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MS211900 | ***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 This study attempted to determine the total direct costs derived from the management of chronic bronchitis and COPD in an ambulatory setting through a prospect i ve , 1-year , follow-up study . METHOD A total of 1,510 patients with chronic bronchitis and COPD were recruited from 268 general practice s located throughout Spain . Patients were followed up for 1 year . All direct medical costs incurred by the cohort and related to their respiratory disease were quantified . Costs were calculated for patients with confirmed COPD according to the degree of severity of airflow obstruction . RESULTS The global mean direct yearly cost of chronic bronchitis and COPD was $ 1,876 . The cost generated by patients with COPD was $ 1,760 , but the cost of severe COPD ( $ 2,911 ) was almost double that of mild COPD ( $ 1,484 ) . Hospitalization costs represented 43.8 % of costs , drug acquisition costs were 40.8 % , and clinic visits and diagnostic tests represented only 15.4 % of costs . CONCLUSION This is the first prospect i ve follow-up study on a large cohort of patients with chronic bronchitis and COPD aim ed at quantifying direct medical costs under usual clinical practice in the community . Costs of chronic bronchitis and COPD were almost twofold those reported for asthma . Patterns of COPD management in the community differ from those recommended in guidelines . COPD represents a great health-care burden in developed countries , and aging of the population and continuing smoking habits predict that it will continue to do so in the future Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results Background Pulmonary rehabilitation ( PR ) is recognized as an evidence -based treatment in improving dyspnea and quality of life in patients with COPD . We evaluated the number needed to treat ( NNT ) to achieve an increase in physical capacity , as defined by a significant improvement in the six-minute walk test ( 6MWT ) in patients with COPD undergoing PR . Methods The study enrolled 284 patients aged 41 to 86 years ( mean age 69.4 years ) divided into two groups : a study group ( 222 patients ) undergoing a PR program , and a control group ( 62 patients ) treated only with drugs . The study group included patients with COPD divided in four subgroups according to GOLD stages . Results In the study group , 142 out of 222 patients ( 64 % ) had an increase of at least 54 m in the 6MWT following PR versus 8 out of 62 patients ( 13 % ) in the control group after the same time interval . The NNT in the overall study group was 2 ; the same NNT was obtained in GOLD stages 2 , 3 , and 4 , but was 8 in stage 1 . Conclusions PR is highly effective in improving the exercise capacity of patients with COPD , as demonstrated by a valuable NNT , with better results in patients with a more severe disease Background Pulmonary rehabilitation is known to be a beneficial treatment for COPD patients . To date , however , there is no agreement for how long a rehabilitation program should be implemented . In addition , current views are that pulmonary rehabilitation does not improve FEV1 or even slow its decline in COPD patients . The aim of the study was to examine the efficacy of a 3 year outpatient pulmonary rehabilitation ( PR ) program for COPD patients on pulmonary function , exercise capability , and body mass index ( BMI ) . Methods A matched controlled trial was performed with outcome assessment s evaluated at 6 , 12 , 18 , 24 , 30 , and 36 months . Eighty patients with moderate to severe COPD ( age 63 ± 7 years ; FEV1 48 % ± 14 ) were recruited . The control group received st and ard care only , while in addition , the case study group received PR for duration of three years . These groups were matched for age , sex , BMI , FEV1 % and number of pack-years smoked . Results The decline in FEV1 after the three years was significantly lower in the PR group compared to control , 74 ml versus 149 ml , respectively ( p < 0.001 ) . Maximal sustained work and endurance time improved after a short period of PR and was maintained throughout the study , in contrast to the control group ( p < 0.01 ) . A decreased BMI was noted in the control group after three years , while in the PR group a mild improvement was seen ( p < 0.05 ) . Conclusion Three years of outpatient pulmonary rehabilitation result ed in modifying the disease progression of COPD , as well as improving physical performance in these patients 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 OBJECTIVE To establish the minimal important difference ( MID ) for the six-minute walk distance ( 6MWD ) in persons with chronic obstructive pulmonary disease ( COPD ) . DESIGN Analysis of data from an observational study using distribution- and anchor-based methods to determine the MID in 6MWD . SETTING Outpatient pulmonary rehabilitation program at 2 teaching hospitals . PARTICIPANTS Seventy-five patients with COPD ( 44 men ) in a stable clinical state with mean age 70 years ( SD 9 y ) , forced expiratory volume in one second 52 % ( SD 21 % ) predicted and baseline walking distance 359 meters ( SD 104 m ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Participants completed the six-minute walk test before and after a 7-week pulmonary rehabilitation program . Participants and clinicians completed a global rating of change score while blinded to the change in 6MWD . RESULTS The mean change in 6MWD in participants who reported themselves to be unchanged was 17.7 meters , compared with 60.2 meters in those who reported small change and 78.4 meters in those who reported substantial change ( P=.004 ) . Anchor-based methods identified an MID of 25 meters ( 95 % confidence interval 20 - 61 m ) . There was excellent agreement with distribution-based methods ( 25.5 - 26.5 m , kappa=.95 ) . A change in 6MWD of 14 % compared with baseline also represented a clinical ly important effect ; this threshold was less sensitive than for absolute change ( sensitivity .70 vs .85 ) . CONCLUSIONS The MID for 6MWD in COPD is 25 meters . Absolute change in 6MWD is a more sensitive indicator than percentage change from baseline . These data support the use of 6MWD as a patient-important outcome in research and clinical practice BACKGROUND The aim of our study was to determine the effect of one year of pulmonary rehabilitation ( PR ) on functional parameters and exacerbation rates in patients with chronic obstructive pulmonary disease ( COPD ) . METHODS A total of 100 patients were enrolled in a multidisciplinary PR program . PR included endurance , resistance and respiratory muscle training . We performed spiroergometry , a modified Bruce Test and measurements of upper and lower limb contractility as well as inspiratory muscle strength before , six and 12 months after beginning rehabilitation . Additionally , we assessed the quality of life and the number of exacerbations and exacerbation days one year before and after starting rehabilitation . RESULTS 100 patients ( 42 female/58 male ) with COPD ( COPD IV-N=36 , COPD III-N=42 , COPD II-N=22 ) , a mean age of 60.5+/-9.6 years , BMI 25.8+/-6.0 attended a rehabilitation training program over a time period of one year . Spiroergometry ( VO2max from 1.1 to 1.3 l/min , P<0.05 ) , modified Bruce Test ( from 13+/-7 Min to 18+/-9 Min ; P<0.001 ) , upper limb ( from 39.9+/-3 to 52.9+/-8 kg ; P<0.001 ) and lower limb strength increased significantly ( from 85.3+/-45 to 131.5+/-57 kg ; P<0.001 ) . The maximal inspiratory pressure rose from 81.1 mbar to 108.8 mbar ( p<0.001 ) . There was no improvement in FEV1 or FEV1/FVC but Saint Georges Respiratory Question naire ( total score ) improved from 37.2+/-3.6 to 26.5+/-2.8 ; P<0.001 . The same was true for exacerbation rates ( they dropped from 2.8 to 0.8 ; P=0.006 ) and the number of hospitalization days ( from 27.3 to 3.3 , P<0.001 ) . CONCLUSIONS One year of outpatient pulmonary rehabilitation is an effective intervention leading to a significant improvement in exercise tolerance and quality of life in patients with COPD also reducing COPD exacerbation rates and hospitalizations
Output:
| : Most of the PR programs had significant positive effects on exercise capacity and HRQOL in patients with mild COPD ; however , their effects on health-care re source use and lung function were inconclusive . |
MS211901 | ***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: Regular physical exercise is broadly recommended by current European and American hypertension guidelines . It remains elusive , however , whether exercise leads to a reduction of blood pressure in resistant hypertension as well . The present r and omized controlled trial examines the cardiovascular effects of aerobic exercise on resistant hypertension . Resistant hypertension was defined as a blood pressure ≥140/90 mm Hg in spite of 3 antihypertensive agents or a blood pressure controlled by ≥4 antihypertensive agents . Fifty subjects with resistant hypertension were r and omly assigned to participate or not to participate in an 8- to 12-week treadmill exercise program ( target lactate , 2.0±0.5 mmol/L ) . Blood pressure was assessed by 24-hour monitoring . Arterial compliance and cardiac index were measured by pulse wave analysis . The training program was well tolerated by all of the patients . Exercise significantly decreased systolic and diastolic daytime ambulatory blood pressure by 6±12 and 3±7 mm Hg , respectively ( P=0.03 each ) . Regular exercise reduced blood pressure on exertion and increased physical performance as assessed by maximal oxygen uptake and lactate curves . Arterial compliance and cardiac index remained unchanged . Physical exercise is able to decrease blood pressure even in subjects with low responsiveness to medical treatment . It should be included in the therapeutic approach to resistant hypertension BACKGROUND Preliminary evidence suggests that meditative exercise may have benefits for patients with chronic systolic heart failure ( HF ) ; this has not been rigorously tested in a large clinical sample . We sought to investigate whether tai chi , as an adjunct to st and ard care , improves functional capacity and quality of life in patients with HF . METHODS A single-blind , multisite , parallel-group , r and omized controlled trial evaluated 100 out patients with systolic HF ( New York Heart Association class I-III , left ventricular ejection fraction ≤40 % ) who were recruited between May 1 , 2005 , and September 30 , 2008 . A group-based 12-week tai chi exercise program ( n = 50 ) or time-matched education ( n = 50 , control group ) was conducted . Outcome measures included exercise capacity ( 6- minute walk test and peak oxygen uptake ) and disease-specific quality of life ( Minnesota Living With Heart Failure Question naire ) . RESULTS Mean ( SD ) age of patients was 67 ( 11 ) years ; baseline values were left ventricular ejection fraction , 29 % ( 8 % ) and peak oxygen uptake , 13.5 mL/kg/min ; the median New York Heart Association class of HF was class II . At completion of the study , there were no significant differences in change in 6-minute walk distance and peak oxygen uptake ( median change [ first quartile , third quartile ] , 35 [ -2 , 51 ] vs 2 [ -7 , 54 ] meters , P = .95 ; and 1.1 [ -1.1 , 1.5 ] vs -0.5 [ -1.2 , 1.8 ] mL/kg/min , P = .81 ) when comparing tai chi and control groups ; however , patients in the tai chi group had greater improvements in quality of life ( Minnesota Living With Heart Failure Question naire , -19 [ -23 , -3 ] vs 1 [ -16 , 3 ] , P = .02 ) . Improvements with tai chi were also seen in exercise self-efficacy ( Cardiac Exercise Self-efficacy Instrument , 0.1 [ 0.1 , 0.6 ] vs -0.3 [ -0.5 , 0.2 ] , P < .001 ) and mood ( Profile of Mood States total mood disturbance , -6 [ -17 , 1 ] vs -1 [ -13 , 10 ] , P = .01 ) . CONCLUSION Tai chi exercise may improve quality of life , mood , and exercise self-efficacy in patients with HF . Trial Registration clinical trials.gov Identifier : NCT00110227 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 Objective : To examine the effects of a brief Tai Chi Chuan Qigong ( ` Qigong ' ) exercise intervention on individuals with traumatic brain injury . Design : A single-centre r and omized controlled trial pilot study . Setting : A registered charity day centre in the community . Subjects : Twenty individuals with traumatic brain injury . Intervention : Intervention participants attended a Qigong exercise session for one hour per week over eight weeks . Control participants engaged in non-exercise-based social and leisure activities for the same intervention period . Measures : Outcome was assessed at baseline and post intervention using the General Health Question naire-12 , the Physical Self-Description Question naire and the Social Support for Exercise Habits Scale , to measure perceived mood , self-esteem , flexibility , coordination , physical activity and social support . Results : Groups were comparable at baseline . After the intervention , mood was improved in the exercise group when compared with controls ( U = 22.0 , P = 0.02 ) . Improvements in self-esteem ( Z = 2.397 , P = 0.01 ) and mood ( Z = —2.032 , P = 0.04 ) across the study period were also evident in the exercise group only . There were no significant differences in physical functioning between groups . In view of the sample size , these findings are inconclusive . Conclusions : This study provides preliminary evidence that a brief Qigong exercise intervention programme may improve mood and self-esteem for individuals with traumatic brain injury . This needs to be tested in a large-scale r and omized trial Objectives . To evaluate the effectiveness of Baduanjin Qigong exercise on sleep , fatigue , anxiety , and depressive symptoms in chronic fatigue syndrome- ( CFS- ) like illness and to determine the dose-response relationship . Methods . One hundred fifty participants with CFS-like illness ( mean age = 39.0 , SD = 7.9 ) were r and omly assigned to Qigong and waitlist . Sixteen 1.5-hour Qigong lessons were arranged over 9 consecutive weeks . Pittsburgh Sleep Quality Index ( PSQI ) , Chalder Fatigue Scale ( ChFS ) , and Hospital Anxiety and Depression Scale ( HADS ) were assessed at baseline , immediate posttreatment , and 3-month posttreatment . The amount of Qigong self- practice was assessed by self-report . Results . Repeated measures analyses of covariance showed a marginally nonsignificant ( P = 0.064 ) group by time interaction in the PSQI total score , but it was significant for the " subjective sleep quality " and " sleep latency " items , favoring Qigong exercise . Improvement in " subjective sleep quality " was maintained at 3-month posttreatment . Significant group by time interaction was also detected for the ChFS and HADS anxiety and depression scores . The number of Qigong lessons attended and the amount of Qigong self- practice were significantly associated with sleep , fatigue , anxiety , and depressive symptom improvement . Conclusion . Baduanjin Qigong was an efficacious and acceptable treatment for sleep disturbance in CFS-like illness . This trial is registered with Hong Kong Clinical Trial Register : HKCTR-1380 OBJECTIVE To assess the effects of a 12-week Tai Chi exercise program on sleep using the sleep spectrogram , a method based on a single channel electrocardiogram (ECG)-derived estimation of cardiopulmonary coupling , previously shown to identify stable and unstable sleep states . METHODS We retrospectively analyzed 24-h continuous ECG data obtained in a clinical trial of Tai Chi exercise in patients with heart failure . Eighteen patients with chronic stable heart failure , left ventricular ejection fraction < or= 40 % ( mean [ + /-st and ard deviation ] age , 59+/-14 years , mean baseline ejection fraction 24%+/-8 % , mean ) were r and omly assigned to receive usual care ( N=10 ) , which included pharmacological therapy and dietary and exercise counseling , or 12 weeks of Tai Chi training ( N=8 ) in addition to usual care . Using the ECG-based sleep spectrogram , we compared intervention and control groups by evaluating baseline and 12-week high ( stable ) and low ( unstable ) frequency coupling ( HFC & LFC , respectively ) as a percentage of estimated total sleep time ( ETST ) . RESULTS At 12 weeks , those who participated in Tai Chi showed a significant increase in HFC ( + 0.05+/-0.10 vs. -0.06+/-0.09 % ETST , p=0.04 ) and significant reduction in LFC ( -0.09+/-0.09 vs. + 0.13+/-0.13 % ETST , p<0.01 ) , compared to patients in the control group . Correlations were seen between improved sleep stability and better disease-specific quality of life . CONCLUSIONS Tai Chi exercise may enhance sleep stability in patients with chronic heart failure . This sleep effect may have a beneficial impact on blood pressure , arrhythmogenesis and quality of life Purpose . To assess if Tai Chi added to endurance training ( ET ) is more effective than ET alone in improving exercise tolerance and quality of life ( QOL ) of elderly patients with chronic heart failure ( CHF ) . Design . Sixty CHF patients , age 73.8 ± 6 years , M/F 51/9 , were enlisted . Thirty pts were r and omized to combined training ( CT ) performing Tai Chi + ET and 30 patients to ET ( ET only ) . Methods . At baseline and after 12 weeks all patients underwent 6-minute walking test ( 6MWT ) , assessment of amino terminal probrain natriuretic peptide ( NT-pro BNP ) , quadriceps maximal voluntary contraction ( MVC ) and peak torque ( PT ) , QOL question naire ( MacNewQLMI ) , blood pressure ( BP ) , and heart rate ( HR ) . All patients performed 4 sessions of exercise/week . Results . Distance at 6mwt improved in both groups with significant between-groups differences ( P = .031 ) . Systolic BP and NT-proBNP decreased significant in the CT group compared to ET ( P = .025 ) and P = .015 ) , resp . ) . CT group had a greater significant improvement in physical perception ( P = .026 ) and a significant increase of PT compared to ET group . Conclusions . The association of Tai Chi and ET improves exercise tolerance and QOL of patients with CHF more efficiently than ET Exercise and relaxation decrease blood pressure . Qigong is a traditional Chinese exercise consisting of breathing and gentle movements . We conducted a r and omised controlled trial to study the effect of Guolin qigong on blood pressure . In all , 88 patients with mild essential hypertension were recruited from the community and r and omised to Goulin qigong or conventional exercise for 16 weeks . The main outcome measurements were blood pressure , health status ( SF-36 scores ) , Beck Anxiety and Depression Inventory scores . In the qigong group , blood pressure decreased significantly from 146.3±7.8/93.0±4.1 mmHg at baseline to 135.5±10.0/87.1±7.7 mmHg at week 16 . In the exercise group , blood pressure also decreased significantly from 140.9±10.9/93.1±3.5 mmHg to 129.7±11.1/86.0±7.0 mmHg . Heart rate , weight , BMI , waist circumference , total cholesterol , renin and 24 h urinary albumin excretion significantly decreased in both groups after 16 weeks . General health , bodily pain , social functioning and depression also improved in both groups . No significant differences between qigong and conventional exercise were found . In conclusion , Guolin qigong and conventional exercise have similar effects on blood pressure in patients with mild hypertension . While no additional benefits were identified , it is nevertheless an alternative to conventional exercise in the nondrug treatment of hypertension In this study , 126 patients ( 90 males , average age 56 years , range 39 - 80 ) were r and omised to Wu Chian-Ch'uan style Tai Chi ( 38 ) , aerobic exercise ( 41 ) or a non-exercise support group ( 47 ) following acute myocardial infa rct ion . Patients attended twice weekly for three weeks then weekly for a further five weeks . Heart rate and blood pressure were recorded before and after each session . Over the 11 sessions of exercise there was a negative trend in diastolic blood pressure only in the Tai Chi group ( Rs = 0.79 , p < 0.01 ) . Significant trends in systolic blood pressure occurred in both exercise groups ( Rs = 0.64 and 0.63 , both p < 0.05 ) . Only four ( 8 % ) patients completed the support group eight-week programme which was less than the number completing Tai Chi ( 82 % ; p < 0.001 ) and aerobic exercise groups ( 73 % ; p < 0.001 ) OBJECTIVES To evaluate the effects on blood pressure , lipid profile , and anxiety status on subjects received a 12-week Tai Chi Chuan exercise program . DESIGN R and omized controlled study of a Tai Chi Chuan group and a group of sedentary life controls . SETTING Taipei Medical University Hospitals and University campus in the Taipei , Taiwan , area . SUBJECTS Two ( 2 ) selected groups of 76 healthy subjects with blood pressure at high-normal or stage I hypertension . INTERVENTION A 12-week
Output:
| Conclusions This study demonstrated that TCE can effectively improve physiological outcomes , biochemical outcomes , physical function , quality of life , and depression among patients with cardiovascular disease . |
MS211902 | ***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 paper is to prospect ively describe early and mid-term outcomes for emergency endovascular aneurysm repair ( eEVAR ) versus open surgery in acute abdominal aortic aneurysms ( aAAAs ) , both unruptured ( symptomatic ) and ruptured . We enrolled all consecutive patients treated for aAAA at our center between April 2002 and April 2008 . The main outcome parameters were 30-day , 6- and 12-month mortality ( all-cause and aneurysm-related ) . Two hundred forty patients were enrolled in the study . In the unruptured aAAA group ( n = 111 ) , 47 ( 42 % ) underwent eEVAR . The 30-day , 6- and 12-month mortality rates were 6 , 13 and 15 % in the eEVAR group versus 11 % ( NS ) , 13 % ( NS ) and 16 % ( NS ) in the open group , respectively . In the ruptured aAAA group ( n = 129 ) , 25 ( 19 % ) underwent eEVAR ( mortality rates : 20 , 28 and 36 % , respectively ) compared with 104 ( 81 % ) patients who underwent open surgery ( mortality rates : 45 % ( P = 0.021 ) , 60 % ( P = 0.004 ) and 63 % ( P = 0.014 ) , respectively ) . In conclusion , the present study showed a reduced 30-day , 6- and 12-month mortality of eEVAR compared with open surgery in all patients with aAAA , mainly due to a lower mortality in the ruptured aAAA group . Late aneurysm-related mortality occurred only in the eEVAR group Endovascular aortic repair ( EVAR ) treatment for ruptured aortoiliac aneurysms ( rAIA ) avoids the additional surgical insult to physiology that comes with laparotomy and open repair ( OR ) . In systematic review s , the pooled mortality rate from rAIA after EVAR is around 20 % and morbidity around 40 % . The proportion of patients with rAIA treated by EVAR is steadily increasing , as most centers are adopting an EVAR as a first line therapy . However , two trials , one r and omized ( n = 32 ) and one nonr and omized , failed to demonstrate any benefit of EVAR to OR . The multicentric r and omized study named ECAR ( for Endosvasculaire vs Chirurgie dans les Anévrysmes Rompus ) was setup on 160 patients to compare the EVAR vs OR in rAIA . The primary outcome is mortality at 1 month . The study started in January 2008 and is still in progress OBJECTIVE Emergency Endovascular Aortic Aneurysm Repair ( eEVAR ) is a rapidly evolving approach to ruptured Abdominal Aortic Aneurysms ( rAAA ) . Yet longer-term outcomes following eEVAR remain unclear . This study compares mid-term outcomes of eEVAR and open rAAA . METHODS A prospect i ve data base for all patients undergoing eEVAR and open rAAA from January 2006 to April 2010 was analysed . Patients were offered eEVAR if anatomically suitable . RESULTS 52 patients ( 45 male , median age 78 years ( 62 - 92 years ) , underwent eEVAR , 50 patients ( 44 male , median age = 71 ( 62 - 95 years ) underwent open rAAA repair . In-hospital mortalities were 12 % ( 6/52 ) for eEVAR , 32 % ( 16/50 ) for open repair . There were five re- interventions ( 10 % ) in the eEVAR group . The peri-operative survival benefits of eEVAR over open rAAA repair were maintained at 1 and 2 years post-operatively with open repair demonstrating a two-fold increased risk of mortality ( Hazard ratio 2.2 , Fisher Exact test , 95 % Confidence Interval ( CI ) 1.108 - 4.62 , p = 0.0122 ) . Overall survival was 81 % at 1 year , 73 % at 2 years for eEVAR , and 62 % at 1 year and 52 % at 2 years for open rAAA repair . CONCLUSION EEVAR is associated with excellent mid-term survival in this cohort . We would recommend eEVAR as the management of choice for rAAA in anatomically suitable patients where local facilities and expertise exist OBJECTIVE Endovascular aneurysm repair ( EVAR ) decreases 30-day mortality for patients with ruptured abdominal aortic aneurysms ( r-AAAs ) compared with open surgical repair ( OSR ) . However , which patients benefit or whether there is any long-term survival advantage is uncertain . METHODS From 2002 to 2011 , 283 patients with r-AAA underwent EVAR ( n = 120 [ 42.4 % ] ) or OSR ( n = 163 [ 57.6 % ] ) at Albany Medical Center . All data were collected prospect ively . Patients were analyzed on an intention-to-treat basis , and outcomes were evaluated by a logistic regression multivariable model . Kaplan-Meier analysis was used to compare long-term survival . RESULTS The EVAR patients had a significantly lower 30-day mortality than did the OSR patients ( 29/120 [ 24.2 % ] vs 72/163 [ 44.2 % ] ; P < .005 ) and better cumulative 5-year survival ( 37 % vs 26 % ; P < .005 ) . Men benefited more from EVAR ( mortality : 20.9 % for EVAR vs 44.3 % for OSR ; P < .001 ) than did women ( mortality : 32.4 % vs 43.9 % ; P = .39 ) . Age ≥80 years was a significant predictor of death for EVAR ( odds ratio [ OR ] , 1.07 ; P = .003 ) but not for OSR ( OR , 1.04 ; P = .056 ) . Preexisting hypertension was a significant predictor of survival for both EVAR ( OR , 0.17 ; P < .001 ) and OSR ( OR , 0.48 ; P = .021 ) . Almost one fourth of EVAR patients ( 21/91 [ 23.1 % ] ) required secondary interventions . Survival advantage was maintained for EVAR patients to 5 years . CONCLUSIONS For r-AAA , EVAR reduces the 30-day mortality and improves long-term survival up to 5 years . However , whereas open survivors require few graft-related interventions , up to 23 % of EVAR patients will require reintervention for endoleaks or graft migration . Close follow-up of all EVAR survivors is m and atory AIM Several studies have shown the feasibility of endovascular repair of ruptured abdominal aortic aneurysms ( rEVAR ) . However , the role and value of rEVAR remains controversial due to selection bias and lack of long-term results . In the present study we describe our short- and long-term results of treating patients with rEVAR irrespective of hemodynamic condition and challenging anatomy . METHODS In April 2006 we started the single centre prospect i ve non-r and omised Ruptured Aneurysm Study ( RASA ) . During a four year enrolment period all consecutive patients presenting with infrarenal ruptured AAA ( rAAA , N.=117 ) were assessed for preferential rEVAR treatment . A rAAA was defined as extravasation of blood or hematoma outside the AAA due to transmural tear in the infrarenal abdominal aorta wall documented by preoperative computed tomography ( CT ) angiography examination or during open repair . Patients with challenging anatomy ( infrarenal neck length below 15 mm and neck angulation above 60 degrees ) were included as part of a damage control concept . Complication and mortality rates were studied at 30 days and yearly afterwards . RESULTS Thirty-five patients ( 33 % of all admitted rAAA ) were treated with rEVAR and 42 % of them were considered hemodynamically unstable ( systolic blood pressure < 100 mmHg ) and 30 % had challenging AAA anatomy . The mortality rate at 30 days in the rEVAR group was 17 % , in the open repair group 31 % , and in the entire rAAA group ( including abstained patients ) 36 % . During the first 30 days , 18 rEVAR patients experienced complications with nine re- interventions as a result . Long-term mortality of the rEVAR patients was 34 % after a median follow-up of 3.4 years . All deaths after one year follow-up were non-AAA related . Multivariate analysis shows that Hardman index , presence of peripheral arterial obstructive disease and lowest systolic blood pressure during surgery are independently associated with long-term survival . Challenging rAAA anatomy was not associated with impaired survival . CONCLUSION Our study shows that rEVAR is feasible irrespective of hemodynamic condition and that it is associated with relative low mortality rates . Challenging rAAA anatomy may not affect overall long-term survival , but six out of ten patients remain unsuitable for rEVAR because of inappropriate anatomy INTRODUCTION The successful application of endovascular techniques for the elective repair of abdominal aortic aneurysms ( AAAs ) has stimulated a strong interest in their possible use in dealing with a long-st and ing surgical challenge : the ruptured abdominal aortic aneurysm ( RAAA ) . The use of a conventional open procedure to repair ruptured aneurysms is associated with a high operative mortality of 45 % to 50 % . In this study , we evaluated the current frequency of endovascular repair of RAAAs in four large states and the impact of this technique on patient outcome . METHODS We examined discharge data sets from 2000 through 2003 from the four states of California , Florida , New Jersey , and New York , whose combined population represents almost a third of the United States population . Proportions and trends were analyzed by chi2 analysis and continuous variables by the Student 's t test . RESULTS We found that since the year 2000 , endovascular repair has begun to emerge as a viable treatment option for RAAAs , accounting for the repair of 6.2 % of cases in 2003 . During the same period , the use of open procedures for RAAAs declined . The overall mortality rate for the 4-year period was significantly lower for endovascular vs open repair ( 39.3 % vs. 47.7 % , P = .005 ) . Moreover , compared with open repair , endovascular repair result ed in a significantly lower rate of pulmonary , renal , and bleeding complications . Survival after endovascular repair correlated with hospital experience , as assessed by the overall volume of elective and nonelective endovascular procedures . For endovascular repairs , mortality ranged from 45.9 % for small volume hospitals to 26 % for large volume hospitals ( P = .0011 ) . Volume was also a determinant of mortality for open repairs , albeit to a much lesser extent ( 51.5 % for small volume hospitals , 44.3 % for large volume hospitals ; P < .0001 ) . CONCLUSION We observed a benefit to using endovascular procedures for RAAAs in institutions with significant endovascular experience ; however , the analysis of administrative data can not rule out selection bias as an explanation of better outcomes . These data strongly endorse the need for prospect i ve studies to clarify to what extent the improved survival in RAAA patients is to be attributed to the endovascular approach rather than the selection of low-risk patients OBJECTIVE To retrospectively compare a single center 's immediate and mid-term outcomes of ruptured abdominal aortic aneurysm open and endovascular repair ( EVAR ) for two patient groups-hemodynamically stable and unstable patients -in the same time period . METHODS Patients presenting at our center with confirmed rupture of an abdominal aortic aneurysm between December 1999 and April 2006 were considered according to an intention-to-treat model with EVAR . Patients with symptomatic or acute ( but not ruptured ) AAAs were not included in this study . Thirty-three patients underwent EVAR , and 91 underwent open repair . Seventy-two patients ( EVAR , 45 % ; open , 63 % ) were classified as hemodynamically unstable at arrival , and 52 were classified as stable ( EVAR , 55 % ; open , 37 % ) . Ninety-seven percent of EVAR procedures commenced under local anesthesia , and 100 % of open repairs occurred with general anesthesia . Overall successful graft deployment , 30-day mortality , overall reintervention rate , and complications were the study primary end points . RESULTS Overall successful graft deployment for EVAR was 91 % ; for open repair , it was 96 % . Overall 30-day mortality for EVAR was 30 % ( unstable , 53 % ; stable , 11 % ) , and the rate was 46 % for open repair ( unstable , 61 % ; stable , 21 % ) . The EVAR postoperative reintervention rate ( within 30 days ) was 15 % ( unstable , 20 % ; stable , 11 % ) , and for open repair it was 10 % ( unstable , 9 % ; stable , 15 % ) . We recorded a 27 % severe complication rate for EVAR patients
Output:
| Endovascular aneurysm repair is not inferior to open repair in patients with a ruptured abdominal aortic aneurysm . |
