulation ( rTMS ) are efficacious in treatment-resistant major depression ( TRD ) . Similar benefit has been suggested for sequential bilateral rTMS ( LFR then HFL ) . There are few published reports on the efficacy of sequential bilateral rTMS compared to HFL and sham rTMS . Therefore , this study evaluated the efficacy of HFL and sequential bilateral rTMS compared to sham in TRD . Methods . Subjects between the ages of 18 and 85 were recruited from a tertiary care university hospital . Seventy-four subjects with TRD and a 17-item Hamilton Depression Rating Scale ( HDRS ) greater than 21 were r and omized to receive unilateral , bilateral , or sham rTMS . The rates of remission were compared among the three treatment groups . Results . The remission rates differed significantly among the three treatment groups using a modified intention to treat analysis that excluded subjects who did not respond to electroconvulsive therapy ( ECT ) during the current episode . The remission rate was significantly higher in the bilateral group than the sham group . The remission rate in the unilateral group did not differ from either group . Conclusion . These findings warrant larger controlled studies that compare the efficacy of sequential bilateral rTMS and HFL rTMS in TRD Selecting a suitable sham condition within the frame of repetitive transcranial magnetic stimulation ( rTMS ) treatment trials is a central issue . On the one h and , the ideal sham condition should not have a real stimulation effect ; on the other h and , it should not be recognized as sham by patients , particularly when considering that real stimulation conditions come along with rTMS specific side effects . Within the course of a multi-centre trial assessing the antidepressant effects of rTMS , patients were r and omized to sham or real stimulation , in both cases using a st and ard stimulation coil . In one centre , patients ( n=33 ) were asked about their impression whether they received the sham or the real treatment , and if they would recommend the treatment to others . 29 patients returned the question naires and were included into the analysis . From 15 subjects with real stimulation , 11 suggested to have obtained real , and 4 to have obtained sham . From 14 sham stimulated subjects , 9 suggested to have obtained the real condition and 5 to have been sham stimulated . This difference was not significant ( p=0.60 , chi square test ) . In addition , the major part of patients in both stimulation conditions would recommend rTMS to others . In both conditions , real and sham , the majority of subjects believed to have obtained the real condition . This implies suitability of the sham condition used since subjects appeared not to be able to identify the condition . The results imply the feasibility of a valid sham condition with a " real " coil OBJECTIVES Repetitive transcranial magnetic stimulation ( rTMS ) has been shown to improve depressive symptoms . We design ed and carried out the following left prefrontal rTMS study to determine the safety , feasibility , and potential efficacy of using TMS to treat the depressive symptoms of bipolar affective disorder ( BPAD ) . METHODS We recruited and enrolled 23 depressed BPAD patients ( 12 BPI depressed state , nine BPII depressed state , two BPI mixed state ) . Patients were r and omly assigned to receive either daily left prefrontal rTMS ( 5 Hz , 1
Output:
| In summary , existing sham rTMS interventions appear to result in acceptable levels of blinding regarding treatment allocation |
MS211257 | ***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: Study Design . A r and omized clinical trial with 1-year and 3-year telephone question naire follow-ups . Objective . To report a specific exercise intervention ’s long-term effects on recurrence rates in acute , first-episode low back pain patients . Summary of Background Data . The pain and disability associated with an initial episode of acute low back pain ( LBP ) is known to resolve spontaneously in the short-term in the majority of cases . However , the recurrence rate is high , and recurrent disabling episodes remain one of the most costly problems in LBP . A deficit in the multifidus muscle has been identified in acute LBP patients , and does not resolve spontaneously on resolution of painful symptoms and resumption of normal activity . Any relation between this deficit and recurrence rate was investigated in the long-term . Methods . Thirty-nine patients with acute , first-episode LBP were medically managed and r and omly allocated to either a control group or specific exercise group . Medical management included advice and use of medications . Intervention consisted of exercises aim ed at rehabilitating the multifidus in cocontraction with the transversus abdominis muscle . One year and three years after treatment , telephone question naires were conducted with patients . Results . Question naire results revealed that patients from the specific exercise group experienced fewer recurrences of LBP than patients from the control group . One year after treatment , specific exercise group recurrence was 30 % , and control group recurrence was 84 % ( P < 0.001 ) . Two to three years after treatment , specific exercise group recurrence was 35 % , and control group recurrence was 75 % ( P < 0.01 ) . Conclusion . Long-term results suggest that specific exercise therapy in addition to medical management and resumption of normal activity may be more effective in reducing low back pain recurrences than medical management and normal activity alone Study Design . A prospect i ve study of multifidus images . Objective . To compare the change of the cross-sectional area ( CSA ) of multifidus in subjects with and without chronic low back pain ( LBP ) at different postures . Summary of Background Data . Ultrasound imaging was shown to be useful in assessing acute LBP patients at rest only . Methods and Measures . Thirty-five male adults participated , including 19 normal and 16 chronic LBP patients . The CSAs of multifidus were assessed on ultrasound images acquired on both sides of the L4 and L5 levels with the subjects in prone lying , upright st and ing , and 25 ° and 45 ° forward stooping . Results . In the control group , the CSA of multifidus increased from prone lying to upright st and ing and then gradually decreased from 25 ° to 45 ° forward stooping . However , a reverse pattern of the CSA changes was identified in patients with chronic LBP . Conclusion . Multifidus contracts maximally at upright st and ing in the normal group , while maximum contraction of the muscle occurs at 25 ° forward stooping in the patient group . The role of multifidus may be altered in the stabilization of the lumbar spine of chronic LBP patients . Assessment of the change in muscle size reacting to different postures is found to be helpful OBJECTIVE To compare trunk muscle coordination in people with and without low back pain with varying speeds of limb movement . STUDY DESIGN Abdominal and back extensor muscle activity in association with upper limb movement was compared among three speeds of movement and between people with and without low back pain . PARTICIPANTS Fourteen subjects with a history of recurrent low back pain and a group of age- and sex-matched control subjects . MEASURES The onsets of electromyographic activity of the trunk and limb muscles , frequency of trunk muscle responses , and angular velocity of arm movements . RESULTS Early activation of transversus abdominis ( TrA ) and obliquus internus abdominis ( OI ) occurred in the majority of trials , with movement at both the fast and intermediate speeds for the control group . In contrast , subjects with low back pain failed to recruit TrA or OI in advance of limb movement with fast movement , and no activity of the abdominal muscles was recorded in the majority of intermediate speed trials . There was no difference between groups for slow movement . CONCLUSION The results indicate that the mechanism of preparatory spinal control is altered in people with lower back pain for movement at a variety of speeds Ultrasonography has recently been proposed for assessing changes in thickness and motion of the diaphragm during contraction in humans . Data on ultrasound assessment of abdominal muscles in humans are scarce . We therefore investigated the changes in thickness and the relevant mechanical effects of abdominal muscles using this technique during respiratory manoeuvres in normal subjects . We evaluated the thickness of the abdominal muscle layers in six normal male subjects ( aged 26 - 36 yrs ) using a 7.5 MHz B-mode ultrasound transducer . Gastric ( Pg ) and mouth pressures , muscle thickness of external oblique ( EO ) , internal oblique ( IO ) , transversus abdominis ( TA ) and rectus abdominis ( RA ) were assessed at functional residual capacity ( FRC ) , residual volume ( RV ) , total lung capacity ( TLC ) , during progressive ( PEEs ) and maximal expiratory efforts ( MEEs ) against a closed airway and during homolateral ( HTR ) and contralateral ( CTR ) trunk rotation . Abdominal muscle thickness was found to be reproducible ( coefficient of variation and two-way analysis of variance ) . Compared to FRC , the thickness of IO , TA and RA significantly increased at RV and during MEEs , whereas EO remained unchanged ; at TLC , the thickness of IO and TA significantly decreased . During PEEs , a significant relationship between increase in Pg and TA thickness was observed in all subjects , the thickness of the other abdominal muscles being inconsistently related to Pg . Finally , a significant increase in the thickness of IO and EO was found during HTR and CTR , respectively . We conclude that during maximal expiratory manoeuvres , transversus abdominis , internal oblique and rectus abdominis thickened similarly . Transversus abdominis seems to be the major contributor in generating abdominal expiratory pressure during progressive expiratory efforts . External oblique seems to be preferentially involved during trunk rotation . These results suggest the possible value of study ing the abdominal muscles by ultrasonography in various respiratory disorders BACKGROUND AND PURPOSE Low abdominal hollowing in four-point kneeling is used clinical ly to test and rehabilitate transversus abdominis ( TrA ) but many people find this exercise difficult to perform . Contracting pelvic floor muscles ( PF ) during low abdominal hollowing may facilitate contraction of TrA. Thickness increase in the abdominal muscles during low abdominal hollowing has been measured with real-time ultrasound scanning and may indicate muscle contraction . The present study investigated the effect of instructing PF contraction on TrA thickness increase during low abdominal hollowing . METHOD Twelve females and eight males with no reported pelvic floor dysfunction or low back pain in the last two years were taught low abdominal hollowing in four-point kneeling . Subjects performed low abdominal hollowing with and without instruction to contract PF in r and om order . Transversus abdominis , obliquus internus ( OI ) and obliquus externus ( OE ) thickness were measured with ultrasound scanning at rest and during both tests . RESULTS Mean increase in TrA thickness during low abdominal hollowing was 49.71 % ( SD 26.76 % ) , during low abdominal hollowing with PF it was 65.81 % ( SD 23.53 % ) . Paired Student 's t-tests indicated a significant difference between tests ( p = 0.015 ) . There were no significant differences between tests for OE or OI thickness increase . CONCLUSIONS Instructing healthy subjects to co-contract PF results in greater increase in TrA thickness during low abdominal hollowing in four-point kneeling . This may indicate greater contraction of TrA and thus be useful for clinicians training TrA. Further research could investigate the validity of change of thickness as a measure of abdominal muscle contraction , investigate the effect of instructing PF co-contraction on TrA in patients with low back pain and measure PF and TrA activity simultaneously This cross-sectional , prospect i ve study aim ed to produce normal reference data for measurements of the lumbar multifidus muscle . A total of 120 subjects , 68 females ( aged 20 - 64 years ) and 52 males ( 20 - 69 years ) were studied . Bilateral transverse ultrasound images were made of multifidus at the fourth and fifth lumbar vertebrae ( L4 & L5 ) . Cross-sectional area ( CSA , cm(2 ) ) and linear dimensions ( AP , anteroposterior ; Lat , lateral ) were measured and the latter expressed as a ratio ( AP/Lat ) to reflect shape . Relationships between CSA and anthropometric measures were examined . Multifidus CSA was larger in males ( P<0.001 ) and age had no effect . The CSA was larger at L5 than L4 ( P<0.001 ) and highly correlated between the two levels ( males r=0.82 , females 0.80 ) . Differences in muscle shape were observed for gender , age and vertebral level . Between-side symmetry was high for size but not shape ( CSA < 10 % difference ) . Linear measurements multiplied ( APxLat ) correlated highly with CSA ( all groups r0.94 , P<0.0001 ) . The AP dimension was also acceptably predictive of CSA at L4 ( r0.79 ) . There were no clinical ly useful correlations between CSA and anthropometric measures . These findings provide normal references ranges for objective assessment of lumbar multifidus . This paper also addresses specific practical issues when scanning multifidus 1 . Human gastrocnemius medialis architecture was analysed in vivo , by ultrasonography , as a function of joint angle at rest and during voluntary isometric contractions up to the maximum force ( MCV ) . maximum force ( MVC ) . 2 . At rest , as ankle joint angle increased from 90 to 150 deg , pennation increased from 15.8 to 27.7 deg , fibre length decreased from 57.0 to 34.0 mm and the physiological cross-sectional area ( PCSA ) increased from 42.1 to 63.5 cm2 . 3 . From rest to MVC , at a fixed ankle joint angle of 110 deg , pennation angle increased from 15.5 to 33.6 deg and fibre length decreased from 50.8 to 32.9 mm , with no significant change in the distance between the aponeuroses . As a result of these changes the PCSA increased by 34.8 % . 4 . Measurements of pennation angle , fibre length and distance between the aponeuroses of the gastrocnemius medialis were also performed by ultrasound on a cadaver leg and found to be in good agreement with direct anatomical measurements . 5 . It is concluded that human gastrocnemius medialis architecture is significantly affected both by changes of joint angle at rest and by isometric contraction intensity . The remarkable shortening observed during isometric contraction suggests that , at rest , the gastrocnemius muscle and tendon are considerably slack . The extrapolation of muscle architectural data obtained from cadavers to in vivo conditions should be made only for matching muscle lengths Study Design . Intrasubject controls with r and omized intervention order . Objective . To quantify the immediate change in posteroanterior ( PA ) spinal stiffness produced by different combinations of trunk muscle contraction . Summary of Background Data . The abdominal hollow and the abdominal brace are 2 different combinations of trunk muscle contractions that are commonly prescribed to increase spinal stability . Unfortunately , the immediate effect of these different contractions on spinal stiffness ( one indicator of spinal stability ) has not yet been quantified directly . Methods . Twenty-eight asymptomatic subjects were taught abdominal hollow and brace contractions then performed them in a r and omized order framed by periods of rest . Surface electromyography and B-mode ultrasound confirmed that all contractions were performed appropriately . During each test condition ( hollow , brace , and rest ) , a noninvasive indentation technique was used to quantify PA spinal stiffness . A repeated measures analysis of variance was used to assess the significance of changes in the PA spinal stiffness between test conditions . Results . Both the abdominal hollow and abdominal brace contractions increased PA spinal stiffness significantly when compared with the rest condition ( P < 0.001 ) . When the abdominal hollow and brace contractions were compared with each other , the abdominal brace contraction produced significantly greater PA spinal stiffness ( P < 0.05 ) . Conclusion . In asymptomatic subjects , the abdominal brace contraction provided an immediate PA stiffening effect that was significantly greater in magnitude when compared with conditions of rest and abdominal hollowing . These findings may allow clinicians to better match commonly prescribed contraction-based interventions with specific patient needs . Future work is required to assess the long-term effect of repeated abdominal brace and hollow contractions on PA spinal stiffness and low back pain Rehabilitative ultrasound imaging ( RUSI ) is considered a valid method to measure muscle activation in key spinal muscles in asymptomatic subjects . Research measuring muscle activation with RUSI in painful subjects is limited . The aim of this study was to determine if changes in muscle activation from experimentally induced pain can be measured by RUSI . Six male subjects performed tasks known to activate the transverse abdominis ( TrA ) and lumbar multifidus ( LM ) while RUSI measurements of muscle thickness were obtained during control and hypertonic saline conditions . The abdominal draw-in maneuver was used to volitionally activate the TrA and a series of upper extremity lifting tasks were used to automatically activate the LM . Pain was induced by injecting 5 % hypertonic saline into the longissimus muscle
Output:
| 10 studies investigated criterion-related validity and provided evidence that while ultrasound may be a valid measure of trunk muscle size , the validity of ultrasound to quantify muscle activation is context -dependent , depending on the muscle involved , the contraction strategy utilised , and the intensity of muscle contraction .
It is valid to use rehabilitative ultrasound imaging to measure trunk muscle size and activation during most isometric sub-maximal contractions .
Ultrasound measures appear sensitive to both positive and negative change |
MS211258 | ***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 A clinical trial , involving 203 resin-bonded bridges ( RBBs ) was undertaken to investigate the influence of retainer-type and luting material on the survival of these restorations . METHODS For this evaluation , 157 patients were available ( 14 % of the original sample was lost to follow-up or excluded from the study following the stopping criteria ) . Fifty per cent of the patients were question ed concerning the fate of the RBBs and 59 % of question ed patients were examined clinical ly . The patients that were seen for examination were representatives of the experimental groups . The findings from the clinical examination were compared with the data obtained from the question naire . Missing data were censored at the date of the last available information . Kaplan-Meier estimates were calculated to assess the survivals at the endpoints and compared using Cox 's proportional hazards procedure . RESULTS A significant difference was found between perforated ( P-type ) and etched ( E-type ) RBBs ( P = 0.05 ) for original bonded restorations but not when rebonded RBBs were taken into account . The results of the survival analysis were : anterior P-type , 49 + /- 7 % after 10.5 years : anterior E-type , 57 + /- 7 % after 10.5 years ; posterior P-type , 18 + /- 11 % after 6.8 years ; posterior E-type , 37 + /- 13 % after 10.2 years . Survivals of RBBs that were rebonded once during the evaluation period were 62 + /- 9 % ( 11.0 years ) for anterior RBBs and 51 + /- 11 % ( 10.2 years ) for posterior RBBs . CONCLUSIONS The factor location ( anterior versus posterior ) was as in previous analyses , highly significant . Differences in survival between cementation material s were not significant The etched-cast restoration was introduced in 1980 , and a prospect i ve study was initiated in March 1981 to determine if resin-bonded prostheses would prove to be a long-term alternative to traditional complete and partial coverage restorations . All resin-bonded restorations placed since that time in the author 's private prosthodontic practice have been recorded in the study . The success rate of 127 restorations has been 92.9 % , with a mean longevity of 5 years and 8 months OBJECTIVES All-ceramic resin-bonded fixed partial dentures ( RBFPDs ) were introduced as a conservative treatment approach 15 years ago . The purpose of this prospect i ve study was to evaluate the long-term clinical survival of RBFPDs made with a conventional two-retainer design or a cantilever single-retainer design . METHOD AND MATERIAL S A total of 37 anterior RBFPDs were made from the glass-infiltrated alumina ceramic In-Ceram . Sixteen RBFPDs with a conventional two-retainer design were inserted in 14 patients , and 21 RBFPDs with a cantilever single-retainer design were inserted in 16 patients . Panavia or Panavia 21 were used as luting agents either after silica-coating and silanation or after air-abrasion only . Patients were recalled every year for a clinical examination to evaluate the restorations with regard to function and possible failures . The mean observation time in the two-retainer group was 75.8 months , and in the single-retainer group it was 51.7 months . RESULTS No restoration debonded . In the two-retainer group , one restoration was lost because it fractured after 3 months at both connectors and one restoration was removed alio loco accidentally . Also in this group , four RBFPDs fractured within 15 months after insertion at one connector , but the pontic remained in situ as a cantilever RBFPD for several years . In the single-retainer group , only one FPD fractured and was lost 48 months after insertion . The 5-year survival rate was 73.9 % in the two-retainer group and 92.3 % in the single-retainer group . When unilateral fracture of a FPD was taken as criterion for failure , the five-year survival rate decreased to 67.3 % in the two-retainer group . CONCLUSIONS Cantilever all-ceramic resin-bonded fixed partial dentures made from high-strength oxide ceramics present a promising treatment alternative to two-retainer RBFPDs in the anterior region This study evaluated posterior resin-bonded prostheses using inlays as retainers . Thirty-nine patients missing at least one premolar or first molar received 51 resin-bonded fixed partial dentures with high noble alloy inlay retainers and a metal ceramic pontic . Resin luting material bonding to the framework was secured by the Silicoating method ( 24 fixed partial dentures ) , lost sugar crystal method ( 13 fixed partial dentures ) , or tin plating ( 14 fixed partial dentures ) . Clinical examinations were performed 1 week , 1 month , 6 months , 1 year , 2 years , and 5 years after cementation . None of the fixed partial dentures with silicoating or sugar crystal impressions lost retention , whereas two of the tin-plated fixed partial dentures required replacement . Resin-bonded inlay-retained prostheses appear to be a favorable alternative to other types of fixed partial dentures Abstract Within the framework of an on-going prospect i ve clinical study begun in 1985 , 120 adhesive-fixed partial dentures ( AFPD ) continued to be examined . The manufacture and the fitting of the AFPDs were carried out following a st and ard procedure . The preparation technique and the metal framework conditioning ( silica-coating , s and blasting and electrochemical etching ) has varied throughout the duration of the study . Using Kaplan-Meier analysis , the survival rate was determined and an analysis of risk with regard to location factors ( anterior , posterior ; maxilla , m and ible ) , conditioning and preparation techniques ( retentive/non-retentive ) was determined using the Cox regression model . The location of the AFPD had no influence on the survival rate . The survival time was determined mainly by the preparation technique . Strict preparation of seating grooves and pin holes made a 95 % survival rate possible after 10 years ( Kaplan-Meier estimation ) . Without retention , the risk of failure increased by a factor of 3.7 A total of 382 resin bonded bridges and splints were fitted , in 309 patients , in a teaching hospital . The restorations were evaluated after a period ranging from 5 months to 8 years . During the evaluation period 125 restorations ( 33 % ) debonded of which 69 ( 55 % ) were rebonded . The survival rates of the rebonded restorations at first , second , third or fourth rebond , where necessary , did not differ from the survival rate of the same restorations up to the first debond . Restorations constructed using the Rochette design had a significantly higher debond rate than the other design s. However , since they also exhibited a high rebond rate Rochette restorations continued to perform well over the study period . Splints had a higher debond rate as did restorations placed in patients in the age group 11 to 20 years , restorations involving more than two abutment teeth , and restorations containing more than one tooth OBJECTIVES To assess prospect ively over 10 years the incidences of technical and /or biological complications and failures occurring in a cohort of consecutive partially edentulous patients with fixed reconstructions on implants of the ITI Dental Implant System . METHODS Eighty-nine patients were available , 34 ( 38.2 % ) were male , 55 ( 61.8 % ) were female . At the 10-year examination ( range 8 - 12 years ) , they were 58.9 years old ( range 28 - 88 years ) . RESULTS Single crowns ( SC ) : 48 patients had been restored with 69 SC on 69 implants . Five of the implants with the crowns were lost because of biological failures . Two crowns ( 2.9 % ) were remade because of technical failures . Total failure amounted to seven ( 10 % ) . Implant borne fixed partial dentures ( I-I FPD ) : In 29 patients who had been restored with 33 implant borne suprastructures , the total number of failed I-I FPD was 2 ( 6.1 % ) . Tooth-implant borne fixed partial dentures ( I-T FPD ) : In 21 patients , 22 mixed tooth-implant borne reconstructions were constructed . The number of failed FPD reached 7 ( 31.8 % ) . Statistically significantly fewer biological failures occurred with I-I FPD compared with the I-T FPDs ( ANOVA , Bonferroni , P=0.022 ) . The I-T FPDs experienced statistically significantly more frequent technical failures compared with the other two groups of suprastructures ( P=0.003 , 0.031 ) . Consequences of complications : The occurrence of loss of retention as a complication increased the odds ratio ( OR ) to 17.6 ( P<0.001 ) to end up in a technical failure . Similarly , the event of a porcelain fracture increased the OR for the suprastructure to be a failure at 10 years to 11.0 ( P < or = 0.004 ) . Treatment of periimplantitis increased the OR to 5.44 ( P < or = 0.011 ) to result in a biological failure compared with implants in which this type of treatment was not applied . CONCLUSION The three groups of suprastructures demonstrated marked differences in their patterns of failures and complications . Complications increased the risk for failure . Support by CRF , University of Berne , Switzerl and STATEMENT OF PROBLEM It is important to evaluate the long-term clinical performance of resin-bonded fixed partial dentures and extracoronal attachments for removable prostheses . PURPOSE A prospect i ve , long-term clinical study was conducted to evaluate the success of resin-bonded fixed partial dentures since 1985 and of resin-bonded extracoronal attachments from 1987 . METHODS Until 1993 , a total of 130 resin-bonded fixed partial dentures had been seated in 101 patients , as well as 12 removable partial dentures ( RPDs ) with 24 extracoronal retainers in 10 patients . The clinical treatment protocol and the laboratory procedures were st and ardized . By the end of 1993 , it was possible to reexamine 98 patients with a total of 127 resin-bonded fixed partial dentures and all 10 patients with removable partial dentures . The average time in function for the resin-bonded fixed partial dentures at the time of examination was 3.4 years and 2.3 years for the removable restorations . RESULTS During the period of observation , one retainer failed on six of the resin-bonded fixed partial dentures , which represents a failure rate of 4.7 % . Debonding of extracoronal attachments was recorded for 8.3 % of the total number of retainers . CONCLUSION The resin-bonded fixed partial denture technique can be considered to be a clinical ly reliable method of treatment , and permits the expansion of indications beyond a classical three-unit resin-bonded fixed partial denture . Long-term clinical success of removable partial dentures with resin-bonded extracoronal retainers warrants additional clinical studies OBJECTIVES The purpose of this clinical pilot study was to evaluate the resin bond to alumina ceramic in vivo when using a bonding method which had been shown to be successful in laboratory testing . METHODS Seventeen resin-bonded all-ceramic bridges and splints fabricated from a glass-infiltrated alumina ceramic were tribochemically silica coated and resin bonded to their abutment teeth . The patients were recalled every 6 months to evaluate the restorations with regard to function and possible failures . RESULTS Over a mean observation time of 3.8 + /- 1.6 years some ceramic fractures occurred . However , the resin bond between the teeth and the alumina ceramic always remained stable . CONCLUSIONS Silica coating of alumina ceramic result ed in a durable resin bond over up to 5 years OBJECTIVES A r and omized controlled clinical trial was undertaken , to study the influence of some patient- and operator-dependent variables on the survival of posterior resin-bonded bridges ( PRBBs ) and to assess the survival of replacement ' PRBBs . This report contains some of the results of the 5-year analysis . METHODS Survival was defined at three levels : ( 1 ) complete survival ( without any debonding ) , ( 2 ) functional survival ( i.e. survival after one loss of retention ) and ( 3 ) replacement survival ( survival of ' replacement ' PRBBs , inserted after rebonded bridges suffered a second dislodgement ) . Potential risk factors were analysed with Cox 's proportional hazards model and differences were tested for significance with the Breslow test . Observed effects are expressed as conditional-relative-risk ( CRR ) . Survival of ' replacement ' PRBBs was assessed with the Kaplan-Meier method . RESULTS Factors showing significant influences on complete survival were : ' location ' ( highest risk for m and ibular PRBBs : CRR = 2.2 ) , ' aetiology ' ( higher risk in treatment of aplasia : CRR = 2.9 ) , and ' time of existence ' ( open spaces existing less than 2 years before insertion of PRBB : CRR : 2.0 ) . The factor ' large open spaces in the m and ible ' was a risk for both complete and functional survival ( CCR values 3.1 and 3.
Output:
| Despite the high survival rate of RBBs , technical complications like debonding are frequent .
This in turn means that a substantial amount of extra chair time may be needed following the incorporation of RBBs .
There is thus an urgent need for studies with a follow-up time of 10 years or more , to evaluate the long-term outcomes |
MS211259 | ***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 Patients with severe burns are at increased risk of developing methicillin-resistant Staphylococcus aureus ( MRSA ) ventilator-associated pneumonia . This study was design ed to determine whether MRSA pneumonia can be prevented by prophylactic administration of trimethoprim-sulfamethoxazole ( TMP-SMX ) . METHODS We conducted a prospect i ve , r and omized , placebo-controlled study in patients with severe burns ( > or = 20 % ) , who required ventilator support . Prophylaxis was done with oral TMP-SMX ( 80 mg/400 mg ) three times daily for 10 days from 4 to 6 days after burn injury . The incidence of MRSA pneumonia and the side effects were evaluated during the administration period . RESULTS Twenty-one patients were assigned to receive TMP-SMX , and 19 patients to receive placebo . The incidence of MRSA pneumonia was 4.8 % in the TMP-SMX group and 36.8 % in the placebo group , showing a significant difference ( p = 0.017 ) . No major side effects of therapy were seen in the TMP-SMX group . CONCLUSION Prophylactic treatment with TMP-SMX can prevent MRSA pneumonia in severely burned patients Objective : To determine whether use of a single heat and moisture exchanger ( HME ) for ≤120 hrs affects efficiency , resistance , level of bacterial colonization , frequency rate of nosocomial pneumonia , and cost compared with changing the HME every 24 hrs . Design : Prospect i ve , controlled , r and omized , unblinded study . Setting : Surgical intensive care unit at a university teaching hospital . Patients : A total of 220 consecutive patients requiring mechanical ventilation for > 48 hrs . Interventions : Patients were r and omized to one of three groups : a ) hygroscopic HME ( Aqua+ ) changed every 24 hrs ( HHME‐24 ) ; b ) hydrophobic HME ( Duration HME ) changed every 120 hrs ( HME‐120 ) ; and c ) hygroscopic HME ( Aqua+ ) changed every 120 hrs ( HHME‐120 ) . Devices in all groups could be changed at the discretion of the staff when signs of occlusion or increased resistance were identified . Measurements and Main Results : Daily measurements of inspired gas temperature , inspired relative humidity , and device resistance were made . Additionally , daily cultures of the patient side of the device were accomplished . The frequency rate of nosocomial pneumonia was made by using clinical criteria . Ventilatory support variables , airway care , device costs , and clinical indicators of humidification efficiency ( sputum volume , sputum efficiency ) were also recorded . Prolonged use of both hygroscopic and hydrophobic devices did not diminish efficiency or increase resistance . There was no difference in the number of colony‐forming units from device cultures over the 5‐day period and no difference between colony‐forming units in devices changed every 24 hrs compared with devices changed after 120 hrs . The average duration of use was 23 ± 4 hrs in the HHME‐24 group , 73 ± 13 hrs in the HME‐120 group , and 74 ± 9 hrs in the HHME‐120 group . Mean absolute humidity was greater for the hygroscopic devices ( 30.4 ± 1.1 mg of H2O/L ) compared with the hydrophobic devices ( 27.8 ± 1.3 mg of H2O/L ) . The frequency rate of nosocomial pneumonia was 8 % ( 8:100 ) in the HHME‐24 group , 8.3 % ( 5:60 ) in the HME‐120 group , and 6.6 % ( 4:60 ) in the HHME‐120 group . Pneumonia rates per 1000 ventilatory support days were 20:1000 in the HHME‐24 group , 20.8:1000 in the HME‐120 group , and 16.6:1000 in the HHME‐120 group . Costs per day were $ 3.24 for the HHME‐24 group , $ 2.98 for the HME‐120 group , and $ 1.65 for the HHME‐120 group . Conclusions : Changing the hydrophobic or hygroscopic HME after 3 days does not diminish efficiency , increase resistance , or alter bacterial colonization . The frequency rate of nosocomial pneumonia was also unchanged . Use of HMEs for > 24 hrs , up to 72 hrs , is safe and cost effective Nosocomial pneumonia is the leading cause of death among all hospital-acquired infections [ 1 ] . The estimated incidence of nosocomial pneumonia in intensive care units ranges from 10 % to 65 % ; most studies [ 2 - 6 ] show case fatality rates of more than 20 % . Ventilator-associated pneumonia specifically refers to nosocomial pneumonia that develops in a mechanically ventilated patient and that was not present at the time of airway intubation [ 7 ] . Various clinical risk factors have been associated with an increased incidence of ventilator-associated pneumonia , either because they predispose the patient to bacterial colonization of the oropharynx and stomach ( for example , the administration of antacids or histamine-2-receptor antagonists ) or because they facilitate aspiration of contaminated contents from these sites ( for example , supine positioning ) [ 1 , 2 , 8 , 9 ] . Craven and colleagues [ 10 ] first showed that the frequency of ventilator circuit changes also influences the incidence of ventilator-associated pneumonia . They found that changing circuits every 24 rather than every 48 hours was independently associated with the occurrence of nosocomial pneumonia [ 10 ] . This association has been attributed to increased manipulation of the patient , the endotracheal tube , and the ventilator circuit , which results in increased aspiration of contaminated tubing condensate or upper airway secretions [ 10 , 11 ] . More recently , several groups of investigators have found that ventilator circuits can be used safely for more than 48 hours without increasing the incidence of nosocomial pneumonia [ 12 - 16 ] . However , because of limitations in the design of these studies and the small number of patients prospect ively examined , the Centers for Disease Control and Prevention has given no clear recommendation for the maximum length of time that ventilator circuits can safely be left in place during prolonged mechanical ventilation [ 17 ] . This has result ed in the development of ambiguous guidelines about the frequency with which ventilator circuits should be changed [ 18 , 19 ] and in a call for well- design ed investigations to resolve this issue [ 20 ] . We did a r and omized , controlled trial to compare the effect and cost-efficacy of routine and no routine ventilator circuit changes in patients having prolonged mechanical ventilation . Our main goals were to determine 1 ) the incidence and outcome of ventilator-associated pneumonia in patients receiving scheduled ventilator circuit changes and 2 ) whether this incidence was increased in patients whose ventilator circuits remained unchanged . Methods Study Location and Patients The study was conducted at two university-affiliated teaching hospitals : Barnes Hospital ( 900 beds ) and Jewish Hospital ( 450 beds ) . During a 7-month period ( June 1994 to December 1994 ) , all patients receiving mechanical ventilation in the intensive care units of these hospitals ( surgical , trauma , medical , cardiothoracic , and neurosurgical units at Barnes Hospital ; surgical , medical , and cardiothoracic units at Jewish Hospital ) were potentially eligible for this investigation . Patients were entered into the trial if they were older than 18 years and had received mechanical ventilation for more than 5 days . Mechanical ventilation for more than 5 days was predetermined , on the basis of our previous experience at these institutions [ 2 , 21 ] , to be necessary so that a more homogeneous cohort of patients requiring prolonged mechanical ventilation could be accrued . Patients were excluded if they were likely to be extubated within 24 hours of r and omization , if they had transferred from other hospitals and had already received mechanical ventilation for more than 24 hours , if they had had lung transplantation , or if they had active hemoptysis . Barnes Hospital and Jewish Hospital share the same respiratory therapy and infection control departments . The study was approved by the Washington University School of Medicine Human Studies Committee and the Institutional Review Board of Jewish Hospital . Both waived the requirement for informed consent because this study was a quality assessment of two low-risk practice s already in clinical use . Study Design Patients were r and omly assigned to receive no routine ventilator circuit changes or circuit changes every 7 days within 24 hours of meeting eligibility criteria . A schedule of changing ventilator circuits every 7 days was selected on the basis of available clinical data [ 12 - 16 ] and our survey of 16 regional medical centers ( DM Baker . Unpublished communication ) . Stratification according to hospital site was done before r and omization to control for differences in patient population s and health care personnel . R and omization within each hospital was done using opaque , sealed envelopes , which were opened at the time each patient was enrolled in the study . For the purpose s of this investigation , ventilator circuits were defined to include gas delivery tubing , humidifier water reservoirs , water traps , and medication delivery devices ( such as metered-dose inhaler chambers or adapters ) . Ventilator circuits could be changed at any time , at the discretion of individual care providers ( physicians , nurses , and respiratory therapists ) , secondary to a mechanical failure of the ventilator circuit ( such as an air leak ) or visible soil ( such as that result ing from hemoptysis or aspirated emesis ) . Scheduled ventilator circuit changes were done during the evening or night shifts to minimize the identification of individual patient group assignments to blinded investigators . All nonscheduled circuit changes were done when an appropriate indication for the circuit change ( that is , a mechanical defect or soil ) was identified . Patients transferred to the operating room for a surgical procedure ( such as tracheotomy ) or to diagnostic radiology received the same mechanical ventilator and circuit when they returned to the intensive care unit . The ventilators used for this study included Siemens Servo 900C ( Siemens-Elema Ventilator Systems , Schaumburg , Illinois ) , Puritan-Bennett 700 Series ( Puritan-Bennett Corporation , Carlsbad , California ) , and Bird 8400 Series ventilators ( Bird Products Corporation , Palm Springs , California ) . All ventilators were equipped with wick-type humidifiers ( Concha Therm III Plus , Hudson Respiratory Care , Inc. , Temecula , California ) filled with sterile irrigation water . All ventilator circuits were disposable ( Hudson Respiratory Care , Inc. , model 1613 ) and equipped with Y connectors . Each ventilator circuit had an attached trap for the collection of tubing condensate ( Marquest Medical Products , Inc. , Englewood , Colorado ) . As per our st and ard procedure , all ventilator circuits were monitored at least every 2 hours and water traps were emptied when full . Data Collection For all study patients , the following characteristics were prospect ively recorded by one of the investigators : age , sex , diagnosis at hospital admission , indication for mechanical ventilation , Premorbid Lifestyle score , the ratio of arterial blood oxygen tension to the concentration of inspired oxygen ( Pao 2 : Fio 2 ) , severity of illness based on APACHE II ( Acute Physiology and Chronic Health Evaluation [ 22 ] ) scores , the Organ System Failure Index , and the occurrence of a witnessed aspiration event . Specific processes of medical care examined to assess risk factors for ventilator-associated pneumonia were the administration of antacids or histamine-2-receptor antagonists , pharmacologic aerosol treatments during mechanical ventilation ( such as bronchodilators , antibiotics , and mucolytics ) , fiberoptic bronchoscopy , surgical tracheostomy , and the number of ventilator circuit changes done and the indications for those changes ( scheduled according to the study protocol , soil , or mechanical defect ) . Two of the investigators made daily rounds in the intensive care units of each hospital to identify eligible patients . Patients entered into the study were prospect ively followed for the occurrence of ventilator-associated pneumonia until they were successfully weaned from mechanical ventilation , were discharged from the hospital , or died . All patients suspected by these investigators of having ventilator-associated pneumonia were prospect ively and independently review ed by another investigator who was blinded to the patient 's treatment group assignment . The diagnosis of ventilator-associated pneumonia was strictly based on the predetermined criteria described below . Patients could not be entered into the study more than once during the same hospitalization , and only the first episode of ventilator-associated pneumonia was evaluated . In addition to the occurrence of ventilator-associated pneumonia , secondary outcomes assessed included the length of hospitalization , the duration of mechanical ventilation , hospital mortality , and mortality directly attributed to ventilator-associated pneumonia . All study variables were recorded in data collection books maintained at each of the participating hospitals . Definitions All definitions were selected prospect ively as part of the original study design . The Premorbid Lifestyle score was used as previously defined [ 23 ] : Zero indicated that the patient was employed without restriction ; 1 indicated that the patient was independent , fully ambulatory , not employed , or employed with restriction ; 2 indicated that the patient had restricted activities , could live alone and get out of the house to do basic necessities , or had severely limited exercise ability ; 3 indicated that the patient was housebound , could not get out of the house unassisted , could not live alone , or could not do heavy chores ; and 4 indicated that
Output:
| Such criteria result in good sensitivity but poor specificity .
Semi-Recumbent Patient Positioning Background and Practice Description Positioning of critically ill patients may affect the incidence of ventilator-associated pneumonia .
Supine patient positioning has been shown to be independently associated with the development of ventilator-associated pneumonia , possibly because of an increased risk for gastroesophageal reflux and aspiration ( 13 ) .
Semi-recumbent positioning ( defined as elevation of the head of the bed to 45 degrees ) may decrease the risk for ventilator-associated pneumonia .
Medications that alter the gastric pH , such as H2-antagonists and antacids , may increase organism counts and increase the risk for ventilator-associated pneumonia ( 18 ) .
Sucralfate , an alternative prophylactic agent that does not affect gastric pH , may not increase this risk .
Conclusions and Recommendations Stress ulcer prophylaxis with any agent may increase the risk for ventilator-associated pneumonia ( 18 ) .
Therefore , sucralfate may decrease risk when compared with H2-antagonists but not when compared with placebo .
The data comparing stress ulcer prophylaxis with sucralfate and H2-antagonists suggest a decreased |
MS211260 | ***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: ABSTRACT Memory loss is one of the first symptoms of typical Alzheimer 's disease ( AD ) , for which there are no effective therapies available . The precuneus ( PC ) has been recently emphasized as a key area for the memory impairment observed in early AD , likely due to disconnection mechanisms within large‐scale networks such as the default mode network ( DMN ) . Using a multimodal approach we investigated in a two‐week , r and omized , sham‐controlled , double‐blinded trial the effects of high‐frequency repetitive transcranial magnetic stimulation ( rTMS ) of the PC on cognition , as measured by the Alzheimer Disease Cooperative Study Pre clinical Alzheimer Cognitive Composite in 14 patients with early AD ( 7 females ) . TMS combined with electroencephalography ( TMS‐EEG ) was used to detect changes in brain connectivity . We found that rTMS of the PC induced a selective improvement in episodic memory , but not in other cognitive domains . Analysis of TMS‐EEG signal revealed an increase of neural activity in patients ' PC , an enhancement of brain oscillations in the beta b and and a modification of functional connections between the PC and medial frontal areas within the DMN . Our findings show that high‐frequency rTMS of the PC is a promising , non‐invasive treatment for memory dysfunction in patients at early stages of AD . This clinical improvement is accompanied by modulation of brain connectivity , consistently with the pathophysiological model of brain disconnection in AD . HighlightsThe precuneus is a key area for memory impairment in Alzheimer ’s disease (AD).We investigated the effects of precuneus‐rTMS on memory in patients with early AD.Precuneus‐rTMS induced a selective improvement in episodic memory . Precuneus‐rTMS enhance precuneus activity and connectivity with frontal areas .Precuneus‐rTMS is a promising treatment for memory dysfunction in early AD patients OBJECTIVE To provide expert recommendations for the safe and effective application of repetitive transcranial magnetic stimulation ( rTMS ) in the treatment of major depressive disorder ( MDD ) . PARTICIPANTS Participants included a group of 17 expert clinicians and research ers with expertise in the clinical application of rTMS , representing both the National Network of Depression Centers ( NNDC ) rTMS Task Group and the American Psychiatric Association Council on Research ( APA CoR ) Task Force on Novel Biomarkers and Treatments . EVIDENCE The consensus statement is based on a review of extensive literature from 2 data bases ( OvidSP MEDLINE and PsycINFO ) search ed from 1990 through 2016 . The search terms included variants of major depressive disorder and transcranial magnetic stimulation . The results were limited to articles written in English that focused on adult population s. Of the approximately 1,500 retrieved studies , a total of 118 publications were included in the consensus statement and were supplemented with expert opinion to achieve consensus recommendations on key issues surrounding the administration of rTMS for MDD in clinical practice setting s. CONSENSUS PROCESS In cases in which the research evidence was equivocal or unclear , a consensus decision on how rTMS should be administered was reached by the authors of this article and is denoted in the article as " expert opinion . " CONCLUSIONS Multiple r and omized controlled trials and published literature have supported the safety and efficacy of rTMS antidepressant therapy . These consensus recommendations , developed by the NNDC rTMS Task Group and APA CoR Task Force on Novel Biomarkers and Treatments , provide comprehensive information for the safe and effective clinical application of rTMS in the treatment of MDD Episodic memory displays the largest degree of age-related decline , a process that is accelerated in pathological conditions such as amnestic mild cognitive impairment and Alzheimer 's disease . Previous studies have shown that the left lateral prefrontal cortex ( PFC ) contributes to the encoding of episodic memories along the life span . The aim of this r and omized , double-blind , placebo-controlled study was to test the hypothesis that anodal trascranial direct current stimulation ( tDCS ) over the left lateral PFC during the learning phase would enhance delayed recall of verbal episodic memories in elderly individuals . Older adults learned a list of words while receiving anodal or placebo ( sham ) tDCS . Memory recall was tested 48 hours and 1 month later . The results showed that anodal tDCS strengthened episodic memories , an effect indicated by enhanced delayed recall ( 48 hours ) compared to placebo stimulation ( Cohen 's d effect size = 1.01 ) . The observation that PFC-tDCS during learning can boost verbal episodic memory in the elderly opens up the possibility to design -specific neurorehabilitation protocol s targeted to conditions that affect episodic memory such as mild cognitive impairment Objective : Given the limited effectiveness of pharmacological treatments , non-pharmacological interventions to treat Alzheimer 's disease ( AD ) have gained attention in recent years . The aim of the present study is to investigate the effects of anodal tDCS ( AtDCS ) combined with memory training on face-name associations in an AD patient sample . Methods : Thirty six AD patients were r and omly assigned to one of three study groups : Group 1 , AtDCS plus individualized computerized memory training ; Group 2 , placebo tDCS plus individualized computerized memory training ; Group 3 , AtDCS plus motor training . Results : A general improvement in performance was observed after 2 weeks of memory training . Both the anodal tDCS plus individualized computerized memory training and the placebo tDCS plus individualized computerized memory training groups had significantly improved performances at 2 weeks compared with the AtDCS plus motor training group . Conclusion : Our findings suggest a beneficial effect of individualized memory rehabilitation in AD patients Background : The purpose of this study was to investigate the long-term efficacy of transcranial direct current stimulation ( tDCS ) in the neurorehabilitation of Alzheimer ’s disease ( AD ) . Methods : Thirty-four AD patients were r and omly assigned to three groups : anodal , cathodal , and sham tDCS . Stimulation was applied over the left dorsolateral prefrontal cortex for 25 min at 2 mA , daily for 10 days . Each patient was su bmi tted to the following psychometric assessment s : mini-mental state examination ( MMSE ) and Wechsler adult intelligence scale-third edition at base line , at the end of the 10th sessions and then at 1 and 2 months after the end of the sessions . Motor cortical excitability and the P300 event-related potential were assessed at baseline and after the last tDCS session . Results : Significant treatment group × time interactions were observed for the MMSE and performance IQ of the WAIS . Post hoc comparisons showed that both anodal and cathodal tDCS ( ctDCS ) improved MMSE in contrast to sham tDCS . Whereas , this was only true for ctDCS in the performance IQ . Remarkably , tDCS also reduced the P300 latency , but had no effect on motor cortex excitability . Conclusion : Our findings reveal that repeated sessions of tDCS could not only improve cognitive function but also reduce the P300 latency , which is known to be pathologically increased in AD Transcranial magnetic stimulation ( TMS ) is a noninvasive brain stimulation technique with potential to improve memory . Mild cognitive impairment ( MCI ) , which still lacks a specific therapy , is a clinical syndrome associated with increased risk of dementia . This study aims to assess the effects of high-frequency repetitive TMS ( HF rTMS ) on everyday memory of the elderly with MCI . We conducted a double-blinded r and omized sham-controlled trial using rTMS over the left dorsolateral prefrontal cortex ( DLPFC ) . Thirty-four elderly out patients meeting Petersen 's MCI criteria were r and omly assigned to receive 10 sessions of either active TMS or sham , 10 Hz rTMS at 110 % of motor threshold , 2,000 pulses per session . Neuropsychological assessment at baseline , after the last session ( 10th ) and at one-month follow-up , was applied . ANOVA on the primary efficacy measure , the Rivermead Behavioural Memory Test , revealed a significant group-by-time interaction ( p = 0.05 ) , favoring the active group . The improvement was kept after one month . Other neuropsychological tests were heterogeneous . rTMS at 10 Hz enhanced everyday memory in elderly with MCI after 10 sessions . These findings suggest that rTMS might be effective as a therapy for MCI and probably a tool to delay deterioration Remembering the location of objects , an integral part of everyday life , is known to decline with advancing age and early in the course of neurodegenerative dementia . Here , we aim ed to test if object-location learning and its retention could be modified by noninvasive brain stimulation . In a group of 20 elderly ( mean age 62.1 years ) right-h and ed individuals , we applied transcranial direct current stimulation ( tDCS ; 20 minutes , 1 mA ) over the right temporoparietal cortex , while subjects acquired the correct position of buildings on a street map using an associative learning paradigm . Each subject participated in a r and omized and balanced order in 1 session of anodal tDCS and 1 session of sham stimulation , in a double-blind design with 2 parallel versions of the task . Outcome measures were learning success at the end of each session , and immediate as well as delayed ( 1 week ) free recall . We found that subjects performed comparably in the learning task in the 2 conditions , but showed improved recall 1 week after learning with anodal tDCS compared with learning with sham stimulation . In conclusion , retention of object-location learning in the elderly may be modulated by noninvasive brain stimulation , a finding of potential relevance not only for normal aging but also for memory deficits in pathological aging The aim of the study was to compare the long-term efficacy of high versus low frequency repetitive transcranial magnetic stimulation ( rTMS ) , applied bilaterally over the dorsolateral prefrontal cortex ( DLPFC ) , on cognitive function and cortical excitability of patients with Alzheimer 's disease ( AD ) . Forty-five AD patients were r and omly classified into three groups . The first two groups received real rTMS over the DLPFC ( 20 and 1 Hz , respectively ) while the third group received sham stimulation . All patients received one session daily for five consecutive days . In each session , rTMS was applied first over the right DLPFC , immediately followed by rTMS over the left DLPFC . Mini Mental State Examination ( MMSE ) , Instrumental Daily Living Activity ( IADL ) scale and the Geriatric Depression Scale ( GDS ) were assessed before , after the last ( fifth ) session , and then followed up at 1 and 3 months . Neurophysiological evaluations included resting and active motor threshold ( rMT and aMT ) , and the duration of transcallosal inhibition ( TI ) before and after the end of the treatment sessions . At base line assessment there were no significant differences between groups in any of the rating scales . The high frequency rTMS group improved significantly more than the low frequency and sham groups in all rating scales ( MMSE , IADL , and GDS ) and at all time points after treatment . Measures of cortical excitability immediately after the last treatment session showed that treatment with 20 Hz rTMS reduced TI duration . These results confirm that five daily sessions of high frequency rTMS over the left and then the right DLPFC improves cognitive function in patients with mild to moderate degree of AD . This improvement was maintained for 3 months . High frequency rTMS may be a useful addition to therapy for the treatment of AD The long pre clinical phase of Alzheimer 's disease provides opportunities for potential disease‐modifying interventions in prodromal stages such as mild cognitive impairment ( MCI ) . Anodal transcranial direct current stimulation ( anodal‐tDCS ) , with its potential to enhance neuroplasticity , may allow improving cognition in MCI The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating INTRODUCTION Repetitive transcranial magnetic stimulation ( rTMS ) is a noninvasive tool for modulating cortical activity . OBJECTIVES In this pilot study , we evaluated the effects of high frequency rTMS applied over the right inferior frontal gyrus ( IFG ) on cognitive functions in patients with amnestic mild cognitive impairment ( MCI ) or incipient dementia due to Alzheimer 's disease ( AD ) . METHODS Ten patients ( 6 men ; 4 women , mean age of 72 ± 8 years ; MMSE 23 ± 3.56 ) were enrolled in a r and omized , placebo-controlled study with a crossover design . All participants received 2 sessions of 10 Hz rTMS over the non-dominant right hemisphere in r and om order : IFG ( active stimulation site ) and vertex ( control stimulation site ) . Intensities were adjusted to 90 % of resting motor threshold . A total of 2250 pulses were applied in a session . The Trail Making Test ( TMT ) , the Stroop test , and the complex visual scene encoding task ( CVSET ) were administered before and immediately after each session . The Wilcoxon paired test was used for data analysis . RESULTS Stimulation applied over the IFG induced improvement in the TMT parts A ( p = 0.037 ) and B ( p = 0.049 ) . No significant changes were found in the Stroop test or the CVSET after the IFG stimulation . We observed no significant cognitive aftereffects of rTMS applied over the vertex . CONCLUSIONS High frequency rTMS of the right IFG induced significant improvement of attention and psychomotor speed in patients with MCI/mild dementia due to AD . This pilot study
Output:
| However , there was no significant improvement in other domains of cognition .
Conclusions NIBS has a positive effect on improving global cognitive function and verbal fluency .
At the same time , it has a small positive effect on improving executive function . |
MS211261 | ***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: Abstract Background Human ageing is a process characterized by loss of muscle mass , strength , and bone mass . We aim ed to examine the efficacy of low‐dose creatine supplementation associated with resistance training on lean mass , strength , and bone mass in the elderly . Methods This was a 12‐week , parallel‐group , double‐blind , r and omized , placebo‐controlled trial . The individuals were r and omly allocated into one of the following groups : placebo plus resistance training ( PL + RT ) and creatine supplementation plus resistance training ( CR + RT ) . The participants were assessed at baseline and after 12 weeks . The primary outcomes were lean mass and strength , assessed by dual energy X‐ray absorptiometry ( DXA ) and ten‐repetition maximal tests ( 10 RM ) , respectively . Secondary outcomes included the lumbar spine , right and left femoral neck , both femur and whole body bone mineral density ( BMD ) , and whole body bone mineral content ( BMC ) , assessed by DXA . Results The CR + RT group had superior gains in lean mass when compared with the PL + RT group ( P = 0.02 ) . Changes in the 10 RM tests in bench press and leg press exercises , body composition , BMD , and BMC of all assessed sites did not significantly differ between the groups ( P > 0.05 ) . Conclusions Twelve weeks of low‐dose creatine supplementation associated with resistance training result ed in increases in lean mass in the elderly Purpose To assess the effects of creatine supplementation , associated or not with strength training , upon emotional and cognitive measures in older woman . Methods This is a 24-week , parallel-group , double-blind , r and omized , placebo-controlled trial . The individuals were r and omly allocated into one of the following groups ( n=14 each ) : 1 ) placebo , 2 ) creatine supplementation , 3 ) placebo associated with strength training or 4 ) creatine supplementation associated with strength training . According to their allocation , the participants were given creatine ( 4 x 5 g/d for 5 days followed by 5 g/d ) or placebo ( dextrose at the same dosage ) and were strength trained or not . Cognitive function , assessed by a comprehensive battery of tests involving memory , selective attention , and inhibitory control , and emotional measures , assessed by the Geriatric Depression Scale , were evaluated at baseline , after 12 and 24 weeks of the intervention . Muscle strength and food intake were evaluated at baseline and after 24 weeks . Results After the 24-week intervention , both training groups ( ingesting creatine supplementation and placebo ) had significant reductions on the Geriatric Depression Scale scores when compared with the non-trained placebo group ( p = 0.001 and p = 0.01 , respectively ) and the non-trained creatine group ( p < 0.001 for both comparison ) . However , no significant differences were observed between the non-trained placebo and creatine ( p = 0.60 ) groups , or between the trained placebo and creatine groups ( p = 0.83 ) . Both trained groups , irrespective of creatine supplementation , had better muscle strength performance than the non-trained groups . Neither strength training nor creatine supplementation altered any parameter of cognitive performance . Food intake remained unchanged . Conclusion Creatine supplementation did not promote any significant change in cognitive function and emotional parameters in apparently healthy older individuals . In addition , strength training per se improved emotional state and muscle strength , but not cognition , with no additive effects of creatine supplementation . Trial Registration Clinical trials.gov Abstract Purpose The present study evaluated the effects of creatine monohydrate ( CrM ) consumption post-exercise on body composition and muscle strength in middle to older males following a 12-week resistance training program . Methods In a double-blind , r and omized trial , 20 males aged between 55 and 70 years were r and omly assigned to consume either CrM-carbohydrate ( CHO ) [ 20 g days−1 CrM + 5 g days−1 CHO × 7 days , then 0.1 g kg−1 CrM + 5 g CHO on training days ( average dosage of ~8.8 g ) ] or placebo CHO ( 20 g days−1 CHO × 7 days , then 5 g CHO on training days ) while participating in a high intensity resistance training program [ 3 sets × 10 repetitions at 75 % of 1 repetition maximum ( 1RM ) ] , 3 days weeks−1 for 12 weeks . Following the initial 7-day “ loading ” phase , participants were instructed to ingest their supplement within 60 min post-exercise . Body composition and muscle strength measurements , blood collection and vastus lateralis muscle biopsy were completed at 0 , 4 , 8 and 12 weeks of the supplement and resistance training program . Results A significant time effect was observed for 1RM bench press ( p = 0.016 ) , leg press ( p = 0.012 ) , body mass ( p = 0.03 ) , fat-free mass ( p = 0.005 ) and total myofibrillar protein ( p = 0.005 ) . A trend for larger muscle fiber cross-sectional area in the type II fibers compared to type I fibers was observed following the 12-week resistance training ( p = 0.08 ) . No supplement interaction effects were observed . Conclusion Post-exercise ingestion of creatine monohydrate does not provide greater enhancement of body composition and muscle strength compared to resistance training alone in middle to older males PURPOSE To determine whether low-dose creatine and protein supplementation during resistance training ( RT ; 3 d x wk(-1 ) ; 10 wk ) in older men ( 59 - 77 yr ) is effective for improving strength and muscle mass without producing potentially cytotoxic metabolites ( formaldehyde ) . METHODS Older men were r and omized ( double-blind ) to receive 0.1 g x kg(-1 ) creatine + 0.3 g x kg(-1 ) protein ( CP ; n = 10 ) , creatine ( C ; n = 13 ) , or placebo ( PLA ; n = 12 ) on training days . Measurements before and after RT included lean tissue mass ( air-displacement plethysmography ) , muscle thickness ( ultrasound ) of elbow , knee , and ankle flexors and extensors , leg and bench press strength , and urinary indicators of cytotoxicity ( formaldehyde ) , myofibrillar protein degradation [ 3-methylhistidine ( 3-MH ) ] , and bone resorption [ cross-linked N-telopeptides of type I collagen ( NTx ) ] . RESULTS Subjects in C and CP groups combined experienced greater increases in body mass and total muscle thickness than PLA ( P < 0.05 ) . Subjects who received CP increased lean tissue mass ( + 5.6 % ) more than C ( + 2.2 % ) or PLA ( + 1.0 % ; P < 0.05 ) and increased bench press strength ( + 25 % ) to a greater extent than C and PLA combined ( + 12.5 % ; P < 0.05 ) . CP and C did not differ from PLA for changes in formaldehyde production ( + 24 % each ) . Subjects receiving creatine ( C and CP ) experienced a decrease in 3-MH by 40 % compared with an increase of 29 % for PLA ( P < 0.05 ) and a reduction in NTx ( -27 % ) versus PLA ( + 13 % ; P = 0.05 ) . CONCLUSIONS Low-dose creatine combined with protein supplementation increases lean tissue mass and results in a greater relative increase in bench press but not leg press strength . Low-dose creatine reduces muscle protein degradation and bone resorption without increasing formaldehyde production Objectives Creatine and protein supplementation can enhance the training outcomes of young subjects , but it is not clear if there are benefits for older individuals . Therefore , the purpose of this study was to determine the effects of creatine and protein supplementation on strength gains following a traditional resistance training program for middle-aged and older men . Design , Setting , Participants This study assessed changes in strength of men aged 48–72 years following 14 weeks of resistance training supplemented with creatine and /or protein . A double-blind , r and omized , placebo-controlled design placed 42 males into one of four groups : Resistance Trained Placebo ( RTP , n=10 ) ; Resistance Trained Creatine ( RTCr , 5 g Cr , n=10 ) ; Resistance Trained Protein ( RTPr , 35 g whey Pr , n=11 ) ; or Resistance Trained Creatine and Protein ( RTCrPr , 5 g Cr and 35 g Pr , n=11).InterventionAll groups trained 3 days per week for 14 weeks . The resistance training program was based on progressive overload . Training loads corresponded to 80 % 1RM ( one repetition maximum strength ) , 3 sets of 8 repetitions for the following exercises : knee extension/knee flexion ; bicep curl/tricep extension ; military press ; lat pull down ; seated leg press ; and bench press . Measurements 1 RM for each exercise and measures of lean body mass were assessed prior to and following the 14 week program . Results Each group significantly ( p<0.05 ) increased strength and lean body mass , however , there were no significant group effects or group X trial interactions . Conclusion Resistance training in middle-aged and older men significantly increased muscular strength and added muscle mass with no additional benefits from creatine and /or protein supplementation This study examined the effects of long-term creatine supplementation combined with resistance training ( RT ) on the one-repetition maximum ( 1RM ) strength , motor functional performance ( e.g. , 30-s chair st and , arm curl , and getting up from lying on the floor tests ) and body composition ( e.g. , fat-free mass , muscle mass , and % body fat using DEXA scans ) in older women . Eighteen healthy women ( 64.9 ± 5.0 years ) were r and omly assigned in a double-blind fashion to either a creatine ( CR , N = 9 ) or placebo ( PL , N = 9 ) group . Both groups underwent a 12-week RT program ( 3 days week−1 ) , consuming an equivalent amount of either creatine ( 5.0 g day−1 ) or placebo ( maltodextrin ) . After 12 week , the CR group experienced a greater ( P < 0.05 ) increase ( Δ% ) in training volume ( + 164.2 ) , and 1RM bench press ( + 5.1 ) , knee extension ( + 3.9 ) and biceps curl ( + 8.8 ) performance than the PL group . Furthermore , CR group gained significantly more fat-free mass ( + 3.2 ) and muscle mass ( + 2.8 ) and were more efficient in performing submaximal-strength functional tests than the PL group . No changes ( P > 0.05 ) in body mass or % body fat were observed from pre- to post-test in either group . These results indicate that long-term creatine supplementation combined with RT improves the ability to perform submaximal-strength functional tasks and promotes a greater increase in maximal strength , fat-free mass and muscle mass in older women Aging is associated with lower muscle mass and an increase in body fat . We examined whether creatine monohydrate ( CrM ) and conjugated linoleic acid ( CLA ) could enhance strength gains and improve body composition ( i.e. , increase fat-free mass ( FFM ) ; decrease body fat ) following resistance exercise training in older adults ( > 65 y ) . Men ( N = 19 ) and women ( N = 20 ) completed six months of resistance exercise training with CrM (5g/d)+CLA ( 6g/d ) or placebo with r and omized , double blind , allocation . Outcomes included : strength and muscular endurance , functional tasks , body composition ( DEXA scan ) , blood tests ( lipids , liver function , CK , glucose , systemic inflammation markers ( IL-6 , C-reactive protein ) ) , urinary markers of compliance ( creatine/creatinine ) , oxidative stress ( 8-OH-2dG , 8-isoP ) and bone resorption ( Ν-telopeptides ) . Exercise training improved all measurements of functional capacity ( P<0.05 ) and strength ( P<0.001 ) , with greater improvement for the CrM+CLA group in most measurements of muscular endurance , isokinetic knee extension strength , FFM , and lower fat mass ( P<0.05 ) . Plasma creatinine ( P<0.05 ) , but not creatinine clearance , increased for CrM+CLA , with no changes in serum CK activity or liver function tests . Together , this data confirms that supervised resistance exercise training is safe and effective for increasing strength in older adults and that a combination of CrM and CLA can enhance some of the beneficial effects of training over a six-month period . Trial Registration . Clinical Trials.gov effect of oral creatine supplementation ( CR ; 5 g/day ) in conjunction with exercise training on physical fitness was investigated in men between 55 and 75 yr of age ( n = 46 ) . A double-blind r and omized placebo-controlled ( PL ) trial was performed over a 6-mo period . Furthermore , a subgroup ( n = 20 ) completed a 1-yr follow-up . The training program consisted of cardiorespiratory endurance training as well as moderate resistance training ( 2 - 3 sessions/wk ) . Endurance capacity was evaluated during a maximal incremental bicycle ergometer test , maximal isometric strength of the knee-extensor muscles was assessed by an isokinetic dynamometer , and
Output:
| These studies suggest that any additive ergogenic creatine effects on upper and /or lower body strength , functional capacity , and lean mass in an older population would require a continuous and daily low-dose creatine supplementation combined with at least 12 weeks of resistance training .
The limited data suggested no additive effects of creatine over exercise alone on indices of mental health .
The beneficial effects of creatine supplementation are more consistent in older women than in men .
Conclusions : Creatine monohydrate is safe to use in older adults . |
MS211262 | ***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 Smoking cessation was examined among high-risk participants in the UK Lung Cancer Screening ( UKLS ) Pilot Trial of low-dose CT screening . Methods High-risk individuals aged 50–75 years who completed baseline question naires were r and omised to CT screening ( intervention ) or usual care ( no screening control ) . Smoking habit was determined at baseline using self-report . Smokers were asked whether they had quit smoking since joining UKLS at T1 ( 2 weeks after baseline scan results or control assignment ) and T2 ( up to 2 years after recruitment ) . Intention-to-treat ( ITT ) regression analyses were undertaken , adjusting for baseline lung cancer distress , trial site and sociodemographic variables . Results Of a total 4055 individuals r and omised to CT screening or control , 1546 were baseline smokers ( 759 intervention , 787 control ) . Smoking cessation rates were 8 % ( control n=36/479 ) versus 14 % ( intervention n=75/527 ) at T1 and 21 % ( control n=79/377 ) versus 24 % ( intervention n=115/488 ) at T2 . ITT analyses indicated that the odds of quitting among screened participants were significantly higher at T1 ( adjusted OR ( aOR ) 2.38 , 95 % CI 1.56 to 3.64 , p<0.001 ) and T2 ( aOR 1.60 , 95 % CI 1.17 to 2.18 , p=0.003 ) compared with control . Intervention participants who needed additional clinical investigation were more likely to quit in the longer term compared with the control group ( aOR 2.29 , 95 % CI 1.62 to 3.22 , p=0.007 ) and those receiving a negative result ( aOR 2.43 , 95 % CI 1.54 to 3.84 , p<0.001 ) . Conclusions CT lung cancer screening for high-risk participants presents a teachable moment for smoking cessation , especially among those who receive a positive scan result . Further behavioural research is needed to evaluate optimal strategies for integrating smoking cessation intervention with stratified lung cancer screening . Trial registration number Results , IS RCT N Background : The effect of low-dose CT screening for lung cancer on smoking habits has not been reported in large r and omised controlled trials . Methods : This study evaluated the effect on smoking habits of screening with low-dose CT at 1-year follow up in the Danish Lung Cancer Screening Trial ( DLCST ) , a 5-year r and omised controlled trial comprising 4104 subjects ; 2052 subjects received annual low-dose CT scan ( CT group ) and 2052 received no intervention ( control group ) . Participants were healthy current and former smokers ( > 4 weeks since smoking cessation ) with a tobacco consumption of > 20 pack years . Smoking habits were determined at baseline and at annual screening . Smoking status was verified using exhaled carbon monoxide levels . Lung function tests , nicotine dependency and motivation to quit smoking were assessed . Quit rates and relapse rates were determined at 1-year follow-up for all subjects . Results : At 1 year the quit rates among smokers were 11.9 % in the CT group and 11.8 % in the control group ( p = 0.95 ) . Relapse rates for former smokers were 10.0 % and 10.5 % in the CT and control groups , respectively ( p = 0.81 ) . Significant predictors ( p<0.05 ) for smoking cessation were : high motivation to quit , low dependency , low ratio of forced expiratory volume in 1 s to forced vital capacity , low pack years , higher age , longer period of abstinence and CT findings necessitating 3-month repeat CT scans . Conclusions : Overall , quit rates were similar in the CT and control group at 1-year follow-up , with a net quit rate of 6.0 % . Quit rates were higher and relapse rate lower among subjects with initial CT findings that necessitated a repeat scan 3 months later Background Lung cancer screening may provide a new opportunity for attempts to quit among smokers or might delay smoking cessation , but studies to date failed to provide evidence for this . This study investigated the effect of lung cancer screening on smoking abstinence in male smokers participating in the Dutch – Belgian r and omised controlled lung cancer screening trial ( NELSON trial ) . Methods In the NELSON trial , 50- to 75-year-old participants at high risk for developing lung cancer were r and omised to either lung cancer screening or no screening . Smoking behaviour was evaluated in two r and om sample s of male smokers in the screen ( n=641 ) and control arm ( n=643 ) before ( T0 ) and 2 years after r and omisation ( T1 ) . In addition , the data were also analysed by intention-to-treat ( ITT ) analysis , as recommended in smoking cessation intervention trials , although non-response in screening trials can also be due to reasons other than continued smoking . Results Almost 17 % ( 16.6 % ) of the trial participants quit smoking , which is higher than the 3–7 % found in the general adult population . However , screening was associated with a lower prolonged abstinence rate ( 14.5 % ) compared with no screening ( 19.1 % ) ( OR 1.40 , 95 % CI 1.01 to 1.92 ; p<0.05 ) . No stastistically significant difference was found after performing an ITT analysis . Conclusions This study showed that all trial participants were inclined to stop smoking more than average , which suggests that screening is a teachable moment to improve smoking behaviour . In those who underwent screening the smoking abstinence rate was significantly lower than for the control group , although the difference was modest . After ITT analysis this difference was no longer observed . Clinical trial number IS RCT N63545820 Abstract Introduction In the German lung cancer screening trial LUSI , smoking cessation counseling ( SCC ) was offered to all participants at time of r and omization , and smoking habits were asked for within annual question naire inquiries . We analyzed the smoking habits of the participants within the first 2 years of follow-up and especially the potential effect of the SCC on these habits . Material s and methods We used the smoking data of the initial inquiry on which the decision on invitation to the study was based , the socio-economic data of the question naire filled-in at time of r and omization , the psycho-social data obtained during the SCC , and the annual question naire data of the first two annual follow-up screening rounds . Results Smoking prevalence decreased in the entire cohort significantly by 4 % , whereby the decrease was with 4.5 % statistically not significantly higher in the control arm than in the screening arm with 3.4 % . The decline was much stronger in the subgroup of attendees to stop-smoking counseling and mounted up therein to 10 % . In some participants , an increase of readiness to quit smoking was observed during the counseling hour , but did not show effects on smoking status 2 years later . Discussion We did not see a tendency to increased smoking among participants of the intervention arm or the entire study . The decline of smoking prevalence among the attendees of the counseling might be due to self- selection . Since the issue of effectiveness of smoking cessation counseling is important , further research with r and omization into offering counseling or no intervention should be taken into consideration Objectives To evaluate the real-life effect of an evidence -based Gold St and ard Programme ( GSP ) for smoking cessation interventions in disadvantaged patients and to identify modifiable factors that consistently produce the highest abstinence rates . Design Observational prospect i ve cohort study . Setting GSPs in pharmacies , hospitals and communities in Denmark , reporting to the national Smoking Cessation Data base . Participants Disadvantaged patients , defined as patients with a lower level of education and those receiving unemployment benefits . Interventions 6-week manualised GSP smoking cessation interventions performed by certified staff . Main outcome measures 6 months of continuous abstinence , response rate : 80 % . Results Continuous abstinence of the 16 377 responders was 34 % ( of all 20 588 smokers : 27 % ) . Continuous abstinence was lower in 5738 smokers with a lower educational level ( 30 % of responders and 23 % of all ) and in 840 unemployed ( 27 % of responders and 19 % of all ) . In respect to modifiable factors , continuous abstinence was found more often after programmes in one-on-one formats ( vs group formats ) among patients with a lower educational level , 34 % ( vs 25 % , p=0.037 ) , or among unemployed , 35 % ( vs 24 % , p=0.099 ) . The variable ‘ format ’ stayed in the final model of multivariable analyses in patients with a lower educational level , OR=1.31 ( 95 % CI 1.05 to 1.63 ) . Conclusions Although continuous abstinence was lower among disadvantaged smokers , the absolute difference was small . If the programme had been as effective in disadvantaged as in non-disadvantaged groups , there would have been an extra 46 or 8 quitters annually , respectively . Promoting individual interventions among those with a low education may increase the effectiveness of GSP Deux etudes longitudinales , prospect ives , examinent le role du soutien social dans le maintien de la decision de ne plus fumer : soutien d'un partenaire ; existence d'un climat social encourageant le sevrage ; participation a un reseau social . Part de chacun des facteurs dans le maintien de la decision et l'absence de rechute . Etudes Importance While the proportion of adults who smoke cigarettes has declined substantially in the past decade , socioeconomic disparities in cigarette smoking remain . Few interventions have targeted low socioeconomic status ( SES ) and minority smokers in primary care setting s. Objective To evaluate a multicomponent intervention to promote smoking cessation among low-SES and minority smokers . Design , Setting , and Participants For this prospect i ve , unblinded , r and omized clinical trial conducted between May 1 , 2015 , and September 4 , 2017 , adults 18 years and older who spoke English , smoked 10 or more cigarettes per day in the past week , were contemplating or preparing to quit smoking , and had a primary care clinician were recruited from general internal medicine and family medicine practice s at 1 large safety-net hospital in Boston , Massachusetts . Interventions Patients were r and omized to a control group that received an enhancement of usual care ( n = 175 participants ) or to an intervention group that received up to 4 hours of patient navigation delivered over 6 months in addition to usual care , as well as financial incentives for biochemically confirmed smoking cessation at 6 and 12 months following enrollment ( n = 177 participants ) . Main Outcomes and Measures The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months . Results Among 352 patients who were r and omized ( mean [ SD ] age , 50.0 [ 11.0 ] years ; 191 women [ 54.3 % ] ; 197 participants who identified as non – Hispanic black [ 56.0 % ] ; 40 participants who identified as Hispanic of any race [ 11.4 % ] ) , all were included in the intention-to-treat analysis . At 12 months following enrollment , 21 participants [ 11.9 % ] in the navigation and incentives group , compared with 4 participants [ 2.3 % ] in the control group , had quit smoking ( odds ratio , 5.8 ; 95 % CI , 1.9 - 17.1 ; number needed to treat , 10.4 ; P < .001 ) . In prespecified subgroup analyses , the intervention was particularly beneficial for older participants ( 19 [ 19.8 % ] vs 1 [ 1.0 % ] ; P < .001 ) , women ( 17 [ 16.8 % ] vs 2 [ 2.2 % ] ; P < .001 ) , participants with household yearly income of $ 20 000 or less ( 15 [ 15.5 % ] vs 3 [ 3.1 % ] ; P = .003 ) , and nonwhite participants ( 21 [ 15.2 % ] vs 4 [ 3.0 % ] ; P < .001 ) . Conclusions and Relevance In this study of adult daily smokers at 1 large urban safety-net hospital , patient navigation and financial incentives for smoking cessation significantly increased the rates of smoking cessation . Trial Registration clinical trials.gov Identifier :
Output:
| There were limited data to identify the optimal form of behavioural SCI for the target population .
Intense multimodal behavioural counselling that uses incentives and peer facilitators , delivered in a community setting and tailored to individual needs indicated a positive impact on smoking outcomes .
CONCLUSION Tailored , multimodal behavioural interventions embedded in local communities could potentially support cessation among older , deprived smokers . |
MS211263 | ***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 Published data on pregnancy outcome after exposure to H2-blockers is scarce . The aim of the present study was to evaluate the data collected by the memberships of the European Network of Teratology Information Services ( ENTIS ) . METHODS The patients were pregnant women who or whose doctor or midwife did contact a Teratology Information Service for risk assessment after the use of a H2-blocker in pregnancy . The data were prospect ively collected , i.e. before the outcome of pregnancy was known . St and ardized procedures for data collection were used by each centre . The data of the exposed women were compared to those of a control group exposed to non-teratogenic substances . RESULTS Data on the outcome of 553 pregnancies with exposure to an H2-blocker were evaluated ( ranitidine n=335 ; cimetidine n=113 , famotidine n=75 ; nizatidine n=15 , roxatidine n=15 ) . Most of them had been exposed at least in the first trimester . The incidence of premature deliveries was higher in the exposed group compared to the control group . There was no increase in the incidence of major malformations . Two pregnancies with maternal use of famotidine in early pregnancy were terminated after the prenatal diagnosis of a neural tube defect . CONCLUSION There is no indication for an increased risk of major malformations after the use of H2-blockers during pregnancy A r and omized controlled trial was performed to study the efficacy of Syn-Ergel with an active placebo in the treatment of heartburn of pregnancy in ninety-two patients completing 7 days of therapy . Syn-Ergel was significantly better ( p 0.001 ) in all groups of pre-treatment pain severity in relieving the symptoms , and had a longer duration of action , than the active placebo . Complete relief of pain was achieved in 79.5 % of Syn-Ergel treatments with a further 10 % of treatments result ing in marked easing of discomfort at 1 hour following administration . The corresponding figures for the ‘ active placebo ’ were 56 % and 20 % . The combination of an antacid and a protective mucosal coating agent would appear to be a useful approach in the treatment of heartburn of pregnancy Objective To determine whether ranitidine ( Zantac ) taken once or twice daily is effective for relieving symptoms of gastroesophageal reflux among pregnant women who had failed conservative measures . Methods Volunteers with heartburn despite antacids were sought among our obstetric clinic population for this double-blind , placebo-controlled , triple crossover trial . After a baseline week , 20 patients were r and omized to receive the three following weekly regimens : ranitidine 150 mg twice daily , placebo in the morning and ranitidine 150 mg in the evening , or placebo twice daily . Daily scores on symptom diaries , global assessment s , and number of antacids taken were compared among the 18 patients completing the study . Results The twice-daily dosage of ranitidine was the only regimen found to reduce heartburn symptoms when compared with the baseline ( P < .001 ) or a placebo ( P < .01 ) . Compared with ranitidine taken once daily , the twice-daily dosing prompted less need for antacid tablets compared with the placebo ( P < .05 versus P > .05 ) and to the baseline ( P < .001 versus P < .05 ) . The average reduction of heartburn severity using twice-daily ranitidine was 55.6 % when compared with baseline ( 95 % confidence interval [ CI ] 34.8 % , 76.5 % ) and was 44.2 % when compared with placebo ( 95 % CI 15.4 % , 72.9 % ) . Conclusion This study indicates the efficacy of ranitidine 150 mg taken twice daily , rather than once daily , for relief of gastroesophageal reflux symptoms during pregnancy A double blind comparative study comparing Mucaine , Mucaine without oxethazaine , and placebo was carried out with 50 patients with symptoms of heartburn during late pregnancy . We found that the 2 active treatments were more effective than placebo for the relief of heartburn , but there was no statistically significant difference between groups for the relief of nausea and regurgitation . There was a significant difference in the percentage of days of use of each medication , with the placebo being used least frequently . Although not statistically significant , for the 3 measures for which placebo differed from the active treatments , patients showed a better response to mucaine . This suggests that the addition of oxethazaine may be of benefit . The lack of statistical significance may be due to the relatively small number of cases , and the findings are promising . No side effects were recorded for any treatment A r and omised crossover trial was performed in 55 pregnant women who complained of heartburn to see whether alkali or acid treatment alleviated it . Each woman was given a week 's treatment with an acid mixture , an alkali mixture , and a placebo in r and omised order . Both acid and alkali mixtures were better than placebo , but there was no significant difference between the acid and alkali treatments . Together with the inconsistent reports of some patients , these findings suggest that both acid reflux and bile regurgitation may cause heartburn in pregnant women and that other factors may also play a part . Because the cause of heartburn may be difficult to determine , treatment should be empirical . If the patient does not respond to seven days ' acid treatment an alkali mixture should be prescribed ; there is a 98 % chance that one of these treatments will relieve symptoms OBJECTIVES This study is aim ed at determining the prevalence of gastrointestinal symptoms among healthy pregnant women attending antenatal clinic at the University of Maiduguri Teaching Hospital . METHODS Question naires were r and omly administered to consecutive antenatal clinic attendees until the sample size was reached . RESULTS Three hundred and seventy pregnant women were interviewed . Heart burns , easy fullness and nausea were the commonest gastrointestinal symptoms in 45 % , 40.2 % and 39.9 % of cases respectively . Primigravidae had significantly more symptoms than multiparae . There were also significantly more gastrointestinal symptoms in the first trimester of pregnancy . CONCLUSION Gastrointestinal symptoms are common among healthy pregnant women . And even though these represent well-known physiological changes , they must be carefully assessed to exclude any pathological disorder that may require intervention In a double-blind study the gastro-oesophageal sphincter pressure profile was measured in a group of twenty women in the last trimester of pregnancy , all of whom suffered from heartburn . The mean gastric and the maximum sphincter pressures were calculated from the pressure profile , and the difference between these two was defined as the barrier pressure . After resting sphincter measurement ten of the women were given 10 mg metocolopramide intravenously , and the other ten had a placebo intravenous injection ; 15 min later the sphincter pressures were measured again . Metoclopramide significantly increased the mean maximum sphincter and barrier pressures compared to the baseline pressure , and there was no significant difference between the pre- and post-injection pressures in the placebo group . However , the raised mean maximum sphincter and barrier pressures following metoclopramide were made up of four patients having very high pressures and six patients on whom metoclopramine appeared to have little effect . The clinical usefulness of metoclopramide in women in labour is discussed Background : Proton pump inhibitors are used to treat gastro‐oesophageal reflux and peptic ulcers . Gastro‐oesophageal reflux is a common condition in pregnancy . Human pregnancy experience with lansoprazole or pantoprazole is very limited . More data exist on the safety of omeprazole in pregnancy OBJECTIVES To evaluate the magnitude of possible fetal risks involved in maternal use of omeprazole during pregnancy . STUDY DESIGN Infants whose mothers used omeprazole during pregnancy were identified from the Swedish Medical Birth Registry . A total of 955 exposed infants born in 1995 - 1999 were identified : 863 of which were exposed in early pregnancy and 131 later in pregnancy and 39 who had been exposed both in early and late pregnancy . Delivery outcome was studied : presence of congenital malformations , perinatal survival , low birth weight , low Apgar score and hospitalization up to the end of 1997 . RESULTS No clear-cut indication of ill effects were seen . Five infants were stillborn and the rate of congenital heart defects was slightly increased , but both effects may be r and om . CONCLUSIONS The present data set and previously published data give no reason for concern after exposure for omeprazole during pregnancy
Output:
| There was little information to draw conclusions on the overall effectiveness of interventions to relieve heartburn in pregnancy |
MS211264 | ***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 A pathologic complete response ( pCR ; ypT0N0 ) of a rectal tumor after neoadjuvant radiochemotherapy ( RCT ) is associated with an excellent prognosis . Several retrospective studies have investigated the effect of increasing the delay after RCT . The aim of this study was to evaluate the effect of increasing the interval between the end of RCT and surgery on the pCR rate . Methods GRECCAR6 was a phase III , multicenter , r and omized , open-label , parallel-group controlled trial . Patients with cT3/T4 or Tx N+ tumors of the mid or lower rectum who had received RCT ( 45 to 50 Gy with fluorouracil or capecitabine ) were included . Patients were r and omly included in the 7-week or the 11-week ( 11w ) group . Primary end point was the pCR rate defined as a ypT0N0 specimen ( NCT01648894 ) . Results A total of 265 patients from 24 centers were enrolled between October 2012 and February 2015 . The majority of the tumors were cT3 ( 82 % ) . After RCT , surgery was not performed in nine patients ( 3.4 % ) because of the occurrence of distant metastasis ( n = 5 ) or other reasons . Two patients underwent local resection of the tumor scar . A total of 47 ( 18.6 % ) specimens were classified as ypT0 ( four had invaded lymph nodes [ 8.5 % ] ) . The primary end point ( ypT0N0 ) was not different ( 7 weeks : 20 of 133 , 15.0 % v 11w : 23 of 132 , 17.4 % ; P = .5983 ) . Morbidity was significantly increased in the 11w group ( 44.5 % v 32 % ; P = .0404 ) as a result of increased medical complications ( 32.8 % v 19.2 % ; P = .0137 ) . The 11w group had a worse quality of mesorectal resection ( complete mesorectum [ I ] 78.7 % v 90 % ; P = .0156 ) . Conclusion Waiting 11 weeks after RCT did not increase the rate of pCR after surgical resection . A longer waiting period may be associated with higher morbidity and more difficult surgical resection BACKGROUND Organ preservation is a concept proposed for patients with rectal cancer after a good clinical response to neoadjuvant chemotherapy , to potentially avoid morbidity and side-effects of rectal excision . The objective of this study was to compare local excision and total mesorectal excision in patients with a good response after chemoradiotherapy for lower rectal cancer . METHODS We did a prospect i ve , r and omised , open-label , multicentre , phase 3 trial at 15 tertiary centres in France that were experts in the treatment of rectal cancer . Patients aged 18 years and older with stage T2T3 lower rectal carcinoma , of maximum size 4 cm , who had a good clinical response to neoadjuvant chemoradiotherapy ( residual tumour ≤2 cm ) were central ly r and omly assigned by the surgeon before surgery to either local excision or total mesorectal excision surgery . R and omisation , which was done via the internet , was not stratified and used permuted blocks of size eight . In the local excision group , a completion total mesorectal excision was required if tumour stage was ypT2 - 3 . The primary endpoint was a composite outcome of death , recurrence , morbidity , and side-effects at 2 years after surgery , to show superiority of local excision over total mesorectal excision in the modified intention-to-treat ( ITT ) population ( expected proportions of patients having at least one event were 25 % vs 60 % for superiority ) . This trial was registered with Clinical Trials.gov , number NCT00427375 . FINDINGS From March 1 , 2007 , to Sept 24 , 2012 , 186 patients received chemoradiotherapy and were enrolled in the study . 148 good clinical responders were r and omly assigned to treatment , three were excluded ( because they had metastatic disease , tumour > 8 cm from anal verge , and withdrew consent ) , and 145 were analysed : 74 in the local excision group and 71 in the total mesorectal excision group . In the local excision group , 26 patients had a completion total mesorectal excision . At 2 years in the modified ITT population , one or more events from the composite primary outcome occurred in 41 ( 56 % ) of 73 patients in the local excision group and 33 ( 48 % ) of 69 in the total mesorectal excision group ( odds ratio 1·33 , 95 % CI 0·62 - 2·86 ; p=0·43 ) . In the modified ITT analysis , there was no difference between the groups in all components of the composite outcome , and superiority was not shown for local excision over total mesorectal excision . INTERPRETATION We failed to show superiority of local excision over total mesorectal excision , because many patients in the local excision group received a completion total mesorectal excision that probably increased morbidity and side-effects , and compromised the potential advantages of local excision . Better patient selection to avoid unnecessary completion total mesorectal excision could improve the strategy . FUNDING National Cancer Institute of France , Sanofi , Roche Pharma Purpose To study the predictive and prognostic value of magnetic resonance imaging (MRI)–assessed tumor response after long-course neoadjuvant therapy for locally advanced rectal cancer . Methods This study included 79 patients who had T3 or T4 and /or N+ rectal cancer treated with long-course neoadjuvant chemoradiation . MRI-assessed tumor regression grade ( mrTRG ) was assessed in 64 patients . MRIs were review ed by the study radiologist . Surgical and pathologic reports for those who underwent surgery were review ed . Disease-free survival ( DFS ) was estimated . Progression during therapy , local relapse , metastasis , and death result ing from the tumor were classified as events . Statistical significance was calculated . Results In 11 patients , the tumor completely disappeared on MRI ; that is , it had an mrTRG of 1 . All but one patient , who chose deferred surgery , had a complete pathologic response ( pCR ) , with a positive predictive value of nearly 100 % . Of the 20 patients who had an mrTRG of 2 on MRI , six had a pCR . mrTRG 3 , mrTRG 4 , and mrTRG 5 were detected in 24 , six , and three patients , respectively , of whom only one patient had a pCR . The 2-year DFS was 77 % . The mrTRG was significant for DFS . The 2-year DFS was 88 % for patients with a good response versus 66 % for those with a poor response ( P = .046 ) . Conclusion MRI-assessed complete tumor response was strongly correlated with pCR and , therefore , can be used as a surrogate marker to predict absence of viable tumor cells . Our results can be used to implement use of mrTRGs in larger prospect i ve correlative studies as a tool to select patients for whom deferred surgery may be appropriate . Also , those with a poor response may be offered further treatment options before definitive surgery OBJECTIVE The purpose of this study was to evaluate the prognostic relevance of a modified 3-point MRI-based tumor regression grading system incorporating DWI for patients with locally advanced rectal cancer after preoperative chemoradiotherapy ( CRT ) . MATERIAL S AND METHODS Between March 2012 and September 2013 , 118 consecutively registered patients with middle or lower locally advanced rectal cancer who underwent CRT followed by surgery were enrolled in this retrospective study . Two radiologists in consensus assessed MRI tumor regression grade ( mrTRG ) based on T2-weighted images and high b value DW images ( 0 and 1000 s/mm2 ) using the following grade s : 0 , complete regression ( no obvious tumor ) ; 1 , intermediate regression ( dominant fibrosis , regression > 50 % ) ; 2 , poor regression ( dominant tumor , regression ≤ 50 % ) . Multivariate analysis with a Cox regression model was performed to evaluate the association between modified mrTRG and 3-year disease-free survival ( DFS ) rate . A Kaplan-Meier method with a log-rank test was used to compare the DFS rate between responder ( grade s 0 and 1 ) and nonresponder ( grade 2 ) groups . RESULTS Both the accuracy ( 72.9 % vs 38.1 % ; p < 0.001 ) and the interreader agreement ( κ = 0.580 vs 0.338 ; p < 0.001 ) of modified 3-point mrTRG were improved over the established 5-point mrTRG . Modified mrTRG ( adjusted hazard ratio , 2.505 ; 95 % CI , 1.231 - 5.100 ) was independently associated with 3-year DFS rate ( p = 0.011 ) . There was also a significant difference in the 3-year DFS rate between responders ( 73.8 % ; 95 % CI , 64.2 - 81.3 % ) and nonresponders ( 41.7 % ; 95 % CI , 10.9 - 70.8 % ) ( p = 0.028 ) . CONCLUSION In patients with middle or lower locally advanced rectal cancer , the modified 3-point mrTRG incorporating DWI was independently associated with the 3-year DFS rate after CRT followed by surgery . The grading scale may be used as a surrogate for expected prognosis of preoperative CRT . Further prospect i ve trials are warranted Introduction : Nonoperative management ( NOM ) of rectal cancer after a complete clinical response ( cCR ) to neoadjuvant therapy is controversial . In this article , we retrospectively review ed the outcomes of patients managed with selective NOM after a cCR to neoadjuvant treatment and compared these with patients who underwent st and ard rectal resection with a pathological complete response ( pCR ) . Methods : Patients completing neoadjuvant chemoradiotherapy ( CRT ) for stage I to III rectal cancer between January 2006 and August 2010 were retrospectively review ed . Median follow-up was calculated in months after completion of CRT . Results : Thirty-two patients ( median follow-up 28 months ) were treated by NOM after a cCR . Among 265 treated by CRT and rectal resection , 57 patients ( 22 % ) had a pCR and formed the control group ( median follow-up 43 months ) . Factors associated with selective use of NOM included lower pretreatment stage , older age , and distal tumor location ( P < 0.05 ) . In the NOM group , 6 recurred locally ( median 11 months , range 7–14 ) , 3 of whom also had concurrent distant recurrence . All 6 local failures were controlled by salvage rectal resection with no further local recurrence of disease ( median follow-up 17 months ) . In the rectal resection/pCR group , there were no local failures . The 2-year distant disease-free survival ( 88 % vs 98 % , P = 0.27 ) and overall survival ( 96 % vs 100 % , P = 0.56 ) were similar for NOM and rectal resection/pCR groups . Conclusions : Rectal resection was successfully avoided in 81 % of patients selected for NOM . When combined with salvage surgery , NOM appears to achieve similar local and distant disease control compared with patients with a pCR treated by rectal resection . Longer follow-up and prospect i ve trials are warranted to evaluate this promising treatment option PURPOSE To retrospectively assess accuracy of magnetic resonance ( MR ) imaging after radiation therapy with concomitant chemotherapy for downsizing of the primary lesion to ypT0 - 2 tumor confined to rectal wall in locally advanced rectal cancer , with histopathologic findings as reference st and ard , and to evaluate additional value of volumetric analysis . MATERIAL S AND METHODS The institutional review board approved the study and waived informed consent . Sixty-seven patients met criteria of the study . T2-weighted MR images obtained before and after radiation therapy with concomitant chemotherapy were assessed for tumor stage by expert abdominal radiologist , colorectal surgeon , and general radiologist . Sensitivity , specificity , positive predictive value ( PPV ) , and negative predictive value ( NPV ) were calculated ; tumor volume was measured ( compared with Mann-Whitney U test ) . Findings were correlated with histopathologic findings . RESULTS Sixty-seven patients ( 38 men , 29 women ; mean age , 63 years ) who underwent radiation therapy with concomitant chemotherapy and surgery ( all but one ) were evaluated . The PPV for prediction of tumor confined to rectal wall ( ypT0 - 2 ) was 91 % ( 10 of 11 ) , 86 % ( six of seven ) , and 88 % ( seven of eight ) for expert abdominal radiologist , surgeon , and general radiologist , respectively . In 24 patients , sensitivity was 42 % ( 10 ) , 25 % ( six ) , and 29 % ( seven ) . ypT0 - 2 tumors had significantly smaller volumes than did ypT3 - 4 tumors before radiation therapy with concomitant chemotherapy ( 55 vs 92 cm(3 ) , P = .038 )
Output:
| mrTRG 1 showed high specificity for pCR and ≤ypT1 , but suboptimal sensitivity .
mrTRG 1 or 2 showed higher sensitivity for pCR and ≤ypT1 , but lower specificity .
Because of the suboptimal sensitivity of mrTRG 1 , it might be limited as a criterion for less aggressive treatment after neoadjuvant chemoradiotherapy . •
Magnetic resonance tumor regression grade 1 shows high specificity for pCR and ≤ypT1 , but suboptimal sensitivity . •
Magnetic resonance tumor regression grade 1 or 2 shows higher sensitivity for pCR and ≤ypT1 , but lower specificity than magnetic resonance tumor regression grade 1 alone |
MS211265 | ***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 test whether a theory-based , literacy , and culturally tailored self-management intervention , Latinos en Control , improves glycemic control among low-income Latinos with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 252 patients recruited from community health centers were r and omized to the Latinos en Control intervention or to usual care . The primarily group-based intervention consisted of 12 weekly and 8 monthly sessions and targeted knowledge , attitudes , and self-management behaviors . The primary outcome was HbA1c . Secondary outcomes included diet , physical activity , blood glucose self-monitoring , diabetes knowledge and self-efficacy , and other physiological factors ( e.g. , lipids , blood pressure , and weight ) . Measures were collected at baseline and at 4- and 12-month follow-up . Change in outcomes over time between the groups and the association between HbA1c and possible mediators were estimated using mixed-effects models and an intention-to-treat approach . RESULTS A significant difference in HbA1c change between the groups was observed at 4 months ( intervention −0.88 [ −1.15 to −0.60 ] versus control −0.35 [ −0.62 to 0.07 ] , P < 0.01 ) , although this difference decreased and lost statistical significance at 12 months ( intervention −0.46 [ −0.77 to −0.13 ] versus control −0.20 [ −0.53 to 0.13 ] , P = 0.293 ) . The intervention result ed in significant change differences in diabetes knowledge at 12 months ( P = 0.001 ) , self-efficacy ( P = 0.001 ) , blood glucose self-monitoring ( P = 0.02 ) , and diet , including dietary quality ( P = 0.01 ) , kilocalories consumed ( P < 0.001 ) , percentage of fat ( P = 0.003 ) , and percentage of saturated fat ( P = 0.04 ) . These changes were in turn significantly associated with HbA1c change at 12 months . CONCLUSIONS Literacy-sensitive , culturally tailored interventions can improve diabetes control among low-income Latinos ; however , strategies to sustain improvements are needed BACKGROUND Type 2 diabetes is up to four times more common in British Asians , but they know little about its management and complications . AIM To design and evaluate a structured pictorial teaching programme for Pakistani Moslem patients in Manchester with type 2 diabetes . METHOD A r and omized controlled trial of pictorial flashcard one-to-one education in 201 patients attending a hospital outpatient clinic or diabetic clinics in ten general practice s in Manchester . Patients ' knowledge , self-caring skills and attitudes to diabetes were measured on four topics before the structured teaching , and compared with results six months later . RESULTS All parameters of knowledge were increased in the study group ; for example , percentage scores for correctly identifying different food values increased from 57 % to 71 % ( Analysis of Variance ( ANOVA ) adjusted difference + 11.8 % ) and knowledge of one diabetic complication from 18 % to 78 % . Self-caring behaviour improved , with 92 % of patients doing regular glucose tests at six months compared with 63 % at the start . Attitudinal views were more resistant to change , with patients still finding it hard to choose suitable foods at social occasions . Haemoglobin A1c control improved by 0.34 % over six months ( ANOVA adjusted difference , 95 % CI -0.8 % to + 0.1 % ) . CONCLUSION It is concluded that this health education programme can empower Asian diabetics to take control of their diets , learn to monitor and interpret glucose results , and underst and the implication s of poor glycaemic control for diabetic complications OBJECTIVES Diabetes self-management is a key element in the overall management of diabetes . Identifying barriers to disease self-management is a critical step in achieving optimal health outcomes . Our goal was to explore patients ' perceptions about barriers to self-management of diabetes that could possibly help explain poor health outcomes among minority patients . STUDY DESIGN Four focus groups were conducted among 31 predominately African American patients with diabetes who were enrolled in the Baltimore Cardiovascular Partnership Study , a NIH-funded multiyear prospect i ve partnership study . The topic guide consisted of a series of open-ended questions about knowledge of current health status , medication use , continuity of care , blood glucose level and nutrition . RESULTS The focus groups confirmed that previously reported barriers to self-management persisted and identified new concerns that could be associated with poor health outcomes among minority patients with diabetes . Attitudes , perceptions and behaviors surrounding diabetes and self-management of the condition did vary across individuals , however , the variation appeared to reflect the individual 's knowledge and opinions rather than patient 's age , sex , or culture . The primary barrier to diabetes self-management result ed from lack of knowledge of target blood glucose and blood pressure . Several participants found some of the health information to be quite confusing . CONCLUSIONS Diabetes is a major public health concern and the lack of awareness of target blood glucose and blood pressure further complicates the problem . The limited health literacy seen in this study could help explain several of the barriers to self-management . The barriers to self-management identified in this qualitative study are amenable to intervention that could improve health outcomes OBJECTIVES We sought to determine the effects of a community-based , culturally tailored diabetes lifestyle intervention on risk factors for diabetes complications among African Americans and Latinos with type 2 diabetes . METHODS One hundred fifty-one African American and Latino adults with diabetes were recruited from 3 health care systems in Detroit , Michigan , to participate in the Racial and Ethnic Approaches to Community Health ( REACH ) Detroit Partnership diabetes lifestyle intervention . The curriculum , delivered by trained community residents , was aim ed at improving dietary , physical activity , and diabetes self-care behaviors . Baseline and postintervention levels of diabetes-specific quality -of-life , diet , physical activity , self-care knowledge and behaviors , and hemoglobin A1C were assessed . RESULTS There were statistically significant improvements in postintervention dietary knowledge and behaviors and physical activity knowledge . A statistically significant improvement in A1C level was achieved among REACH Detroit program participants ( P<.0001 ) compared with a group of patients with diabetes in the same health care system in which no significant changes were observed ( P=.160 ) . CONCLUSIONS A culturally tailored diabetes lifestyle intervention delivered by trained community residents produced significant improvement in dietary and diabetes self-care related knowledge and behaviors as well as important metabolic improvements Background : The prevalence of type 2 diabetes and diabetesrelated morbidity and mortality is higher among low-income Hispanics when compared to that of Whites . However , little is known about how to effectively promote self-management in this population . Purpose : The objectives were first to determine the feasibility of conducting a r and omized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects . Methods : Participants for this pilot study were recruited from a community health center , an elder program , and a community-wide data base developed by the community health center , in collaboration with other agencies serving the community , by surveying households in the entire community . Participants were r and omly assigned to an intervention ( n = 15 ) or a control ( n = 10 ) condition . Assessment s were conducted at baseline and at 3 months and 6 months postr and omization . The intervention consisted of 10 group sessions that targeted diabetes knowledge , attitudes , and self-management skills through culturally specific and literacysensitive strategies . The intervention used a cognitivebehavioral theoretical framework . Results : Recruitment rates at the community health center , elder program , and community registry were 48 % , 69 % , and 8 % , respectively . Completion rates for baseline , 3-month , and 6-month assessment s were 100 % , 92 % , and 92 % , respectively . Each intervention participant attended an average of 7.8 out of 10 sessions , and as a group the participants showed high adherence to intervention activities ( 93 % turned in daily logs , and 80 % self-monitored glucose levels at least daily ) . There was an overall Group × Time interaction ( p = .02 ) indicating group differences in glycosylated hemoglobin over time . The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was −0.8 % ( 95 % confidence intervals = −1.1 % , −0.5 % ) compared with the change in the control group ( p = .02 ) . At 6 months , the decrease in the intervention group remained significant , −0.85 % ( 95 % confidence intervals = −1.2 , −0.5 ) , and the decrease was still significantly different from that of the controls ( p = .005 ) . There was a trend toward increased physical activity in the intervention group as compared to that of the control group ( p = .11 ) and some evidence ( nonsignificant ) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants . Adjusting for baseline depressive scores , we oberved a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment ( p = .02 ) . Conclusions : Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research . This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a r and omized clinical trial PURPOSE The purpose of this r and omized controlled trial is to determine the effectiveness of an intervention led by promotoras ( community lay workers ) on the glycemic control , diabetes knowledge , and diabetes health beliefs of Mexican Americans with type 2 diabetes living in a major city on the Texas-Mexico border . METHODS One hundred fifty Mexican American participants were recruited at a Catholic faith-based clinic and r and omized into 2 groups . Personal characteristics , acculturation , baseline A1C level , diabetes knowledge , and diabetes health beliefs were measured . The intervention was culturally specific and consisted of participative group education , telephone contact , and follow-up using inspirational faith-based health behavior change postcards . The A1C levels , diabetes knowledge , and diabetes health beliefs were measured 3 and 6 months postbaseline , and the mean change between the groups was analyzed . RESULTS The 80 % female sample , with a mean age of 58 years , demonstrated low acculturation , income , education , health insurance coverage , and strong Catholicism . No significant changes were noted at the 3-month assessment , but the mean change of the A1C levels , F(1 , 148 ) = 10.28 , P < .001 , and the diabetes knowledge scores , F(1 , 148 ) = 9.0 , P < .002 , of the intervention group improved significantly at 6 months , adjusting for health insurance coverage . The health belief scores decreased in both groups . CONCLUSIONS The intervention result ed in decreased A1C levels and increased diabetes knowledge , suggesting that using promotoras as part of an interdisciplinary team can result in positive outcomes for Mexican Americans who have type 2 diabetes . Clinical implication s and recommendations for future research are suggested Background Latinos comprise the largest racial/ethnic group in the United States and have 2–3 times the prevalence of type 2 diabetes mellitus as Caucasians . Methods and design The Lawrence Latino Diabetes Prevention Project ( LLDPP ) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a ≥ 30 % probability of developing diabetes in the next 7.5 years per a predictive equation . The project was conducted in Lawrence , Massachusetts , a predominantly Caribbean-origin urban Latino community . Individuals were identified primarily from a community health center 's patient panel , screened for study eligibility , r and omized to either a usual care or a lifestyle intervention condition , and followed for one year . Like the efficacious Diabetes Prevention Program ( DPP ) , the LLDPP intervention targeted weight loss through dietary change and increased physical activity . However , unlike the DPP , the LLDPP intervention was less intensive , tailored to literacy needs and cultural preferences , and delivered in Spanish . The group format of the intervention ( 13 group sessions over 1 year ) was complemented by 3 individual home visits and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist . Study measures included demographics , Stern predictive equation components ( age , gender , ethnicity , fasting glucose , systolic blood pressure , HDL-cholesterol , body mass index , and family history of diabetes ) , glycosylated hemoglobin , dietary intake , physical activity , depressive symptoms , social support , quality of life , and medication use . Body weight was measured at baseline , 6-months , and one-year ; all other measures were assessed at baseline and one-year . All surveys were orally administered in Spanish . Results A community-academic partnership enabled the successful recruitment , intervention , and assessment of Latinos at risk of diabetes with a one-year study retention rate of 93%.Trial registration Poor adjustment to diabetes in older African American women may result from uncertainty , stemming from a lack of information about self-care activities , a complexity of self-care activities , comorbid conditions , and a lack of re sources . This study evaluated a telephone intervention to reduce uncertainty ( through problem-solving strategies , information , cognitive reframing ,
Output:
| Most programs obtained some benefits over st and ard care in improving diabetes knowledge , self-management behaviors and clinical outcomes .
Meta-regressions showed larger reduction in glycated hemoglobin in individual and face to face delivered interventions , as well as in those involving peer educators , including cognitive reframing techniques , and a lower number of teaching methods .
The long-term effects remain unknown and cost-effectiveness was rarely estimated .
Conclusions Diabetes self-management educational programs targeted to racial/ethnic minority groups can produce a positive effect on diabetes knowledge and on self-management behavior , ultimately improving glycemic control . |
MS211266 | ***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: This study examined the effects of abstinence from smoking , of smoking history , and of nicotine administration on visual attention ( 2-Letter Search Task ) , verbal information processing ( Logical Reasoning Task ) , and working memory ( N-Back Tasks ) . Fourteen smokers , 15 ex-smokers , and 9 never-smokers took part . All subjects participated in a training session ( when smokers had been smoking ad libitum ) and in two subsequent test sessions after administration of 4 mg nicotine gum or placebo , respectively . Smokers were 12-h abstinent when they received gum . An effect of acute nicotine administration ( independent of smoking history ) was seen only with respect to reaction time on the 2-Letter Search Task . Working memory performance was related to smoking history ( smokers performed most poorly and never-smokers best ) . The Logical Reasoning Task showed no effects of either acute or chronic nicotine exposure . The findings indicate that nicotine may influence focusing of attention in smokers as well as nonsmokers , and that trait-like differences in some cognitive domains , such as working memory , may be either long-term effects or etiological factors related to smoking In the elderly , cigarette smoking has been related to reduced cognitive performance and moderate alcohol consumption to increased cognitive performance . It is not clear whether these associations also exist in middle age . The authors examined these relations in a population -based cohort study of 1,927 r and omly selected , predominantly middle-aged subjects aged 45 - 70 years at the time of cognitive testing and living in the Netherl and s. From 1995 until 2000 , an extensive cognitive battery was administered , and compound scores were calculated . Risk factors had been assessed approximately 5 years previously . Multiple linear regression analyses ( in which one unit of the cognitive score = one st and ard deviation ) showed that , after the authors adjusted for age , sex , education , alcohol consumption , and cardiovascular risk factors , current smokers had reduced psychomotor speed ( beta = -0.159 , 95 % confidence interval : -0.071 , -0.244 ; p = 0.0003 ) and reduced cognitive flexibility ( beta = -0.133 , 95 % confidence interval : -0.035 , -0.230 ; p = 0.008 ) compared with never smokers . This effect was similar to that of being approximately 4 years older . Alcohol consumption was related to increased speed and better flexibility , especially among women who drank 1 - 4 alcoholic beverages a day . In conclusion , among middle-aged subjects , current smoking was inversely and alcohol consumption positively related to psychomotor speed and cognitive flexibility . This finding suggests that actions to prevent cognitive decline can be taken in middle age Auditory P300 latency prolongation or amplitude reduction has been reported in patients affected by bipolar disorder and in schizophrenia . The purpose of this study was to test whether the auditory P300 and earlier event-related potential ( ERP ) components elicited during an auditory discrimination task could differentiate between these two disorders . Thirteen patients with manic or mixed bipolar disorder , 12 patients with schizophrenia , and 24 control subjects were evaluated . None of the subjects had a history of alcohol or substance abuse or dependence . ERPs were elicited during an auditory discrimination task in which a subject pressed a key to infrequent 1500 Hz tones interspersed amid a series of 1000 Hz tones . The amplitude and latency of N100 and P200 were measured from ERPs to non-target tones , and N200 and P300 were measured from ERPs to target tones . N100 , P200 and N200 amplitudes were reduced in schizophrenia patients , but not in bipolar patients . Both bipolar disorder and schizophrenia patients showed reduced P300 amplitude and prolonged P300 latency . Amplitude reduction in the early ERP components implicates auditory processing deficits in schizophrenia . Both groups showed reductions in P300 amplitude , suggesting a disturbance of the temporal-parietal generators of this component . Prolonged P300 latency is consistent with impaired attentional processing in schizophrenia and symptomatic bipolar disorder patients Numerous studies have evaluated event-related potentials ( ERPs ) as biological indicators of the liability for alcoholism . This study extends that approach by investigating ERPs in boys at risk for other substance use disorders . Prepubertal ( 10 - 12 years ) sons of fathers diagnosed with psychoactive substance dependence ( n = 28 ) were compared to matched sons of nonaffected fathers ( n = 26 ) on an auditory ERP oddball task . Multivariate analyses of variance applied to peak amplitude and latency measures indicated small to moderate between-groups differences at midline or parietal sites : N2 and P3 amplitude ; P2 , N2 , P3 , and Nc latency . This replicated P3 amplitude findings in alcoholism-risk studies , though the effect size was moderate . Analysis of event-related alpha power indicated significantly longer latency of alpha synchronization and oscillations of desynchronization in boys at risk . The alpha power findings were statistically the more robust of the measures applied . The role of neurocognitive factors in determining liability for substance use disorders is discussed A 21-mg dose of nicotine was administered transdermally to 16 overnight smoking-deprived smokers in a double-blind , placebo-controlled design . Mood ratings , electroencephalography ( EEG ) , behavioral performance and event-related potential ( ERP : P300 ) indices of attention and information processing speed were assessed before and 4 h after placebo/nicotine treatment . Although nicotine , relative to placebo , failed to alter mood , it increased absolute and relative power indices of EEG arousal , shortened reaction times , and increased P300 amplitudes . The results are discussed in relation to nicotine 's actions on cholinergic transmission and its role in smoking behavior BACKGROUND Previous studies suggested a protective effect of smoking on Alzheimer 's disease , but most were case-control studies based on prevalent cases . The findings of prospect i ve studies on the association between smoking and the risk of dementia are inconclusive . METHODS We did a population -based follow-up study of elderly people who were initially free of dementia . 6870 people aged 55 years and older agreed to take part . Smoking history was taken at baseline and participants were classified as never smokers , former smokers , and current smokers . During follow-up , we recorded all incident cases of dementia . We used never smokers as the reference category to calculate relative risks of dementia and Alzheimer 's disease by Cox proportional hazards regression , after adjustment for age , sex , education , and alcohol intake . We also examined modification of risk by age , sex , and the apolipoprotein E ( APOE ) genotype . FINDINGS During mean follow-up of 2.1 ( range 1.5 - 3.4 ) years , 146 incident cases of dementia were detected , of which 105 were Alzheimer 's disease . Compared with never smokers , smokers had an increased risk of dementia ( relative risk 2.2 [ 95 % CI 1.3 - 3.6 ] ) and Alzheimer 's disease ( 2.3 [ 1.3 - 4.1 ] ) . Smoking was a strong risk factor for Alzheimer 's disease in individuals without the APOEepsilon4 allele ( 4.6 [ 1.5 - 14.2 ] ) , but had no effect in participants with this allele ( 0.6 [ 0.1 - 4.8 ] ) . INTERPRETATION Smoking was associated with a doubling of the risk of dementia and Alzheimer 's disease . Our finding that carriers of the APOEepsilon4 had no increased risk of dementia suggests an interaction between smoking and the APOEepsilon4 genotype in the aetiology of Alzheimer 's disease OBJECTIVES Early diagnosis and monitoring of disease progression have become vital in clinical practice as disease modifying treatments for Alzheimer 's disease ( AD ) become available . This one-year prospect i ve study aim ed to clarify the usefulness of event-related potentials ( ERPs ) in cognitive decline and eluci date their cognitive significance in AD . METHODS Using the Cognitive Abilities Screening Instrument ( CASI ) and ERPs , probable AD patients , mild cognitive impairment ( MCI ) patients , and normal controls were recruited . RESULTS The AD and MCI patients had significantly decreased cognitive function and manifested a delay of P300 latency . The P300 latencies demonstrated significantly more prolongation than their baseline values in probable AD and MCI patients , although their CASI scores showed no statistically significant decline . Whereas N100 , P200 , and N200 components did not reach statistical differences between groups either in the baseline or follow-up assessment s and did not show significant change on follow-up . CONCLUSION The combination of neuropsychological tests and P300 measurements proved useful in improving reliability and increasing sensitivity to early cognitive decline or disease progression in AD patients . SIGNIFICANCE The P300 latency may reflect cognitive decline more sensitively than neuropsychological tests in the longitudinal follow-up of AD patients OBJECTIVE Previous studies indicate that people respond defensively to threatening health information , especially when the information challenges self-relevant goals . The authors investigated whether reduced acceptance of self-relevant health risk information is already visible in early attention processes , that is , attention disengagement processes . DESIGN In a r and omized , controlled trial with 29 smoking and nonsmoking students , a variant of Posner 's cueing task was used in combination with the high-temporal resolution method of event-related brain potentials ( ERPs ) . MAIN OUTCOME MEASURES Reaction times and P300 ERP . RESULTS Smokers showed lower P300 amplitudes in response to high- as opposed to low-threat invalid trials when moving their attention to a target in the opposite visual field , indicating more efficient attention disengagement processes . Furthermore , both smokers and nonsmokers showed increased P300 amplitudes in response to the presentation of high- as opposed to low-threat valid trials , indicating threat-induced attention-capturing processes . Reaction time measures did not support the ERP data , indicating that the ERP measure can be extremely informative to measure low-level attention biases in health communication . CONCLUSION The findings provide the first neuroscientific support for the hypothesis that threatening health information causes more efficient disengagement among those for whom the health threat is self-relevant Event-related potentials ( ERPs ) can eluci date aspects of sensory and cognitive processing that have been compromised due to closed head injury . We present the results of two investigations , one previously unreported , in which we used ERPs to evaluate information processing in head-injury survivors . In the first study , we used visual and auditory reaction time tasks differing in attentional dem and s to assess processing after head trauma . We found numerous changes in auditory processing in survivors : longer reaction times ( but normal accuracy ) , longer N200 and P300 latencies , and reduced N100 and N200 amplitudes . In contrast , on visual tasks , only reduced N200 amplitude distinguished survivors and controls . To increase attentional dem and s , in a second study , we administered the continuous performance test ( CPT ) . Survivors performed with lower accuracy than controls on visual and auditory tasks , and their ERPs were characterized by smaller visual and auditory N200s and P300s and smaller auditory N100s . We also present a synthesis , derived from a review of the literature , of closed head-injury effects on ERPs . Our own findings are in agreement with that synthesis . Namely , cognitive ERP components are more sensitive than sensory components to the effects of trauma . Specifically , in survivors , the amplitudes of N200 and P300 are often reduced , and their latencies prolonged . In general , as compared with visual ERPs , auditory ERPs may be more susceptible to the effects of closed head injury , suggesting that the auditory processing system is more vulnerable than the visual system . We conclude by discussing the potential use of ERPs to monitor clinical course and recovery in survivors of closed head injury The aim of this study was to eluci date the chronic effects of tobacco smoking on the P300 , a neurophysiological index of cognitive function . Prospect i ve study participants were recruited from a family medicine polyclinic . We selected 32 right-h and ed smokers who had smoked more than 15 cigarettes per day , by inhalation , for more than 2 years . The control population consisted of 32 right-h and ed , age-matched healthy individuals who had never smoked . Event-related potentials ( ERPs ) were recorded with the auditory " oddball " two-tone discrimination task . The data from the central ( Cz ) and frontal ( Fz ) electrodes were analyzed . The P300 and N1 amplitudes at Fz were lower in the study population compared to the control group . The early component of ERP , the measure of mental speed ( N1 ) latency at Fz was prolonged in the study group compared to the controls , possibly because early cognitive processes such as sensory input or initial encoding of sensory information were delayed in this group . For those who smoke , a decreased N1 amplitude might indicate delayed information processing and possibly short-term memory disturbance . Thus , chronic tobacco smoking may produce prefrontal cognitive dysfunction BACKGROUND P300 event-related brain potential ( ERP ) amplitude is reduced in patients with schizophrenia . Little attention has been paid to gender differences underlying this abnormality , despite clinical differences between male and female schizophrenics . Studies have also largely ignored the fact that the P300 represents the activity of multiple neural generators and have not
Output:
| CONCLUSIONS P300 amplitude was smaller in cigarette smokers than in nonsmoking controls , and a possible dose-response relationship was apparent .