MS211903 | ***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 : To evaluate the efficacy and tolerability of the urokinase plasminogen activator ( uPA ) inhibitor upamostat in combination with gemcitabine in locally advanced pancreatic adenocarcinoma ( LAPC ) . Methods : Within a prospect i ve multicenter study , LAPC patients were r and omly assigned to receive 1000 mg m−2 of gemcitabine IV weekly either alone ( arm A ) or in combination with 200 mg ( arm B ) or 400 mg ( arm C ) oral upamostat daily . Efficacy endpoints of this proof-of-concept study included response rate , time to first metastasis , progression-free and overall survival ( OS ) . Results : Of the 95 enroled patients , 85 were evaluable for response and 93 for safety . Median OS was 12.5 months ( 95 % CI 8.2–18.2 ) in arm C , 9.7 months ( 95 % CI 8.4–17.1 ) in arm B and 9.9 months ( 95 % CI 7.4–12.1 ) in arm A ; corresponding 1-year survival rates were 50.6 % , 40.7 % and 33.9 % , respectively . More patients achieved a partial remission ( confirmed responses by RECIST ) with upamostat combination therapy ( arm C : 12.9 % ; arm B : 7.1 % ; arm A : 3.8 % ) . Overall , only 12 patients progressed by developing detectable distant metastasis ( arm A : 4 , arm B : 6 , arm C : 2 ) . The most common adverse events considered to be related to upamostat were asthenia , fever and nausea . Conclusion : In this proof-of-concept study targeting the uPA system in LAPC , the addition of upamostat to gemcitabine was tolerated well ; similar survival results were observed for the three treatment arms Gemcitabine is a key drug for the treatment of pancreatic cancer ; however , with its limitation in clinical benefits , the development of another potent therapeutic is necessary . Vascular endothelial growth factor receptor 2 is an essential target for tumor angiogenesis , and we have conducted a phase I clinical trial using gemcitabine and vascular endothelial growth factor receptor 2 peptide ( elpamotide ) . Based on the promising results of this phase I trial , a multicenter , r and omized , placebo‐controlled , double‐blind phase II/III clinical trial has been carried out for pancreatic cancer . The eligibility criteria included locally advanced or metastatic pancreatic cancer . Patients were assigned to either the Active group ( elpamotide + gemcitabine ) or Placebo group ( placebo + gemcitabine ) in a 2:1 ratio by the dynamic allocation method . The primary endpoint was overall survival . The Harrington – Fleming test was applied to the statistical analysis in this study to evaluate the time‐lagged effect of immunotherapy appropriately . A total of 153 patients ( Active group , n = 100 ; Placebo group , n = 53 ) were included in the analysis . No statistically significant differences were found between the two groups in the prolongation of overall survival ( Harrington – Fleming P‐value , 0.918 ; log – rank P‐value , 0.897 ; hazard ratio , 0.87 , 95 % confidence interval [ CI ] , 0.486–1.557 ) . Median survival time was 8.36 months ( 95 % CI , 7.46–10.18 ) for the Active group and 8.54 months ( 95 % CI , 7.33–10.84 ) for the Placebo group . The toxicity observed in both groups was manageable . Combination therapy of elpamotide with gemcitabine was well tolerated . Despite the lack of benefit in overall survival , subgroup analysis suggested that the patients who experienced severe injection site reaction , such as ulceration and erosion , might have better survival Abstract Background Statins have potential antineoplastic properties via arrest of cell-cycle progression and induction of apoptosis . A previous study demonstrated in vitro and in vivo antineoplastic synergism between statins and gemcitabine . The present r and omized , double-blinded , phase II trial compared the efficacy and safety of gemcitabine plus simvastatin ( GS ) with those of gemcitabine plus placebo ( GP ) in patients with locally advanced and metastatic pancreatic cancer . Methods Patients were r and omly assigned to receive a 3-week regimen with GS ( gemcitabine 1,000 mg/m2 on days 1 , 8 , and 15 plus simvastatin 40 mg once daily ) or GP ( gemcitabine 1,000 mg/m2 on days 1 , 8 , and 15 plus placebo ) . The primary end point was time to progression ( TTP ) . Results Between December 2008 and April 2012 , 114 patients were enrolled . The median TTP was not significantly different between the two arms , being 2.4 months ( 95 % CI 0.7–4.1 months ) and 3.6 months ( 95 % CI 3.1–4.1 months ) in the GS and GP arms , respectively ( P = 0.903 ) . The overall disease control rate was 39.7 % ( 95 % CI 12.2–33.8 % ) and 57.1 % ( 95 % CI 19.8–44.2 % ) in the GS and GP arms , respectively ( P = 0.09 ) . The 1-year expected survival rates were similar ( 27.7 and 31.7 % in the GS and GP arms , respectively ; P = 0.654 ) . Occurrence of grade 3 or 4 adverse events was similar in both arms , and no patients had rhabdomyolysis . Conclusions Adding low-dose simvastatin to gemcitabine in advanced pancreatic cancer does not provide clinical benefit , although it also does not result in increased toxicity . Given the emerging role of statins in overcoming resistance to anti-EGFR treatment , further studies are justified to evaluate the efficacy and safety of combined simvastatin and anti-EGFR agents , such as erlotinib or cetuximab , plus gemcitabine for treating advanced pancreatic cancer BACKGROUND Axitinib ( AG-013736 ) is a potent and selective oral inhibitor of vascular endothelial growth factor receptors 1 , 2 , and 3 , which have an important role in pancreatic cancer . The aim of this study was to assess the safety and efficacy of gemcitabine plus axitinib versus gemcitabine alone . METHODS Between January and August , 2006 , 103 patients with unresectable , locally advanced , or metastatic pancreatic cancer were r and omly assigned in a two to one ratio to receive gemcitabine ( 1000 mg/m(2 ) ) plus axitinib 5 mg twice daily ( n=69 ) or gemcitabine ( 1000 mg/m(2 ) ) alone ( n=34 ) by a central ised registration system . The primary endpoint was overall survival . Analyses were done by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00219557 . FINDINGS All r and omised patients were included in the efficacy analyses . Median overall survival was longer with gemcitabine plus axitinib than with gemcitabine alone ( 6.9 [ 95 % CI 5.3 - 10.1 ] months vs 5.6 [ 3.9 - 8.8 ] months ) . The hazard ratio for survival with gemcitabine plus axitinib versus with gemcitabine alone , adjusted for stratification factors , was 0.71 ( 95 % CI 0.44 - 1.13 ) . The most common grade 3 or worse adverse events were fatigue ( 15 [ 22 % ] patients in the gemcitabine plus axitinib group vs one [ 3 % ] in the gemcitabine alone group ) , abdominal pain ( eight [ 12 % ] vs five [ 16 % ] ) , and asthenia ( eight [ 12 % ] vs one [ 3 % ] ) . INTERPRETATION Gemcitabine plus axitinib showed a similar safety profile to gemcitabine alone ; the small , non-statistically significant gain in overall survival needs to be assessed in a r and omised phase III trial BACKGROUND Axitinib is a potent , selective inhibitor of vascular endothelial growth factor ( VEGF ) receptors 1 , 2 , and 3 . A r and omised phase 2 trial of gemcitabine with or without axitinib in advanced pancreatic cancer suggested increased overall survival in axitinib-treated patients . On the basis of these results , we aim ed to assess the effect of treatment with gemcitabine plus axitinib on overall survival in a phase 3 trial . METHODS In this double-blind , placebo-controlled , phase 3 study , eligible patients had metastatic or locally advanced pancreatic adenocarcinoma , no uncontrolled hypertension or venous thrombosis , and Eastern Cooperative Oncology Group performance status 0 or 1 . Patients , stratified by disease extent ( metastatic vs locally advanced ) , were r and omly assigned ( 1:1 ) to receive gemcitabine 1000 mg/m(2 ) intravenously on days 1 , 8 , and 15 every 28 days plus either axitinib or placebo . Axitinib or placebo were administered orally with food at a starting dose of 5 mg twice a day , which could be dose-titrated up to 10 mg twice daily if well tolerated . A central ised r and omisation procedure was used to assign patients to each treatment group , with r and omised permuted blocks within strata . Patients , investigators , and the trial sponsor were masked to treatment assignments . The primary endpoint was overall survival . All efficacy analyses were done in all patients assigned to treatment groups for whom data were available ; safety and treatment administration and compliance assessment s were based on treatment received . This study is registered at Clinical Trials.gov , number NCT00471146 . FINDINGS Between July 27 , 2007 , and Oct 31 , 2008 , 632 patients were enrolled and assigned to treatment groups ( 316 axitinib , 316 placebo ) . At an interim analysis in January , 2009 , the independent data monitoring committee concluded that the futility boundary had been crossed . Median overall survival was 8·5 months ( 95 % CI 6·9 - 9·5 ) for gemcitabine plus axitinib ( n=314 , data missing for two patients ) and 8·3 months ( 6·9 - 10·3 ) for gemcitabine plus placebo ( n=316 ; hazard ratio 1·014 , 95 % CI 0·786 - 1·309 ; one-sided p=0·5436 ) . The most common grade 3 or higher adverse events for gemcitabine plus axitinib and gemcitabine plus placebo were hypertension ( 20 [ 7 % ] and 5 [ 2 % ] events , respectively ) , abdominal pain ( 20 [ 7 % ] and 17 [ 6 % ] ) , fatigue ( 27 [ 9 % ] and 21 [ 7 % ] ) , and anorexia ( 19 [ 6 % ] and 11 [ 4 % ] ) . INTERPRETATION The addition of axitinib to gemcitabine does not improve overall survival in advanced pancreatic cancer . These results add to increasing evidence that targeting of VEGF signalling is an ineffective strategy in this disease . FUNDING Pfizer BACKGROUND In a phase 1 - 2 trial of albumin-bound paclitaxel ( nab-paclitaxel ) plus gemcitabine , substantial clinical activity was noted in patients with advanced pancreatic cancer . We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer . METHODS We r and omly assigned patients with a Karnofsky performance-status score of 70 or more ( on a scale from 0 to 100 , with higher scores indicating better performance status ) to nab-paclitaxel ( 125 mg per square meter of body-surface area ) followed by gemcitabine ( 1000 mg per square meter ) on days 1 , 8 , and 15 every 4 weeks or gemcitabine monotherapy ( 1000 mg per square meter ) weekly for 7 of 8 weeks ( cycle 1 ) and then on days 1 , 8 , and 15 every 4 weeks ( cycle 2 and subsequent cycles ) . Patients received the study treatment until disease progression . The primary end point was overall survival ; secondary end points were progression-free survival and overall response rate . RESULTS A total of 861 patients were r and omly assigned to nab-paclitaxel plus gemcitabine ( 431 patients ) or gemcitabine ( 430 ) . The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group ( hazard ratio for death , 0.72 ; 95 % confidence interval [ CI ] , 0.62 to 0.83 ; P<0.001 ) . The survival rate was 35 % in the nab-paclitaxel-gemcitabine group versus 22 % in the gemcitabine group at 1 year , and 9 % versus 4 % at 2 years . The median progression-free survival was 5.5 months
Output:
| The use of molecular targeted agents does not translate into clinical benefit . |
MS211904 | ***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 ORACLE I trial compared the use of erythromycin and /or amoxicillin-clavulanate ( co-amoxiclav ) with that of placebo for women with preterm rupture of the membranes without overt signs of clinical infection , by use of a factorial r and omised design . The aim of the present study --the ORACLE Children Study I -- was to determine the long-term effects on children of these interventions . METHODS We assessed children at age 7 years born to the 4148 women who had completed the ORACLE I trial and who were eligible for follow-up with a structured parental question naire to assess the child 's health status . Functional impairment was defined as the presence of any level of functional impairment ( severe , moderate , or mild ) derived from the mark III Multi-Attribute Health Status classification system . Educational outcomes were assessed with national curriculum test results for children resident in Engl and . FINDINGS Outcome was determined for 3298 ( 75 % ) eligible children . There was no difference in the proportion of children with any functional impairment after prescription of erythromycin , with or without co-amoxiclav , compared with those born to mothers who received no erythromycin ( 594 [ 38.3 % ] of 1551 children vs 655 [ 40.4 % ] of 1620 ; odds ratio 0.91 , 95 % CI 0.79 - 1.05 ) or after prescription of co-amoxiclav , with or without erythromycin , compared with those born to mothers who received no co-amoxiclav ( 645 [ 40.6 % ] of 1587 vs 604 [ 38.1 % ] of 1584 ; 1.11 , 0.96 - 1.28 ) . Neither antibiotic had a significant effect on the overall level of behavioural difficulties experienced , on specific medical conditions , or on the proportions of children achieving each level in reading , writing , or mathematics at key stage one . INTERPRETATION The prescription of antibiotics for women with preterm rupture of the membranes seems to have little effect on the health of children at 7 years of age . FUNDING UK Medical Research Council OBJECTIVE This study aims to determine the incidence of prelabor rupture of membranes ( PROM ) in a tertiary care institution , the bacterial pathogens involved in maternal and neonatal colonization , and the major bacterial pathogens of neonatal sepsis in PROM . METHODS This prospect i ve study was conducted over 2 years from March 1999 to February 2001 in Abha Maternity Hospital , Abha , Kingdom of Saudi Arabia . Consecutive admissions of infant- and -mother pairs with PROM constitute the subjects of this survey . Every mother had endocervical swab taken before delivery , and their infants had surface swabs and sepsis screening before starting antibiotic therapy . RESULTS The incidence of PROM was 12.6 per 1000 live births . Premature delivery rate was 54.6 % while , the overall prematurity rate was 7.2 % . The major microorganisms involved in genital colonization of the mothers were coagulase negative Staphylococcus ( CONS ) ( 24 % ) , Klebsiella pneumoniae ( 13 % ) , Pseudomonas aeruginosa ( 11.3 % ) and Enterococcus species ( 11.3 % ) . The infants were colonized largely with CONS ( 31 % ) , Klebsiella pneumoniae ( 18 % ) and Escherichia coli ( E.coli ) ( 17 % ) . Fourteen percent of the infants were infected but in only 6 % was septicemia documented ( Staphylococcus aureus , 3 cases and 1 case each with CONS , group B Streptococci ( GBS ) and E.coli ) . In contrast to Western experience , the incidence of GBS was uncommon in both mothers and infants . The bacterial pattern suggests vancomycin and cefotaxime or aminoglycoside combination as empirical antibiotic therapy for both infected infants and selected contaminated mothers with PROM . CONCLUSION Generally , it appears wasteful to routinely admit , screen and empirically treat all infants born after PROM ; only ill infants , febrile mothers , or either , with associated chorioamnionitis deserve antibiotic treatment Fifty-one babies with prolonged rupture of fetal membranes ( longer than 24 hours ) were studied for evidence of latent infection . Cord blood was taken from all babies for a full blood count and blood culture . Gastric aspirates were collected and vernix swabs were taken immediately after delivery . Microscopy , culture and antibiotic sensitivity tests were done on the appropriate specimens . Each baby had a thorough medical examination immediately after birth , and 3 and 7 days afterwards . After the initial investigation they were allocated to a treatment ( penicillin 50 000 U/kg/d and kanamycin 10 mg/kg/d ) or a non-treatment group by r and omised card selection . Six patients became infected , as was shown by a positive blood culture , while 4 of the 6 had clinical signs of infection as well . These infants were treated with penicillin and kanamycin , and all did well . None of the remaining babies showed any signs of infection . There were no deaths . Blood culture was found to correlate well with clinical infections , and many be used as a guide to latent infection and treatment Background : Few studies from developing countries have examined sensitivity , specificity , positive and negative predictive values of routine surface cultures . Objectives : The purpose of the study was to determine sensitivity , specificity , and positive predictive value ( PPV ) of skin cultures among preterm neonates admitted to Dhaka Shishu Hospital , Bangladesh . Methods : The study was nested within a prospect i ve , r and omized , controlled trial of emollient treatment in Dhaka Shishu Hospital , Bangladesh . A total of 497 preterm infants <33 weeks gestational age and < 72 h of chronological age were enrolled , and the sensitivity , specificity , and PPV of skin cultures were analyzed among 3,765 blood-skin culture pairs , wherein the skin culture was obtained within 13 days before the blood culture . Results : Overall sensitivity , specificity , and PPV were 16 , 38 , and 5 % , respectively . PPV during Klebsiella pneumoniae outbreaks was about 9 % , and the inguinal site had the highest PPV ( 6 % ) among the three skin sites . Acinetobacter spp.- and K. pneumoniae-specific PPVs were 28 and 23 % , respectively . PPV was < 2 % for C and ida spp . , Enterobacter spp . , and Salmonella spp . Conclusion : Routine skin culture is inefficient in predicting the pathogen responsible for sepsis among premature neonates , even in a developing country setting , where the burden of bacterial infection is relatively high . Skin cultures are also of limited utility during K. pneumoniae outbreaks , and are not recommended CONTEXT Intrauterine infection is thought to be one cause of preterm premature rupture of the membranes ( PPROM ) . Antibiotic therapy has been shown to prolong pregnancy , but the effect on infant morbidity has been inconsistent . OBJECTIVE To determine if antibiotic treatment during expectant management of PPROM will reduce infant morbidity . DESIGN R and omized , double-blind , placebo-controlled trial . SETTING University hospitals of the National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network . PATIENTS A total of 614 of 804 eligible gravidas with PPROM between 24 weeks ' and 0 days ' and 32 weeks ' and 0 days ' gestation who were considered c and i date s for pregnancy prolongation and had not received corticosteroids for fetal maturation or antibiotic treatment within 1 week of r and omization . INTERVENTIONS Intravenous ampicillin ( 2-g dose every 6 hours ) and erythromycin ( 250-mg dose every 6 hours ) for 48 hours followed by oral amoxicillin ( 250-mg dose every 8 hours ) and erythromycin base ( 333-mg dose every 8 hours ) for 5 days vs a matching placebo regimen . Group B streptococcus ( GBS ) carriers were identified and treated . Tocolysis and corticosteroids were prohibited after r and omization . MAIN OUTCOME MEASURES The composite primary outcome included pregnancies complicated by at least one of the following : fetal or infant death , respiratory distress , severe intraventricular hemorrhage , stage 2 or 3 necrotizing enterocolitis , or sepsis within 72 hours of birth . These perinatal morbidities were also evaluated individually and pregnancy prolongation was assessed . RESULTS In the total study population , the primary outcome ( 44.1 % vs 52.9 % ; P=.04 ) , respiratory distress ( 40.5 % vs 48.7 % ; P=.04 ) , and necrotizing enterocolitis ( 2.3 % vs 5.8 % ; P=.03 ) were less frequent with antibiotics . In the GBS-negative cohort , the antibiotic group had less frequent primary outcome ( 44.5 % vs 54.5 % ; P=.03 ) , respiratory distress ( 40.8 % vs 50.6 % ; P=.03 ) , overall sepsis ( 8.4 % vs 15.6 % ; P=.01 ) , pneumonia ( 2.9 % vs 7.0 % ; P=.04 ) , and other morbidities . Among GBS-negative women , significant pregnancy prolongation was seen with antibiotics ( P<.001 ) . CONCLUSIONS We recommend that women with expectantly managed PPROM remote from term receive antibiotics to reduce infant morbidity BACKGROUND There is paucity of information on the pattern of bacterial colonization of a new neonatal intensive care unit . OBJECTIVE To study the pattern of bacterial colonization on the environmental surfaces in a new neonatal intensive care unit ( NICU ) and correlate it with infections in the infants . METHODS Environmental cultures from the faucets and computer keyboards in the NICU were obtained prospect ively every 2 weeks for 1 year . Positive blood , cerebrospinal fluid , and respiratory cultures from the infants in the NICU were also obtained . RESULTS A total of 175 swab cultures was collected , which were sterile for initial 6-week period . Subsequently , 31 cultures grew microbes : 26 ( 83.8 % ) from the faucets and 5 ( 16.2 % ) from the computers keyboard ( P < .001 ) . Of the 48 positive blood cultures in NICU patients , 6 ( 12.5 % ) matched the organism growing from the surveillance sites , but the correlation was not significant ( P = .076 ) . None of the 31 positive respiratory cultures and 1 positive cerebrospinal fluid culture correlated to the organisms grown from the NICU environment . CONCLUSION The environment was colonized after an initial period of sterile cultures in a new NICU . Once colonized , they can persist , increasing the risk of developing resistance to antibiotics . They did not correlate with the positive cultures from the infants admitted to the NICU during the study period Summary A prospect i ve case control study that was conducted at the University of Ilorin Teaching Hospital , Ilorin , Nigeria , between 1st January and 31st December 2002 . The purpose of this study was to determine the association and the pattern of bacteria/microorganisms in the aetiology of pre-labour premature rupture of membrane ( PROM ) in this centre . A total of 108 cases of PROM and 98 control cases that presented between 37 completed weeks ' and 40 weeks ' gestation were analysed . Pathogens were isolated in 48 patients , giving a recovery rate of 44.4 % . The common pathogens include Gardnerella vaginalis ( 29.1 % ) , C and ida ( 23.0 % ) and Staphylococcus aureus ( 18.7 % ) . Others were Streps . Pyogenes ( 16.6 % ) , coagulase negative staphylococcus ( CONS ) ( 6.3 % ) and Klebsiella ( 6.3 % ) . Only C and ida and S. aureus were isolated in the controls . Ofloxacin and azithromycin were 100 % active against all the isolated pathogens , while ampicillin was the least active . G. vaginalis was the most sensitive among the isolates while CONS and Klebsiella were the least sensitive . It is evident in this study that some pathogens were associated with PROM and that G. vaginalis was the most common organism and azithromycin was the only antibiotic with 100 % sensitivity . We suggest that metronidazole should be added to azithromycin to cover for anaerobes in cases of PROM , where facilities for screening for anaerobes are not available Editor 's Note : In order to encourage dissemination of the STROBE Statement , this article is being published simultaneously in Annals of Internal Medicine , Epidemiology , and PLoS Medicine . It is freely accessible on the Annals of Internal Medicine Web site ( www.annals.org ) and will also be published on the Web sites of Epidemiology and PLoS Medicine . The authors jointly hold the copyright of this article . For details on further use , see the STROBE Web site ( www
Output:
| Subgroup analysis showed the distribution of microorganisms from the six regions of China varied .
The main pathogens derived from women with PROM and their newborns were Staphylococcus and E. coli , which differs from the pathogens in Western countries . |
MS211905 | ***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 This prospect i ve r and omized study determined the influence of closed-suction drainage on the incidence of postoperative complications after elective hepatic resection . Summary Background Data Routine drainage is no longer advocated after several intra-abdominal surgical procedures . Methods A series of 81 patients who underwent elective hepatic resection were r and omly allocated to either a nondrainage group ( n = 39 ) and a drainage group with closed-suction drainage ( n = 42 ) . Indications for resection were 42 benign lesions and 39 malignant tumors , including 19 with cirrhosis . Major hepatic resection was performed in 25 patients and minor resection , in 56 . All patients underwent ultrasonography with puncture for bacteriologic cultures of all fluid collection s within the first 5 postoperative days . Results One patient died in each group . Ultrasonography found a significantly higher rate of subphrenic collection s in the drainage group compared with the nondrainage group ( respectively , 36 % vs. 15 % , p < 0.05 ) . These collection s were more frequently infected in the drainage group ( n = 6 ) than in the nondrainage group ( n = 2 ) . After major liver resection , the rate of intra-abdominal postoperative complications ( i.e. , subphrenic fluid collection s , hematomas , and bilomas ) was similar between the two groups . Conclusion Minor liver resection is safer without drainage . Major liver resection can be performed with or without abdominal drainage 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 Background and aims The clinical value of synbiotics in surgical patients remains unclear . The aim of this study was to investigate the effect of synbiotics on intestinal integrity and microflora , as well as on surgical outcome , in patients undergoing high-risk hepatectomy . Methods Fifty-four patients with biliary cancer were r and omly allocated to two groups before hepatectomy . One group received postoperative enteral feeding that included synbiotics ; the other received enteral feeding only . Lactulose/mannitol ( L/M ) ratio , serum diamine oxidase ( DAO ) activity , and fecal microflora and organic acid concentrations were determined . Postoperative infectious complications were recorded . Results Of the 54 patients , 44 completed the trial ( 21 receiving synbiotics and 23 others as controls ) . Postoperative changes in L/M ratios and serum DAO activities were identical between the two groups . Numbers of beneficial bacteria increased in the synbiotics group after surgery but decreased in controls . Numbers of harmful microorganisms decreased in the synbiotics group but increased in controls . Total organic acid concentrations increased in the synbiotics group but decreased in controls . Incidence of infectious complications was 19 % ( 4/21 ) in the synbiotics group and 52 % ( 12/23 ) in controls ( P<0.05 ) . All study patients tolerated surgery ( mortality 0 % ) . Conclusions Synbiotics , combined with early enteral nutrition , can reduce postoperative infections . This beneficial effect presumably involves correction of an intestinal microbial imbalance induced by surgical stress Introduction : Despite advances in antibiotic prophylaxis , postoperative wound infection remains a major source of morbidity after digestive surgery . Its prevention is a challenging problem , especially in high-risk patients . The authors introduced a new method to prevent surgical wound infections and evaluated its efficacy in a prospect i ve , r and omized trial in markedly high-risk patients . Methods : Patients with biliary tract carcinoma who were scheduled to undergo combined liver and extrahepatic bile duct resection with biliary reconstruction were r and omly assigned to one of two groups , well matched in terms of clinical characteristics at baseline . In one group the new treatment was employed ( sealed group , n=31 ) , and in the other the wound was treated in the usual fashion ( open group , n=28 ) . In the sealed group , povidone-iodine gel was administered to the subcutaneous tissue , and the skin and peritoneum were approximated with a continuous suture . Wound infection was registered up to 30 days after surgery . Results : Wound infection occurred in 18 patients : 5 ( 16 % ) patients in the sealed group and 13 ( 46 % ) in the open group ( P<0.05 ) . All 18 underwent preoperative percutaneous transhepatic biliary drainage and had positive bile culture findings . In 13 of these 18 patients ( 72 % ) the micro-organisms isolated from the infected wound were identical to those in the bile . Conclusions : Our results confirm the close association between infected bile and wound infection in hepatobiliary surgery . Our new method , “ direct wound sealing , ” is simple , easy to perform , virtually cost-free , and has the potential to prevent wound infections even in markedly high-risk patients Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . Objective To analyze postoperative leukocyte functions in patients undergoing hemihepatectomy , and to assess the effect of treatment with the endotoxin-neutralizing agent bactericidal/permeability-increasing protein ( rBPI21 ) . Summary Background Data Extensive liver resection is associated with a high incidence of infectious complications . Because elimination of pathogenic microorganisms occurs mainly by leukocytes , this increased rate of infections is most likely due to an impaired function of these cells . Endotoxin , translocated from the gut into the systemic circulation as a result of increased gut permeability and reduced hepatic clearance function after major liver resection , may play an important role in the impairment of posthepatectomy leukocyte function . Methods To investigate whether hemihepatectomy results in impaired leukocyte functions and to determine the role of endotoxin in this process , leukocyte oxidative burst and leukocyte antigen expression were studied in three groups of patients : patients undergoing a hemihepatectomy and receiving rBPI21 treatment , patients undergoing hemihepatectomy and receiving placebo , and as an extra control group patients undergoing other major abdominal surgeries . Blood sample s were collected before surgery , 2 hours after surgery , and at days 1 , 2 , 5 , and 7 . Phorbol myristate acetate-stimulated oxidative burst was measured using dihydrorhodamine , and leukocyte surface expression of the antigens CD11b , CD16 , and CD14 was investigated by indirect immunofluorescence . Both oxidative burst and membrane surface expression were quantified by flow cytometry . An indication of the antiendotoxin effect of rBPI21 treatment was provided by assessment of plasma lipopolysaccharide binding protein ( LBP ) levels by enzyme-linked immunosorbent assay . Results The oxidative burst in the hemihepatectomized patients receiving placebo and the controls increased 2 hours after surgery , whereas it decreased in the rBPI21-treated patients , result ing in significant differences between the groups . On day 1 , neutrophil CD11b expression and monocyte CD14 expression in the rBPI21-treated patients and controls were significantly lower than in the placebo group . At 2 hours , CD16 expression in the placebo-treated patients was significantly higher than in the rBPI21-treated patients and controls . On day 5 and day 7 , plasma LBP levels were significantly higher in the placebo-treated patients compared with the rBPI21-treated patients . Conclusions The results of this study show that patients undergoing major liver resection have an increased activation of leukocytes compared with those undergoing other major abdominal surgery . This enhanced activation may contribute to the increased risk of infection in these patients . Administration of the endotoxin-neutralizing agent rBPI21 to hemihepatectomy patients was shown to reduce plasma LBP levels , to preserve leukocyte functions partially , and to reduce leukocyte activation to the level of other , nonhepatic abdominal surgery OBJECTIVES Although the usefulness of antimicrobial prophylaxis for clean-contaminated surgery has been recognized , only a few r and omized controlled studies on the duration of administration after hepatectomy have been performed . We investigated the duration of antimicrobial prophylaxis after hepatectomy . METHODS The subjects were 180 patients who underwent hepatectomy without reconstruction of the biliary or intestinal tract between April 2003 and March 2006 at our department . The patients were r and omly allocated to groups to be treated with flomoxef sodium as antimicrobial prophylaxis for 2 days ( 89 patients ) or 5 days ( 91 patients ) , including the operation day . The presence or absence of systemic inflammatory response syndrome ( SIRS ) and infections was investigated . RESULTS No significant differences were noted in patient background between the two groups . Infections occurred in seven and six patients in the 2 day and 5 day treatment groups ( 7.9 % and 6.6 % ) , respectively , showing no significant difference between the two groups . No significant difference was noted when the cases were divided into surgical site infections and remote infections . The positive rate of SIRS was significantly higher in the 2 day treatment group than in the 5 day treatment group on days 2 and 3 after surgery . The risk factors in patients who developed infections were blood loss , operation time and the complication of biliary fistula . CONCLUSIONS Two day administration of flomoxef sodium may be sufficient for antimicrobial prophylaxis after hepatectomy . However , when SIRS is positive on post-operative day 2 , and induction of liver failure is of concern , it may be safer to continue antimicrobial drug administration until SIRS is eliminated PURPOSE A prospect i ve , r and omized trial was performed to determine if intra-abdominal drainage catheters are necessary after elective liver resection . PATIENTS AND METHODS Between April 1992 and April 1994 , 120 patients subjected to liver resection , stratified by extent of resection and by surgeon , were r and omized to receive or not receive operative closed-suction drainage . Operative blood loss was not an exclusion criteria , and no patient who consented to the study was excluded . RESULTS Eighty-seven patients ( 73 % ) had resection of one hepatic lobe or more ( 27 lobectomies , 54 trisegmentectomies , and 6 bilobar atypical resections ) and 33 had less than a lobectomy ( 8 wedge resections or enucleations , 9 segmentectomies , and 16 bisegmentectomies ) . Eighty-four patients ( 70 % ) had metastatic cancer and 36 patients ( 30 % ) had primary liver pathology . There were no differences in outcome , including length of hospital stay ( no drain , 13.4 + /- 0.9 days ; drain , 13.1 + /- 0.8 days ; P = not significant [ NS ] ) , mortality ( no drain , 3.3 % ; drain , 3.3 % ) , complication rate ( no drain , 43 % ; drain , 48 % ; P = NS ) , or requirement for subsequent percutaneous drainage ( no drain , 18 % ; drain , 8 % ; P = NS ) . All infected collection s ( n = 3 ) occurred in operatively drained patients . Two other complications were directly related to the operatively placed
Output:
| There was no significant differences in mortality or severe morbidity in any of the comparisons .
There is currently no evidence to support or refute the use of any treatment to reduce infectious complications after liver resections . |
MS211906 | ***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 Recently , advances in human IVF-embryo transfer ( ET ) have been reported using sequential media and blastocyst stage ET . In our previous report , using a prospect i ve , r and omized study , no advantage was found using the blastocyst stage ET compared with day 3 ET . This study was performed in order to evaluate implantation and pregnancy rates of hatching blastocyst stage ET compared with conventional day 3 ET . METHODS AND RESULTS A total of 480 patient cycles were evaluated using a prospect i ve , r and omized study . The pregnancy rate and implantation rate were compared between the day 3 ET ( n = 240 ) and hatching blastocyst stage ET ( Hat ET ; n = 240 ) . The Hat ET group had a pregnancy rate of 29.3 % ( 55 out of 188 ) and an implantation rate of 21.4 % ( 67 out of 313 ) . The day 3 ET group had a pregnancy rate of 29.2 % ( 70 out of 240 ) and an implantation rate of 19.1 % ( 93 out of 488 ) . In the Hat ET group , the pregnancy rate , implantation rate and ongoing pregnancy rate of day 5 ET and day 6 ET were all higher than the respective rates in the day 7 - 9 ET group . CONCLUSION We found that the pregnancy rate and implantation rate of ET with hatching stage blastocysts had no advantage compared with the conventional day 3 ET OBJECTIVE : To evaluate the efficacy of blastocyst transfer in comparison with cleavage stage transfer . STUDY DESIGN : A r and omized , prospect i ve study was conducted in Infertility clinic , Department of Obstetrics and Gynecology , Mahatma G and hi Hospital , Jaipur on 300 patients aged 25 - 40 years undergoing in-vitro fertilization (IVF)/intra-cytoplasmic sperm injection ( ICSI ) cycle from May 2010-April 2011 . When three or more Grade -I embryos were observed on day 2 of culture , patients were divided r and omly into two study groups , cleavage stage transfer and blastocyst transfer group having 150 patients each . Primary outcomes evaluated were , Clinical pregnancy rate and Implantation rate . The results were analyzed using proportions , st and ard deviation and Chi-square test . RESULTS : Both the groups were similar for age , indication and number of embryos transferred . Clinical pregnancies after blastocyst transfer were significantly higher 66 ( 44.0 % ) compared to cleavage stage embryo transfer 44 ( 29.33 % ) ( P < 0.01 ) . Implantation rate for blastocyst transfer group was also significantly higher ( P < 0.001 ) . CONCLUSION : Blastocyst transfer having higher implantation rate and clinical pregnancy rate lead to reduction in multiple pregnancies OBJECTIVE To compare blastocyst-stage embryo transfers ( ETs ) with day 2 - 3 ETs in patients who failed to conceive in three or more day 2 - 3 IVF/ET cycles . DESIGN Prospect i ve , r and omized . SETTING Fertility unit in a university medical center . PATIENT(S ) Fifty-four patients with an adequate ovarian response underwent oocyte retrievals . The patients were prospect ively and r and omly divided into blastocyst-stage and day 2 - 3 ET groups . INTERVENTION(S ) Ovarian down-regulation was obtained using GnRH agonist , and controlled ovarian hyperstimulation was achieved using daily administration of gonadotropins . MAIN OUTCOME MEASURE(S ) The rate of blastocyst formation , ET cancellations , pregnancies , implantation , multiple gestation , and live births . RESULT ( S ) The clinical pregnancy rates per oocyte retrieval were 21.7 % and 12.9 % per blastocyst and day 2 - 3 ETs , respectively . Although there was a significantly higher implantation rate for blastocyst embryos ( 21.2 % ) as compared with 48- to 72-hour embryos ( 6 % ) , the multiple-pregnancy rate was not significantly different between both groups . An ET cancellation rate of 26 % and 6.4 % for blastocyst and day 2 - 3 ETs , respectively , was observed . The presence of two or more 8-cell embryos on day 3 in culture carried a high probability of obtaining blastocysts for transfer . CONCLUSION ( S ) This prospect i ve r and omized study suggests that in patients with an adequate ovarian response who failed to conceive in at least three IVF/ET cycles [ 1 ] . transfer of blastocyst-stage embryos carries a significantly higher implantation rate ; [ 2 ] . the pregnancy rate per oocyte retrieval and ET are higher in the blastocyst-stage group , even if it did not reach statistical significance ; [ 3 ] . a higher ET cancellation rate was observed in the whole blastocyst-stage group ; [ 4 ] . the ET cancellation rate was reduced significantly if the decision to proceed to blastocyst transfer was made on day 3 after oocyte retrieval , which is a post hoc conclusion BACKGROUND The respective advantages of day 3 and day 5 embryo transfer are a matter of debate . Previous comparisons did not include pronuclear stage zygote scoring and cumulative success rates ( fresh and cryopreserved embryos ) . METHODS Patients were r and omized prospect ively for day 3 or day 5 embryo transfer . Day 3 embryos were selected for transfer and cryopreservation by using combined evaluation at the pronuclear and cleavage stages . RESULTS There was no difference between day 3 and day 5 fresh embryo transfers as to the rates of pregnancy ( 58 versus 62 % ) , clinical pregnancy ( 56 versus 58 % ) , delivery ( 50 versus 48 % ) , implantation ( 35 versus 38 % ) and birth ( 33 versus 36 % ) rates . The corresponding values for cryopreserved embryo transfers were also similar . However , day 3 embryo transfer compared favourably with day 5 transfer when the pregnancy ( 90 versus 66 % ) , clinical pregnancy ( 85 versus 62 % ) and delivery ( 77 versus 52 % ) rates were calculated per oocyte recovery attempt . CONCLUSIONS With a selected population of good prognosis patients and our embryo selection criteria , the implantation potential of day 3 and day 5 embryos is equal . Per oocyte recovery attempt , day 3 transfer is more clinical ly efficient than day 5 transfer , but at least one transfer of cryopreserved embryos is necessary to manifest this superiority The effectiveness of blastocyst culture and transfer in human in-vitro fertilization ( IVF ) was evaluated in a prospect i ve r and omized trial in patients having a moderate to good response to gonadotrophin stimulation . Embryos were transferred either on day 3 after culture to around the 8-cell stage in Ham 's F-10 medium supplemented with fetal cord serum , or on day 5 after culture to the blastocyst stage in the sequential serum-free media G 1.2 and G 2.2 . The pregnancy rates after transfer on day 3 or day 5 were equivalent , 66 and 71 % respectively ; however , significantly more embryos were transferred on day 3 ( 3.7 ) than on day 5 ( 2.2 ) . The number of blastocysts transferred did not affect the implantation rate , and pregnancy rates when either two or three blastocysts were transferred were 68 and 87 % respectively . The implantation rate of the blastocysts ( 50.5 % fetal heart beat ) was significantly higher compared to the cleavage stage embryos transferred on day 3 ( 30.1 % ) . The percentage of blastocyst development was not affected by the number of 2-pronuclear embryos , or by maternal age . Irrespective of the number of blastocysts formed , pregnancy rates were similar . Furthermore , the pregnancy rate following blastocyst transfer in patients with 10 or more follicles at the time of human chorionic gonadotrophin administration was not affected by patient age . More than 60 % of patients having blastocyst culture and transfer had supernumerary embryos for cryopreservation . The establishment of a pregnancy following thaw and transfer confirmed the viability of cryopreserved blastocysts cultured in the absence of serum or co-culture . The ability to transfer just two blastocysts while maintaining high pregnancy rates will therefore help to eliminate high order multiple gestations and improve the overall efficiency of human IVF Transfer of embryos at the blastocyst stage has been associated with exceptionally high implantation rates . There are , however , only a few prospect i ve r and omized studies comparing day 3 versus day 5 embryo transfer . Furthermore , the number of embryos replaced in the day 3 group transfer is often higher than the number of blastocysts replaced , thereby affecting implantation rates . A total of 118 patients undergoing st and ard IVF/intracytoplasmic sperm injection who had developed at least three 8-cell embryos showing < 20 % extracellular fragmentation on day 3 were r and omized for day 3 or day 5 transfer . A maximum of two embryos were replaced . In this prospect i ve , r and omized study the implantation and pregnancy potential of embryos transferred on day 3 or day 5 were compared . Equal numbers of embryos were replaced in the two groups . There was no statistically significant difference between day 3 and day 5 transfer regarding positive human chorionic gonadotrophin rates ( 70 versus 67 % ) , clinical pregnancy rates ( 61 versus 51 % ) , implantation rates ( 44 versus 37 % ) , twinning rates ( 42 versus 41 % ) and rates of early pregnancy loss ( 15 versus 29 % ) . Transfer of embryos on day 3 or 5 showed similar implantation rates when equal numbers of embryos were transferred . Embryo transfer at the blastocyst stage seems to have no advantage over day 3 transfer in patients with more than two 8-cell embryos showing less than 20 % fragmentation on day 3 BACKGROUND Whether extended culture allowing selection of embryos with high development potential has any advantage over cleavage-stage embryo transfer remains a matter of debate . Among the currently unsolved questions , the cumulative delivery rate result ing from fresh and frozen embryo transfers needs to be taken into account in both strategies . The aim of our study was , therefore , to compare the efficacy of single embryo transfer either on Day 2 or on Day 5/6 combining fresh and frozen embryo transfers . METHODS A prospect i ve study including 478 couples assigned on a voluntary basis to undergo elective single embryo transfer ( eSET , n = 243 ) on Day 2 or single blastocyst transfer ( SBT , n = 235 ) on Day 5/6 was performed . The primary outcome measurement was the cumulative delivery rate including fresh and frozen-thawed cycles in both groups . RESULTS The delivery rate per cycle following fresh embryo transfer was significantly higher in the SBT group compared with the eSET group ( P < 0.01 ) . Conversely , frozen embryo and /or blastocyst transfers tended to result in a higher number of deliveries in the eSET compared with the SBT group . Altogether , the cumulative delivery rate per couple , including fresh and frozen embryo transfers , was similar between the two groups ( 37.9 % versus 34.2 % in the SBT and eSET groups , respectively ) . CONCLUSIONS The observed cumulative delivery rates in this study do not allow us to take a position in favor of SBT or eSET . An improvement in blastocyst cryopreservation may change this attitude BACKGROUND This r and omized controlled study was performed in an unselected IVF/ICSI population to test the hypothesis that blastocyst transfers result in higher clinical pregnancy rates ( CPR ) per oocyte retrieval when compared with day 2 transfers . METHODS Blind r and omization for transfer on day 2 ( group 1 ) or day 5/6 ( group 2 ) was performed before stimulation . Oocytes and embryos were cultured in sequential media in 5.5 % CO(2 ) , 5 % O(2 ) , 89.5 % N(2 ) and 90 % humidity . A maximum of two embryos was transferred . RESULTS The two groups were similar for age , IVF indication , number of treatment cycles , rate of ICSI/IVF , number of fertilized oocytes and number of embryos transferred . The CPR/oocyte retrieval was comparable in group 1 ( 32 % ) and in group 2 ( 44 % ) , while the CPR/embryo transfer was significantly higher ( P < 0.01 ) in group 2 ( 60 % ) than in group 1 ( 35 % ) . Similarly , the implantation rate per embryo transferred was significantly higher ( P < 0.03 ) in group 2 ( 46 % ) than in group 1 ( 29 % ) . The cryo-augmented delivery rate/oocyte retrieval was comparable in group 2 ( 36.3 % ) and in group 1 ( 28.6 % ) . CONCLUSION This r and omized study in an unselected population showed a significantly higher CPR/embryo transfer and a tendency toward a higher CPR/oocyte retrieval in patients receiving blastocysts when compared with day 2 transfers BACKGROUND The existence of a real benefit of blastocyst transfer is still a matter of debate . The
Output:
| Current evidence shows no superiority of blastocyst compared with cleavage-stage embryo transfer in clinical practice . |
MS211907 | ***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 Federal and Drug Administration ( FDA ) recently revised statin drug labels to include the information that increases in fasting serum glucose and glycated haemoglobin levels have been reported with the use of statins . Yet in a survey , 87 % of the doctors stated that they had never or infrequently observed increases in glucose or HbA1c levels in patients on statin . In this study we would like to determine the association between the use of statins and glycaemic control in a retrospective cohort of patients with hypertension . Methods A retrospective review of 1060 medical records of patients with hypertension at a primary care clinic was conducted . These records were selected using systematic r and om sampling ( 1:4 ) . Data on patient socio-demographic factors ; clinical profile ; investigation results and prescribed medications were collected . Independent t-test was used for continuous variables while Pearson ’s χ 2 test was used for categorical variables . Logistic regression was done to adjust for confounders . Results 810 ( 76.4 % ) patients with hypertension were on statins , out of which 792 ( 97.8 % ) were taking simvastatin 10 mg or 20 mg daily . Analysis of the whole group regardless of diabetes status showed that the statin user group had higher HbA1c and fasting blood glucose values . The difference in HbA1c levels remained significant ( adjusted OR = 1.290 , p = 0.044 , 95 % CI 1.006 , 1.654 ) after adjustment for diabetes , diabetic medication and fasting blood glucose . In the study population who had diabetes , statin users again had significantly higher HbA1c level compared to statin non-users . This difference remained significant ( adjusted OR 1.208 , p = 0.037 , 95 % CI 1.012 , 1.441 ) after adjustment for age and diabetic medications . Conclusions Statins use is associated with increased HbA1c levels among hypertensive patients and hypertensive patients with diabetes . Clinicians managing hypertensive patients on statins should consider monitoring the HbA1c level and ensure that those with diabetes have their hyperglycaemia kept under control OBJECTIVES We investigated whether atorvastatin might decrease insulin sensitivity and increase ambient glycemia in hypercholesterolemic patients . BACKGROUND Clinical trials suggest that some statin treatments might increase the incidence of diabetes despite reductions in low-density lipoprotein ( LDL ) cholesterol and improvement in endothelial dysfunction . METHODS A r and omized , single-blind , placebo-controlled parallel study was conducted in 44 patients taking placebo and in 42 , 44 , 43 , and 40 patients given daily atorvastatin 10 , 20 , 40 , and 80 mg , respectively , during a 2-month treatment period . RESULTS Atorvastatin 10 , 20 , 40 , and 80 mg significantly reduced LDL cholesterol ( 39 % , 47 % , 52 % , and 56 % , respectively ) and apolipoprotein B levels ( 33 % , 37 % , 42 % , and 46 % , respectively ) after 2 months of therapy when compared with either baseline ( all p < 0.001 by paired t test ) or placebo ( p < 0.001 by analysis of variance [ ANOVA ] ) . Atorvastatin 10 , 20 , 40 , and 80 mg significantly increased fasting plasma insulin ( mean changes : 25 % , 42 % , 31 % , and 45 % , respectively ) and glycated hemoglobin levels ( 2 % , 5 % , 5 % , and 5 % , respectively ) when compared with either baseline ( all p < 0.05 by paired t test ) or placebo ( p = 0.009 for insulin and p = 0.008 for glycated hemoglobin by ANOVA ) . Atorvastatin 10 , 20 , 40 , and 80 mg decreased insulin sensitivity ( 1 % , 3 % , 3 % , and 4 % , respectively ) when compared with either baseline ( p = 0.312 , p = 0.008 , p < 0.001 , and p = 0.008 , respectively , by paired t test ) or placebo ( p = 0.033 by ANOVA ) . CONCLUSIONS Despite beneficial reductions in LDL cholesterol and apolipoprotein B , atorvastatin treatment result ed in significant increases in fasting insulin and glycated hemoglobin levels consistent with insulin resistance and increased ambient glycemia in hypercholesterolemic patients . ( Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients ; NCT00745836 ) OBJECTIVE This study evaluated the effect of a atorvastatin-fenofibrate combination on lipid profile , in comparison to each drug alone , in patients with type 2 diabetes and combined hyperlipidemia ( CHL ) . RESEARCH DESIGN AND METHODS A total of 120 consecutive patients , who were free of coronary artery disease ( CAD ) at entry , were studied for a period of 24 weeks . These patients were r and omly assigned to atorvastatin ( 20 mg/day , n = 40 ) , micronized fenofibrate ( 200 mg/day , n = 40 ) , or a combination of both ( atorvastatin 20 mg/day plus fenofibrate 200 mg/day , n = 40 ) . The effect of treatment on LDL cholesterol , triglycerides ( TGs ) , HDL cholesterol , apolipoprotein A-I and B , lipoprotein(a ) , and plasma fibrinogen ( PF ) was recorded . Moreover , the percentage of patients that reached the American Diabetes Association treatment goals and the estimated CAD risk status were calculated . RESULTS No patient was withdrawn from the study because of side effects . The atorvastatin-fenofibrate combination reduced total cholesterol by 37 % , LDL cholesterol by 46 % , TGs by 50 % , and PF by 20 % , whereas it increased HDL cholesterol by 22 % ( P < 0.0001 for all ) . These changes were significantly better than those of both monotherapies . Of the patients on drug combination , 97.5 % reached the LDL cholesterol treatment goal of < 100 mg/dl , 100 % reached the desirable TG levels of < 200 mg/dl , and 60 % reached the optimal HDL cholesterol levels of > 45 mg/dl . These rates were significantly higher than those of both monotherapies . Combined treatment reduced the 10-year probability for myocardial infa rct ion from 21.6 to 4.2 % . CONCLUSIONS The atorvastatin-fenofibrate combination has a highly beneficial effect on all lipid parameters and PF in patients with type 2 diabetes and CHL . It improved patients ' CAD risk status significantly more than each drug alone Objective . To investigate the effect of simvastatin on glucose homeostasis in streptozotocin induced type 2 diabetic rats . Methods . Forty male Wistar rats were r and omly divided into four groups . Normal control rats were fed with st and ard diet , others were fed with high-fat diet . Diabetic rats were induced by a single intraperitoneal injection of STZ . The simvastatin intervention rats were fed with simvastatin during the experiment process , and the simvastatin treatment rats were fed with simvastatin after diabetes rats were induced . We measured body weight , fasting plasma glucose , cholesterol , high-density lipoprotein cholesterol , and triglyceride after an overnight fast . Results . The FPG was higher in diabetic rats when compared to normal control ones ; the simvastatin intervention rats had a higher FPG compared to the diabetic rats and were more easily be induced to diabetes at the end of 4 weeks , FPG level of simvastatin treatment rats was increased compared with diabetic model rats after 12 weeks . Conclusion . These data indicate that simvastatin intervention rats may cause hyperglycemia by impairing the function of islet β cells and have an adverse effect on glucose homeostasis , especially on FPG level While a large numbers of clinical trials using various kinds of statins has been reported , a possible preventive effect on new onset of type 2 diabetes mellitus was shown only by the sub analysis of The West of Scotl and Coronary Prevention Study ( WOSCOPS ) using pravastatin . The aim of this study was to investigate whether pravastatin has a preferable effect on glucose tolerance among statins . An open-label prospect i ve cross-over trial was performed to compare the effect of pravastatin ( 10 mg/day ) or atorvastatin ( 10 mg/day ) in Japanese early-state type 2 diabetes mellitus with hypercholesterolemia . The analyzed study subjects were treated with pravastatin ( 10 mg/day , n = 12 ) or atorvastatin ( 10 mg/day , n = 12 ) for 12 weeks . After a 4-week-washout period , the drugs were switched and treatment was continued for another 12 weeks . Oral glucose tolerance test ( OGTT ) was performed to evaluate several parameters including the appropriateness of beta cell function for the individual insulin sensitivity ( disposition index : product of a vali date d secretion parameter and sensitivity ) at the end of each therapy . HbA(1c ) and 2 h-glucose levels during OGTT in the pravastatin treatment were significantly lower than atorvastatin treatment . Disposition index after pravastatin treatment was significantly higher than after atorvastatin treatment . In conclusion , our study suggests that pravastatin has a favorable effect on pancreatic beta cell function compared with atorvastatin AIM To compare the long-term efficacy and safety of pitavastatin with atorvastatin in patients with type 2 diabetes and combined ( mixed ) dyslipidaemia . METHODS R and omised , double-blind , active-controlled , multinational non-inferiority study . Patients were r and omised 2 : 1 to pitavastatin 4 mg ( n = 279 ) or atorvastatin 20 mg ( n = 139 ) daily for 12 weeks . Patients completing the core study could continue on pitavastatin 4 mg ( n = 141 ) or atorvastatin 20 mg ( n = 64 ) [ 40 mg ( n = 7 ) if lipid targets not reached by week 8 ] for a further 44 weeks ( extension study ) . The primary efficacy variable was the change in low-density lipoprotein cholesterol ( LDL-C ) . RESULTS Reductions in LDL-C were not significantly different at week 12 between the pitavastatin ( -41 % ) and atorvastatin ( -43 % ) groups . Attainment of National Cholesterol Education Program and European Atherosclerosis Society targets for LDL-C and non-high-density lipoprotein cholesterol ( non-HDL-C ) was similarly high for both treatment groups . Changes in secondary lipid variables ( e.g. HDL-C , apolipoprotein B and triglycerides ) were similar between treatments . Post hoc analysis showed that adjusted mean treatment differences for pitavastatin vs. atorvastatin were within the non-inferiority margin at weeks 16 ( + 0.11 % ; 95 % confidence interval ( CI ) , -5.23 to 5.44 ) and 44 ( -0.02 % ; 95 % CI , -5.46 to 5.41 ) of the extension study . Both treatments were well tolerated ; atorvastatin increased fasting blood glucose from baseline ( + 7.2 % ; p < 0.05 ) , whereas pitavastatin had no significant effect ( + 2.1 % ) . CONCLUSIONS Reductions in LDL-C and changes in other lipids were not significantly different in patients treated with pitavastatin 4 mg or atorvastatin 20 or 40 mg . Pitavastatin may , however , have a more favourable effect on the glycaemic status To clarify whether 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ( statin ) increases lipoprotein lipase mass in preheparin plasma ( preheparin LPL mass ) , we observed the change in preheparin LPL mass during administration of atorvastatin and pravastatin to type 2 diabetes mellitus patients with hypercholesterolemia . The subjects were r and omly divided into two groups . One group was 24 patients given atorvastatin ( 10 mg/day ) , and the other was 23 patients given pravastatin ( 20 mg/day ) for 4 months . After 4 months of administration , no significant change of HbA1c was observed . TC significantly decreased in the atorvastatin group compared to the pravastatin group . TG significantly decreased in the atorvastatin group . Low density lipoprotein cholesterol level significantly decreased in both groups ( - 36.3 % , p < 0.01 in atorvastatin , - 24.3 % , p < 0.01 in pravastatin ) . Preheparin LPL mass slightly increased in both groups after
Output:
| Statins were found to affect glucose control through several ways , namely , by affecting insulin production and secretion by & bgr;‐pancreatic cells , insulin resistance , insulin uptake by the muscles and adipocytes and production of adipokines .
Current evidence available shows that most of the statins give unfavorable side effects with regards to glucose control among diabetic patients .
A dose‐dependent and time‐dependent effect was also observed in some statins which may be present among other statins as well |
MS211908 | ***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 Fifth Commission on Antiepileptic Drugs of the International League Against Epilepsy was asked to advise the ILAE Executive on the place of new drugs in the treatment of patients with newly diagnosed or chronic epilepsy . With the licensing of a significant number of new antiepileptic drugs ( AEDs ) in the last 5 - 10 years , there is an obvious need for these new treatments to be introduced efficiently and effectively to benefit the care and management of people with epilepsy . Implicit in this will be a determination of the comparative efficacy , tolerability , and overall effectiveness against st and ard ( existing ) AEDs and against other new drugs . Although many of the issues relating to comparative studies were addressed in Guidelines for the Clinical Evaluation of Antiepileptic Drugs , produced by the Fourth Commission , several complex ethical and method ological problems remain that would benefit from further discussion aim ed at the establishment of some form of consensus . Although determination of the relative risks of rare but potentially serious idiosyncratic adverse reactions and teratogenicity can be determined only by adequate postmarketing surveillance , other issues concerning the efficacy , tolerability , and effectiveness of new drugs can best be determined within the context of well- design ed r and omized ( or otherwise controlled ) clinical trials ( RCTs ) . It is the design , structure , and outcomes of such comparative RCTs that dem and further consideration . Many of the difficulties arise because the most meaningful and satisfactory comparative studies will essentially be those that compare monotherapy with a new agent with monotherapy with alternative agents . The Commission recognizes that several different parties have interests in comparative studies . First and foremost patients and their doctors require adequate information to guide daily practice in an “ evidence -based ” way so that patients can make fully informed decisions about their drug treatment . Individual pharmaceutical manufacturers need to know how their drug compares with other products so that a drug can be appropriately positioned in the market . Licensing authorities have traditionally ignored issues of comparative A benzodiazepine drug , clobazam , was evaluated in 14 refractory epileptic patients , nine of whom received the drug double-blind . Ten patients have been given clobazam long enough to assess results . Four showed marked benefit , four failed to respond and two showed a transient benefit which was maintained by dose changes of both clobazam and clonazepam . Side effects were minimal ; doses ranged from 15 to 60 mg per day . Clobazam may have place in the treatment of the Lennox Gastaut syndrome and other types of refractory seizures Objective To compare the effectiveness of intermittent clobazam versus diazepam therapy in preventing the recurrence of febrile seizures and assess adverse effects of each drug . Methods This prospect i ve r and omized controlled trial was performed on neurologically normal children aged from 6 months to 5 years with a history of simple febrile seizures and normal electroencephalogram without any evidence of acute central nervous system infection . The patients were r and omly prescribed with oral clobazam ( 37 cases ) or diazepam ( 35 cases ) when they developed a febrile disease . They were advised to use the medications during the first 48 h of the onset of fever . All the patients were monitored regarding developing seizure and adverse effects of the drugs . All patients were followed for 12 months . Results Overall , 243 episodes of fever occurred during the period , including 116 episodes in the clobazam group and 127 episodes in the diazepam group . Recurrence of seizures occurred in 2 ( 1.7 % ) subjects in the clobazam group , and in 4(3.1 % ) cases in the diazepam group . ( P value = 0.474 ) . Twenty cases ( 54 % ) in the diazepam group and 5 ( 14.2 % ) cases in the clobazam group developed drowsiness and sedation during the follow-up period ( P value = 0.0001 ) . Conclusions Intermittent clobazam therapy seems advantageous to diazepam due to similar efficacy but significantly lower adverse effects such as drowsiness and sedation BACKGROUND It is now agreed that the prognosis of seizure disorder due to solitary cysticercus granuloma ( SCG ) is generally good . However , the choice antiepileptic drugs ( AEDs ) remain empirical , with no comparative trials of different AEDs being available . AIMS To determine the safety and efficacy ( measured by the incidence of ' treatment failure ' ) of clobazam in comparison to st and ard treatment with phenytoin-sodium for prevention of seizures in persons with solitary cysticercus granulomas ( SCGs ) . SETTING S AND DESIGN This pilot study was conducted in a neurology department of a medical college hospital in the form of a prospect i ve , r and omized , open-labeled trial . MATERIAL S AND METHODS Forty-eight patients with seizures due to SCG were r and omized in an open-labeled trial to either , clobazam ( 1 mg/kg oral loading followed by 0.5 mg/kg/d ) ( n=21 ) or phenytoin ( 15 mg/kg , oral loading in 3 divided doses over 24 h , followed by 5 mg/kg/d ) ( n=27 ) . They were followed over 6 months with the primary outcome measure being treatment failure ( either discontinuation or modification of AEDs ) due to either adverse effects or breakthrough seizures . RESULTS Treatment failures were noted to be significantly less common ( P = 0.03 ) in the clobazam-treated group ( n=1 ; 4.7 % ) than in phenytoin-treated group ( n=9 ; 33.3 % ) . These included one patient ( 4.7 % ) in the clobazam-group who had breakthrough seizures and 3 ( 11.1 % ) who had breakthrough seizures and 6 ( 22.2 % ) in the phenytoin-treated group who had adverse effects requiring treatment discontinuation . CONCLUSIONS Clobazam was well tolerated , safe and more effective than phenytoin in the AED treatment of patients with SCG Clobazam was compared with placebo as antiepileptic adjunct medication in 129 therapy-resistant epileptic patients who were mainly suffering from complex partial seizures . The study was performed in five European countries according to a double-blind crossover design lasting 7 months . Two treatment periods of 3 months ( 1 month adjustment and 2 months maintenance medication ) were separated by one medication switch-over month . The difference in seizure reduction between clobazam and placebo was significant ( p less than 0.05 ) . Nineteen percent of patients receiving clobazam became seizure-free during the maintenance dose period . In contrast , freedom from seizures was not observed in any placebo patient . Electroencephalogram ( EEG ) signs , mood ratings , and global impressions also indicated therapeutic effects of clobazam in epilepsy . The most frequent adverse reactions to clobazam were drowsiness and dizziness . However , the sedative effects of clobazam seemed to be less pronounced in comparison with other benzodiazepines . The study gives evidence of the therapeutic value of clobazam as adjunct medication in therapy-resistant partial seizures . The use of clobazam as monotherapy and long-term treatment , as well as the particular seizure response pattern to clobazam , has to be further investigated The effect of 1,5-benzodiazepine clobazam was assessed in a double-blind add-on trial in 20 patients with chronic complex partial seizures uncontrolled by maximally tolerable daily dosage of st and ard antiepileptic drug therapy . The number of seizures was lower during the three months of active treatment . At the end of the third month , eight ( 40 % ) of the patients had a seizure reduction by more than 75 % , including four patients ( 20 % ) who had complete control . Tolerance to the antiepileptic effect of clobazam was noted in 56 % of the patients , and mild transient sedation occurred in 40 % of the patients . Despite these drawbacks , clobazam is an effective add-on drug for individual patients with refractory focal epilepsy The cyclical exacerbations of epilepsy ( catamenial epilepsy ) were used to assess the antiepileptic effect of a benzodiazepine , clobazam . Doses of 20 mg , and in some cases 30 mg , per day were compared with placebo over predetermined ten-day periods in a double-blind cross-over study . The results were evaluated by preference in a sequential procedure . In 14 of 18 patients who received both treatments clobazam was superior to placebo , and in 4 patients no preference was established . Clobazam completely prevented seizures in most of the patients , and toxic effects were of low frequency and severity Clobazam , 20 or 30 mg/day was given for 10 days around menstruation in successive menstrual cycles to 13 women who had responded favourably to this drug in an earlier short-term placebo controlled cross-over study . Three patients have been successfully treated , with complete freedom from seizures around menstruation , for 3 - 3 1/2 years and two others responded favourably until pregnancy made treatment inappropriate . A further four patients did well during a shorter period ( 6 - 13 months ) of follow-up . An increase in seizures between periods of clobazam therapy was observed in three patients , and led to the withdrawal of this drug in two of them . However , tolerance to the antiepileptic effect of clobazam was not observed in any patient , even though nine were treated for 1 year or more . In only once case was it necessary to discontinue treatment because of sedative side effects Clobazam is a benzodiazepine with special molecular structure ( its nitrogen radicals are in positions 1 and 5 , rather than 1 and 4 as in all other antiepileptic benzodiazepines ) , and it is rapidly effective -- in a matter of hours or within a few days -- against all varieties of epileptic seizures in 52 % of subjects treated with it . Its effects are relatively mild . Unfortunately , its outst and ing antiepileptic properties are exhausted after only a few weeks in one-third of all cases . The authors discuss the potential significance of this phenomenon , and stress the urgent need for intensive study of the basic mechanism governing exhaustion of the antiepileptic properties of the benzodiazepines in general and clobazam in particular Objective : To evaluate the efficacy of intermittent clobazam therapy in preventing the recurrence of febrile seizures and to assess its safety . Methods : The study was a prospect i ve , r and omized , double-blind placebo-controlled trial conducted in the Department of Child Health , Christian Medical College Hospital , Vellore between July 2001 and September 2002 . Neurologically normal children between 6 months and 3 years of age with a history of febrile seizures and no evidence of acute CNS infection or EEG abnormality were included into the study . 19 children in a clobazam group and 20 in the placebo group were r and omly allocated . Temperature reduction measures with paractamol and tepid sponging were advised to all children . In addition the dispensed medication was to be administered at the onset of fever and continued for 48 hours irrespective of the duration of fever . The children were then monitored for seizures and adverse effects of clobazam . The children were followed up for a mean period of 9.9 months . The analysis was done on the number of febrile episodes in both the groups . Results : There were a total of 110 episodes of fever during the study period . Mean number of febrile episodes in the clobazam group was 3.1 and in placebo group 2.56 . Six ( 12.5 % ) of the 48 episodes in placebo group and one ( 1.7 % ) of 60 episodes in clobazam group had seizure recurrence . This was statistically significant ( p=0.01 ) . Drowsiness and weakness were present equally in both clobazam and placebo group whereas ataxia was present only in the clobazam group , the difference being statistically significant ( p=0.04 ) . Conclusion : Intermittent clobazam therapy is an effective measure in the prevention of recurrence of febrile seizures . The ataxia due to clobazam was much lower than that reported with diazepam PURPOSE To compare the cognitive and behavioural effects of clobazam versus st and ard monotherapy in the treatment of childhood epilepsy . METHODS A r and omized , double-blind , prospect i ve design was carried out at three Canadian pediatric epilepsy centres . This study was part of a larger multi-centre study on the efficacy of clobazam . Children with newly diagnosed epilepsy were assigned r and omly to receive clobazam or carbamazepine . Children who had failed previous treatment with carbamazepine were assigned r and omly to clobazam or phenytoin . Children who had failed on any other antiepileptic drug were assigned r and omly to receive clobazam or carbamazepine . In a subset of patients neuropsychological assessment s were carried out at 6 weeks and 12 months after initiation of medication . Intelligence , memory , attention , psychomotor speed , and impulsivity were assessed . RESULTS There were no differences between the clobazam and st and ard monotherapy groups on any of the neuropsychological measures obtained at 6 weeks or 12 months . There was no evidence for a deterioration in performance for those children who remained on clobazam for the entire 12-month study period . CONCLUSION The cognitive and behavioural effects of clobazam appear to be similar to those of st and ard monotherapy
Output:
| We found no advantage for clobazam over carbamazepine for retention at 12 months in drug-naïve children and a slight advantage of clobazam over phenytoin for retention at six months in adolescents and adults with neurocysticercosis in a single clinical trial each . |
MS211909 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In a clinical trial of two antirheumatic agents two methods of collection of side effects were used , one with and the other without a check list of possible symptoms . Findings suggested that the use of a check list interfered with the collection of side effects . Known side effects of aspirin — tinnitus , deafness , and gastrointestinal disturbance — were more efficiently shown and symptoms not included in the check list were more likely to be reported when a check list was not used OBJECTIVE The authors sought to identify predictors of self-harm adverse events in treatment-resistant , depressed adolescents during the first 12 weeks of treatment . METHOD Depressed adolescents ( N=334 ) who had not responded to a previous trial with an SSRI antidepressant were r and omized to a switch to either another SSRI or venlafaxine , with or without cognitive behavior therapy . Self-harm events , i.e. , suicidal and non-suicidal self-injury adverse events were assessed by spontaneous report for the first 181 participants , and by systematic weekly assessment for the last 153 participants . RESULTS Higher rates of suicidal ( 20.8 % vs. 8.8 % ) and nonsuicidal self-injury ( 17.6 % vs. 2.2 % ) , but not serious adverse events ( 8.4 % vs. 7.3 % ) were detected with systematic monitoring . Median time to a suicidal event was 3 weeks , predicted by high baseline suicidal ideation , family conflict , and drug and alcohol use . Median time to nonsuicidal self-injury was 2 weeks , predicted by previous history of nonsuicidal self-injury . While there were no main effects of treatment , venlafaxine treatment was associated with a higher rate of self-harm adverse events in those with higher suicidal ideation . Adjunctive use of benzodiazepines , while in a small number of participants ( N=10 ) was associated with higher rate of both suicidal and nonsuicidal self-injury adverse events . CONCLUSIONS Since predictors of suicidal adverse events also predict poor response to treatment , and many of these events occurred early in treatment , improving the speed of response to depression , by targeting of family conflict , suicidal ideation , and drug use may help to reduce their incidence . The relationship of venlafaxine and of benzodiazepines to self-harm events requires further study and clinical caution Summary The incidence of side-effects on administration of chloranolol ( Tobanum ® ) , a beta-adrenergic receptor blocking drug , to 2066 patients with hypertension , angina pectoris or arrhythmias was measured by three different methods . In 600 patients in an efficacy trial ( Group 1 ) both spontaneously reported complaints and objective signs were tabulated . A side effect — directed method , utilising a question naire containing a list of possible side-effects was also used , with the question naire being completed by the physician . 35 questions referred to anticipated and other side-effects . The trial was performed in two groups : in 537 patients a placebo was also given ( Group 2 ) , and in another set of 929 patients ( Group 3 ) the question naire inquiry was performed uncontrolled , without placebo . All three groups were comparable in their distribution of sexes , ages and diagnoses , the mean daily dose of chloranolol its use alone or in combination , and in a similar duration of treatment . 55 % of all patients received chloranolol therapy for a period of more than 3 months . The ratio of in- and out patients was 1:5 . The side-effect incidence was independent of the age and sex of the patients and of the dose of chloranolol . The incidence was also unaffected whether chloranolol was used alone or in combination . The number of side-effects differed markedly between the three groups , their ratio was 1:10:24 in Groups 1 , 2 and 3 . Two-thirds of the side-effects subsided spontaneously within 1 month of their onset . The duration of the side-effects varied according to their character : cardiorespiratory side-effects were of the shortest duration and those affecting the central nervous system were the most enduring . The appreciable differences in incidence could be attributed to the methods of collection of the data . It has been stated that placebo controlled trials using a detailed question naire are the most suitable for estimating the incidence of side-effects ; recording side-effects spontaneously reported by patients are insufficiently sensitive , and uncontrolled trials using a question naire have been shown to be too sensitive . The revealed incidence of side effects leading to interruption of treatment is less affected by the method chosen . In 100 patients ( 4.8 % ) therapy had to be suspended because of the side-effects of chloranolol ( Group 1 : 1 % , Group 2 : 6.20 % , Group 3 : 6.6 % ) . Comparison of the incidence of cessation of therapy due to side-effects did not show an appreciable difference between the various beta-adrenergic receptor blocking agents , including chloranolol Introduction An increasing number of generic alendronate formulations have become available . Although expected to have the same tolerability and efficacy , head-to head comparison of generic and br and alendronate was never performed . Therefore , we compared the tolerability and efficacy of generic and br and alendronate . Methods In a r and omized double-blinded single centre cross-over study in 37 postmenopausal women ( mean age 65.4±6.4 years ) with osteoporosis were treated with generic and br and ed alendronate during 24 ( 2x12 ) weeks . Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale ( GSRS ) and self-reported side effects . Efficacy was assessed by serum bone turnover markers , carboxy terminal telopeptide ( CTX ) and procollagen type I N-terminal propeptide ( PINP ) . No wash out period was allowed ( ethical reasons ) . Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models . Results There were no significant differences in overall tolerance ( GSRS ) between treatment groups . However , for subscale abdominal pain , patients using generic had a significantly higher mean GSRS score at week 4 ( estimated mean difference ( B ) : 0.40 ; 95%CI : 0.05 to 0.74 , p = 0.024 ) . The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and br and ed alendronate ( p < 0.001 ) . Mean level of CTX was significantly lower with br and ed at week 4 ( B : 121.3 ; 95%CI : 52.0 to 190.5 ) , but not at week 12 ( B : 53.6 ; 95%CI:-3.7 to 110.9 ) . No significant differences were found for PINP at week 4 or 12 . Conclusions Bone turnover markers were significantly reduced with br and ed and generic alendronate . With br and ed , CTX was significantly lower at 4 weeks . Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment . Therefore , generic alendronate may not have the same tolerability and efficacy as br and ed alendronate in the first weeks after starting treatment in patients with a recent fracture . Trial Registration Dutch Trial Register NTR number 1867 http://www.trialregister.nl/trialreg/admin/ rct Background Historically , skin toxicity has been assessed in prospect i ve clinical trials using the clinician-reported National Cancer Institute Common Terminology Criteria for Adverse Events ( CTCAE ) . The patient-reported Skindex-16 measures symptoms and perceptions of toxicity . This study was design ed to compare information provided by these two measures . Methods Data were compiled from three placebo-controlled North Central Cancer Treatment Group studies ( N06C4 , N03CB , N05C4 ) having rash prevention as the primary objective . All used the Skindex-16 and CTCAE at baseline , weekly during treatment and during a minimum 2-week follow-up period . Statistical procedures , including Pearson correlations , were utilized to determine relationships between adverse event ( AE ) grade s and Skindex-16 scores . Results Four hundred and twelve individual patients provided data ( median age , 61 ; 134 male ) . Patients ' Skindex-16 score results show a 0.9 overall mean ( range 0–6 with 6 being worse symptoms ) , a 0.4 baseline mean ( range , 0–4.3 ) and a 1.3 end-of-treatment mean ( range , 0–5.9 ) . Ninety-three , 142 and 177 patients experienced a grade 0 , 1 and 2 + CTCAE skin toxicity , respectively . Baseline Skindex-16 scores had relatively low correlation with CTCAE grade s. The correlation of rash grade with Skindex-16 scores ranged from r = 0.49 with the function subscale to r = 0.62 with the symptom subscale . The highest correlations of the maximum grade of any dermatological AE with the Skindex-16 were r = 0.48 for the total score and r = 0.55 for the symptom subscale . Conclusions The data reported support the decision to include both measures in a clinical trial to assess the patient experience , as each measure may specifically target varying symptoms and intensities Introduction Dose-limiting neurotoxicity is a major side effect of oxaliplatin treatment , producing initial acute neurotoxicity and chronic neuropathy with increasing exposure . The improvement in survival for patients with early-stage colorectal cancer treated with oxaliplatin has highlighted the need for valid and reliable assessment of peripheral neuropathy . Objectives The objective of this paper was to explore neuropathic symptoms in oxaliplatin-treated patients as assessed using different methods . Methods Consecutive symptomatic patients reporting peripheral neuropathy after oxaliplatin chemotherapy for colorectal cancer were interviewed using a semi-structured clinical interview . Neurotoxicity was also assessed using the National Cancer Institute Common Toxicity Criteria scale ( clinician-rated ) , patient ‘ self-report ’ question naires ( PNQ ) , nerve conduction and clinical assessment . Results Twenty patients were assessed , 12.6 ± 2.8 months after treatment cessation ( mean cumulative oxaliplatin dose , 789 mg/m2 ) . In 40 % of patients , neurotoxicity necessitated early cessation of treatment . Only 10 % of patients were design ated by clinicians with severe neurotoxicity , whilst , in contrast , patient interviews and self-report question naires described significant physical limitations due to neuropathic symptoms in 60 % of patients . The majority ( 85 % ) of patients had objective evidence of sensory neuropathy with nerve conduction studies . Reports from clinical interviews were strongly correlated with patient self- assessment ( Pearson coefficient = 0.790 , p < 0.0005 ) . Conclusion Given the discrepancies in symptom prevalence highlighted by these findings , the monitoring of oxaliplatin-induced neurotoxicity would benefit from more informative clinical assessment , with inclusion of patient-reported outcome measures . Such an approach would be beneficial in a clinical trial setting to monitor the efficacy of interventions and in prospect i ve studies of survivorship to determine the true burden of peripheral neuropathy in oxaliplatin-treated patients Summary 251 patients from 23 primary health care centres were recruited to a clinical trial in which either felodipine or placebo was added to baseline metoprolol treatment . Three methods of symptom reporting were used in 191 patients , namely two previously documented self-administered question naires and an adverse event monitoring system ( spontaneous reports to treating physician).Higher frequencies of symptoms were seen with the question naires compared to spontaneous reporting . However , the overlap between the methods was moderate and they were found to complement one another . The question naires were completed twice during the study and the adverse event monitoring system was applied on five occasions . The rate of application had consequences for the ability of each method to detect transient , dose-related symptoms , e.g. headache and dizziness . Regardless of method , the possibility of detecting dose-related symptoms was enhanced when symptoms were measured not only during active treatment but also during a run-in or other baseline period , and both phases were considered in the analyses BACKGROUND A relative lack of extrapyramidal symptoms ( EPS , i.e. , the syndromes of dystonia , parkinsonism , akathisia , dyskinesia ) is one criterion used to determine whether an antipsychotic is " atypical . " The extrapyramidal symptom profiles of the novel antipsychotic olanzapine and the conventional antipsychotic haloperidol were compared in a population of 2606 patients from three well-controlled prospect i ve clinical trials . METHOD Extrapyramidal symptom data were analyzed for 1796 patients treated with olanzapine ( 5 to 20 mg/day ) and 810 patients treated with haloperidol ( 5 to 20 mg/day ) for up to 6 weeks of therapy . Patients were monitored weekly by three methods of extrapyramidal symptom assessment : ( 1 ) detection of extrapyramidal adverse events ( signs and symptoms ) by casual observation , nonprobing inquiry , and spontaneous report ; ( 2 ) objective rating scale scores : and ( 3 ) use of concomitant anticholinergic medications . Emergence of EPS was assessed by ( 1 ) analysis of the incidence of extrapyramidal syndrome categories based on adverse events , ( 2 ) the incidence of extrapyramidal syndromes based on categorical analysis of rating scale scores , ( 3 ) analysis of mean maximum change in rating scale scores , and ( 4 ) categorical analysis of antich
Output:
| Despite different design s , population s and details of question ing methods , the narrative review showed that more specific question ing of participants led to more AEs detected compared to a more general enquiry .