Findings indicate a possible association between cigarette smoking and decreased P300 amplitude |
MS211267 | ***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: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Background Pressure sores are important and common complications of spinal cord injury . Many preventive and therapeutic approaches have been tried and new trials are evolving . One relatively recent method is application of a hydrocolloid dressing ( HD ) . In this study we compared the therapeutic effects of HD on pressure ulcer healing with two other topical applications , phenytoin cream ( PC ) and simple dressing ( SD ) . Methods Ninety-one stage I and stage II pressure ulcers of 83 paraplegic male victims of the Iran-Iraq war were r and omly allocated to three treatment groups . Mean age and weight of the participants were 36.64 ± 6.04 years and 61.12 ± 5.08 kg , respectively . All the patients were managed in long term care units or in their homes for 8 weeks by a team of general practitioners and nurses , and the ulcer status was recorded as " Complete healing " , " Partial healing " , " Without improvement " and " Worsening " . Results Complete healing of ulcers , regardless of location and stage , was better in the HD group than the PC [ 23/31(74.19 % ) vs 12/30(40 % ) ; difference : 34.19 % , 95 % CI = 10.85–57.52 , ( P < 0.01 ) ] or the SD [ 23/31(74.19 % ) vs 8/30(26.66 % ) ; difference : 47.53 % , 95 % CI = 25.45–69.61 , ( P < 0.005 ) ] groups . Complete healing of stage I ulcers in the HD group [ 11/13(85 % ) ] was better than in the SD [ 5/11(45 % ) ; difference : 40 % , 95 % CI = 4.7–75.22 , ( P < 0.05 ) ] or PC [ 2/9 ( 22 % ) ; difference : 63 % , 95 % CI = 29.69–96.3 , ( P < 0.005 ) ] groups . Complete healing of stage II ulcer in the HD group [ 12/18 ( 67 % ) ] was better than in the SD group [ 3/19(16 % ) ; difference : 51 % , 95 % CI = 23.73–78.26 , ( P < 0.005 ) ] , but not significantly different from the PC group [ 10/21 ( 48 % ) ; difference : 19 % , 95 % CI = -11.47–49.47 , ( P > 0.05 ) ] . We performed a second analysis considering only one ulcer per patient ( i.e. 83 ulcers in 83 patients ) . This " per patient " analysis showed that complete ulcer healing in the HD group was better than in the PC [ 20/28(71.4 % ) vs 11/28 ( 39.3 % ) ; difference : 32.1 % , 95 % CI = 7.4–56.7 , ( P < 0.01 ) ] or SD [ 20/28(71.4 % ) vs 8/27 ( 29.6 % ) ; difference : 41.8 % , 95 % CI = 17.7–65.8 , ( P < 0.005 ) ] groups . Conclusion We deduced that HD is the most effective method investigated for treating stage I and II pressure ulcers in young paraplegic men An occlusive hydrocolloid dressing ( Comfeel Ulcus ) was compared with a conventional wet saline gauze dressing regarding the effect on ulcer cleansing and healing processes , experience of pain and the consumption of nursing time , in a controlled , r and omized and partially single-blind study with parallel groups of long-stay patients with pressure sores . After a few weeks ' treatment the relative decrease in ulcer areas with time was larger in the group treated with the hydrocolloid dressing . The difference was almost statistically significant at week 5 ( p = 0.054 ) and definite at week 6 ( p = 0.006 ) . At week 6 the median remaining ulcer area in per cent of the initial area was 0 % in the hydrocolloid dressing group and 31 % in the group treated with saline gauze ( p = 0.016 ) . Analysis of the healing distribution function showed the hydrocolloid dressing to be more effective , although the overall difference was non-significant ( p = 0.15 ) . Care of the pressure sore took significantly less time with hydrocolloid dressings Nonprofessional caregivers currently are participating in managing pressure ulcers at home . As this can be a stressful experience , innovative and easy-to-use products are needed to support caregiver confidence . A multicenter , r and omized clinical trial was conducted to compare clinical performance and case of instruction of a change indicator dressing ( SIG ) and a hydrocolloid alginate dressing ( HAD ) in the management of pressure ulcers in the home and long-term care setting s. SIG and HAD were r and omized to 17 and 18 partial- or full-thickness pressure ulcers respectively . During five dressing changes , wound area , dressing application , maintenance , appearance , removal , wear time , ease of teaching , and caregiver underst and ing of each dressing 's instructions were measured . Both dressings were rated highly regarding ease of teaching , ease of use , appearance , maintenance , and helpfulness in signaling the need for dressing change by both professional and nonprofessional wound caregivers . Average dressing wear time was 3.2 days for SIG and 2.7 days for HAD . Of these wounds managed in a moist environment , 6 of 17 ( 35 % ) subjects whose wounds were dressed with SIG , and 1 of 18 ( 6 % ) dressed with HAD healed during the course of the study ( alpha < 0.04 ) . Percent wound reduction in area per day of care was also greater for SIG ( alpha < 0.01 ) . Innovative dressings may help caregivers provide consistent quality pressure ulcer care and improve wound-healing outcomes A hydropolymer dressing ( Tielle ) and a hydrocolloid dressing ( Granuflex ) were compared in a r and omised controlled clinical study involving 100 patients with leg ulcers and 99 patients with pressure sores in the community . Statistically significant differences in favour of the hydropolymer dressing were detected for dressing leakage and odour production , but no statistically significant differences were recorded in the number of patients with either leg ulcers or pressure sores who healed in each treatment group The management of pressure sores in community setting s , poses a clinical problem which challenges the patient ’s tolerance and the clinician ’s diligence and ingenuity . Pressure sores can be painful , lead to infection and are associated with considerable morbidity and increased mortality ( Patterson & Bennett , 1995:919 ; Bale , Banks , Hagelstein & Harding , 1998:65 ) . Treatment costs of these wounds are high in terms of re sources ( Colin 1995:65 ; Wood , Griffiths & Stoner , 1997:256 ) . However , since there are untold cost in terms of pain and suffering to the patient , it is impossible to calculate the true cost of pressure sores ( Dealey , 1994:87 ) OBJECTIVES To compare the effects of topical collagen and hydrocolloid on pressure ulcer healing . DESIGN R and omized ( allocation concealed ) , single-blind ( outcome assessors ) , controlled trial with 8-week follow-up . SETTING Eleven nursing homes in central Illinois . PARTICIPANTS Sixty-five patient-residents with Stage II or III pressure ulcers : median age 83.1 , median Braden score 12 , 63 % female , 80 % Stage II ulcers , and 20 % Stage III ulcers . Exclusion criteria included cellulitis and osteomyelitis . INTERVENTION Thirty-five patients were allocated to topical collagen daily , 30 to topical hydrocolloid twice weekly . MEASUREMENTS The primary outcome was complete healing within 8 weeks . Secondary outcomes were time to heal , ulcer area healed per day , linear healing of wound edge , and cost of therapy . RESULTS Analysis by intention to treat revealed similar complete ulcer healing within 8 weeks in collagen ( 51 % ) and hydrocolloid ( 50 % ) recipients ( difference 1 % , 95 % confidence interval ( CI ) = 26 - 29 % ) . Mean healing time was similar : collagen healed in 5 weeks ( 95 % CI = 4 - 6 ) , hydrocolloid healed in 6 weeks ( 95 % CI = 5 - 7 ) . Mean area healed per day was 6 mm(2)/d in both treatment groups . Mean linear healing of the wound edge was 3 mm in both groups . In multivariate analysis , baseline ulcer depth was the only independent predictor of complete ulcer healing within 8 weeks ( odds ratio = 0.56 , 95 % CI = 0.38 - 0.81 ) . Cost analysis favored hydrocolloid . CONCLUSIONS There were no significant differences in healing outcome between collagen and hydrocolloid . Collagen was more expensive and offered no major benefits to patients otherwise eligible for hydrocolloid treatment A total of 67 patients with pressure ulcers were r and omized into one of three treatment modalities : hydrogel sheet dressing , hydrocolloid , or wet-to-moist gauze . Safety , efficacy , and physical attributes of the three dressings were evaluated . No statistical significance was found in wound healing rate among the three treatments . Hydrogel sheets were advantageous in allowing wound visualization without dressing or wound disruption One-hundred and three patients with Stage II and III sacral pressure ulcers were enrolled in a prospect i ve , controlled , multi-center clinical study to evaluate and compare dressing performance , safety and efficacy . Fifty-two patients were r and omized to treatment with a triangle-shaped hydrocolloid border dressing and 51 patients were r and omized to a different , oval shape , hydrocolloid dressing . The majority of patients ( 70 percent ) utilized a pressure reducing mattress or bed . Most ulcers were Stage II , had existed for < 1 month and exhibited no change utilizing previous treatments . Patients and wounds were similarly distributed among treatment groups . Patients in the oval dressing group were more likely to exhibit a product related adverse reaction result ing in discontinuation of treatment as compared to patients treated with the triangle border dressing ( p = 0.057 , Fisher 's Exact Test ) . Wear time was longest for wounds dressed with the triangle dressing applied point down . Incontinence reduced the interval between dressing changes in both groups . Healing was more likely to occur in wounds dressed with the triangle border dressing . These ulcers showed a greater reduction in ulcer width as compared to wounds dressed with the oval dressing ( p < 0.03 , Fisher 's Exact Test ) This study compared an adhesive hydrocellular dressing with a leading hydrocolloid dressing in the management of pressure ulcers . Forty adult patients of both sexes who had Stage II or III pressure ulcers ( according to the Agency for Health Care Policy and Research system ) were enrolled in the study and were r and omized to either the hydrocellular or hydrocolloid dressing . Dressing changes were done as required , and each ulcer was assessed on a weekly basis . Patients were followed for 8 weeks , until ulcer closure was achieved , or until the patient was withdrawn from the study , whichever occurred first . The hydrocellular dressing was found to compare favorably with the hydrocolloid dressing . In terms of ease of use , the hydrocellular dressing was found to be significantly easier to remove ( P < 0.001 ) and quicker to change ( P < 0.001 ) than the hydrocolloid dressing . No differences were detected between the two dressing groups regarding mean wound pain , odor , and changes in ulcer appearance and ulcer area OBJECTIVES Pressure ulcers , like other chronic wounds , fail to proceed through an orderly and timely process to produce anatomical or functional integrity . Treatment of pressure ulcers is directed to improving host factors and providing an optimum wound environment . In addition to providing a moist wound environment , it has been theorized that preventing hypothermia in a wound and maintaining a normothermic state might improve wound healing . DESIGN / SETTING Forty-one subjects with a stage 3 or stage 4 truncal pressure ulcer > 1.0 cm(2 ) were recruited from outpatient
Output:
| Concerning the healing of the pressure ulcer , hydrocolloids are more effective than gauze dressings for the reduction of the wound dimensions .
The absorption capacity , the time needed for dressing changes , the pain during dressing changes and the side-effects were significantly in favour of hydrocolloids if compared to gauze dressings .
Based on the available cost-effectiveness data , hydrocolloids seemed to be less expensive compared with collagen- , saline- and povidine-soaked gauze but more expensive compared to hydrogel , polyurethane foam and collagenase .
CONCLUSIONS This review demonstrates that hydrocolloids are to be preferred to gauze dressings in the treatment of pressure ulcers .
RELEVANCE TO CLINICAL PRACTICE Based on the studies included in this review , hydrocolloids are frequently used in the treatment of grade 2 and 3 pressure ulcers and are more effective and less expensive than gauze dressings .
Compared with alginates , polyurethane dressings , less-contact layers , topical enzymes and biosynthetic dressings , hydrocolloids are less effective |
MS211268 | ***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: Abstract The relationship of the degree of use of each of ten types of illicit drugs with each of eight types of violent criminal offenses , is reported for an African-American , inner-city , low SES , young adult study sample ( N = 612 ) . Prospect i ve data from the time of birth was available for the statistical analyses , to provide 51 control variables on factors other than substance use which might predict to later violent behavior . Findings : Greater frequency of use of marijuana was found unexpectedly to be associated with greater likelihood to commit weapons offenses ; and this association was not found for any of the other drugs , except for alcohol . Marijuana use was also found associated with commission of Attempted Homicide/Reckless Endangerment offenses . Cocaine/crack and marijuana were the only two types of drugs the frequency of use of which was found , for this sample , to be significantly related to the frequency of being involved in the selling of drugs . These findings may not apply to a middle-class African-American sample Long-term cocaine and alcohol use is associated with neuropsychological impairments that implicate poor inhibitory mechanisms of behavioural control . This study tested acquisition and discrimination-reversal learning in a group of polydrug users ( n 20 ) with a history of cocaine and heavy alcohol use and a group of age-matched controls ( n 20 ) . A cued go/nogo task measured subjects ’ ability to learn stimulus-response associations that involved the quick activation and sudden inhibition of responses . Compared with controls , drug users displayed similar acquisition , but impaired discrimination-reversal learning of both inhibitory and activational responses . The results suggest that some drug-related neuropsychological deficits might reflect specific impairments of the ability to inhibit interference from prior learning . The findings contribute to growing evidence that suggests cocaine and alcohol use could produce broad inhibitory impairments that increase the risk for learning deficits and poor impulse control Deficits in cognitive control are implicated in cocaine dependence . Previously , combining functional magnetic resonance imaging and a stop signal task , we demonstrated altered cognitive control in cocaine-dependent individuals . However , the clinical implication s of these cross-sectional findings and , in particular , whether the changes were associated with relapse to drug use , were not clear . In a prospect i ve study , we recruited 97 treatment-seeking individuals with cocaine dependence to perform the stop signal task during functional magnetic resonance imaging and participate in follow-up assessment s for 3 months , during which time cocaine use was evaluated with timeline follow back and ascertained by urine toxicology tests . Functional magnetic resonance imaging data were analysed using general linear models as implemented in Statistical Parametric Mapping 8 , with the contrast ' stop error greater than stop success trials ' to index error processing . Using voxelwise analysis with logistic and Cox regressions , we identified brain activations of error processing that predict relapse and time to relapse . In females , decreased error-related activations of the thalamus and dorsal anterior cingulate cortex predicted relapse and an earlier time to relapse . In males , decreased error-related activations of the dorsal anterior cingulate cortex and left insula predicted relapse and an earlier time to relapse . These regional activations were vali date d with data resampling and predicted relapse with an average area under the curve of 0.849 in receiver operating characteristic analyses . These findings provide direct evidence linking deficits in cognitive control to clinical outcome in a moderate-sized cohort of cocaine-dependent individuals . These results may provide a useful basis for future studies to examine how psychosocial factors interact with cognitive control to determine drug use and to evaluate the efficacy of pharmacological or behavioural treatment in remediating deficits of cognitive control in cocaine addicts Chronic and recreational use of cocaine has been shown to impair inhibitory output control ( response inhibition ) but whether input control is also affected is an open question . For the first time , this study compared the ability to perform a cued target-discrimination task that measured inhibition of return ( IOR ) , a reflexive inhibitory mechanism that delays attention from returning to a previously attended location , in adult recreational users and in a cocaine-free-matched sample controlled for age , race , gender distribution , and level of intelligence . Results show that the recreational use of cocaine eliminates IOR , suggesting that input control is strongly impaired Two experiments investigated attentional biases for smoking-related cues in smokers and nonsmokers , using the visual probe task . In Experiment 1 , when pictures were displayed for 500 ms , smokers who had made repeated quit attempts showed an attentional bias for smoking-related scenes . Experiment 2 replicated this finding and revealed that when pictures were presented for 2,000 ms , the smoker group as a whole showed vigilance for smoking-related cues , but nonsmokers did not . The findings from the 500-ms exposure condition suggest that initial orienting of attention to smoking cues was associated with repeated unsuccessful attempts at abstinence in smokers . Results are discussed with reference to incentive-sensitization theories of addiction and to component processes of selective attention , such as initial orienting versus maintenance
Output:
| In 90 % of the studies review ed the presence of inhibitory control deficits was reported , verified by impaired cognitive processing and response monitoring , as well as high levels of impulsiveness , regardless of the pattern of crack and /or cocaine consumption ( recreational or chronic ) .
Former users showed high levels of impulsiveness even after long periods of abstinence .
Crack and /or cocaine users may have inhibitory control deficits , irrespective of different consumption patterns .
High levels of impulsiveness can represent a factor of vulnerability to drug use and relapse |
MS211269 | ***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 There is no more effective intervention for secondary prevention of coronary heart disease than smoking cessation . Yet , evidence about the (cost-)effectiveness of smoking cessation treatment methods for cardiac in patients that also suit nursing practice is scarce . This protocol describes the design of a study on the (cost-)effectiveness of two intensive smoking cessation interventions for hospitalised cardiac patients as well as first results on the inclusion rates and the characteristics of the study population . Methods / design An experimental study design is used in eight cardiac wards of hospitals throughout the Netherl and s to assess the (cost-)effectiveness of two intensive smoking cessation counselling methods both combined with nicotine replacement therapy . R and omization is conducted at the ward level ( cross-over ) . Baseline and follow-up measurements after six and 12 months are obtained . Upon admission to the cardiac ward , nurses assess patients ’ smoking behaviour , ensure a quit advice and subsequently refer patients for either telephone counselling or face-to-face counselling . The counselling interventions have a comparable structure and content but differ in provider and delivery method , and in duration . Both counselling interventions are compared with a control group receiving no additional treatment beyond the usual care . Between December 2009 and June 2011 , 245 cardiac patients who smoked prior to hospitalisation were included in the usual care group , 223 in the telephone counselling group and 157 in the face-to-face counselling group . Patients are predominantly male and have a mean age of 57 years . Acute coronary syndrome is the most frequently reported admission diagnosis . The ultimate goal of the study is to assess the effects of the interventions on smoking abstinence and their cost-effectiveness . Telephone counselling is expected to be more (cost-)effective in highly motivated patients and patients with high SES , whereas face-to-face counselling is expected to be more (cost-)effective in less motivated patients and patients with low SES . Discussion This study examines two intensive smoking cessation interventions for cardiac patients using a multi-centre trial with eight cardiac wards . Although not all eligible patients could be included and the distribution of patients is skewed in the different groups , the results will be able to provide valuable insight into effects and costs of counselling interventions varying in delivery mode and intensity , also concerning subgroups . Trial registration Dutch Trial Register PURPOSE / OBJECTIVES To determine the predictors of participation in a smoking-cessation program among patients with head and neck cancer . DESIGN This cross-sectional study is a sub study of a larger , r and omized trial of patients with head and neck cancer that determined the predictors of smokers ' participation in a cessation intervention . SETTING Otolaryngology clinics at three Veterans Affairs medical centers ( Ann Arbor , MI , Gainesville , FL , and Dallas , TX ) , and the University of Michigan Hospital in Ann Arbor . SAMPLE 286 patients who had smoked within six months of the screening survey were eligible for a smoking-cessation intervention . METHODS Descriptive statistics and bivariate and multivariate logistic regression were used to determine the independent predictors of smokers ' participation in an intervention study . MAIN RESEARCH VARIABLES Perceived difficulty quitting ( as a construct of self-efficacy ) , health behaviors ( i.e. , smoking and problem drinking ) , clinical characteristics ( i.e. , depression and cancer site and stage ) , and demographic variables . FINDINGS Forty-eight percent of those eligible participated . High perceived difficulty quitting was the only statistically significant predictor of participation , whereas problem drinking , lower depressive symptoms , and laryngeal cancer site approached significance . CONCLUSIONS Special outreach may be needed to reach patients with head and neck cancer who are overly confident in quitting , problem drinkers , and patients with laryngeal cancer . IMPLICATION S FOR NURSING Oncology nurses are in an opportune position to assess patients ' perceived difficulty quitting smoking and motivate them to enroll in cessation programs , ultimately improving quality of life , reducing risk of recurrence , and increasing survival for this population Abstract Objective : To evaluate the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease . Design : R and omised controlled trial of clinics over one year with assessment by self completed postal question naires and audit of medical records at the start and end of the trial . Setting : R and om sample of 19 general practice s in northeast Scotl and . Subjects : 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease who did not have terminal illness or dementia and were not housebound . Intervention : Clinic staff promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures : Health status measured by the SF-36 question naire , chest pain by the angina type specification , and anxiety and depression by the hospital anxiety and depression scale . Use of health services before and during the study . Results : There were significant improvements in six of eight health status domains ( all functioning scales , pain , and general health ) among patients attending the clinic . Role limitations attributed to physical problems improved most ( adjusted difference 8.52 , 95 % confidence interval 4.16 to 12.9 ) . Fewer patients reported worsening chest pain ( odds ratio 0.59 , 95 % confidence interval 0.37 to 0.94 ) . There were no significant effects on anxiety or depression . Fewer intervention group patients required hospital admissions ( 0.64 , 0.48 to 0.86 ) , but general practitioner consultation rates did not alter . Conclusions : Within their first year secondary prevention clinics improved patients ' health and reduced hospital admissions . Key messages Nurse led clinics in general practice were used to promote secondary prevention to patients with coronary heart disease Within the first year the health of patients invited to the clinics improved Most benefit was in functional status , but chest pain improved too There was no effects on anxiety or depression There were significant reductions in hospital admissions in the first Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT This paper describes the planning and implementation of an individualized teaching programme for patients and their families following primary uncomplicated myocardial infa rct ion . This preliminary study was design ed and implemented by a senior nurse while working in the clinical area . Patients were r and omly allocated to a control or study group . Both groups of patients were interviewed on the fourth day following admission to hospital and again at 2 and 6 months after discharge . Nurse intervention in the form of individually planned consecutive teaching sessions achieved a reduction in anxiety and modification of identifiable risk factors ( smoking , obesity , diet , exercise ) in the patients included in the teaching programme BACKGROUND This study examined the 1-year effects of a minimal-contact smoking cessation intervention for cardiac in patients . METHODS The multicenter study included cardiac in patients who had smoked prior to hospitalization . A pretest-posttest quasi-experimental design was used . Patients ' experimental condition depended on the hospital they were assigned to . The design was partially r and omized : 4 of the 11 hospitals selected the experimental condition themselves ( 2 experimental , 2 control ) , while the remaining 7 hospitals were r and omly assigned . The experimental group consisted of patients of 5 hospitals ( N = 388 ) . Patients of 6 other hospitals served as the control group ( N = 401 ) . The intervention included stop-smoking advice by the cardiologist , brief counseling by the nurse , the provision of self-help material s , and aftercare by the cardiologist . RESULTS Logistic regression analyses controlling for baseline differences and covariates did not show significant intervention effects on point prevalence and continuous abstinence . The study also showed that the outcomes were not significantly related to the way hospitals were assigned to the experimental condition . CONCLUSIONS While short-term effects were found , the minimal-contact intervention did not result in significant effects after 12 months , at least if patients lost to follow-up were treated as posttest smokers . Efforts should be made to improve the intervention , especially the aftercare Objective . To evaluate an intervention programme on smoking cessation in patients with diabetes mellitus in primary healthcare . Design . Regional controlled intervention study . Setting . Seventeen primary healthcare centres in Sweden . Intervention . In the intervention centres , nurses with education in diabetes were given one half-day of training in motivational interviewing and smoking cessation . An invitation to participate in a smoking cessation group was mailed to patients from the intervention centres followed by a telephone call from the patient 's diabetes nurse . The nurses who intervened were specially educated in smoking cessation . The control group received a letter containing advice to stop smoking and information about a one-year follow-up . Patients . Daily smokers with diabetes mellitus , 30–75 years of age . In the intervention centres 241 patients fulfilled the criteria and in the control centres 171 patients . Main outcome measures . Self-reported smoking habits after one year . Results . In total , 21 % of the smokers accepted group treatment . After 12 months , 20 % ( 42/211 ) in the intervention centres reported that they had stopped smoking and 7 % ( 10/140 ) in the control centres ; 40 % ( 19/47 ) of the smokers who had participated in group treatment reported that they had stopped smoking . Conclusion . A computerized record system for patients in primary healthcare was used to identify diabetic patients who were smokers . The selected group was invited to a stop smoking programme . At a one-year follow-up significantly more patients in the intervention centres had stopped smoking compared with patients in the control centres Purpose . Assess the effectiveness of a two-step health education program by nurses delivered through nonsmoking mothers to help fathers of sick children quit smoking . Design . R and omized , controlled trial . Setting . General pediatric wards of four major hospitals in Hong Kong . Subjects . Nonsmoking mothers who had a live-in smoking spouse were recruited when they brought sick children to the hospital . A total of 752 mothers were r and omized into the intervention arm and 731 into the control arm . Intervention . The intervention group received st and ardized health advice , behavior modification booklets , and a 1–week telephone reminder . The control group received usual care . Measurements . The main outcome measure was the quit rate ( 7–day point prevalence ) of smoking fathers as determined by telephone follow-up with mothers at 3 and 12 months . Quit attempts and smoking reduction were secondary outcome measures . Results . At 3 months , more fathers in the intervention group had quit smoking ( 7.4 % vs. 4.8 % ; p = .03 ) , reduced daily cigarette consumption by 50 % or more ( 30.6 % vs. 22.6 % ; p < .001 ) , and reported quit attempts ( 6.5 % vs. 3.6 % ; p = .01 ) . The differences were not statistically significant by 12 months . Conclusion . A simple health education intervention provided by nurses to mothers of sick children has a short-term effect in helping smoking fathers quit , reduce consumption , and trigger quit attempts . Future studies should confirm the longer-term sustainability of the effect Abstract Objective . To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care . Design and setting . Cluster r and omised trial in general practice s. Intervention . Nurse-led structured diabetes care with a protocol
Output:
| Subgroup analyses found no evidence that high-intensity interventions , interventions with additional follow-up or interventions including aids that demonstrate the pathophysiological effect of smoking are more effective than lower intensity interventions , or interventions without additional follow-up or aids .
There was no evidence that the effect of support differed by patient group or across healthcare setting s. AUTHORS ' CONCLUSIONS There is moderate quality evidence that behavioural support to motivate and sustain smoking cessation delivered by nurses can lead to a modest increase in the number of people who achieve prolonged abstinence .
There is insufficient evidence to assess whether more intensive interventions , those incorporating additional follow-up , or those incorporating pathophysiological feedback are more effective than one-off support .
There was no evidence that the effect of support differed by patient group or across healthcare setting |
MS211270 | ***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: Locally advanced rectal cancer is currently treated with pre-operative radiochemotherapy ( p RCT ) , but the response is not uniform . Identification of patients with higher likelihood of responding to p RCT is clinical ly relevant , as patients with resistant tumors could be spared exposure to radiation or DNA-damaging drugs that are associated with adverse side effects . To highlight predictive biomarkers of response to p RCT , a systematic search of PubMed was conducted with a combination of the following terms : “ rectal ” , “ predictive ” , “ radiochemotherapy ” , “ neoadjuvant ” , “ response ” and “ biomarkers ” . Genetic polymorphisms in epithelial growth factor receptor ( EGFR ) and thymidylate synthase ( TS ) genes , the expression of several markers , such as EGFR , bcl-2/bax and cyclooxygenase (COX)-2 , and circulating biomarkers , such as serum carcinoembryonic antigen ( CEA ) level , are promising as predictor markers , but need to be further evaluated . The majority of the studies did not support the predictive value of p53 , while the values of Ki-67 , TS and p21 is still controversial . Gene expression profiles of thous and s of genes using microarrays , microRNA studies and the search for new circulating molecules , such as human telomerase reverse transcriptase mRNA and cell-free DNA , are providing interesting results that might lead to the identification of new useful biomarkers . Evaluation of biomarkers in larger , prospect i ve trials are required to guide therapeutic strategies Objective : To prospect ively describe patient-reported outcomes ( PROs ) after preoperative chemoradiotherapy ( pCRT ) for rectal cancer . Background : Little evidence is available on PROs after pCRT for rectal cancer . Patients and Methods : Patients with rectal cancer , c and i date s to receive pCRT , were enrolled in a multicenter prospect i ve observational trial . Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-C30 and its colorectal cancer module ( QLQ-CR38 ) , and fecal incontinence and bowel function were evaluated using the fecal incontinence score question naire and a set of ad hoc questions . Question naires were filled out before CRT ( t0 ) , 2 to 3 weeks after completion of CRT ( t1 ) , and at 6 ( t2 ) and 12 months ( t3 ) after surgery . Primary analysis of selected scales included : global quality of life , physical functioning , social functioning , fatigue , body image , future prospect i ve , and gender-related sexual problems . Results : Of 149 eligible patients , question naires were completed in 100 % , 95 % , 88 % and 77 % of cases at t0 , t1 , t2 , and t3 , respectively . At t3 , 78 % of patients reported stool fractionation and 72 % sensation of incomplete defecation . Only 14 % of patients had optimal continence . Physical/social functioning , fatigue , and body image showed a decrease just after pCRT and returned to baseline levels at 1 year after treatment . Global quality of life was stable over time . Male sexual problems were greatly impaired throughout the study period ( P < 0.001 ) with major clinical ly meaningful changes between baseline and 1 year after treatment . Conclusions : These findings add to the body of evidence available regarding pCRT and help clinicians to make more informed treatment decisions AIMS The identification of predictive markers of response to chemoradiotherapy treatment remains a promising approach for patient management in order to obtain the best response with minor side effects . Initially , we investigated whether the analysis of several markers previously studied and others not yet evaluated could predict response to 5-fluorouracil- and capecitabine-based neoadjuvant treatment in locally advanced rectal cancer . METHODS & MATERIAL S We studied germline and tumoral sample s of 65 stage II/III rectal patients . A panel of pharmacogenetic markers was genotyped in paired peripheral blood sample s and rectal cancer tumors . RESULTS Our results seem to confirm the previously described association of thymidylate synthase and the prediction of chemoradiotherapy response in rectal cancer . However , it failed to confirm the clinical utility proposed for XRCC1 , ERCC1 , ERCC2 , MTHFR and EGFR polymorphisms in blood/germline sample s. Subsequently , with the aim of improving prediction of individual response and assessing the role of studied polymorphisms in response to treatment , we determined if changes in tumor response to these markers could predict clinical outcome . We found a high degree of changes between germline and tumor sample s , mainly somatic mutations without microsatellite instability , and a minor frequency of loss-of-heterozygosity events . In tumoral sample s , XRCC1 appeared to be significantly associated ( p = 0.006 ) with downstaging of the tumor ( odds ratio : 7.93 ; 95 % CI : 1.03 - 60.83 ) , but the increasing of TYMS low-expression alleles contradict the previous results observed in germline sample s. CONCLUSION The detection of somatic mutations in rectal cancer tumors led us to re-evaluate the utility of the tests performed in blood sample s for these polymorphisms in rectal cancer . Furthermore , studies aim ed at assessing the influence of pharmacogenetic markers in treatment response performed in blood sample s should take into account the particular pattern of hypermutability present in each tumor type . We hypothesize that different patterns of hypermutability present in each tumor type would be related to the different results in association studies related to response to the treatment PURPOSE We compared the combined radiation therapy ( RT ) plus chemotherapy segments of two separate parallel phase I trials to determine if combined pelvic RT , fluorouracil ( 5-FU ) , and high-dose leucovorin ( LV ) had less acute toxicity when delivered preoperatively versus postoperatively in patients with rectal cancer . PATIENTS AND METHODS Patients with unresectable disease received preoperative RT plus LV and 5-FU followed by surgery and postoperative LV and 5-FU . Patients with resectable disease received identical doses , techniques , and schedules of RT and LV and 5-FU except all therapy was delivered postoperatively . On day 1 , patients received LV and 5-FU times one cycle . RT began on day 8 . A second cycle of LV and 5-FU was given concurrently with the fourth week of RT . RESULTS Although more patients ( 75 % v 32 % ; P = .02 ) received the higher dose level of 5-FU ( 250 mg/m2 ) , significantly fewer experienced acute grade 3 to 4 toxicity with preoperative versus postoperative therapy ( 13 % v 48 % ; P = .045 ) . There was no grade 3 to 4 myelosuppression in either group . The two grade 3 toxicities in the preoperative group were gastrointestinal . The grade 3 toxicities in the postoperative group included seven gastrointestinal and two genitourinary ; four patients had a grade 4 toxicity . CONCLUSION Given the high incidence of grade 3 to 4 toxicity also reported in the postoperative combined modality adjuvant r and omized trials , future adjuvant trials should explore the preoperative approach The present study retrospectively examined the correlation between the outcome of patients with locally advanced oesophageal squamous cell carcinoma ( cT3 - 4 cN0 - 1 cM0 ) after multimodal treatment ( radiochemotherapy±surgical resection ) , and the presence of genetic polymorphisms in genes involved in folate metabolism . In total , 68 patients who took part in a prospect i ve multicentric trial received 5-fluorouracil (FU)-based radiochemotherapy , optionally followed by surgery . DNA was extracted from pretherapeutic tumour biopsies and was subsequently genotyped for common genetic polymorphisms of three genes ( MTHFR C677 T , MTR A2756 G , TS t and em repeat polymorphism ) involved in folate metabolism and potentially in sensitivity to 5-FU-based chemotherapy . The genotypes were correlated with tumour response to polychemotherapy , radiochemotherapy and with overall survival . Tumours with the MTR wild-type genotype ( 2756AA ) showed a median survival time of 16 months , whereas tumours with an MTR variant genotype ( 2756AG/2756GG ) showed a median survival time of 42 months ( P=0.0463 ) . No prognostic impact could be verified for the genotypes of the MTHFR genes and the TS gene . Among tumours treated with radiochemotherapy and subsequent resection , MTR variant genotype showed higher histopathological response rate than tumours with MTR wild-type genotype ( P=0.0442 ) . In contrast , no significant relationship between clinical ly determined tumour regression after polychemotherapy and polymorphisms of the three genes under analysis was observed . In conclusion , pretherapeutic determination of the MTR A2756 G polymorphism may predict survival of multimodally treated oesophageal squamous cell carcinomas . Determination of MTHFR C677 T and TS t and em repeat polymorphism has no predictive value Objective The objective of the present study was to evaluate whether germline methylenetetrahydrofolate reductase ( MTHFR ) C677 T and A1298C polymorphisms as well as polymorphisms in the thymidylate synthase gene promoter , namely the variable number t and em repeat polymorphism ( TS VNTR ) and the intrarepeat G to C single nucleotide polymorphism ( TS SNP ) , are predictive markers of tumor regression in rectal cancer patients following preoperative chemoradiotherapy . Basic methods Blood sample s from 125 patients with primary adenocarcinoma of the mid – low rectum who received 5-fluorouracil-based chemotherapy and external beam radiotherapy ( median dose 48.4 Gy ) , 125 patients ( women n=45 , men n=80 ; median age 60 years , range 31–79 years ) were genotyped . Response to preoperative treatment was evaluated employing the Tumor Regression Grade criteria . On the basis of the pathologic response , patients were classified as responders ( TRG 1–2 , n=48 ) and non-responders ( TRG 3–5 , n=74 ) . Three patients were excluded because of insufficient data . Main results Among the polymorphic variants examined , the MTHFR 677T-1298A haplotype was , upon univariate analysis , the only variable found associated with tumor regression ( P=0.004 ) . Moreover , at multivariate analysis , the MTHFR 677T-1298A haplotype was an independent predictor of tumor regression . Patients not carrying the MTHFR 677T-1298A haplotype ( odds ratio 0.29 , 95 % confidence interval 0.13–0.64 , P=0.002 ) displayed a higher response rate than patients with the MTHFR 677T-1298A haplotype . Conclusions Unlike TS VNTR and SNP polymorphisms , MTHFR 677T-1298A haplotype in genomic DNA has the potential to be a predictive marker of tumor response in rectal cancer patients su bmi tted to preoperative Objective : To identify a biomarker profile associated with tumor response to chemoradiation ( CRT ) in locally advanced rectal cancer . Background : Rectal cancer response to neoadjuvant CRT is variable . Whereas some patients have a minimal response , others achieve a pathologic complete response ( pCR ) and have no viable cancer cells in their surgical specimens . Identifying biomarkers of response will help select patients more likely to benefit from CRT . Methods : This study includes 132 patients with locally advanced rectal cancer treated with neoadjuvant CRT followed by surgery . Tumor DNA from pretreatment tumor biopsies and control DNA from paired normal surgical specimens was screened for mutations and polymorphisms in 23 genes . Genetic biomarkers were correlated with tumor response to CRT ( pCR vs non-pCR ) , and the association of single or combined biomarkers with tumor response was determined . Results : Thirty-three of 132 ( 25 % ) patients achieved a pCR and 99 ( 75 % ) patients had non-pCR . Three individual markers were associated with non-pCR ; v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog mutation ( P = 0.0145 ) , cyclin D1 G870A ( AA ) polymorphism ( P = 0.0138 ) , and methylenetetrahydrofolate reductase ( NAD(P)H ) C677 T ( TT ) polymorphism ( P = 0.0120 ) . Analysis of biomarker combinations revealed that none of the 27 patients with both tumor protein p53 ( p53 ) and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog mutations had a pCR . Further , in patients with both p53 and v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog mutations or the cyclin D1 G870A ( AA ) polymorphism or the methylenetetrahydrofolate reductase ( NAD(P)H ) C677 T ( TT ) polymorphism ( n = 52 ) the association with non-pCR was further strengthened ; 51 of 52 ( 98 % ) of patients were non-pCR . These biomarker combinations had a validity of more than 70 % and a positive predictive value of 97 % to 10
Output:
| Conclusions MTHFR C677 T might be correlated with the tumor response to p RCT . |
MS211271 | ***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: Methylenetetrahydrofolate reductase ( MTHFR ) gene polymorphisms have been reported to be associated with response to methotrexate ( MTX ) in certain population s of patients with rheumatoid arthritis ( RA ) . This study aims at investigating any relationship of two single nucleotide polymorphisms ( SNPs ) in MTHFR gene , C677 T and A1298C with response to therapy with MTX in Pakistani RA patients . Allelic frequencies of the two polymorphisms ( C677 T and A1298C ) were determined in 67 RA patients ( 9 males and 58 females ; mean age 42.87 ± 13.5 years ) who had previously participated in a prospect i ve clinical trial . Fifty-one patients had received MTX and were followed up for response up to 6 months . Genotyping of the two MTHFR polymorphisms was carried out using PCR-RFLP , while fasting concentration of plasma homocysteine was determined using a kit method . Twenty-eight patients were found to be " good responders " , while twenty-three were " poor responders " . MTHFR 1298C and MTHFR 677 T alleles ' frequencies in " good responders " were not different from frequencies in " poor responders " ( 0.574 vs. 0.521 ; p=0.6 and 0.197 vs. 0.196 ; p=0.75 , respectively ) . Plasma homocysteine levels in female RA patients were significantly higher compared to general population in Karachi ( 13.1 ± 6.7 µmol/l vs. 11.4 ± 5.3 µmol/l ; p<0.001 ) . MTHFR C677 T and A1298C polymorphisms are not associated with response to MTX in a population of Pakistani RA patients INTRODUCTION Methotrexate ( MTX ) , widely used in the treatment of rheumatoid arthritis ( RA ) , inhibits dihydrofolate reductase and folate-dependent enzymes . Methylenetetrahydrofolate reductase ( MTHFR ) is involved in folate metabolism and has been shown to be polymorphic , affecting the enzyme activity . METHODS To examine the association between 677C > T and 1298A > C MTHFR polymorphisms and MTX efficacy in the treatment of RA , a total of 174 RA patients , treated with MTX plus methylprednisone 4 mg and folic acid 5 mg were analyzed . RESULTS In univariate regression analysis model , the MTHFR 677 T allele was associated with significantly higher frequency of remission , whereas in the case of the 1298C allele , a tendency for higher remission rate was observed . In multivariate regression analysis , the presence of both 677 T and 1298C alleles was associated with an increased frequency of remission . CONCLUSION The results of our study suggest that the MTHFR 677 T and 1298C alleles may be associated with an increased rate of RA remission in patients treated with MTX receiving high doses of folic acid supplementation Methotrexate ( MTX ) exhibits large inter-individual and inter-ethnic differences in the dose required for its anti-rheumatic effect . To maintain low disease activity , patients may require increased MTX doses or co-administration of biologic disease-modifying anti-rheumatic drugs ( bDMARDs ) . The availability of a marker predicting the effect of MTX will make it possible to increase the MTX dose and prescribe bDMARDs to patients at an early stage . To establish individualized medication for rheumatoid arthritis ( RA ) , we investigated genetic polymorphisms of the folate pathway in Japanese RA patients . Eighty-nine patients were treated with MTX alone ( MTX group ) . MTX and bDMARDs were co-administered to 81 patients because of insufficient MTX efficacy ( MTX + bDMARDs group ) ; an equally stable therapeutic effect was achieved in both groups . Polymorphism analyses using bDMARD co-treatment as the objective variable revealed a significant association between age and the G80A polymorphism of the reduced folate carrier 1 gene ( RFC1 ) as an explanatory variable . Compared to patients with the A allele , patients with the G allele may have less intracellular MTX uptake and , therefore , poor efficacy ; a greater number of them were found to be bDMARD concomitant cases . The results of this study suggest that the RFC1 G80A polymorphism may be a useful marker for predicting MTX efficacy in Japanese patients with RA
Output:
| However , for the polymorphisms not being associated following meta- analysis could still be associated if larger cohorts were used , and studies of other polymorphisms are necessary in large cohorts and a rigorous way , which may provide more accurate results for the effect of the gene polymorphisms on the MTX response |
MS211272 | ***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 Measuring the strength of individual foot muscles is very challenging ; however , measuring muscle morphology has been shown to be associated with strength . A reliable method of assessing foot muscle atrophy and hypertrophy would therefore be beneficial to research ers and clinicians . Thus , the aim of this study was to evaluate the test-retest intra-observer reliability of ultrasound to measure the morphology of the primary toe flexor muscles . Method The abductor hallucis , flexor hallucis brevis , flexor digitorum brevis , quadratus plantae and abductor digiti minimi muscles in the foot , and the flexor digitorum longus and flexor hallucis longus muscles in the shank were assessed in five males and five females ( mean age = 32.1 ± 10.1 years ) . Muscles were imaged using a GE Venue 40 ultrasound ( 6 - 9 or 7.6 - 10.7 MHz transducer ) in a r and om order , and on two occasions 1 - 6 days apart . Muscle thickness and cross-sectional area were measured using Image J software with the assessor blinded to muscle and day of scan . Intraclass correlation coefficients ( ICC ) and limits of agreement were calculated to assess day-to-day repeatability of the measurements . Results The method was found to have good reliability ( ICC = 0.89 - 0.99 ) with limits of agreement between 8 - 28 % of the relative muscle size . Conclusion The protocol described in this paper showed that ultrasound is a reliable method to measure morphology of the toe flexor muscles . The portability and advantages of ultrasound make it a useful tool for clinical and research setting Abstract Reliability refers to the reproducibility of values of a test , assay or other measurement in repeated trials on the same individuals . Better reliability implies better precision of single measurements and better tracking of changes in measurements in research or practical setting s. The main measures of reliability are within-subject r and om variation , systematic change in the mean , and retest correlation . A simple , adaptable form of within-subject variation is the typical ( st and ard ) error of measurement : the st and ard deviation of an individual ’s repeated measurements . For many measurements in sports medicine and science , the typical error is best expressed as a coefficient of variation ( percentage of the mean ) . A biased , more limited form of within-subject variation is the limits of agreement : the 95 % likely range of change of an individual ’s measurements between 2 trials . Systematic changes in the mean of a measure between consecutive trials represent such effects as learning , motivation or fatigue ; these changes need to be eliminated from estimates of within-subject variation . Retest correlation is difficult to interpret , mainly because its value is sensitive to the heterogeneity of the sample of participants . Uses of reliability include decision-making when monitoring individuals , comparison of tests or equipment , estimation of sample size in experiments and estimation of the magnitude of individual differences in the response to a treatment . Reasonable precision for estimates of reliability requires approximately 50 study participants and at least 3 trials . Studies aim ed at assessing variation in reliability between tests or equipment require complex design s and analyses that research ers seldom perform correctly . A wider underst and ing of reliability and adoption of the typical error as the st and ard measure of reliability would improve the assessment of tests and equipment in our disciplines This prospect i ve , blinded study investigates the test retest reliability of measures of muscle thickness made by one sonographer across two cohort groups ( n = 29 ) of people hospitalised with acute stroke . Reliability was assessed in cohort one ( n = 14 ) for measurements made bilaterally at the anterior and posterior upper arms , the anterior and posterior thighs ( total of eight measurements ) and in cohort two ( n = 15 ) , for measurements made bilaterally at the lateral forearms , the anterior abdominal wall and the anterior and lower legs ( total of eight measurements ) . Reliability estimates varied between measurement sites ; intraclass correlation coefficients ( ICCs ) ranged from -0.26 ( lateral forearm , paretic side ) to 0.95 ( anterior thigh , nonparetic side ) , percent mean differences ranged from 0.42 % ( posterior upper arm , nonparetic side ) to 14.68 % ( anterior lower limb , nonparetic side ) and method error ranged from 1.08 ( abdomen , nonparetic side ) to 9.69 mm ( posterior lower limb , nonparetic side ) . Only four measurement sites ( anterior upper arm , posterior upper arm , abdomen and anterior thigh ) were within the acceptable ranges ( ICC 0.60 to 1.00 , mean percent difference range 0%-5 % and method error range 0 - 5 mm ) and considered reliable to use for measures of muscle thickness in people hospitalised with acute stroke The present study was performed to develop regression-based prediction equations for skeletal muscle ( SM ) mass by ultrasound and to investigate the validity of these equations in Japanese adults . Seventy-two Japanese men ( n=38 ) and women ( n=34 ) aged 18–61 years participated in this study and were r and omly separated into two groups : the model development group ( n=48 ) and the validation group ( n=24 ) . The total and regional SM mass were measured using magnetic resonance imaging ( MRI ) 1.5 T-scanners with spin-echo sequence . Contiguous transverse images ( about 150 slices ) with a slice thickness of 1 cm were obtained from the first cervical vertebra to the ankle joints . The volume of SM was calculated from the summation of digitized cross-sectional area . The SM volume was converted into mass units ( kg ) by an assumed SM density of 1.04 kg l−1 . The muscle thickness ( MTH ) was measured by B-mode ultrasound ( 5 MHz scanning head ) at nine sites on the anatomical SM belly . Strong correlations were observed between the site-matched SM mass ( total , arm , trunk body , thigh , and lower leg ) by MRI measurement and the MTH × height ( in m ) in the model development group ( r=0.83–0.96 in men , r=0.53–0.91 in women , P<0.05 ) . When the SM mass prediction equations were applied to the validation group , significant correlations were also observed between the MRI-measured and predicted SM mass ( P<0.05 ) . The predicted total SM mass for the validation group was 19.6 ( 6.5 ) kg and was not significantly different from the MRI-measured SM mass of 20.2 ( 6.5 ) kg . Bl and –Altman analysis did not indicate a bias in prediction of the total SM mass for the validation group ( r=0.00 , NS ) . These results suggested that ultrasound-derived prediction equations are a valid method to predict SM mass and an alternative to MRI measurement in healthy Japanese adults Abstract . This study aim ed to investigate the suitability of using ultrasonograph muscle thickness ( MT ) measurements to estimate the muscle volume ( MV ) of the quadriceps femoris as an alternative approach to magnetic resonance imaging ( MRI ) . The subjects were 46 men aged from 20 to 70 years who were r and omly allocated to either a validation or a cross-validation group . In the validation group , multiple and simple regression equations , which used a set of MT values determined at mid-thigh and thigh length ( l ) and the product of π , (MT/2)2 , and l [ π·(MT/2)2·l ] , respectively , as independent variables , were derived to estimate the MV measured by MRI . Because the two equations were cross-vali date d , the data from the two groups were pooled to generate the final prediction equations : MV (cm3)=(MT × 311.732)+(l × 53.346 ) –2058.529 as the multiple regression equation and MV (cm3)=[π·(MT/2)2·l] × 1.1176 + 663.040 as the simple regression equation . In the multiple regression equation , MT explained 75 % of the variation in the MV measured by MRI . The r2 and the st and ard error of the estimate ( SEE ) of the equations were 0.824 and 175.6 cm3 ( 10.6 % ) , respectively , for the multiple regression equation and 0.829 and 173.7 cm3 ( 10.5 % ) , respectively , for the simple regression equation . Thus , the present results indicate that ultrasonograph MT measurements at mid-thigh are useful for estimating the MV of knee extensors . However , the observed SEE values suggest that the prediction equation obtained in this study may be limited to population studies rather than individual assessment s in longitudinal studies BACKGROUND AND AIMS sarcopenia has been indicated as a reliable marker of frailty and poor prognosis among the oldest individuals . We evaluated the impact of sarcopenia on the risk of all-cause death in a population of frail older persons living in community . METHODS we analysed data from the Aging and Longevity Study , a prospect i ve cohort study that collected data on all subjects aged 80 years and older residing in the Sirente geographic area ( n = 364 ) . The present analysis was conducted among those subjects who were between 80 and 85 years of age at the time of the baseline assessment ( n = 197 ) . The main outcome measure was all-cause mortality over 7-year follow-up . According to the European Working Group on Sarcopenia in Older People ( EWGSOP ) criteria , the diagnosis of sarcopenia required the documentation of low muscle mass and the documentation of either low muscle strength or low physical performance . Cox proportional regression models were used to estimate crude and adjusted hazard ratios and 95 % confidence intervals of death by the presence of sarcopenia . RESULTS using the EWGSOP-suggested criteria , 43 subjects with sarcopenia ( 21.8 % ) were identified . During the 7-year follow-up , 29 ( 67.4 % ) participants died among subjects with sarcopenia compared with 63 subjects ( 41.2 % ) without sarcopenia ( P < 0.001 ) . After adjusting for potential confounders including age , gender , education , activities of daily living ( ADL ) impairment , body mass index , hypertension , congestive heart failure , chronic obstructive pulmonary disease , number of diseases , TNF-α , participants with sarcopenia had a higher risk of death for all causes compared with non-sarcopenic subjects ( HR : 2.32 , 95 % CI : 1.01 - 5.43 ) . CONCLUSIONS our results obtained from a representative sample of very old and frail subjects show that sarcopenia is associated with mortality , independently of age and other clinical and functional variables The increase of elderly in our society requires simple tools for quantification of sarcopenia in inpatient and outpatient setting s. The aim of this study was to compare parameters determined with musculoskeletal ultrasound ( M-US ) with muscle strength in young and elderly patients . In this prospect i ve , r and omised and observer blind study , 26 young ( 24.2 ± 3.7 years ) and 26 old ( age 67.8 ± 4.8 years ) patients were included . Muscle thickness , pennation angle and echogenicity of all muscles of musculus quadriceps were measured by M-US and correlated with isometric maximum voluntary contraction force ( MVC ) of musculus quadriceps . Reproducibility of M-US measurements as well as simple and multiple regression models were calculated . Of all measured M-US variables the highest reproducibility was found for measurements of thickness ( intraclass correlation coefficients , 85–97 % ) . Simple regression analysis showed a highly significant correlation of thickness measurements of all muscles of musculus quadriceps with MVC in the elderly and in the young . Multiple regression analysis revealed that thickness of musculus vastus medialis had the best correlation with MVC in the elderly . This study showed that measurement of muscle thickness , especially of musculus vastus medialis , by M-US is a reliable , bedside method for monitoring the extent of sarcopenia
Output:
| This systematic review shows that ultrasound is a reliable and valid tool for the assessment of muscle size in older adults . |
MS211273 | ***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 present study examined the cardiovascular health effects of 16 weeks of recreational football training in untrained premenopausal women in comparison with continuous running training . Fifty healthy women were matched and r and omized to a football ( FG , n=25 ) or a running ( RG , n=25 ) group and compared with a control group with no physical training ( CO , n=15 ) . Training was performed for 1 h twice a week . After 16 weeks , systolic and diastolic blood pressure was reduced ( P<0.05 ) in FG ( 7+/-2 and 4+/-1 mmHg ) and systolic blood pressure was lowered ( P<0.05 ) in RG ( 6+/-2 mmHg ) . After 16 weeks , resting heart rate was lowered ( P<0.05 ) by 5+/-1 bpm both in FG and RG , and maximal oxygen uptake was elevated ( P<0.05 ) by 15 % in FG and by 10 % in RG ( 5.0+/-0.7 and 3.6+/-0.6 mL/min/kg , respectively ) . Total fat mass decreased ( P<0.05 ) by 1.4+/-0.3 kg in FG and by 1.1+/-0.3 kg in RG . After 16 weeks , pulse pressure wave augmentation index ( -0.9+/-2.5 vs 4.2+/-2.4 % ) , skeletal muscle capillarization ( 2.44+/-0.15 vs 2.07+/-0.05 cap/fib ) and low-density lipoprotein/high-density lipoprotein cholesterol ratio were improved ( P<0.05 ) in FG , but not altered in RG . No changes were observed in CO . In conclusion , regular recreational football training has significant favorable effects on the cardiovascular risk profile in untrained premenopausal women and is at the least as efficient as continuous running The present study investigated whether football has favorable effects in the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men . Twenty-five untrained males aged 31 - 54 year with mild-to-moderate hypertension were r and omized to a football training group ( FTG , two 1-h sessions per week ) and a control group receiving physician-guided traditional recommendations on cardiovascular risk factor modification ( doctoral advice group , DAG ) . After 3 months , systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) were lowered ( P<0.05 ) by 12 + /- 3 and 7 + /- 1 mmHg in FTG , respectively , whereas no significant changes were observed for DAG , with the 3 months values being lower ( P<0.05 ) in FTG than DAG ( SBP : 138 + /- 2 vs 148 + /- 2 mmHg ; DBP : 84 + /- 2 vs 92 + /- 2 mmHg ) . The resting heart rate was lowered ( P<0.05 ) by 12 + /- 2 b.p.m . in FTG after 3 months ( 67 + /- 3 vs 79 + /- 3 b.p.m . ) , whereas no change was observed for DAG . After 3 months , FTG had higher ( P<0.05 ) VO(2max ) ( 8 + /- 2 % ; 35.0 + /- 1.6 vs 32.5 + /- 1.3 mL/min/kg ) and lower ( P<0.05 ) fat mass ( 1.7 + /- 0.6 kg ) , whereas no change was observed for DAG . In conclusion , football training is an attractive non-pharmacological supplement to the treatment of mild-to-moderate arterial hypertension in untrained middle-aged men The effects of 16 weeks of football or strength training on performance and functional ability were investigated in 26 ( 68.2 ± 3.2 years ) untrained men r and omized into a football ( FG ; n = 9 ) , a strength training ( ST ; n = 9 ) , or a control group ( CO ; n = 8) . FG and ST trained 1.6 ± 0.1 and 1.5 ± 0.1 times per week , respectively , with higher ( P < 0.05 ) average heart rate ( HR ) ( ∼140 vs 100 bpm ) and time > 90%HRmax ( 17 vs 0 % ) in FG than ST , and lower ( P < 0.05 ) peak blood lactate in FG than ST ( 7.2 ± 0.9 vs 10.5 ± 0.6 mmol/L ) . After the intervention period ( IP ) , VO₂ max ( 15 % ; P < 0.001 ) , cycle time to exhaustion ( 7 % ; P < 0.05 ) , and Yo-Yo Intermittent Endurance Level 1 performance ( 43 % ; P < 0.01 ) were improved in FG , but unchanged in ST and CO . HR during walking was 12 % and 10 % lower ( P < 0.05 ) in FG and ST , respectively , after IP . After IP , HR and blood lactate during jogging were 7 % ( P < 0.05 ) and 30 % lower ( P < 0.001 ) in FG , but unchanged in ST and CO . Sit-to-st and performance was improved ( P < 0.01 ) by 29 % in FG and 26 % in ST , but not in CO . In conclusion , football and strength training for old men improves functional ability and physiological response to submaximal exercise , while football additionally elevates maximal aerobic fitness and exhaustive exercise performance The purpose of this study was to determine the effects of recreational soccer ( SOC ) compared to moderate-intensity continuous running ( RUN ) on all health-related physical fitness components in healthy untrained men . Sixty-nine participants were recruited and r and omly assigned to one of three groups , of which sixty-four completed the study : a soccer training group ( SOC ; n = 20 , 34±4 ( means±SD ) years , 78.1±8.3 kg , 179±4 cm ) ; a running group ( RUN ; n = 21 , 32±4 years , 78.0±5.5 kg , 179±7 cm ) ; or a passive control group ( CON ; n = 23 , 30±3 years , 76.6±12.0 kg , 178±8 cm ) . The training intervention lasted 12 weeks and consisted of three 60-min sessions per week . All participants were tested for each of the following physical fitness components : maximal aerobic power , minute ventilation , maximal heart rate , squat jump ( SJ ) , countermovement jump with arm swing ( CMJ ) , sit- and -reach flexibility , and body composition . Over the 12 weeks , VO2max relative to body weight increased more ( p<0.05 ) in SOC ( 24.2 % , ES = 1.20 ) and RUN ( 21.5 % , ES = 1.17 ) than in CON ( -5.0 % , ES = -0.24 ) , partly due to large changes in body mass ( -5.9 , -5.7 and + 2.6 kg , p<0.05 for SOC , RUN and CON , respectively ) . Over the 12 weeks , SJ and CMJ performance increased more ( p<0.05 ) in SOC ( 14.8 and 12.1 % , ES = 1.08 and 0.81 ) than in RUN ( 3.3 and 3.0 % , ES = 0.23 and 0.19 ) and CON ( 0.3 and 0.2 % ) , while flexibility also increased more ( p<0.05 ) in SOC ( 94 % , ES = 0.97 ) than in RUN and CON ( 0–2 % ) . In conclusion , untrained men displayed marked improvements in maximal aerobic power after 12 weeks of soccer training and moderate-intensity running , partly due to large decreases in body mass . Additionally soccer training induced pronounced positive effects on jump performance and flexibility , making soccer an effective broad-spectrum fitness training intervention The study examined the effects of 1 year of football or strength training on cardiovascular function in 65- to 75-year-old men . Twenty-six untrained men ( age : 68.2 ± 3.2 years ) were r and omized to football training ( FTG ; n = 9 ) , strength training ( STG ; n = 9 ) , or control ( CG ; n = 8) . In FTG , left ventricular ( LV ) internal diastolic diameter , end-diastolic volume , and mass index were 8 % , 21 % , and 18 % higher ( P < 0.01 ) , respectively , after 12 months , with no changes in STG and CG . After 12 months , LV ejection fraction was increased ( P < 0.05 ) by 8 % and 5 % in FTG and STG , respectively , and systolic longitudinal two-dimensional strain by 8 % and 6 % , whereas right ventricular systolic function improved ( P < 0.05 ) by 22 % in FTG , but not in STG and CG . In FTG , LV diastolic mitral inflow ( E/A ) ratio and peak early diastolic velocity ( E ' ) improved ( P < 0.05 ) by 25 % and 12 % , respectively , after 12 months , with no changes in STG and CG . In FTG , maximum oxygen uptake was 16 % and 18 % higher ( P < 0.001 ) after 4 and 12 months , respectively , and resting heart rate was 6 and 8 beats per minute lower ( P < 0.001 ) , respectively , with no changes in STG and CG . In conclusion , football training elicited superior cardiovascular effects compared with strength training in elderly untrained men Abstract We investigated the musculoskeletal health profile of elite female football players ( ET ) in comparison to untrained ( UT ) young women subjected to 16 weeks of football training ( 2 × 1 h per week ) . DXA scans , blood sampling , sprint testing and Flamingo postural balance testing were carried out for 27 Danish national team players and 28 untrained women , with eight women being tested after training . At baseline total BMD and BMC were 13 % ( 1.305 ± 0.050 versus 1.159 ± 0.056 g · cm−2 ) and 23 % ( 3047 ± 235 versus 2477 ± 526 g ) higher ( P < 0.001 ) and leg BMD and BMC were 24 and 28 % higher ( P < 0.01 ) in ET than in UT . Resting plasma osteocalcin was 45 % higher in ET than in UT ( 28.8 ± 10.9 versus 19.9 ± 9.9 µg · L−1 , P < 0.05 ) . Total lean body mass was 14 % higher ( 50.4 ± 3.3 versus 44.3 ± 4.0 kg ) in ET compared with UT , with no difference in total body mass . The number of Flamingo test falls was 56–63 % less ( P < 0.01 ) and 30 m sprinting speed was 31 % faster ( P < 0.001 ) in ET than UT . After 16 weeks of football training for UT , lean body mass increased by 1.4 ± 0.5 kg and the number of left leg falls decreased by 29 % ( P < 0.05 ) . No significant changes occurred in BMD or BMC , but plasma osteocalcin increased ( P < 0.05 ) by 37 % . In summary , elite women footballers have an impressive musculoskeletal health profile compared with untrained controls , but short-term football training seems to reduce the risk of falls and increase bone formation The present study examined the cardiac effects of football training and running for inactive pre-menopausal women by st and ard echocardiography and tissue Doppler imaging . Thirty-seven subjects were r and omized to two training groups ( football : FG ; n=19 ; running ; RG ; n=18 ) training 1 h with equal average heart rates twice a week for 16 weeks and compared with a matched inactive control group ( CG ; n=10 ) . During the training period , left ventricular end-diastolic volume increased by 13 % in FG and 11 % in RG ( P<0.05 ) . Left ventricular posterior wall thickness increased in FG from 8.5+/-1.4 to 9.0+/-1.3 mm ( P<0.05 ) . Right ventricle diameter increased by 12 % in FG and 10 % in RG ( P<0.05 ) . Tissue Doppler imaging demonstrated increased left ventricular systolic and diastolic performances in both training groups . Peak systolic velocity increased by 26 % in FG and 17 % in RG ( P<0.05 ) and left ventricular longitudinal displacement increased in both groups by 13 % ( P<0.05 ) . Isovolumetric relaxation time decreased significantly more in FG than in RG ( 26 % vs 14 % , respectively P<0.05 ) . In conclusion , 16 weeks of football and running exercise training induced significant changes of cardiac dimensions and had favorable effects on both left ventricular systolic and diastolic function . These training-
Output:
| Clear evidence was found that RS had positive effects on many health-related indices and variables , including VO2max ( gains of 7 - 16 % ) , blood pressure ( reductions of 6 - 13 mmHg ) , body composition ( decreased fat mass and improved indices of bone health ) , and metabolic and cardiac function .