This review supports concerns that methods to elicit participant-reported AEs influence the detection of these data .
There was a risk for under-detection of AEs in studies using a more general elicitation method compared to those using a comprehensive method .
These AEs may be important from a clinical perspective or for patients .
This under-detection could compromise ability to pool AE data . |
MS211910 | ***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 dementia are almost invariably unable to use any form of inhaler . Some elderly patients are unable to learn to use a metered dose inhaler or Turbohaler despite a normal abbreviated mental test score . Studies have shown that in many people this is due to unrecognised cognitive impairment and /or dyspraxia . The executive domains of cognition are particularly important in planning and sequencing ; it might be expected therefore that disordered frontal ( executive ) function could be a predictor of poor inhaler technique in subjects with no overt features of dementia . OBJECTIVE to explore the relationship between cognitive , and executive , function and the ability to acquire metered dose inhaler and Turbohaler technique in old age . DESIGN a prospect i ve r and omised observational study with blinded evaluation . SUBJECTS 30 inhaler-naive in patients ( 21 female ) with a mean age of 85 ( range 75 - 94 ) and having a normal ( 8 - 10 ) abbreviated mental test score . METHODS subjects received st and ardised metered dose inhaler and Turbohaler training and were scored on an analogue scale ( for metered dose inhaler ) or for competence ( Turbohaler ) the following day . The Mini-Mental State Examination and EXIT25 ( for executive function ) were performed by separate observers . RESULTS significant correlation was found between the metered dose inhaler score and Mini-Mental State Examination ( r 0.540 , P<0.002 ) and EXIT25 ( r -0.702 , P<0.0001 ) . Threshold effects emerged for the metered dose inhaler in that 18/19 with a competent score compared to 2/11 scored as incompetent had a Mini-Mental State Examination of > 23 ( P<0.01 ) and 19/19 compared to 0/11 had an EXIT25 of < 15 ( P<0.01 ) . Similarly , for the Turbohaler 21/21 of the competent subjects had a Mini-Mental State Examination of > 23 compared with 3/9 incompetent subjects ( P<0.01 ) , with 21/21 competent compared with 0/9 incompetent having an EXIT25 < 15 ( P<0.01 ) . CONCLUSION acquisition and short-term retention of metered dose inhaler and Turbohaler techniques is unlikely to be successful in frail elderly people who have an abnormal Mini-Mental State Examination and /or EXIT25 test . The latter test , when abnormal , is probably the superior predictor of inability to learn inhaler techniques Systemic inflammation is present in chronic obstructive pulmonary disease ( COPD ) , which has been linked to cardiovascular morbidity and mortality . We determined the effects of oral and inhaled corticosteroids on serum markers of inflammation in patients with stable COPD . We recruited 41 patients with mild to moderate COPD . After 4 weeks during which inhaled corticosteroids were discontinued , patients were assigned to fluticasone ( 500 mcg twice a day ) , oral prednisone ( 30 mg/day ) , or placebo over 2 weeks , followed by 8 weeks of fluticasone at 500 mcg twice a day and another 8 weeks at 1,000 mcg twice a day . Withdrawal of inhaled corticosteroids increased baseline C-reactive protein ( CRP ) levels by 71 % ( 95 % confidence interval [ CI ] , 16 - 152 % ) . Two weeks with inhaled fluticasone reduced CRP levels by 50 % ( 95 % CI , 9 - 73 % ) ; prednisone reduced it by 63 % ( 95 % CI , 29 - 81 % ) . No significant changes were observed with the placebo . An additional 8 weeks of fluticasone were associated with CRP levels that were lower than those at baseline ( a 29 % reduction ; 95 % CI , 7 - 46 % ) . Inhaled and oral corticosteroids are effective in reducing serum CRP levels in patients with COPD and suggest their potential use for improving cardiovascular outcomes in COPD The Nocturnal Oxygen Therapy Trial ( NOTT ) showed previously that patients with hypoxemic chronic obstructive pulmonary disease ( COPD ) frequently suffered from neuropsychologic deficit and experienced disturbed mood , personality , and life quality . The present study has followed up 150 NOTT patients six months after they were r and omized to continuous oxygen treatment ( COT ) or nocturnal oxygen treatment ( NOT ) . Tested off oxygen , 42 % showed modest neuropsychologic improvement after six months of therapy , and the rates for COT and NOT were comparable . A sub sample ( n = 37 ) was examined a third time , after 12 months of treatment . At this point patients receiving COT registered better neuropsychologic performance than those receiving NOT . Concurrently , the COT group began showing improved survival . Despite mild neuropsychologic improvement , patients reported little change in emotional status or life quality . It is concluded that prolonged oxygen treatment is associated with small but definite improvement in brain functioning among patients with hypoxemic COPD , and that COT might have some advantage over NOT in enhancing neuropsychologic functioning as well as survival BACKGROUND Cognitive impairment frequently occurs in elderly COPD patients , but little is known about its prognostic implication s. We aim ed at evaluating the prognostic role of cognitive impairment in patients with severe COPD . METHODS Our series consisted of 149 stable patients ( mean [ + /- SD ] age , 68.7 + /- 8.5 years ) with COPD and a Pao(2 ) of < 57 mm Hg at rest ( n = 97 ) or at the end of the 6-min walking test ( n = 37 ) who were enrolled in a prospect i ve observational study . After a multidimensional baseline assessment , patients were followed up by telephone calls for a mean duration of 32.5 + /- 9.2 months ( minimal follow-up duration , 24 months ) ; 134 patients were successfully tracked . We used multivariable Cox proportional hazard analysis to identify predictors of death among clinical /functional variables that previously were shown to have prognostic implication s and among neuropsychological indexes selected on the basis of univariate analysis . RESULTS We observed 29 deaths over a median follow-up time of 32 months . Only the two following variables were independently associated with the outcome : an abnormal score on the copy with l and mark test ( hazard ratio [ HR ] , 2.93 ; 95 % confidence interval [ CI ] , 1.34 to 6.39 ) ; and a 6-min walk distance of < 300 m ( HR , 3.46 ; 95 % CI , 1.15 to 10.5 ) . A Pao(2 ) of < 57 mm Hg at rest ( HR , 2.19 ; 95 % CI , 0.93 to 5.18 ) and an FEV(1 ) of < 40 % predicted ( HR , 2.74 ; 95 % CI , 0.99 to 7.57 ) were nearly significantly associated with the outcome , while Paco(2 ) , body mass index , physical dependence , comorbid diseases , and the impairment of cognitive domains other than drawing impairment were unrelated to the outcome . CONCLUSIONS Drawing impairment is a risk factor for mortality and might improve the assessment of hypoxemic COPD patients The objective of the study was to evaluate the effect of multidisciplinary pulmonary rehabilitation program on cognitive function in COPD patients , adjusting for potential confounders ( gender , age , tobacco consumption , and educational level ) . In this prospect i ve study , 34 COPD patients were su bmi tted to neuropsychological testing before and after a 3-month pulmonary rehabilitation program . A control group with 18 healthy subjects of similar age , sex , and educational status was used to compare the cognitive function of COPD patients and healthy subjects at baseline . The association between the rehabilitation and change on th scores of cognitive variables , adjusted for each covariate , was estimated by means of linear r and om-intercept regression models . At baseline , the COPD patients had worse cognitive function with regard to verbal learning , memory , subjective organization , and verbal processing in comparison to the healthy volunteers . The improvement in cognitive performance by the COPD patients was evidence d even after adjusting for the sociodemographic factors that could potentially interfere on cognitive function . Male gender and age less than 65 years old were associated to higher scores in verbal learning and memory at baseline and after the rehabilitation program . The clinical approach to COPD -induced cognitive dysfunction should include participation in pulmonary rehabilitation programs . There were gender- and age-related differences in cognitive scores that persisted after rehabilitation
Output:
| The review of the findings of the articles showed a significant relationship between COPD and cognitive impairment .
The most widely studied cognitive domains are memory and attention .
Verbal memory and learning constitute the second most commonly impaired cognitive domain in patients with COPD .
We found that cognitive impairment is associated with the profile of COPD severity and its comorbidities .
The articles review ed demonstrated that there is considerable impairment of the cognitive domains memory and attention in patients with COPD . |
MS211911 | ***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 demonstrate the safety and immunogenicity of intradermal rabies pre-exposure prophylaxis with purified chick embryo cell vaccine ( PCECV ) in schoolchildren age 5 to 8 years in Thail and . STUDY DESIGN In a r and omized , open-label , phase II clinical trial , 2 or 3 intradermal doses of 0.1 mL PCECV ( Rabipur ) were administered to 703 schoolchildren on days 0 and 28 or on days 0 , 7 , and 28 . In 206 children , 2 simulated post-exposure booster doses were given 1 year after the primary vaccination series . Rabies virus- neutralizing antibody ( RVNA ) titers were determined by the rapid fluorescent focus inhibition test . RESULTS In school-age children in Thail and , a pre-exposure immunization regimen of 3 intradermal doses of PCECV produced adequate immune responses . After primary vaccination , all subjects developed RVNA titers > or = 0.5 IU/mL and demonstrated a rapid increase in RVNA titer after 2 simulated post-exposure booster immunizations 1 year after the primary vaccination series . No serious adverse drug reactions occurred . CONCLUSIONS Rabies pre-exposure immunization with PCECV is safe and immunogenic , and its implementation could save the lives of many children in rabies-endemic areas Objectives . To assess the immunogenicity of intradermal ( ID ) booster doses of Purified Chick Embryo Cell rabies vaccine ( PCECV , Rabipur ) administered to Thai schoolchildren one , three and five years after a primary ID pre-exposure ( PrEP ) vaccination series . Methods . In this follow-up study of a r and omized , open-label , phase II clinical trial , two simulated post-exposure booster doses of PCECV were administered on days 0 and 3 intradermally to 703 healthy schoolchildren , one , three or five years after primary vaccination with either two or three ID doses of 0.1 mL PCECV . Blood was drawn immediately before and 7 , 14 and 365 days after the first booster dose to determine rabies virus neutralizing antibody ( RVNA ) concentrations . Results . An anamnestic response of approximately 30-fold increase in RVNA concentrations was demonstrated within 14 days after booster . All children ( 100 % ) developed adequate RVNA concentrations above 0.5 IU/mL. No vaccine related serious adverse events were seen in any of the vaccinees . Conclusion . ID rabies PrEP with PCECV is safe and immunogenic in schoolchildren and the anamnestic response to a two booster dose vaccination series was found to be adequate one , three , and five years after a two- or three-dose primary PrEP vaccination series BACKGROUND Chikungunya is an emerging arthropod-borne disease that has spread from tropical endemic areas to more temperate climates of the USA and Europe . However , no specific treatment or preventive measure is yet available . We aim ed to investigate the immunogenicity and safety of a live recombinant measles-virus-based chikungunya vaccine . METHODS We did a r and omised , double-blind , placebo-controlled , active-comparator , phase 1 , dose-escalation study at one centre in Vienna , Austria . Healthy men and women aged 18 - 45 years with no comorbidities were r and omly assigned , by computer-generated block r and omisation ( block size of 14 ) , to receive either one of three escalating doses of the measles-virus-based c and i date vaccine ( low dose [ 1·5 × 10(4 ) median tissue culture infection doses ( TCID50 ) per 0·05 mL ] , medium dose [ 7·5 × 10(4 ) TCID50 per 0·25 mL ] , or high dose [ 3·0 × 10(5 ) TCID50 per 1·0 mL ] ) , or the active comparator-Priorix . Participants were additionally block-r and omised to receive a booster injection on either day 28 or day 90 after the first vaccination . Participants and study investigators were masked to group allocation . The primary endpoint was the presence of neutralising anti-chikungunya antibodies on day 28 , as assessed by 50 % plaque reduction neutralisation test . Analysis was by intention to treat and per protocol . This trial is registered with EudraCT , number 2013 - 001084 - 23 . FINDINGS Between Nov 22 , 2013 , and Feb 25 , 2014 , we r and omly assigned 42 participants to receive the low dose ( n=12 ) , the medium dose ( n=12 ) , or the high dose ( n=12 ) of the measles-virus-based c and i date vaccine , or Priorix ( n=6 ) , of whom 36 participants ( 86 % ; n=9 , n=12 , n=10 , n=5 , respectively ) were included in the per- protocol population . The c and i date vaccine raised neutralising antibodies in all dose cohorts after one immunisation , with seroconversion rates of 44 % ( n=4 ) in the low-dose group , 92 % ( n=11 ) in the medium-dose group , and 90 % ( n=10 ) in the high-dose group . The immunogenicity of the c and i date vaccine was not affected by pre-existing anti-measles immunity . The second vaccination result ed in a 100 % seroconversion for all participants in the c and i date vaccine groups . The c and i date vaccine had an overall good safety profile , and the rate of adverse events increased with vaccine dose and volume . No vaccination-related serious adverse events were recorded . INTERPRETATION The live recombinant measles-virus-based chikungunya vaccine had good immunogenicity , even in the presence of anti-vector immunity , was safe , and had a generally acceptable tolerability profile . This vaccine is the first promising measles-virus-based c and i date vaccine for use in human beings . FUNDING Themis Bioscience GmBH A multivariate analysis was used to identify factors influencing the immunogenicity of rabies vaccine and to assess the efficacy of booster injections in a cohort of 407 people monitored prospect ively for 10 years after primary vaccination . Rabies vaccine ( HDCV or PVRV ) was injected by intramuscular route either on days 0 and 28 or on days 0 , 7 and 28 . All the participants received a booster injection on day 365 . At the end of follow-up ( year 10 ) , 163 subjects had titers > 0.5IU/ml ( group A ) and 59 subjects had titers < 0.5IU/ml ( group B : poor responders ) . The number of injections had a significant influence ( P<0.001 ) on the magnitude of the serological response to rabies vaccine , but the type of vaccine and the potency of the batches did not ( P=0.07 and P=0.06 , respectively ) . The difference between GMTs on day 365 and day 379 was significantly lower in group B than in group A ( 13 and 50.70IU/ml , respectively ; P<0.001 ) . In conclusion , our study confirms that the rabies pre-exposure vaccination protocol of three intramuscular injections significantly decreases the proportion of poor responders at 10 years . Moreover , our findings indicate that a routine booster injection at 1 year could significantly increase the levels and duration of antibody titers BACKGROUND For individuals traveling at short notice to rabies and Japanese encephalitis ( JE ) endemic countries , concomitant administration of travel vaccines within a short period is often required . METHODS The aim of this study was to determine whether an accelerated ( one-week : Days 1 - 8 ) pre-exposure rabies ( Rabipur ( ® ) , Novartis Vaccines ) vaccination regimen administered concomitantly with a Japanese encephalitis ( JE ) vaccination ( Ixiaro ( ® ) , Valneva ) regimen , is non-inferior to the st and ard ( four-week : Days 1 , 8 , 29 ) rabies regimen administered alone or concomitantly with the JE vaccine . Healthy adults ( 18 to ≤ 65 years ) were r and omized into Rabies + JE-St and ard , Rabies + JE-Accelerated , Rabies-St and ard and JE-St and ard groups . Relative immunogenicity for rabies in each regimen was assessed using the rapid fluorescent focus inhibition test . Safety was evaluated up to and including Day 57 . RESULTS Non-inferior immunogenicity for rabies was established between the Rabies + JE-Accelerated group compared to both the Rabies-St and ard and Rabies + JE-St and ard groups ; as well as between the Rabies + JE-St and ard regimen and the Rabies-St and ard regimen . By Day 57 , adequate neutralizing levels were achieved by 97 - 100 % of subjects across all groups . Adverse events ( AEs ) were comparable for all groups . CONCLUSIONS An accelerated pre-exposure rabies and JE vaccination regimen is non-inferior to the st and ard four-week rabies regimen and may thus provide a more convenient regimen for individuals traveling to endemic countries at short notice . NCT01662440 Children have a high risk of exposure to rabies in countries where the disease is endemic . This prospect i ve , 5-year study followed two groups of children who had received diphtheria , tetanus , whole-cell pertussis and inactivated poliomyelitis vaccine ( DTP-IPV ) at 2 , 3 , 4 months and 1 year ( Group B ) or concomitant with three doses of purified Vero cell rabies vaccine ( PVRV ) , given at 2 , 4 months and 1 year ( Group A ) . Antibody determinations were made annually for 5 years . Data were available from a total of 72 subjects ; 30 in Group A and 32 in Group B. In Group A , the percentage of patients immunized against rabies ( anti-rabies > or = 0.5 IU/ml ) decreased from 100 % after the third vaccination to 63 % , 5 years later . After 5 years , 93.8 % in Group A and 96.7 % in Group B had seroprotective diphtheria antibody titers > or = 0.01 IU/ml , and all subjects had anti-polio ( type 1 , 2 and 3 ) seroprotective titers > or = 5 1:dil . We conclude that co-administration of PVRV with DTP-IPV elicited protective antibody concentrations to all antigens that persist for at least 5 years , with continued protection against rabies in over 60 % of subjects . These results are consistent with integration of pre-exposure rabies vaccination into the Exp and ed Program on Immunization ( EPI ) in countries where rabies is endemic OBJECTIVE To evaluate abbreviated preexposure rabies vaccination schedules that would reduce cost and shorten time required for completion . METHOD A r and om prospect i ve immunogenicity study , using a group of 96 volunteer pre clinical veterinary students , primary school children , and hospital-based health care workers . They were divided into six groups and administered abbreviated schedules of preexposure tissue culture rabies vaccines . Neutralizing antibodies were determined on days 0 and 360 , and following boosters on days 367 and 374 . RESULTS All subjects , including one group that received only 0.1 mL intradermally at two sites on one day , had detectable neutralizing antibody titers 1 year later and responded with an accelerated antibody response when given booster injections . CONCLUSION It might be possible to develop a 1-week and even one clinic visit preexposure vaccine schedule that would provide at least 1 year of immune memory OBJECTIVE To evaluate the humoral immune response to the pre-exposure schedule of human rabies vaccination through intradermal and intramuscular routes , as well as the need for serological monitoring . METHODS A r and omized and controlled intervention study was carried out in São Paulo , Southeastern Brazil , from 2004 - 2005 . There were 149 volunteers , of which 127 completed the vaccination schedule ( 65 intradermal and 62 intramuscular ) and underwent humoral immune response evaluation at ten , 90 and 180 days post-vaccination . Two outcomes were considered for comparing the two routes of administration : the geometric average of neutralizing antibody titers and the proportion of individuals with satisfactory titers ( > 0.5 IU/mL ) at each evaluation point . The association of the humoral immune response with anthropometric and demographic data was analyzed through a normal distribution test and a chi-square test with a Yates correction . After completion of the vaccination schedule , the proportion of seropositive results was compared by the Kruskall Wallis test , and the average titers were compared by variance analysis . RESULTS the average antibody titers were higher in patients who were vaccinated intramuscularly . The percentage of volunteers with satisfactory titers ( > 0.5 % IU/mL ) decre
Output:
| The evidence available indicates that shorter regimens and regimens involving fewer doses are safe and immunogenic and that booster intervals could be extended up to 10 years .
The few studies on cost suggest that , at current vaccine and delivery costs , pre-exposure prophylaxis campaigns would not be cost-effective in most situations . |
MS211912 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality Objective Independently of total caloric intake , a better quality of the diet ( for example , conformity to the Mediterranean diet ) is associated with lower obesity risk . It is unclear whether a brief dietary assessment tool , instead of full-length comprehensive methods , can also capture this association . In addition to reduced costs , a brief tool has the interesting advantage of allowing immediate feedback to participants in interventional studies . Another relevant question is which individual items of such a brief tool are responsible for this association . We examined these associations using a 14-item tool of adherence to the Mediterranean diet as exposure and body mass index , waist circumference and waist-to-height ratio ( WHtR ) as outcomes . Design Cross-sectional assessment of all participants in the “ PREvención con DIeta MEDiterránea ” ( PREDIMED ) trial . Subjects 7,447 participants ( 55–80 years , 57 % women ) free of cardiovascular disease , but with either type 2 diabetes or ≥3 cardiovascular risk factors . Trained dietitians used both a vali date d 14-item question naire and a full-length vali date d 137-item food frequency question naire to assess dietary habits . Trained nurses measured weight , height and waist circumference . Results Strong inverse linear associations between the 14-item tool and all adiposity indexes were found . For a two-point increment in the 14-item score , the multivariable-adjusted differences in WHtR were −0.0066 ( 95 % confidence interval , –0.0088 to −0.0049 ) for women and –0.0059 ( –0.0079 to –0.0038 ) for men . The multivariable-adjusted odds ratio for a WHtR>0.6 in participants scoring ≥10 points versus ≤7 points was 0.68 ( 0.57 to 0.80 ) for women and 0.66 ( 0.54 to 0.80 ) for men . High consumption of nuts and low consumption of sweetened/carbonated beverages presented the strongest inverse associations with abdominal obesity . Conclusions A brief 14-item tool was able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern ( Mediterranean diet ) and obesity indexes in a population of adults at high cardiovascular risk
Output:
| New evidence from prospect i ve cohort studies , cross-sectional studies and clinical trials supports the beneficial role of adherence to the Mediterranean dietary pattern regarding metabolic syndrome presence and progression . |
MS211913 | ***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 The aims of this study were to establish absolute ranges for right ventricular ( RV ) structural and functional parameters for endurance athletes and to establish any impact of body size . These data may help differentiate physiologic conditioning from arrhythmogenic RV cardiomyopathy . METHODS A prospect i ve observational study design was used , and st and ard two-dimensional echocardiography was performed on 102 endurance athletes , providing RV structural indices . A two-dimensional strain ( ε ) technique was used to provide indices of RV ε and strain rate . The association of RV chamber size to body surface area ( BSA ) and functional indices was examined by simple ratio scaling as well as adoption of the general , nonlinear allometric model . RESULTS The values for RV inflow , outflow , length , and diastolic area were greater than published " normal ranges " in 57 % , 40 % , 69 % , and 59 % of the population , respectively , while 28 % of the population had RV outflow tract values greater than the proposed " major criteria " for arrhythmogenic RV cardiomyopathy . Simple ratio scaling for all RV dimensions to BSA did not produce size independence , whereas scaling for BSA allometrically did . Strain and strain rate values were consistent with published normal ranges , and there is no evidence to suggest that scaling is required . CONCLUSIONS RV chamber dimensions are larger in endurance athletes than those described by " normal ranges " and frequently meet the major criteria for the diagnosis of arrhythmogenic RV cardiomyopathy . Functional assessment of RV ε may aid in this differential diagnosis . RV size is allometrically related to BSA and therefore scaling for population -specific b exponents is encouraged Deformation analysis using 2-dimensional strain echocardiography can detect early systolic function abnormalities in patients with left ventricular hypertrophy . This study was design ed to characterize global and regional myocardial deformation using 2-dimensional strain in professional soccer players ( PSPs ) compared with control subjects and patients with hypertrophic cardiomyopathy ( HC ) . Twenty nine PSPs , 26 patients with HC , and 17 controls were investigated at rest using transthoracic echocardiography with 2-dimensional strain analysis . Radial and transverse strains were significantly higher in PSPs compared with controls , whereas longitudinal strain was lower . Compared with patients with HC , athletes had higher values for transverse , radial , and circumferential strains . In pathologic hypertrophic segments , longitudinal strain was lower in patients with HC than in PSPs . In conclusion , 2-dimensional strain can identify specific patterns of myocardial deformation in PSPs , controls , and patients with HC . It has the potential to become a routinely used method for the differentiation of athlete 's heart and HC During incremental exercise , stroke volume ( SV ) plateaus at 40 - 50 % of maximal exercise capacity . In healthy individuals , left ventricular ( LV ) twist and untwisting ( " LV twist mechanics " ) contribute to the generation of SV at rest , but whether the plateau in SV during incremental exercise is related to a blunting in LV twist mechanics remains unknown . To test this hypothesis , nine healthy young males performed continuous and discontinuous incremental supine cycling exercise up to 90 % peak power in a r and omized order . During both exercise protocol s , end-diastolic volume ( EDV ) , end-systolic volume ( ESV ) , and SV reached a plateau at submaximal exercise intensities while heart rate increased continuously . Similar to LV volumes , two-dimensional speckle tracking-derived LV twist and untwisting velocity increased gradually from rest ( all P < 0.001 ) and then leveled off at submaximal intensities . During continuous exercise , LV twist mechanics were linearly related to ESV , SV , heart rate , and cardiac output ( all P < 0.01 ) while the relationship with EDV was exponential . In diastole , the increase in apical untwisting was significantly larger than that of basal untwisting ( P < 0.01 ) , emphasizing the importance of dynamic apical function . In conclusion , during incremental exercise , the plateau in LV twist mechanics and their close relationship with SV and cardiac output indicate a mechanical limitation in maximizing LV output during high exercise intensities . However , LV twist mechanics do not appear to be the sole factor limiting LV output , since EDV reaches its maximum before the plateau in LV twist mechanics , suggesting additional limitations in diastolic filling to the heart Left ventricular ( LV ) rotation occurs due to contraction of obliquely oriented myocardial fibres . Left ventricular twist ( LVT ) results from rotation of the apex and base in opposite directions . Although LVT is altered in various cardiac diseases , physiological factors that affect LVT remain incompletely understood . Isometric h and grip testing ( IHGT ) , a well-established laboratory-based technique to increase LV afterload , was performed for 3 min at 40 % maximum force generation in healthy human subjects ( n = 18 , mean age 29.7 ± 2.7 years ) . Speckle-tracking echocardiography was used to measure LV volumes , LV apical and basal rotation , peak systolic LVT and peak early diastolic untwisting rate ( UTR ) at rest and at peak IHGT . IHGT led to significant increase in systemic blood pressure ( systolic , 120.6 ± 9.7 vs. 155.6 ± 14.5 mmHg , P < 0.001 ; diastolic , 67.5 ± 6.4 vs. 94.1 ± 21.1 mmHg , P < 0.001 ) and LV end-systolic volume ( 44.2 ± 7.8 vs. 50.5 ± 10.8 ml , P = 0.005 ) , as well as a significant increase in heart rate ( 62.8 ± 11.7 vs. 84.7 ± 13.8 beats min−1 ; P < 0.001 ) . IHGT produced a significant acute reduction in LV stroke volume ( 63.9 ± 12.0 vs. 49.4 ± 7.8 ml , P < 0.001 ) . In this setting , there was a significant decrease in peak systolic apical rotation ( 11.9 ± 3.0 vs. 8.6 ± 2.2 deg , P < 0.001 ) and a result ant 25 % decrease in peak systolic LVT ( 16.6 ± 2.8 vs. 12.5 ± 2.8 deg , P < 0.001 ) . The magnitude of peak early diastolic UTR did not change ( −114.5 ± 26.4 vs. −110.6 ± 39.8 deg s−1 , P = 0.71 ) . Peak systolic apical rotation and LVT decrease during IHGT in healthy humans . This impairment of LV twist mechanics may in part underlie the LV dysfunction that can occur in the clinical context of acute increase in afterload AIMS To investigate the physiological adaptation of the right ventricle ( RV ) in response to endurance training and to define reference values for regional deformation in the RV in endurance athletes . METHODS AND RESULTS Healthy controls ( n = 61 ) , athletes ( n = 58 ) , and elite athletes ( n = 63 ) were prospect ively enrolled with a training intensity of 2.2 + /- 1.6 , 12.5 + /- 2.3 and 24.2 + /- 5.7 h/week , respectively ( P < 0.001 ) . Conventional echocardiographic parameters , tissue Doppler imaging ( TDI ) , and 2D strain echo (2DSE)-derived velocity , strain , and strain rate ( SR ) were calculated in three RV segments . Left ventricular and RV dimensions were significantly increased ( P < 0.001 ) in both groups of athletes compared with controls . Right ventricular systolic velocities and displacement were not different between the groups . Right ventricular strain and SR values were reduced in the RV basal and mid-segment in athletes . Athletes with marked RV dilatation showed lower strain and SR values in the basal ( -20.9 + /- 4.7 vs. -24.5 + /- 4.9 % , P < 0.001 and -1.23 + /- 0.31 vs. -1.50 + /- 0.33 s(-1 ) , P < 0.001 ) and mid ( -29.3 + /- 5.4 vs. -32.1 + /- 5.3 % , P = 0.017 and -1.58 + /- 0.41 vs. -1.82 + /- 0.42 s(-1 ) , P = 0.009 ) segment , whereas athletes without RV dilatation showed no significant difference compared with the controls . CONCLUSION Regional deformation and deformation rates ( TDI and 2DSE ) are reduced in the basal RV segment in athletes . This phenomenon is most pronounced in athletes with RV dilatation and should be interpreted as normal when evaluating athletes suspected for RV pathology AIMS In individuals who exercise regularly and for extended periods of time , some structural alterations in the heart , called the athlete 's heart , develop in time . These alterations vary in type , can be eccentric or concentric , depending on the nature of exercise . Speckle tracking echocardiography ( STE ) is a novel , angle-independent method that accurately and reliably measures systolic and diastolic functions of the left ventricle ( LV ) with considerably lower inter-operator variability . METHODS AND RESULTS Twenty-two marathon runners , 24 wrestlers , and 20 healthy sedentary individuals were included in the study . The average age of subjects is 17.5 ± 2.2 in marathon runners , 16.8 ± 1.9 in wrestlers , and 16.4 ± 1.8 in control group . The parameters of LV longitudinal strain ( S ) , LV longitudinal strain rate systolic ( SRS ) , LV longitudinal strain rate diastolic early filling ( SRE ) , and longitudinal strain rate diastolic late filling ( SRA ) were evaluated by apical two- , three- , and four-chamber grayscale imaging using the global longitudinal strain ( GLS ) and GLS rate ( GLSR ) . Conventional echocardiographic parameters demonstrated increased LV diameters and wall thickness in the marathon runners and increased wall thickness without increased LV diameters in the wrestlers . Systolic and diastolic functions were comparable between the marathon runners and wrestlers with conventional echocardiography . Analysis with STE , however , yielded higher systolic strain and strain rates in the athletes . Normalized GLS parameters and end-diastolic volume ( EDV ) were shown to be correlated . CONCLUSION Overall , conventional echocardiography can detect some differences between young athletes with eccentric and concentric type of athlete 's heart but it is incapable of revealing differences in intrinsic myocardial functions . However , analysis using STE demonstrated increased systolic functions in athletes commensurate with increased load , with unaltered diastolic functions Aims This study evaluated ( a ) global LV adaption to endurance versus resistance training in male athletes , ( b ) LV assessment using by modern imaging technologies and ( c ) the impact of scaling for body size on LV structural data . Methods A prospect i ve cross-sectional design assessed the LV in 18 elite endurance-trained ( ET ) , 19 elite resistance-trained ( RT ) and 17 sedentary control ( CT ) participants . St and ard 2D , tissue Doppler and speckle tracking echocardiography assessed LV structure and function . Indexing of LV structures to body surface area ( BSA ) was undertaken using ratio and allometric scaling . Results Absolute and scaled LV end-diastolic volume ( ET : 43.7±6.8 ; RT : 34.2±7.4 ; CT 32.5±8.9 mL/m1.5 ; p<0.05 ) and LV mass ( ET : 29.8±6.6 ; RT : 25.4±8.7 ; CT 25.9±6.4 g/m2.7 ; p < 0.05 ) were significantly higher in ET compared with RT and CT . LV wall thickness were not different between ET and RT . 65 % of ET and 95 % of RT had normal geometry . Stroke volume was higher in ET compared with both RT and CT ( p<0.05 ) . Whilst regional tissue velocity data were not different between groups , longitudinal and basal circumferential strain ( ε ) was reduced in RT compared with ET . Conclusions In this comprehensive evaluation of the male athlete 's heart ( AH ) , normal LV geometry was predominant in both athlete groups . In the ET , 30 % demonstrated an eccentric hypertrophy with no concentric hypertrophy in RT . Cardiac ε data in RT require further evaluation , and any interpretation of LV size should appropriately index for differences in body size BACKGROUND The aim of this study was to investigate the systolic and diastolic properties of the right cardiac chambers ( the right ventricle and right atrium ) among different subsets of athletes to unveil potential variations in right ventricular and right atrial remodeling secondary to different training modes . METHODS A cohort of Caucasian male top-level athletes ( n = 108 ; 80 endurance athletes [ EAs ] , mean age , 31.2 ± 10
Output:
| Conclusion Echocardiographic 2D speckle tracking can identify subtle physiological differences in adaptations to cardiac strain and twist mechanics between athletes and healthy controls .