These positive effects were observed in both healthy individuals and clinical patients , irrespective of age or sex .
Regular RS training leads to significant cardiovascular and muscular adaptations and gains of health both in sedentary individuals and clinical patients at all ages , suggesting that RS is a potentially highly motivational method to enhance population health |
MS211274 | ***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: This article evaluates the effects and use of adjuncts to a televised smoking cessation program , based on the American Lung Association 's " Freedom From Smoking in 20 Days . " Subjects were r and omized to maintenance and control conditions . The maintenance condition received newsletters with information and support addressing different stages in the cessation process and information about a telephone hotline . The maintenance condition did not increase cessation at any wave of interviewing , assessed by multiple point or point prevalence of abstinence . Those abstinent at 6 months and those who had made an attempt to stop smoking by that time were more likely to have used the newsletters and were more likely to have used the sections relevant to their cessation stage . Rates of use of the telephone hotline were low . The newsletters appear to be useful to smokers who are predisposed to use written material Objective : To assess the efficacy of an innovative smoking cessation intervention targeted to a multiethnic , economically disadvantaged HIV-positive population . Design : A two-group r and omized clinical trial compared a smoking cessation intervention delivered by cellular telephone with usual care approach . Methods : Current smokers from a large , inner city HIV/AIDS care center were recruited and r and omized to receive either usual care or a cellular telephone intervention . The usual care group received brief physician advice to quit smoking , targeted self-help written material s and nicotine replacement therapy . The cellular telephone intervention received eight counseling sessions delivered via cellular telephone in addition to the usual care components . Smoking-related outcomes were assessed at a 3-month follow-up . Results : The trial had 95 participants and 77 ( 81.0 % ) completed the 3-month follow-up assessment . Analyses indicated biochemically verified point prevalence smoking abstinence rates of 10.3 % for the usual care group and 36.8 % for the cellular telephone group ; participants who received the cellular telephone intervention were 3.6 times ( 95 % confidence interval , 1.3 - 9.9 ) more likely to quit smoking compared with participants who received usual care ( P = 0.0059 ) . Conclusions : These results suggest that individuals living with HIV/AIDS are receptive to , and can be helped by , smoking cessation treatment . In addition , smoking cessation treatment tailored to the special needs of individuals living with HIV/AIDS , such as counseling delivered by cellular telephone , can significantly increase smoking abstinence rates over that achieved by usual care BACKGROUND Previous research has demonstrated the efficacy of an interactive expert system intervention for smoking cessation for a general population . The intervention provides individualized feedback that guides participants through the stages of change for cessation . Enhancing the expert system by adding proactive telephone counseling or a stimulus control computer design ed to produce nicotine fading could produce preventive programs with greater population impacts . METHODS Four interventions were compared : ( a ) the interactive expert system intervention ; ( b ) the expert system intervention plus counselor calls ; ( c ) the expert system intervention plus the stimulus control computer ; and ( d ) an assessment only condition . A 4 ( intervention ) x 4 ( occasions ) ( 0,6,12 , and 18 months ) design was used . Smokers were contacted at home via telephone or mail . The initial subject pool was the 24,178 members of a managed care company . Screening was completed for 19,236 members ( 79.6 % ) , of whom 4,653 were smokers ; 85.3 % of the smokers were enrolled . RESULTS Thirty-eight percent were in the precontemplation stage , 45 % in the contemplation stage , and only 17 % in the preparation stage . At 18 months , the expert system result ed in 23.2 % point prevalence abstinence , which was 33 % greater than that of assessment only . The counselor enhancement produced increased cessation at 12 months but not at 18 months . The stimulus control computer produced no improvement , result ing in 20 % worse cessation rates than the assessment only condition . CONCLUSIONS The enhanced conditions failed to outperform the expert system alone . The study also demonstrated the ability of the interactive expert system to produce significantly greater cessation in a population of smokers than assessment alone Mounting evidence suggests that smokers living with HIV/AIDS have a significantly increased risk of numerous adverse health outcomes ( both AIDS- and non-AIDS-related ) compared with HIV-positive nonsmokers . Therefore , efforts to design and implement effective cessation programs for this ever-growing special population are warranted . The present study assessed the effects of a cell phone intervention ( CPI ) on hypothesized mediators ( i.e. , changes in depression , anxiety , social support , and self-efficacy ) demonstrated to influence cessation outcomes in other population s. Ninety-five participants from an inner-city AIDS clinic were r and omized to receive either the CPI or recommended st and ard of care ( RSOC ) smoking cessation treatment . Participants r and omized to the RSOC group ( n=47 ) received brief advice to quit , a 10-week supply of nicotine patches , and self-help material s. Participants r and omized to the CPI group ( n=48 ) received RSOC components plus a series of eight proactive counseling sessions delivered via cell phones . A series of regression analyses ( linear and logistic ) was used to assess the relationships between treatment group , the hypothesized mediators , and biochemically confirmed smoking cessation outcomes . Results indicated that the CPI group experienced greater reductions in anxiety and depression , and increases in self-efficacy compared with the RSOC group . Further , changes in depression , anxiety , and self-efficacy weakened the association between treatment group and cessation outcome . The mediator hypothesis , however , for social support was rejected , as the difference score was not significantly associated with treatment group . These results suggest that the efficacy of the CPI is at least partially mediated by its ability to decrease symptoms of distress while increasing self-efficacy BACKGROUND This study was conducted to determine the efficacy of the nicotine patch in smoking cessation when combined with self-help material s , three brief visits , and telephone counseling . METHODS One hundred fifty-nine healthy volunteers who smoked at least one pack of cigarettes per day and desired to quit smoking were enrolled in a double-blind trial with 6-week treatment and 6-month follow-up periods . After review of self-help material s , subjects were r and omly assigned to regimens of nicotine or placebo patches . Subjects wore two patches per day for 4 weeks ( 25 mg of nicotine per 24 hours ) , then one patch per day for 2 weeks . Return visits were at the ends of weeks 4 and 6 . Telephone counseling was given during weeks 1 , 2 , 3 , and 5 . Abstinence at 6 weeks was defined as zero cigarettes smoked for the previous 28 days , verified by exhaled carbon monoxide less than 8 ppm at 4 weeks and 6 weeks . Abstinence at 3 and 6 months was defined as self-report of zero cigarettes since the previous contact , verified by carbon monoxide value at 6 months . RESULTS Abstinence rates at 6 weeks , 3 months , and 6 months were 29.5 % , 21.8 % , and 20.5 % in the active group , and 8.8 % , 3.8 % , and 2.5 % in the placebo group ( P < or = .001 for each comparison ) , respectively . Skin irritation was the main side effect , causing 1.3 % to drop out . CONCLUSION The nicotine patch is efficacious in smoking cessation over a 6-month period , when combined with only self-help material s , three brief visits , and telephone counseling This study was based on a ten-year follow-up of smokers who had participated in a r and omized controlled trial of a behavioral self-help program for smoking cessation . The original sample was made up of 200 smokers assigned at r and om to two treatment groups . Ten years later 93.5 % ( n=187 ) of the sample were successfully located ( of the 13 not located , 6 had died ) , from whom information was obtained about their current state and the evolution of their smoking over the 10-year period . Reported abstinence at this follow-up was confirmed by carbon monoxide in expired air . Significant differences were found in the abstinence rates of the two groups at the follow-ups 1 year ( 14 % vs. 28 % ) and 2 years ( 13 % vs. 24 % ) after the end of the treatment . After 10 years 26 % ( n=52 ) of the total sample were abstinent . Over the ten-year period , 62.0 % tried to give up smoking at some point , the mean figure for attempts being 1.3 . According to the results of the 10-year follow-up , low nicotine dependence at pretreatment is a major factor predicting long-term cessation in smokers Background Smoking is more prevalent among lower-income individuals and certain racial/ethnic minorities . Addressing tobacco cessation among diverse population s is an urgent public health priority . As Internet use continues to rise among all segments of the US population , Web-based interventions have enormous potential to reach priority population s. Conducting Web-based smoking cessation research in priority population s requires psychometrically sound measurement instruments . To date , only one published study has examined the psychometric properties of Internet-administered measures commonly used in Web-based cessation trials . However , the sample was homogeneous with regard to race/ethnicity and income . We sought to replicate and extend these findings in a more diverse sample of smokers . Objective The aim was to examine the internal consistency and test-retest reliability of measures commonly used in smoking cessation clinical trials among racial/ethnic minorities and smokers with lower income . Methods Participants were enrolled in a r and omized trial of the efficacy of an Internet smoking cessation program between June 2005 and September 2006 . Following a baseline telephone assessment and r and omization into the parent trial , participants were recruited to the reliability sub study . In phase I of recruitment , all participants in the parent trial were recruited to the sub study ; in phase II , all consecutive racial/ethnic minority participants in the parent trial were recruited . Race and ethnicity were assessed via self-report using two st and ard items from the US Office of Management and Budget . An email was sent 2 days after the telephone assessment with a link to the Internet survey . Measures examined were quit methods , perceived stress , depression , social support , smoking temptations , alcohol use , perceived health status , and income . Internal consistency and test-retest reliability of Internet- versus telephone-administered measures were examined within four strata defined by race/ethnicity ( non-Hispanic White , racial/ethnic minority ) and annual household income ( US $ 40,000 or less , more than $ 40,000 ) . Results Of the 442 individuals invited , 319 participated ( 72 % response rate ) : 52.4 % were non-Hispanic White , 22.9 % Black , 11.6 % Hispanic , 7.8 % Asian , 4.4 % American Indian / Alaska Native , and 1 % Native Hawaiian / Other Pacific Isl and er . About half ( 49.4 % ) reported an annual household income of US $ 40,000 or less , and 25.7 % had a high school degree or less . Test-retest reliability was satisfactory to excellent across all strata for the majority of measures examined : 9 of 12 continuous variables had intraclass correlation coefficients ≥ 0.70 , and 10 of 18 binary variables and both ordinal variables had kappa coefficients ≥ 0.70 . Test-retest reliability of several quit methods varied across strata . Conclusions Race/ethnicity and income do not affect the psychometric properties of most Internet-administered measures examined . This knowledge adds to the confidence of conducting Web-based smoking cessation research and strengthens the scientific rigor of collecting information via the Internet on racial/ethnic minority and low-income subgroups . Trial registration clinical trials.gov NCT00282009 ( parent trial Abstract Objective To compare the hazards of cigarette smoking in men who formed their habits at different periods , and the extent of the reduction in risk when cigarette smoking is stopped at different ages . Design Prospect i ve study that has continued from 1951 to 2001 . Setting United Kingdom . Participants 34 439 male British doctors . Information about their smoking habits was obtained in 1951 , and periodically thereafter ; cause specific mortality was monitored for 50 years . Main outcome measures Overall mortality by smoking habit , considering separately men born in different periods . Results The excess mortality associated with smoking chiefly involved vascular , neoplastic , and respiratory diseases that can be caused by smoking . Men born in 1900 - 1930 who smoked only cigarettes and continued smoking died on average about 10 years younger than lifelong non-smokers . Cessation at age 60 , 50 , 40 , or 30 years gained , respectively , about 3 , 6 , 9 , or 10 years of life expectancy . The excess mortality associated with cigarette smoking was less for men born in the 19th century and was greatest for men born in the 1920s . The cigarette smoker versus non-smoker probabilities of dying in middle age ( 35 - 69 ) were 42 % ν24 % ( a twofold death rate ratio ) for those born in 1900 - 1909 , but were 43 % ν 15 % ( a threefold death rate
Output:
| There was clearer evidence of benefit in the subgroup of trials recruiting smokers motivated to quit .
Proactive telephone counselling helps smokers interested in quitting .
Three or more calls increases the odds of quitting compared to a minimal intervention such as providing st and ard self-help material s , brief advice , or compared to pharmacotherapy alone .
Telephone quitlines provide an important route of access to support for smokers , and call-back counselling enhances their usefulness |
MS211275 | ***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: This prospect i ve r and omized study analyses the use of a prescribed 4.8 % tranexamic acid post-operative mouthwash over 2 days vs 5 days to prevent bleeding in patients taking warfarin who require dental extraction s. Eighty-five patients therapeutically anticoagulated with warfarin for various conditions , ranging in age from 21 to 86 years and requiring dental extraction s , were r and omly divided into two groups . Group A postoperatively received a 4.8 % tranexamic acid mouthwash to be used over a 2-day period . Group B received the same mouthwash and instructions postoperatively , to be taken over 5 days . All procedures were performed on an ambulatory basis under local anaesthetic by the same surgeon . Patients were review ed 1 , 3 , and 7 days postoperatively to assess bleeding . Eighty-two of the 85 patients encountered no postoperative problems . Two patients in group A and one in group B had minor postoperative bleeds that required minor ambulatory intervention to control . This study shows that a 2-day postoperative course of a 4.8 % tranexamic acid mouthwash is as equally effective as a 5-day course in controlling haemostasis post-dental extraction s in patient 's anticoagulated with warfarin OBJECTIVE To estimate the 3-month cumulative incidence of thromboembolism ( TE ) , bleeding , and death among consecutive patients with nonvalvular atrial fibrillation ( AF ) who were receiving long-term anticoagulation therapy and were referred to the Thrombophilia Center at Mayo Clinic for periprocedural anticoagulation management . PATIENTS AND METHODS In a prospect i ve cohort study of consecutive patients receiving long-term anticoagulation therapy who were referred to the Thrombophilia Center for periprocedural anticoagulation management over the 7-year period , January 1 , 1997 , to December 31 , 2003 , 345 patients with nonvalvular AF were eligible for inclusion . Warfarin was stopped 4 to 5 days before and was restarted after surgery as soon as hemostasis was assured . The decision to provide bridging therapy with heparin was individualized and based on the estimated risks of TE and bleeding . RESULTS The 345 patients with AF ( mean + /- SD age , 74+/-9 years ; 33 % women ) underwent 386 procedures . Warfarin administration was not interrupted for 44 procedures . Periprocedural heparin was provided for 204 procedures . Patients receiving heparin were more likely to have prior TE ( 43 % vs 24 % ; P<.001 ) and a higher CHADS2 ( congestive heart failure , hypertension , age , diabetes , stroke ) score ( 2.2 vs 1.9 ; P=.06 ) . Four patients had 6 episodes of TE ( 3 strokes and 3 acute coronary episodes ; TE rate , 1.1 % ; 95 % confidence interval , 0.0%-2.1 % ) . Nine patients had 10 major bleeding events ( major bleeding rate , 2.7 % ; 95 % confidence interval , 1.0%-4.4 % ) . There were no deaths . Neither bleeding nor TE rates differed by anticoagulant management strategy . CONCLUSION The 3-month cumulative incidence of TE and bleeding among patients with AF in whom anticoagulation was temporarily interrupted for an invasive procedure was low and was not significantly influenced by bridging therapy Objective : The management of anticoagulated patients with warfarin during dental extraction is an intricate issue . We carefully design ed the current study so that the amount of bleeding was measured with objective methods and the data from the same patient in different dental extraction appointments could be compared , eliminating the bleeding diathesis differences of patients . Methods : This prospect i ve and controlled study was conducted in 36 adult patients with prosthetic valve requiring multiple tooth extraction s. The first dental extraction was performed without the discontinuation of warfarin therapy , and the second procedure was performed with a discontinuation of warfarin and bridging with low-molecular weight heparin ( LMWH ) . The two dental extraction protocol s in the same patient group were compared . The total amount of bleeding was calculated as the difference between the weights of gauze swabs used before and after the tamponade ; the number of gauze swabs used for bleeding control in the first 48 h was recorded . Result : The median number of used gauze swabs was 2.5 ( IQR : 1–5 ) and 3.0 ( IQR : 2–7 ) in the first and second dental extraction procedures , respectively . The median bleeding time was 50.0 ( IQR : 20–100 ) in the first procedure compared with 60.0 ( IQR : 40–140 ) min in the second procedure . The mean amounts of bleeding were 2194±1418 mg in the first dental extraction procedure and 2950±1694 mg in the second dental extraction procedure . The median number of used gauze swabs , the median bleeding time , and the mean amount of bleeding were statistically higher in the second dental extraction procedure ( p<0.001 ) . Conclusion : Continued warfarin treatment at the time of dental extraction s reduces the total amount of bleeding compared with bridging therapy in patients with prosthetic valves BACKGROUND Patients on therapeutic anticoagulation are at risk of bleeding from minor oral surgical sites . When the anticoagulant regime is modified to prevent the risk of bleeding , this at the same time predisposes the patient to risks of the medical condition for which they are being treated . METHODS A total of 70 patients who were on warfarin treatment requiring minor oral surgical procedures were treated in the Oral Surgery Department . A control group of 35 had their warfarin stopped prior to the minor oral surgical procedure . The other 35 formed the study group . Patients with an International Normalized Ratio outside the therapeutic range of 2 - 4 , or with history of liver disease or on drugs affecting liver function were excluded from the study . Any incidences of post-operative bleeding were recorded . RESULTS None of the patients in either control or study group had any serious bleeding complications . CONCLUSION The data suggest that patients can safely undergo routine minor oral surgical procedures without alterations of their therapeutic anticoagulation regime We found no prospect i ve studies on dental extraction in anticoagulated patients in the literature , even though most authors suggest that there is no need to change anticoagulant treatment and to utilize a local haemostatic measure after extraction . In the present study , we have verified the incidence of bleeding complications after dental extraction in a group of 250 consecutive anticoagulated patients . Two hundred and fifty non-anticoagulated subjects requiring dental extraction represented the control group . In all patients , anticoagulant treatment was not changed ( International Normalized Ratio , 1.8–4 ) and local haemostatic measures ( fibrin sponge , silk suture and a gauze saturated with tranexamic acid ) were used . All procedures were performed in an outpatient clinic setting . We registered four bleeding complications in the group of anticoagulated patients and three in the control group . The difference of bleeding complications in the two groups was not statistically different ( relative risk , 1.14 ; 95 % confidence interval , 0.29–6.04 ; P = 0.7 ) . None of the post-operative late bleeding required hospitalization and /or blood transfusions , and further local measures were sufficient to stop the bleeding . The protocol proposed in the present study makes dental extraction s in anticoagulated patients possible on an outpatient basis with a cost reduction for the community and minor discomfort for the patients Background — Dabigatran reduces ischemic stroke in comparison with warfarin ; however , given the lack of antidote , there is concern that it might increase bleeding when surgery or invasive procedures are required . Methods and Results — The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the R and omized Evaluation of Long-Term Anticoagulation Therapy ( RE-LY ) trial treated with dabigatran and warfarin . Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures , considering only the first procedure for each patient . A total of 4591 patients underwent at least 1 invasive procedure : 24.7 % of patients received dabigatran 110 mg , 25.4 % received dabigatran 150 mg , and 25.9 % received warfarin , P=0.34 . Procedures included : pacemaker/defibrillator insertion ( 10.3 % ) , dental procedures ( 10.0 % ) , diagnostic procedures ( 10.0 % ) , cataract removal ( 9.3 % ) , colonoscopy ( 8.6 % ) , and joint replacement ( 6.2 % ) . Among patients assigned to either dabigatran dose , the last dose of study drug was given 49 ( 35–85 ) hours before the procedure on comparison with 114 ( 87–144 ) hours in patients receiving warfarin , P<0.001 . There was no significant difference in the rates of periprocedural major bleeding between patients receiving dabigatran 110 mg ( 3.8 % ) or dabigatran 150 mg ( 5.1 % ) or warfarin ( 4.6 % ) ; dabigatran 110 mg versus warfarin : relative risk , 0.83 ; 95 % CI , 0.59 to 1.17 ; P=0.28 ; dabigatran 150 mg versus warfarin : relative risk , 1.09 ; 95 % CI , 0.80 to 1.49 ; P=0.58 . Among patients having urgent surgery , major bleeding occurred in 17.8 % with dabigatran 110 mg , 17.7 % with dabigatran 150 mg , and 21.6 % with warfarin : dabigatran 110 mg ; relative risk , 0.82 ; 95 % CI , 0.48 to 1.41 ; P=0.47 ; dabigatran 150 mg : relative risk , 0.82 ; 95 % CI , 0.50 to 1.35 ; P=0.44 . Conclusions — Dabigatran and warfarin were associated with similar rates of periprocedural bleeding , including patients having urgent surgery . Dabigatran facilitated a shorter interruption of oral anticoagulation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00262600 OBJECTIVES This prospect i ve clinical comparative study aim ed to analyze the postoperative bleeding risk of patients continuing their anticoagulation therapy ( AT ) and undergoing implant surgery and bone grafting procedures . MATERIAL S AND METHODS The treatments ranged from the insertion of single or multiple dental implants over implant exposures to sinus floor augmentation and vertical and /or lateral bone grafting with autologous bone grafts . The patients of the test groups ( AT groups ) were treated with platelet aggregation inhibitors ( PAIs ) , Vitamin-K inhibitors , Vitamin-K inhibitor withdrawal bridged with heparin ( LMWH ) , or new/direct oral anticoagulants ( NOACs/DOACs ) . Patients of the control group were non-anticoagulated ( non-AT group ) . Surgical procedures were performed in the same manner in all groups . Pre , intra , and postoperative data concerning the treatment , extent of the surgery and bleedings was recorded and statistically evaluated . RESULTS There were seven postoperative bleedings in 564 patients ( 1.2 % ) , four in the AT groups ( 3.4 % ) , and three in the non-AT group ( 0.6 % ) . No thromboembolic complication occurred in the whole observation period . The invasiveness of the surgical procedure had no statistically significant effect on bleeding frequencies . Patients taking Vitamin-K inhibitors had a significantly higher risk of a postoperative bleeding compared to patients without any AT ( P = 0.038 ) . Two patients were hospitalized due to the severity of the bleeding as a pre caution ary measure ( one in the non-AT and one in the PAI group ) . All bleedings were easily controllable with local hemostatic measures . There was no postoperative bleeding recorded for patients taking DOACs . CONCLUSIONS Anticoagulation therapy should be continued in patients undergoing implant surgery and bone grafting procedures avoiding thromboembolic complications . Surgeons should always apply the most minimally invasive approach to reduce postoperative risks and be able to apply local hemostatic measures in terms of a bleeding complication PURPOSE To evaluate postoperative bleeding and thromboembolic complications during dental extraction s in anticoagulated patients , using 2 different protocol s. PATIENTS AND METHODS In total , 214 anticoagulated patients in need of simple dental extraction s were r and omized into 2 groups . Group A consisted of 109 patients on continuous oral anticoagulation therapy ( OAT ) , with a mean international normalized ratio ( INR ) of 2.45 + /- 0.54 . Local hemostasis in these patients was achieved with resorbable collagen sponges , without wound suturing . Group B consisted of 105 patients on bridging therapy with low-molecular-weight heparin ( nadroparin-calcium ) , with a mean INR of 1.26 + /- 0.11 on the day of the procedure . Neither local hemostatic agents nor suturing
Output:
| Although none of the studies reported a thromboembolic event after interruption of anticoagulation , the follow-up periods were short and inconsistent , and the heightened thromboembolic risk when stopping anticoagulation is well known in the literature .
Heparin bridging was associated with an increased bleeding incidence . |
MS211276 | ***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 relative bioavailability of oral lisdexamfetamine dimesylate , a prodrug of d-amphetamine , and active d-amphetamine was assessed in an open-label , single-dose , 3-treatment , 3-period , r and omized , crossover study in 18 healthy adult volunteers . Following a fast of at least 10 hours , subjects were administered an intact capsule of 70 mg lisdexamfetamine , a solution containing the capsule contents , or an intact capsule with a high-fat meal . St and ard meals started 4 hours following lisdexamfetamine administration . Blood sample s were taken predose ( 0 hours ) and 0.5 to 72 hours postdose , and the concentrations of d-amphetamine and lisdexamfetamine were measured . AUC and C(max ) for d-amphetamine were similar when lisdexamfetamine 70 mg was administered to healthy adults in the fed or fasted state . The AUC of intact lisdexamfetamine was similar when the latter was taken without food or in solution , but C(max ) was lower when lisdexamfetamine was administered with food . The t(max ) of d-amphetamine and intact lisdexamfetamine was similar when taken in solution or in the fasted state but was about 1 hour longer when taken with food . Adverse events were typical for amphetamine products . These findings indicate that food does not have a significant effect on d-amphetamine or lisdexamfetamine bioavailability in healthy adults and that lisdexamfetamine was well tolerated Abstract Lisdexamfetamine dimesylate ( LDX ) is the first prodrug stimulant and is indicated for the treatment of attention-deficit/hyperactivity disorder . A single-centre , double-blind , r and omised , placebo-controlled , 6-period crossover study evaluated the abuse potential of single oral doses of 50 , 100 ( equivalent to 40 mg d-amphetamine ) , and 150 mg LDX , 40 mg d-amphetamine and 200 mg diethylpropion in 36 individuals with a history of stimulant abuse . On the primary abuse liability measure , maximum change of the Drug Rating Question naire-Subject Liking Scale compared with placebo , d-amphetamine and diethylpropion showed significant differences of 4.5 and 4.0 units , respectively ( P < 0.001 for both vs placebo ) . LDX , administered at 50 , 100 and 150 mg , showed nonsignificant differences of 2.0 and 2.1 units , respectively , at the two lower doses but a significant ( P < 0.001 vs placebo ) difference of 6.1 units at the highest dose . Subjects significantly favoured d-amphetamine 40 mg versus LDX 100 mg ( 2.4 units difference ; P < 0.05 ) . There was no significant difference in liking scores between d-amphetamine 40 mg and LDX 150 mg . Drug Rating Question naire-Subject Feel-Drug-Effect score was significantly lower for 100 mg LDX than for 40 mg d-amphetamine . There were no statistically significant differences between LDX and diethylpropion hydrochloride , a Schedule IV amphetamine-like stimulant , on abuse-related liking scores . Cardiovascular responses of LDX and d-amphetamine were similar at equivalent doses . In conclusion , at an equivalent amount of amphetamine base taken orally , LDX 100 mg had attenuated responses on measures of abuse liability compared with immediate-release d-amphetamine 40 mg . Abuse-related liking scores of LDX at a dose corresponding to a 50 % higher amphetamine base ( LDX 150 mg ) were similar to d-amphetamine 40 mg ABSTRACT Objective : To evaluate the pharmacokinetics of lisdexamfetamine dimesylate ( LDX ; Vyvanse * ) in fasting healthy adult volunteers . Background : LDX is the first pro-drug stimulant and is indicated for the treatment of attention-deficit/hyperactivity disorder . LDX was developed with the goal of providing an extended effect that is consistent throughout the day , with a reduced potential for abuse , overdose toxicity , and drug tampering . Methods : This was an open-label , multiple-dose phase 1 study . LDX 70 mg/d was administered in the morning to 12 subjects for 7 days . Twenty blood sample s were drawn during the study . Descriptive statistics were used for pharmacokinetic parameters . Results : Based on Cmin , steady-state d-amphetamine concentration ( 20.6 ng/mL ) was reached by day 5 , whereas LDX was undetectable , and 95 % of the d-amphetamine was eliminated within 48 hours following the final dose on day 7 . At steady state , d-amphetamine achieved a mean ± st and ard deviation Cmax of 90.1 ± 29.6 ng/mL , with a median Tmax of 3.0 hours . The AUC0–inf for d-amphetamine was 1453 ± 645.7 ng.h/mL.Complete elimination of the pro-drug occurred approximately 6 hours following the final dose on day 7 . Adverse events were mild to moderate and similar to other oral amphetamines . Conclusions : This study describes the steady-state pharmacokinetics of LDX , a new pro-drug stimulant . Possible study limitations include an open-label design and a small sample size The pharmacokinetics of lisdexamfetamine dimesylate , a long-acting prodrug stimulant , and its active moiety , d-amphetamine , including dose-proportionality and variability , were assessed in 20 healthy adults . Subjects received a single dose , sequentially , of 50 , 100 , 150 , 200 , and 250 mg of lisdexamfetamine dimesylate . Plasma lisdexamfetamine dimesylate and d-amphetamine were measured before dosing and 0.25 to 96 hours postdose . Dose-proportionality and intersubject and intrasubject variability of pharmacokinetic parameters were examined . Safety assessment s included adverse events . All 20 subjects received 50 and 100 mg while 18 , 12 , and 9 subjects received 150 , 200 , and 250 mg of lisdexamfetamine dimesylate , respectively . Ten subjects were discontinued during the study for prespecified stopping rules ( 2 consecutive hourly readings of blood pressure : systolic > 160 mm Hg or diastolic > 100 mm Hg ) . Mean maximum observed plasma concentration ( C(max ) ) and area under the concentration-time curve from time 0 to infinity ( AUC(0-∞ ) ) increased linearly and dose-dependently for d-amphetamine . Median time to C(max ) ranged from 4 to 6 hours for d-amphetamine and 1.0 to 1.5 hours for lisdexamfetamine dimesylate . Intersubject and intrasubject variability over doses from 50 to 150 mg was low ( < 20 % ) for both C(max ) and AUC(0-∞ ) . Adverse events included nausea , dizziness , headache , psychomotor hyperactivity , and dysuria . These findings indicate that the pharmacokinetic parameters of d-amphetamine were dose-proportional and predictable over a wide range of lisdexamfetamine dimesylate doses IMPORTANCE Binge-eating disorder ( BED ) , a public health problem associated with psychopathological symptoms and obesity and possibly with metabolic syndrome , lacks approved pharmacotherapies . OBJECTIVE To examine the efficacy and safety of lisdexamfetamine dimesylate , a dextroamphetamine prodrug , to treat moderate to severe BED . DESIGN , SETTING , AND PARTICIPANTS We performed a r and omized , double-blind , parallel-group , forced dose titration , placebo-controlled clinical trial at 30 sites from May 10 , 2011 , through January 30 , 2012 . Safety and intention-to-treat analyses included 259 and 255 adults with BED , respectively . INTERVENTIONS Lisdexamfetamine dimesylate at dosages of 30 , 50 , or 70 mg/d or placebo were provided to study participants ( 1:1:1:1 ) . Dosages were titrated across 3 weeks and maintained for 8 weeks . We followed up participants for a mean ( SD ) of 7 ( 2 ) days after the last dose . MAIN OUTCOMES AND MEASURES We assessed the change in binge-eating ( BE ) behaviors measured as days per week ( baseline to week 11 ) with a mixed-effects model using transformed log ( BE days per week ) + 1 . Secondary measures included BE cessation for 4 weeks . Safety assessment s included treatment-emergent adverse events , vital signs , and change in weight . RESULTS At week 11 , log-transformed BE days per week decreased with the 50-mg/d ( least squares [ LS ] mean [ SE ] change , -1.49 [ 0.066 ] ; P = .008 ) and 70-mg/d ( LS mean [ SE ] change , -1.57 [ 0.067 ] ; P < .001 ) treatment groups but not the 30-mg/d treatment group ( LS mean [ SE ] change , -1.24 [ 0.067 ] ; P = .88 ) compared with the placebo group . Nontransformed mean ( SD ) days per week decreased for placebo and the 30- , 50- , and 70-mg/d treatment groups by -3.3 ( 2.04 ) , -3.5 ( 1.95 ) , -4.1 ( 1.52 ) , and -4.1 ( 1.57 ) , respectively . The percentage of participants achieving 4-week BE cessation was lower with the placebo group ( 21.3 % ) compared with the 50-mg/d ( 42.2 % [ P = .01 ] ) and 70-mg/d ( 50.0 % [ P < .001 ] ) treatment groups . The incidence of any treatment-emergent adverse events was 58.7 % for the placebo group and 84.7 % for the combined treatment group . In the treatment groups , 1.5 % of participants had serious treatment-emergent adverse effects . Events with a frequency of at least 5 % and changes in heart rate were generally consistent with the known safety profile . The mean ( SD ) change in body weight was -0.1 ( 3.09 ) , -3.1 ( 3.64 ) , -4.9 ( 4.43 ) , -4.9 ( 3.93 ) , and -4.3 ( 4.09 ) kg for the placebo group , the 30- , 50- , and 70-mg/d treatment groups , and the combined treatment groups , respectively ( P < .001 for each dose vs placebo group comparison in post hoc analysis ) . CONCLUSIONS AND RELEVANCE The 50- and 70-mg/d treatment groups demonstrated efficacy compared with the placebo group in decreased BE days , BE cessation , and global improvement . The safety profile was generally consistent with previous findings in adults with attention-deficit/hyperactivity disorder . Further investigation of lisdexamfetamine in BED is ongoing . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01291173 The two specialty psychological therapies of CBT and IPT remain the treatments of choice for the full range of BED patients , particularly those with high levels of specific eating disorder psychopathology such as overvaluation of body shape and weight . They produce the greatest degree of remission from binge eating as well as improvement in specific eating disorder psychopathology and associated general psychopathology such as depression . The CBT protocol evaluated in the research summarized above was the original manual from Fairburn and colleagues . Fairburn has subsequently developed a more elaborate and sophisticated form of treatment , namely , enhanced CBT ( CBT-E ) for eating disorders . Initial research suggests that CBT-E may be more effective than the earlier version with bulimia nervosa and Eating Disorder Not Otherwise Specified patients . CBT-E has yet to be evaluated for the treatment of BED , although it would currently be the recommended form of CBT . Of relevance in this regard is that the so-called broad form of the new protocol includes 3 optional treatment modules that could be used to address more complex psychopathology in BED patients . One of the modules targeted at interpersonal difficulties is IPT , as described earlier in this chapter . Thus , the broader protocol could represent a combination of the two currently most effective therapies for BED . Whether this combined treatment proves more effective than either of the components alone , particularly for a subset of BED patients with more complex psychopathology , remains to be tested . CBT-E also includes a module design ed to address what Fairburn terms “ mood intolerance ” ( problems in coping with negative affect ) that can trigger binge eating and
Output:
| LDX is the first pharmacological agent that has received regulatory approval for the treatment of BED .
LDX 50 or 70 mg/day significantly reduced BED symptoms as measured by the number of binge eating days per week . |
MS211277 | ***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 Mobile health ( mHealth ) has continuously been used as a method in behavioral research to improve self-management in patients with chronic diseases . However , the evidence of its effectiveness in chronic disease management in the adult population is still lacking . We conducted a systematic review to examine the effectiveness of mHealth interventions on process measures as well as health outcomes in r and omized controlled trials ( RCTs ) to improve chronic disease management . Methods Relevant r and omized controlled studies that were published between January 2005 and March 2016 were search ed in six data bases : PubMed , CINAHL , EMBASE , the Cochrane Library , PsycINFO , and Web of Science . The inclusion criteria were RCTs that conducted an intervention using mobile devices such as smartphones or tablets for adult patients with chronic diseases to examine disease management or health promotion . Results Of the 12 RCTs review ed , 10 of the mHealth interventions demonstrated statistically significant improvement in some health outcomes . The most common features of mHealth systems used in the review ed RCTs were real-time or regular basis symptom assessment s , pre-programed reminders , or feedbacks tailored specifically to the data provided by participants via mHealth devices . Most studies developed their own mHealth systems including mobile apps . Training of mHealth systems was provided to participants in person or through paper-based instructions . None of the studies reported the relationship between health outcomes and patient engagement levels on the mHealth system . Conclusions Findings from mHealth intervention studies for chronic disease management have shown promising aspects , particularly in improving self-management and some health outcomes Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers BACKGROUND In 2015 , India had an estimated 69.2 million people with diabetes and a national prevalence of 8.7 % . Evidence is mounting for the benefits of telemedicine in diabetes care , but remains limited on mobile-health ( m-Health ) interventions . INTRODUCTION This study assessed the impact of an m-Health diabetes platform on clinical outcomes , patient-reported outcomes , patient and provider satisfaction , and app usage . MATERIAL S AND METHODS This open-label , two-arm parallel study enrolled 91 people at 3 sites in India , aged 18 - 65 , with type 2 diabetes , and an A1c between 7.5 % and 12.5 % ( 58 - 113 mmol/mol ) . Participants were r and omly assigned 1:1 to m-Health or usual care and observed for 6 months . All received free visits , laboratory tests , transportation fees , and strips and lancets . Intervention participants received the m-Health app and a mobile phone data stipend . RESULTS A1c change was previously reported as statistically significant . Significantly more participants in intervention than control had improved medication adherence ( 39.0 % vs. 12.8 % ; p = 0.03 ) and increased frequency of blood glucose ( BG ) self-testing ( 39.0 % vs. 10.3 % ; p = 0.01 ) at 6 months from baseline . No other outcomes were significantly different . Among m-Health users , 75 % of participants actively used the app at week 24 . Participants entered 29,668 medications and 2,575 BG readings , sent 497 messages , and received 890 messages . Most participants ( 80 % ) were satisfied with all aspects of the app and all seven providers rated the software very acceptable . DISCUSSION Participants assigned to m-Health had increased medication adherence and frequency of BG testing compared with usual care participants . CONCLUSIONS This tool could be an effective way to exp and access to quality chronic disease care and improve outcomes Background : Mobile phone technology is being used worldwide to improve follow-ups in health care . Aim : Aim of the study is to evaluate whether the use of mobile technology will improve or not the follow-up of Indian patients from a community mental health center . Material s and Methods : Patients or caregivers having mobile phones and consenting for study were enrolled , and sociodemographic and clinical details of patients were taken . Participants were r and omized into two groups ( short message service [ SMS ] vs. non-SMS group ) . At first intervention level , a SMS was sent to SMS group ( not in non-SMS group ) 1 day before their appointment . At second-level intervention ( voice call level ) , patients from both groups who missed their first appointment were given a voice call requesting them to come for follow-up , and the reasons for first missed appointments ( MA ) were also elicited . The effect of these two intervention levels ( first SMS for SMS group and next voice calls for both groups ) on follow-up was evaluated . Results : A total of 214 patients were enrolled in the study . At first SMS intervention level of SMS group ( n = 106 ) , 62.26 % of participants reached appointment-on-time ( RA ) , while in the non-SMS/as usual group ( n = 108 ) , 45.37 % of patients RA . The difference of these groups is statistically significant . At second-level intervention ( voice call ) , 66 of 88 ( another 15 were unable to contact ) were came for follow-up consultation within 2 days of MA . Distance and diagnosis of alcohol dependence were significantly associated with MA . Social reasons were most common reasons for first MA . Conclusion : The use of mobile phone technology in an outpatient community psychiatric clinic improved follow-up significantly The purpose of this review was to determine whether mHealth interventions were effective in low- and middle-income countries in order to create a baseline for the evidence to support mHealth in developing countries . Studies were identified by search ing Medline on 02 October 2014 for articles published in the English language between January 2000 and September 2014 . Inclusion criteria were : 1 ) written in English , 2 ) completion of an mHealth intervention in a low or middle-income country , 3 ) measurement of patient outcomes , and 4 ) participants 18 years of age or older . 7,920 titles were review ed and 7 were determined eligible based on inclusion criteria . Interventions included a cluster r and omized trial , mixed methods study , retrospective comparison of an opt-in text message program , a two-arm proof of concept , single arm trial , a r and omized trial , and a single subject design . Five out of seven of the studies showed significant difference between the control and intervention . Currently there is little evidence on mHealth interventions in developing countries , and existing studies are very diverse ; however initial studies show changes in clinical outcomes , adherence , and health communication , including improved communication with providers , decrease in travel time , ability to receive expert advice , changes in clinical outcomes , and new forms of cost-effective education . While this initial review is promising , more evidence is needed to support and direct system-level re source investment BACKGROUND Type 2 diabetes can often be prevented by lifestyle modification ; however , successful lifestyle intervention programmes are labour intensive . Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification . We aim ed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes in Indian Asian men with impaired glucose tolerance . METHODS We did a prospect i ve , parallel-group , r and omised controlled trial between Aug 10 , 2009 , and Nov 30 , 2012 , at ten sites in southeast India . Working Indian men ( aged 35 - 55 years ) with impaired glucose tolerance were r and omly assigned ( 1:1 ) with a computer-generated r and omisation sequence to a mobile phone messaging intervention or st and ard care ( control group ) . Participants in the intervention group received frequent mobile phone messages compared with controls who received st and ard lifestyle modification advice at baseline only . Field staff and participants were , by necessity , not masked to study group assignment , but allocation was concealed from laboratory personnel as well as principal and co-investigators . The primary outcome was incidence of type 2 diabetes , analysed by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00819455 . RESULTS We assessed 8741 participants for eligibility . 537 patients were r and omly assigned to either the mobile phone messaging intervention ( n=271 ) or st and ard care ( n=266 ) . The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls : 50 ( 18 % ) participants in the intervention group developed type 2 diabetes compared with 73 ( 27 % ) in the control group ( hazard ratio 0·64 , 95 % CI 0·45 - 0·92 ; p=0·015 ) . The number needed to treat to prevent one case of type 2 diabetes was 11 ( 95 % CI 6 - 55 ) . One patient in the control group died suddenly at the end of the first year . We recorded no other serious adverse events . INTERPRETATION Mobile phone messaging is an effective and acceptable method to deliver advice and support towards lifestyle modification to prevent type 2 diabetes in men at high risk . FUNDING The UK India Education and Research Initiative , the World Diabetes Foundation OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Background : Stress among diabetic patients is much more as compared to normal individuals . A delayed recognition of stress undoubtedly worsens the prognosis for survival for many diabetic patients . Hence , this study was planned to develop an intervention model for the reduction of stress among diabetic patients and to evaluate the developed intervention model in
Output:
| All the studies reported positive health outcomes following the intervention , including better self-management , increased patient – provider communication , improved medication adherence , and reduced disease symptoms .
Conclusion Current evidence suggests a low number of interventions with positive outcomes . |
MS211278 | ***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 introduction of antiretroviral therapy ( ART ) has dramatically reduced the mortality rate of people living with HIV ( PLHIV ) . However , complications of both HIV and ART , such as peripheral neuropathy currently affect PLHIV . The purpose of this study was to establish the prevalence of peripheral neuropathy of the lower extremity and , its association with demographic and health status , characteristics among people on ART in Rw and a. Methods A cross sectional study was conducted among 507 women and men aged between 18 and 60 years , on ART , r and omly selected from eight selected ART clinics in Rw and a. Brief Peripheral Neuropathy Screen was used to assess peripheral neuropathy . Results Peripheral neuropathy prevalence was 59 % overall , mean age of the participants was 39.7 ( ±9.2 ) and a slightly older age was associated with peripheral neuropathy ; [ 42(±9.2 ) vs 37 ( ±8.8 ) ( p < 0.001 ) ] . 78 % of participants living in urban setting s compared to 40 % in rural setting s reported peripheral neuropathy , 69 % of participants with higher levels of education ( secondary level and above ) reported lower extremity neuropathy . The three factors were significantly associated with peripheral neuropathy in multivariable model analysis : older age [ aOR = 1.1 , 95 % CI ( 1.0 , 1.2 ) , p < 0.001 ] , primary education level [ aOR = 0.6 95 % Cl ( 0.3 , 1.0 ) , p = 0.04 ] and urban setting [ aOR = 0.1 , 95 % CI ( 0.06 , 0.3 ) , p < 0.001 ] , after adjusting for other factors . None of the health status characteristics namely ; the level of CD4 cell count , duration of HIV infection and duration on ART , was independently associated with peripheral neuropathy . Conclusions The prevalence of peripheral neuropathy among PLHIV on ART in Rw and a is high . It is unclear why urban setting has an effect on PN levels in this cross sectional study , but does suggest that unidentified social and lifestyles factors may have a role in subjective symptoms and objective signs , of PN Aim To clinical ly evaluate the effectiveness of acupuncture when used in the management of chemotherapy-induced peripheral neuropathy ( PN ) . Background During cancer treatment , certain chemotherapies can cause varying degrees of PN . Patients ’ quality of life can be seriously impaired through loss of sensation , pain or mobility problems . Conventional medications routinely used to manage neuropathic symptoms have poor side-effect profiles and there is little or no evidence justifying their use to treat chemotherapy-related neurotoxicities . There are studies suggesting that acupuncture may be an effective therapy in treating PN across a number of different aetiologies . Design A retrospective service evaluation . Method Patients ( n=18 ) were referred for acupuncture by the medical staff and /ornurse specialists or they self-referred for treatment . A course of six weekly acupuncture sessions was offered to them , and their details were recorded on an evaluation form prior to session one . Points were selected by acupuncturists , based on patient presentation , and needles remained in situ for 30–45 min . Treatments took place in outpatient clinics , chemotherapy day case ward or a drop-in clinic based in a physiotherapy gym . The evaluation form was completed at the end of session 6 by a therapist who had not been involved in patient care . Results 82 % ( n=14 ) of patients reported an improvement in symptoms following their course of acupuncture ; one patient with advanced disease died during the 6 weeks . Some patients derived additional benefits from the treatment including a reduction in analgesic use and improved sleeping patterns . The most common acupoints used were SP6 ( n=18 ) , ST36 ( n=18 ) and LV3 ( n=14 ) . Conclusion Although these results are encouraging , they are uncontrolled . They suggest that acupuncture could be an option for these patients and controlled trials using vali date d patient-reported outcome measures are justified Objective To evaluate the effect of 8-week moderate intensity aerobic ( heart-rate reserve 40–60 % ) exercise on neuropathy quality of life in type 2 diabetes . Methods A single blind , parallel-group , r and omized controlled trial was carried out in a tertiary setting . People with type 2 diabetes were eligible for the study if they had clinical neuropathy which was defined by a minimum score of seven on the Michigan diabetic neuropathy score . Following which , the patients were r and omly assigned to an 8-week program by a computer-generated r and om number tables to intervention or control group . Repeated measure analysis of variance was used for data analysis ( p < 0.05 was considered significant ) . Results There were 47 participants in the control group and 40 participants in the study group after r and omization but 37 from the control group and 29 from the intervention group completed the final analysis . The two groups had a significant difference , pre – post intervention in scores of pain ( F = 7 , p = 0.01 ) , sensory symptoms ( F = 4.60 , p = 0.04 ) , restricted activities of daily living ( F = 4.97 , p = 0.03 ) , disruptions in social relationships ( F = 5.43 , p = 0.02 ) , specific impact on quality of life ( F = 9.28 , p < 0.001 ) overall quality of life ( F = 28.72 , p < 0.001 ) , and total score ( F = 31.10 , p < 0.001 ) . Degrees of freedom for all the components were 1 , 62 . Conclusion Moderate intensity aerobic exercise is cornerstone in improving the quality of life of individuals with peripheral neuropathy in type 2 diabetes OBJECTIVE Labor pain and its management is a major concern for childbearing women , their families and health care providers . This study aim ed to investigate the effects of two non-pharmacological methods such as birth ball and heat therapy on labor pain relief . MATERIAL & METHODS This r and omized control trial was undertaken on 90 primiparous women aged 18 - 35 years old who were r and omly assigned to two intervention ( birth ball and heat ) and control groups . The pain score was recorded by using Visual Analogue Scale ( VAS ) before the intervention and every 30 min in three groups until cervical dilatation reached 8 cm . RESULTS The mean pain severity score in the heat therapy group was less than that of in control group at 60 and 90 min after intervention ( p < 0.05 ) . In addition there were significantly differences between the pain scores in the birth ball group after all three investigated times in comparison to control group . CONCLUSION Both heat therapy and birth ball can use as inexpensive complementary and low risk treatment for labor pain PURPOSE The aim of this study was to determine the effects of Tai Chi exercise on glucose control , neuropathy scores , balance , and quality of life in patients with type 2 diabetes and neuropathy . METHODS A pretest-posttest design with a nonequivalent control group was utilized to recruit 59 diabetic patients with neuropathy from an outpatient clinic of a university hospital . A st and ardized Tai Chi for diabetes program was provided , which comprised 1 hour of Tai Chi per session , twice a week for 12 weeks . Outcome variables were fasting blood glucose and glycosylated hemoglobin for glucose control , the Semmes-Weinstein 10-g monofilament examination scores and total symptom scores for neuropathy , single leg stance for balance , and the Korean version of the SF-36v2 for quality of life . Thirty-nine patients completed the posttest measures after the 12-week Tai Chi intervention , giving a 34 % dropout rate . RESULTS The mean age of the participants was 64 years , and they had been diagnosed with type 2 diabetes for more than 12 years . The status was significantly better for the participants in the Tai Chi group ( n=20 ) than for their control ( i.e. , nonintervention ) counterparts ( n=19 ) in terms of total symptom scores , glucose control , balance , and quality of life . CONCLUSION Tai Chi improved glucose control , balance , neuropathic symptoms , and some dimensions of quality of life in diabetic patients with neuropathy . Further studies with larger sample s and long-term follow-up are needed to confirm the effects of Tai Chi on the management of diabetic neuropathy , which may have an impact on fall prevention in this population [ Purpose ] The aim of this double-blind , r and omized and placebo-controlled study is to investigate the effects of Transcutaneous Electrical Nerve Stimulation for reducing the side effects of Chemotherapy-induced Peripheral Neuropathy in cancer patients undergoing chemotherapy with oxaloplatin or paclitaxel . [ Subjects and Methods ] Twenty-four patients were r and omly allocated into two groups : active or placebo stimulation . All patients were assessed for pain , numbness/tingiling , frequency of symptoms , and quality of life . The transcutaneous Electrical Nerve Stimulation device was applied daily with modulating frequencies ranging between 7 Hz and 65 Hz in distal limb regions during three cycles of chemotherapy ( 45 days ) . The other stimulation parameters were : pulse duration of 200 μsec , intensity at the highest tolerable level , and increases in intensity when it diminished . [ Results ] The data showed no difference between active or placebo groups in terms of pain , numbness/tingling , frequency of symptoms or impact on daily life activities . [ Conclusion ] These results suggest that Transcutaneous Electrical Nerve Stimulation applied in the frequency variation mode was not proven to be effective to improve the symptoms of Chemotherapy-induced Peripheral Neuropathy during chemotherapy cycles . There was no worsening of symptoms in subsequent cycles of the onset of symptoms of the disease OBJECTIVE —The purpose of this study was to determine the efficacy of anodyne monochromatic infrared photo energy ( MIRE ) in-home treatments over a 90-day period to improve peripheral sensation and self-reported quality of life in individuals with diabetes . RESEARCH DESIGN AND METHODS —This was a double-blind , r and omized , sham-controlled clinical trail . We r and omly assigned 69 individuals with diabetes and a vibration perception threshold ( VPT ) between 20 and 45 V to two treatment groups : active or sham treatment . Sixty patients ( 120 limbs ) completed the study . Anodyne units were used at home every day for 40 min for 90 days . We evaluated nerve conduction velocities , VPT , Semmes-Weinstein monofilaments ( SWM ) ( 4- , 10- , 26- , and 60-g monofilaments ) , the Michigan Neuropathy Screening Instrument ( MNSI ) , a 10-cm visual analog pain scale , and a neuropathy-specific quality of life instrument . We used a nested repeated- measures multiple ANOVA design . Two sites ( great toe and fifth metatarsal ) were tested on both the left and right feet of each patient , so two feet were nested within each patient and two sites were nested within each foot . To analyze the ordinal SWM scores , we used a nonparametric factorial analysis for longitudinal data . RESULTS —There were no significant differences in measures for quality of life , MNSI , VPT , SWM , or nerve conduction velocities in active or sham treatment groups ( P > 0.05 ) . CONCLUSIONS —Anodyne MIRE therapy was no more effective than sham therapy in the treatment of sensory neuropathy in individuals with diabetes BACKGROUND AND PURPOSE The effects of a home exercise program for persons with chronic peripheral neuropathies ( CPN ) have not been documented . We compared changes in impairment and health-related quality of life ( HRQL ) between exercise and control groups , investigated the relationship between HRQL and measures of impairment , and contrasted the HRQL of individuals with CPN to that previously described for the general population . SUBJECTS Twenty-eight subjects with CPN , aged 23 to 84 years ( mean = 56.2 , SD = 14.9 ) , completed the study . METHODS Impairment measures included average muscle score ( AMS ) , h and grip force , walking time , and forced vital capacity . The HRQL instrument measured the eight scales of the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) and the component scales . The exercise group ( n = 14 ) completed a 6-week home exercise program . The control group ( n = 14 ) did not participate in a home exercise program . RESULTS There was an increase in the AMS in the exercise group compared with the control group . No other between-group differences were found . The exercise group improved in scores on the role limitation scales of the SF-36 . The AMS and walking time were moderately correlated with the physical function scale of the SF-36 ( r = .55 and -.62 , respectively ) . The SF-36 scores of individuals with CPN were lower than scores previously described for the general population . CONCLUSION AND DISCUSSION The home exercise program appears to be an important component of the treatment of persons with CPN . Compared with the general population , patients with CPN appear to have a lower HRQL , but some areas appear to improve following a home exercise program Purpose Muscle pain is a natural consequence of intense and prolonged exercise and has been suggested to be a limiter of performance . Transcutaneous electrical nerve stimulation ( TENS ) and interferential current ( IFC ) have been shown to reduce both chronic and acute pain in a variety of conditions . This study sought to ascertain whether TENS and IFC could reduce exercise-induced pain ( EIP ) and whether this would affect
Output:
| This review identified that a number of self-management strategies that were initiated by patients , including heat , exercise , meditation , and transcutaneous electrical nerve stimulation ( TENS ) therapy , may reduce self-reported PN symptoms .