Differences in speckle tracking echocardiography-derived parameters can be identified using suitable sporting categorizations |
MS211914 | ***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: Using a disposable syringe to feed 1 - 14-week-old babies with cleft lip and palate ( CLP ) was studied . 57 CLP babies were r and omly divided into : syringe-fed ( intervention ) and cup- and -spoon-fed groups and compared with 55 normal breast- or bottle-fed babies . Differences in weight gained from birth to 6 , 10 and 14 weeks were compared . Syringe-fed CLP babies fed breast milk had a significant difference in weight gain ( 0.7 and 0.8 kg ) compared with cup- and -spoon-fed babies ( 0.4 kg ) , at 10 and 14 weeks , respectively . Normal breast-fed babies gained 0.6 and 0.7 kg . Cup- and -spoon-fed CLP babies fed artificial and breast milk gained 0.5 and 0.6 kg ; syringe-fed CLP babies gained 0.6 and 1.2 kg . Normal babies gained 1.0 and 1.7 kg for the same age and food . Average feeding times were 10 ml/1.25 min for syringe-fed and 10 ml/2.08 min for cup- and -spoon-fed CLP babies at 6 weeks . 19 ( 100 % ) cup- and -spoon-fed babies exhibited spill and regurgitation at 6 weeks compared with 30 ( 79 % ) CLP syringe-fed babies ( P<0.05 ) . In both groups spill and regurgitation decreased with age . CLP babies fed with the modified method had a faster feeding time , less spill and regurgitation and gained the same weight as normal babies at 10 and 14 weeks It has been a tradition for plastic surgeons to withhold breast feeding from babies after cleft lip repair to prevent wound disruption . A prospect i ve , r and omised trial of 40 infants showed that early postoperative breast feeding after cleft lip repair is safe , results in more weight gain at 6 weeks after surgery ( P < 0.01 ) and is more economical than spoon feeding OBJECTIVE To compare two feeding methods advocated for infants with cleft palate : ( a ) a squeezable plastic container with a narrow , long crosscut nipple ( squeezable cleft palate nurser ) ; and ( b ) a st and ard nipple with a crosscut ( crosscut nipple ) . The effectiveness of a nutrition intervention protocol for these infants was also documented . DESIGN Thirty-one infants ( median age = 15 days ) were r and omized to one of two feeding methods ( 18 infants , squeezable cleft lip/palate nurser ; 13 infants , crosscut nipple ) within sex ( 21 boys , 10 girls ) and palatal defect ( 22 cleft lip and palate , 9 isolated cleft palate ) categories . The intervention included feeding technique instructions , nutrition counseling at each clinic visit , use of the same 20 kcal/oz st and ard formula for 12 months , and introduction of infant and soft table foods at 6 months . Four-day food records and growth data were obtained . MAIN OUTCOME MEASURES Mean energy and protein intakes at 3 and 6 months of age and growth measurements during the first 18 months of life were obtained . STATISTICAL ANALYSES A repeated measures analysis of variance for intakes was performed with time as the repeated measure and feeding method as the covariable . Similar analyses were completed for growth measures with sex and feeding method as covariates . RESULTS Mean energy intake at 3 and 6 months of age ( P = .24 ) and growth measurements during the first 18 months of life ( P values : weight gain [ grams per day ] , .73 ; weight , .21 ; length , .07 ; head circumference , .18 ; triceps and subscapular skinfolds and mid-arm circumference , .47 , .48 , and .69 , respectively ) were not significantly different . Both feeding methods were effective in supporting normal growth . APPLICATIONS With adequate instruction related to the use of either feeding technique and close nutrition follow-up early in infancy , a dietitian or other health care practitioner may advise the use of either feeding method . These data support the need for feeding and nutrition education and early nutrition intervention This prospect i ve study conducted at the Hospital for the Rehabilitation of Craniofacial Anomalies aim ed to compare the best technique - a cup or a spoon - for feeding children immediately after palatoplasty . We assessed 44 children and their caregivers during feeding every 4 hours ; this generated 176 evaluations : 88 using a cup and 88 using a spoon . The Fisher exact test and the Mann-Whitney test were used for statistical analysis , with a significance level of 5 % ( p<0.05 ) . When the spoon was used , the percentage of patients with food escaping through the labial commissure was lower ( 17 % ; p=0.024 , the portion administrated was higher ( 12 % ; p=0.029 ) , and coughing was less frequent ( 13 % ; p=0.026 ) compared with use of a cup . We conclude that using a spoon to administer food after palatoplasty is better than using a cup OBJECTIVE To compare the effectiveness of squeezable and rigid feeding bottles for infants with clefts . DESIGN Patients were r and omly assigned at birth to feeding with a squeezable bottle ( assisted feeding ) or to feeding with a rigid bottle and were followed for 1 year . The data were analyzed on the basis of intention to treat . SETTING The trial was conducted within the existing arrangements for hospital and home care for children with clefts within the National Health Service in the north of Engl and . PATIENTS The patients were 101 consecutively born children with cleft lip and /or palate who were otherwise healthy . All patients completed the trial . Two were excluded from the analysis when unrelated developmental problems became apparent . MAIN OUTCOME MEASURES Anthropometric measures -nude weight , crown-heel length ( CHL ) , and occipito-frontal circumference (OFC)-were recorded . RESULTS There were statistically significant differences between the two groups in weight at 12 months ( p = .038 , with an adjusted mean difference of 0.43 kg ) and in head circumference ( p = .004 with an adjusted mean difference of 0.77 cm ) , indicating increased growth in the squeezable bottle group . The difference in CHL was not significant at conventional levels ( p = .082 ) . Whereas 25 of 52 ( 48 % ) rigid bottles required modification by the health visitor , this was needed for only 4 of 49 ( 8 % ) squeezable bottles . There was a highly significant difference when numbers of modifications for each method were compared ( p < .0001 ) . Despite modifications , six infants feeding with a rigid bottle ( 11 % ) were transferred to a squeezable bottle due to problems with feeding , but none were transferred from squeezable to rigid bottles . Thus , the squeezable bottle generally appeared to be a more satisfactory method , requiring less support or intervention after initial instruction . CONCLUSIONS Both feeding methods achieved similar anthropometric outcomes , with a beneficial effect on head circumference and weight in the assisted feeding group . We recommend that this last observation be treated with caution . The squeezable bottles were easier to use , and we recommend that they be routinely prescribed Objective To evaluate the nutritional status and behavior of the surgical wound following cheiloplasty . Setting Hospital for Rehabilitation of Craniofacial Anomalies , University of São Paulo ( HRAC/USP ) , Bauru , São Paulo , Brazil . Participants Forty-five nursing children aged 3 to 13 months old , either bottle-fed or spoon-fed , su bmi tted to cheiloplasty during the study period . Results The results did not demonstrate significant differences between the study groups regarding gender , age , nutritional status , and condition of the surgical wound . Upon completion of the study , the infants of both groups were eutrophic , presenting increase in growth and development , with no hematoma , significant edema , sutural dehiscence , bleeding , or infection at the operated area . Conclusions Both kinds of nursing , spoon- and bottle-feeding , had the same influence on nutritional status and wound condition in both study groups . We suggest that bottle-feeding should be tried in patients in the postoperative period of cheiloplasty , because this method was used after surgery without causing any damage to the lip surgical wound Although bottle-feeding after cheiloplasty is widely accepted , postoperative feeding regimen after palatoplasty is still controversial . The aim of this prospect i ve r and omized study was to evaluate the effect of bottle-feeding on early postoperative course after palatoplasty in a relatively homogeneous group of patients . Eighty-two consecutive patients with nonsyndromic cleft palate undergoing 2-flap palatoplasty by a single surgeon were r and omized to feeding from a bottle with the usual nipple ( G1 , N = 42 ) or to feeding with a spoon , cup , or syringe ( G2 , N = 40 ) . Complication rates , postoperative sedative use , oral intake for the first 6 days , and relative weight gain at 1 and 2 months were compared . There were no significant complications such as bleeding or respiratory problem . The overall complication rate including wound dehiscence and oronasal fistula was similar in G1 and G2 ( 11.9 % versus 12.5 % , P = 1.000 ) as was postoperative sedative use and mean daily oral intake for the first 5 days . Mean intake on the sixth day was significantly higher in G1 . There were no significant between-group differences in relative weight gain after 1 and 2 months . In conclusion , bottle-feeding had no adverse effect on the early postoperative course after palatoplasty including complication rate , oral intake , and weight gain . These findings suggest that an unrestricted feeding regimen is appropriate immediately after palatoplasty Objective To compare the efficacy of the three feeding techniques commonly used in authors ’ setup in improving the weight gain pattern of children with orofacial cleft . Methods A cohort prospect i ve study was employed . A total sample of 150 infants at the age of 2 mo with cleft of both lip and palate were recruited and followed bimonthly until their first birthday to assess the pattern of weight gain . The subjects were categorized into three groups based on their habitual feeding techniques such as Group I : Paladai fed ; Group II : Bottle fed and Group III : Spoon fed with 50 subjects in each group . The three groups were counseled on nutritional aspects , correct infant positioning and hygienic practice s. Results The mean weight of the Group I subjects was observed to be higher than the other two groups at every visit and was also found to be statistically significant at p < 0.001 . Over all comparison proved that the weight gain of 1.364 ± 0.191 , 1.348 ± 0.284 and 1.450 ± 0.205 and the velocity of weight gain , kg per week of 0.17 ± 0.023 , 0.168 ± 0.035 and 0.181 ± 0.025 of Group I at 4 , 6 and 8th mo respectively were significantly higher than the other two groups ( p < 0.001 ) . Conclusions Of the three feeding techniques adopted by the mothers of infants with orofacial cleft , it was noted that paladai feeding was better than the bottle or spoon-feeding AIMS To determine the effect of nasogastric ( NG ) feeding compared with oral feeding on morphine requirements after primary cleft palate repair , and secondarily on enteral intake . METHODS This was a pilot study involving 50 infants , aged five to ten months , who were r and omised to receive NG or oral feeding after palate repair . All infants received the same anaesthetic and analgesic management . Post-operatively , paracetamol and ibuprofen were administered regularly and intravenous ( IV ) morphine was given on dem and using a nurse-controlled analgesia device . The primary outcome measure was the total morphine consumption in the first 24 hours . Secondary outcome measures included the numbers of painful episodes and the volumes of IV fluid and enteral feed administered . RESULTS Of the 50 infants enrolled , 18 and 23 received either NG or oral feeding , respectively , and completed the study . Numbers of painful episodes and morphine consumption in the first 24 hours were similar in each group . Volumes of feed administered in the first 24 hours were significantly different : the NG group received approximately three times more than the oral group . Nine of the oral group required IV fluids in the 24 hours compared with none in the NG group . CONCLUSION NG feeding was more effective than oral feeding in the first 24 hours after surgery , but numbers of painful episodes recorded were similar . Further research is required
Output:
| Likewise , the post-lip repair studies showed better results with suction methods .
CONCLUSION The studies show that prior to surgical repair , the use of alternative methods can be beneficial .
In the postoperative period following lip repair , methods with suction are more beneficial .
However , in the postoperative period of palatoplasty , there are divergences of opinion regarding the most appropriate feeding methods |
MS211915 | ***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: For clinical trials of acupuncture , it would be desirable to have a sham procedure that is indistinguishable from the real treatment , yet inactive . A sham needle has been design ed which telescopes instead of penetrating the skin . The Park Sham Device involves an improved method of supporting the sham needle and requires validation . The objective of these studies was to test whether the sham procedure using the new device was 1 ) indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and 2 ) inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . The studies were design ed as subject and assessor blind , r and omised controlled trials . Study 1 ) included 58 patients enrolled in a clinical trial of acupuncture for acute stroke . Study 2 ) included 63 healthy , acupuncture naïve , adult volunteers . The interventions used were real or sham acupuncture using the Park Sham Device . Study 1 ) was set in a district general hospital , and study 2 ) in a university laboratory . The outcome measure in study 1 ) was the form of treatment that patients believed they had received . In study 2 ) the outcome measure was experience of de qi , as judged by three acupuncture experts . No patient in either group ( study 1 ) believed he or she had been treated with the sham needle . In 40 volunteers ( study 2 ) for whom experts achieved consensus , the relative risk of experiencing de qi with real acupuncture to that with sham acupuncture was 15.38 ( 95 % CI 2.26 to 104.86 ) . The inter-rater reliability of all 13 experts ( study 2 ) , calculated from their judgements on 10 subjects selected by r and omisation , was 0.52 ( 95 % CI 0.19 to 0.61 ) . In conclusion , the results suggest that the procedure using the new device is indistinguishable from the same procedure using real needles in acupuncture naïve subjects , and is inactive , where the specific needle sensation ( de qi ) is taken as a surrogate measure of activity . It is therefore a valid control for acupuncture trials . The findings also lend support to the existence of de qi , a major concept underlying traditional Chinese acupuncture OBJECTIVE To compare the differences of therapeutic effect in lower limb sensation disorder after lumbar disc herniation operation treated with plum-blossom needle along meridians and Methylcobalamin with oral administration , and explore the best time for plum-blossom needle intervention . METHODS Eighty cases of lower limb sensation disorder caused by nucleus pulposus discectomy of lumbar disc herniation were r and omly divided into a plum-blossom needle group ( 40 cases ) and a western medication group ( 40 cases ) . In plum-blossom needle group , tapping with plum-blossom needle along meridians was received , the meridians located at sensation areas which were dominated by relevant segmental nerve root in operation were selected : the lower limb section of the Spleen Meridian of Foot-Taiyin was selected for operation at L3/L4 ; the lower limb section of the Gall Bladder Meridian of Foot-Shaoyang was selected for operation at L4 /L5 ; the lower limb section of the Bladder Meridian of Foot-Taiyang was selected for operation at L5/S1 ; once treatment was applied every 3 days , and 20 times treatments were applied totally . In western medication group , Methylcobalamin was orally taken for 500 microg , 3 times a day . The recovery of lower limb sensation disorder was evaluated and compared by the comprehensive evaluation method of sensory function of body nerve after 2 months in both groups . RESULTS The total effective rate was 90.0 % ( 36/40 ) in plum-blossom needle group , superior to that of 60.0 % ( 24/40 ) in western medication group ( P < 0.05 ) . In plum-blossom needle group , the effect for the cases which received treatment within one month after operation was superior to that received treatment during 1 - 3 months after operation ( P < 0.05 ) ; and there was no significant differences between the cases which received the treatment during 1 - 3 months after operation and more than 3 months after operation ( P > 0.05 ) . CONCLUSION The therapeutic effect of lower limb sensation disorder after lumbar disc herniation operation treated with plum-blossom needle along meridians is superior to that of Methylcobalamin with oral administration ; the plum-blossom needle intervention within one month after operation can receive the best effect & NA ; Motion style acupuncture treatment ( MSAT ) was more effective for pain relief and functional recovery than diclofenac injection in acute low back pain patients with disability . & NA ; Review s of the efficacy of acupuncture as a treatment for acute low back pain ( aLBP ) have shown that there is insufficient evidence for its effect and that more research is needed . Motion style acupuncture treatment ( MSAT ) is novel in that it requires a part of the patient ’s body to move passively or actively while acupuncture needles are retained . A multicenter , r and omized , comparative effectiveness trial was conducted to evaluate the effects of MSAT in aLBP with severe disability . A total of 58 aLBP patients with severe functional disability ( defined per Oswestry Disability Index [ ODI ] ≥60 % ) were recruited and assigned r and omly to receive 1 session of either conventional diclofenac injection ( n = 29 ) or MSAT ( n = 29 ) . The primary outcome measured improvement in LBP using the 10‐point numerical rating scale of LBP , and the secondary outcome assessed disability using the Oswestry Disability Index at 30 minutes and at 2 , 4 , and 24 weeks after treatment . Analyses were by intention to treat . The numerical rating scale of the MSAT group decreased 3.12 ( 95 % confidence interval = 2.26 , 3.98 ; P < .0001 ) more than that of the injection group and the Oswestry Disability Index of the MSAT group decreased 32.95 % ( 95 % confidence interval = 26.88 , 39.03 ; P < .0001 ) more than that of the injection group , respectively . The difference between the 2 groups maintained statistical significance at 2 and 4 weeks after treatment . These results suggest that MSAT has positive effects on immediate pain relief and the functional recovery of aLBP patients with severe disability Acupuncture is increasingly used , so it is important to establish whether its benefits outweigh its risks . Numerous case reports of adverse events show that acupuncture is not free of risk , but accurate data from prospect i ve investigations is scarce . A prospect i ve survey was undertaken using intensive event monitoring . Forms were developed for reporting minor events each month and significant events as they occurred . The sample size was calculated to identify any adverse events that occurred more frequently than once in 10,000 consultations . Acupuncturists were recruited from two professional organisations in the UK . Seventy-eight acupuncturists , all doctors or physiotherapists , reported a total of 2178 events occurring in 31,822 consultations , an incidence of 684 per 10,000 consultations . The most common minor adverse events were bleeding , needling pain , and aggravation of symptoms ; aggravation was followed by resolution of symptoms in 70 % of cases . There were 43 significant minor adverse events reported , a rate of 14 per 10,000 , of which 13 ( 30 % ) interfered with daily activities . One patient suffered a seizure ( probably reflex anoxic ) during acupuncture , but no adverse event was classified as serious . Avoidable events included forgotten patients , needles left in patients , cellulitis and moxa burns . In conclusion , the incidence of adverse events following acupuncture performed by doctors and physiotherapists can be classified as minimal ; some avoidable events do occur . Acupuncture seems , in skilled h and s , one of the safer forms of medical intervention Management of acute and chronic low back and leg pain often includes the use of acupuncture . The effectiveness of this form of therapy is dependent upon compliance , which in turn is dependent on availability , response , treatment of proper acupoints , and the placebo effect . We hypothesized that classical acupuncture would be more effective than placebo acupuncture . One hundred and thirty-two patients with acute and chronic low back and leg pain were examined before and after surgery for lumbar disc protrusion . Diagnosis was based on CT and MRT findings . Patients received acupuncture drug-free throughout the study period . The visual analogue scale was used to assess pain intensity before and after ( i.e. 30 min . 60 min . 2 h and 6 h ) acupuncture . Classical acupuncture result ed in a significant reduction in pain that become increasingly stronger during the 6h study period . Placebo acupuncture lead to same early pain relief that did not reach statistic significant and then declined thereafter OBJECTIVE This study aim ed to examine the adjuvant effects of auricular acupres-sure in augmenting intravenous patient-controlled analgesia with morphine and droperidol for postoperative lumbar surgery patients in terms of postoperative pain relief satisfaction , and the incidence of postoperative nausea and vomiting ( PONV ) . METHODS In this single-blind experimental study , 94 subjects were r and omly assigned to the experimental group in which patients received auricular acupressure to six auricular acupoints or a control group without acupressure . Data were collected using the American Pain Society Patient Outcome Question naire . Descriptive analyses , t tests , chi(2 ) tests , Mann-Whitney tests , and the generalized estimating equation model were used . RESULTS The experimental group had lower average pain scores than the control group , but no between-group difference was found . Analgesic dose and satisfaction were similar in both groups . The incidence of PONV was low and similar in both groups . CONCLUSION Although this study did not demonstrate adjuvant effects of auricular acupressure on postoperative pain , analgesic dose , analgesic satisfaction and PONV , most subjects were satisfied with the pain management even though they were subjected to moderate pain because of insufficient analgesia . Further studies should reconfirm the effects of auricular acupressure on analgesia provided by intravenous patient-controlled analgesia in postoperative patients , and its influence on the frequency and duration of analgesia administration OBJECTIVE To investigate the clinical effects of acupuncture after surgical operation in patients with prolapse of the lumbar intervertebral disc ( PLID ) . METHODS Sixty-nine patients in this series , who had undergone the removal of nucleus pulposus and the intervertebral fusion as well , were r and omly divided into a treatment group of 35 cases and a control group of 34 cases . The former was treated by acupuncture and conventional rehabilitation therapy , and the latter only by the rehabilitation therapy . The therapeutic effects were evaluated according to the scoring system stipulated by Japanese Orthopedics Association ( JOA ) . RESULTS In the treatment group , the average functional recovery rates in 3-month , 6-month and one-year periods were respectively 49.93 % , 90.31 % and 95.08 % ; while the rates were repesctively 26.24 % , 63.42 % and 71.36 % in the control group , showing statistically significant difference between the two groups ( P<0.05 ) . CONCLUSIONS Acupuncture can confirmatively promote the functional recovery for ' patients with prolapse of the lumbar intervertebral disc after surgical removal of nucleus pulposus and with intervertebral fusion Seventy two patients , from 15 to 60 years old , in good physical status and su bmi tted to surgery in the upper or lower abdominal , rectal or lumbar areas were studied . In the immediate postoperative period , they were r and omly divided in three groups and each group was su bmi tted to one of the following treatments : intravenous meperidine , transcutaneous nerve stimulation ( TNS ) or electroacupuncture ( EA ) . Each treatment was divided in two phases with one hour interval between them . Each phase was constituted of 30 minutes of stimulation in case of TNS and EA and fractionated administration of meperidine in all groups . The pain level was evaluated through a visual analogue scale before and after each phase of treatment . The results were compared among groups and , on each group , between the phases of treatment . In all surgery types , the postoperative pain relief presented by TNS and EA groups of patients was greater than that of meperidine treated group . But , the analgesia presented by the EA treated group of patients lasted longer and increased with the repetition of treatment . The differences of behaviour of TNS and EA analgesia suggest that their neurochemical mechanisms may not be the same OBJECTIVES The purpose of this study was to evaluate the effect of acupoint electrical stimulation with patient-controlled analgesia ( PCA ) on reducing acute pain , nausea , and vomiting after surgery for nontraumatic spinal cord injury . METHODS A r and omized , controlled , repeated measures research design was used . Ninety-nine patients undergoing lumbar spinal surgery were r and omly assigned to one of three groups . Patients in experimental group 1 ( EG1 ) received true acupoint electrical simulation three times , whereas those in experimental group 2 ( EG2 ) received sham acupoint manually . Patients in the control group ( CG ) received no acupoint intervention . All patients were measured for pain , initial dem and for PCA , dem and for opiates , opiate dose , vital signs , and postoperative nausea and vomiting ( PONV ) . RESULTS Significant differences were
Output:
| Our systematic review finds encouraging but limited evidence for the effectiveness of acupuncture treatment for acute postoperative pain after back surgery . |
MS211916 | ***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 Vascular dementia is the second commonest form of dementia , and vascular factors contribute to the development of dementia in many patients with Alzheimer 's disease . Galantamine amplifies the acetylcholine response by inhibiting acetylcholinesterase and modulating nicotinic receptors . It has shown broad , sustained benefits in patients with Alzheimer 's disease . We investigated the effects of galantamine in patients with a diagnosis of probable vascular dementia or Alzheimer 's disease combined with cerebrovascular disease . METHODS Eligible patients were r and omly assigned galantamine 24 mg/day ( n=396 ) or placebo ( n=196 ) in a multicentre , double-blind , 6-month trial . Primary endpoints were cognition ( Alzheimer 's disease assessment scale , cognitive subscale [ ADAS-cog ] ) and global functioning ( clinician 's interview-based impression of change plus caregiver input [ CIBIC-plus ] ) . Secondary endpoints included assessment s of activities of daily living and behavioural symptoms . Patients were monitored for adverse events . Analyses were on the basis of observed case or last observation carried forward . FINDINGS Galantamine showed greater efficacy than placebo on ADAS-cog ( galantamine change -1.7 [ SE 0.4 ] vs placebo 1.0 [ 0.5 ] ; treatment effect 2.7 points ; p<0.0001 ) and CIBIC-plus ( 213 [ 74 % ] vs 95 [ 59 % ] patients remained stable or improved , p=0.0001 ) . Activities of daily living and behavioural symptoms were also significantly improved compared with placebo ( p=0.002 and p=0.016 , respectively ) . Galantamine was well tolerated . INTERPRETATION Galantamine showed a therapeutic effect on all key areas of cognitive and non-cognitive abilities in this group of dementia patients OBJECTIVE To determine the long-term effectiveness of comprehensive support and counseling for spouse-caregivers and families in postponing or preventing nursing home placement of patients with Alzheimer disease ( AD ) . DESIGN R and omized controlled intervention study . SETTING Outpatient research clinic in the New York City metropolitan area . PARTICIPANTS Referred , volunteer sample of 206 spouse-caregivers of AD patients who enrolled in the study during a 3 1/2-year period . All patients were living at home at baseline and had at least 1 relative living in the area . INTERVENTION Caregivers in the treatment group were provided with 6 sessions of individual and family counseling within 4 months of enrollment in the study and were required to join support groups . In addition , counselors were available for further counseling at any time . MAIN OUTCOME MEASURE Time from enrollment of caregivers in the study to placement of the AD patients in a nursing home . RESULTS Using Kaplan-Meier survival analysis , we estimated that the median time ( weighted average of estimates for male and female caregivers ) from baseline to nursing home placement of AD patients was 329 days longer in the treatment group than in the control group ( z=2.29 ; P=.02 ) . The relative risk ( RR ) from a Cox proportional hazard model of nursing home placement ( intent-to-treat estimate ) after adjusting for caregiver sex , patient age , and patient income was 0.65 ( 95 % confidence interval [ CI ] , 0.45 to 0.94 ; P=.02 ) , indicating that caregivers were approximately two thirds as likely to place their spouses in nursing homes at any point in time if they were in the treatment group than if they were in the control group . Treatment had the greatest effect on risk of placement for patients who were mildly demented ( RR , 0.18 ; 95 % CI , 0.04 to 0.77 ) or moderately demented ( RR , 0.38 ; 95 % CI , 0.17 to 0.82 ) . CONCLUSIONS A program of counseling and support can substantially increase the time spouse-caregivers are able to care for AD patients at home , particularly during the early to middle stages of dementia when nursing home placement is generally least appropriate Spouse-caregivers of Alzheimer 's disease patients were r and omly assigned to either a treatment group ( individual and family counseling , support group participation , and ad hoc consultation ) or a control group ( only routine support ) . In the first year after intake , the treatment group had less than half as many nursing home placements as the control group . This suggests that a comprehensive counseling program can reduce the socioeconomic impact of Alzheimer 's disease . Nursing home placement also was affected by the patient 's need for assistance with activities of daily living , patient income , and the age of the patients and caregivers BACKGROUND The purpose of this study was to evaluate the utility ( i.e. , positive and negative predictive value ) of the 7 Minute Screen in identifying patients with probable Alzheimer 's disease ( AD ) in a primary care practice . A second objective was to estimate the number of undiagnosed AD patients in a typical primary care practice . METHODS One hundred thirty-seven successive admissions ( 96 % ) of patients over the age of 60 to a primary care practice over a 53-day period who completed informed consent documents were administered the 7 Minute Screen . All patients who screened positive ( n = 13 ) and a r and om sample of those who screened negative ( n = 26 ) returned for full diagnostic evaluation . Positive predictive value ( PPV ) and negative predictive value ( NPV ) of the 7 Minute Screen were determined using the criterion st and ard of clinical diagnosis established by examination , history , and laboratory studies . Test-retest reliability and time for administration were also determined . RESULTS Of the 137 patients evaluated , 13 screened positive and 124 screened negative . Eleven of the 13 patients who screened positive were willing to return to the primary care practice for follow-up evaluation . A r and om sample of 26 patients who screened negative all agreed to return for follow-up evaluation . Of the 11 patients who screened positive and who returned for evaluation , 10 were subsequently diagnosed with probable AD . The remaining patient was diagnosed with mixed dementia . The caregivers of the two patients who refused to return were contacted and both indicated that the patients were having significant cognitive problems as verified by an activities of daily living scale . Of the 26 patients who screened negative , 25 were judged to be cognitively normal and the 26th was judged to have mild cognitive impairment . DISCUSSION In successive admissions of patients over the age of 60 in a primary care practice , the 7 Minute Screen showed a PPV of 91 % and an NPV of 96 % in identifying patients who were subsequently identified with AD or other dementing disorder . These data suggest that this may be a useful instrument in identifying patients who should undergo diagnostic evaluation for AD and other dementing disorders . Additionally , extrapolation from the data in this practice suggests that there may be between 75 and 100 AD patients in the typical primary care practice , many of whom may not be diagnosed We studied 56 subjects , 30 patients with a clinical diagnosis of Alzheimer ’s disease ( AD ) and 26 healthy controls , using two telephone screens for cognitive impairment , a self-report interview referred to as the TELE and the Telephone Interview for Cognitive Status ( TICS ) . The sensitivity and specificity of the TELE to differentiate AD patients from healthy controls was 90.0 and 88.5 % and those of the TICS were 86.7 and 88.5 % , respectively . When receiver operator characteristic curves were constructed , the area under the curve for the TELE was 96.0 % ( SE 2.4 % ) and for the TICS 90.3 % ( SE 4.2 % ) . Pearson ’s correlation between the TELE and the Mini-Mental State Examination ( MMSE ) was 0.87 ( p < 0.0001 ) and between the TICS and the MMSE 0.86 ( p < 0.0001 ) . The correlation between the TELE and the sum of the boxes of the Clinical Dementia Rating scale ( CDR-SB ) was –0.71 ( p < 0.0001 ) and –0.75 between the TICS and the CDR-SB ( p < 0.0001 ) . These results indicate that both screens are sensitive and specific instruments for differentiating AD patients from healthy controls and have a strong correlation with face-to-face measures of cognitive function Among the psychiatric illnesses associated with old age primary degenerative dementia of the Alzheimer type ( DAT ) has gained increasing importance in recent years . Even though a curative treatment of the disease is currently impossible , various drugs can be used to slow down its progression . In the present study the influence of oral treatment with 240 mg/day of Ginkgo biloba special extract EGb 761 ( Tebonin ® forte , manufactured by Dr. Willmar Schwabe , Karlsruhe ) on the clinical course of DAT was investigated in a double-blind , r and omized , placebo-controlled parallel-group design in 20 out patients . The duration of treatment was 3 months . The primary outcome variable was the sum score in the SKT-test for the determination of attention and memory . Other psychometric tests ( trailmaking test , ADAS , CGI ) and electrophysiological investigations ( EEG topography ) were evaluated descriptively . Although the active-treatment group , with a mean sum score of 19.67 points in the S.K.T. , had a poorer baseline level than the placebo group ( 18.11 points ) , it experienced an improvement to 16.78 points under treatment with EGb 761 whereas the placebo group deteriorated to 18.89 points . The differences between the baseline and final values formed the basis for a statistical group comparison , which gave a result favourable to EGb 761 , at a significance level of p < .013 . In addition to this psychometric confirmation of efficacy , certain descriptive trends were found at the psychopathological ( Clinical Global Impression ) and dynamic functional ( EEG findings ) levels , which can be interpreted as evidence of effectiveness of Ginkgo biloba special extract EGb 761 in mild to moderate dementia and of local effects in the central nervous system . Inter-group differences in the ADAS cognitive and non-cognitive subscales did not reach statistical significance , probably because of the small sample size OBJECTIVE To determine the efficacy of donepezil hydrochloride for the treatment of Alzheimer disease in patients drawn from clinical practice . DESIGN Two-center , r and omized , placebo-controlled , double-masked crossover study . SETTING Memory disorders units at Massachusetts General and Brigham and Women 's hospitals , Boston . PATIENTS Sixty individuals ( 30 men and 30 women ; mean + /- SD age , 75.0+/-9.5 years ) with probable Alzheimer disease and scores of 20 or less on the information-memory-concentration subscale of the Blessed Dementia Scale . INTERVENTIONS Placebo wash-in , followed in r and omized sequence by ( 1 ) donepezil hydrochloride therapy , 5 mg/d , for 6 weeks , followed by placebo washout for 6 weeks and ( 2 ) placebo treatment for 6 weeks . PRIMARY OUTCOME MEASURE Change in Alzheimer 's Disease Assessment Scale cognitive subscale scores from the beginning to the end of the two 6-week treatment periods . RESULTS Among patients completing treatment and testing for both periods ( n = 48 ) , subscale scores improved ( mean + /- SEM ) 2.17+/-0.98 points ( 95 % confidence interval , 0.20 - 4.10 points ) during donepezil therapy relative to placebo therapy ( P = .04 ) . Scores returned toward baseline within 3 weeks of drug washout . There was no associated change in caregiver-rated global impression ( donepezil vs placebo : proportion improved , 0.24 vs 0.22 ; proportion worsened , 0.27 vs 0.35 ; P = .34 ) or on specific tests of explicit memory or verbal fluency . Contrary to studies with tacrine , the presence of the apolipoprotein E epsilon4 allele did not predict donepezil treatment failure . Most common adverse events related to donepezil therapy were nausea ( 5 patients ) , diarrhea ( 3 patients ) , and agitation ( 3 patients ) . Serious events possibly related to drug use were seizure , pancreatitis , and syncope ( 1 patient each ) . CONCLUSION This independent confirmation of data from phase 3 trials suggests that donepezil therapy modestly improves cognition in patients with Alzheimer disease who are encountered in clinical practice Dementia induces morbidity not only in the patients but also in the families taking care of them . Many studies described the impact of care-giving on physical and psychological health . Support groups were design ed to alleviate the burden of care-givers . The objective of this study was to measure the efficacy of a support group programme for care-givers of demented patients in the community . Forty-one primary care-givers were r and omly assigned to a study ( n=23 ) or a control group ( n=18 ) . Subjects of the study group attended a structured programme of eight 2-h sessions . These weekly sessions consisted of information on the disease , role-playing on management of behavior problems , discussion on emotional impact of care-giving , and learning of stress management techniques . Subjects of the control group were referred to informal monthly meetings of the Alzheimer 's Society . Subjects of both groups were evaluated at the entry ( T1 ) , after 8 weeks ( T2 ) and after 8 months ( T
Output:
| For patients , it leads to increased dependency and complicates other comorbid conditions .
Results The best evidence for or against screening for dementia would be derived from a well- design ed RCT of screening with health outcomes .
New screening in primary care practice could therefore potentially double the number of patients who receive a diagnosis of dementia . |
MS211917 | ***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: Epidemiologic data on local complications after breast augmentation are scarce . In particular , few prospect ively collected data are available on modern breast implants on this issue . Using data from the Danish Registry for Plastic Surgery of the Breast , the authors examined determinants of surgery-requiring complications and capsular contracture grade s III to IV among 2277 women who underwent cosmetic breast implantation from June 1999 through April 2003 . During an average follow-up period of 1.6 years after implantation , 4.3 % of these women ( 3 % of implants ) required secondary surgery as a result of short-term complications . The most frequent clinical indications for surgery were displacement of the implant ( 38 % ) , capsular contracture grade s III to IV ( 16 % ) , ptosis ( 13 % ) , and hematoma ( 11 % ) . Overall , the authors found that inframammary incision and subgl and ular placement were associated with decreased risks of developing complications requiring surgical intervention , whereas implants larger than 350 mL increased the risk of such complications ( relative risk [ RR ] , 2.3 ; 95 % confidence interval [ CI ] , 1.3–4.0 ) . Thirty-nine Baker III to IV capsular contractures were identified , of which 22 were treated surgically within the study period . Submuscular placement of the implant decreased the risk of capsular contracture grade s III to IV ( RR , 0.3 ; 95 % CI , 0.2–0.8 ) , whereas surgical routes other than inframammary and drainage of implant cavity were associated with increased risk of capsular contracture . Current surgical practice s and modern implants used for breast augmentation produce fewer short-term complications than procedures and devices of the past . This prospect i ve study indicates that surgical procedures are more important predictors for local ( short-term ) complications than implant or patient characteristics Background : The role of prophylactic antibiotics in reduction mammaplasty remains controversial . However , most surgeons choose to use antibiotics . In addition to cost and potential allergic reactions , unnecessary administration of antibiotics can suppress host natural flora and produce resistant organisms . Methods : Fifty patients were sequentially assigned to one of three study limbs : ( 1 ) no antibiotics , ( 2 ) preoperative antibiotics only , or ( 3 ) preoperative and postoperative antibiotics . The study was design ed to include approximately 17 patients in each group . Cephalosporin antibiotics were used unless there was any question of allergy , in which case an alternative antibiotic regimen was used . Preoperative data collected on patients included age , body mass index , history of diabetes mellitus , peripheral vascular disease , previous breast surgery , steroid therapy , and tobacco use . Operative data included specimen weight , operative time , estimated blood loss , prolonged intraoperative hypotension , adjunctive axillary and breast tail liposuction , and intraoperative breast tissue culture . Results : The patient population in the three limbs of the study was similar . Thus , there was no significant difference among the groups insofar as the preoperative data were concerned ( p > 0.20 ) : age , body mass index , diabetes mellitus , peripheral vascular disease , previous breast surgery , and steroid or tobacco use . Furthermore , no significant difference ( p > 0.12 ) was noted among intraoperative data in the three groups : specimen weight , operative time , estimated blood loss , prolonged hypotension , adjunctive breast liposuction , and positive bacterial culture from intraoperative breast tissue sample s. Ninety percent of positive intraoperative breast tissue cultures revealed Staphylococcus epidermidis . Using strict criteria , the infection rate ranged from 19 to 20 percent . There was no significant difference ( p > 0.91 ) in rate of infection among the three study limbs . There was , however , a significant reduction ( p = 0.002 ) in delayed wound healing in the group that received preoperative antibiotics only . Among the studied risk factors for infection , only positive intraoperative culture of breast tissue was significant ( p = 0.008 ) for development of infection . There was a significant association between delayed wound healing and infection ( p = 0.003 ) . Conclusions : This prospect i ve study did not find that prophylactic antibiotics in reduction mammaplasty have an effect on infection ; however , a single preoperative dose significantly improved wound healing Over a 9-month period from September of 1991 to May of 1992 , 339 patients were included in a r and omized , double-blind , placebo-controlled study using azithromycin as the prophylactic agent to determine whether it effects a clinical ly meaningful reduction in postoperative surgical infections in plastic surgery . Azithromycin was given as prophylaxis in 171 patients and placebo in 168 patients . The study medication was a single oral dose taken at 8 P.M. the day before surgery . The patients were followed up for a minimum of 4 weeks after surgery . The patients who received wound infection prophylaxis had 5.1 percent infections compared with 20.5 percent in the placebo group ( p = 0.00009 ) . Eighty percent of all wound infections were first seen after discharge , explaining why plastic surgeons might overlook their infectious complications . There was a significant reduction in postoperative complications ( p = 0.04 ) and in the additional use of antibiotics postoperatively ( p = 0.007 ) in the prophylaxis group . Subgroup analysis showed a significant reduction in surgical infections in breast surgery ( p < 0.05 ) and reconstructive surgery with flaps ( p < 0.05 ) . No effect of the prophylactic regime was demonstrated in patients undergoing secondary surgery for cleft lip and palate disease This prospect i ve study was conducted to assess the influence of antibiotics use on surgical site infections ( SSI ) rates after reduction mammaplasty . Patients undergoing reduction mammaplasty were assigned to group 1 ( n = 50 ) , which received intravenous cephalotin pre- and postoperatively , besides oral cephalexin for 6 days after discharge , or to group 2 ( n = 50 ) , which received no antibiotics . Patients were followed up weekly for 30 days , regarding to SSI , by a blinded surgeon . The Centers for Disease Control and Prevention definitions and classification of SSI were adopted . There was no statistical difference between the groups in regard to age , body mass index , duration of operation , and total resection weight . SSI rates were 2 % and 14 % in groups 1 and 2 , respectively ( P = 0.03 ) . In group 2 , older patients and those with higher resection weight had significant higher SSI rates ( P = 0.02 and P = 0.04 , respectively ) . We observed that antibiotics use decreased SSI rates after reduction mammaplasty The use of prophylactic antibiotics in reduction mammoplasty has been r and om and its efficacy unproven . This study review ed 106 consecutive inferior pedicle technique reduction mammoplasties . Two groups were identified ; 47 patients received prophylactic antibiotics and 59 patients did not . The decision of who received prophylactic antibiotics was r and om based on resident rotation and resident preoperative orders . The demographics were equal between the antibiotic group and the control group . The wound infection rate and the rate of delayed healing were examined in both groups . There were no statistically significant differences in the infection rate or the rate of delayed wound healing in either the antibiotic group or the control group . Individual risk factors were also studied in each group . These risk factors included obesity , older age , smoking history , and large reductions . The use of prophylactic antibiotics did not reduce the infection rate in any of these high-risk groups . Comparing the individual risk factors for the remainder of the patient population showed that the infection rate was higher in obese patients but was unaffected by prophylactic antibiotics . Delayed healing was also higher in larger reductions but also was unaffected by the use of prophylactic antibiotics . We conclude that the use of prophylactic antibiotics in reduction mammoplasty is not efficacious in reducing the rate of wound infection or delayed healing The main drawback with augmentation mammaplasty using implants is capsular contracture . The cause of this complication is still unknown . Silicone particles , hematoma , and bacterial contamination are some of the etiologic factors discussed . In this r and omized , double-blind study on 76 breast-augmented women , 50 percent of the patients had preoperative prophylaxis with benzylpeni-cillin and dicloxacillin . Bacteria sample s were taken intra-operatively . The number of negative cultures increased significantly with antibiotic prophylaxis . In four follow-ups during the first postoperative year , the rate of contractures was evaluated by subjective and objective methods . The results showed no statistically significant difference between the placebo and the antibiotic group with respect to the incidence of capsular contracture In a prospect i ve , r and om , double-blind , and concurrently controlled clinical study of 124 patients having augmentation mammaplasty , using multiple independent subjective judges as well as objective compressibility measurements , the use of a variety of local antibacterials in or around inflatable retromammary prosthetic implants reduced the early postoperative onset of class III to IV capsular contracture by sevenfold ( 85 percent ) and the final incidence by more than half ( 50 percent ) ( p < 0.01 ) . We believe this study provides the most unequivocal evidence to date that the cause of capsular contracture in retromammary augmentation is periprosthetic bacterial contamination . Irrigation with a 5 percent povidone-iodine ( 50 percent Betadine ) solution was as effective as other techniques and is currently our procedure of choice We assessed the efficacy of perioperative antibiotic prophylaxis for surgery in a r and omized , double-blind trial of 1218 patients undergoing herniorrhaphy or surgery involving the breast , including excision of a breast mass , mastectomy , reduction mammoplasty , and axillary-node dissection . The prophylactic regimen was a single dose of cefonicid ( 1 g intravenously ) administered approximately half an hour before surgery . The patients were followed up for four to six weeks after surgery . Blinding was maintained until the last patient completed the follow-up and all diagnoses of infection had been made . The patients who received prophylaxis had 48 percent fewer probable or definite infections than those who did not ( Mantel-Haenszel risk ratio , 0.52 ; 95 percent confidence interval , 0.32 to 0.84 ; P = 0.01 ) . For patients undergoing a procedure involving the breast , infection occurred in 6.6 percent of the cefonicid recipients ( 20 of 303 ) and 12.2 percent of the placebo recipients ( 37 of 303 ) ; for those undergoing herniorrhaphy , infection occurred in 2.3 percent of the cefonicid recipients ( 7 of 301 ) and 4.2 percent of the placebo recipients ( 13 of 311 ) . There were comparable reductions in the numbers of definite wound infections ( Mantel-Haenszel risk ratio , 0.49 ) , wounds that drained pus ( risk ratio , 0.43 ) , Staphylococcus aureus wound isolates ( risk ratio , 0.49 ) , and urinary tract infections ( risk ratio , 0.40 ) . There were also comparable reductions in the need for postoperative antibiotic therapy , non-routine visits to a physician for problems involving wound healing , incision and drainage procedures , and readmission because of problems with wound healing . We conclude that perioperative antibiotic prophylaxis with cefonicid is useful for herniorrhaphy and certain types of breast surgery The aim of this r and omized clinical trial was to determine whether a single intravenous dose of 2 g flucloxacillin could prevent wound infection after primary non‐reconstructive breast surgery
Output:
| In cases of reduction mammaplasty , when antibiotics are administered as a single preoperative dose , the risk of developing surgical-site infection is halved .
With augmentation mammaplasty , there was no effect on infection rates with any antibiotic regimen .
For augmentation mammaplasty , there is no evidence to refute current guidelines , based on recommendations obtained from other forms of implant surgery . |
MS211918 | ***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 Ablative therapy is increasing for the management of small renal masses . Laparoscopic as well as percutaneous cryotherapy and radiofrequency ablation ( RFA ) have been utilized . Herein we review our experience with renal biopsy immediately prior to laparoscopic RFA . METHODS AND MATERIAL S A prospect ively collected data base containing all patients who underwent laparoscopic RFA by three different surgeons at two different institutions was review ed . Renal biopsies were performed in each patient during transperitoneal laparoscopy after mobilization of the kidney and prior to RFA . The biopsy needle was passed percutaneously via a sheath through the abdominal wall . Multiple core biopsies ( 3 - 5 ) were taken under visual and ultrasonic guidance . All were su bmi tted for permanent pathologic sectioning . RESULTS 138 patients underwent renal biopsy prior to RFA . Mean tumor size was 3.0 cm ( range 1.0 - 6.9 ) . The mean age was 72 years ( range 39 - 90 ) . There were 42 females and 96 males . Mean blood loss was 28 ml ( 0 - 400 ml ) . Only 5 patients lost more than 50 ml , and in each case the bleeding was associated with complicated renal mobilization and dissection prior to biopsy . Final pathology revealed renal cell carcinoma in 95 , oncocytic neoplasm in 26 , and angiomyolipoma in 9.8 patients were considered to have nondiagnostic biopsies . In this group , final pathology revealed benign cysts in 3 , inconclusive specimens in 3 , fibrosis in 1 , and normal tissue in 1 . Hence , a clear diagnosis was possible in 130 of 138 patients , which is 94.2 % . RCC was diagnosed in 68.8 % of the patients , and in 73.1 % of the conclusive biopsies . Eight patients had perioperative complications , including low- grade fevers ( 2 ) perirenal/retroperitonal hematoma ( 2 ) , pleural tear/pneumothorax ( 2 ) , CHF exacerbation , and wound infection . CONCLUSIONS In our multicenter experience , renal biopsy of 138 renal lesions at the time of laparoscopic RFA had a diagnostic yield of 94.2 % . RCC was diagnosed in 68.8 % of the patients , and in 73.1 % of the conclusive biopsies BACKGROUND Besides clinical tumour size , other anatomical aspects of the renal tumour are routinely considered when evaluating the feasibility of elective nephron-sparing surgery ( NSS ) . OBJECTIVE To propose an original , st and ardised classification of renal tumours suitable for NSS based on their anatomical features and size and to evaluate the ability of this classification to predict the risk of overall complications result ing from the surgery . DESIGN , SETTING , AND PARTICIPANTS We enrolled prospect ively 164 consecutive patients who underwent NSS for renal tumours at a tertiary academic referral centre from January 2007 to December 2008 . INTERVENTION Open partial nephrectomy without vessel clamping . MEASUREMENTS All tumours were classified by integrating size with the following anatomical features : anterior or posterior face , longitudinal , and rim tumour location ; tumour relationships with renal sinus or urinary collecting system ; and percentage of tumour deepening into the kidney . We generated an algorithm evaluating each anatomical parameter and tumour size ( the preoperative aspects and dimensions used for an anatomical [ PADUA ] score ) to predict the risk of complications . RESULTS AND LIMITATIONS Overall rates of complication were significantly correlated to all the evaluated anatomical aspects , excluding clinical size and anterior or posterior location of the tumour . By multivariate analysis , PADUA scores were independent predictors of the occurrence of any grade complications ( hazard ratio [ HR ] for score 8 - 9 vs 6 - 7 : 14.535 ; HR for score ≥10 vs 6 - 7 : 30.641 ) . Potential limitations were the limited number of patients with T1b tumours included in the study and the lack of laparoscopically treated patients . Further external validation of the PADUA score is needed . CONCLUSIONS The PADUA score is a simple anatomical system that can be used to predict the risk of surgical and medical perioperative complications in patients undergoing open NSS . The use of an appropriate score can help clinicians stratify patients suitable for NSS into subgroups with different complication risks and can help research ers evaluate the real comparability among patients undergoing NSS with different surgical approaches PURPOSE The majority of cytogenetic studies in renal cell carcinoma ( RCC ) have been impaired by small sample size , retrospective character , and lack of a survival end point . We prospect ively studied the prognostic impact of cytogenetic abnormalities on a larger cohort of patients having up to 108 months of follow-up . PATIENTS AND METHODS Tumors of 282 patients who underwent nephrectomy for clear cell RCC were cytogenetically analyzed . Results were correlated with pathological factors and disease-specific survival . RESULTS The most frequently observed cytogenetic abnormalities were loss of 3p ( 60 % ) , gain of 5q ( 33 % ) , loss of 14q ( 28 % ) , trisomy 7 ( 26 % ) , loss of 8p ( 20 % ) , loss of 6q ( 17 % ) , loss of 9p ( 16 % ) , loss of 4p ( 13 % ) , and loss of chromosome Y in men ( 55 % ) . Tumors with loss of 3p presented at lower TNM stages . Loss of 4p , 9p , and 14q were all associated with higher TNM stages , higher grade , and greater tumor size . A deletion of 3p was associated with better prognosis ( P = .03 ) , while loss of 4p ( P < .001 ) , loss of 9p ( P < .01 ) , and loss of 14q ( P < .01 ) were each associated with worse prognosis . Loss of the Y chromosome led to improved progression-free survival in metastatic patients ( P = .02 ) . In multivariate analysis , loss of 9p was retained as an independent prognostic factor . CONCLUSION This cytogenetic study serves as a proof of principal that genetic information , such as loss of chromosome 9 , can be obtained from widely available technology , and can provide additional prognostic information to st and ard clinicopathologic variables PURPOSE We review our single center experience in the management of renal angiomyolipoma ( AML ) in patients who were treated with active surveillance ( AS ) or invasive treatment protocol s. PATIENTS AND METHODS A prospect ively evaluated data base was review ed , and we identified 91 patients with the diagnosis of renal AML who presented between June 1985 and February 2009 . Patient characteristics , clinical presentation , treatment modalities , and patient outcomes were evaluated . Patients on AS were analyzed for successful completion of the surveillance protocol considering age , symptomatic presentation , and tumor size as potential predictors of invasive treatment . RESULTS A total of 91 patients with AMLs were identified . The mean patient age was 57 years . Seventy-three ( 83.9 % ) patients presented incidentally , and 14 ( 16 % ) patients were symptomatic at presentation . Forty-five patients were treated with AS , 4 underwent embolization , and 38 patients had extirpative surgery . After a median follow-up of 54.8 months ( range 0.2 - 211.7 mos ) , there was a mean growth rate of 0.088 cm/year in the group who were treated with AS . AS failed in three patients . Two patients had retroperitoneal bleeding during the observation period , and one patient manifested an expeditious growth rate of 0.7 cm/year and underwent a radical nephrectomy . CONCLUSIONS AML is a renal tumor that usually exhibits a benign course . Surgical removal and embolization are the st and ard invasive treatment modalities . AS for AMLs is associated with a slow and consistent growth rate ( 0.088 cm/year ) , typically has minimal morbidity , and is a reasonable option in selected patients . Symptomatic presentation and size ( > 3 cm ) are not predictive for necessitating an invasive procedure BACKGROUND Most early stage kidney cancers are renal cell carcinomas ( RCCs ) , and most are diagnosed incidentally by imaging as small renal masses ( SRMs ) . Indirect evidence suggests that most small RCCs grow slowly and rarely metastasize . OBJECTIVE To determine the progression and growth rates for newly diagnosed SRMs stratified by needle core biopsy pathology . DESIGN , SETTING , AND PARTICIPANTS A multicenter prospect i ve phase 2 clinical trial of active surveillance of 209 SRMs in 178 elderly and /or infirm patients was conducted from 2004 until 2009 with treatment delayed until progression . INTERVENTION Patients underwent serial imaging and needle core biopsies . MEASUREMENTS We measured rates of change in tumor diameter ( growth measured by imaging ) and progression to ≥ 4 cm , doubling of tumor volume , or metastasis with histology on biopsy . RESULTS AND LIMITATIONS Local progression occurred in 25 patients ( 12 % ) , plus 2 progressed with metastases ( 1.1 % ) . Of the 178 subjects with 209 SRMs , 127 with 151 SRMs had>12 mo of follow-up with two or more images , with a mean follow-up of 28 mo . Their tumor diameters increased by an average of 0.13 cm/yr . Needle core biopsy in 101 SRMs demonstrated that the presence of RCC did not significantly change growth rate . Limitations included no central review of imaging and pathology and a short follow-up . CONCLUSIONS This is the first SRM active surveillance study to correlate growth with histology prospect ively . In the first 2 yr , the rate of local progression to higher stage is low , and metastases are rare . SRMs appear to grow very slowly , even if biopsy proven to be RCC . Many patients with SRMs can therefore be initially managed conservatively with serial imaging , avoiding the morbidity of surgical or ablative treatment Purpose Exploratory subgroup analyses from the phase 3 global advanced renal cell carcinoma ( ARCC ) trial were conducted to assess the influence of tumor histology on outcome of patients treated with temsirolimus ( Torisel ™ ) or interferon-α ( IFN ) . Patients and methods Patients with ARCC including clear cell and other types such as papillary and chromophobe histologies received either IFN ( 3 million units [ MU ] subcutaneously three times weekly , escalating to 18 MU ) or temsirolimus ( 25 mg intravenously weekly ) . Results Approximately 80 % of patients had clear cell and 20 % of patients had other histologies , the majority of which were papillary . Patients with clear cell and other RCC histologies , treated with temsirolimus , demonstrated comparable median overall and progression-free survival . In contrast , patients with other RCC histologies , treated with IFN , demonstrated shorter median overall and progression-free survival than patients with clear cell RCC . Hazard ratios for death for treatment with temsirolimus versus IFN were less than 1 for patients regardless of tumor histology . For patients treated with temsirolimus , 59 % with clear cell and 68 % with other RCC histologies experienced tumor reductions . For patients treated with IFN , 35 % with clear cell and 14 % with other RCC histologies had tumor reductions . However , temsirolimus did not appear to improve the objective response rate compared to IFN . Temsirolimus result ed in a superior clinical benefit rate compared with IFN , regardless of tumor histology . Conclusion Temsirolimus appears to be efficacious in patients with clear cell and non-clear cell histologies and can , therefore , be used for the treatment of all types of RCC PURPOSE We present 5 to 11-year ( median 8) oncological outcomes after laparoscopic renal cryoablation . MATERIAL S AND METHODS Between September 1997 and October 2008 we performed renal cryoablation in 340 patients , of whom 80 treated laparoscopically by a single surgeon before October 2003 had a minimum 5-year followup . Followup involved magnetic resonance imaging on postoperative day 1 , at 3 , 6 and 12 months , and annually thereafter . Cryolesion biopsy was performed at 6 months . All data were prospect ively accrued . RESULTS In the 80 patients with minimum 5-year followup mean age was 66 years , mean tumor size was 2.3 cm ( range 0.9 to 5.0 ) , median American Society of Anesthesiologists score was 3 and mean body mass index was 28 kg/m(2 ) . Five patients had local recurrence , 2 had locoregional recurrence with metastasis and 4 had distant metastasis without locoregional recurrence . Six patients died of cancer . In the 55 patients with biopsy proven renal cell cancer at a median followup of 93 months ( range 60 to 132 ) 5-year overall , disease specific and disease-free survival rates were 84 % , 92 % and 81 % , and 10-year rates were 51 % , 83 % and 78 % , respectively . On multivariate analysis previous radical
Output:
| Percutaneous biopsy for diagnostic assessment of SRMs can avoid unnecessary surgeries and support treatment decisions , especially in patients at high surgical risk .
Biopsies can confirm histologic success after thermal ablation of SRMs and support the selection of the appropriate systemic therapy for metastatic RCC .