As the available studies were of low quality , these strategies warrant further investigation with more homogeneous sample s , using more rigorously design ed trials and larger sample s. Patients experiencing PN may find a range of self-initiated strategies beneficial in reducing PN symptoms and improving quality of life . |
MS211279 | ***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: Introduction The Predicting Risk of Cancer at Screening study in Manchester , UK , is a prospect i ve study of breast cancer risk estimation . It was design ed to assess whether mammographic density may help in refinement of breast cancer risk estimation using either the Gail model ( Breast Cancer Risk Assessment Tool ) or the Tyrer-Cuzick model ( International Breast Intervention Study model ) . Methods Mammographic density was measured at entry as a percentage visual assessment , adjusted for age and body mass index . Tyrer-Cuzick and Gail 10-year risks were based on a question naire completed contemporaneously . Breast cancers were identified at the entry screen or shortly thereafter . The contribution of density to risk models was assessed using odds ratios ( ORs ) with profile likelihood confidence intervals ( CIs ) and area under the receiver operating characteristic curve ( AUC ) . The calibration of predicted ORs was estimated as a percentage [ ( observed vs expected ( O/E ) ] from logistic regression . Results The analysis included 50,628 women aged 47–73 years who were recruited between October 2009 and September 2013 . Of these , 697 had breast cancer diagnosed after enrolment . Median follow-up was 3.2 years . Breast density [ interquartile range odds ratio ( IQR-OR ) 1.48 , 95 % CI 1.34–1.63 , AUC 0.59 ] was a slightly stronger univariate risk factor than the Tyrer-Cuzick model [ IQR-OR 1.36 ( 95 % CI 1.25–1.48 ) , O/E 60 % ( 95 % CI 44–74 ) , AUC 0.57 ] or the Gail model [ IQR-OR 1.22 ( 95 % CI 1.12–1.33 ) , O/E 46 % ( 95 % CI 26–65 % ) , AUC 0.55 ] . It continued to add information after allowing for Tyrer-Cuzick [ IQR-OR 1.47 ( 95 % CI 1.33–1.62 ) , combined AUC 0.61 ] or Gail [ IQR-OR 1.45 ( 95 % CI 1.32–1.60 ) , combined AUC 0.59 ] . Conclusions Breast density may be usefully combined with the Tyrer-Cuzick model or the Gail model PURPOSE To estimate the effects of a tablet-based , breast cancer risk education intervention for use in primary care setting s ( BreastCARE ) on patients ' breast cancer knowledge , risk perception and concern . METHODS From June 2011-August 2012 , we enrolled women from two clinics , aged 40 - 74 years with no personal breast cancer history , and r and omized them to the BreastCARE intervention group or to the control group . All patients completed a baseline telephone survey and risk assessment ( via telephone for controls , via tablet computer in clinic waiting room prior to visit for intervention ) . All women were categorized as high or average risk based on the Referral Screening Tool , the Gail model or the Breast Cancer Surveillance Consortium model . Intervention patients and their physicians received an individualized risk report to discuss during the visit . All women completed a follow-up telephone survey 1 - 2 weeks after risk assessment . Post-test comparisons estimated differences at follow-up in breast cancer knowledge , risk perception and concern . RESULTS 580 intervention and 655 control women completed follow-up interviews . Mean age was 56 years ( SD = 9 ) . At follow-up , 73 % of controls and 71 % of intervention women correctly perceived their breast cancer risk and 22 % of controls and 24 % of intervention women were very concerned about breast cancer . Intervention patients had greater knowledge ( ≥75 % correct answers ) of breast cancer risk factors at follow-up ( 24 % vs. 16 % ; p = 0.002 ) . In multivariable analysis , there were no differences in correct risk perception or concern , but intervention patients had greater knowledge ( [ OR ] = 1.62 ; 95 % [ CI ] = 1.19 - 2.23 ) . CONCLUSIONS A simple , practical intervention involving physicians at the point of care can improve knowledge of breast cancer without increasing concern . TRIAL REGISTRATION Clinical Trials.gov identifier NCT01830933 Introduction Clinicians use different breast cancer risk models for patients considered at average and above-average risk , based largely on their family histories and genetic factors . We used longitudinal cohort data from women whose breast cancer risks span the full spectrum to determine the genetic and nongenetic covariates that differentiate the performance of two commonly used models that include nongenetic factors - BCRAT , also called Gail model , generally used for patients with average risk and IBIS , also called Tyrer Cuzick model , generally used for patients with above-average risk . Methods We evaluated the performance of the BCRAT and IBIS models as currently applied in clinical setting s for 10-year absolute risk of breast cancer , using prospect i ve data from 1,857 women over a mean follow-up length of 8.1 years , of whom 83 developed cancer . This cohort spans the continuum of breast cancer risk , with some subjects at lower than average population risk . Therefore , the wide variation in individual risk makes it an interesting population to examine model performance across subgroups of women . For model calibration , we divided the cohort into quartiles of model-assigned risk and compared differences between assigned and observed risks using the Hosmer-Lemeshow ( HL ) chi-squared statistic . For model discrimination , we computed the area under the receiver operator curve ( AUC ) and the case risk percentiles ( CRPs ) . Results The 10-year risks assigned by BCRAT and IBIS differed ( range of difference 0.001 to 79.5 ) . The mean BCRAT- and IBIS-assigned risks of 3.18 % and 5.49 % , respectively , were lower than the cohort 's 10-year cumulative probability of developing breast cancer ( 6.25 % ; 95 % confidence interval ( CI ) = 5.0 to 7.8 % ) . Agreement between assigned and observed risks was better for IBIS ( HL X42 = 7.2 , P value 0.13 ) than BCRAT ( HL X42 = 22.0 , P value < 0.001 ) . The IBIS model also showed better discrimination ( AUC = 69.5 % , CI = 63.8 % to 75.2 % ) than did the BCRAT model ( AUC = 63.2 % , CI = 57.6 % to 68.9 % ) . In almost all covariate-specific subgroups , BCRAT mean risks were significantly lower than the observed risks , while IBIS risks showed generally good agreement with observed risks , even in the subgroups of women considered at average risk ( for example , no family history of breast cancer , BRCA1/2 mutation negative ) . Conclusions Models developed using extended family history and genetic data , such as the IBIS model , also perform well in women considered at average risk ( for example , no family history of breast cancer , BRCA1/2 mutation negative ) . Extending such models to include additional nongenetic information may improve performance in women across the breast cancer risk continuum Patients can benefit from accessible breast cancer risk information . The Gail model is a well-known means of providing risk information to patients and for guiding clinical decisions . Risk presentation often includes 5-year and lifetime percent chances for a woman to develop breast cancer . How do women perceive their risks after Gail model risk assessment ? This exploratory study used a r and omized clinical trial design to address this question among women not previously selected for breast cancer risk . Results suggest a brief risk assessment intervention changes quantitative and comparative risk perceptions and improves accuracy . This study improves our underst and ing of risk perceptions by evaluating an intervention in a population not previously selected for high-risk status and measuring perceptions in a variety of formats Purpose The Gail model is one of the most widely used tools to assess the risk of breast cancer . However , it is known to overestimate breast cancer risk for Asian women . Here , we vali date the Gail model and the Korean model using Korean data , and subsequently up date and revali date the Korean model using recent data . Methods We vali date d the modified Gail model ( model 2 ) , Asian American Gail model , and a previous Korean model using screening patient data collected between January 1999 and July 2004 . The occurrence of breast cancer was confirmed by matching the resident registration number with data from the Korean Breast Cancer Registration Program . The expected-to-observed ( E/O ) ratio was used to vali date the reliability of the program , and receiver operating characteristics curve analysis was used to evaluate the program 's discriminatory power . There has been a rapid increase in the incidence of breast cancer in Korea , and we up date d and revali date d the Korean model using incidence and mortality rate data from recent years . Results Among 40,229 patients who were included in the validation , 161 patients were confirmed to have developed breast cancer within 5 years of screening . The E/O ratios and 95 % confidence intervals ( CI ) were 2.46 ( 2.10 - 2.87 ) for the modified Gail model and 1.29 ( 1.11 - 1.51 ) for the Asian American Gail model . The E/O ratio and 95 % CI for the Korean model was 0.50 ( 0.43 - 0.59 ) . For the up date d Korean model , the E/O ratio and 95 % CI were 0.85 ( 0.73 - 1.00 ) . In the discriminatory power , the area under curve and 95 % CI of the modified Gail model , Asian American Gail model , Korean model and up date d Korean model were 0.547 ( 0.500 - 0.594 ) , 0.543 ( 0.495 - 0.590 ) , 0.509 ( 0.463 - 0.556 ) , and 0.558 ( 0.511 - 0.605 ) , respectively . Conclusion The up date d Korean model shows a better performance than the other three models . It is hoped that this study can provide the basis for a clinical risk assessment program and a future prospect i ve study of breast cancer prevention Introduction The Gail model ( GM ) is a risk- assessment model used in individual estimation of the absolute risk of invasive breast cancer , and has been applied to both clinical counselling and breast cancer prevention studies . Although the GM has been vali date d in several Western studies , its applicability outside North America and Europe remains uncertain . The Singapore Breast Cancer Screening Project ( SBCSP ) is a nation-wide prospect i ve trial of screening mammography conducted between Oct 1994 and Feb 1997 , and is the only such trial conducted outside North America and Europe to date . With the long-term outcomes from this study , we sought to evaluate the performance of GM in prediction of individual breast cancer risk in a Asian developed country . Methods The study population consisted of 28,104 women aged 50 to 64 years who participated in the SBSCP and did not have breast cancer detected during screening . The national cancer registry was used to identify incident cases of breast cancer . To evaluate the performance of the GM , we compared the expected number of invasive breast cancer cases predicted by the model to the actual number of cases observed within 5-year and 10-year follow-up . Pearson 's Chi-square test was used to test the goodness of fit between the expected and observed cases of invasive breast cancers . Results The ratio of expected to observed number of invasive breast cancer cases within 5 years from screening was 2.51 ( 95 % confidence interval 2.14 - 2.96 ) . The GM over-estimated breast cancer risk across all age groups , with the discrepancy being highest among older women aged 60 - 64 years ( E/O = 3.53 , 95 % CI = 2.57 - 4.85 ) . The model also over-estimated risk for the upper 80 % of women with highest predicted risk . The overall E/O ratio for the 10-year predicted breast cancer risk was 1.85 ( 1.68 - 2.04 ) . Conclusions The GM over-predicts the risk of invasive breast cancer in the setting of a developed Asian country as demonstrated in a large prospect i ve trial , with the largest difference seen in older women aged between 60 and 64 years old . The reason for the discrepancy is likely to be multifactorial , including a truly lower prevalence of breast cancer , as well as lower mammographic screening prevalence locally To vali date an established breast cancer incidence model in an independent prospect i ve data set . After aligning time periods for follow-up , we restricted population s to comparable age ranges ( 47–74 years ) , and followed them for incident invasive breast cancer ( follow-up 1994–2008 , Nurses ’ Health Study [ NHS ] ; and 1995–2009 , California Teachers Study [ CTS ] ) . We identified 2026 cases during 540,617 person years of follow-up in NHS , and 1,400 cases during 288,111 person years in CTS . We fit the Rosner – Colditz log-incidence model and the Gail model using baseline data . We imputed future use of hormones based on type and prior duration of use and other covariates . We assessed performance using area under the curve ( AUC ) and calibration methods . Participants in the CTS had fewer children , were leaner , consumed more alcohol , and were more frequent users of postmenopausal hormones . Incidence rate ratios for breast cancer showed significantly higher breast cancer in the CTS ( IRR = 1.32 , 95 % CI 1.24–1.42 ) . Parameters for the log-incidence model were comparable across the two cohorts . Overall , the NHS model performed equally well when applied in the CTS . In the
Output:
| Conclusion The results are not strong enough to develop breast cancer risk in the setting of Asian countries . |
MS211280 | ***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 This study sought to determine whether epicardial fat volume predicts coronary events in the general population . BACKGROUND Epicardial adipose tissue ( EAT ) is suggested to promote plaque development in the coronary artery tree . METHODS We quantified EAT volume in participants from the prospect i ve population -based Heinz Nixdorf Recall cohort study free of cardiovascular disease . Incident coronary events were assessed during a follow-up period of 8.0 ± 1.5 years . Multivariable association of EAT with cardiovascular risk factors , coronary artery calcification ( CAC ) , and coronary events was assessed using regression analysis . RESULTS From the overall 4,093 participants ( age 59.4 years , 47 % male ) , 130 subjects developed a fatal or nonfatal coronary event . Incidence of coronary events increased by quartile of EAT ( 0.9 % vs. 4.7 % for 1(st ) and 4th quartile , respectively , p < 0.001 ) . Doubling of EAT was associated with a 1.5-fold risk of coronary events when adjusting for cardiovascular risk factors ( hazard ratio [ HR ] [ 95 % confidence interval ( CI ) ] : 1.54 [ 1.09 to 2.19 ] ) , which remained unaltered after further adjustment for CAC score ( HR [ 95 % CI ] : 1.50 [ 1.07 to 2.11 ] ) . For discrimination of subjects with events from those without , we observed a trend for improvement of Harrell 's C and explained variance by EAT over traditional cardiovascular risk factors , which , however , did not reach statistical significance ( 0.720 to 0.730 for risk factors alone and with EAT added , respectively , p = 0.10 , R(2 ) = 2.73 % to R(2 ) = 2.92 % , time-dependent integrated discrimination improvement = 0.196 % ) . CONCLUSIONS Epicardial fat is associated with fatal and nonfatal coronary events in the general population independent of traditional cardiovascular risk factors and complements information from cardiac computed tomography above the CAC score OBJECTIVES The aim of this study was to determine whether ectopic fat depots are prospect ively associated with cardiovascular disease , cancer , and all-cause mortality . BACKGROUND The morbidity associated with excess body weight varies among individuals of similar body mass index . Ectopic fat depots may underlie this risk differential . However , prospect i ve studies of directly measured fat are limited . METHODS Participants from the Framingham Heart Study ( n = 3,086 ; 49 % women ; mean age of 50.2 years ) underwent assessment of fat depots ( visceral adipose tissue , pericardial adipose tissue , and periaortic adipose tissue ) using multidetector computed tomography and were followed up longitudinally for a median of 5.0 years . Cox proportional hazards regression models were used to examine the association of each fat depot ( per 1 SD increment ) with the risk of incident cardiovascular disease , cancer , and all-cause mortality after adjustment for st and ard risk factors , including body mass index . RESULTS Overall , there were 90 cardiovascular events , 141 cancer events , and 71 deaths . After multivariable adjustment , visceral adipose tissue was associated with cardiovascular disease ( hazard ratio : 1.44 ; 95 % confidence interval : 1.08 to 1.92 ; p = 0.01 ) and cancer ( hazard ratio : 1.43 ; 95 % confidence interval : 1.12 to 1.84 ; p = 0.005 ) . Addition of visceral adipose tissue to a multivariable model that included body mass index modestly improved cardiovascular risk prediction ( net reclassification improvement of 16.3 % ) . None of the fat depots were associated with all-cause mortality . CONCLUSIONS Visceral adiposity is associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and generalized adiposity . These findings support the growing appreciation of a pathogenic role of ectopic fat Background —Noncontrast cardiac computed tomography allows calculation of coronary artery calcium score ( CACS ) and measurement of epicardial adipose tissue ( EATv ) and intrathoracic fat ( ITFv ) volumes . It is unclear whether fat volume information contributes to risk stratification . Methods and Results —Cardiac computed tomography was performed in 760 consecutive patients with acute chest pain admitted thorough the emergency department . None had prior coronary artery disease . CACS was calculated using the Agatston method . EATv and ITFv were semiautomatically calculated . Median patient follow-up was 3.3 years . Mean patient age was 54.4±13.7 years and Framingham risk score 8.2±8.2 . The 45 patients ( 5.9 % ) with major acute cardiac events ( MACE ) were older ( 64.8±13.9 versus 53.7±13.4 years ) , more frequently male ( 60 % versus 40 % ) , and had a higher median Framingham risk score ( 16 versus 4 ) and CACS ( 268 versus 0 ) versus those without events ( all P<0.01 ) . The MACE group had a higher median of EATv ( 154 versus 116 mL ) and ITFv ( 330 versus 223 mL ) , and a higher prevalence of EATv > 125 mL ( 67 % versus 44 % ) and ITFv > 250 mL ( 64 % versus 42 % ) ( all P<0.01 ) . CACS , EATv , and ITFv were all independently associated with MACE . CACS was associated with MACE after adjustment for fat volumes ( P<0.0001 ) , whereas EATv and ITFv improved the risk model only in patients with CACS > 400 . Conclusions —CACS and fat volumes are independently associated with MACE in acute chest pain patients and beyond that provided by clinical information alone . Although fat volumes may add prognostic value in patients with CACS > 400 , CACS is most strongly correlated with outcome BACKGROUND Epicardial adipose tissue ( EAT ) has been described in the general population as an independent risk marker for incident coronary artery disease . In hemodialysis patients , it correlates with other markers of cardiovascular disease , but it is unknown if it is associated with adverse events . METHODS post hoc analysis of the Renagel in New Dialysis ( RIND ) patients study , a r and omized trial of sevelamer versus calcium-based phosphate binders in 109 incident hemodialysis patients , followed for all-cause mortality for a median of 49.3 months . Patients underwent baseline cardiac computed tomography imaging within 120 days of dialysis initiation . RESULTS Baseline EAT measurements were available in 95 patients ; EAT was positively correlated with age , body mass index , triglycerides , C-reactive protein , coronary artery calcium and aortic calcium , and negatively correlated with systolic and diastolic blood pressure , serum high density lipoprotein ( HPL ) cholesterol and serum phosphate ( all P < 0.05 ) . During follow-up , a total of 27 ( 28.4 % ) patients expired [ mortality per 1000 patients /year : 95 % confidence interval ( 95 % CI ) = 77 ( 64 - 94 ) ] . Five-year survival rate was 44 . 6 % ( 95 % CI : 21.1 - 65.7 ) and 71.2 % ( 95 % CI : 45.95 - 86.25 ) in patients with EAT above or below the median , respectively . Each 10 cc increase in EAT volume was associated with a significant 6 % increase in the risk of death during follow-up [ hazard ratio ( HR ) : 1.060 ; 95 % CI : 1.013 - 1.109 ; P-value = 0.012 ] . CONCLUSIONS In this sub analysis of a r and omized trial , EAT was an independent predictor of mortality in incident hemodialysis patients after ~4 years of follow-up . These hypothesis-generating findings will need confirmatory evidence BACKGROUND Coronary artery disease ( CAD ) diagnosis by coronary computed tomographic angiography ( CCTA ) is useful for identification of symptomatic diabetic individuals at heightened risk for death . Whether CCTA-detected CAD enables improved risk assessment of asymptomatic diabetic individuals beyond clinical risk factors and coronary artery calcium scoring ( CACS ) remains unexplored . METHODS From a prospect i ve 12-center international registry of 27,125 individuals undergoing CCTA , we identified 400 asymptomatic diabetic individuals without known CAD . Coronary stenosis by CCTA was grade d as 0 % , 1 - 49 % , 50 - 69 % , and ≥70 % . CAD was judged on a per-patient , per-vessel and per-segment basis as maximal stenosis severity , number of vessels with ≥50 % stenosis , and coronary segments weighted for stenosis severity ( segment stenosis score ) , respectively . We assessed major adverse cardiovascular events ( MACE ) - inclusive of mortality , nonfatal myocardial infa rct ion ( MI ) , and late target vessel revascularization ≥90 days ( REV ) - and evaluated the incremental utility of CCTA for risk prediction , discrimination and reclassification . RESULTS Mean age was 60.4 ± 9.9 years ; 65.0 % were male . At a mean follow-up 2.4 ± 1.1 years , 33 MACE occurred ( 13 deaths , 8 MI , 12 REV ) [ 8.25 % ; annualized rate 3.4 % ] . By univariate analysis , per-patient maximal stenosis [ hazards ratio ( HR ) 2.24 per stenosis grade , 95 % confidence interval ( CI ) 1.61 - 3.10 , p < 0.001 ] , increasing numbers of obstructive vessels ( HR 2.30 per vessel , 95 % CI 1.75 - 3.03 , p < 0.001 ) and segment stenosis score ( HR 1.14 per segment , 95 % CI 1.09 - 1.19 , p < 0.001 ) were associated with increased MACE . After adjustment for CAD risk factors and CACS , maximal stenosis ( HR 1.80 per grade , 95 % CI 1.18 - 2.75 , p = 0.006 ) , number of obstructive vessels ( HR 1.85 per vessel , 95 % CI 1.29 - 2.65 , p < 0.001 ) and segment stenosis score ( HR 1.11 per segment , 95 % CI 1.05 - 1.18 , p < 0.001 ) were associated with increased risk of MACE . Beyond age , gender and CACS ( C-index 0.64 ) , CCTA improved discrimination by maximal stenosis , number of obstructive vessels and segment stenosis score ( C-index 0.77 , 0.77 and 0.78 , respectively ) . Similarly , CCTA findings improved risk reclassification by per-patient maximal stenosis [ integrated discrimination improvement ( IDI ) index 0.03 , p = 0.03 ] and number of obstructive vessels ( IDI index 0.06 , p = 0.002 ) , and by trend for segment stenosis score ( IDI 0.03 , p = 0.06 ) . CONCLUSION For asymptomatic diabetic individuals , CCTA measures of CAD severity confer incremental risk prediction , discrimination and reclassification on a per-patient , per-vessel and per-segment basis BACKGROUND Pericardial fat ( ie , fat around the heart ) may have a direct role in the atherosclerotic process in coronary arteries through local release of inflammation-related cytokines . Cross-sectional studies suggest that pericardial fat is positively associated with coronary artery disease independent of total body fat . OBJECTIVE We investigated whether pericardial fat predicts future coronary heart disease events . DESIGN We conducted a case-cohort study in 998 individuals , who were r and omly selected from 6814 Multi-Ethnic Study of Atherosclerosis ( MESA ) participants and 147 MESA participants ( 26 from those 998 individuals ) who developed incident coronary heart disease from 2000 to 2005 . The volume of pericardial fat was determined from cardiac computed tomography at baseline . RESULTS The age range of the subjects was 45 - 84 y ( 42 % men , 45 % white , 10 % Asian American , 22 % African American , and 23 % Hispanic ) . Pericardial fat was positively correlated with both body mass index ( correlation coefficient = 0.45 , P < 0.0001 ) and waist circumference ( correlation coefficient = 0.57 , P < 0.0001 ) . In unadjusted analyses , pericardial fat ( relative hazard per 1-SD increment : 1.33 ; 95 % CI : 1.15 , 1.54 ) , but not body mass index ( 1.0
Output:
| Conclusions The majority of studies suggest that EFV quantification is significantly associated with clinical outcomes and provides incremental prognostic value over coronary artery calcium scoring .
Future research should use a binary cutoff of 125 mL for evaluation of EFV to provide consistency with other research .Key Points• Epicardial fat volume ( EFV ) has prognostic value for adverse cardiac events • Establishment of st and ardized quantitative categories for EFV is needed • Quantification of EFV could improve risk assessment with calcium |
MS211281 | ***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 1,5-Anhydroglucitol ( 1,5AG ) is a major circulating polyol arising primarily from ingestion and excreted competitively with glucose . Japanese studies have demonstrated reduced concentrations of 1,5AG in serum in hyperglycemic patients in comparison with euglycemic subjects and a gradual normalization of 1,5AG values for patients responding to antihyperglycemic therapies . In this first U.S. study , we assessed the ability of 1,5AG measurements to monitor glycemic control in a cohort of 77 patients with diabetes ( 22 with type 1 diabetes , 55 with type 2 diabetes ) who presented with suboptimal glycemic control at baseline ( defined as HbA(1c ) > or=7 % ) . RESEARCH DESIGN AND METHODS Each patient received therapies consisting of combinations of diabetes education , nutritional counseling , and addition or dose adjustment of various insulins or oral antihyperglycemic medications . Therapy was targeted to reduce mean HbA(1c ) by > or=1.0 % over the monitoring period . 1,5AG , HbA(1c ) , fructosamine , and r and om glucose measurements were performed at baseline and at 2 , 4 , and 8 weeks after the initiation of therapy . RESULTS 1,5AG , fructosamine , and glucose values progressed significantly toward euglycemia by week 2 of monitoring ( Wilcoxon 's signed-rank test , P < 0.05 ) , with median changes of 93 , -7 , and -13 % for 1,5AG , fructosamine , and glucose , respectively . In contrast , HbA(1c ) values did not respond significantly to therapy until week 4 . On an individual patient basis , 89.6 % of patients displayed longitudinal changes of 1,5AG from baseline to week 8 in concordance with HbA(1c ) . 1,5AG was also highly correlated with HbA(1c ) and fructosamine ( Spearman rho = -0.6459 and -0.6751 , respectively ; both P < 0.0001 ) . CONCLUSIONS We conclude that 1,5AG responds sensitively and rapidly to changes in glycemia and monitors glycemic control in accordance with established markers Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items OBJECTIVE Branched-chain and aromatic amino acids are associated with the risk for future type 2 diabetes ; however , the underlying mechanisms remain elusive . We tested whether amino acids predict insulin resistance index in healthy young adults . RESEARCH DESIGN AND METHODS Circulating isoleucine , leucine , valine , phenylalanine , tyrosine , and six additional amino acids were quantified in 1,680 individuals from the population -based Cardiovascular Risk in Young Finns Study ( baseline age 32 ± 5 years ; 54 % women ) . Insulin resistance was estimated by homeostasis model assessment ( HOMA ) at baseline and 6-year follow-up . Amino acid associations with HOMA of insulin resistance ( HOMA-IR ) and glucose were assessed using regression models adjusted for established risk factors . We further examined whether amino acid profiling could augment risk assessment of insulin resistance ( defined as 6-year HOMA-IR > 90th percentile ) in early adulthood . RESULTS Isoleucine , leucine , valine , phenylalanine , and tyrosine were associated with HOMA-IR at baseline and for men at 6-year follow-up , while for women only leucine , valine , and phenylalanine predicted 6-year HOMA-IR ( P < 0.05 ) . None of the other amino acids were prospect ively associated with HOMA-IR . The sum of branched-chain and aromatic amino acid concentrations was associated with 6-year insulin resistance for men ( odds ratio 2.09 [ 95 % CI 1.38–3.17 ] ; P = 0.0005 ) ; however , including the amino acid score in prediction models did not improve risk discrimination . CONCLUSIONS Branched-chain and aromatic amino acids are markers of the development of insulin resistance in young , normoglycemic adults , with most pronounced associations for men . These findings suggest that the association of branched-chain and aromatic amino acids with the risk for future diabetes is at least partly mediated through insulin resistance Plasma concentrations of amino acids are frequently elevated in insulin-resistant states , and a protein-enriched diet can impair glucose metabolism . This study examined effects of short-term plasma amino acid ( AA ) elevation on whole-body glucose disposal and cellular insulin action in skeletal muscle . Seven healthy men were studied for 5.5 h during euglycemic ( 5.5 mmol/l ) , hyperinsulinemic ( 430 pmol/l ) , fasting glucagon ( 65 ng/l ) , and growth hormone ( 0.4 microg/l ) somatostatin clamp tests in the presence of low ( approximately 1.6 mmol/l ) and increased ( approximately 4.6 mmol/l ) plasma AA concentrations . Glucose turnover was measured with D-[6,
Output:
| Carbohydrate ( glucose and fructose ) , lipid ( phospholipids , sphingomyelins , and triglycerides ) , and amino acid ( branched-chain amino acids , aromatic amino acids , glycine , and glutamine ) metabolites were higher in individuals with type 2 diabetes compared with control subjects .
Prospect i ve studies provided evidence that blood concentrations of several metabolites , including hexoses , branched-chain amino acids , aromatic amino acids , phospholipids , and triglycerides , were associated with the incidence of prediabetes and type 2 diabetes .
In studies using high-throughput metabolomics , several blood amino acids appear to be consistently associated with the risk of developing type 2 diabetes |
MS211282 | ***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: This study was undertaken to investigate the effects of progressive resistance-training ( PRT ) on plasma oxidative stress and antioxidant enzyme activity in erythrocytes . Twenty male volunteers were r and omly assigned to 2 groups : PRT and control . Blood sample s were collected before and after 8 wk of PRT and analyzed for enzymatic activities of superoxide dismutase ( SOD ) and glutathione peroxidase ( GPx ) in erythrocytes , plasma total antioxidant capacity ( TAC ) , and malondialdehyde concentration ( MDA , an index of lipid per oxida- tion in plasma ) . Resistance training commenced with 8 exercises on nonconsecutive days for 8 wk at 50 % of estimated 1-repetition maximum ( E1RM ) and reached 80 % E1RM by Week 8 . The results showed that PRT significantly increased erythrocyte SOD activity ( 1,323 ± 212.52 vs. 1,449.9 ± 173.8 U/g Hb , p = .014 ) . Plasma concentration of MDA also decreased ( 5.39 ± 1.7 vs. 3.67.4 ± 0.7 nmol/ml , p = .030 ) , although TAC ( 1.42 ± 0.21 vs. 1.61 ± 0.19 mmol/L , p = .1530 ) and GPx ( 39.87 ± 11.5 vs. 48.18 ± 14.48 U/g Hb , p = .883 ) activity did not undergo any considerable changes . Based on these data , the authors conclude that an 8-wk program of PRT strengthens the defensive system of erythrocytes against free-radical damage and therefore can be applied as a useful approach to alleviate oxidative stress Objective To determine the effect of Tai Chi on oxidative stress in a population of elderly Mexican subjects . Design It was carried out a quasi-experimental study with a sample of 55 healthy subjects r and omly divided into two age-matched groups : ( i ) a control group with 23 subjects and ( ii ) an experimental group with 32 subjects . The experimental group received daily training in Tai Chi for 50 min . Measurements It was measured before and after 6-month of exercise period : thiobarbituric acid reactive substances ( TBARS ) , total antioxidant status ( TAS ) , superoxide dismutase ( SOD ) , and glutathione peroxidase ( GPx ) . Results It was found that the experimental group exhibited a statistically significant decrease in glucose levels , total cholesterol , low-density lipoprotein cholesterol ( LDLC ) , and systolic blood pressure , as well as an increase in SOD and GPx activity and TAS compared with the control group ( p < 0.05 ) . Conclusions Our findings suggest that the daily practice of Tai Chi is useful for reducing OxS in healthy older adults Prehypertension is associated with reduced conduit artery endothelial function and perturbation of oxidant/antioxidant status . It is unknown whether endothelial dysfunction persists to resistance arteries and whether exercise training affects oxidant/antioxidant balance in young prehypertensives . We examined resistance artery function using venous occlusion plethysmography measurement of forearm ( FBF ) and calf blood flow ( CBF ) at rest and during reactive hyperaemia ( RH ) , as well as lipid peroxidation ( 8-iso-PGF2α ) and antioxidant capacity ( Trolox-equivalent antioxidant capacity ; TEAC ) before and after exercise intervention or time control . Forty-three unmedicated prehypertensive and 15 matched normotensive time controls met screening requirements and participated in the study ( age : 21.1±0.8 years ) . Prehypertensive subjects were r and omly assigned to resistance exercise training ( PHRT ; n=15 ) , endurance exercise training ( PHET ; n=13 ) or time-control groups ( PHTC ; n=15 ) . Treatment groups exercised 3 days per week for 8 weeks . Peak and total FBF were lower in prehypertensives than normotensives ( 12.7±1.2 ml min−1 per100 ml tissue and 89.1±7.7 ml min−1 per 100 ml tissue vs 16.3±1.0 ml min−1 per 100 ml tissue and 123.3±6.4 ml min−1 per 100 ml tissue , respectively ; P<0.05 ) . Peak and total CBF were lower in prehypertensives than normotensives ( 15.3±1.2 ml min−1 per 100 ml tissue and 74±8.3 ml min−1 per 100 ml tissue vs 20.9±1.4 ml min−1 per 100 ml tissue and 107±9.2 ml min−1 per 100 ml tissue , respectively ; P<0.05 ) . PHRT and PHET improved humoral measures of TEAC ( + 24 and + 30 % ) and 8-iso-PGF2α ( −43 and −40 % , respectively ; P⩽0.05 ) . This study provides evidence that young prehypertensives exhibit reduced resistance artery endothelial function and that short-term ( 8 weeks ) resistance or endurance training are effective in improving resistance artery endothelial function and oxidant/antioxidant balance in young prehypertensives BACKGROUND there have been few population -based , r and omized controlled trials on the effects of strength or endurance training on cardiovascular fitness in older women . OBJECTIVE to study the effects of strength or endurance training on cardiovascular fitness in women aged 76 - 78 years . DESIGN a population -based , r and omized controlled trial . SETTING exercise laboratory in a university faculty of sport and health sciences . SUBJECTS we r and omly assigned 42 medically-screened women aged 76 - 78 years , drawn from the population register to strength ( n=16 ) , endurance ( n=15 ) or control ( n=11 ) groups . METHODS subjects in the two exercise groups performed a supervised , individually tailored 18-week strength or endurance training programme . Controls continued with physical activity at their normal level . RESULTS the strength training group showed an increase in cycle ergometer peak power from 68.1 to 70.3 W ( P=0.035 compared with controls ) . Their peak power per kg body weight increased from 1.02 to 1.05 , while that of the endurance training group increased from 0.91 to 0.93 ( P=0.027 and P=0.049 respectively ) . Peak oxygen uptake increased from 18.1 to 19.7 ml x kg(-1 ) x min(-1 ) in the strength and from 17.1 to 18.2 in the endurance group ( non-significant ) . Six subjects ( 19 % ) in the exercise groups withdrew from the study because of health problems . CONCLUSIONS even with its limitations , the study suggests that the effect of 18-week strength or endurance training on cardiovascular fitness among women aged > /=75 is relatively small . Furthermore , health problems can emerge during training programmes in medically-screened elderly women The purpose of this trial was to determine whether exercise without weight loss would reduce F2-isoprostanes in previously sedentary young women . Participants ( N=319 ) were r and omized to four months of 150min/week aerobic exercise or a control group . Plasma free F2-isoprostanes were measured by gas chromatography-mass spectrometry . Other assessment s included fitness and % body fat . Intervention groups were compared with stratification by quartiles of baseline plasma F2-isoprostane . This stratified comparison was linearly adjusted for baseline plasma F2-isoprostane and we also used baseline plasma F2-isoprostane as a propensity score to balance the intervention . Training result ed in significant improvements in aerobic fitness ( 0.88 METs ) and body fat percent ( 1 % ) in exercisers compared to controls ( p<0.001 ) . The exercise group had significantly higher mean baseline plasma F2-isoprostanes ( 79.1 vs 67.9pg/mL ) than the control group in the highest quartile of baseline plasma F2-isoprostanes . Within this highest quartile , exercise led to a greater decline in plasma F2-isoprostanes ( -20.2±2.5pg/mL ) than control ( -7.4±2.5pg/mL ) ; with adjustment for baseline plasma F2-isoprostanes and in the balanced groups , this difference was reduced but remained significant . Four months of exercise training result ed in significant reductions of systemic oxidative stress only among previously sedentary young women who were in the highest quartile of plasma F2-isoprostanes at baseline ( ≥57pg/mL ) . Our findings indicate that the benefits of aerobic exercise in reducing systemic oxidative stress may be limited to those who present higher baseline levels of plasma F2-isoprostanes OBJECTIVE To assess the effect of a 12-week arm-cranking exercise program on reducing oxidative damage in untrained adults with chronic spinal cord injury ( SCI ) . DESIGN R and omized controlled trial . SETTING Community-based supervised intervention . PARTICIPANTS Male adults with complete SCI at or below the fifth thoracic level ( T5 ) ( N=17 ) volunteered for this study . Participants were r and omly allocated to the intervention ( n=9 ) or control ( n=8 ) group using a concealed method . INTERVENTION A 12-week arm-cranking exercise program , 3 sessions/wk , consisting of warming-up ( 10 - 15min ) followed by a main part in arm-crank ( 20 - 30min [ increasing 2min and 30s every 3wk ] ) at a moderate work intensity of 50 % to 65 % of the heart rate reserve ( starting at 50 % and increasing 5 % every 3 weeks ) and by a cooling-down period ( 5 - 10min ) . MAIN OUTCOME MEASURES Plasmatic levels of total antioxidant status as well as erythrocyte glutathione peroxidase activity were measured . Lipid and protein oxidation were determined as malondialdehyde and carbonyl group levels , respectively . Furthermore , physical fitness and body composition were assessed . RESULTS When compared with baseline results , maximum oxygen consumption was significantly increased ( P=.031 ) , suggesting an improvement in physical fitness in the intervention group . Regarding the antioxidant defense system , it was found that both total antioxidant status ( P=.014 ) and erythrocyte glutathione peroxidase activity ( P=.027 ) were significantly increased at the end of the training program . As a consequence , plasmatic levels of malondialdehyde ( P=.008 ) and carbonyl groups ( P=.022 ) were significantly reduced . CONCLUSION A 12-week arm-cranking exercise program improved the antioxidant defense system in adults with chronic SCI , which may finally attenuate both lipid and protein oxidation in this population Purpose Rheumatoid arthritis ( RA ) patients display high levels of oxidative stress . Transient exercise-induced increases in oxidative stress are thought to be adaptive in healthy population s. This study investigated the effect of exercise on markers of oxidative stress in RA , following acute exercise and a period of exercise training . Methods Acute exercise study : RA patients ( N = 12 , age : 56 ± 11 ) undertook a bout of exercise ( 30–40 min , 70 % VO2MAX ) , and blood sample s were taken before and after exercise to assess markers of oxidative stress . Training study : RA patients ( N = 19 , age : 56 ± 10 ) were r and omised into either a control or exercise group , who undertook 3 exercise sessions per week ( 30–40 min @70 % VO2MAX ) for 3 months . Plasma markers of oxidative stress ( protein carbonyls ( PC ) , lipid hydroperoxides ( LOOH ) , 3-nitrotyrosine ( 3-NT ) , total antioxidant capacity ( TAC ) and catalase ( CAT ) activity ) , inflammation ( interleukin-8 ( IL-8 ) and C-reactive protein ( CRP ) ) and nitric oxide metabolites ( NOx ) were assessed before and after training . Results Acute exercise study : Protein carbonyls ( PC ) ( + 18 % ) and NOx ( + 27 % ) were significantly increased following exercise . Training study : 3-nitrotyrosine ( 3-NT ) decreased ( 2.18 ± 1.78 to 1.10 ± 0.93 μM ) in the exercise group only , alongside increases in aerobic fitness ( 24.45 ± 4.98 to 27.10 ± 4.51 ml/kg/min−1 ) and reductions in disease activity score ( DAS : 3.47 ± 1.17 to 2.88 ± 0.76 ) . PC , LOOH , TAC , IL-8 , CRP and NOx concentrations , and CAT activity were unchanged in both groups . Conclusions Aerobic exercise training did not increase markers of oxidative stress in RA patients . 3-Nitrotyrosine and disease activity were decreased following exercise training Abstract Exercise can be an effective treatment for depression . Although the efficacy of exercise is well established , little is
Output:
| Conclusion The pooled analysis revealed that regardless of intensity , volume , type of exercise , and studied population , the antioxidant indicators tended to increase and pro-oxidant indicators tended to decrease after training .
Therefore , we conclude that exercise training seems to induce an antioxidant effect .
Thus , it is suggested that people practice some kind of exercise to balance the redox state , regardless of their health status , to improve health-related outcomes |
MS211283 | ***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: OBJECTIVES The aim of this r and omized , controlled clinical trial was to compare the potential of a synthetic bone substitute or a bovine-derived xenograft combined with a collagen membrane to preserve the alveolar ridge dimensions following tooth extraction . METHODS Twenty-seven patients were r and omized into two treatment groups following single tooth extraction in the incisor , canine and premolar area . In the test group , the alveolar socket was grafted with Straumann Bone Ceramic ( SBC ) , while in the control group , Bio-Oss deproteinized bovine bone mineral ( DBBM ) was applied . In both groups , a collagen barrier was used to cover the grafting material . Complete soft tissue coverage of the barriers was not achieved . After 8 months , during re-entry procedures and before implant placement , the horizontal and vertical dimensions of the residual ridge were re-evaluated and trephine biopsies were performed for histological analysis in all patients . RESULTS Twenty-six patients completed the study . The bucco-lingual dimension of the alveolar ridge decreased by 1.1+/-1 mm in the SBC group and by 2.1+/-1 in the DBBM group ( P<0.05 ) . Both material s preserved the mesio-distal bone height of the ridge . No differences in the width of buccal and palatal bone plate were observed between the two groups . The histological analysis showed new bone formation in the apical part of the biopsies , which , in some instances , was in direct contact with both SBC and DBBM particles . The coronal part of the biopsies was occupied by a dense fibrous connective tissue surrounding the SBC and DBBM particles . CONCLUSION Both bio material s partially preserved the width and the interproximal bone height of the alveolar ridge PURPOSE This prospect i ve case series evaluated the use of a new titanium-reinforced nonresorbable membrane ( high-density polytetrafluoroethylene ) , in combination with a mixture of anorganic bovine bone-derived mineral ( ABBM ) and autogenous particulated bone , for vertical augmentation of deficient alveolar ridges . MATERIAL S AND METHODS A mixture of ABBM and autogenous particulated bone was used for vertical ridge augmentation and covered with a new titanium-reinforced nonresorbable membrane . Ridge measurements were obtained before and after the procedure , complications were recorded , and biopsy specimens were taken for histologic examination . RESULTS Twenty vertical ridge augmentation procedures were carried out in 19 patients . All treated defect sites exhibited excellent bone formation , with an average bone gain of 5.45 mm ( st and ard deviation 1.93 mm ) . The healing period was uneventful , and no complications were observed . Eight specimens were examined histologically ; on average , autogenous or regenerated bone represented 36.6 % of the specimens , ABBM 16.6 % , and marrow space 46.8 % . No inflammatory responses or foreign-body reactions were noted in the specimens . CONCLUSION The treatment of vertically deficient alveolar ridges with guided bone regeneration using a mixture of autogenous bone and ABBM and a new titanium-reinforced nonresorbable membrane can be considered successful OBJECTIVES S and wich bone augmentation ( SBA ) has been proposed to augment the width of edentulous ridges for implant placement . This study aim ed to investigate the effect of a membrane on SBA for the regeneration of buccal implant dehiscence defects . MATERIAL AND METHODS Twenty-six healthy patients , each with a single defect , were r and omly assigned into two groups . Both groups received an inner and outer layer of mineralized human cancellous and cortical particulate allograft . In the test group , a bovine pericardium membrane covered the bone grafts , while no membrane was placed in the control group . Cone beam computed tomography ( CBCT ) scans were taken before and immediately after implant placement and at 6 months post-surgery . RESULTS All implants placed were successfully osseointegrated at 6 months . Clinical re-entry measurements showed significant buccal bone gain in the test group compared with the control group ( P < 0.05 ) . The test group had 1.12 , 2.21 and 2.44 mm more buccal bone thickness at 2 , 4 and 6 mm below the bone crest . There were no significant differences in the mid-buccal vertical bone height , defect height and width reductions and bone fill between the two groups ( P > 0.05 ) . Cone beam computed tomography analysis demonstrated significant buccal bone gain of 1.22 mm in the test group . Radiographic vertical bone loss at 1-year post-surgery showed no significant differences between the groups . CONCLUSION S and wich bone augmentation is a predictable technique for regenerating buccal bone on implant dehiscence defects . Addition of a barrier membrane prevented significant horizontal buccal bone resorption as space was maintained more effectively when compared with sites treated without a membrane 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 Background and Purpose : The resorption of alveolar bone following tooth extraction results in a narrowing and shortening of the residual ridge , which leads to esthetic and restorative problems , and reduces the bone volume available for implant therapy . The aim of this study was to evaluate the prevention of alveolar collapse after tooth extraction , using titanium membrane ( Frios Boneshield ; DENTSPLY Friadent , Mannheim , Germany ) , associated ( or not ) with autologous bone graft . Material s and Methods : A total of 10 nonsmoking healthy subjects , ranging from 35 to 60 years old , were selected for this study . Each patient had a minimum of 2 uni-radicular periodontally hopeless teeth , which were scheduled for extraction . After the procedure , 2 titanium pins were fixed on the vestibular bone surfaces that were used as references for the initial measures ( depth , width , and height ) of the socket . Of the sockets,1 was r and omly chosen to be filled with autologous bone graft ( test ) removed from superior maxillary tuber , and the other one did not receive the graft ( control ) . A titanium membrane was adapted and fixed , covering the sockets , which remained for at least 10 weeks . After a 6-month healing , the final measures were performed . Results : There was exposure of the membrane in 5 of the 10 treated subjects . Average bone filling ( ±st and ard deviation ) among the 10 subjects was 8.80 ± 2.93 mm ( range 4 - 13 ) in the control group and 8.40 ± 3.35 mm ( range 4 - 13 ) in the test group . Average bone loss in width in both group was 1.40 ± 1.97 mm ( range −4 - 1 ) in the control group and 1.40 ± 0.98 mm ( range −4 - 0 ) in the test group . There was no significant statistical difference between groups considering the evaluated st and ards . Conclusion : The use of titanium membrane , alone or in association with autogenous bone , favored the prevention of alveolar ridge after tooth extraction . This membrane seems to be a possible and safe alternative to other nonresorbable membranes when the prevention of alveolar ridge resorption is the objective OBJECTIVES This study was conducted to evaluate the effect of barrier membranes on s and wich bone augmentation ( SBA ) for the treatment of implant dehiscence defects . MATERIAL AND METHODS Twenty-six implant-associated buccal dehiscence defects in 22 patients were treated according to the SBA concept - mineralized human cancellous allograft ( inner layer ) , mineralized human cortical allograft ( outer layer ) and coverage with barrier membrane . The defects were r and omly assigned to the bovine collagen membrane ( BME ) group ; acellular dermal matrix ( ADM ) group ; and no membrane group . Measurements at baseline and 6 months re-entry included defect height ( DH : from smooth-rough junction to the most apical part of the defect ) , defect width ( DW : at the widest part of the defect ) , and horizontal defect depth ( HDD : at three locations - smooth-rough junction , middle , and most apical portion of the defect ) . All measurements were taken from a reference stent . Statistical analyses were performed for comparison of intra- and inter-group comparisons . RESULTS All implants placed were successfully osseointegrated . DH at baseline for three groups were not significantly different ( P=0.858 ) . Mean % DH reductions for ADM , BME , and control groups at 6 months were 73.9+/-17.6 % , 68.1+/-30.1 % , and 63.6+/-23.9 % , respectively , with no significant difference among the groups ( P=0.686 ) . Mean horizontal bone gain , however , was significantly greater for membrane groups ( 1.7 mm for ADM , 1.6 mm for BME ) compared with control group ( 1 mm ) ( P=0.044 ) . Implant exposure result ed in significant reduction in total height gain ( 79.1+/-14.3 % vs. 57+/-23.5 % , P=0.021 ) . CONCLUSIONS Within the limit of this study , it is concluded that SBA technique achieved predictable clinical outcomes . The addition of absorbable membranes enhanced bone gain in thickness compared with membrane-treated sites BACKGROUND Platelet-rich plasma ( PRP ) contains a number of biologically active growth factors , and previous studies have reported conflicting ridge augmentation results . The primary aim of this r and omized , controlled , masked , clinical trial was to determine if PRP combined with a rapidly resorbing cancellous allograft would enhance the regenerative result compared with an allograft without PRP . METHODS Thirty-two patients with an edentulous ridge defect were sequentially entered into the study ; four were excluded from data analysis . Fourteen patients received a cancellous allograft ( CAN group ) and the other 14 received a cancellous allograft mixed with PRP ( PRP group ) . All 28 grafted sites were covered with a resorbable polylactide membrane . After elevation of a full-thickness flap , horizontal ridge dimensions were measured with a digital caliper at the crest and 5 mm apical to the crest . Vertical ridge dimensions were measured from a tooth-supported stent . All sites were reentered at 4 months , and a trephine core was obtained for histologic analysis before implant placement . RESULTS The crestal ridge width for the CAN group had a mean gain of 2.0 ± 1.2 mm , whereas the PRP group gained 2.9 ± 1.0 , and the difference was statistically significant between groups ( P < 0.05 ) . The percent vital bone was 36 % ± 14 % for the CAN group compared with 51 % ± 15 % for the PRP group and was statistically significant between groups ( P < 0.05 ) . Loss of augmented ridge width was 34 % ± 17 % for the CAN group and 28 % ± 17 % for the PRP group ( P > 0.05 ) . CONCLUSION These clinical and histologic findings suggest that PRP enhanced bone regeneration and result ed in increased horizontal bone gain and percentage vital bone One of the key factors for attaining osseointegration is the presence of an adequate osseous volume . In patients with inadequate osseous width or height , a bone augmentation using the guided bone regeneration ( GBR ) concept may be applied either with a simultaneous or a
Output:
| Regardless of the material used for regeneration , different degrees of graft resorption should be expected .
Given the sample of investigations analyzed in this review , block grafts seemed to maintain the volume of the initial augmentation site more than GBR techniques .
During the initial stages of healing , the GBR technique experienced more changes compared with block grafts .