There is increasing evidence that further diagnostic and prognostic information can be obtained from renal tumour biopsies with the use of immunohistochemistry , cytogenetic and molecular analysis , and high-throughput gene expression profiling . |
MS211919 | ***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 OBJECTIVES Optical coherence tomography ( OCT ) permits high-resolution imaging of tissue subsurfaces up to 2 mm in depth . The purpose of this study was to evaluate the accuracy and reproducibility of OCT in the characterization of cervical intraepithelial neoplasia ( CIN ) and to distinguish between different CIN grade s. STUDY DESIGN / MATERIAL S AND METHODS Colposcopy-guided OCT images were taken from unsuspicious and suspicious areas in women with suspected CIN . Each woman then underwent directed biopsies . All OCT images were separately evaluated by two blinded investigators and later compared to the corresponding histology based on a 6- grade classification ( normal , inflammation , CIN 1 , CIN 2 , CIN 3 , squamous carcinoma ) . Sensitivity and specificity of OCT in detecting CIN were determined . To assess the interobserver agreement , kappa coefficients were calculated from the ratings of each investigator for each OCT image seen . RESULTS A total of 210 OCT images were compared with the corresponding histology in 120 women undergoing colposcopy for suspected CIN . Sensitivity calculated for both investigators was 98 % and 96 % respectively with the threshold at CIN1 and 86 % and 84 % respectively with the threshold at CIN2 . Thirty nine ( 38 ) false positive results reduced the specificity to 39 % and 41 % respectively with the threshold at CIN1 . Defining the threshold at CIN2 the specificity increased to 64 % and 60 % respectively . Unweighted kappa from a dichotomous classification with the threshold at CIN1 was 0.69 ( 95 % CI , 0.54 - 0.84 ) and 0.62 ( 95 % CI , 0.51 - 0.73 ) with the threshold at CIN2 . CONCLUSION OCT is highly sensitive in identifying pre-invasive and invasive cancer of the uterine cervix . Improvements in resolution and the development of new light sources and optics may improve the specificity as well as the differentiation of cervical dysplasia . The interobserver agreement was substantial OBJECTIVE To assess whether the use of a novel optical detection system ( ODS ) as an adjunct to colposcopy increases the detection of biopsy-confirmed CIN 2,3 . METHODS This is a multicenter two-arm r and omized trial comparing colposcopy alone with colposcopy plus a pre-commercial ODS system that utilizes fluorescence , white light tissue reflectance , and cervical video imaging . Patients were recruited from 13 colposcopy clinics in a variety of practice setting s. 2299 women referred for the evaluation of an abnormal cervical cytology were r and omized with stratification by cytology ; subsequently 113 women were excluded for a variety of reasons . The main study outcomes were differences in true-positive rates ( CIN 2,3 and cancer identified ) and false-positive rates between the study arms . RESULTS The true-positive ( TP ) rates were 14.4 % vs. 11.4 % ( p=0.035 , one-sided ) for the combined colposcopy and ODS arm compared to colposcopy-only arm , respectively , in women with either an atypical squamous cell ( ASC ) or low- grade squamous intraepithelial lesion ( LSIL ) cytology result . TP rates were similar between the two arms among women referred for the evaluation of HSIL . The 26.5 % gain in true-positives observed with the use of ODS and colposcopy among women referred for an ASC or LSIL cytology was achieved with only a fractional increase in number of biopsies obtained per patient ( 0.30 ) and a modest increase in false-positive rate ( 4 % ) . In the combined colposcopy and ODS arm among women with ASC or LSIL , the PPV of biopsies indicated by ODS was 15.0 % and the PPV of biopsies indicated by colposcopy was 15.2 % . Joint hypothesis testing indicates that ODS and colposcopy provides benefit compared to colposcopy alone among women with ASC or LSIL . CONCLUSIONS Combining ODS with colposcopy provides a clinical ly meaningful increase in the detection of CIN 2,3 in women referred for the evaluation of mildly abnormal cytology results Objective : Our aim was to present our initial clinical experience using a novel exoscopically based colposcopy system ( VITOM ) for the evaluation of cervical , vulvar , and vaginal diseases . Material s and Methods : Women referred to the Charite Cervix Center , Charite University , Berlin , Germany , were included . Patients with abnormal Pap smear results , vulvar lesions , or a biopsy report of neoplasia of the lower genital tract were included into the study . The VITOM was used for colposcopic evaluation and directed biopsies . Colposcopic findings were reported according to the criteria of the Committee on Nomenclature of the International Federation of Cervical Pathology and Colposcopy . Histologic diagnosis was described as normal , low- grade lesion , high- grade lesion ( including cervical intraepithelial neoplasia 2,3 , vulvar intraepithelial neoplasia 2,3 , vaginal intraepithelial neoplasia 2,3 ) , or cancer . Results : We recruited 76 patients ( 54 with cervical , 4 with vaginal , and 18 with vulvar disease ) to the prospect i ve study . Four patients were pregnant . Of patients with cervical disease , 29 % had a history of previous conization and 3.7 % had a history of trachelectomy . The sensitivity , specificity , negative predictive value , and positive predictive value of the VITOM for cervical intraepithelial neoplasia 2 , 3 were 90 % , 77 % , 90 % and 77 % , respectively . Concordance of exocolposcopic impressions and histologic results was higher in high- grade lesions ( K = 0.68 , 95 % CI = 0.32 - 0.87 , p < .001 ) than in low- grade lesions ( K = 0.41 , 95 % CI = 0.1 - 0.41 , p < .05 ) . Conclusions : Exocolposcopy with the VITOM is accurate and shows good correlation to histologic findings in high- grade disease of the lower genital tract . The potential advantages include patient and trainee involvement in examination , decision making , and documentation Cervical intraepithelial neoplasia 3 ( CIN3 ) is the precursor of mostsquamous carcinomas and serves as a surrogate end point . However , small CIN3 lesions are rarely associated with concurrent invasion . We hypothesized that aggressive follow-up for cytology of atypical squamous cells of undetermined significance ( ASCUS ) or low- grade squamous intraepithelial lesion ( LSIL ) leads predominantly to detection of smaller CIN3 lesions than those usually associated with cancer . We assessed this hypothesis in a masked histopathologic review of 330 CIN3 lesions in the ASCUS LSILTriage Study , focusing on ASCUS referrals . ASCUS referrals underwent r and omized management [ colposcopy for repeat cytology of high- grade squamous intraepithelial lesion ( HSIL ) , colposcopy for oncogenic human papillomavirus ( HPV ) detection or repeat HSIL , or immediate colposcopy ] ; then all were followed with repeat cytology for 2 years , followed by colposcopy and aggressive treatment . We assessed all CIN3 lesions qualitatively and measured 39 of them . CIN3 lesions were overwhelmingly small . Compared with enrollment , lesions found at follow-up or exit involved fewer tissue fragments ( P < 0.01 ) and showed less diffuse gl and involvement ( P = 0.03 ) . CIN3 lesions found postenrollment after HPV testing involved the fewest tissue fragments [ versus immediate colposcopy ( P = 0.04 ) or repeat cytology of HSIL ( P = 0.02 ) ] , and none showed diffuse gl and involvement . The median distal-proximal length was 6.5 mm ( median replacement of total epithelium = 5 % ) in the 39 measured cases . We conclude that CIN3 lesions underlying ASCUS or LSIL generally lack features associated with invasion , particularly if managed using HPV testing , suggesting that aggressive management leads to early detection of CIN3 but probably prevents relatively few cancers in screened population The objective of this study was to assess the performance of cervical impedance spectroscopy in the detection of cervical intraepithelial neoplasia ( CIN ) using the new MKIII impedance probe . A prospect i ve observational study recruited women referred to colposcopy with an abnormal Papanicolaou smear . A pencil probe incorporating four gold electrodes was used to measure electrical impedance spectra from cervical epithelium . Colposcopy examinations , including probe positioning , were video recorded to allow for correlation between results obtained from colposcopic impression , histopathologic examination of colposcopic punch biopsies , and impedance measurements . Cervical impedance – derived parameters R , S , R/S , C , and Fc were assessed to see if significant difference in values obtained in CIN and normal epithelium existed . The performance of the probe in identifying women with CIN was also assessed . One hundred seventy-six women were recruited and 1168 points analyzed . Parameters R , S , and Fc showed significant separation of CIN or squamous intraepithelial lesion ( SIL ) from squamous , mature metaplastic , and columnar epithelium . Sensitivities of 74 % and specificity of 53 % can be achieved in identifying CIN 2/3 ( High- grade SIL ) in screened women . We conclude that cervical impedance spectrometry provides a potentially promising real-time screening tool for CIN with similar sensitivity and specificity to currently used screening tests . Further research is ongoing to develop the probe for potential clinical use OBJECTIVE To evaluate the efficacy of an electrical impedance probe ( Epitheliometer ) in the diagnosis of high grade cervical intraepithelial neoplasia ( CIN ) in women referred with cervical smear abnormalities and to assess the effect of acetic acid ( AA ) and tissue boundaries on the measurements . METHODS A prospect i ve observational study was undertaken in the colposcopy clinic . One hundred and sixty-five women , either with a clinical indication or abnormal cervical cytology , were recruited into the study . A pencil type probe was used to record impedance spectra from 12 points on the cervix before and after the application of 5 % AA . Spectra were also recorded from tissue boundaries . Colposcopic examinations , including probe positioning , were video recorded to allow for correlations between histopathological diagnosis of colposcopically directed biopsies , colposcopic impression and the diagnosis based on impedance measurements . RESULTS Receiver operating characteristic ( ROC ) curves were derived . The areas under the curves ( AUCs ) to discriminate original squamous from high grade CIN were 0.80 ( pre AA ) and 0.79 ( post AA ) . Comparison of these curves showed no significant difference , indicating that application of AA does not produce a large change in spectra . The probe could distinguish tissue boundaries from homogeneous tissue points . CONCLUSION The Epitheliometer has the potential to be used as an adjunct to colposcopy in the diagnosis of high grade CIN . It has the advantage of real time results , decreasing the need for diagnostic cervical biopsies , and facilitates a wider use of the ' see and treat ' policy without the risk of overtreatment Fluorescence spectroscopy has shown promise for the in vivo , real-time detection of cervical neoplasia . However , selection of excitation wavelength has in the past been based on in vitro studies and the availability of light sources . The goal of this study was to determine optimal excitation wavelengths for in vivo detection of cervical neoplasia . Fluorescence excitation-emission matrices ( EEMs ) were measured in vivo from 351 sites in 146 patients . Data were analyzed in pairs of diagnostic classes to determine which combination of excitation wavelengths yields classification algorithms with the greatest sensitivity and specificity . We find that 330 - 340- , 350 - 380- , and 400 - 450-nm excitation yield the best performance . The sensitivity and specificity for discrimination of squamous normal tissue and high- grade squamous intraepithelial lesion ( HGSIL ) were 71 % and 77 % on cross validation using three excitation wavelengths . These results are comparable with those found in earlier in vivo studies ; however , in this study we find that the proportion of sample s which are HGSIL influences performance . Furthermore stratification of sample s within low- grade squamous intraepithelial lesion and HGSIL also appears to influence diagnostic performance . Future diagnostic studies should be carried out at these excitation wavelengths in larger groups so that data can be stratified by diagnostic subcategory , age and menopausal status . Similarly , large studies should be done in screening population Large phase II trials of fluorescence and reflectance spectroscopy using a fiber optic probe in the screening and diagnostic setting s for detecting cervical neoplasia have been conducted . We present accrual and histopathology data , instrumentation , data processing , and the preliminary results of interdevice consistencies throughout the progression of a trial . Patients were recruited for either a screening trial ( no history of abnormal Papanicolaou smears ) or a diagnostic trial ( a history of abnormal Papanicolaou smears ) . Colposcopy identified normal and abnormal squamous , column
Output:
| An instrument that globally assesses the cervix , such as computer-assisted colposcopy , optical spectroscopy , and dynamic spectral imaging , would provided the most comprehensive estimate of disease and is therefore best suited when treatment is preferred .
Electrical impedance spectroscopy , confocal microscopy , and optical coherence tomography provide information at the cellular level to estimate histology and are therefore best suited when deferment of treatment is preferred .
If a device is to eventually replace the colposcope , it will likely combine technologies to best meet the needs of the target population , and as such , no single instrument may prove to be universally appropriate . |
MS211920 | ***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 objective of this study was to assess the effectiveness of a hygiene program in reducing the incidence of respiratory and diarrheal diseases in toddlers attending day care centers . A r and omized field trial was conducted in 52 day care centers in Quebec , Canada , between September 1 , 1996 and November 30 , 1997 . Absences for any reasons and the daily occurrence of colds and /or diarrhea in toddlers were recorded on calendars by the educators . The number of fecal coliforms on children 's h and s and on educators ' h and s was measured during three unannounced visits . Overall , 1,729 children were followed in 47 day care centers for a total of 153,643 child-days . The incidence rate of diarrhea was considerably reduced by the effect of monitoring ( IRR = 0.73 , 95 % CI = 0.54,0.97 ) , and the intervention reduced the incidence rate of upper respiratory tract infections ( IRR = 0.80 , 95 % CI = 0.68,0.93 ) . Monitoring alone also had an important effect in reducing the level of bacterial contamination on children 's and educators ' h and s. The results indicate that both an intervention program and monitoring alone play a role in reducing infections in children attending day care centers Please cite this paper as : Simmerman et al. ( 2011 ) Findings from a household r and omized controlled trial of h and washing and face masks to reduce influenza transmission in Bangkok , Thail and . Influenza and Other Respiratory Viruses 5(4 ) , 256–267 Background Evidence is needed on the effectiveness of non‐pharmaceutical interventions ( NPIs ) to reduce influenza transmission . Methodology We studied NPIs in households with a febrile , influenza‐positive child . Households were r and omized to control , h and washing ( HW ) , or h and washing plus paper surgical face masks ( HW + FM ) arms . Study nurses conducted home visits within 24 hours of enrollment and on days 3 , 7 , and 21 . Respiratory swabs and serum were collected from all household members and tested for influenza by RT‐PCR or serology . Principal Findings Between April 2008 and August 2009 , 991 ( 16·5 % ) of 5995 pediatric influenza‐like illness patients tested influenza positive . Four hundred and forty‐two index children with 1147 household members were enrolled , and 221 ( 50·0 % ) were aged < 6 years . Three hundred and ninety‐seven ( 89·8 % ) households reported that the index patient slept in the parents ’ bedroom . The secondary attack rate was 21·5 % , and 56/345 ( 16·3 % ; 95 % CI 12·4–20·2 % ) secondary cases were asymptomatic . H and ‐washing subjects reported 4·7 washing episodes/day , compared to 4·9 times/day in the HW + FM arm and 3·9 times/day in controls ( P = 0·001 ) . The odds ratios ( ORs ) for secondary influenza infection were not significantly different in the HW arm ( OR = 1·20 ; 95 % CI 0·76–1·88 ; P‐0.442 ) , or the HW + FM arm ( OR = 1·16 ; 95 % CI .0·74–1·82 ; P = 0.525 ) . Conclusions Influenza transmission was not reduced by interventions to promote h and washing and face mask use . This may be attributable to transmission that occurred before the intervention , poor facemask compliance , little difference in h and ‐washing frequency between study groups , and shared sleeping arrangements . A prospect i ve study design and a careful analysis of sociocultural factors could improve future NPI studies Background : Laboratory-based evidence is lacking regarding the efficacy of nonpharmaceutical interventions ( NPIs ) such as alcohol-based h and sanitizer and respiratory hygiene to reduce the spread of influenza . Methods : The Pittsburgh Influenza Prevention Project was a cluster-r and omized trial conducted in 10 elementary schools in Pittsburgh , PA , during the 2007 to 2008 influenza season . Children in 5 intervention schools received training in h and and respiratory hygiene , and were provided and encouraged to use h and sanitizer regularly . Children in 5 schools acted as controls . Children with influenza-like illness were tested for influenza A and B by reverse-transcriptase polymerase chain reaction . Results : A total of 3360 children participated in this study . Using reverse-transcriptase polymerase chain reaction , 54 cases of influenza A and 50 cases of influenza B were detected . We found no significant effect of the intervention on the primary study outcome of all laboratory-confirmed influenza cases ( incidence rate ratio [ IRR ] : 0.81 ; 95 % confidence interval [ CI ] : 0.54 , 1.23 ) . However , we did find statistically significant differences in protocol -specified ancillary outcomes . Children in intervention schools had significantly fewer laboratory-confirmed influenza A infections than children in control schools , with an adjusted IRR of 0.48 ( 95 % CI : 0.26 , 0.87 ) . Total absent episodes were also significantly lower among the intervention group than among the control group ; adjusted IRR 0.74 ( 95 % CI : 0.56 , 0.97 ) . Conclusions : NPIs ( respiratory hygiene education and the regular use of h and sanitizer ) did not reduce total laboratory-confirmed influenza . However , the interventions did reduce school total absence episodes by 26 % and laboratory-confirmed influenza A infections by 52 % . Our results suggest that NPIs can be an important adjunct to influenza vaccination programs to reduce the number of influenza A infections among children Transmission of enteric pathogens is facilitated in child day care centers , including family day care homes , by frequent and intimate exposure among susceptible hosts , with diaper changing as the highest-risk procedure for such transmission . The objective of this study was to evaluate the effectiveness of an intervention program in decreasing the incidence of infectious disease symptoms in children attending family day care homes during a 12-month period . Each of 24 family day care homes was r and omly assigned to an intervention or control group . The intervention included four components : ( 1 ) a h and washing educational program and ( 2 ) use of vinyl gloves , ( 3 ) use of disposable diaper changing pads , and ( 4 ) use of an alcohol-based h and rinse by the day care provider . Symptoms of enteric disease ( diarrhea and vomiting ) were significantly reduced in intervention family day care homes ( p less than or equal to 0.05 ) , whereas respiratory symptoms were not significantly different between intervention and control family day care homes ( p = 0.35 ) . Diarrhea was reported in 1 of every 100 child care days , representing one diarrhea episode per month in a typical family day care home INTRODUCTION The purpose was to determine the effectiveness of an instructional program on h and washing . The hypothesis stated that an instructional program on germs and h and washing in child care could significantly reduce the spread of infectious diseases in the test center . METHOD A longitudinal study was conducted in a field setting with a test group and a control group of 3- to 5-year-old children and their teachers in two similar child care setting s. For 21 weeks illnesses and symptoms of infectious diseases were assessed with a health assessment checklist . The test group received a developmentally appropriate instructional program on germs and h and washing . The teachers in the test group attended workshops on infectious diseases and h and washing . The control group maintained their usual h and washing procedures . RESULT At weeks 1 through 11 benchmark data were collected . At weeks 12 through 21 , peak cold and flu season , the test group had significantly fewer colds than the control group ( chi-squared analysis , 4.338 , 1 df , p < .05 ) ; thus the hypothesis was confirmed . DISCUSSION H and washing has been recognized as one way to manage the spread of infectious diseases in child care centers . H and washing helped to reduce colds at the test center where frequent and proper h and washing practice s were incorporated into the curriculum through an intervention program Background Previous controlled studies on the effect of non-pharmaceutical interventions ( NPI ) - namely the use of facemasks and intensified h and hygiene - in preventing household transmission of influenza have not produced definitive results . We aim ed to investigate efficacy , acceptability , and tolerability of NPI in households with influenza index patients . Methods We conducted a cluster r and omized controlled trial during the p and emic season 2009/10 and the ensuing influenza season 2010/11 . We included households with an influenza positive index case in the absence of further respiratory illness within the preceding 14 days . Study arms were wearing a facemask and practicing intensified h and hygiene ( MH group ) , wearing facemasks only ( M group ) and none of the two ( control group ) . Main outcome measure was laboratory confirmed influenza infection in a household contact . We used daily question naires to examine adherence and tolerability of the interventions . Results We recruited 84 households ( 30 control , 26 M and 28 MH households ) with 82 , 69 and 67 household contacts , respectively . In 2009/10 all 41 index cases had a influenza A ( H1N1 ) pdm09 infection , in 2010/11 24 had an A ( H1N1 ) pdm09 and 20 had a B infection . The total secondary attack rate was 16 % ( 35/218 ) . In intention-to-treat analysis there was no statistically significant effect of the M and MH interventions on secondary infections . When analysing only households where intervention was implemented within 36 h after symptom onset of the index case , secondary infection in the pooled M and MH groups was significantly lower compared to the control group ( adjusted odds ratio 0.16 , 95 % CI , 0.03 - 0.92 ) . In a per- protocol analysis odds ratios were significantly reduced among participants of the M group ( adjusted odds ratio , 0.30 , 95 % CI , 0.10 - 0.94 ) . With the exception of MH index cases in 2010/11 adherence was good for adults and children , contacts and index cases . Conclusions Results suggest that household transmission of influenza can be reduced by the use of NPI , such as facemasks and intensified h and hygiene , when implemented early and used diligently . Concerns about acceptability and tolerability of the interventions should not be a reason against their recommendation .Trial registration The study was registered with Clinical Trials.gov ( Identifier NCT00833885 ) Background The economical impact of absenteeism and reduced productivity due to acute infectious respiratory and gastrointestinal disease is normally not in the focus of surveillance systems and may therefore be underestimated . However , large community studies in Europe and USA have shown that communicable diseases have a great impact on morbidity and lead to millions of lost days at work , school and university each year . H and disinfection is acknowledged as key element for infection control , but its effect in open , work place setting s is unclear . Methods Our study involved a prospect i ve , controlled , intervention-control group design to assess the epidemiological and economical impact of alcohol-based h and disinfectants use at work place . Volunteers in public administrations in the municipality of the city of Greifswald were r and omized in two groups . Participants in the intervention group were provided with alcoholic h and disinfection , the control group was unchanged . Respiratory and gastrointestinal symptoms and days of work were recorded based on a monthly question naire over one year . On the whole , 1230 person months were evaluated . Results H and disinfection reduced the number of episodes of illness for the majority of the registered symptoms . This effect became statistically significant for common cold ( OR = 0.35 [ 0.17 - 0.71 ] , p = 0.003 ) , fever ( OR = 0.38 [ 0.14 - 0.99 ] , p = 0.035 ) and coughing ( OR = 0.45 [ 0.22 - 0.91 ] , p = 0.02 ) . Participants in the intervention group reported less days ill for most symptoms assessed , e.g. colds ( 2.07 vs. 2.78 % , p = 0.008 ) , fever ( 0.25 vs. 0.31 % , p = 0.037 ) and cough ( 1.85 vs. 2.00 % , p = 0.024 ) . For diarrhoea , the odds ratio for being absent became statistically significant too ( 0.11 ( CI 0.01 - 0.93 ) . Conclusion H and disinfection can easily be introduced and maintained outside clinical setting s as part of the daily h and hygiene . Therefore it appears as an interesting , cost-efficient method within the scope of company health support programmes . Trial registration numberIS RCT N : IS RCT BACKGROUND During the influenza A(H1N1 ) p and emic , antiviral prescribing was limited , vaccines were not available early , and the effectiveness of nonpharmaceutical interventions ( NPIs ) was uncertain . Our study examined whether use of face masks and h and hygiene reduced the incidence of influenza-like illness ( ILI ) . METHODS A r and
Output:
| There was high- quality evidence of a small reduction in respiratory infection in childcare setting s. There was high- quality evidence for a large reduction in respiratory infection with a h and hygiene intervention in squatter settlements in a low-income setting .
There was moderate- to high- quality evidence of no effect on secondary transmission of influenza in households that had already experienced an index case .
While h and hygiene interventions have potential to reduce transmission of influenza and acute respiratory tract infections , their effectiveness varies depending on setting , context and compliance |
MS211921 | ***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 To study the efficacy of alfuzosin compared with tamsulosin in the management of lower ureteral stones . METHODS A total of 102 patients with stones < 1 cm size and located in the lower ureter were enrolled in the present study and r and omized into 3 equal groups . Group 1 patients ( n = 34 ) received 0.4 mg tamsulosin daily , group 2 patients ( n = 34 ) received 10 mg alfuzosin daily , and group 3 patients ( n = 34 ) received placebo ( control group ) . The patients were given 75 mg diclofenac injection intramuscularly on dem and and were followed up for 4 weeks . RESULTS The average stone size for groups 1 , 2 , and 3 was comparable ( 6.17 , 6.70 , and 6.35 mm , respectively ) . Stone expulsion was observed in 28 of 34 patients ( 82.3 % ) in group 1 , 24 of 34 patients ( 70.5 % ) in group 2 , and 12 of 34 patients ( 35.2 % ) in group 3 . The average expulsion time for groups 1 , 2 , and 3 was 12.3 , 14.5 , and 24.5 days , respectively . The results of both study groups ( groups 1 and 2 ) were superior to those in the placebo group ( P = .003 and P = .001 , respectively ) , but the study failed to show any statistically significant differences between tamsulosin and alfuzosin ( P = .25 ) . Alfuzosin was associated with fewer side effects than tamsulosin , especially in terms of retro grade ejaculation . CONCLUSIONS Medical treatment of lower ureteral calculi with tamsulosin and alfuzosin result ed in a significantly increased stone expulsion rate , decreased expulsion time , and a reduced need for analgesic therapy Abstract Objective : To evaluate and compare the efficacy of tamsulosin and alfuzosin as medical expulsive therapy for ureteric stones . Patients and methods : In all , 112 patients with ureteric stones of ⩽10 mm , located along the ureter , were r and omly divided into three groups . In group I , 32 patients received no α-blockers ( controls ) , in group II 40 patients received tamsulosin 0.4 mg daily , and in group III 40 patients received alfuzosin 10 mg daily . All patients were given analgesia and antibiotics when indicated . The follow-up was weekly for 4 weeks . Results : The mean stone size and age were comparable in the three groups . The stone expulsion rate was 44 % , 85 % and 75 % in groups I , II and III , respectively . Half of the stones in group II passed within 2 weeks , half in group III passed within 3 weeks , while more than half of the stones in group I did not pass even after 4 weeks . The mean number of painful episodes was 2.45 , 1.38 and 1.64 in groups I , II and III , respectively . The drug-related side-effects reported by patients were mild and transient . Conclusion : The use of tamsulosin or alfuzosin as medical expulsive therapy for ureteric stones in the three sections of the ureter ( upper , middle and lower ) was safe and effective , as shown by the increased overall stone expulsion rate , reduced stone expulsion time and fewer pain episodes . Tamsulosin was associated with a greater rate of stone expulsion than was alfuzosin BACKGROUND Using a selective α-blocker for medical expulsive therapy ( MET ) is a cost-effective treatment approach widely used for ureteral stones . OBJECTIVE To evaluate the efficacy of silodosin , a selective α-1a receptor antagonist , in this setting . DESIGN , SETTING , AND PARTICIPANTS This was a multicenter , phase 2 study conducted in adult patients with a unilateral ureteral calculus of 4 - 10 mm . Of 239 patients in the safety population , six discontinued due to adverse events . INTERVENTION Patients were r and omized 1:1 to receive silodosin 8 mg or placebo for up to 4 wk . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was spontaneous stone passage , analyzed using logistic regression . Secondary outcomes included time to stone passage , emergency room ( ER ) visits , hospital admissions , analgesic use , and incidence and severity of pain . RESULTS AND LIMITATIONS No significant differences between the silodosin and placebo groups were observed for passage rate of all stones ( 52 % vs 44 % , respectively ; p=0.2 ) . However , silodosin achieved a significantly greater rate of distal ureter stone passage than placebo ( p=0.01 ) . Significant differences were not observed for ER visits , hospital admission , or use of analgesics . The number of patients in the intent-to-treat population was slightly below the calculated sample size ( 232 vs 240 ) and sample sizes were not calculated for subgroup analyses . CONCLUSIONS This is among the first prospect i ve , r and omized , multi-institutional trials to examine the efficacy of a selective α-1a antagonist as MET in patients with ureteral calculi and did not demonstrate a benefit to the entire ureter . However , silodosin was found to be well tolerated and beneficial in facilitating the passage of distal ureteral stones , warranting additional future studies on distal stone elimination . PATIENT SUMMARY In this report , we looked at the efficacy of silodosin for the treatment of ureteral stones . We found that silodosin increased passage of distal ureteral stones BACKGROUND Recent large high- quality trials have question ed the clinical effectiveness of medical expulsive therapy using tamsulosin for ureteral stones . OBJECTIVE To evaluate the efficacy and safety of tamsulosin for distal ureteral stones compared with placebo . DESIGN , SETTING , AND PARTICIPANTS We conducted a double-blind , placebo-controlled study of 3296 patients with distal ureteral stones , across 30 centers , to evaluate the efficacy and safety of tamsulosin . INTERVENTION Participants were r and omly assigned ( 1:1 ) into tamsulosin ( 0.4 mg ) or placebo groups for 4 wk . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary end point of analysis was the overall stone expulsion rate , defined as stone expulsion , confirmed by negative findings on computed tomography , over a 28-d surveillance period . Secondary end points included time to stone expulsion , use of analgesics , and incidence of adverse events . RESULTS AND LIMITATIONS Among 3450 patients r and omized between September 1 , 2011 , and August 31 , 2013 , 3296 ( 96 % ) were included in the primary analysis . Tamsulosin benefits from a higher stone expulsion rate than the placebo ( 86 % vs 79 % ; p<0.001 ) for distal ureteral stones . Subgroup analysis identified a specific benefit of tamsulosin for the treatment of large distal ureteral stones ( > 5 mm ) . Considering the secondary end points , tamsulosin-treated patients reported a shorter time to expulsion ( p<0.001 ) , required lower use of analgesics compared with placebo ( p<0.001 ) , and significantly relieved renal colic ( p<0.001 ) . No differences in the incidence of adverse events were identified between the two groups . CONCLUSIONS Our data suggest that tamsulosin use benefits distal ureteral stones in facilitating stone passage and relieving renal colic . Subgroup analyses find that tamsulosin provides a superior expulsion rate for stones > 5 mm , but no effect for stones ≤5 mm . PATIENT SUMMARY In this report , we looked at the efficacy and safety of tamsulosin for the treatment of distal ureteral stones . We find that tamsulosin significantly facilitates the passage of distal ureteral stones and relieves renal colic BACKGROUND α-Blockers induce selective relaxation of ureteral smooth muscle with subsequent inhibition of ureteral spasms and dilatation of the ureteral lumen . The aim of the study was to evaluate the efficacy and safety of the α-blocker tamsulosin hydrochloride in patients with ureteral colic owing to a distal ureteral stone . METHODS This was a multicenter , placebo-controlled , r and omized , double-blind study . Patients with emergency admission for ureteral colic with a 2- to 7-mm-diameter radio-opaque distal ureteral stone were included in the study . They received tamsulosin ( 0.4 mg/d ) or matching placebo until stone expulsion or day 42 , whichever came first . The main end point was time to stone expulsion between inclusion and day 42 . Sequential statistical analysis was performed using the triangular test . RESULTS A total of 129 patients with acute renal colic were recruited from emergency wards between February 1 , 2002 , and December 8 , 2006 , in 6 French hospitals . Of these 129 r and omized patients ( placebo , 63 ; tamsulosin , 66 ) , 7 were excluded from analyses : 5 for major deviations from inclusion criteria , 1 for stone expulsion before the first treatment administration , and 1 for consent withdrawal . At inclusion , mean ( SD ) stone diameters were 3.2 ( 1.2 ) and 2.9 ( 1.0 ) mm in the placebo and tamsulosin groups , respectively ( P = .23 ) . Expulsion delay distributions during 42 days did not show any difference ( P = .30 ) . The numbers of patients who spontaneously expelled their stone within 42 days were 43 of 61 ( 70.5 % ) and 47 of 61 ( 77.0 % ) in the placebo and tamsulosin groups , respectively ( P = .41 ) . Corresponding delays were 10.1 ( 10.0 ) and 9.6 ( 9.8 ) days ( P = .82 ) . Other secondary end points and tolerance were not different between groups . CONCLUSION Although well tolerated , a daily administration of 0.4 mg of tamsulosin did not accelerate the expulsion of distal ureteral stones in patients with ureteral colic . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00151567 Objectives A prospect i ve , multicenter , r and omized , double-blind , placebo-controlled trial evaluated the effects of naftopidil 75 mg for medical expulsive therapy for a single ureter stone . Material s and methods Patients diagnosed with a ureter stone were prescribed aceclofenac 100 mg or a combined medication of tramadol 37.5 mg and acetaminophen 325 mg . Patients then r and omly received either naftopidil 75 mg or placebo . Primary endpoint was the stone passage rate at 14 days after medication . Results The 150 patients enrolled in 6 institutions r and omly received either naftopidil ( n = 75 ) or placebo ( n = 75 ) . The percentages of ureter stone passed spontaneously 14 days after medication was 60.9 % in the naftopidil group and 53.3 % in the placebo group . Stone-free rates and the total use of analgesics showed no significant differences between the two groups . Stone-free rates at 14 days after medication were decreased when maximal stone size was increased : 39.4 % ( ≥ 5 mm ) , 15.5 % ( ≥ 6 mm ) , and 7.0 % ( ≥ 7 mm ) . Conclusions The use of naftopidil 75 mg once daily was not effective in increasing spontaneous stone passage rates or reducing analgesic use . The maximal stone size < 6 mm and the follow-up for two weeks would be appropriate for applying medical expulsive therapy to patients with a single ureter stone Purpose We evaluated and compared the efficacy of tamsulosin and alfuzosin in the medical treatment of symptomatic , uncomplicated distal ureteral stones . Material s and Methods A total of 87 patients with distal ureteral stones of ≤10 mm were r and omly divided into 3 groups . Group I patients ( n=29 ) received 0.4 mg tamsulosin daily , group II patients ( n=30 ) received 10 mg alfuzosin daily , and group III patients ( n=28 ) were not given tamsulosin or alfuzosin . Patients in all groups received Diclofenac sodium regularly for 1 week and then on dem and . Follow-up was done on a weekly basis for 30 days . Results The mean stone size was comparable in the 3 groups ( 4.97±2.24 , 5.47±2.13 , and 5.39±1.81 mm , respectively ) . The stone expulsion rate was 86.2 % , 76.6 % , and 50 % in groups I , II , and III , respectively . The difference in groups I and II with respect to group III was significant ( p=0.0028 and 0.035 ) . The mean expulsion time for groups I to III was 7.52±7.06 , 8.26±7.34 , and 13.90±6.99 days , respectively . The expulsion time was significantly shorter in groups I and II than in group III ( p=0.0097 and 0.026 ) . Patients taking tamsulosin and alfuzosin had fewer pain attacks than did group III patients (
Output:
| We did not find evidence for possible subgroup effects based on stone location or α-blocker type .
CONCLUSIONS In patients with ureteric stones , α-blockers likely increase stone clearance but probably also slightly increase the risk of major adverse events .