The resorption of the xenograft group was inferior compared with the combination of xenograft and autologous bone groups . |
MS211284 | ***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 The goal of the present study was to examine the re source and economic implication s of an early hospital discharge and home-based rehabilitation scheme for patients with acute stroke . METHODS A cost minimization analysis in conjunction with a r and omized controlled trial was carried out at 2 affiliated teaching hospitals in the southern metropolitan region of Adelaide , South Australia , between 1997 and 1998 . Eighty-six hospitalized patients with acute stroke who required rehabilitation were r and omized to receive both early hospital discharge and home-based rehabilitation , or conventional in-hospital rehabilitation and community care . Direct and indirect costs related to stroke rehabilitation were calculated , including hospital bed days , home-based intervention program , community services , and personal expenses during the 6 months after r and omization . RESULTS The mean cost per patient was lower for patients r and omized to the early hospital discharge and home-based rehabilitation ( $ 8040 ) compared with those who received conventional care ( $ 10 054 ) . This cost saving was not statistically significant ( P=0.14 ) . However , sensitivity analyses indicated that the cost of home-based rehabilitation was consistently lower than that of conventional care except when hospital costs were assumed to be 50 % less than those used in the main analysis . Multiple regression analysis demonstrated that the cost of the home-based program was significantly related to a patient 's level of disability after adjustment for age , comorbidity , and the presence or absence of a caregiver . CONCLUSIONS The early hospital discharge and home-based rehabilitation scheme was less costly than conventional hospital care for patients with stroke . Limitation of the provision of such services to patients with mild disability is likely to be most cost effective Abstract Objectives : To examine the cost of providing hospital at home in place of some forms of inpatient hospital care . Design : Cost minimisation study within a r and omised controlled trial . Setting : District general hospital and catchment area of neighbouring community trust . Subjects : Patients recovering from hip replacement ( n=86 ) , knee replacement ( n=86 ) , and hysterectomy ( n=238 ) ; elderly medical patients ( n=96 ) ; and patients with chronic obstructive airways disease ( n=32 ) . Interventions : Hospital at home or inpatient hospital care . Main outcome measures : Cost of hospital at home scheme to health service , to general practitioners , and to patients and their families compared with hospital care . Results : No difference was detected in total healthcare costs between hospital at home and hospital care for patients recovering from a hip or knee replacement , or elderly medical patients . Hospital at home significantly increased healthcare costs for patients recovering from a hysterectomy ( ratio of geometrical means 1.15 , 95 % confidence interval 1.04 to 1.29 , P=0.009 ) and for those with chronic obstructive airways disease ( Mann-Whitney U test , P=0.01 ) . Hospital at home significantly increased general practitioners ' costs for elderly medical patients ( Mann-Whitney U test , P<0.01 ) and for those with chronic obstructive airways disease ( P=0.02 ) . Patient and carer expenditure made up a small proportion of total costs . Conclusion : Hospital at home care did not reduce total healthcare costs for the conditions studied in this trial , and costs were significantly increased for patients recovering from a hysterectomy and those with chronic obstructive airways disease . There was some evidence that costs were shifted to primary care for elderly medical patients and those with chronic obstructive airways disease . Key messages Hospital at home schemes are a popular alternative to st and ard hospital care , but there is uncertainty about their cost effectiveness In our r and omised controlled trial we compared the cost of hospital at home care with that of inpatient hospital care for patients recovering from hip replacement , knee replacement , and hysterectomy ; elderly medical patients ; and those with chronic obstructive airways disease There were no major differences in health service costs between the two arms of the trial for patients recovering from hip or knee replacement and elderly medical patients Hospital at home care increased healthcare costs for patients recovering from hysterectomy and for those with chronic obstructive airways disease Hospital at home care result ed in some costs shifting to general practitioners for elderly medical patients and those with chronic obstructive airways Purpose : To evaluate the feasibility and effectiveness of early supported discharge ( ESD ) following acute stroke . Method : An ESD scheme was compared to conventional rehabilitation in a r and omized controlled trial . All patients admitted with acute stroke were considered for inclusion . Eighty-eight ( 20.2 % ) were found to be eligible and 82 were r and omized either to early supported discharge ( n=42 ) or conventional rehabilitation ( n=40 ) . The primary outcome measure was the Nottingham Extended Activities of Daily Living Scale . The General Health Question naire , the Montgomery Aasberg Depression Rating Scale , mortality , placement and patient and carer satisfaction served as secondary outcome measures . Results : Median length of stay was reduced from 31 days in the conventional hospital rehabilitation group to 22 days in the early supported discharge group ( p=0.09 ) . No differences were found regarding primary outcome . The General Health Question naire score showed a significant difference in favour of the early supported discharge group at three months ( 19.5/24 , p = 0.02 ) , but not at six . At six months , the proportion of patients being dead or in institution showed a trend of being higher in the conventional rehabilitation group ( OR 3.8 , 95 % CI 0.8 - 23 ) . Conclusions : Early supported discharge after stroke is feasible and it is possible that it has benefits compared with conventional rehabilitation BACKGROUND AND PURPOSE This study describes the methodology , patient outcome , and use of hospital and rehabilitation services at 3 months of a population -based r and omized controlled trial . The purpose was to evaluate rehabilitation at home after early supported discharge from the Department of Neurology , Huddinge Hospital , for moderately disabled stroke patients in southwest Stockholm . METHODS The patients were eligible if they were continent , independent in feeding , had mental function within normal limits , and had impaired motor function and /or aphasia 1 week after stroke . Patients were r and omized either to early supported discharge with continuity of rehabilitation at home for 3 to 4 months or to routine rehabilitation service in a hospital , day care , and /or outpatient care . The home rehabilitation team consisted of two physical therapists , two occupational therapists , and one speech therapist ; one of the therapists was assigned as case manager for the patient . The rehabilitation program at home emphasized a task- and context -oriented approach . The activities were chosen on the basis of the patient 's personal interests . Spouses were offered education and individual counseling . A total of 81 patients were followed up for a minimum of 3 months . Patient outcome was assessed by the Frenchay Social Activity Index , Extended Katz Index , Barthel Index , Lindmark Motor Capacity Assessment , Nine-Hole Peg Test , walking speed over 10 m , reported falls , and subjective dysfunction according to the Sickness Impact Profile . Patient use of hospital and home rehabilitation service and patient satisfaction with care were studied . RESULTS Overall there were no statistical significant differences in outcome . Multivariate logistic regression analysis suggested a systematic positive effect for the home rehabilitation group in social activity , activities of daily living , motor capacity , manual dexterity , and walking . A considerable difference in re source use during such a 3-month period was seen . A 52 % reduction in hospitalization was observed : from 29 days in the routine rehabilitation group to 14 days in the home rehabilitation group . Patient satisfaction was in favor of the latter group . CONCLUSIONS Early supported discharge with continuity of home rehabilitation services for the majority of moderately disabled stroke patients during the first 3-month period after acute stroke is not less beneficial than routine rehabilitation and can be a rehabilitation service of choice if follow-up at 6 and 12 months confirms the suggested effectiveness and considerable reduction in use of health care BACKGROUND AND PURPOSE In an inner-London teaching hospital , a r and omized trial of " conventional " care versus early discharge to community-based therapy found no significant differences in clinical outcomes between patient groups . This report examines the economic consequences of the alternative strategies . METHODS One hundred sixty-seven patients received the early discharge package , and 164 received conventional care . Patient utilization of health and social services was recorded over a 12-month period , and cost was determined using data from provider departments and other published sources . RESULTS Inpatient stay after r and omization was 12 days ( intervention group ) versus 18 days ( controls ) ( P=0.0001 ) . Average units of therapy per patient were as follows : physiotherapy , 22.4 ( early discharge ) versus 15.0 ( conventional ) ( P=0.0006 ) ; occupational therapy , 29.0 versus 23.8 ( P=0.002 ) ; speech therapy , 13 . 7 versus 5.8 ( P=0.0001 ) . The early discharge group had more annual hospital physician contacts ( P=0.015 ) and general practitioner clinic visits ( P=0.019 ) but fewer incidences of day hospital attendance ( P=0.04 ) . Other differences in utilization were nonsignificant . Average annual costs per patient were pound sterling 6800 ( early discharge ) and pound sterling 7432 ( conventional ) . The early discharge group had lower inpatient costs per patient ( pound sterling 4862 [ 71 % of total cost ] versus pound sterling 6343 [ 85 % ] for controls ) but higher non-inpatient costs ( pound sterling 1938 [ 29 % ] versus pound sterling 1089 [ 15 % ] ) . Further analysis demonstrated that early discharge is unlikely to lead to financial savings ; its main benefit is to release capacity for an expansion in stroke caseload . CONCLUSIONS Overall results of this trial indicate that early discharge to community rehabilitation for stroke is cost-effective . It may provide a means of addressing the predicted increase in need for stroke care within existing hospital capacity BACKGROUND AND PURPOSE Organized acute stroke treatment reduces mortality , functional deficits , and the need of institutionalization after stroke . It is largely unknown whether the effects of treatment are due to early or subacute efforts . The aim of this r and omized , controlled study was to test the hypothesis that rehabilitation of stroke patients in the subacute phase in a hospital rehabilitation unit is beneficial in reducing death and dependency and increasing health-related quality of life . METHODS 251 patients initially treated in the hospital were r and omized to subacute rehabilitation in a hospital rehabilitation unit ( n = 127 ) or to the health services in the municipality ( n = 124 ) and were followed up for 7 months . RESULTS The combined outcome of patients being dead or dependent ( Barthel Index score of < 75 ) was 23 % in the hospital group and 38 % in the municipality group ( P=.01 ) . Seven-month survival rates were 90.6 % and 83.9 % ( P=.11 ) , respectively . Dependency in activities of daily living was 12.6 % in the hospital group and 25.0 % in the municipality group ( P=.07 ) . Patients with a BI score of < 50 before rehabilitation had significantly better outcome in the hospital rehabilitation unit , with fewer patients becoming dependent ( P=.005 ) and patients having higher Sc and inavian Stroke Scale ( P=.026 ) and BI scores ( P=.005 ) . No significant differences in health-related quality of life were found . Many patients treated in the municipalities ( 30 % ) did not receive any organized rehabilitation in this study . CONCLUSIONS Subacute rehabilitation of stroke patients in a hospital-based rehabilitation unit improves outcome . Patients with moderate or severe stroke appear to benefit most We previously conducted a r and omized controlled trial in which early supported discharge from the Department of Neurology at Huddinge Hospital in southwest Stockholm with continuity of rehabilitation at home ( n = 41 ) was compared to routine rehabilitation services ( n = 40 ) for moderately disabled selected stroke patients . No statistical significant differences were found in patient outcome at 3 or 6 months , but a moderately positive effect in the home rehabilitation group was suggested . In the present study we evaluated re source utilization of health and social care , impact on family caregivers during 6 months after acute stroke and patient satisfaction . A 50 % reduction in total hospitalization ( initial and recurrent ) was observed , from 30 days in the routine rehabilitation group to 15 days in the home rehabilitation group ( p < 0.001 ) . After discharge , the mean number of home visits in the home rehabilitation group was 12 . In total , the routine rehabilitation group had a higher frequency of therapy contacts and daycare in outpatient care . Seventy-eight percent received help from a family caregiver in activities of daily living , yet only 15 % had formal home help service . No major differences were found in use of home help service or impact on family caregivers in the form of time devoted to helping the patient or subjective well-being of spouses as per Sickness Impact Profile . Patient satisfaction was in favour of the home rehabilitation group , but a significant difference was only found in active participation in rehabilitation programme planning . In conclusion , early supported discharge with continuity of rehabilitation at home , using goal -directed functional activities based on the patient 's personal interests , should be the rehabilitation service of choice for moderately disabled stroke patients fulfilling certain criteria , provided that further evaluation during the first year after stroke reveals no great changes in outcome or re source use . More research into the effectiveness and cost implication s of early supported discharge with continuity of rehabilitation at home is needed in other parts of Sweden and in other countries before it can be asserted that the conclusions drawn from this study are applicable elsewhere Hospital-at-Home schemes have been cl
Output:
| REVIEW ER 'S CONCLUSIONS ESD services provided for a selected group of stroke patients can reduce the length of hospital stay . |
MS211285 | ***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: In the present study , the role of individual response patterns in the treatment of social phobic patients was investigated . Seventy-four patients were diagnosed as social phobics . On the basis of extreme scores on a behavioral test ( the Simulated Social Interaction Test ) and on a cognitive measure ( the Rational Behavior Inventory ) , the response patterns of 39 patients were analyzed , and the patients themselves were classified as either ' behavioral reactors ' or ' cognitive reactors ' . Half of the patients with each response pattern received a behavioral focused treatment , i.e. social skills training ( SST ) , while the other half received a cognitive oriented treatment , i.e. rational emotive therapy ( RET ) . Patients received group therapy in eight weekly sessions . Within-group differences showed a considerable improvement in all treatment groups . Between-group differences failed to lend support to the hypothesis that treatment that fits a response pattern ( i.e. SST for behavioral reactors and RET for cognitive reactors ) will result in a greater improvement than one that does not Psychological group treatments , such as behavioral or cognitive-behavioral therapy , are generally effective interventions for social phobia . However , a substantial number of individuals discontinue these treatments prematurely . Participant attrition can threaten the validity of treatment outcome studies if attrition during therapy does not occur r and omly . In order to examine this issue , we studied 133 individuals with a principal diagnosis of social phobia who initiated a 12-week behavioral or cognitive-behavioral group treatment for social phobia . Thirty-four participants discontinued therapy prematurely . These dropouts were compared to treatment completers in demographic characteristics , Axis I and II psychopathology , and their attitude toward treatment . The results only showed a small difference between treatment completers and dropouts in their attitude toward treatment : dropouts rated the treatment rationale as less logical than completers at the beginning of treatment . No other differences between dropouts and completers were observed . Therefore , dropouts are unlikely to present a serious threat to the external validity of treatment outcome studies for social phobia Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Patients with depression are often excluded from studies on the treatment of social anxiety disorder ( SAD ) , leaving gaps in our knowledge about the impact of depressive affect on treatment for SAD . Patients participated in a r and omized , placebo‐controlled study of treatment for SAD . As in previous studies , patients were excluded from the study if they met criteria for major depressive disorder in the past 6 months . This exclusion notwithst and ing , patients who enrolled in the study exhibited a range of depressive symptoms , permitting an examination of the impact of depressive symptoms on treatment outcome for SAD . Assessment measures included the Clinical Global Impression Scale , Hamilton Rating Scale for Depression , Brief Social Phobia Scale , and Beck Depression Inventory . Higher levels of depressive symptoms were related to more severe social anxiety overall , and to less change in social anxiety symptoms over the course of the study . Patients who were deemed nonresponders to treatment had higher levels of depressive symptoms at pretreatment than those who responded . In addition , patients who dropped out of the study had higher levels of depressive symptoms at pretreatment than those who completed the study . These results suggest that modifications should be made to existing treatments to improve outcomes and decrease attrition in the substantial proportion of patients with SAD who also evidence depressive symptoms . Such modifications are likely to be more important when treating patients with SAD and comorbid major depressive disorder . Depression and Anxiety 22:161–167 , 2005 . © 2005 Wiley‐Liss , This study was a replication of a study on the prediction of treatment outcome in social phobic patients [ Chambless , D. L. , Tran , G. Q. Glass , C.R. ( 1997 ) . Predictors of response to cognitive-behavioral group therapy for social phobia . Journal of Anxiety Disorders , 11 221 - 240 ] . Results at the posttest and the 18-months follow-up were analyzed for DSM-III-R social phobic patients , with either a generalized social phobia ( n = 50 ) or a nongeneralized fear , i.e. fear of blushing , trembling or sweating in social situations ( n = 26 ) . Predictors were pretreatment depression , personality disorder traits , clinician rated severity of impairment and frequency of negative self-statements during social interactions . The criterium variable was ( the residual gain score of ) self-reported avoidance of social situations . In line with Chambless et al. , pretreatment depression showed some predictive value , but smaller and only at the posttest . Change in the frequency of negative self-statements paralleled , but did not predict , change in social phobia symptoms . In contrast with Chambless et al. , clinician rated severity was ( slightly ) predictive for treatment outcome , whereas avoidant personality traits had reverse correlations with outcome in both subgroups . The results are discussed and directions for further research are given Social phobia patients with fear of blushing , trembling , sweating and /or freezing as main complaint ( N = 65 ) were r and omly assigned to either task concentration training ( TCT ) or applied relaxation ( AR ) both followed by cognitive therapy ( CT ) . Measurements took place before and after wait-list , after TCT or AR ( within-test ) , after CT ( post-test ) , at 3-months and at 1-year follow-up . Effects were assessed on fear of showing bodily symptoms ( the central outcome variable ) , social phobia , other psychopathology , social skills , self-consciousness , self-focused attention , and dysfunctional beliefs . No changes occurred during wait-list . Both treatments were highly effective . TCT was superior to AR in reducing fear of bodily symptoms and dysfunctional beliefs at within-test . This difference disappeared after CT , at post-test and at 3-months follow-up . However , at 1-year follow-up the combination TCT-CT was superior to AR-CT in reducing fear of bodily symptoms , and effect sizes for TCT-CT reached 3 . Furthermore , at all assessment moments TCT or the combination TCT-CT was superior to AR-CT in reducing self-consciousness and self-focused attention . The superior long-term effect of TCT on fear of showing bodily symptoms is explained by lasting changes in attentional focus Ninety individuals with social phobia ( social anxiety disorder ) participated in a r and omized controlled trial and completed cognitive-behavioral group therapy , exposure group therapy without explicit cognitive interventions , or a wait-list control condition . Both treatments were superior to the wait-list group in reducing social anxiety but did not differ from one another at posttest . Changes in estimated social cost mediated treatment changes in both treatment conditions from pre- to posttest . However , only participants who received cognitive-behavioral therapy showed continued improvement from posttest to 6-month follow-up , which was associated with a reduction of estimated social cost from pretest to posttest . These results suggest that cognitive intervention leads to better maintenance of treatment gains , which is mediated through changes in estimated social cost
Output:
| No pre-treatment patient variables were found to predict drop-out .
Consistently across studies , higher levels of pre-treatment symptomatic severity predicted higher levels of end-state symptomatic severity , but not degree of improvement .
There was some evidence that comorbid depression and avoidant personality disorder before treatment negatively influenced post-treatment end-state functioning , but not consistently improvement .
Generally , the results are in line with the conclusion that more disturbed patients with SP both begin and end treatment at a higher symptomatic level but with a similar degree of improvement . |
MS211286 | ***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 study of the peripheral skeletal muscle function in patients with chronic obstructive pulmonary disease ( COPD ) is of growing interest , but often requires biopsies , usually with the Bergström technique . The current study was design ed to test the validity of a minimally invasive technique : the microbiopsy . In 17 patients with COPD and four normal subjects , two specimens of the vastus lateralis were taken percutaneously under local anaesthesia , one with a 16-gauge needle ( microbiopsy ) and the other with the Bergström needle . The enzymatic activity of citrate synthase ( CS ) and phosphofructokinase ( PFK ) , and the myosin heavy chain ( MyoHC ) composition were measured for both techniques . The subjects reported no pain or much less with the microbiopsy compared with the Bergström biopsy . The microbiopsy sample weight reached 55±17 mg . The two techniques showed excellent agreement for CS activity and MyoHC composition . The PFK activity did not differ statistically between the techniques , but the agreement was moderate . The agreement between both biopsy techniques was stable over time . The median ( range ) fibre number within the microbiopsy specimens was 144 ( 38–286 ) . In conclusion , the current study shows the feasibility and validity of a minimally invasive muscle biopsy technique that appears more comfortable for subjects , compared with the Bergström technique The aim of this study was to investigate the effects of mobilisation on respiratory and haemodynamic variables in the intubated , ventilated abdominal surgical patient . Mobilisation was defined as the progression of activity from supine , to sitting over the edge of the bed , st and ing , walking on the spot for one minute , sitting out of bed initially , and sitting out of bed for 20 minutes . Seventeen patients with age ( mean + /- SD ) 71.4 + /- 7.1 years satisfied inclusion criteria . Respiratory and haemodynamic parameters were measured in each of the above positions and compared with supine . In the 15 subjects who completed the protocol , st and ing result ed in significant increases in minute ventilation ( VE ) from 15.1 + /- 3.1 l/min in supine to 21.3 + /- 3.6 l/min in st and ing ( p < 0.001 ) . The increase in VE in st and ing was achieved by significant increases in tidal volume ( VT ) from 712.7 + /- 172.8 ml to 883.4 + /- 196.3 ml ( p = 0.008 ) and in respiratory rate ( fR ) from 21.4 + /- 5.0 breaths/min to 24.9 + /- 4.5 breaths/min ( p = 0.03 ) . No further increases were observed in these parameters beyond st and ing when activity was progressed to walking on the spot for one minute . When supine values were compared with walking on the spot for one minute , inspiratory flow rates ( VT/TI ) increased significantly from 683 + /- 131.8 ml/sec to 985.1 + /- 162.3 ml/sec ( p = 0.001 ) with significant increases in rib cage displacement ( p = 0.001 ) and no significant increase in abdominal displacement ( p = 0.23 ) . Arterial blood gases displayed no improvements following mobilisation . Changes in VT , fR , and VE were largely due to positional changes when moving from supine to st and ing Objective : To determine whether early activity is feasible and safe in respiratory failure patients . Design : Prospect i ve cohort study . Setting : From June 1 , 2003 , through December 31 , 2003 , we assessed safety and feasibility of early activity in all consecutive respiratory failure patients who required mechanical ventilation for > 4 days admitted to our respiratory intensive care unit ( RICU ) . A majority of patients were treated in another intensive care unit ( ICU ) before RICU admission . We excluded patients who required mechanical ventilation for ≤4 days . Patients : Eight‐bed RICU at LDS Hospital . Interventions : We assessed patients for early activity as part of routine respiratory ICU care . We prospect ively recorded activity events and adverse events . We defined three activity events as sit on bed , sit in chair , and ambulate . We defined six activity‐related adverse events as fall to knees , tube removal , systolic blood pressure > 200 mm Hg , systolic blood pressure < 90 mm Hg , oxygen desaturation < 80 % , and extubation . Measurements and Main Results : During the study period , we conducted a total of 1,449 activity events in 103 patients . The activity events included 233 ( 16 % ) sit on bed , 454 ( 31 % ) sit in chair , and 762 ( 53 % ) ambulate . In patients with an endotracheal tube in place , there were a total of 593 activity events , of which 249 ( 42 % ) were ambulation . There were < 1 % activity‐related adverse events , including fall to the knees without injury , feeding tube removal , systolic blood pressure > 200 mm Hg , systolic blood pressure < 90 mm Hg , and desaturation < 80 % . No patient was extubated during activity . Conclusions : We conclude that early activity is feasible and safe in respiratory failure patients . A majority of survivors ( 69 % ) were able to ambulate > 100 feet at RICU discharge . Early activity is a c and i date therapy to prevent or treat the neuromuscular complications of critical illness Objectives : To investigate whether a daily exercise session , using a bedside cycle ergometer , is a safe and effective intervention in preventing or attenuating the decrease in functional exercise capacity , functional status , and quadriceps force that is associated with prolonged intensive care unit stay . A prolonged stay in the intensive care unit is associated with muscle dysfunction , which may contribute to an impaired functional status up to 1 yr after hospital discharge . No evidence is available concerning the effectiveness of an early exercise training intervention to prevent these detrimental complications . Design : R and omized controlled trial . Setting : Medical and surgical intensive care unit at University Hospital Gasthuisberg . Patients : Ninety critically ill patients were included as soon as their cardiorespiratory condition allowed bedside cycling exercise ( starting from day 5 ) , given they still had an expected prolonged intensive care unit stay of at least 7 more days . Interventions : Both groups received respiratory physiotherapy and a daily st and ardized passive or active motion session of upper and lower limbs . In addition , the treatment group performed a passive or active exercise training session for 20 mins/day , using a bedside ergometer . Measurements and Main Results : All outcome data are reflective for survivors . Quadriceps force and functional status were assessed at intensive care unit discharge and hospital discharge . Six-minute walking distance was measured at hospital discharge . No adverse events were identified during and immediately after the exercise training . At intensive care unit discharge , quadriceps force and functional status were not different between groups . At hospital discharge , 6-min walking distance , isometric quadriceps force , and the subjective feeling of functional well-being ( as measured with “ Physical Functioning ” item of the Short Form 36 Health Survey question naire ) were significantly higher in the treatment group ( p < .05 ) . Conclusions : Early exercise training in critically ill intensive care unit survivors enhanced recovery of functional exercise capacity , self-perceived functional status , and muscle force at hospital discharge STUDY OBJECTIVES To evaluate the effects of early exercise training in patients recovering from acute respiratory failure needing mechanical ventilation ( MV ) . DESIGN Prospect i ve , r and omized , and controlled study . SETTING Three respiratory intermediate ICUs ( RIICUs ) . PATIENTS Of 228 patients admitted to an RIICU , 66 patients weaned from MV from > 48 to < 96 h were considered eligible and enrolled in the study . INTERVENTION Sixty-six patients were r and omized to either supported arm exercise training plus general physiotherapy ( gPT ) [ group 1 , 32 patients ] or to gPT alone ( group 2 , 34 patients ) . MEASUREMENTS AND RESULTS Twenty-five patients in each group completed the protocol . Group 1 showed a greater improvement in exercise capacity , as assessed by an arm incremental test ( IT ) [ p = 0.003 ] and an endurance test ( ET ) [ p = 0.021 ] , compared to group 2 . Posttraining maximal inspiratory pressure ( MIP ) significantly improved in both groups ( p < 0.001 and p = 0.003 in groups 1 and 2 respectively ; not significant ) . IT isoworkload dyspnea improved significantly in both groups ( p = 0.005 and p = 0.009 in groups 1 and 2 , respectively ; not significant between groups ) , whereas IT isoworkload peripheral muscle fatigue ( p < 0.001 ) , ET isotime dyspnea ( p < 0.01 ) , and ET isotime muscular fatigue ( p < 0.005 ) improved significantly in group 1 but not in group 2 . IT improvers ( chi2 = 0.004 ) and ET improvers ( chi2 = 0.047 ) were more frequently observed in group 1 than in group 2 . Baseline MIP could discriminate for IT ( p = 0.013 ; odds ratio [ OR ] , 1.116 ) and ET improvers ( p = 0.022 ; OR , 1.067 ) . CONCLUSION Early upper-limb exercise training is feasible in RIICU patients recently weaned from MV and can enhance the effects of gPT . Baseline inspiratory muscle function is related to exercise capacity improvement BACKGROUND : Chair-sitting may allow for more readily activated scalene , sternocleidomastoid , and parasternal intercostal muscles , and may raise and enlarge the upper thoracic cage , thereby allowing the thoracic cage to be more easily compressed . OBJECTIVE : To evaluate the effect of chair-sitting during exercise training on respiratory muscle function in mechanically ventilated patients . METHODS : We r and omized 16 patients to a control group and 18 patients to a chair-sitting group . The patients in the chair-sitting group were transferred by 2 intensive care unit nurses from bed to armchair and rested for at least 30 min , based on the individual patient 's tolerance . We measured heart rate , blood pressure , SpO2 , and respiratory rate . In the treatment group , before transferring the patient from bed to armchair , and 30 min after the completion of chair-sitting we measured respiratory muscle function variables , including the ratio of respiratory rate ( f ) to tidal volume ( VT ) , SpO2 , maximum inspiratory pressure ( PImax ) and maximum expiratory pressure ( PEmax ) . In the control patients we took those same measurements while the patient was in semirecumbent position , before and after treatments , for at least 6 days or until the patient was discharged from the intensive care unit or died . RESULTS : The 2 groups did not significantly differ in age , sex , or clinical outcomes . Respiratory rate , VT , f/VT , SpO2 , PImax , and PEmax were not significantly better in the chair-sitting group . The study period significantly improved respiratory rate , VT , PImax , and PEmax ( all P < .001 ) , but not f/VT . CONCLUSIONS : Six days of chair-sitting exercise training did not significantly improve respiratory muscle function in mechanically ventilated patients OBJECTIVE Patients in intensive care exhibit a high degree of loss of muscle mass . Appropriate instruments are needed to document muscle wasting in these patients . The aim of this pilot study was to describe muscle wasting in patients in the intensive care unit . DESIGN Two-fold study setting : prospect i ve longitudinal and cross-sectional single-blind . PATIENTS A total of 118 patients in the intensive care unit ( length of stay 1 - 98 days ; male : female ratio 88:30 ; age 55 + /- 17 years ) were included in a two-fold study setting . METHODS Muscle layer thickness of the M. quadriceps femoris was documented using ultrasound measurement at well-defined points . Seventeen pilot- patients were measured twice ; at baseline and after 28 days . In another group of 101 patients , muscle layer thickness was determined once after a r and om length of stay . The results of both groups were compared and correlated . RESULTS In both groups , M. quadriceps femoris thickness showed a significant negative correlation with length of stay in the intensive care unit ( p < 0.01 ) . Furthermore , muscle wasting in intensive care patients could be described using a logarithmic function . CONCLUSION Loss of muscle mass shows a negative correlation with length of stay , and seems to be higher during the first 2 - 3 weeks of immobilization/intensive care unit stay . Ultrasound is a valid and practical measurement tool for documenting muscle mass ( e.g. muscle layer thickness ) as part of the daily routine at an intensive care unit BACKGROUND : The functional status and outcomes in patients with prolonged mechanical ventilation ( PMV ) are often limited by poor endurance and pulmonary mechanics , which result from the primary diseases or prolonged time bedridden . We evaluate the impact of exercise training on pulmonary mechanics , physical functional status , and hospitalization outcomes in PMV patients . METHODS : Twenty-seven subjects with PMV in our respiratory care center ( RCC ) were divided r and omly into an exercise training group ( n = 12 ) and a control group ( n = 15 ) . The exercise program comprised 10 sessions of exercise training . The measurement of pulmonary mechanics and physical functional status ( Functional Independence Measurement and Barthel index
Output:
| We found that active mobilization may improve muscle strength , functional independence , and the ability to wean from ventilation and may decrease the length of stay in the intensive care unit ( ICU ) and hospital .
Active mobilization appears to have a positive effect on physical function and hospital outcomes in mechanical ventilation patients . |
MS211287 | ***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 international and national guidelines patient education is recommended as an integral part of an effective management for both , asthma and COPD , respectively . The evaluation of numerous structured education programs for adult asthmatics revealed an increase of quality of life of the educated patients , reduced morbidity with less asthmatic attacks , a decrease of emergency visits , sick leave days and hospitalizations due to asthma . On the basis of cost/benefit analysis cost effectiveness could be demonstrated for education programs for asthmatics . On the basis of education programs in COPD including self-management , in a r and omized controlled study an improvement of the patient 's ability to react to exacerbations could be shown , thus reducing the morbidity by the disease . Further controlled studies of the effects of patient education on morbidity , mortality and cost effectiveness are necessary to establish the role of structured education programs in the treatment of COPD with sufficient validity Introduction COPD is a leading cause of morbidity and mortality . Self-management interventions are considered important in order to limit the progression of the disease . Computer-tailored interventions could be an effective tool to facilitate self-management . Methods This r and omized controlled trial tested the effectiveness of a web-based , computer-tailored COPD self-management intervention on physical activity and smoking behavior . Participants were recruited from an online panel and through primary care practice s. Those at risk for or diagnosed with COPD , between 40 and 70 years of age , proficient in Dutch , with access to the Internet , and with basic computer skills ( n=1,325 ) , were r and omly assigned to either the intervention group ( n=662 ) or control group ( n=663 ) . The intervention group received the web-based self-management application , while the control group received no intervention . Participants were not blinded to group assignment . After 6 months , the effect of the intervention was assessed for the primary outcomes , smoking cessation and physical activity , by self-reported 7-day point prevalence abstinence and the International Physical Activity Question naire – Short Form . Results Of the 1,325 participants , 1,071 ( 80.8 % ) completed the 6-month follow-up question naire . No significant treatment effect was found on either outcome . The application however , was used by only 36 % of the participants in the experimental group . Conclusion A possible explanation for the nonsignificant effect on the primary outcomes , smoking cessation and physical activity , could be the low exposure to the application as engagement with the program has been shown to be crucial for the effectiveness of computer-tailored interventions . ( Netherl and s Trial Registry number : NTR3421 . Background Low levels of physical activity are common in patients with chronic obstructive pulmonary disease ( COPD ) , and a sedentary lifestyle is associated with poor outcomes including increased mortality , frequent hospitalizations , and poor health-related quality of life . Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD . Methods / Design This manuscript describes the design and rationale of a r and omized controlled trial that tests the effectiveness of Taking Healthy Steps , an Internet-mediated walking program for Veterans with COPD . Taking Healthy Steps includes an uploading pedometer , a website , and an online community . Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are r and omized on a 2:1 ratio to Taking Healthy Steps or to a wait list control . The intervention arm receives iterative step-count feedback ; individualized step-count goals , motivational and informational messages , and access to an online community . Wait list controls are notified that they are enrolled , but that their intervention will start in one year ; however , they keep the pedometer and have access to a static webpage . Discussion Participants include 239 Veterans ( mean age 66.7 years , 93.7 % male ) with 155 r and omized to Taking Healthy Steps and 84 to the wait list control arm ; rural-living ( 45.2 % ) ; ever-smokers ( 93.3 % ) ; and current smokers ( 25.1 % ) . Baseline mean St. George ’s Respiratory Question naire Total Score was 46.0 ; 30.5 % reported severe dyspnea ; and the average number of comorbid conditions was 4.9 . Mean baseline daily step counts was 3497 ( + /- 2220).Veterans with COPD can be recruited to participate in an online walking program . We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy .Trial registration Clinical Trials.gov Computer-tailored printed education can be a promising way of promoting physical activity . The present study tested whether computer-tailored feedback on physical activity is effective and whether there are differences between respondents with low and high motivation to change . Respondents ( n = 487 ) were r and omly assigned to a tailored intervention group or a no information control group . Physical activity and determinants were measured at baseline and after 3 months . At post-test , the motivated respondents in the control group were more likely not to meet the recommendation for physical activity than to meet it , and motivated respondents in the experimental group were more likely to engage in transport-related activities and showed more improvement over time for the total activity score than respondents in the control group ( beta = 0.24 , P = 0.02 ) . Both groups improved their behaviour over time . No group differences in physical activity were found for the unmotivated respondents . The results showed that the effects of the tailored feedback were restricted to respondents who had a positive motivation to change at baseline . Possible explanations could be that unmotivated respondents were unwilling to read and process the information because they felt ' no need to change ' . Alternatively , one tailored feedback letter may not have been sufficient for this unmotivated group Objective To determine the feasibility and efficacy of a six-month , cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease ( COPD ) following pulmonary rehabilitation . Methods Participants who completed a two-week run-in were r and omly assigned to either MOBILE-Coached ( n = 9 ) or MOBILE-Self-Monitored ( n = 8) . All participants met with a nurse to develop an individualized exercise plan , were issued a pedometer and exercise booklet , and instructed to continue to log their daily exercise and symptoms . MOBILE-Coached also received weekly reinforcement text messages on their cell phones ; reports of worsening symptoms were automatically flagged for follow-up . Usability and satisfaction were assessed . Participants completed incremental cycle and six minute walk ( 6MW ) tests , wore an activity monitor for 14 days , and reported their health-related quality of life ( HRQL ) at baseline , three , and six months . Results The sample had a mean age of 68 ±11 and forced expiratory volume in one second 18 % predicted . Participants reported that logging their exercise and symptoms ( FEV1 ) of 40 ± was easy and that keeping track of their exercise helped them remain active . There were no differences between groups over time in maximal workload , 6MW distance , or HRQL ( p > 0.05 ) ; however , MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months ( p = 0.04 ) . Conclusions We showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring . The latter finding needs to be interpreted with caution since this was a purely exploratory study . Trial registration Clinical Trials.gov ( NCT00373932 ) Background Distributing a multiple computer-tailored smoking cessation intervention through the Internet has several advantages for both provider and receiver . Most important , a large audience of smokers can be reached while a highly individualized and personal form of feedback can be maintained . However , such a smoking cessation program has yet to be developed and implemented in the Netherl and s. Objective To investigate the effects of a Web-based multiple computer-tailored smoking cessation program on smoking cessation outcomes in a sample of Dutch adult smokers . Methods Smokers were recruited from December 2009 to June 2010 by advertising our study in the mass media and on the Internet . Those interested and motivated to quit smoking within 6 months ( N = 1123 ) were r and omly assigned to either the experimental ( n = 552 ) or control group ( n = 571 ) . Respondents in the experimental group received the fully automated Web-based smoking cessation program , while respondents in the control group received no intervention . After 6 weeks and after 6 months , we assessed the effect of the intervention on self-reported 24-hour point prevalence abstinence , 7-day point prevalence abstinence , and prolonged abstinence using logistic regression analyses . Results Of the 1123 respondents , 449 ( 40.0 % ) completed the 6-week follow-up question naire and 291 ( 25.9 % ) completed the 6-month follow-up question naire . We used a negative scenario to replace missing values . That is , we considered respondents lost to follow-up to still be smoking . The computer-tailored program appeared to have significantly increased 24-hour point prevalence abstinence ( odds ratio [ OR ] 1.85 , 95 % confidence interval [ CI ] 1.30–2.65 ) , 7-day point prevalence abstinence ( OR 2.17 , 95 % CI 1.44–3.27 ) , and prolonged abstinence ( OR 1.99 , 95 % CI 1.28–3.09 ) rates reported after 6 weeks . After 6 months , however , no intervention effects could be identified . Results from complete-case analyses were similar . Conclusions The results presented suggest that the Web-based computer-tailored smoking cessation program had a significant effect on abstinence reported after a 6-week period . At the 6-month follow-up , however , no intervention effects could be identified . This might be explained by the replacement of missing values on the primary outcome measures due to attrition using a negative scenario . While results were similar when using a less conservative scenario ( ie , complete-case analyses ) , the results should still be interpreted with caution . Further research should aim at identifying strategies that will prevent high attrition in the first place and , subsequently , to identify the best strategies for dealing with missing data when studies have high attrition rates . Trial Registration Dutch Trial Register NTR1351 ; http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=1351 ( Archived by WebCite at http://www.webcitation.org/67egSTWrz The objective of this pilot study was to investigate the use of and satisfaction with a chronic obstructive pulmonary disease ( COPD ) telehealth program applied in both primary and secondary care . The program consisted of four modules : 1 ) activity coach for ambulant activity monitoring and real-time coaching of daily activity behavior , 2 ) web-based exercise program for home exercising , 3 ) self-management of COPD exacerbations via a triage diary on the web portal , including self-treatment of exacerbations , and 4 ) teleconsultation . Twenty-nine COPD patients were r and omly assigned to either the intervention group ( telehealth program for 9 months ) or the control group ( usual care ) . Page hits on the web portal showed the use of the program , and the Client Satisfaction Question naire showed satisfaction with received care . The telehealth program with decision support showed good satisfaction ( mean 26.4 , maximum score 32 ) . The program was accessed on 86 % of the treatment days , especially the diary . Patient adherence with the exercise scheme was low ( 21 % ) . Health care providers seem to play an important role in patients ’ adherence to telehealth in usual care . Future research should focus on full-scale implementation in daily care and investigating technological advances , like gaming , to increase adherence Inhaled medication is important in the treatment of chronic obstructive pulmonary disease ( COPD ) . In this paper a comparison of the long-term efficacy of three instruction-models is presented . A total of 152 COPD - patients were r and omized into one of four groups : Personal- , video- , group-instruction and a control group . Inhalation technique was assessed by means of checklists , on which essential inhalation manoeuvres were identified . Up to 9 months later , 148 patients returned for follow-up assessment . Prior to instruction 61 % of patients in the control group had a perfect score on essential actions , compared to 62 , 65 and 53 % for those receiving group- , personal- and video-instruction respectively . At follow-up these percentages were 49 , 97 , 75 and 76 % . For group-(35 % ) and video-instruction ( 24 % ) the increase from baseline was significant . Examining the different inhalers under investigation , it is striking , that only 24 % of all patients with a Metered Dose Inhaler ( MDI ) performed all essential checklist items correctly , versus 96 % for those using a Diskhaler . The fact that for the MDI this percentage improved to 90 % post-instruction , shows that time spent on instruction , is time well spent . We conclude that group instruction seems superior to personal counselling , and equally effective or even better than video instruction . Personal instruction should not be dismissed and a combination with video instruction might prove to be effective as well Background Regular physical activity ( PA ) is recommended for persons with chronic obstructive pulmonary disease ( COPD ) . Interventions that promote PA and sustain long-term adherence to PA are needed . Objective We examined the effects of an Internet-mediated , pedometer-based walking intervention , called Taking Healthy Steps , at 12 months . Methods Veterans with COPD ( N=239 ) were r and omized in a 2:1 ratio to the
Output:
| Although our review suggests that interventions aim ed at facilitating , supporting , and sustaining self-managment in people with COPD and delivered via smart technology significantly improved HRQoL and levels of activity up to six months compared with interventions given through face-to-face/digital and /or written support , no firm conclusions can be drawn .
This improvement may not be sustained over a long duration .
The only included study that measured outcomes up to 12 months highlighted the need to ensure sustained engagement with the technology over time .
Limited evidence suggests that using computer and mobile technology for self-management for people with COPD is not harmful and may be more beneficial for some people than for others , for example , those with an interest in using technology may derive greater benefit .
The evidence , provided by three studies at high risk of bias , is of poor quality and is insufficient for advising healthcare professionals , service providers , and members of the public with COPD about the health benefits of using smart technology as an effective means of supporting , encouraging , and sustaining self-management . |
MS211288 | ***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 Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction < or = 35 % were r and omized to receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the AlereNet system and 142 received st and ard care . Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes . No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P < .003 ) for patients r and omized to the AlereNet group . CONCLUSIONS This is the largest multicenter , r and omized trial of a technology-based daily weight and symptom-monitoring system for patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups AIMS To test the effect of education and support by a nurse on self-care and re source utilization in patients with heart failure . METHODS A total of 179 patients ( mean age 73 , 58 % male , NYHA III-IV ) hospitalized with heart failure were evaluated prospect ively . Patients were r and omized to the study intervention or to ' care as usual ' . The supportive educative intervention consisted of intensive , systematic and planned education by a study nurse about the consequences of heart failure in daily life , using a st and ard nursing care plan developed by the research ers for older patients with heart failure . Education and support took place during the hospital stay and at a home visit within a week of discharge . Data were collected on self-care abilities , self-care behaviour , readmissions , visits to the emergency heart centre and use of other health care re sources . RESULTS Education and support from a nurse in a hospital setting and at home significantly increases self-care behaviour in patients with heart failure . Patients from both the intervention and the control group increased their self-care behaviour within 1 month of discharge , but the increase in the intervention group was significantly more after 1 month . Although self-care behaviour in both groups decreased during the following 8 months , the increase from baseline remained statistically significant in the intervention group , but not in the control group . No significant effects on re source utilization were found . CONCLUSIONS Intensive , systematic , tailored and planned education and support by a nurse results in an increase in patients ' self-care behaviour . No significant effects were found on use of health care re sources . Additional organisational changes , such as longer follow-up and the availability of a heart failure specialist would probably enhance the effects of education and support Abstract Objectives : To determine whether specialist nurse intervention improves outcome in patients with chronic heart failure . Design : R and omised controlled trial . Setting : Acute medical admissions unit in a teaching hospital . Participants : 165 patients admitted with heart failure due to left ventricular systolic dysfunction . The intervention started before discharge and continued thereafter with home visits for up to 1 year . Main outcome measures : Time to first event analysis of death from all causes or readmission to hospital with worsening heart failure . Results : 31 patients ( 37 % ) in the intervention group died or were readmitted with heart failure compared with 45 ( 53 % ) in the usual care group ( hazard ratio=0.61 , 95 % confidence interval 0.33 to 0.96).Compared with usual care , patients in the intervention group had fewer readmissions for any reason ( 86 v 114 , P=0.018 ) , fewer admissions for heart failure ( 19 v 45 , P<0.001 ) and spent fewer days in hospital for heart failure ( mean 3.43 v 7.46 days , P=0.0051 ) . Conclusions : Specially trained nurses can improve the outcome of patients admitted to hospital with heart failure . What is already known on this topic Studies have suggested that nurse intervention may reduce readmission in patients with heart failure What this study adds Home based intervention from nurses reduces readmissions for worsening heart failure Regular contact to review treatment and patient education are likely to contribute to this CONTEXT Most older adults with dementia will be cared for by primary care physicians , but the primary care practice environment presents important challenges to providing quality care . OBJECTIVE To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease . DESIGN , SETTING , AND PATIENTS Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were r and omized by physician to receive collaborative care management ( n = 84 ) or augmented usual care ( n = 69 ) at primary care practice s within 2 US university-affiliated health care systems from January 2002 through August 2004 . Eligible patients ( identified via screening or medical record ) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver . INTERVENTION Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient 's family caregiver and integrated within primary care . The team used st and ard protocol s to initiate treatment and identify , monitor , and treat behavioral and psychological symptoms of dementia , stressing nonpharmacological management . MAIN OUTCOME MEASURES Neuropsychiatric Inventory ( NPI ) administered at baseline and at 6 , 12 , and 18 months . Secondary outcomes included the Cornell Scale for Depression in Dementia ( CSDD ) , cognition , activities of daily living , re source use , and caregiver 's depression severity . RESULTS Initiated by caregivers ' reports , 89 % of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocol s. Intervention patients were more likely to receive cholinesterase inhibitors ( 79.8 % vs 55.1 % ; P = .002 ) and antidepressants ( 45.2 % vs 27.5 % ; P = .03 ) . Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months ( mean difference , -5.6 ; P = .01 ) and at 18 months ( mean difference , -5.4 ; P = .01 ) . Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months ; at 18 months , caregivers showed improvement in depression as measured by the Patient Health Question naire-9 . No group differences were found on the CSDD , cognition , activities of daily living , or on rates of hospitalization , nursing home placement , or death . CONCLUSIONS Collaborative care for the treatment of Alzheimer disease result ed in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers . These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00246896 OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) < 40 % were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure OBJECTIVES We sought to determine whether a multidisciplinary outpatient management program decreases chronic heart failure ( CHF ) hospital readmissions and mortality over a six-month period . BACKGROUND Hospital admission for CHF is an important problem amenable to improved outpatient management . METHODS Two hundred patients hospitalized with CHF at increased risk of hospital readmission were r and omized to a multidisciplinary program or usual care . A study cardiologist and a CHF nurse evaluated each patient and made recommendations to the patient 's primary physician before r and omization . The intervention team consisted of a cardiologist , a CHF nurse , a telephone nurse coordinator and the patient 's primary physician . Contact with the patient was on a prespecified schedule . The CHF nurse followed an algorithm to adjust medications . Patients in the nonintervention group were followed as usual . The primary outcome was the composite of the number of CHF hospital admissions and deaths over six months , compared by using a log transformation t test by intention-to-treat analysis . RESULTS The median age of the study patients was 63.5 years , and 39.5 % were women . There were 43 CHF hospital admissions and 7 deaths in the intervention group , as compared with 59 CHF hospital admissions and 13 deaths in the nonintervention group ( p = 0.09 ) . The quality -of-life score , percentage of patients on target vasodilator therapy and percentage of patients compliant with diet recommendations were significantly better in the intervention group . Cost per patient , in 1998 U.S. dollars , was similar in both groups . CONCLUSIONS This study demonstrates that a six-month , multidisciplinary approach to CHF management can improve important clinical outcomes at a similar cost in recently hospitalized high-risk patients with CHF BACKGROUND Nursing approaches to manage patients with heart failure ( HF ) showed benefits in reducing the morbidity and mortality . However , combining intra-hospital education with telephone contact after hospital discharge has been little explored . OBJECTIVE To compare two nursing intervention groups among patients hospitalized due to decompensated HF : the intervention group ( IG ) received educational nursing intervention during hospitalization followed by telephone monitoring after discharge and the control group ( CG ) received in-hospital intervention only . Outcomes were levels of HF and self-care knowledge , the frequency of visits to the emergency room , rehospitalizations and deaths in a three-month period . METHODS R and omized clinical trial . We studied adult HF patients with left ventricle ejection fraction ( LVEF ) < 45 % who could be contacted by telephone after discharge . HF awareness was evaluated through a st and ardized question naire that also included questions regarding self-care knowledge , which was answered during the hospitalization period and three months later . For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study . RESULTS Forty-eight patients were assigned to the IG and 63 to the CG . Mean age ( 63 ± 13 years ) and L ( around 29 % ) were similar in the two groups . Scores for HF and self-care knowledge were similar at baseline . Three months later , both groups showed significantly improved HF awareness and self-care knowledge scores ( P < 0.001 ) . Other outcomes were similar . CONCLUSION An in-hospital educational nursing intervention benefitted all HF patients in underst and ing their disease , regardless of telephone contact after discharge Background : home visits and telephone calls are two often used approaches in transitional care but their differential effects are unknown . Objective : to examine the overall effects of a transitional care programme for discharged medical patients and the differential effects of telephone calls only . Design : r and omised controlled trial . Setting : a regional hospital in Hong
Output:
| High-intensity TCIs ( combining home visits with telephone followup , clinic visits , or both ) reduced readmission risk regardless of the duration of follow-up .
High-intensity interventions seem to be the best option .
Moderate-intensity interventions implemented for 6 months or longer may be another option |
MS211289 | ***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 : To compare the course of inflammation after small‐incision cataract surgery with implantation of 1 of 3 types of foldable intraocular lenses ( IOLs ) in eyes with uveitis . Setting : Department of Ophthalmology , University of Vienna , Vienna , Austria . Methods : Seventy‐four eyes with uveitis and cataract and 68 control eyes with cataract were prospect ively selected to receive a foldable hydrophilic acrylic ( Hydroview ® , Bausch & Lomb ) , hydrophobic acrylic ( AcrySof ® , Alcon ) , or silicone ( CeeOn ® 911 , Pharmacia ) IOL . All surgery was performed by the same surgeon using a st and ardized protocol : clear corneal incision , capsulorhexis , phacoemulsification , and in‐the‐bag IOL implantation . Preoperative and postoperative inflammation was evaluated by measuring aqueous flare preoperatively and 1 , 3 , 7 , 28 , 90 , and 180 days after surgery using the Kowa FC‐1000 ® laser flare‐cell meter . All uveitic eyes were in remission for at least 3 months before surgery . Results : In the uveitic eyes , there was no statistically significant difference in the postoperative course of flare and cell among the 3 IOL groups . Six months after surgery in uveitic eyes , flare values reached preoperative levels and the cell count was lower than preoperatively in all 3 IOL groups . Relative flare values were higher in the eyes with uveitis and a CeeOn 911 IOL ; however , the difference between this group and the 2 acrylic IOL groups was not significant . Conclusions : There were no significant differences in inflammation after implantation of foldable IOLs in uveitic eyes . Although absolute flare values and cell counts in eyes with uveitis were higher than in control eyes , primarily because of a damaged blood‐aqueous barrier ( BAB ) , BAB recovery was similar between the 2 groups . The changes in the BAB indicate that foldable IOL implantation is safe in uveitic eyes Purpose : To evaluate the postoperative outcomes in uveitic eyes after phacoemulsification and posterior chamber intraocular lens ( IOL ) implantation . Setting : Multicenter ( 19 ) international study . Methods : This prospect i ve r and omized comparative interventional case series comprised 140 eyes of 140 patients who had phacoemulsification and implantation of IOLs of various material s : hydrophobic acrylic ( n = 48 ) , silicone ( n = 44 ) , poly(methyl methacrylate ) ( PMMA ) ( n = 26 ) , or heparin‐surface‐modified PMMA ( HSM PMMA ) ( n = 22 ) . Preoperative and postoperative grading and control of intraocular inflammation were performed . Clinical ly significant observations , visual outcomes , and the incidence of postoperative complications were recorded . Results : At the final follow‐up , 64 eyes ( 46.3 % ) had a best corrected visual acuity of 20/40 or better , an improvement that was highly significant ( P < .0001 ) . One day after surgery , the acrylic group had the lowest inflammation values and the silicone group the highest ( P = .02 ) . The acrylic group continued to have the lowest inflammation grade values until the 3‐month follow‐up . The acrylic and HSM PMMA groups had the lowest incidence of relapses . Posterior capsule opacification developed in 48 eyes ( 34.2 % ) , with the highest incidence in the silicone group . Conclusions : Phacoemulsification with IOL implantation in selected uveitic eyes was safe and effective . Acrylic IOLs provided a better visual outcome and lower complication rate than IOLs of other material Background To compare a hydrophobic and a hydrophilic acrylic single-piece intraocular lens ( IOL ) in uveitis patients with respect to biocompatibility and visual outcome . Methods Prospect i ve , r and omized study in patients with noninfectious uveitis after phacoemulsification and implantation of either a hydrophobic AcrySof ™ ( group 1 , n = 30 ) or a hydrophilic Akreos adapt ™ ( group 2 , n = 30 ) , sharp-edged acrylic IOL . The primary outcome was uveal biocompatibility , detected by giant-cell deposition , anterior chamber cell count and laserflare photometry over a 6-month follow-up period . Secondary outcome measures were capsular biocompatibility , as detected by posterior capsule opacification ( PCO ) , lens epithelial cell outgrowth and Nd : YAG capsulotomies , and visual outcome . Results The groups did not differ with respect to anatomic type of uveitis , immunosuppressive treatment , associated systemic disease , and intraoperative manipulation . The number of giant cells on the anterior IOL surface was higher in group 1 than in group 2 ( p = 0.03 ) . The number of anterior chamber cells , laser flare photometry levels , and uveitis reactivations after surgery did not differ between the groups . After 6 months , the number of patients with PCO development ( p = 1.0 ) and Nd : YAG capsulotomies ( p = 0.21 ) , lens epithelial cell outgrowth , visual outcome and uveitis complications were comparable in both groups . Conclusions Both of the acrylic IOLs used had good uveal and capsular biocompatibility , leading to significant improvement in BCVA in patients with noninfectious uveitis . No obvious differences were detected at 6 months with respect to uveal and capsular biocompatibility and visual outcome OBJECTIVE To assess the outcome of cataract surgery in eyes of patients with uveitis . DESIGN Prospect i ve , noncomparative case series . PARTICIPANTS A total of 90 eyes of 76 patients fulfilled the enrollment criteria . INTERVENTION All patients had their surgery performed using st and ard cataract extraction techniques . Unless contraindicated , preoperative systemic steroids were administered to all patients with posterior disease , chronic anterior uveitis , with known macular edema , and those in whom outcome of cataract surgery on the fellow eye had been poor . RESULTS Patients were divided into those with anterior disease ( n = 53 ) and those with posterior disease ( n = 37 ) . Overall , 81 ( 90 % ) of 90 eyes showed improvement in vision ( median + 4 Snellen lines ) . In those with anterior disease , the development of severe uveitis in the first week postsurgery was associated with a greater incidence of macular edema ( P = 0.014 ) . The single largest diagnosis in those with posterior disease was that of panuveitis ( n = 24 ) . This group showed the poorest visual outcomes in this study . The majority of patients , however , were noted to have visual loss secondary to conditions present before surgery . CONCLUSION Cataract surgery in eyes with uveitis leads to an improvement of vision in the majority of cases . Severe postoperative uveitis is the most common postoperative complication and is associated with a significant risk of macular edema in those with anterior disease . In the posterior group , poor visual outcome after surgery is most commonly the result of preoperative vision-limiting conditions Purpose To compare the clinical results of heparin surface modified ( HSM ) hydrophilic acrylic intraocular lens ( IOL ) with those of hydrophobic acrylic IOL . Methods One hundred patients with cataract were r and omized to receive one of acrylic foldable IOLs after phacoemulsification : HSM hydrophilic acrylic IOL ( n=50 ) BioVue3 ® ( BioVue , OII , Ontario , CA , USA ) and hydrophobic acrylic IOL ( n=50 ) Sensar ® ( AR40e , AMO , Santa Ana , CA , USA ) . Best-corrected visual acuity and refractive error were measured at 1 week , 2 months , 6 months and 12 months after surgery in both IOL groups . To assess posterior capsular opacification ( PCO ) , digital retroillumination image of posterior capsule was analyzed at 12 months using POCOman software . Results Best-corrected visual acuity ( log MAR ) was 0.032±0.082 in BioVue3 ® group and 0.034±0.077 in Sensar ® group at 12 months . There was no statistically significant difference between the two groups ( p=0.554 ) . Refractive error was −0.247±0.821 diopter in BioVue3 ® group and −0.264±0.808 diopter in Sensar ® group at 12 months . There was no statistically significant difference of refractive error between the two groups ( p=0.909 ) . At 12 months , BioVue3 ® IOL group had a lower percentage area and severity of PCO than Sensar ® group . However , it was not statistically significant ( p=0.349 , p=0.288 ) . No Nd : YAG capsulotomy was performed in BioVue3 ® group while it was required in two eyes ( 4.0 % ) in Sensar ® group . Conclusions There was no statistically significant difference of postoperative visual acuity , refractive error and degree of PCO between HSM hydrophilic acrylic IOL and hydrophobic acrylic IOL Purpose . To evaluate various available intraocular lenses ( IOL ) ( PMMA , acrylic , heparin coated PMMA , and silicone ) in patients with cataracta complicata and evaluate IOL tolerance , post-operative inflammation , cystoid macular edema , and posterior capsular opacification(PCO ) requiring Nd : YAG capsulotomy . Design . r and omized , double masked clinical trial . Participants . Patients evaluated in the Ocular Immunology and Uveitis Service of the Massachusetts Eye and Ear Infirmary and deemed to need cataract surgery by st and ard criteria were asked to participate in the clinical trial . Patients had to have a diagnosis of chronic uveitis , which was inactive for 3 months prior to cataract surgery . Results . Acrylic lenses appeared to provide the best overall results when evaluated for post-operative inflammation , PCO rates , visual acuity , and cystoid macular edema ( CME ) ( compared to PMMA , silicone , and heparin coated PMMA ) Purpose : To evaluate the uveal and capsular biocompatibility of hydrophilic acrylic , hydrophobic acrylic , and silicone intraocular lenses ( IOLs ) in eyes with uveitis . Setting : Department of Ophthalmology , University of Vienna , Vienna , Austria . Methods : This prospect i ve study comprised 72 eyes with uveitis and 68 control eyes having phacoemulsification and IOL implantation by 1 surgeon . Patients received 1 of the following IOLs : foldable hydrophilic acrylic ( Hydroview ® , Bausch & Lomb ) , hydrophobic acrylic ( AcrySof ® , Alcon ) , or silicone ( CeeOn ® 911 , Pharmacia ) . Postoperative evaluations were at 1 , 3 , and 7 days and 1 , 3 , and 6 months . Cell reaction was evaluated by specular microscopy of the anterior IOL surface and the anterior and posterior capsule reaction , by biomicroscopy . Results : Small round cell deposition was observed on all IOLs in the immediate postoperative period , especially in eyes with uveitis . This reaction decreased 3 to 6 months after surgery . Although the CeeOn 911 had a higher mean grade of small cells , there was no statistical difference between the 3 IOL types after 6 months in the uveitis and control groups . Foreign‐body giant cells ( FBGCs ) increased after 1 week to 1 month . The AcrySof IOLs had the highest number of FBGCs ; after 6 months , there was a statistically significant difference between the AcrySof and Hydroview uveitis groups ( P = .036 ) and the AcrySof and CeeOn 911 uveitis groups ( P = .003 ) but there was no difference among the 3 IOL types in the control group . Lens epithelial cell outgrowth persisted on the Hydroview IOLs in control eyes and regressed on all 3 IOL types in uveitic eyes and on the AcrySof and CeeOn 911 IOLs in control eyes ( P = .0001 ) . Anterior capsule opacification ( ACO ) was more severe on all IOL types in uveitic eyes and on the CeeOn 911 IOL in control eyes . Posterior capsule opacification ( PCO ) was more severe in uveitic eyes . The Hydroview group had more severe PCO than the AcrySof and the CeeOn 911 groups in uveitis and control eyes . Six months postoperatively , the difference was significant ( P = .0001 ) . There was no significant difference between the AcrySof and CeeOn 911 IOLs . Conclusions : Intraocular lens biocompatibility is inversely related to inflammation . Hydrophilic acrylic material had good uveal but worse capsular biocompatibility . Hydrophobic acrylic material had lower uveal but better capsular biocompatibility . Silicone showed a higher small cell count ( mild ) and more severe ACO but achieved PCO results comparable to FBGC results and better than those with the AcrySof lens 6 months after surgery . Despite the differences in IOL biocompatibility , all patients benefited from the surgery PURPOSE A heparin surface modified posterior chamber intraocular lens ( IOL ) was compared with a conventional polymethylmethacrylate ( PMMA ) IOL regarding postoper
Output:
| AUTHORS ' CONCLUSIONS Based on the trials identified in this review , there is uncertainty as to which type of IOL provides the best visual and clinical outcomes in people with uveitis undergoing cataract surgery .
However , due to small sample sizes and heterogeneity in outcome reporting , we found insufficient information to assess these and other types of IOL material s for cataract surgery for eyes with uveitis |
MS211290 | ***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: Wolfberry ( fruit of Lycium barbarum ) has been prized for many years in China for its immunomodulatory property and its high specific antioxidant content . However , clear clinical evidence demonstrating the effect of wolfberry dietary supplementation is still lacking . After our earlier report showing that a proprietary milk-based wolfberry formulation ( Lacto-Wolfberry ) enhances in vivo antigen-specific adaptive immune responses in aged mice , the present study aim ed at demonstrating the effect of dietary Lacto-Wolfberry supplementation on immune functions in the elderly , especially vaccine response known to decline with aging . A 3-month r and omized , double-blinded , placebo-controlled study was conducted on 150 healthy community-dwelling Chinese elderly ( 65 - 70 years old ) supplemented with Lacto-Wolfberry or placebo ( 13.7 grams/day ) . Immune response to influenza vaccine was assessed in the study , along with inflammatory and physical status . No serious adverse reactions were reported during the trial , neither symptoms of influenza-like infection . No changes in body weight and blood pressure , blood chemistry or cells composition , as well as autoantibodies levels were observed . The subjects receiving Lacto-Wolfberry had significantly higher postvaccination serum influenza-specific immunoglobulin G levels and seroconversion rate , between days 30 and 90 , compared with the placebo group . The postvaccination positive rate was greater in the Lacto-Wolfberry group compared to the placebo group , but did not reach statistical significance . Lacto-Wolfberry supplementation had no significant effect on delayed-type hypersensitivity response and inflammatory markers . In conclusion , long-term dietary supplementation with Lacto-Wolfberry in elderly subjects enhances their capacity to respond to antigenic challenge without overaffecting their immune system , supporting a contribution to reinforcing immune defense in this population Abstract This study evaluated the effects of 10-day broccoli ( 250 g/day ) intake on dietary markers and markers of inflammations in young male smokers . A dietary intervention study with a repeated measures crossover design was conducted . Circulating levels of carotenoids , folate , C-reactive protein ( CRP ) , tumor necrosis factor alpha ( TNF-α ) , interleukin 6 ( IL-6 ) , interleukin 6 receptor ( IL-6sR ) and adiponectin were measured . Broccoli intake significantly increased plasma levels of folate ( + 17 % ) and lutein ( + 39 % ) , while no significant effect was observed for TNF-α , IL-6 , IL-6sR or adiponectin . Plasma CRP decreased by 48 % ( post-hoc analysis , p < 0.05 ) following broccoli diet ; this result ed to be independent from the plasma variations in lutein and folate . An inverse correlation between lycopene , TNF-α and IL-6sR was observed at baseline . In conclusion , broccoli consumption may reduce CRP levels in smokers , consistent with epidemiologic observations that fruit and vegetable intake is associated with lower circulating CRP concentrations Obesity and sedentary lifestyle are associated with increased oxidative stress , inflammation and vessel dysfunction . Previous research has shown that an encapsulated fruit/berry/vegetable juice powder ( FBV ) supplement or controlled exercise training improve the markers of redox biology , low- grade inflammation and circulation . The aim of the present study was to assess the effects of 8 weeks of supplementation with FBV or placebo , and a single bout of controlled walking on the markers of oxidation , inflammation and skin capillary microcirculation in forty-two obese pre-menopausal women ( 41 ( sd 5 ) years , non-smokers and BMI 34·5 ( sd 3·8 ) kg/m2 ) using a r and omised , double-blind , placebo-controlled design . All assessment s were made before and after 8 weeks of capsule supplementation , and pre- and post-30 min of controlled treadmill walking at 70 % of VO2max . Venous blood was collected for the determination of carbonyl proteins ( CP ) , oxidised LDL ( ox-LDL ) , total oxidation status ( TOS ) of lipids , malondialdehyde , TNF-α and IL-6 . Capillary blood flow , O2 saturation of Hb ( SO2Hb ) and the relative concentration of Hb ( rHb ) were assessed at a 2 mm skin depth . Following 8 weeks of supplementation , compared with placebo , the FBV group had a significant ( P < 0·05 ) reduction in CP , ox-LDL , TOS and TNF-α , and a significant increase in blood flow , SO2Hb and rHb . Independent of supplementation , moderate exercise significantly increased blood flow and rHb , with a trend towards increased SO2Hb . Compared with placebo , 8 weeks of supplementation with FBV decreased the markers of systemic oxidation and inflammation . Both FBV supplementation and a single walking bout improved the markers of the microcirculation in these obese women In the elderly , immunosenescence and malnourishment can contribute to increased risk and severity of upper respiratory tract infections ( URTI ) . Gold kiwifruit ( Actinidia chinensis ' Hort16A ' ) contains nutrients important for immune function and mitigation of symptoms of infection , including vitamins C and E , folate , polyphenols and carotenoids . The objective of the present study was to evaluate whether regular consumption of gold kiwifruit reduces symptoms of URTI in older people , and determine the effect it has on plasma antioxidants , and markers of oxidative stress , inflammation and immune function . A total of thirty-two community-dwelling people ( ≥65 years ) participated in a r and omised crossover study , consuming the equivalent of four kiwifruit or two bananas daily for 4 weeks , with treatments separated by a 4-week washout period . Participants completed the Wisconsin Upper Respiratory Symptom Survey-21 daily , and blood sample s were collected at baseline and at the end of each treatment and washout period . Gold kiwifruit did not significantly reduce the overall incidence of URTI compared with banana , but significantly reduced the severity and duration of head congestion , and the duration of sore throat . Gold kiwifruit significantly increased plasma vitamin C , α-tocopherol and lutein/zeaxanthin concentrations , and erythrocyte folate concentrations , and significantly reduced plasma lipid peroxidation . No changes to innate immune function ( natural killer cell activity , phagocytosis ) or inflammation markers ( high-sensitivity C-reactive protein , homocysteine ) were detected . Consumption of gold kiwifruit enhanced the concentrations of several dietary plasma analytes , which may contribute to reduced duration and severity of selected URTI symptoms , offering a novel tool for reducing the burden of URTI in older individuals Introduction Air pollutant exposure has been associated with an increase in inflammatory markers and a decline in lung function in asthmatic children . Several studies suggest that dietary intake of fruits and vegetables might modify the adverse effect of air pollutants . Methods A total of 158 asthmatic children recruited at the Children 's Hospital of Mexico and 50 non-asthmatic children were followed for 22 weeks . Pulmonary function was measured and nasal lavage collected and analyzed every 2 weeks . Dietary intake was evaluated using a 108-item food frequency question naire and a fruit and vegetable index ( FVI ) and a Mediterranean diet index ( MDI ) were constructed . The impact of these indices on lung function and interleukin-8 ( IL-8 ) and their interaction with air pollutants were determined using mixed regression models with r and om intercept and r and om slope . Results FVI was inversely related to IL-8 levels in nasal lavage ( p < 0.02 ) with a significant inverse trend ( test for trend p < 0.001 ) , MDI was positively related to lung function ( p < 0.05 ) , and children in the highest category of MDI had a higher FEV1 ( test for trend p < 0.12 ) and FVC ( test for trend p < 0.06 ) than children in the lowest category . A significant interaction was observed between FVI and ozone for FEV1 and FVC as was with MDI and ozone for FVC . No effect of diet was observed among healthy children . Conclusion Our results suggest that fruit and vegetable intake and close adherence to the Mediterranean diet have a beneficial effect on inflammatory response and lung function in asthmatic children living in Mexico City Phytochemicals from fruit and vegetables reduce systemic inflammation . This study examined the effects of an encapsulated fruit and vegetable ( F&V ) juice concentrate on systemic inflammation and other risk factors for chronic disease in overweight and obese adults . A double-blinded , parallel , r and omized placebo-controlled trial was conducted in 56 adults aged ≥40 years with a body mass index ( BMI ) ≥28 kg/m2 . Before and after eight weeks daily treatment with six capsules of F&V juice concentrate or placebo , peripheral blood gene expression ( microarray , quantitative polymerase chain reaction ( qPCR ) ) , plasma tumour necrosis factor (TNF)α ( enzyme-linked immunosorbent assay ( ELISA ) ) , body composition ( Dual-energy X-ray absorptiometry ( DEXA ) ) and lipid profiles were assessed . Following consumption of juice concentrate , total cholesterol , low-density lipoprotein ( LDL ) cholesterol and plasma TNFα decreased and total lean mass increased , while there was no change in the placebo group . In subjects with high systemic inflammation at baseline ( serum C-reactive protein ( CRP ) ≥3.0 mg/mL ) who were supplemented with the F&V juice concentrate ( n = 16 ) , these effects were greater , with decreased total cholesterol , LDL cholesterol and plasma TNFα and increased total lean mass ; plasma CRP was unchanged by the F&V juice concentrate following both analyses . The expression of several genes involved in lipogenesis , the nuclear factor-κB ( NF-κB ) and 5′ adenosine monophosphate-activated protein kinase ( AMPK ) signalling pathways was altered , including phosphomevalonate kinase ( PMVK ) , zinc finger AN1-type containing 5 ( ZF AND 5 ) and calcium binding protein 39 ( CAB39 ) , respectively . Therefore , F&V juice concentrate improves the metabolic profile , by reducing systemic inflammation and blood lipid profiles and , thus , may be useful in reducing the risk of obesity-induced chronic disease A freeze-dried fruit and vegetable juice powder ( JUICE ) was investigated as a countermeasure nutritional strategy to exercise-induced inflammation , oxidative stress , and immune perturbations in trained cyclists . Thirty-four cyclists ( 25 male , 9 female ) were r and omized to control ( nonJUICE ) or JUICE for 17 days . JUICE provided 230 mg·day(-1 ) of flavonoids , doubling the typical adult daily intake . During a 3-d period of intensified exercise ( days 15 - 17 ) , subjects cycled at 70%-75 % V̇O2max for 2.25 h per day , followed by a 15-min time trial . Blood sample s were collected presupplementation , post supplementation ( pre-exercise ) , and immediately and 14-h post exercise on the third day of exercise . Sample s were analyzed for inflammation ( interleukin (IL)-6 , IL-8 ; tumor necrosis factor alpha ( TNFα ) ; monocyte chemoattractant protein-1 ( MCP-1 ) ) , oxidative stress ( oxygen radical absorbance capacity ( ORAC ) , ferric reducing ability of plasma ( FRAP ) , reduced and oxidized glutathione , protein carbonyls ) , and innate immune function ( granulocyte ( G-PHAG ) and monocyte ( M-PHAG ) phagocytosis and oxidative burst activity ) . A 2 ( group ) × 4 ( time points ) repeated measures ANOVA revealed significant time effects due to 3 days of exercise for IL-6 ( 396 % increase ) , IL-8 ( 78 % increase ) , TNFα ( 12 % increase ) , MCP-1 ( 30 % increase ) , G-PHAG ( 38 % increase ) , M-PHAG ( 36 % increase ) , FRAP ( 12.6 % increase ) , ORAC ( 11 % decrease at 14 h post exercise ) , and protein carbonyls ( 82 % increase at 14 h post exercise ) ( p < 0.01 ) . No significant interaction effects were found for any of the physiological measures . Although providing 695 gallic acid equivalents of polyphenols per day , JUICE treatment for 17 days did not change exercise-induced alterations in inflammation and oxidative stress or immune function in trained cyclists after a 3-day period of overreaching Inflammation and endothelial activation are associated with an increased risk of CVD and epidemiological evidence suggests an association between levels of markers of inflammation or endothelial activation and the intake of fruit . Also , vitamin E , a fat-soluble antioxidant , has anti-inflammatory properties . We performed a r and omised 2 x 2 factorial , crossover trial to determine the effect of orange and blackcurrant juice ( 500 ml/d ) and vitamin E ( 15 mg RRR-alpha-tocopherol/d ) supplementation on markers of inflammation and endothelial
Output:
| Conclusions In conclusion , this review suggests that higher intakes of fruit and vegetables lead to both a reduction in proinflammatory mediators and an enhanced immune cell profile |
MS211291 | ***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: Reports on the relationship between comorbidity and glycemia control in diabetic patients are conflicting and the method of measuring comorbidity varies widely among studies . The aim of the present study was to evaluate the relationship between diabetes control and comorbidity , taking into account all comorbidities and their severity , in a primary care setting . We performed a retrospective descriptive study based on chart review of 96 r and omly selected type 2 diabetic patients . Comorbidity was measured with the cumulative illness rating scale ( CIRS ) , an exhaustive comorbidity index . Diabetes was considered as controlled if the mean value of two measurements of glycosylated hemoglobin A ( HbA1c ) was less than 7 % . Taking diabetes control as the dependent variable , its relationship with the CIRS score , age , sex , diabetes duration , and diabetes-related complications was explored . Diabetes control was not significantly related with the CIRS score , age , sex or diabetes severity . Diabetes duration was the only variable significantly related to diabetes control . Our study suggests that comorbidity measured with the CIRS in patients with type 2 diabetes is not a factor that prevents the achievement of a good glycemia control Diabetes mellitus is a leading cause of death in the United States and is associated with microvascular and macrovascular complications . Approximately 29.1 million persons , or 9.3 % of the U.S. population , have type 2 diabetes ( 1 ) . In 2012 , the total direct and indirect costs associated with diabetes in the United States were $ 245 billion ( 1 ) . Markedly elevated glucose levels can result in subacute symptoms , such as polyuria , polydipsia , weight loss , and dehydration . Over time , the metabolic derangements associated with diabetes may lead to vision loss , painful neuropathy or sensory loss , foot ulcers , amputations , myocardial infa rct ions , strokes , and end-stage renal disease . Lowering blood glucose may decrease risk for complications , but lowering strategies come with harms , patient burden , and costs . Blood glucose can be measured in various ways , including the hemoglobin A1c ( HbA1c ; also called glycosylated or glycated hemoglobin ) level , which approximates average blood glucose control over about 3 months . As with all laboratory tests , HbA1c measurements are associated with variability ( 2 ) and can vary further with race and ethnicity ( 35 ) . Guidelines have historically recommended initiation or intensification of pharmacologic therapy to achieve specific HbA1c targets , depending on the population in question . The ideal target that optimally balances benefits and harms remains uncertain . Guidance Statement Focus and Target Population The purpose of this American College of Physicians ( ACP ) guidance statement is to critically review the available guidelines from various organizations and the evidence included therein to assist clinicians in making decisions about targets when using pharmacologic therapy in adults with type 2 diabetes . Recent data suggesting that newer agents reduce cardiovascular morbidity and mortality in high-risk patients with type 2 diabetes have prompted calls for a fundamental shift in diabetes management . Some anticipate that treatment decisions will eventually be based more on cardiovascular risk than achievement of specific HbA1c targets , analogous to recent changes in lipid management . However , for the foreseeable future , glycemic targets will continue to influence management decisions by front-line clinicians ( 6 ) . This statement focuses on the benefits and harms of targeting lower versus higher HbA1c levels and does not cover use of specific medications outside of their use to achieve HbA1c targets . The intended audience is all clinicians , and the target population is nonpregnant adults with type 2 diabetes . Methods The Clinical Guidelines Committee ( CGC ) of ACP develops guidance statements on topics where several conflicting guidelines are available . We provide clinicians with a rigorous review of the guidelines and the evidence they include . We then adopt the clinical recommendations if we agree with their evaluation of benefits and harms or adapt them if changes are needed based on our assessment of the recommendations and evidence . Data Sources and Guideline Selection We search ed the National Guideline Clearinghouse and the Guidelines International Network library ( May 2017 ) for guidelines on recommended HbA1c targets in the treatment of type 2 diabetes in nonpregnant outpatient adults . We included guidelines that were developed by national organizations , were published in English , and targeted the correct population . We review ed titles and abstract s and excluded guidelines that were modified or adapted from other organizations or addressed specific population s ( such as pregnant women or patients with kidney disease ) . Our search yielded guidelines from the National Institute for Health and Care Excellence ( NICE ) ( 7 ) and the Institute for Clinical Systems Improvement ( ICSI ) ( 8) . On the basis of the knowledge and expertise of ACP CGC members , we also selected the following 4 guidelines not identified in either data base at the time of the search but commonly used in clinical practice : the American Association of Clinical Endocrinologists and American College of Endocrinology ( AACE/ACE ) guideline ( 9 ) , the American Diabetes Association ( ADA ) guideline ( 10 ) , the Scottish Intercollegiate Guidelines Network ( SIGN ) guideline ( 11 ) , and the U.S. Department of Veterans Affairs and Department of Defense ( VA/DoD ) guideline ( 12 ) . Quality Assessment Six co authors independently review ed and assessed each guideline using the AGREE II ( Appraisal of Guidelines for Research and Evaluation II ) instrument ( 13 ) . This instrument asks 23 questions in the following 6 domains : scope and purpose , stakeholder involvement , rigor of development , clarity of presentation , applicability , and editorial independence . The authors scored each guideline independently , and the scores were compared ( Appendix Figure and Appendix Table 1 ) . Authors then provided a summary determination of whether they would recommend this guideline for use by recording yes , no , or yes with modifications . Appendix Figure . Mean AGREE II scores for items in each domain across the 6 review ers . Each question was rated on a Likert scale with a minimum of 1 point and a maximum of 7 points . The scores were averaged for each of the 6 review ers . Error bars represent calculated st and ard deviation . AACE/ACE = American Association of Clinical Endocrinologists and American College of Endocrinology ; ADA = American Diabetes Association ; AGREE II = Appraisal of Guidelines for Research and Evaluation II ; GDG = guideline development group ; ICSI = Institute for Clinical Systems Improvement ; NICE = National Institute for Health and Care Excellence ; SIGN = Scottish Intercollegiate Guidelines Network ; VA/DoD = U.S. Department of Veterans Affairs and Department of Defense . Appendix Table 1 . Scaled AGREE II Domain Scores for Each Guideline and Overall Assessment Peer Review The draft guidance statement was peer- review ed through Annals of Internal Medicine and was posted online for comments from ACP Regents and Governors , who represent ACP members at the regional level . The final guidance statement incorporated comments from peer review ers and ACP Regents and Governors . Public Panel Review The development of this guidance statement also included perspectives , values , and preferences of 2 CGC members who represent the public and a 7-member public panel . Summary of Evaluated Guidelines Using the AGREE II Instrument We review ed and rated 6 guidelines ( AACE/ACE [ 9 ] , ADA [ 10 ] , ICSI [ 8 ] , NICE [ 7 ] , SIGN [ 11 ] , and VA/DoD [ 12 ] ) , focusing solely on sections addressing HbA1c targets in patients with type 2 diabetes . Appendix Table 1 shows the detailed scaled domain scores and average quality ratings for each guideline , and the Appendix Figure shows average AGREE II scores for each item in each of the 6 domains . The fundamental difference between high- and low-scoring guidelines was methodology . The 2 lowest-scoring guidelines , AACE/ACE and ADA , scored lowest on stakeholder involvement , applicability , editorial independence , and scientific rigor . A systematic review is the backbone for any trustworthy guideline , but some guidelines might not be based on a systematic review or may not have made the review publicly available ( 14 , 15 ) . Several factors were important in considering guideline quality . For example , although many guidelines described benefits , adverse effects , and the strength and limitations of evidence or linked the evidence to the recommendation , they often inadequately described how they had considered or weighted these factors in developing the final recommendations . The guidelines frequently relied on selective reporting of studies or outcomes and focused on relative versus absolute effects and asymptomatic surrogate measures rather than patient-centered health outcomes . All of the review ed guidelines recommend individualizing HbA1c targets on the basis of patient characteristics , such as comorbid conditions and risk for hypoglycemia ( Appendix ) . The ADA and SIGN guidelines recommend a target of 7 % for the general population , whereas AACE/ACE recommends 6.5 % ( if it can be achieved safely ) . The NICE guideline specifies 6.5 % or 7 % , depending on the patient 's treatment regimen . Both ICSI and VA/DoD recommend target ranges . The ICSI guideline recommends less than 7 % to less than 8 % based on patient factors , whereas the VA/DoD recommends the following target ranges based on life expectancy and comorbid conditions : 6 % to 7 % for patients with a life expectancy greater than 10 to 15 years and no or mild microvascular complications ; 7 % to 8.5 % for those with established microvascular or macrovascular disease , comorbid conditions , or a life expectancy of 5 to 10 years ; and 8 % to 9 % for those with a life expectancy less than 5 years , significant comorbid conditions , advanced complications of diabetes , or difficulties in self-management attributable to mental status , disability , or other factors ( 12 ) . All guidelines recognize that HbA1c targets can be higher in patients with comorbid conditions and limited life expectancy . We looked into the evidence presented in these guidelines , specifically 5 large , long-term r and omized trials with a treat-to-target strategy and corresponding reports on extended follow-up ( 1623 ) . We summarize below the individual studies and result ing benefits and harms . Note that recent studies evaluating the effectiveness and safety of several newer diabetes drugs ( for example , recently approved sodiumglucose cotransporter-2 inhibitors , dipeptidyl peptidase-4 inhibitors , and glucagon-like peptide-1 receptor agonists ) were not considered in guideline sections pertaining to HbA1c targets because these studies were not design ed to evaluate treat-to-target strategies . Therefore , their findings are not described here . Benefits and Harms of Lower HbA1c Targets : Evidence From Clinical Trials Five large , long-term r and omized controlled trials investigated intensive ( achieved HbA1c levels , 6.3 % to 7.4 % ) versus less intensive ( achieved HbA1c levels , 7.3 % to 8.4 % ) OBJECTIVE To determine the relationship between social support and certain indicators of physical and mental wellbeing in older adults with type 2 diabetes . MATERIAL AND METHODS We undertook a population -based cross sectional study of 705 adults with type 2 diabetes from the Instituto Mexicano del Seguro Social ( IMSS ) . Participants were r and omly selected from a list of diabetic patients located in the south of Mexico City . Physical and mental wellbeing were assessed through three indicators : 1 ) Health related quality of life ( HRQL ) ; 2 ) depressive symptomatology , and 3 ) glycemic control . Level of social support level was determined using the The Social Support Health Survey instrument . Multiple linear regression models were used to analyze the independent association of social support with the physical and mental wellbeing indicators , controlling for progression time , diabetes complications , co-morbidity and socio-demographic variables . RESULTS High levels of social support were reported by 64 % of participants . Social support and HRQL increased in direct proportion : the more social support a participant reported the less depressive distress and better fasting glucose levels they showed . The results maintained their significance in the four social support subscales , with the exception of affectionate and emotional or informational support subscales , which were not significantly correlated with fasting glucose . Multiple linear regression analyses showed that better levels of social support are associated with improved HRQL ( beta = 0.12 ) , less incidence of depressive symptoms ( beta = -0.20 ) and lower fasting glucose ( beta = -0.10 ) . CONCLUSIONS Our findings suggest that greater levels of social support may improve certain indicators of physical and mental wellbeing in older adults with type 2 diabetes , regardless of the presence of diabetes complications and other chronic pathologies . Thus , promoting social support for the IMSS ' diabetic patients could be a useful intervention The objective of this study was to develop a prospect ively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies . A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients . The 1-yr mortality rates for the different scores were : " 0 " , 12 % ( 181 ) ; " 1 - 2 " , 26 % ( 225 ) ; " 3 - 4 " , 52 % ( 71 ) ; and " greater than or equal to 5 " , 85 % ( 82 ) . The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up . The percent of patients who died of comorbid disease for the different scores were : " 0 " , 8 % ( 588 ) ; " 1 " , 2
Output:
| This review demonstrates that MM in T2D is associated with higher mortality and hypoglycaemia , whilst evidence regarding the association with other measures of glycaemic control is mixed . |
MS211292 | ***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 evaluate the outcomes of patients undergoing subpectoral biceps tenodesis for bicipital tendonitis with a superior labral anterior-posterior ( SLAP ) tear . Patients undergoing primary subpectoral biceps tenodesis for arthroscopically confirmed SLAP tears with signs or findings of bicipital tendonitis were included . An independent observer collected data prospect ively as part of a data repository , which was then analyzed retrospectively . Primary outcome measures were the American Shoulder and Elbow Surgeons ( ASES ) score and pain relief via visual analog scale ( VAS ) . Secondary outcome measures included the Simple Shoulder Test ( SST ) , Constant , Single Assessment Numeric Evaluation ( SANE ) , and Short Form 12 ( SF-12 ) scores . Twenty-eight patients with a mean±SD age of 43.7±13.4 years and a mean±SD follow-up of 2.0±1.0 years met inclusion criteria . Workers ' compensation was involved with 43 % of cases , and 46 % of the included patients were manual laborers . Eight ( 32 % ) patients were athletes , and 88 % of the athletes were overhead athletes . Intraoperatively , 15 ( 54 % ) patients had type I SLAP tears , 10 ( 36 % ) had type II SLAP tears , 1 ( 3 % ) had a type III SLAP tear , and 2 ( 7 % ) had type IV SLAP tears . Significant improvements were seen in the following outcome measures pre- vs postoperatively : ASES score ( 58±23 vs 89±18 ; P=.001 ) , SST score ( 6.3±3.6 vs 10.6±3.3 ; P=.001 ) , SANE score ( 54±24 vs 88±25 ; P=.003 ) , VAS score ( 3.8±2.0 vs 1.1±1.8 ; P=.001 ) , SF-12 overall score ( 35±6 vs 42±6 ; P=.001 ) , and SF-12 physical component score ( 39±6 vs 50±10 ; P=.001 ) . Overall satisfaction was excellent in 80 % of patients . Subpectoral biceps tenodesis demonstrates excellent clinical outcomes in select patients with SLAP tears . [ Orthopedics . 2015 ; 38(1):e48-e53 . ] Background Labral repair and biceps tenodesis are routine operations for superior labrum anterior posterior ( SLAP ) lesion of the shoulder , but evidence of their efficacy is lacking . We evaluated the effect of labral repair , biceps tenodesis and sham surgery on SLAP lesions . Methods A double-blind , sham-controlled trial was conducted with 118 surgical c and i date s ( mean age 40 years ) , with patient history , clinical symptoms and MRI arthrography indicating an isolated type II SLAP lesion . Patients were r and omly assigned to either labral repair ( n=40 ) , biceps tenodesis ( n=39 ) or sham surgery ( n=39 ) if arthroscopy revealed an isolated SLAP II lesion . Primary outcomes at 6 and 24 months were clinical Rowe score ranging from 0 to 100 ( best possible ) and Western Ontario Shoulder Instability Index ( WOSI ) ranging from 0 ( best possible ) to 2100 . Secondary outcomes were Oxford Instability Shoulder Score , change in main symptoms , EuroQol ( EQ-5D and EQ-VAS ) , patient satisfaction and complications . Results There were no significant between-group differences at any follow-up in any outcome . Between-group differences in Rowe scores at 2 years were : biceps tenodesis versus labral repair : 1.0 ( 95 % CI −5.4 to 7.4 ) , p=0.76 ; biceps tenodesis versus sham surgery : 1.6 ( 95 % CI −5.0 to 8.1 ) , p=0.64 ; and labral repair versus sham surgery : 0.6 ( 95 % CI −5.9 to 7.0 ) , p=0.86 . Similar results —no differences between groups — were found for WOSI scores . Postoperative stiffness occurred in five patients after labral repair and in four patients after tenodesis . Conclusion Neither labral repair nor biceps tenodesis had any significant clinical benefit over sham surgery for patients with SLAP II lesions in the population studied . Trial registration number Clinical Trials.gov identifier : This study compared arthroscopic biceps tenodesis with biceps repair for isolated type II superior labrum anterior and posterior ( SLAP ) lesions in patients older than 35 years . The authors identified isolated type II SLAP lesions that were surgically managed over a 5-year period . Minimum 2-year follow-up data were available for 22 patients who underwent biceps repair ( repair group ) and for 15 patients who underwent a primary biceps tenodesis ( tenodesis group ) . Mean age at surgery was 45.2±5.5 years in the repair group and 52.0±8.0 years in the tenodesis group . In the repair group , functional outcome improved from baseline to final follow-up using the American Shoulder and Elbow Surgeons ( ASES ) ( 47.5 to 87.4 , respectively ; P<.0001 ) and University of California , Los Angeles ( UCLA ) scores ( 18.5 to 31.2 , respectively ; P<.0001 ) . In the tenodesis group , similar findings were observed for the ASES ( 43.4 to 89.9 , respectively ; P<.0001 ) and UCLA scores ( 19.0 to 32.7 , respectively ; P<.0001 ) . No difference was found in functional outcome between the groups . Full range of motion recovery was delayed by approximately 3 months in the repair group compared with the tenodesis group ( P=.0631 ) . Two patients in the repair group required a secondary capsular release . Seventy-seven percent of patients in the repair group and 100 % of patients in the tenodesis group were satisfied and returned to normal activity ( P=.0673 ) . In the current study , individuals older than 35 years with an isolated type II SLAP lesion had a shorter postoperative recovery , a more predictable functional outcome , and a higher rate of satisfaction and return to activity with a biceps tenodesis compared with a biceps repair . Based on these observations , biceps tenodesis is preferable to biceps repair for isolated type II SLAP lesions in nonoverhead athletes older than 35 years Background : There are no studies examining superior labrum anterior and posterior ( SLAP ) repair combined with repair of large to massive rotator cuff tears , and it is unclear whether a combined SLAP repair would lead to better outcomes than biceps tenotomy . Hypothesis : Tenotomy and rotator cuff repair would lead to better outcomes compared with those of combined SLAP and rotator cuff repair . Study Design : Cohort study ; Level of evidence , 2 . Methods : Our study population consisted of 36 patients who had undergone either combined SLAP and rotator cuff repair ( when the biceps was too healthy to cut ; group R = 16 patients ) or tenotomy and rotator cuff repair ( when any fraying or partial tear existed in the biceps tendon ; group T = 20 patients ) for concomitant type II SLAP lesions and large to massive rotator cuff tears . The cuff repair was performed in a single row for both groups . Outcomes were assessed by comparing range of motion as well as Simple Shoulder Test ( SST ) , American Shoulder and Elbow Surgeons ( ASES ) , and University of California , Los Angeles ( UCLA ) scores between the 2 groups . Results : At the 2-year follow-up , both groups demonstrated significant improvements in functional shoulder scores and range of motion . However , group T had better SST scores ( group T , 9.3 ± 1.6 ; group R , 7.8 ± 1.9 ; P = .012 ) , ASES scores ( group T , 88.6 ± 8.9 ; group R , 80.4 ±8.9 ; P = .009 ) , UCLA scores ( group T , 29.6 ± 3.0 ; group R , 26.0 ± 4.2 ; P = .007 ) , and forward flexion ( group T , 145.9 ° ± 13.0 ° ; group R , 132.5 ° ± 15.3 ° ; P = .008 ) . The mean tear size and the degree of preoperative muscle atrophy and fatty infiltration on magnetic resonance imaging were similar between the groups . Conclusion : For patients with concomitant type II SLAP lesions and large to massive rotator cuff tears , the outcomes of simultaneous arthroscopic SLAP and rotator cuff repair were inferior to those of arthroscopic biceps tenotomy and cuff repair in terms of functional shoulder scores and range of motion . Biceps tenotomy and rotator cuff repair may be a more reliable method to address concomitant type II SLAP lesions and large to massive rotator cuff tears in patients , although a r and omized controlled trial is needed to confirm the results Background Arthroscopic management has been recommended for some superior labrum anterior and posterior ( SLAP ) lesions , but no studies have focused on patients over 50 years of age with rotator cuff tear and a type II SLAP lesion . Hypothesis In patients over 50 years of age with an arthroscopically confirmed lesion of the rotator cuff and a type II SLAP lesion , there is no difference between ( 1 ) repair of both lesions and ( 2 ) repair of the rotator cuff tear without repair of the SLAP II lesion but with a tenotomy of the long head of the biceps . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods We recruited 63 patients . In 31 patients , we repaired the rotator cuff and the type II SLAP lesion ( group 1 ) . In the other 32 patients , we repaired the rotator cuff and tenotomized the long head of the biceps ( group 2 ) . Seven patients ( 2 in group 1 and 5 in group 2 ) were lost to final follow-up . Results At a minimum 2.9 years ’ follow-up , statistically significant differences were seen with respect to the University of California , Los Angeles ( UCLA ) score and range of motion values . In group 1 ( SLAP repair and rotator cuff repair ) , the UCLA showed a statistically significant improvement from a preoperative average rating of 10.4 ( range , 6–14 ) to an average of 27.9 ( range , 24–35 ) postoperatively ( P < .001 ) . In group 2 ( biceps tenotomy and rotator cuff repair ) , the UCLA showed a statistically significant improvement from a preoperative average rating of 10.1 ( range , 5–14 ) to an average of 32.1 ( range , 30–35 ) postoperatively ( P < .001 ) There was a statistically significant difference in total postoperative UCLA scores and range of motion when comparing the 2 groups postoperatively ( P < .05 ) . Conclusions There are no advantages in repairing a type II SLAP lesion when associated with a rotator cuff tear in patients over 50 years of age . The association of rotator cuff repair and biceps tenotomy provides better clinical outcome compared with repair of the type II SLAP lesion and the rotator cuff PURPOSE The aims of this prospect i ve cohort study were to assess the long-term results after isolated superior labral repair and to determine whether the results were associated with age . METHODS One hundred seven patients underwent repair of isolated SLAP tears . There were 36 women and 71 men with a mean age of 43.8 years ( range , 20 to 68 years ) . Mean follow-up was 5.3 years ( range , 4 to 8 years ) . Of the patients , 62 ( 57.9 % ) were aged 40 years or older . Follow-up examinations were performed by an independent examiner ; 102 patients ( 95.3 % ) had a 5-year follow-up . RESULTS The Rowe score improved from 62.8 ( SD , 11.4 ) preoperatively to 92.1 ( SD , 13.5 ) at follow-up ( P < .001 ) . Satisfaction was rated excellent/good for 90 patients ( 88 % ) at 5 years . There was no significant difference in the results for patients aged 40 years or older and those aged under 40 years . Difficulty with postoperative stiffness and pain was reported by 14 patients ( 13.1 % ) . CONCLUSIONS Our results suggest that long-term outcomes after isolated labral repair for SLAP lesions are good and independent of age . Postoperative stiffness was registered in 13.1 % of the patients . LEVEL OF EVIDENCE Level IV , therapeutic case series The aim of this study was to determine whether or not detaching the biceps tendon from the glenoid after tenodesis performed with the inclusion of the biceps in the rotator cuff suture results in an improved outcome . From 1999 to 2001 , 22 patients had an arthroscopic rotator cuff repair and associated biceps tendon lesions that were repaired with two new arthroscopic techniques of tenodesis incorporating the biceps tendon in the rotator cuff suture . Patients were r and omised into one of two groups : tenodesis without tenotomy ( group 1 ) and tenodesis with tenotomy ( group 2 ) . Preoperative and postoperative functions were assessed by means of a modified UCLA rating scale and shoulder ROM . The mean follow-up period was 47.2 months ( range 36– 59 ) . In group 1 ( tenodesis without tenotomy ) , eight patients had an excellent postoperative score and three a good
Output:
| The pooled results of UCLA score , SST score , and complications showed that the differences were not statistically significant between the two interventions .
The difference of ASES score and satisfaction rate was statistically significant between arthroscopic repair and biceps tenotomy and tenodesis intervention , and arthroscopic biceps tenotomy and tenodesis treatment was more effective .
Conclusions Both arthroscopic repair and biceps tenotomy and tenodesis interventions had benefits in type II SLAP lesions .
Arthroscopic biceps tenotomy and tenodesis treatment provides better clinical outcome in ASES score and satisfaction rate and comparable complications compared with arthroscopic repair treatment . |
MS211293 | ***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 US National Institutes of Health ( NIH ) and Centers for Medicare and Medicaid Services ( CMS ) sponsored a r and omized clinical trial comparing six versus three times per week in-center hemodialysis ( the Frequent Hemodialysis Network [ FHN ] Daily Trial ) , to test the effects of frequent hemodialysis on an array of intermediate outcomes . Herein we report challenges to enrollment and r and omization into the trial . METHODS Screening and enrollment was tracked at all participating dialysis clinics and specific reasons for dropout after baseline assessment were recorded for all enrolled subjects . Reasons for consent refusal were recorded in a subset of ( 10 out of 65 ) sites . RESULTS The trial screened 6276 hemodialysis patients on three times weekly hemodialysis in 65 hemodialysis clinics , 3481 ( 55 % ) were considered eligible for enrollment , and 3124 ( 90 % ) were approached for consent ; 378 ( 12 % ) consented and 245 were r and omized ( 65 % of those enrolled ) . Prospect i ve subjects chose not to participate primarily because of the anticipated time required for three extra treatments per week and the difficulties in following the protocol . CONCLUSIONS Recruitment into the FHN Daily Trial proved challenging but the goal of 250 r and omized subjects was almost met Provider and patient enthusiasm for frequent home nocturnal hemodialysis ( FHNHD ) has been renewed ; however , the cost-effectiveness of this technique is unknown . We performed a cost-utility analysis of FHNHD compared with conventional hemodialysis ( CvHD ; 4 hours three times per week ) from a health payer perspective over a lifetime horizon using patient information from the Alberta NHD r and omized controlled trial . Costs , including training costs , were obtained using microcosting and administrative data ( CAN$2012 ) . We determined the incremental cost per quality -adjusted life year ( QALY ) gained . Robustness was assessed using scenario , sensitivity , and probabilistic sensitivity analyses . Compared with CvHD ( 61 % in-center , 14 % satellite , and 25 % home dialysis ) , FHNHD led to incremental cost savings ( -$6700 ) and an additional 0.38 QALYs . In sensitivity analyses , when the annual probability of technique failure with FHNHD increased from 7.6 % ( reference case ) to ≥19 % , FHNHD became unattractive ( > $ 75,000/QALY ) . The cost/QALY gained became $ 13,000 if average training time for FHNHD increased from 3.7 to 6 weeks . In scenarios with alternate comparator modalities , FHNHD remained dominant compared with in-center CvHD ; cost/QALYs gained were $ 18,500 , $ 198,000 , and $ 423,000 compared with satellite CvHD , home CvHD , and peritoneal dialysis , respectively . In summary , FHNHD is attractive compared with in-center CvHD in this cohort . However , the attractiveness of FHNHD varies by technique failure rate , training time , and dialysis modalities from which patients are drawn , and these variables should be considered when establishing FHNHD programs BACKGROUND In this r and omized clinical trial , we aim ed to determine whether increasing the frequency of in-center hemodialysis would result in beneficial changes in left ventricular mass , self-reported physical health , and other intermediate outcomes among patients undergoing maintenance hemodialysis . METHODS Patients were r and omly assigned to undergo hemodialysis six times per week ( frequent hemodialysis , 125 patients ) or three times per week ( conventional hemodialysis , 120 patients ) for 12 months . The two co primary composite outcomes were death or change ( from baseline to 12 months ) in left ventricular mass , as assessed by cardiac magnetic resonance imaging , and death or change in the physical-health composite score of the R AND 36-item health survey . Secondary outcomes included cognitive performance ; self-reported depression ; laboratory markers of nutrition , mineral metabolism , and anemia ; blood pressure ; and rates of hospitalization and of interventions related to vascular access . RESULTS Patients in the frequent-hemodialysis group averaged 5.2 sessions per week ; the weekly st and ard Kt/V(urea ) ( the product of the urea clearance and the duration of the dialysis session normalized to the volume of distribution of urea ) was significantly higher in the frequent-hemodialysis group than in the conventional-hemodialysis group ( 3.54±0.56 vs. 2.49±0.27 ) . Frequent hemodialysis was associated with significant benefits with respect to both co primary composite outcomes ( hazard ratio for death or increase in left ventricular mass , 0.61 ; 95 % confidence interval [ CI ] , 0.46 to 0.82 ; hazard ratio for death or a decrease in the physical-health composite score , 0.70 ; 95 % CI , 0.53 to 0.92 ) . Patients r and omly assigned to frequent hemodialysis were more likely to undergo interventions related to vascular access than were patients assigned to conventional hemodialysis ( hazard ratio , 1.71 ; 95 % CI , 1.08 to 2.73 ) . Frequent hemodialysis was associated with improved control of hypertension and hyperphosphatemia . There were no significant effects of frequent hemodialysis on cognitive performance , self-reported depression , serum albumin concentration , or use of erythropoiesis-stimulating agents . CONCLUSIONS Frequent hemodialysis , as compared with conventional hemodialysis , was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score but prompted more frequent interventions related to vascular access . ( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; Clinical Trials.gov number , NCT00264758 . ) Background Left ventricular ( LV ) hypertrophy is common among patients on hemodialysis . While a relationship between blood pressure ( BP ) and LV hypertrophy has been established , it is unclear which BP measurement method is the strongest correlate of LV hypertrophy . We sought to determine agreement between various blood pressure measurement methods , as well as identify which method was the strongest correlate of LV hypertrophy among patients on hemodialysis . Methods This was a post-hoc analysis of data from a r and omized controlled trial . We evaluated the agreement between seven BP measurement methods : st and ardized measurement at baseline ; single pre- and post-dialysis , as well as mean intra-dialytic measurement at baseline ; and cumulative pre- , intra- and post-dialysis readings ( an average of 12 monthly readings based on a single day per month ) . Agreement was assessed using Lin 's concordance correlation coefficient ( CCC ) and the Bl and Altman method . Association between BP measurement method and LV hypertrophy on baseline cardiac MRI was determined using receiver operating characteristic curves and area under the curve ( AUC ) . Results Agreement between BP measurement methods in the 39 patients on hemodialysis varied considerably , from a CCC of 0.35 to 0.94 , with overlapping 95 % confidence intervals . Pre-dialysis measurements were the weakest predictors of LV hypertrophy while st and ardized , post- and inter-dialytic measurements had similar and strong ( AUC 0.79 to 0.80 ) predictive power for LV hypertrophy . Conclusions A single st and ardized BP has strong predictive power for LV hypertrophy and performs just as well as more re source intensive cumulative measurements , whereas pre-dialysis blood pressure measurements have the weakest predictive power for LV hypertrophy . Current guidelines , which recommend using pre-dialysis measurements , should be revisited to confirm these results CONTEXT Morbidity and mortality rates in hemodialysis patients remain excessive . Alterations in the delivery of dialysis may lead to improved patient outcomes . OBJECTIVE To compare the effects of frequent nocturnal hemodialysis vs conventional hemodialysis on change in left ventricular mass and health-related quality of life over 6 months . DESIGN , SETTING , AND PARTICIPANTS A 2-group , parallel , r and omized controlled trial conducted at 2 Canadian university centers between August 2004 and December 2006 . A total of 52 patients undergoing hemodialysis were recruited . INTERVENTION Participants were r and omly assigned in a 1:1 ratio to receive nocturnal hemodialysis 6 times weekly or conventional hemodialysis 3 times weekly . MAIN OUTCOME MEASURES The primary outcome was change in left ventricular mass , as measured by cardiovascular magnetic resonance imaging . The secondary outcomes were patient-reported quality of life , blood pressure , mineral metabolism , and use of medications . RESULTS Frequent nocturnal hemodialysis significantly improved the primary outcome ( mean left ventricular mass difference between groups , 15.3 g , 95 % confidence interval [ CI ] , 1.0 to 29.6 g ; P = .04 ) . Frequent nocturnal hemodialysis did not significantly improve quality of life ( difference of change in EuroQol 5-D index from baseline , 0.05 ; 95 % CI , -0.07 to 0.17 ; P = .43 ) . However , frequent nocturnal hemodialysis was associated with clinical ly and statistically significant improvements in selected kidney-specific domains of quality of life ( P = .01 for effects of kidney disease and P = .02 for burden of kidney disease ) . Frequent nocturnal hemodialysis was also associated with improvements in systolic blood pressure ( P = .01 after adjustment ) and mineral metabolism , including a reduction in or discontinuation of antihypertensive medications ( 16/26 patients in the nocturnal hemodialysis group vs 3/25 patients in the conventional hemodialysis group ; P < .001 ) and oral phosphate binders ( 19/26 patients in the nocturnal hemodialysis group vs 3/25 patients in the conventional dialysis group ; P < .001 ) . No benefit in anemia management was seen with nocturnal hemodialysis . CONCLUSION This preliminary study revealed that , compared with conventional hemodialysis ( 3 times weekly ) , frequent nocturnal hemodialysis improved left ventricular mass , reduced the need for blood pressure medications , improved some measures of mineral metabolism , and improved selected measures of quality of life . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N25858715 BACKGROUND The annual mortality rate for maintenance hemodialysis patients in the United States is unacceptably high at 15%-20 % . In 2004 , we initiated the Frequent Hemodialysis Network ( FHN ) clinical trials . This report presents baseline characteristics of FHN Trial participants and compares them with hemodialysis patients tracked in US Renal Data System ( USRDS ) data . STUDY DESIGN 2 separate r and omized clinical trials . SETTING S & PARTICIPANTS FHN includes 332 patients with chronic kidney disease requiring long-term dialysis therapy enrolled in 2 separate r and omized clinical trials . The FHN Daily Trial ( 245 r and omly assigned participants ) was design ed to compare outcomes of 6-times-weekly in-center daily hemodialysis ( 1.5 - 2.75 h/session ) with conventional 3-times-weekly in-center hemodialysis . The FHN Nocturnal Trial ( 87 r and omly assigned participants ) was design ed to compare outcomes of 6-times-weekly home nocturnal ( 6 - 8 h/session ) with conventional 3-times-weekly hemodialysis . USRDS data include 338,109 incident and prevalent long-term hemodialysis patients from the calendar year 2007 . RESULTS Participants in both trials were on average younger than the average hemodialysis patient in the United States ( Daily Trial , 50.4 years ; P < 0.001 ; Nocturnal Trial , 52.8 years ; P < 0.001 ) . Compared with USRDS data , whites were under-represented in the Daily Trial ( 36 % vs 55 % ; P < 0.001 ) , whereas Hispanics were under-represented in the Nocturnal Trial and over-represented in the Daily Trial ( 0 % vs 28 % ; P < 0.001 ) . In addition , there were more fistulas and fewer catheters in the Daily Trial ( 61 % and 20 % , respectively ; P < 0.001 for both ) and fewer grafts and more catheters in the Nocturnal Trial ( 10 % and 44 % , respectively ; P < 0.005 for both ) . LIMITATIONS Clinical trial exclusion criteria and patient willingness to participate limit comparisons with the USRDS . CONCLUSIONS FHN participants were younger and the racial composition for each study was different from the racial composition of the aggregate US dialysis population . Catheters for vascular access were more common in FHN Nocturnal Trial participants We investigated the effects of frequency of hemodialysis on nutritional status by analyzing the data in the Frequent Hemodialysis Network Trial . We compared changes in albumin , body weight and composition among 245 patients r and omized to 6- or 3-times per week in-center hemodial
Output:
| Overall , home haemodialysis reduced 24 hour ambulatory blood pressure and improved uraemic symptoms , but increased treatment-related burden of disease and interference in social activities . |
MS211294 | ***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: Subarachnoid hemorrhage ( SAH ) often leads to hydrocephalus , which is commonly treated by placement of a ventriculoperitoneal ( VP ) shunt . There is controversy over which factors affect the need for such treatment . In this study , data were prospect ively collected from 389 consecutive patients who presented with an aneurysm-associated SAH at a single center . External ventricular drainage placement was performed as part of the treatment for acute hydrocephalus , and VP shunts were placed in patients with chronic hydrocephalus . The data were retrospectively analyzed using two- sample t-tests , Fisher 's exact test and logistic regression analysis . Overall , shunt dependency occurred in 91 of the 389 patients ( 23.4 % ) . Using logistic regression analysis , two factors were found to be significantly associated with VP shunt placement : an initial Glasgow Coma Scale ( GCS ) score of 8 - 14 ( 8 - 14 versus 3 - 7 , p = 0.016 ; 15 versus 3 - 7 , p = 0.55 ) ; and aneurysm coiling ( p = 0.017 ) . Patients with an initial GCS score of 8 - 14 after aneurysm-associated SAH had a 2.5-fold higher risk of receiving a VP shunt than those with a GCS score of 3 - 7 . Those with a GCS of 15 had a 50 % lower risk of becoming shunt dependent than did the subgroup with a GCS score of 8 - 14 . To clarify and strengthen these observations , prospect i ve , r and omized trials are needed OBJECTIVE Chronic hydrocephalus requiring shunt placement and cerebral vasospasm are common complications after aneurysmal subarachnoid hemorrhage . Recent publications have investigated the possibility that microsurgical fenestration of the lamina terminalis during aneurysm surgery may reduce the incidence of shunt-dependent hydrocephalus and cerebral vasospasm . We review ed a single-surgeon series to compare postsurgical outcomes of patients who underwent fenestration of the lamina terminalis against those who did not . METHODS This study is a retrospective review of the medical records of 369 consecutive patients with aneurysmal subarachnoid hemorrhage admitted to Columbia University Medical Center between January 2000 and July 2006 . All patients underwent craniotomy and clipping of at least one ruptured cerebral aneurysm by a single neurosurgeon ( ESC ) . The incidences of shunt-dependent hydrocephalus , conversion from acute hydrocephalus on admission to chronic hydrocephalus , and clinical cerebral vasospasm were compared in patients who underwent fenestration of the lamina terminalis with those who did not . The patient cohort was thus divided into three subgroups : 1 ) patients whose operative records clearly indicated that they underwent fenestration of the lamina terminalis , 2 ) patients whose operative records clearly indicated that they did not undergo fenestration of the lamina terminalis , and 3 ) patients whose operative records did not indicate one way or another whether they received fenestration of the lamina terminalis . We performed two separate analyses by comparing the postsurgical outcomes in those patients who were fenestrated versus those who were definitively not fenestrated and comparing the postsurgical outcomes in those patients who were fenestrated versus those who were not plus those whose records did not document fenestration . To further control for any cohort differences , we performed a comparison between patients who were fenestrated and those who were not after matching 1:1 for presenting radiographic and clinical characteristics predictive of hydrocephalus and vasospasm . Outcomes were compared using logistic regression and multivariable analysis . RESULTS In the first model , fenestrated patients had a shunt rate , conversion rate , and rate of clinical vasospasm of 25 , 50 , and 23 % , respectively , versus 20 , 27 , and 27 % in nonfenestrated patients , respectively ( P = 0.28 , 0.21 , and 0.32 , respectively ) . In the second model , the nonfenestrated patients plus nondocumented patients had a shunt rate , conversion rate , and rate of clinical vasospasm of 16 , 40 , and 20 % , respectively ( P = 0.19 , 0.33 , and 0.60 , respectively ) . In the matched cohort , fenestrated patients had a shunt rate , conversion rate , and rate of clinical vasospasm of 29 , 67 , and 20 % , respectively , versus 20 , 25 , and 25 % in nonfenestrated patients , respectively ( P = 0.30 , 0.24 , and 0.20 , respectively ) . CONCLUSION In contrast to other retrospective multisurgeon series , our retrospective single-surgeon series suggests that microsurgical fenestration of the lamina terminalis may not reduce the incidence of shunt-dependent hydrocephalus or cerebral vasospasm after aneurysmal subarachnoid hemorrhage . A prospect i ve multicenter trial is needed to definitively address the use of this maneuver BACKGROUND Shunt-dependent hydrocephalus is a common complication of aneurysmal subarachnoid hemorrhage ( aSAH ) . There is a need to identify patients who require ventriculoperitoneal shunt ( VPS ) insertion so that any modifiable risk factors can be addressed early after aSAH . METHODS Exploratory analysis was performed on 413 patients enrolled in CONSCIOUS-1 , a prospect i ve r and omized controlled trial of patients with aSAH treated with clazosentan . The association between clinical and neuroimaging covariates and VPS placement was first determined by univariate analysis . Covariates with P < 0.15 on univariate analysis were then analyzed in a multivariate logistic regression model . Receiver operating characteristic curve analysis was used to define optimal predictive thresholds . The published literature was review ed to determine the overall rate of VPS insertion after aSAH . RESULTS Overall , 17.2 % ( 71/413 ) of patients required VPS insertion . Multivariate analysis demonstrated that insertion of an external ventricular drain ( odds ratio , 6.21 ; 95 % confidence interval , 2.51 - 16.91 ) and increasing volume of cerebrospinal fluid ( CSF ) drainage per day ( odds ratio , 1.004 ; 95 % confidence interval , 1.000 - 1.009 ) were associated with VPS insertion . Receiver operating characteristic curve analysis revealed an optimal daily CSF output threshold of 78 mL was predictive of VPS insertion . Among 41,789 patients with aSAH from 66 published studies , the overall VPS insertion rate was 12.7 % . CONCLUSIONS The presence of an external ventricular drain and increased daily CSF output ( above 78 mL/day ) seems to be predictive of subsequent VPS insertion after aSAH . Although we could not identify modifiable risk factors for needing a VPS , nevertheless , these findings identify patients at greatest risk of VPS placement and inform treatment decisions as well as patient expectations OBJECTIVE The goals of this study were to investigate the risk factors , indications , complications , and outcome for patients with ventriculoperitoneal shunts ( VPSs ) after subarachnoid hemorrhage and to define a subgroup eligible for future prospect i ve studies design ed to clarify indications for placement of a VPS . METHODS Clinical characteristics of 236 prospect ively evaluated patients with subarachnoid hemorrhage and 6 months of follow-up were analyzed . Hydrocephalus was estimated by the relative bicau date index ( RBCI ) measured on computed tomographic scans at the time of shunting . Patients were divided into three groups by ventricle size : Group 1 included 121 patients with small ventricles ( RBCI < 1.0 ) , Group 2 included 88 patients with borderline ventricle size ( RBCI 1.0–1.4 ) , and Group 3 included 27 patients with markedly enlarged ventricles ( RBCI > 1.4 ) . RESULTS Initially , 86 patients ( 36 % ) underwent ventriculoperitoneal shunting : 19 in Group 1 ( 16 % ) , 43 in Group 2 ( 49 % ) , and 24 in Group 3 ( 90 % ) . Indications for placement of a VPS , risk factors , and outcome differed markedly by group . Four patients ( 3 % of those not initially shunted ) developed delayed hydrocephalus requiring a VPS , including one in Group 2 ( 2 % ) . The 6-month shunt complication rate was 13 % . Evaluation of patients in Group 2 indicated that functional status was an important factor in selecting c and i date s for shunting , and that patients receiving shunts and shunt-free patients demonstrated improvement in functional status during follow-up . CONCLUSION Although we currently use a proactive shunting paradigm for posthemorrhagic hydrocephalus , this report demonstrates that a conservative approach to patients with borderline ventricle size ( i.e. , RBCI of 1.0–1.4 ) and normal intracranial pressure should be evaluated in a prospect i ve r and omized trial Background Hydrocephalus ( HC ) after aneurysmal subarachnoid hemorrhage ( aSAH ) is a common sequel . Proper selection of patients in need of permanent cerebrospinal fluid ( CSF ) diversion is , however , not straightforward . The aim of this study was to identify predictors of CSF shunt dependency following aSAH . Methods We re-analyzed data acquired from aSAH patients previously enrolled in a prospect i ve , controlled single-center clinical trial in which shunt dependency was not one of the end points . In the present study patients were allocated into two groups : those receiving a shunt ( here denoted as shunt dependent ) and those not receiving a shunt , based on a clinical decision process . Predictors of shunt dependency were identified by applying uni- and multivariable analysis . We tested a set of predefined possible risk factors based on the results of the clinical trial , including the impact of CSF drainage volume exceeding 1,500 ml during the 1st week after ictus . Results Ninety patients were included in the study . Significant predictors of shunt dependency were poor clinical grade at admission [ odds ratio ( OR ) 4.7 , 95 % confidence interval ( CI ) 1.2–18.4 ] , large amounts of subarachnoid blood ( OR 3.8 , 95 % CI 1.0–14.0 ) , large ventricular size on preoperative cerebral computer tomographic ( CT ) scans ( OR 1.0 , 95 % CI 1.0–1.1 ) , and CSF volume drainage exceeding 1,500 ml during the 1st week after the ictus ( OR 16.3 , 95 % CI 4.0–67.1 ) . Age ≥70 years , larger amounts of intraventricular blood , vertebrobasilar aneurysm , and endovascular treatment tended to increase the likelihood of receiving a shunt . Outcome was not significantly different between shunted and non-shunted patients . Conclusions In this cohort of patients with clinical grade aSAH at admission , larger amounts of subarachnoid blood and large ventricular size on preoperative cerebral CT , and CSF drainage in excess of 1,500 ml during the 1st week after the ictus were significant predictors of shunt dependency . Shunt dependency did not hamper outcome BACKGROUND Acute hydrocephalus is a well-known sequela of aneurysmal subarachnoid hemorrhage ( SAH ) . Controversy exists about whether open microsurgical methods serve to reduce shunt dependency compared with endovascular techniques . OBJECTIVE To determine predictors of shunt-dependent hydrocephalus and functional outcomes after aneurysmal SAH . METHODS A total of 471 patients who were part of a prospect i ve , r and omized , controlled trial from 2003 to 2007 were retrospectively review ed . All variables including demographic data , medical history , treatment , imaging , and functional outcomes were included as part of the trial . No additional variables were retrospectively collected . RESULTS Ultimately , 147 patients ( 31.2 % ) required a ventriculoperitoneal shunt ( VPS ) in our series . Age , dissecting aneurysm type , ruptured vertebrobasilar aneurysm , Fisher grade , Hunt and Hess grade , admission intraventricular hemorrhage , admission intraparenchymal hemorrhage , blood in the fourth ventricle on admission , perioperative ventriculostomy , and hemicraniectomy were significant risk factors ( P < .05 ) associated with shunt-dependent hydrocephalus on univariate analysis . On multivariate analysis , intraventricular hemorrhage and intraparenchymal hemorrhage were independent risk factors for shunt dependency ( P < .05 ) . Clipping vs coiling treatment was not statistically associated with VPS after SAH on both univariate and multivariate analyses . Patients who did not receive a VPS at discharge had higher Glasgow Outcome Scale and Barthel Index scores and were more likely to be functionally independent and to return to work 72 months after surgery ( P < .05 ) . CONCLUSION There is no difference in shunt dependency after SAH among patients treated by endovascular or microsurgical means . Patients in whom shunt-dependent hydrocephalus does not develop after SAH tend to have improved long-term functional outcomes OBJECT This study was design ed to determine whether the frequency of shunt-dependent hydrocephalus in patients suffering from aneurysmal subarachnoid hemorrhage ( SAH ) differs when comparing surgical clip application with endov
Output:
| Several new predictors of SDHC after aSAH were identified that may assist with the early recognition and prevention of SDHC .
The controversial evidence found in this study was insufficient to support the potential of neurosurgical clipping for reducing the risk of shunt dependency . |
MS211295 | ***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 Previous research on alcohol mixed with energy drinks ( AmED ) suffers from measurement problems . Missing from the research literature are studies that assess caffeine-alcohol co-ingestion in natural drinking environments . METHODS This field study collected data in a U.S. college bar district from 328 r and omly selected patrons . Anonymous data were obtained from face-to-face interviews and self-administered surveys , and from breath tests . RESULTS Cola-caffeinated alcoholic beverage consumers left bars in a more highly intoxicated state than those who consumed alcohol only . There was no significant difference between the intoxication level of the AmED group and the cola-caffeinated alcoholic beverage group . Results from a multivariate regression model indicated that quantity of caffeinated alcoholic beverage consumption had a significant , positive association with bar patron intoxication after adjusting for potential confounders . CONCLUSIONS Findings indicate that caffeine may have a dose-dependent relationship with alcohol intoxication in the bar/nightclub setting . In addition , results revealed that cola-caffeinated alcoholic drinks may pose similar levels of risk to bar patrons as those associated with AmED beverage consumption . Product labeling requirements about alcohol risks may need to be extended not only to energy drinks , but to caffeinated soft drinks as well BACKGROUND There are popular reports on the combined use of alcohol and energy drinks ( such as Red Bull and similar beverages , which contain caffeine , taurine , carbohydrates , etc . ) to reduce the depressant effects of alcohol on central nervous system , but no controlled studies have been performed . The main purpose of this study was to verify the effects of alcohol , and alcohol combined with energy drink , on the performance of volunteers in a maximal effort test ( cycle ergometer ) and also on physiological indicators ( oxygen uptake , ventilatory threshold , respiratory exchange rate , heart rate , and blood pressure ) , biochemical variables ( glucose , lactate , insulin , cortisol , ACTH , dopamine , noradrenaline , and adrenaline ) , and blood alcohol levels . METHODS Fourteen healthy subjects completed a double-blind protocol made up of four sessions : control ( water ) , alcohol ( 1.0 g/kg ) , energy drink ( 3.57 ml/kg Red Bull ) , and alcohol + energy drink , each 1 week apart . The effort test began 60 min after drug or control ingestion , and the dependent variables were measured until 60 min after the test . RESULTS Heart rate at the ventilatory threshold was higher in the alcohol and alcohol + energy drink sessions in comparison with control and energy drink sessions . Although in comparison to the control session , the peak oxygen uptake was 5.0 % smaller after alcohol ingestion , 1.4 % smaller after energy drink , and 2.7 % smaller after the combined ingestion , no significant differences were detected . Lactate levels ( 30 min after drug ingestion , 30 and 60 min after the effort test ) and noradrenaline levels ( 30 min after the effort test ) were higher in the alcohol and alcohol + energy drink sessions compared with the control session . CONCLUSIONS The performance in the maximal effort test observed after alcohol + energy drink ingestion was similar to that observed after alcohol only . No significant differences between alcohol and alcohol + energy drink were detected in the physiological and biochemical parameters analyzed . Our findings suggest that energy drinks , at least in the tested doses , did not improve performance or reduce alterations induced by acute alcohol ingestion BACKGROUND Well-known reports suggest that the use of energy drinks might reduce the intensity of the depressant effects of alcohol . However , there is little scientific evidence to support this hypothesis . OBJECTIVE AND METHODS The present study aim ed at evaluating the effects of the simultaneous ingestion of an alcohol ( vodka(37.5%v/v ) ) and an energy drink ( Red Bull-3.57 mL/kg ) , compared with those presented after the ingestion of an alcohol or an energy drink alone . Twenty-six young healthy volunteers were r and omly assigned to 2 groups that received 0.6 or 1.0 g/kg alcohol , respectively . They all completed 3 experimental sessions in r and om order , 7 days apart : alcohol alone , energy drink alone , or alcohol plus energy drink . We evaluated the volunteers ' breath alcohol concentration , subjective sensations of intoxication , objective effects on their motor coordination , and visual reaction time . RESULTS When compared with the ingestion of alcohol alone , the ingestion of alcohol plus energy drink significantly reduced subjects ' perception of headache , weakness , dry mouth , and impairment of motor coordination . However , the ingestion of the energy drink did not significantly reduce the deficits caused by alcohol on objective motor coordination and visual reaction time . The ingestion of the energy drink did not alter the breath alcohol concentration in either group . CONCLUSIONS Even though the subjective perceptions of some symptoms of alcohol intoxication were less intense after the combined ingestion of the alcohol plus energy drink , these effects were not detected in objective measures of motor coordination and visual reaction time , as well as on the breath alcohol concentration OBJECTIVES The consumption of alcohol mixed with energy drinks ( AmED ) is popular on college campuses in the United States . Limited research suggests that energy drink consumption lessens subjective intoxication in persons who also have consumed alcohol . This study examines the relationship between energy drink use , high-risk drinking behavior , and alcohol-related consequences . METHODS In Fall 2006 , a Web-based survey was conducted in a stratified r and om sample of 4,271 college students from 10 universities in North Carolina . RESULTS A total of 697 students ( 24 % of past 30-day drinkers ) reported consuming AmED in the past 30 days . Students who were male , white , intramural athletes , fraternity or sorority members or pledges , and younger were significantly more likely to consume AmED . In multivariable analyses , consumption of AmED was associated with increased heavy episodic drinking ( 6.4 days vs. 3.4 days on average ; p < 0.001 ) and twice as many episodes of weekly drunkenness ( 1.4 days/week vs. 0.73 days/week ; p < 0.001 ) . Students who reported consuming AmED had significantly higher prevalence of alcohol-related consequences , including being taken advantage of sexually , taking advantage of another sexually , riding with an intoxicated driver , being physically hurt or injured , and requiring medical treatment ( p < 0.05 ) . The effect of consuming AmED on driving while intoxicated depended on a student 's reported typical alcohol consumption ( interaction p = 0.027 ) . CONCLUSIONS Almost one-quarter of college student current drinkers reported mixing alcohol with energy drinks . These students are at increased risk for alcohol-related consequences , even after adjusting for the amount of alcohol consumed . Further research is necessary to underst and this association and to develop targeted interventions to reduce risk AIM To assess event-level associations between energy drink consumption , alcohol intoxication , and intention to drive a motor vehicle in patrons exiting bars at night . METHOD Alcohol field study . Data collected in a U.S. college bar district from 802 r and omly selected and self-selected patrons . Anonymous interview and survey data were obtained as well as breath alcohol concentration ( BrAC ) readings . RESULTS Results from logistic regression models revealed that patrons who had consumed alcohol mixed with energy drinks were at a 3-fold increased risk of leaving a bar highly intoxicated ( BrAC > or = 0.08g/210L ) , as well as a 4-fold increased risk of intending to drive upon leaving the bar district , compared to other drinking patrons who did not consume alcoholic beverages mixed with energy drinks . DISCUSSION These event-level associations provide additional evidence that energy drink consumption by young adults at bars is a marker for elevated involvement in nighttime risk-taking behavior . Further field research is needed to develop sound regulatory policy on alcohol/energy drink sales practice s of on-premise establishments 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 There has been a dramatic rise in the consumption of alcohol mixed with energy drinks ( AmED ) in young people . AmED have been implicated in risky drinking practice s and greater accidents and injuries have been associated with their consumption . Despite the increased popularity of these beverages ( e.g. , Red Bull and vodka ) , there is little laboratory research examining how the effects of AmED differ from alcohol alone . This experiment was design ed to investigate if the consumption of AmED alters neurocognitive and subjective measures of intoxication compared with the consumption of alcohol alone . METHODS Participants ( n=56 ) attended 1 session where they were r and omly assigned to receive one of 4 doses ( 0.65 g/kg alcohol , 3.57 ml/kg energy drink , AmED , or a placebo beverage ) . Performance on a cued go/no-go task was used to measure the response of inhibitory and activational mechanisms of behavioral control following dose administration . Subjective ratings of stimulation , sedation , impairment , and level of intoxication were recorded . RESULTS Alcohol alone impaired both inhibitory and activational mechanisms of behavioral control , as evidence d by increased inhibitory failures and increased response times compared to baseline performance . Coadministration of the energy drink with alcohol counteracted some of the alcohol-induced impairment of response activation , but not response inhibition . For subjective effects , alcohol increased ratings of stimulation , feeling the drink , liking the drink , impairment , and level of intoxication , and alcohol decreased the rating of ability to drive . Coadministration of the energy drink with alcohol increased self-reported stimulation , but result ed in similar ratings of the other subjective effects as when alcohol was administered alone . CONCLUSIONS An energy drink appears to alter some of the objective and subjective impairing effects of alcohol , but not others . Thus , AmED may contribute to a high-risk scenario for the drinker . The mix of impaired behavioral inhibition and enhanced stimulation is a combination that may make AmED consumption riskier than alcohol consumption alone OBJECTIVE Studies have shown that expectations of alcohol-induced impairment can produce adaptive responses to alcohol that reduce the degree of behavioral impairment displayed . The present study tested psychomotor performance following combined caffeine and alcohol administration in 42 social drinkers ( 23 men ) . Subjects were led to expect either that caffeine would antagonize alcohol-induced impairment or that it would have no effect . The study tested the hypothesis that drinkers who expected an antagonist effect of caffeine would display greater alcohol impairment than those who expected no antagonist effect . METHOD Groups practice d a pursuit rotor task and received a moderate dose of alcohol ( 0.65 g/kg ) combined with either 4.0 mg/kg caffeine or placebo caffeine . Some groups were led to expect that caffeine would counteract the impairing effect of alcohol and others were led to expect no counteracting effect . Psychomotor performance was then tested over a 3-hour period . RESULTS In accord with the hypothesis , groups led to expect counteracting effects of caffeine displayed greater impairment than those led to expect no counteraction . Caffeine had no significant antagonist effect on alcohol impairment . CONCLUSIONS The findings suggest that compensation for alcohol impairment occurs when drinkers hold clear expectations that the drug will disrupt performance . When no such clear expectation exists , no compensatory response occurs and the impairing effects of alcohol are observed The consumption of alcohol mixed with energy drinks ( AmED ) has become a popular and controversial practice among young people . Increased rates of impaired driving and injuries have been associated with AmED consumption . The purpose of this study was to examine if the consumption of AmED alters cognitive processing and subjective measures of intoxication compared with the consumption of alcohol alone . Eighteen participants ( nine men and nine women ) attended four test sessions where they received one of four doses in r and om order ( 0.65 g/kg alcohol , 3.57 ml/kg energy drink , AmED , or a placebo beverage ) . Performance on a psychological refractory period ( PRP ) task was used to measure dual-task information processing and performance on the Purdue pegboard task was used to measure simple and complex motor coordination following dose administration . In addition , various subjective measures of stimulation , sedation , impairment , and level of intoxication were recorded . The results indicated that alcohol slowed dual-task information processing and impaired simple and complex motor coordination . The coadministration of the energy drink with alcohol did not alter the alcohol-induced impairment on these objective measures . For subjective effects , alcohol increased various ratings indicative of feelings of intoxication . More importantly , coadministration of the energy drink with alcohol reduced perceptions of mental fatigue and enhanced feelings of stimulation compared to alcohol alone . In conclusion , AmED may contribute to a high-risk scenario for a drinker . The mix of behavioral impairment with reduced fatigue and enhanced stimulation may lead AmED consumers to erroneously perceive themselves as better able to function than is actually the case Summary . The effects of Red Bull Energy Drink , which includes taurine , glucuronolactone , and caffeine amongst the ingredients , were examined over 3 studies in a total of 36 volunteers . Assessment s included psychomotor performance ( reaction time , concentration , memory ) , subjective alertness and physical endurance . When compared with control drinks , Red Bull Energy Drink significantly ( P < 0.05 ) improved aerobic endurance ( maintaining 65–75 % max . heart rate ) and anaerobic performance ( maintaining max . speed ) on cycle ergometers . Significant improvements in mental performance included choice reaction time , concentration ( number cancellation ) and memory ( immediate recall ) , which reflected increased subjective alertness . These consistent and
Output:
| These findings typically have not been reflected in experimental research , due possibly to the low doses administered relative to typical self-reported ' real-life ' intake .
AmED consumers generally report more hazardous alcohol consumption patterns and greater engagement in risk-taking behaviour than alcohol consumers .
While most studies had equivocal findings , two studies showed lower odds of risk-taking behaviour for AmED relative to alcohol drinking sessions but limitations with respect to the outcome measures used restrict conclusions with regard to the behavioural outcomes of AmED use .
Mixing alcohol with energy drinks may exert a dual effect , increasing stimulation-based effects and reducing sedation-based outcomes ; the clinical severity and dose threshold has not been established .
At this stage it is unclear whether these changes in the nature of intoxication translate into greater alcohol intake and risk-taking behaviour |
MS211296 | ***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: STUDY OBJECTIVE To determine the dose of succinylcholine during inhalation induction of a patient . DESIGN ED Prospect i ve , double-blind , r and omized study . SETTING Operating room of a university hospital . PATIENTS 180 adult , ASA physical status 1 and 2 patients with a suspected difficult airway , who were scheduled for surgery . INTERVENTIONS Nonpremedicated patients were anesthetized with inhalation of 8 % sevoflurane , followed by succinylcholine . Group 1 received intravenous ( IV ) succinylcholine 0.3 mg/kg , Group 2 had IV succinylcholine 0.6 mg/kg , and Group 3 was given IV succinylcholine 1.0 mg/kg . Direct laryngoscopy and tracheal intubation were performed after onset of succinylcholine . MEASUREMENTS Intubation conditions were scored as excellent , good , or poor . The recovery time of spontaneous respiration , end-tidal carbon dioxide partial pressure ( PETCO2 ) , and pulse oxygen saturation ( SpO2 ) were recorded . MAIN RESULTS Acceptable conditions ( excellent and good ) for intubation were rated in 80 % of Group 1 patients ( 0.3 mg/kg succhinylcholine ) , 91.7 % of Group 2 patients ( 0.6 mg/kg ) , and 93.3 % of Group 3 patients ( 1.0 mg/kg ) , respectively . Intubation scores were similar in Groups 2 and 3 , and were significantly higher than in Group 1 patients ( 0.3 mg ; P < 0.01 ) . Time to recovery of spontaneous respiration in Group 3 was significantly prolonged compared with Groups 1 and 2 ( 238 ± 59 sec vs 132 ± 43 sec , P < 0.001 ; 238 ± 59 sec vs 151 ± 47 sec , P < 0.001 , respectively ) . SpO2 in Group 3 did not differ significantly from Group 1 and 2 values . However , PETCO2 in Group 3 was significantly higher than in Groups 1 or 2 . CONCLUSIONS Succinylcholine at a dose of 0.6 mg/kg IV provided intubation conditions similar to succinylcholine at 1.0 mg/kg IV , and recovery of spontaneous respiration following a 0.6 mg/kg dose of succinylcholine was significantly shorter We have studied the effectiveness and sequelae of low-dose suxamethonium in 60 day-case oral surgery patients requiring nasal intubation . Anaesthesia was induced with propofol and alfentanil ; 60 patients were allocated r and omly to three groups of 20 patients and received no suxamethonium , suxamethonium 0.25 mg kg-1 or 0.5 mg kg-1 . All patients received i.v . fentanyl and diclofenac 100 mg rectally for analgesia . Good intubating conditions were produced in all 20 patients receiving suxamethonium 0.25 mg kg-1 , in 19 patients receiving suxamethonium 0.5 mg kg-1 and in 11 patients not receiving a neuromuscular blocker . The incidence of postoperative myalgia after suxamethonium 0.25 mg kg-1 ( 20 % ) did not differ significantly from the incidence after propofol and alfentanil alone ( 28 % ) Succinylcholine 1.0 mg/kg usually produces excellent tracheal intubation conditions in 60 s. Recovery of respiratory muscle function after this dose , however , is not fast enough to forestall oxyhemoglobin desaturation when ventilation can not be assisted . In this study , we investigated whether smaller doses of succinylcholine can produce satisfactory intubation conditions fast enough to allow rapid sequence induction with a shorter recovery time . Anesthesia was induced with fentanyl/propofol and maintained by propofol infusion and N2O in O2 . After the induction , 115 patients were r and omly allocated to five groups according to the dose of succinylcholine ( 0.3 mg/kg , 0.4 mg/kg , 0.5 mg/kg , 0.6 mg/kg , or 1.0 mg/kg ) . Evoked adductor pollicis responses to continuous 1-Hz supramaximal ulnar nerve stimulation were recorded using acceleromyography . Tracheal intubation conditions were grade d 60 s after succinylcholine administration . Onset time , maximal twitch depression , time to initial twitch detection after paralysis , and to 10 % , 25 % , 50 % , and 90 % twitch height recovery were recorded . Time to initial diaphragmatic movement as well as time to resumption of regular spontaneous respiratory movements were calculated . Onset times ranged between 82 s and 52 s , decreasing with increasing doses of succinylcholine but not differing between 0.6 and 1 mg/kg . Maximum twitch depression was similar after 0.5 , 0.6 , and 1 mg/kg ( 98.2%–100 % ) . Recoveries of twitch height and apnea time were dose-dependent . Intubation conditions were often unacceptable after 0.3- and 0.4-mg/kg doses . Acceptable intubation conditions were achieved in all patients receiving a 0.5 , 0.6 , and 1 mg/kg dose of succinylcholine . Intubation conditions in patients receiving 0.6 and 1 mg/kg were identical , whereas times to T1 = 50 % and 90 % and time to regular spontaneous reservoir bag movements were significantly shorter in the 0.6-mg/kg dose group ( 5.78 , 7.25 , and 4.0 min , respectively ) versus patients receiving 1 mg/kg ( 8.55 , 10.54 , and 6.16 min , respectively ) . The use of 0.5 to 0.6 mg/kg of succinylcholine can produce acceptable intubation conditions 60 s after administration . The conditions achieved after 0.6 mg/kg are similar to those after 1.0 mg/kg . These smaller doses are associated with faster twitch recovery and shorter apnea time Background : The aim of this prospect i ve , r and omized , double-blind study was to compare tracheal intubating conditions and the duration of apnoea following administration of 0.4 , 0.6 and 1.0 mg/kg of succinylcholine during simulated rapid sequence induction of anaesthesia . Methods : Anaesthesia was induced with fentanyl 2 μg/kg and propofol 2 mg/kg followed by application of cricoid pressure . Patients were r and omly allocated to three groups according to the dose of succinylcholine administered ( 0.4 , 0.6 or 1.0 mg/kg ) . Intubating conditions were assessed at 60 s after succinylcholine administration . Time to first diaphragmatic contraction ( apnoea time ) and time to resumption of regular spontaneous breathing were noted . Results : Excellent intubating conditions were obtained in 52.4 % , 95.7 % and 100 % of the patients after 0.4 , 0.6 and 1.0 mg/kg succinylcholine , respectively ; P<0.001 . Acceptable intubating conditions ( excellent and good grade combined ) were obtained in 66.7 % , 100 % and 100 % of the patients after 0.4 , 0.6 and 1.0 mg/ kg succinylcholine , respectively ; P<0.001 . Apnoea time and resumption of regular spontaneous breathing were dose-dependent . Apnoea time was 3.8±1.1 min , 4.3±0.9 min and 8.2±3.4 min in groups 0.4 , 0.6 and 1.0 mg/kg , respectively ; P<0.001 . Time to regular spontaneous breathing was 5.3±1.2 min , 5.5±1.1 min and 8.9±3.5 min in groups 0.4 , 0.6 and 1.0 mg/kg , respectively ; P<0.001 . Conclusion : A dose of 0.6 mg/kg succinylcholine can be used for rapid sequence induction of anaesthesia as it provides acceptable intubating conditions with a shorter apnoea time compared with a dose of 1 mg/kg Background The usually cited “ intubation dose ” of succinylcholine is 1.0 mg/kg . In the majority of patients , this dose will produce apnea of sufficient duration that significant hemoglobin desaturation may occur before neuromuscular recovery takes place in those whose ventilation is not assisted . This study was undertaken to examine the extent to which reducing this dose would decrease the duration of action of succinylcholine . Methods During stable desflurane/oxygen/opioid anesthesia and after adequate twitch stabilization , neuromuscular function was recorded with an acceleromyographic monitor . Supramaximal stimuli were delivered at 0.10 Hz . Patients received 0.40 , 0.60 , or 1.0 mg/kg succinylcholine , and twitch height was monitored for at least 20 min thereafter . Results The onset times to maximal effect were 105 ± 23 s , 81 ± 19 s , and 71 ± 22 s , respectively . The lowest dose ( 0.40 mg/kg ) did not reliably produce 100 % twitch depression . The times to 90 % twitch recovery at the adductor pollicis in the three groups were 6.6 ± 1.5 min , 7.6 ± 1.6 min , and 9.3 ± 1.2 min , respectively . Conclusions Reducing the dose of succinylcholine from 1.0 mg/kg to 0.60 mg/kg shortens the duration of effect at the adductor pollicis by more than 90 s. The authors believe that even this modest decrease in the duration of drug-induced paralysis is often worth pursuing Background The authors reappraised the conventional wisdom that the intubating dose of succinylcholine must be 1.0 mg/kg and attempted to define the lower range of succinylcholine doses that provide acceptable intubation conditions in 95 % of patients within 60 s. Methods This prospect i ve , r and omized , double-blind study involved 200 patients . Anesthesia was induced with 2 & mgr;g/kg fentanyl and 2 mg/kg propofol . After loss of consciousness , patients were r and omly allocated to receive 0.3 , 0.5 , or 1.0 mg/kg succinylcholine or saline ( control group ) . Tracheal intubation was performed 60 s later . A blinded investigator performed all laryngoscopies and also grade d intubating conditions . Results Intubating conditions were acceptable ( excellent plus good grade combined ) in 30 % , 92 % , 94 % , and 98 % of patients after 0.0 , 0.3 , 0.5 , and 1.0 mg/kg succinylcholine , respectively . The incidence of acceptable intubating conditions was significantly greater ( P < 0.05 ) in patients receiving succinylcholine compared with those in the control group but was not different among the different succinylcholine dose groups . The calculated doses of succinylcholine ( and their 95 % confidence intervals ) that were required to achieve acceptable intubating conditions in 90 % and 95 % of patients at 60 s were 0.24 ( 0.19–0.31 ) mg/kg and 0.56 ( 0.43–0.73 ) mg/kg , respectively . Conclusions The use of 1.0 mg/kg of succinylcholine may be excessive if the goal is to achieve acceptable intubating conditions within 60 s. Comparable intubating conditions were achieved after 0.3 , 0.5 , or 1.0 mg/kg succinylcholine . In a rapid-sequence induction , 95 % of patients with normal airway anatomy anesthetized with 2 & mgr;g/kg fentanyl and 2 mg/kg propofol should have acceptable intubating conditions at 60 s after 0.56 mg/kg succinylcholine . Reducing the dose of succinylcholine should allow a more rapid return of spontaneous respiration and airway reflexes In this prospect i ve , r and omized , double-blind , placebo-controlled study , we attempted to define the dose of succinylcholine that provides excellent intubation conditions in patients within 60 s during simulated rapid-sequence induction of anesthesia . Anesthesia was induced in 180 patients with 2 & mgr;g/kg fentanyl and 2 mg/kg propofol . After loss of consciousness , patients were r and omly allocated to receive 0.3 , 0.5 , 1.0 , 1.5 , or 2.0 mg/kg succinylcholine or saline solution ( control group ) . Tracheal intubation was performed 60 s later . A blinded investigator performed all laryngoscopies and grade d intubating conditions . Intubating conditions were excellent in 0.0 % , 43.3 % , 60.0 % , 63.3 % , 80.0 % , and 86.7 % of patients after 0.0 , 0.3 , 0.5 , 1.0 , 1.5 , and 2.0
Output:
| With succinylcholine regimens ≤0.5 mg kg− 1 , excellent intubating conditions are less likely and apnoea times are shorter , compared with 1 mg kg− 1 .
With 0.3 and 0.4 mg kg− 1 , unacceptable intubating conditions are more common .
Succinylcholine 1.5 mg kg− 1 does not produce more often excellent conditions compared with 1 mg kg− 1 , while 2.0 mg kg− 1 does , but the data base with these regimens is weak and apnoea times remain unknown . |
MS211297 | ***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 survey was carried out asking patients to evaluate the criteria of good dental practice proposed by patients and dentists . A total of 344 patients from 4 different general dental practice s in South East Engl and evaluated 16 criteria of good dental practice . Eight criteria were generated by 30 general dental practitioners and the other eight by 30 patients . Question naires containing the 8 pairs of criteria r and omly assigned by a computer were drawn up , with each pair containing one patient and one general dental practitioner criterion . Patients were asked to indicate their preference . The number of times each criterion was preferred was scored and ranked . The three highest ranked criteria were explanation of procedures , sterilisation/hygiene and dentist 's skills ( all criteria proposed from patients ) , whilst the three lowest ranked criteria were up-to- date equipment , pleasant decor and surroundings and good practice image ( all criteria proposed from dentists ) . Overall the criteria proposed by patients as a group scored significantly more highly than those proposed by dentists as a group . There was variation in rankings relating to the sex , age , pattern of attendance and social class of the respondents Background Precisely defining the different applications of patient-reported outcome measures ( PROs ) in clinical practice can be difficult . This is because the intervention is complex and varies amongst different studies in terms of the type of PRO used , how the PRO is fed back , and to whom it is fed back . Methods A theory-driven approach is used to describe six different applications of PROs in clinical practice . The evidence for the impact of these applications on the process and outcomes of care are summarised . Possible explanations for the limited impact of PROs on patient management are then discussed and directions for future research are highlighted . Results The applications of PROs in clinical practice include screening tools , monitoring tools , as a method of promoting patient-centred care , as a decision aid , as a method of facilitating communication amongst multidisciplinary teams ( MDTs ) , and as a means of monitoring the quality of patient care . Evidence from r and omised controlled trials suggests that the use of PROs in clinical practice is valuable in improving the discussion and detection of HRQoL problems but has less of an impact on how clinicians manage patient problems or on subsequent patient outcomes . Many of the reasons for this may lie in the ways in which PROs fit ( or do not fit ) into the routine ways in which patients and clinicians communicate with each other , how clinicians make decisions , and how healthcare as a whole is organised . Conclusions Future research needs to identify ways in with PROs can be better incorporated into the routine care of patients by combining qualitative and quantitative methods and adopting appropriate trial design BACKGROUND We design ed this observational cohort study to assess the association between patient-centered communication in primary care visits and subsequent health and medical care utilization . METHODS We selected 39 family physicians at r and om , and 315 of their patients participated . Office visits were audiotaped and scored for patient-centered communication . In addition , patients were asked for their perceptions of the patient-centeredness of the visit . The outcomes were : ( 1 ) patients ' health , assessed by a visual analogue scale on symptom discomfort and concern ; ( 2 ) self-report of health , using the Medical Outcomes Study Short Form-36 ; and ( 3 ) medical care utilization variables of diagnostic tests , referrals , and visits to the family physician , assessed by chart review . The 2 measures of patient-centeredness were correlated with the outcomes of visits , adjusting for the clustering of patients by physician and controlling for confounding variables . RESULTS Patient-centered communication was correlated with the patients ' perceptions of finding common ground . In addition , positive perceptions ( both the total score and the subscore on finding common ground ) were associated with better recovery from their discomfort and concern , better emotional health 2 months later , and fewer diagnostic tests and referrals . CONCLUSIONS Patient-centered communication influences patients ' health through perceptions that their visit was patient centered , and especially through perceptions that common ground was achieved with the physician . Patient-centered practice improved health status and increased the efficiency of care by reducing diagnostic tests and referrals OBJECTIVE This paper defines an interactional analysis instrument to characterize patient-centered care and identify associated variables . METHODS In this study , 509 new adult patients were r and omized to care by family physicians and general internists . An adaption of the Davis Observation Code was used to measure a patient-centered practice style . The main outcome measures were visit-specific satisfaction and healthcare re source utilization . RESULTS In initial primary care visits , patient-centered practice style was positively associated with higher patient self-reported physical health status ( p=0.0328 ) , higher educational level ( p=0.0050 ) , and non-smoking status ( p=0.0108 ) ; it was also observed more often in the interactions of family physicians compared to internists ( p=0.0003 ) . Controlling for patient sociodemographic variables , self-reported health status , pain , health risk behaviors ( obesity , alcohol abuse , and smoking ) , and clinic assignment , patient satisfaction was not related to the provision of patient-centered care . Moreover , a higher average amount of patient-centered care recorded in visits throughout the one-year study period was significantly related to lower annual medical charges ( p=0.0003 ) . CONCLUSIONS Patient-centered care was observed more often with family physician caring for healthier , more educated patients , and was associated with lower charges . PRACTICE IMPLICATION S Reduced annual medical care charges are an important outcome of patient-centered medical visits Purpose : This article uses an interactional analysis instrument to characterize patient-centered care in the primary care setting and to examine its relationship with health care utilization . Methods : Five hundred nine new adult patients were r and omized to care by family physicians and general internists . An adaption of the Davis Observation Code was used to measure a patient-centered practice style . The main outcome measures were their use of medical services and related charges monitored over 1 year . Results : Controlling for patient sex , age , education , income , self-reported health status , and health risk behaviors ( obesity , alcohol abuse , and smoking ) , a higher average amount of patient-centered care recorded in visits throughout the 1-year study period was related to a significantly decreased annual number of visits for specialty care ( P = .0209 ) , less frequent hospitalizations ( P = .0033 ) , and fewer laboratory and diagnostic tests ( P = .0027 ) . Total medical charges for the 1-year study were also significantly reduced ( P = .0002 ) , as were charges for specialty care clinic visits ( P = .0005 ) , for all patients who had a greater average amount of patient-centered visits during that same time period . For female patients , the regression equation predicted 15.47 % of the variation in total annual medical charges compared with male patients , for whom 31.18 % of the variation was explained by the average percent of patient-centered care , controlling for sociodemographic variables , health status , and health risk behaviors . Conclusions : Patient-centered care was associated with decreased utilization of health care services and lower total annual charges . Reduced annual medical care charges may be an important outcome of medical visits that are patient-centered
Output:
| Conclusions This systematic review reveals a lack of underst and ing of PCC within dentistry , and in particular general dental practice .
There is currently a poor evidence base to support the use of the current patient reported outcome measures as indicators of patient-centredness . |
MS211298 | ***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 this paper , Choi and colleagues analyzed levels of mitochondrial DNA in two prospect i ve observational cohort studies and found that increased mtDNA levels are associated with ICU mortality , and improve risk prediction in medical ICU patients . The data suggests that mtDNA could serve as a viable plasma biomarker in MICU patients We propose a model wherein chronic stress results in glucocorticoid receptor resistance ( GCR ) that , in turn , results in failure to down-regulate inflammatory response . Here we test the model in two viral-challenge studies . In study 1 , we assessed stressful life events , GCR , and control variables including baseline antibody to the challenge virus , age , body mass index ( BMI ) , season , race , sex , education , and virus type in 276 healthy adult volunteers . The volunteers were subsequently quarantined , exposed to one of two rhinoviruses , and followed for 5 d with nasal washes for viral isolation and assessment of signs/symptoms of a common cold . In study 2 , we assessed the same control variables and GCR in 79 subjects who were subsequently exposed to a rhinovirus and monitored at baseline and for 5 d after viral challenge for the production of local ( in nasal secretions ) proinflammatory cytokines ( IL-1β , TNF-α , and IL-6 ) . Study 1 : After covarying the control variables , those with recent exposure to a long-term threatening stressful experience demonstrated GCR ; and those with GCR were at higher risk of subsequently developing a cold . Study 2 : With the same controls used in study 1 , greater GCR predicted the production of more local proinflammatory cytokines among infected subjects . These data provide support for a model suggesting that prolonged stressors result in GCR , which , in turn , interferes with appropriate regulation of inflammation . Because inflammation plays an important role in the onset and progression of a wide range of diseases , this model may have broad implication s for underst and ing the role of stress in health Objective Mitochondria are multifunctional life-sustaining organelles that represent a potential intersection point between psychosocial experiences and biological stress responses . This article provides a systematic review of the effects of psychological stress on mitochondrial structure and function . Methods A systematic review of the literature investigating the effects of psychological stress on mitochondrial function was conducted . The review focused on experimentally controlled studies allowing us to draw causal inference about the effect of induced psychological stress on mitochondria . Results A total of 23 studies met the inclusion criteria . All studies involved male laboratory animals , and most demonstrated that acute and chronic stressors influenced specific facets of mitochondrial function , particularly within the brain . Nineteen studies showed significant adverse effects of psychological stress on mitochondria and four found increases in function or size after stress . In humans , only six observational studies were available , none with experimental design s , and most only measured biological markers that do not directly reflect mitochondrial function , such as mitochondrial DNA copy number . Conclusons Overall , evidence supports the notion that acute and chronic stressors influence various aspects of mitochondrial biology , and that chronic stress exposure can lead to molecular and functional recalibrations among mitochondria . Limitations of current animal and human studies are discussed . Maladaptive mitochondrial changes that characterize this subcellular state of stress are termed mitochondrial allostatic load . Prospect i ve studies with sensitive measures of specific mitochondrial outcomes will be needed to establish the link between psychosocial stressors , emotional states , the result ing neuroendocrine and immune processes , and mitochondrial energetics relevant to mind-body research in humans Mitochondrial components , including mitochondrial DNA ( mtDNA ) , when released extracellularly , can act as " damage-associated molecular pattern " ( DAMP ) agents and cause inflammation . As many elderly people are characterized by a low- grade , chronic inflammatory status defined " inflamm-aging , " we evaluated if circulating mtDNA can contribute to this phenomenon . Eight hundred and thirty-one Caucasian subjects were enrolled in the study , including 429 siblings aged 90 - 104 ( 90 + siblings ) . mtDNA plasma levels increased gradually after the fifth decade of life . In 90 + subjects , mtDNA values of two members of the same sibling relationship were directly correlated , suggesting a role for familiar/genetic background in controlling the levels of circulating mtDNA . The subjects with the highest mtDNA plasma levels had the highest amounts of TNF-α , IL-6 , RANTES , and IL-1ra ; the subjects with the lowest mtDNA levels had the lowest levels of the same cytokines . In vitro stimulation of monocytes with mtDNA concentrations similar to the highest levels observed in vivo result ed in an increased production of TNF-α , suggesting that mtDNA can modulate the production of proinflammatory cytokines . Our findings therefore show that circulating mtDNA increases with age , and can significantly contribute to the maintenance of the low- grade , chronic inflammation observed in elderly people BACKGROUND Decreased hippocampal volume is observed in patients with Cushing 's syndrome and other conditions associated with elevated cortisol levels , stress , or both . Reversibility of hippocampal neuronal atrophy result ing from stress occurs in animals . Our study investigated the potential for reversibility of human hippocampal atrophy . METHODS The study included 22 patients with Cushing 's disease . Magnetic resonance brain imaging was performed prior to transsphenoidal microadenomectomy and again after treatment . RESULTS Following treatment , hippocampal formation volume ( HFV ) increased by up to 10 % . The mean percent change ( 3.2 + /- 2.5 ) was significantly greater ( p < .04 ) than that of the comparison structure , cau date head volume ( 1.5 + /- 3.4 ) . Increase in HFV was significantly associated with magnitude of decrease in urinary free cortisol ( r = -.61 , p < .01 ) . This relationship strengthened after adjustments for age , duration of disease , and months elapsed since surgery ( r = -.70 , p < .001 ) . There was no significant correlation between cau date head volume change and magnitude of cortisol decrease . CONCLUSIONS Changes in human HFV associated with sustained hypercortisolemia are reversible , at least in part , once cortisol levels decrease . While many brain regions are likely affected by hypercortisolemia , the human hippocampus exhibits increased sensitivity to cortisol , affecting both volume loss and recovery Objective : To investigate progression of MRI-assessed manifestations of cerebral degeneration related to cognitive changes in a population of elderly patients with diabetes mellitus ( DM ) compared to age-matched control subjects . Methods : From a r and omized controlled trial ( PROSPER study ) , a study sample of 89 patients with DM and 438 control subjects without DM aged 70–82 years were included for brain MRI scanning and cognitive function testing at baseline and reexamination after 3 years . Changes in brain atrophy , white matter hyperintensities ( WMHs ) , number of infa rct ions , and cognitive function test results were determined in patients with DM and subjects without DM . Linear regression analysis was performed with correction for age , gender , hypertension , pravastatin treatment , educational level , and baseline test results . In patients with DM , baseline MRI parameters were correlated with change in cognitive function test result using linear regression analysis with covariates age and gender . Results : Patients with DM showed increased progression of brain atrophy ( p < 0.01 ) after follow-up compared to control subjects . No difference in progression of WMH volume or infa rct ions was found . Patients with DM showed increased decline in cognitive performance on Stroop Test ( p = 0.04 ) and Picture Learning Test ( p = 0.03 ) . Furthermore , in patients with DM , change in Picture Learning Test was associated with baseline brain atrophy ( p < 0.02 ) . Conclusion : Our data show that elderly patients with DM without dementia have accelerated progression of brain atrophy with significant consequences in cognition compared to subjects without DM . Our findings add further evidence to the hypothesis that diabetes exerts deleterious effects on neuronal integrity The hippocampus shrinks in late adulthood , leading to impaired memory and increased risk for dementia . Hippocampal and medial temporal lobe volumes are larger in higher-fit adults , and physical activity training increases hippocampal perfusion , but the extent to which aerobic exercise training can modify hippocampal volume in late adulthood remains unknown . Here we show , in a r and omized controlled trial with 120 older adults , that aerobic exercise training increases the size of the anterior hippocampus , leading to improvements in spatial memory . Exercise training increased hippocampal volume by 2 % , effectively reversing age-related loss in volume by 1 to 2 y. We also demonstrate that increased hippocampal volume is associated with greater serum levels of BDNF , a mediator of neurogenesis in the dentate gyrus . Hippocampal volume declined in the control group , but higher preintervention fitness partially attenuated the decline , suggesting that fitness protects against volume loss . Cau date nucleus and thalamus volumes were unaffected by the intervention . These theoretically important findings indicate that aerobic exercise training is effective at reversing hippocampal volume loss in late adulthood , which is accompanied by improved memory function BACKGROUND Pre clinical studies demonstrate that the neonatal environment can permanently alter an individual 's responses to stress . To demonstrate a similar phenomenon in humans , we prospect ively examined the relationships of maternal stress beginning in infancy and concurrent stress on preschoolers ' hypothalamic-pituitary-adrenal activity and later mental health symptoms . METHODS Salivary cortisol levels were assessed in 282 4.5-year-old children and 154 of their siblings . Maternal reports of stress were obtained when the children were ages 1 , 4 , and 12 months , and again at 4.5 years . Children 's mental health symptoms were assessed in first grade . RESULTS A cross-sectional analysis revealed that preschoolers exposed to high levels of concurrent maternal stress had elevated cortisol levels ; however , a longitudinal analysis revealed that concurrently stressed children with elevated cortisol also had a history of high maternal stress exposure in infancy . Importantly , children exposed only to high levels of concurrent or early stress had cortisol levels that did not significantly differ from those never exposed to stress . Further analysis of the components of stress indicated that maternal depression beginning in infancy was the most potent predictor of children 's cortisol . We also found that preschoolers with high cortisol levels exhibited greater mental health symptoms in first grade . CONCLUSIONS These results link the findings of pre clinical studies to humans by showing that exposure to early maternal stress may sensitize children 's pituitary-adrenal responses to subsequent stress exposure OBJECTIVE — We determined whether reduced insulin sensitivity , mitochondrial dysfunction , and other age-related dysfunctions are inevitable consequences of aging or secondary to physical inactivity . RESEARCH DESIGN AND METHODS — Insulin sensitivity was measured by hyperinsulinemic-euglycemic clamp and ATP production in mitochondria isolated from vastus lateralis biopsies of 42 healthy sedentary and endurance-trained young ( 18–30 years old ) and older ( 59–76 years old ) subjects . Expression of proteins involved in fuel metabolism was measured by mass spectrometry . Citrate synthase activity , mitochondrial DNA ( mtDNA ) abundance , and expression of nuclear-encoded transcription factors for mitochondrial biogenesis were measured . SIRT3 , a mitochondrial sirtuin linked to lifespan-enhancing effects of caloric restriction , was measured by immunoblot . RESULTS — Insulin-induced glucose disposal and suppression of endogenous glucose production were higher in the trained young and older subjects , but no age effect was noted . Age-related decline in mitochondrial oxidative capacity was absent in endurance-trained individuals . Although endurance-trained individuals exhibited higher expression of mitochondrial proteins , mtDNA , and mitochondrial transcription factors , there were persisting effects of age . SIRT3 expression was lower with age in sedentary but equally elevated regardless of age in endurance-trained individuals . CONCLUSIONS — The results demonstrate that reduced insulin sensitivity is likely related to changes in adiposity and to physical inactivity rather than being an inevitable consequence of aging . The results also show that regular endurance exercise partly normalizes age-related mitochondrial dysfunction , although there are persisting effects of age on mtDNA abundance and expression of nuclear transcription factors and mitochondrial protein . Furthermore , exercise may promote longevity through pathways common to effects of caloric restriction Chronic stress in non-human animals decreases the volume of the hippocampus , a brain region that supports learning and memory and that regulates neuroendocrine activity . In humans with stress-related psychiatric syndromes characterized by impaired learning and memory and dysregulated neuroendocrine activity , surrogate and retrospective indicators of chronic stress are also associated with decreased hippocampal volume . However , it is unknown whether chronic stress is associated with decreased hippocampal volume in those without a clinical syndrome . We tested whether reports of life stress obtained prospect ively over an approximate 20-year period predicted later hippocampal grey matter volume in 48 healthy postmenopausal women . Women completed the Perceived Stress Scale repeatedly from 1985 to 2004 ; in 2005 and 2006 , their hippocampal grey matter volume was quantified by voxel-based morphometry . Higher Perceived Stress Scale scores from 1985 to 2004 - an indicator of more chronic life stress - predicted decreased grey matter volume in the right orbitofrontal cortex and right hippocampus . These relationships persisted after
Output:
| Mitochondrial function and dysfunction also contribute to systemic physiological regulation through the release of mitokines and other metabolites .
At the cellular level , mitochondrial signaling influences gene expression and epigenetic modifications , and modulates the rate of cellular aging .
Conclusions This evidence suggests that mitochondrial allostatic load represents a potential subcellular mechanism for transducing psychosocial experiences and the result ing emotional responses — both adverse and positive — into clinical ly meaningful biological and physiological changes . |
MS211299 | ***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 determine whether massage therapy improves postoperative mood , pain , anxiety , and physiologic measurements ; shortens hospital stay ; and decreases occurrence of atrial fibrillation . METHODS Two hundred fifty-two adults undergoing cardiac surgery were r and omized to usual postoperative care ( n=126 ) or usual care plus two massages ( n=126 ) . Assessment s of mood , depression , anxiety , pain , physiologic status , cardiac rhythm , and hospital length of stay were completed . Logistic and linear regressions were performed . RESULTS Preoperative pain , mood , and affective state scores were positively associated with postoperative scores ; however , there were no postoperative differences between groups for any measures ( P=.11 to .93 ) . There were no differences in physiologic variables except lower postoperative blood pressure after massage ( P = .01 ) . Postoperative atrial fibrillation occurrence ( P = .6 ) and median postoperative hospital length of stay ( P = .4 ) were similar between groups . CONCLUSION Massage therapy is feasible in cardiac surgical patients ; however , it does not yield therapeutic benefit . Nevertheless , it should be a patient-selected and -paid option BACKGROUND The conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments OBJECTIVE To examine the effects of adjunctive postoperative massage and vibration therapy on short-term postsurgical pain , negative affect , and physiologic stress reactivity . DESIGN Prospect i ve , r and omized controlled trial . The treatment groups were : ( 1 ) usual postoperative care ( UC ) ; ( 2 ) UC plus massage therapy ; or ( 3 ) UC plus vibration therapy . SETTING The University of Virginia Hospital Surgical Units , Gynecology-Oncology Clinic , and General Clinical Research Center . SUBJECTS One hundred and five ( N = 105 ) women who underwent an abdominal laparotomy for removal of suspected cancerous lesions . INTERVENTIONS All patients received UC with analgesic medication . Additionally , the massage group received st and ardized 45-minute sessions of gentle Swedish massage on the 3 consecutive evenings after surgery and the vibration group received 20-minute sessions of inaudible vibration therapy ( physiotones ) on the 3 consecutive evenings after surgery , as well as additional sessions as desired . OUTCOME MEASURES Sensory pain , affective pain , anxiety , distress , analgesic use , systolic blood pressure , 24-hour urine free cortisol , number of postoperative complications , and days of hospitalization . RESULTS On the day of surgery , massage was more effective than UC for affective ( p = 0.0244 ) and sensory pain ( p = 0.0428 ) , and better than vibration for affective pain ( p = 0.0015 ) . On postoperative day 2 , massage was more effective than UC for distress ( p = 0.0085 ) , and better than vibration for sensory pain ( p = 0.0085 ) . Vibration was also more effective than UC for sensory pain ( p = 0.0090 ) and distress ( p = .0090 ) . However , after controlling for multiple comparisons and multiple outcomes , no significant differences were found . CONCLUSIONS Gentle Swedish massage applied postoperatively may have minor effects on short-term sensory pain , affective pain , and distress among women undergoing an abdominal laparotomy for removal of suspected malignant tissues This r and omized-controlled study examined the effects of foot massage on patients ' perception of care received following surgery . The sample of 59 women who underwent laparoscopic sterilization as day case patients were r and omly allocated into two groups . The experimental group received a foot massage and analgesia post-operatively , whilst the control group received only analgesia post-operatively . Each participant was asked to complete a question naire on the day following surgery . This examined satisfaction , memory and analgesia taken . The 76 % response rate was comparable with other patient satisfaction studies following day-case surgery . Statistical analysis showed no overall significant difference in the pain experienced by the two groups ; however , the mean pain scores recorded following surgery showed a significantly different pattern over time , such that the experimental group consistently reported less pain following a foot massage than the control group . This study has attempted to explore the use of foot massage in a systematic way and is therefore a basis for further study PURPOSE Cardiopulmonary resuscitation ( CPR ) during flight is challenging and has to be sustained for long periods . In this setting a mechanical-resuscitation-device ( MRD ) might improve performance . In this study we compared the quality of resuscitation of trained flight attendants practicing either st and ard basic life support ( BLS ) or using a MRD in a cabin-simulator . METHODS Prospect i ve , open , r and omized and crossover simulation study . Study participants , competent in st and ard BLS were trained to use the MRD to deliver both chest compressions and ventilation . 39 teams of two rescuers resuscitated a manikin for 12 min in r and om order , st and ard BLS or mechanically assisted resuscitation . Primary outcome was " absolute h and s-off time " ( sum of all periods during which no h and was placed on the chest minus ventilation time ) . Various parameters describing the quality of chest compression and ventilation were analysed as secondary outcome parameters . RESULTS Use of the MRD led to significantly less " absolute h and s-off time " ( 164±33 s vs. 205±42 s , p<0.001 ) . The quality of chest compression was comparable among groups , except for a higher compression rate in the st and ard BLS group ( 123±14 min(-1 ) vs. 95±11 min(-1 ) , p<0.001 ) . Tidal volume was higher in the st and ard BLS group ( 0.48±0.14 l vs. 0.34±0.13 l , p<0.001 ) , but we registered fewer gastric inflations in the MRD group ( 0.4±0.3 % vs. 16.6±16.9 % , p<0.001 ) . CONCLUSION Using the MRD result ed in significantly less " absolute h and s-off time " , but less effective ventilation . The translation of higher chest compression rate into better outcome , as shown in other studies previously , has to be investigated in another human outcome study Integrative therapies such as massage have gained support as interventions that improve the overall patient experience during hospitalization . Cardiac surgery patients undergo long procedures and commonly have postoperative back and shoulder pain , anxiety , and tension . Given the promising effects of massage therapy for alleviation of pain , tension , and anxiety , we studied the efficacy and feasibility of massage therapy delivered in the postoperative cardiovascular surgery setting . Patients were r and omized to receive a massage or to have quiet relaxation time ( control ) . In total , 113 patients completed the study ( massage , n=62 ; control , n=51 ) . Patients receiving massage therapy had significantly decreased pain , anxiety , and tension . Patients were highly satisfied with the intervention , and no major barriers to implementing massage therapy were identified . Massage therapy may be an important component of the healing experience for patients after cardiovascular surgery UNLABELLED Factors contributing to pain following surgery are poorly understood , with previous research largely focused on adults . With approximately 6 million children undergoing surgery each year , there is a need to study pediatric persistent postsurgical pain . The present study includes patients with adolescent idiopathic scoliosis undergoing spinal fusion surgery enrolled in a prospect i ve , multicentered registry examining postsurgical outcomes . The Scoliosis Research Society Question naire-Version 30 , which includes pain , activity , mental health , and self-image subscales , was administered to 190 patients prior to surgery and at 1 and 2 years postsurgery . A subset ( n = 77 ) completed 5-year postsurgery data . Pain prevalence at each time point and longitudinal trajectories of pain outcomes derived from SAS PROC TRAJ were examined using analyses of variance and post hoc pairwise analyses across groups . Thirty-five percent of patients reported pain in the moderate to severe range presurgery . One year postoperation , 11 % reported pain in this range , whereas 15 % reported pain at 2 years postsurgery . At 5 years postsurgery , 15 % of patients reported pain in the moderate to severe range . Among the 5 empirically derived pain trajectories , there were significant differences on self-image , mental health , and age . Identifying predictors of poor long-term outcomes in children with postsurgical pain may prevent the development of chronic pain into adulthood . PERSPECTIVE This investigation explores the prevalence of pediatric pain following surgery , up to 5 years after spinal fusion surgery . Five pain trajectories were identified and were distinguishable on presurgical characteristics of age , mental health , and self-image . This is the largest study to examine longitudinal pediatric pain trajectories after surgery INTRODUCTION : Poor sleep quality is common among patients following cardiopulmonary artery bypass graft surgery . Pain , stress , anxiety and poor sleep quality may be improved by massage therapy . OBJECTIVE : This study evaluated whether massage therapy is an effective technique for improving sleep quality in patients following cardiopulmonary artery bypass graft surgery . METHOD : Participants included cardiopulmonary artery bypass graft surgery patients who were r and omized into a control group and a massage therapy group following discharge from the intensive care unit ( Day 0 ) , during the postoperative period . The control group and the massage therapy group comprised participants who were subjected to three nights without massage and three nights with massage therapy , respectively . The patients were evaluated on the following mornings ( i.e. , Day 1 to Day 3 ) using a visual analogue scale for pain in the chest , back and shoulders , in addition to fatigue and sleep . Participants kept a sleep diary during the study period . RESULTS : Fifty-seven cardiopulmonary artery bypass graft surgery patients were enrolled in the study during the preoperative period , 17 of whom were excluded due to postoperative complications . The remaining 40 participants ( male : 67.5 % , age : 61.9 years ± 8.9 years , body mass index : 27.2 kg/m2 ± 3.7 kg/m2 ) were r and omized into control ( n = 20 ) and massage therapy ( n = 20 ) groups . Pain in the chest , shoulders , and back decreased significantly in both groups from Day 1 to Day 3 . The participants in the massage therapy group had fewer complaints of fatigue on Day 1 ( p = 0.006 ) and Day 2 ( p = 0.028 ) in addition , they reported a more effective sleep during all three days ( p = 0.019 ) when compared with the participants in the control group . CONCLUSION : Massage therapy is an effective technique for improving patient recovery from cardiopulmonary artery bypass graft surgery because it reduces fatigue and improves sleep BACKGROUND Opioid analgesia alone may not fully relieve all aspects of acute postoperative pain . Complementary medicine techniques used as adjuvant therapies have the potential to improve pain management and palliate postoperative distress . STUDY DESIGN This prospect i ve r and omized clinical trial compared pain relief after major operations in 202 patients who received one of three nursing interventions : massage , focused attention , or routine care . Interventions were performed twice daily starting 24 hours after the operation through postoperative day 7 . Perceived pain was measured each morning . RESULTS The rate of decline in
Output:
| Based on the available evidence , weak recommendations are suggested for massage therapy , compared to active comparators for reducing pain intensity/severity and anxiety in patients undergoing surgical procedures . |
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