Subgroup analyses suggest that α-blockers may be less effective in smaller ( ≤5 mm ) than larger stones ( > 5 mm ) |
MS211922 | ***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: We report results from a r and omized controlled trial design ed to evaluate the efficacy of a video-based sexual risk reduction intervention and to measure assessment reactivity . Patients ( N = 1010 ; 56 % male ; 69 % African American ) receiving care at a sexually transmitted infection ( STI ) clinic were assigned to one of four conditions formed by crossing assessment condition ( i.e. , sexual health vs. general health ) with intervention condition ( i.e. , sexual risk reduction intervention vs. general health promotion ) . After completing their assigned baseline assessment , participants received their assigned intervention , and subsequently returned for follow-up assessment s at 3 , 6 , 9 , and 12 months . Participants in all conditions reduced their self-reported sexual risk behavior , and the incidence of new STIs declined from baseline through the follow-ups ; however , there was no effect of intervention or assessment condition . We conclude that further risk reduction will require more intensive interventions , especially in STI clinics that already provide excellent clinical care . ResumenPresentamos los result ados de un estudio experimental aleatorizado con grupo de control diseñado para evaluar la eficacia de una intervención basada en un video para reducir el comportamiento sexual de riesgo y para medir reactividad . Se crearon cuatro condiciones experimentales al cruzar las condiciones de evaluación ( es decir , salud sexual versus salud general ) con las de intervención ( es decir , reducción de comportamiento sexual de riesgo versus promoción de la salud general ) . Los pacientes , ( N = 1010 ; 56 % hombres ; 69 % afroamericanos ) que recibían atención en una clínica de infecciones de transmisión sexual ( ITS ) , fueron asignados a unas de las cuatro condiciones experimentales . Después de completar la evaluación inicial a la que fueron asignados , los participantes recibieron la intervención correspondiente y posteriormente regresaron para el seguimiento a los 3 , 6 , 9 y 12 meses . Los participantes en todas las condiciones redujeron su comportamiento de riesgo sexual , medido mediante un cuestionario que completaron ellos mismos , y la incidencia de nuevas infecciones de transmisión sexual se redujo compar and o cada seguimiento con la línea base . Sin embargo , no se observó efecto de la intervención o condición de comparación . Llegamos a la conclusión de que para reducir en mayor medida el comportamiento de riesgo sexual se requieren intervenciones más intensivas , sobre todo en las clínicas de ITS en las que ya se proporciona una excelente atención clínica OBJECTIVES We tested the efficacy of a brief intervention to promote correct and consistent use of condoms among Black male youths attending sexually transmitted infection ( STI ) clinics in 3 southern US cities . METHODS In 2010 to 2012 , we screened ( n = 1102 ) and enrolled ( n = 702 ) youths aged 15 to 23 years who identified as Black and reported recent ( past 2 months ) sexual activity and r and omized them to a private , brief , interactive intervention ( n = 349 ) or an attention-equivalent control condition ( n = 353 ) . Assessment s occurred at baseline and 2 and 6 months after the intervention . RESULTS At 6 months , with adjustment for age and pretest nonequivalence of the outcome variable , an estimated odds ratio ( EOR ) of 1.63 ( 95 % confidence interval [ CI ] = 1.07 , 2.49 ; P = .02 ) indicated efficacy for correct condom use . An adjusted generalized estimating equations model with both 2- and 6-month condom use variables produced an EOR of 1.49 ( 95 % CI = 1.06 , 2.08 ; P = .02 ) . We did not observe significant effects on chlamydia and gonorrhea incidence . CONCLUSIONS This brief intervention , delivered as part of STI clinical care , could help alleviate the disproportionate STI-HIV burden among young Black men Background We evaluated brief combination interventions to simultaneously reduce sexual and injection risks among female sex workers who inject drugs ( FSW-IDUs ) in Tijuana and Ciudad Juarez , Mexico during 2008–2010 , when harm reduction coverage was exp and ing rapidly in Tijuana , but less so in Juarez . Methods FSW-IDUs ≥18 years reporting sharing injection equipment and unprotected sex with clients within the last month participated in a r and omized factorial trial comparing four brief , single-session conditions combining either an interactive or didactic version of a sexual risk intervention to promote safer sex in the context of drug use , and an injection risk intervention to reduce sharing of needles/injection paraphernalia . Women underwent quarterly interviews and testing for HIV , syphilis , gonorrhea , Chlamydia and Trichomonas , blinding interviewers and assessors to assignment . Poisson regression with robust variance estimation and repeated measures ordinal logistic regression examined effects on combined HIV/STI incidence and receptive needle sharing frequency . Findings Of 584 initially HIV-negative FSW-IDUs , retention was ≥90 % . After 12 months , HIV/STI incidence decreased > 50 % in the interactive vs. didactic sex intervention ( Tijuana : AdjRR:0.38,95 % CI:0.16–0.89 ; Juarez : AdjRR:0.44,95 % CI:0.19–0.99 ) . In Juarez , women receiving interactive vs. didactic injection risk interventions decreased receptive needle-sharing by 85 % vs. 71 % , respectively ( p = 0.04 ) ; in Tijuana , receptive needle sharing declined by 95 % , but was similar in active versus didactic groups . Tijuana women reported significant increases in access to syringes and condoms , but Juarez women did not . Interpretation After 12 months in both cities , the interactive sexual risk intervention significantly reduced HIV/STI incidence . Exp and ing free access to sterile syringes coupled with brief , didactic education on safer injection was necessary and sufficient for achieving robust , sustained injection risk reductions in Tijuana . In the absence of exp and ing syringe access in Juarez , the injection risk intervention achieved significant , albeit more modest reductions , suggesting that community-level interventions incorporating harm reduction are more powerful than individual-level interventions . Trial Registration clinical trials.gov 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 Objective : To evaluate the effectiveness of a clinician-delivered intervention , implemented during routine clinical care , in reducing unprotected sexual behavior of HIV-infected patients . Design : A prospect i ve clinical trial comparing the impact of a clinician-delivered intervention arm vs. a st and ard-of-care control arm on unprotected sexual behavior of HIV-infected patients . Setting : The 2 largest HIV clinics in Connecticut . Participants : A total of 497 HIV-infected patients , aged ≥18 years , receiving HIV clinical care . Intervention : HIV clinical care providers conducted brief client-centered interventions at each clinical encounter that were design ed to help HIV-infected patients reduce unprotected sexual behavior . Main Outcome Measures : Unprotected insertive and receptive vaginal and anal intercourse and unprotected insertive oral sex ; unprotected insertive and receptive vaginal and anal intercourse only . Results : HIV-infected patients who received the clinician-delivered intervention showed significantly reduced unprotected insertive and receptive vaginal and anal intercourse and insertive oral sex over a follow-up interval of 18 months ( P < 0.05 ) . These behaviors increased across the study interval for patients in the st and ard-of-care control arm ( P < 0.01 ) . For the measure of unprotected insertive and receptive vaginal and anal sex only , there was a trend toward a reduction in unprotected sex among intervention arm participants over time ( P < 0.09 ) , and a significant increase in unprotected sex in the st and ard-of-care control arm ( P < 0.01 ) . Conclusions : A clinician-delivered HIV prevention intervention targeting HIV-infected patients result ed in reductions in unprotected sex . Interventions of this kind should be integrated into routine HIV clinical care OBJECTIVE To determine whether condom use among high-risk female adolescents could be increased by a behavioral intervention , with the use of infection with Chlamydia trachomatis as a biomarker of condom practice s. DESIGN Prospect i ve , r and omized , controlled intervention . SETTING Urban family planning and sexually transmitted disease clinics . PARTICIPANTS Two hundred nine female adolescents , aged 15 through 19 years , who were treated for C. trachomatis genitourinary infection , were r and omly assigned to st and ard ( control ) or experimental ( behavioral intervention ) groups . One hundred twelve subjects returned for follow-up 5 to 7 months after enrollment and comprise the study subjects . MEASUREMENTS Subjects completed a multiinstrument question naire measuring sexual behavior , condom practice s , attitudes and beliefs , cognitive complexity , sociodemographics , and motivation at enrollment and follow-up . Endourethral and endocervical sites were sample d for C. trachomatis . RESULTS Among the 112 subjects who returned for repeated examination , those who had received the experimental intervention reported increased use of condoms by their sexual partners for protection against sexually transmitted diseases ( odds ratio = 2.4 ; p = 0.02 ) and for vaginal intercourse ( odds ratio = 3.1 ; p = 0.005 ) at the 6-month follow-up . Multivariable logistic regression analysis controlling for condom use at enrollment demonstrated that the experimental intervention ( odds ratio = 2.8 ; p = 0.03 ) and the higher cognitive complexity ( odds ratio = 4.6 ; p = 0.02 ) independently contributed to greater condom use at follow-up . Despite greater use of condoms among the group who had received the intervention , use remained inconsistent and rates of reinfection with C. trachomatis were not significantly different ( 26 % vs 17 % ; p = 0.3 ) . CONCLUSION Although a brief behavioral intervention among high-risk female adolescents can increase condom use by their sexual partners , incident infection does not appear to be reduced , because condom use remained inconsistent Background Sexually transmitted disease ( STD ) prevention remains a public health priority . Simple , practical interventions to reduce STD incidence that can be easily and inexpensively administered in high-volume clinical setting s are needed . We evaluated whether a brief video , which contained STD prevention messages targeted to all patients in the waiting room , reduced acquisition of new infections after that clinic visit . Methods and Findings In a controlled trial among patients attending three publicly funded STD clinics ( one in each of three US cities ) from December 2003 to August 2005 , all patients ( n = 38,635 ) were systematic ally assigned to either a theory-based 23-min video depicting couples overcoming barriers to safer sexual behaviors , or the st and ard waiting room environment . Condition assignment alternated every 4 wk and was determined by which condition ( intervention or control ) was in place in the clinic waiting room during the patient 's first visit within the study period . An intent-to-treat analysis was used to compare STD incidence between intervention and control patients . The primary endpoint was time to diagnosis of incident laboratory-confirmed infections ( gonorrhea , chlamydia , trichomoniasis , syphilis , and HIV ) , as identified through review of medical records and county STD surveillance registries . During 14.8 mo ( average ) of follow-up , 2,042 patients ( 5.3 % ) were diagnosed with incident STD ( 4.9 % , intervention condition ; 5.7 % , control condition ) . In survival analysis , patients assigned to the intervention condition had significantly fewer STDs compared with the control condition ( hazard ratio [ HR ] , 0.91 ; 95 % confidence interval [ CI ] , 0.84 to 0.9
Output:
| Conclusions The technical content of brief behaviour interventions was identified in a reliable and st and ardized way providing preliminary indications on potentially effective techniques to achieve behaviour change |
MS211923 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Objective : The objective of this study was to psychometrically evaluate a tool to measure adult caregivers ’ level of satisfaction with the delivery device used to administer injections of recombinant human growth hormone ( rhGH ) to a child – the Satisfaction Measure of the Injection of Growth Hormone Therapy ( SMIGHTy * SMIGHTy is a trademark of Genentech , Inc. , South San Francisco , CA , USA . ) question naire . Research design and methods : One hundred caregivers who administer rhGH to a child using an injection device completed the SMIGHTy question naire at baseline and 7–14 days later , and also completed other measures of treatment adherence and treatment satisfaction at baseline . Main outcome measures : SMIGHTy reliability ( inter-item and test – retest ) and external validity ( association with other study measures ) were assessed . Results : Analyses revealed good inter-item agreement and test – retest reliability for the SMIGHTy question naire . External validity , measured by associations with adherence and other measures of treatment satisfaction , was high . Study limitations : This study assessed only adult caregivers ; the instrument was not vali date d for use by young or adult patients . Conclusions : The SMIGHTy instrument is more comprehensive than existing instruments for assessing the growth hormone treatment experience . It is multidimensional , assesses both positive and negative aspects of the treatment experience ( Device Satisfaction , Negative Events , Benefits ) , and has separate measures of overall satisfaction and preference The causes of growth retardation of children with thalassaemia major are multifactorial . We studied the GH response to provocation by clonidine and glucagon , measured the circulating concentrations of insulin , IGF-I , IGF-binding protein-3 ( IGFBP-3 ) and ferritin , and evaluated IGF-I generation after a single dose of GH ( 0.1 mg/kg per dose ) in 15 prepubertal patients with thalassaemia , 15 age-matched children with constitutional short stature ( CSS ) ( height st and ard deviation score less than -2 , with normal GH response to provocation ) and 11 children with isolated GH deficiency ( GHD ) . Children with thalassaemia had significantly lower peak GH response to provocation by clonidine and glucagon ( 6.2 + /- 2.3 and 6.8 + /- 2.1 microg/l respectively ) than the CSS group ( 18.6 + /- 2.7 and 16.7 + /- 3.7 microg/l respectively ) . They had significantly decreased circulating concentrations of IGF-I and IGFBP-3 ( 47.5 + /- 19 ng/ml and 1.2 + /- 0.27 mg/l respectively ) compared with those with CSS ( 153 + /- 42 ng/ml and 2.06 + /- 0.37 mg/l respectively ) , but the IGF-I and IGFBP-3 concentrations were not different from those with GHD ( 56 + /- 25 ng/ml and 1.1 + /- 0.32 mg/l respectively ) . These data demonstrate that the GH-IGF-I-IGFBP-3 axis in thalassaemic children is defective . Serum ferritin concentration correlated significantly with GH peak response to provocation ( r = -0.36 , P < 0.05 ) and circulating IGF-I ( r = -0.47 , P < 0.01 ) and IGFBP-3 ( r = -0.42 , P < 0.01 ) concentrations . In the IGF-I generation test , after GH injection , the thalassaemic children had significantly lower IGF-I and IGFBP-3 levels 86.7 + /- 11.2 ng/ml and 2.05 + /- 0.51 mg/l respectively ) than those in the CSS group ( 226 + /- 45.4 ng/ml and 2.8 + /- 0.43 mg/l respectively ) . The IGF-I response was significantly higher in children with GHD ( 158 + /- 50 ng/ml ) than in thalassaemic children . Six short ( height st and ard deviation score less than -2 ) thalassaemic children who had defective GH response to provocation ( < 10 microg/l ) , all the children with GHD and eight short normal children ( CSS ) were treated for 1 year with human GH ( 18 units/m2 per week divided into daily s.c . doses ) . After 1 year of GH therapy there was a marked acceleration of growth velocity in both thalassaemic children ( from 3.8 + /- 0.6 cm/year to 7.2 + /- 0.8 cm/year ) and controls . However , the linear acceleration of growth velocity on GH therapy was significantly slower in thalassaemic children ( 3.3 + /- 0.3 cm/year increment ) compared with those with CSS ( 5.3 + /- 0.4 cm/year increment ) and GHD ( 6.9 + /- 1.2 cm/year increment ) ( P < 0.05 ) . Their circulating IGF-I concentration ( 105 + /- 36 ng/ml ) was significantly lower than those for CSS ( 246 + /- 58 ng/ml ) and GHD ( 189 + /- 52 ng/ml ) after 1 year of GH therapy . These data prove that some children with beta-thalassaemia major have a defective GH-IGF-I-IGFBP-3 axis and suggest the presence of partial resistance to GH Background : Quality of life ( QoL ) as it is related with growth hormone deficiency ( GHD ) is a matter of controversy . Methods : We analyzed QoL in 95 children aged 8–18 years with isolated GHD ( 72 % male ) treated with growth hormone ( GH ) . These children were compared to 190 age- and gender-matched healthy children with similar height [ height < 10th percentile ; control group 1 ( CG1 ) ] and age- and gender-matched 285 healthy children of normal stature ( control group 2 : CG2 ) . QoL was measured by the KINDL ® question naire referring to six domains ( physical well-being , emotional well-being , self-esteem , family , friends , and school ) . Results : QoL was significantly reduced in CG1 ( effect-size 0.21 ) compared to CG2 , while QoL was not significantly altered in children with GHD . In multiple linear regression analyses adjusted to age , gender , BMI , migration background , and socioeconomic status , decreasing height-SDS was associated with poorer QoL ( especially emotional well-being ) , and treatment with GH was related significantly to better self-esteem . Increase of height-SDS in children treated with GH was associated positively with QoL and all its subscales except family and school . Conclusions : These findings suggest psychological consequences of short stature in children and an improvement of QoL in children treated with GH with the focus on self-esteem and emotional well-being To assess whether delaying puberty may improve final height in GH-deficient children with a poor height prediction at early puberty , we studied 24 girls with isolated GH deficiency until they reached their final height , in a controlled trial . Patients were taking recombinant human GH ( r-hGH ) substitutive therapy from 2.1 + /- 0.5 yr ( 0.1 IU/kg.day sc ) before entering the study , without showing any improvement in height prediction ( 149.6 + /- 2.9 vs.150.3 + /- 2.2 cm ) on entering puberty . Fourteen girls agreed to add a GnRH agonist ( GnRHa ) to r-hGH , whereas the remaining 10 decided against it and served as controls . At the start of the study , girls treated with or without GnRHa had similar auxological characteristics ( bone age , 10.9 + /- 0.6 vs. 10.7 + /- 1.3 yr ; height SD score for chronological age , -1.87 + /- 0.3 vs. -1.82 + /- 0.2 ) , including pubertal development . The GnRHa ( long-acting D-Trp-6-GnRH ) was given at 60 microg/kg i m every 28 days for 1.9 + /- 0.9 yr , then patients continued the r-hGH at the same dosage ( 3.1 + /- 0.7 yr ) . At the end of the study , bone age was 16.2 + /- 0.3 yr in GnRHa-treated girls and 16.6 + /- 0.9 yr in controls . Bone maturation was significantly slower during GnRHa ( 1.4 + /- 0.2 yr ) , and height SD score for bone age improved ( -0.31 + /- 0.3 ) in comparison with controls ( 2.6 + /- 0.4 yr and -1.35 + /- 0.3 SD score ; P < 0.001 and P < 0.0001 , respectively ) . As a result , girls given the combined therapy reached a final height higher than that of controls ( height SD score , -0.39 + /- 0.5 vs. -1.45 + /- 0.2 ; P < 0.0001 ) and also higher than their midparental height ( -1.1 + /- 0.5 ; P < 0.0005 ) . Controls reached their midparental height . In conclusion , our results demonstrate that slowing pubertal development with the administration of GnRHa for a limited time may improve final height in GH-deficient girls selected because of a poor height prediction at early puberty We measured the final height ( FH ) of 25 short polytransfused thalassemia major ( Th ) patients ( 18 males ) with a reduced GH reserve treated for 3.3±1.2 yr with recombinant GH ( rhGH ) , 0.2 mg/kg/week sc . At baseline , all patients were clinical ly prepubertal ; their chronological ( CA ) and bone ages ( BA ) were 13.6±2.0 and 11.4±1.6 yr , respectively . In 9 out of 18 males and 5 out of 7 females , the onset of puberty occurred spontaneously during the treatment . At the end of the rhGH administration , the height of the enrolled children was not significantly increased when calculated for CA ( HxCA ) , while it was significantly decreased ( p=0.004 ) when calculated for BA ( HxBA ) ; the BA increase ( 3.29±1.65 yr ) was significantly higher ( p<0.001 ) than the height age increase ( 2.16±0.98 yr ) . The FHxCA showed a significant increase ( p=0.001 ) compared to both baseline and the end of therapy , while the FHxBA was significantly decreased ( p<0.001 ) compared with the corresponding value at baseline . At the end of therapy , both HxCA and HxBA result ed positively related to the BA at baseline ( r=0.50 and 0.42 , p=0.012 and 0.034 , respectively ) . FH was positively correlated with CA ( r=0.63 , p=0.001 ) , BA ( r=0.68 , p<0.001 ) and HxBA ( r=0.59 , p=0.002 ) evaluated at baseline , and with both HxCA and HxBA ( r=0.82 and 0.74 , respectively , p<0.001 ) , evaluated at the end of treatment . A negative correlation was found between FH and the length of treatment ( r=−0.56 , p=0.004 ) . Our data seem to exclude that prolonged rhGH therapy could improve FH in Th patients ; on the contrary , a negative effect may be hypothesized Patients with beta-thalassemia major ( beta-thalassemia ) frequently have bone disorders of multifactorial etiology . We attempted to analyze the relationship between the bone mineral density ( [ BMD ] measured by dual-photon absorptiometry ) and auxanologic parameters , degree of siderosis , function of the growth hormone (GH)/insulin-like growth factor-I (IGF-I)/IGF-binding protein-3 ( IGFBP3 ) axis , calcium-phosphate balance , parathyroid hormone ( PTH ) , and cytokines ( interleukin-1beta [ IL-1 ] and tumor necrosis factor-alpha [ TNF-alpha ] ) in 30 prepubertal children with beta-thalassemia major and 15 age-matched children with constitutional short stature ( CSS ) , who have normal glucose tolerance and thyroid function . Children with beta-thalassemia had a significantly decreased BMD and mean BMD% for age and sex ( 0.75+/-0.24 g/cm2 and 71%+/-10 % , respectively ) versus children with CSS ( 1.06+/-0.3 g/cm2 and 92%+/-7 % , respectively ) . Thalassemic patients had significantly lower circulating concentrations of IGF-I and IGFBP3 ( 49+/-21 ng/mL and 1.2+/-0.25 mg/L , respectively ) compared with control children ( 153+/-42 ng/mL and 2.1+/-0.37 mg/L , respectively ) . The GH response to provocation by clonidine and glucagon was defective ( peak GH < 7 microg/L ) in 12 of the 30 thalassemic children . Serum concentrations of IL-1beta and TNF-alpha did not differ among the two study groups . Hypocalcemia
Output:
| A small single trial contributed evidence of moderate quality that the use of growth hormone for a year may improve height velocity of children with thalassaemia although height SD score in the treatment group was similar to the control group . |
MS211924 | ***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 Incretin hormones , such as glucagon-like peptide 1 ( GLP-1 ) and glucose-dependent insulinotropic polypeptide ( GIP ) , play an important role in meal-related insulin secretion . We previously demonstrated that glutamine is a potent stimulus of GLP-1 secretion in vitro . OBJECTIVE Our objective was to determine whether glutamine increases circulating GLP-1 and GIP concentrations in vivo and , if so , whether this is associated with an increase in plasma insulin . DESIGN We recruited 8 healthy normal-weight volunteers ( LEAN ) , 8 obese individuals with type 2 diabetes or impaired glucose tolerance ( OB-DIAB ) and 8 obese nondiabetic control subjects ( OB-CON ) . Oral glucose ( 75 g ) , glutamine ( 30 g ) , and water were administered on 3 separate days in r and om order , and plasma concentrations of GLP-1 , GIP , insulin , glucagon , and glucose were measured over 120 min . RESULTS Oral glucose led to increases in circulating GLP-1 concentrations , which peaked at 30 min in LEAN ( 31.9 + /- 5.7 pmol/L ) and OB-CON ( 24.3 + /- 2.1 pmol/L ) subjects and at 45 min in OB-DIAB subjects ( 19.5 + /- 1.8 pmol/L ) . Circulating GLP-1 concentrations increased in all study groups after glutamine ingestion , with peak concentrations at 30 min of 22.5 + /- 3.4 , 17.9 + /- 1.1 , and 17.3 + /- 3.4 pmol/L in LEAN , OB-CON , and OB-DIAB subjects , respectively . Glutamine also increased plasma GIP concentrations but less effectively than glucose . Consistent with the increases in GLP-1 and GIP , glutamine significantly increased circulating plasma insulin concentrations . Glutamine stimulated glucagon secretion in all 3 study groups . CONCLUSION Glutamine effectively increases circulating GLP-1 , GIP , and insulin concentrations in vivo and may represent a novel therapeutic approach to stimulating insulin secretion in obesity and type 2 diabetes Gastric emptying of a liquid glucose meal was measured with scintigraphic techniques in nine recently diagnosed Type 2 diabetic patients and nine sex- and age-matched nondiabetic control subjects . Seven of the nine Type 2 diabetic patients were receiving oral hypoglycemic therapy which was discontinued the evening prior to the study . The other two diabetic patients were taking no medication . The average gastric half-emptying time was 33.6 min ( s.e.m . = 3.2 ) for the diabetic patients and 64.6 min ( s.e.m . = 4.2 ) for the nondiabetic controls ( p = 0.0005 ) . These measurements indicate rapid gastric emptying in Type 2 diabetic patients which may contribute to worsening of glucose control in these patients OBJECTIVE In patients with type 2 diabetes , but not type 1 diabetes , abnormal secretion of incretins in response to oral nutrients has been described . In healthy youths , we recently reported accentuated glucagon-like peptide 1 ( GLP-1 ) secretion in response to a diet soda sweetened with sucralose and acesulfame-K. In this study , we examined the effect of diet soda on gut hormones in youths with diabetes . RESEARCH DESIGN AND METHODS Subjects aged 12–25 years with type 1 diabetes ( n = 9 ) or type 2 diabetes ( n = 10 ) , or healthy control participants ( n = 25 ) drank 240 mL cola-flavored caffeine-free diet soda or carbonated water , followed by a 75-g glucose load , in a r and omized , cross-over design . Glucose , C-peptide , GLP-1 , glucose-dependent insulinotropic peptide ( GIP ) , and peptide Tyr-Tyr ( PYY ) were measured for 180 min . Glucose and GLP-1 have previously been reported for the healthy control subjects . RESULTS GLP-1 area under the curve ( AUC ) was 43 % higher after ingestion of diet soda versus carbonated water in individuals with type 1 diabetes ( P = 0.020 ) , similar to control subjects ( 34 % higher , P = 0.029 ) , but was unaffected by diet soda in patients with type 2 diabetes ( P = 0.92 ) . Glucose , C-peptide , GIP , and PYY AUC were not statistically different between the two conditions in any group . CONCLUSIONS Ingestion of diet soda before a glucose load augmented GLP-1 secretion in type 1 diabetic and control subjects but not type 2 diabetic subjects . GIP and PYY secretion were not affected by diet soda . The clinical significance of this increased GLP-1 secretion , and its absence in youths with type 2 diabetes , needs to be determined In type-2 diabetes , the overall incretin effect is reduced . The present investigation was design ed to compare insulinotropic actions of exogenous incretin hormones ( gastric inhibitory peptide [ GIP ] and glucagon-like peptide 1 [ GLP-1 ] [ 7 - 36 amide ] ) in nine type-2 diabetic patients ( fasting plasma glucose 7.8 mmol/liter ; hemoglobin A1c 6.3 + /- 0.6 % ) and in nine age- and weight-matched normal subjects . Synthetic human GIP ( 0.8 and 2.4 pmol/kg.min over 1 h each ) , GLP-1 [ 7 - 36 amide ] ( 0.4 and 1.2 pmol/kg.min over 1 h each ) , and placebo were administered under hyperglycemic clamp conditions ( 8.75 mmol/liter ) in separate experiments . Plasma GIP and GLP-1 [ 7 - 36 amide ] concentrations ( radioimmunoassay ) were comparable to those after oral glucose with the low , and clearly supraphysiological with the high infusion rates . Both GIP and GLP-1 [ 7 - 36 amide ] dose-dependently augmented insulin secretion ( insulin , C-peptide ) in both groups ( P < 0.05 ) . With GIP , the maximum effect in type-2 diabetic patients was significantly lower ( by 54 % ; P < 0.05 ) than in normal subjects . With GLP-1 [ 7 - 36 amide ] type-2 diabetic patients reached 71 % of the increments in C-peptide of normal subjects ( difference not significant ) . Glucagon was lowered during hyperglycemic clamps in normal subjects , but not in type-2 diabetic patients , and further by GLP-1 [ 7 - 36 amide ] in both groups ( P < 0.05 ) , but not by GIP . In conclusion , in mild type-2 diabetes , GLP-1 [ 7 - 36 amide ] , in contrast to GIP , retains much of its insulinotropic activity . It also lowers glucagon concentrations Exogenous glucagon-like peptide 1(GLP-1 ) bioactivity is preserved in type 2 diabetic patients , result ing the peptide administration in a near-normalization of plasma glucose mainly through its insulinotropic effect . GLP-1 also reduces meal-related insulin requirement in type 1 diabetic patients , suggesting an impairment of the entero-insular axis in both diabetic conditions . To investigate this metabolic dysfunction , we evaluated endogenous GLP-1 concentrations , both at fasting and in response to nutrient ingestion , in 16 type 1 diabetic patients ( age = 40.5 + /- 14yr , HbA1C = 7.8 + /- 1.5 % ) , 14 type 2 diabetics ( age = 56.5 + /- 13yr , HbA1C = 8.1 + /- 1.8 % ) , and 10 matched controls . In postabsorptive state , a mixed breakfast ( 230 KCal ) was administered to all subjects and blood sample s were collected for plasma glucose , insulin , C-peptide and GLP-1 determination during the following 3 hours . In normal subjects , the test meal induced a significant increase of GLP-1 ( 30 ' , 60 ' : p < 0.01 ) , returning the peptide values towards basal concentrations . In type 2 diabetic patients , fasting plasma GLP-1 was similar to controls ( 102.1 + /- 1.9 vs. 97.3 + /- 4.01 pg/ml ) , but nutrient ingestion failed to increase plasma peptide levels , which even decreased during the test ( p < 0.01 ) . Similarly , no increase in postpr and ial GLP-1 occurred in type 1 diabetics , in spite of maintained basal peptide secretion ( 106.5 + /- 1.5 pg/ml ) . With respect to controls , the test meal induced in both diabetic groups a significant increase in plasma glucagon levels at 60 ' ( p < 0.01 ) . In conclusion , either in condition of insulin resistance or insulin deficiency chronic hyperglycemia , which is a common feature of both metabolic disorders , could induce a progressive desensitization of intestinal L-cells with consequent peptide failure response to specific stimulation BACKGROUND Glucagon-like peptide 1 ( GLP-1 ) has been proposed as a treatment for type 2 diabetes . We have investigated the long-term effects of continuous administration of this peptide hormone in a 6-week pilot study . METHODS 20 patients with type 2 diabetes were alternately assigned continuous subcutaneous infusion of GLP-1 ( n=10 ) or saline ( n=10 ) for 6 weeks . Before ( week 0 ) and at weeks 1 and 6 , they underwent beta-cell function tests ( hyperglycaemic clamps ) , 8 h profiles of plasma glucose , insulin , C-peptide , glucagon , and free fatty acids , and appetite and side-effect ratings on 100 mm visual analogue scales ; at weeks 0 and 6 they also underwent dexascanning , measurement of insulin sensitivity ( hyperinsulinaemic euglycaemic clamps ) , haemoglobin A(1c ) , and fructosamine . The primary endpoints were haemoglobin A(1c ) concentration , 8-h profile of glucose concentration in plasma , and beta-cell function ( defined as the first-phase response to glucose and the maximum insulin secretory capacity of the cell ) . Analyses were per protocol . FINDINGS One patient assigned saline was excluded because no veins were accessible . In the remaining nine patients in that group , no significant changes were observed except an increase in fructosamine concentration ( p=0.0004 ) . In the GLP-1 group , fasting and 8 h mean plasma glucose decreased by 4.3 mmol/L and 5.5 mmol/L ( p<0.0001 ) . Haemoglobin A(1c ) decreased by 1.3 % ( p=0.003 ) and fructosamine fell to normal values ( p=0.0002 ) . Fasting and 8 h mean concentrations of free fatty acids decreased by 30 % and 23 % ( p=0.0005 and 0.01 , respectively ) . Gastric emptying was inhibited , bodyweight decreased by 1.9 kg , and appetite was reduced . Both insulin sensitivity and beta-cell function improved ( p=0.003 and p=0.003 , respectively ) . No important side-effects were seen . INTERPRETATION GLP-1 could be a new treatment for type 2 diabetes , though further investigation of the long-term effects of GLP-1 is needed Background Sleeve gastrectomy ( SG ) and Roux-en-Y gastric bypass ( RYGBP ) are associated with similar type 2 diabetes mellitus ( T2DM ) resolution rates for morbidly obese subjects . However , the mechanisms underlying the resolution of T2DM after SG have not been clarified to date . This study aim ed to compare the early changes in gastrointestinal hormones involved in insulin and glucagon secretion in morbidly obese T2DM subjects undergoing SG or RYGBP . Methods This prospect i ve study investigated 12 subjects with T2DM who had undergone SG ( n = 6 ) or RYGBP ( n = 6 ) . Five body mass index ( BMI ) -matched obese non-diabetic subjects and five BMI -matched obese diabetic subjects served as control subjects . Glucose , insulin , glucagon , glucagon-like peptide 1 ( GLP-1 ) , glucose-dependent insulinotropic polypeptide ( GIP ) , and GLP-2 were determined after a st and ardized mixed liquid meal before surgery and 6 weeks afterward . Results After 6 weeks , five of the six subjects in each surgical group presented with T2DM remission , although the area under the curve (AUC)0–120 of glucose was greater than that of the non-diabetic control subjects ( P < 0.01
Output:
| Fixed effects meta- analysis revealed higher peak plasma GLP-1 concentrations in patients with type 2 diabetes .
Meta-regression analyses showed that HbA1c and fasting plasma glucose predicted the outcomes iAUC and iAUC min−1 , respectively .
Conclusions /interpretationThe present analysis suggests that patients with type 2 diabetes , in general , do not exhibit reduced GLP-1 secretion in response to an OGTT or meal test , and that deteriorating glycaemic control may be associated with reduced GLP-1 secretion |
MS211925 | ***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 effectiveness and safety of cervical arthroplasty and anterior cervical discectomy fusion methods . METHODS The r and omised clinical trial was conducted at the neurosurgical clinic of University of Harran , Turkey , between February 2009 and January 2010 . The patients had single level disc disorder between C4-C7 levels . Before surgery , all of the patients had taken medical treatment with no improvement . Surgery was conducted with anterior approach , and disc prosthesis or polyetheretherketone cage for fusion were applied after patients were r and omly divided into two groups . For preoperative and postoperative clinical evaluations Neck Disability Index and Visual Analogue Scale were used . Surgical results were evaluated according to Odom 's criterion , and ' excellent ' and ' good ' results were accepted as successful . P<0.05 was taken as statistically significant . RESULTS Of the 42 patients in the study , 23(54.76 % ) were treated with Anterior Cervical Discectomy and Fusion , and 19(45.23 % ) with Cervical Disc Arthroplasty . There were no statistical differences between postoperative mean Visual Analogue Scale score ( p<0.86 ) and Neck Disability Index scores ( p<0.11 ) in the two groups . Average decrease in lordosis angle was 1.2 degree in Arthroplasty group , while it was 1 degree in the Fusion group . Postoperative adjacent segment degeneration was not detected in either group . CONCLUSION Anterior Cervical Discectomy and Fusion , and Cervical Disc Arthroplasty are safe and successful methods for the treatment of single level cervical disc disease . Although the latter is a relatively new technique performed with increased frequency , but its superiority is still uncertain BACKGROUND CONTEXT Cervical total disc replacement ( TDR ) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease ( SCDD ) . PURPOSE The purpose of this trial is to compare the safety and efficacy of cervical TDR , ProDisc-C ( Synthes Spine Company , L.P. , West Chester , PA ) , to anterior cervical discectomy and fusion ( ACDF ) surgery for the treatment of one-level SCDD between C3 and C7 . STUDY DESIGN / SETTING The study was conducted at 13 sites . A noninferiority design with a 1:1 r and omization was used . PATIENT SAMPLE Two hundred nine patients were r and omized and treated ( 106 ACDF ; 103 ProDisc-C ) . OUTCOME MEASURES Visual analog scale ( VAS ) pain and intensity ( neck and arm ) , VAS satisfaction , neck disability index ( NDI ) , neurological exam , device success , adverse event occurrence , and short form-36 ( SF-36 ) st and ardized question naires . METHODS A prospect i ve , r and omized , controlled clinical trial was performed . Patients were enrolled and treated in accordance with the US Food and Drug Administration ( FDA ) -approved protocol . Patients were assessed pre- and postoperatively at six weeks , 3 , 6 , 12 , 18 , and 24 months . RESULTS Demographics were similar between the two patient groups ( ProDisc-C : 42.1+/-8.4 years , 44.7 % males ; Fusion : 43.5 + /- 7.1 years , 46.2 % males ) . The most commonly treated level was C5-C6 ( ProDisc-C : 56.3 % ; Fusion=57.5 % ) . NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups ( p<.0001 ) . VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels ( p<.0001 ) but were not different between treatments . Neurologic success ( improvement or maintenance ) was achieved at 24 months in 90.9 % of ProDisc-C and 88.0 % of Fusion patients ( p=.638 ) . Results show that at 24 months postoperatively , 84.4 % of ProDisc-C patients achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline at the operated level . There was a statistically significant difference in the number of secondary surgeries with 8.5 % of Fusion patients needing a re-operation , revision , or supplemental fixation within the 24 month postoperative period compared with 1.8 % of ProDisc-C patients ( p=.033 ) . At 24 months , there was a statistically significant difference in medication usage with 89.9 % of ProDisc-C patients not on strong narcotics or muscle relaxants , compared with 81.5 % of Fusion patients . CONCLUSIONS The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease . By all primary and secondary measures evaluated , clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion OBJECT The authors report the results of a prospect i ve r and omized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion ( ACDF ) in patients treated for symptomatic single-level cervical degenerative disc disease ( DDD ) . METHODS Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and r and omly assigned to one of two treatment groups : 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System ( Medtronic Sofamor Danek ) ; 265 patients in the control group underwent decompressive ACDF . Eighty percent of the arthroplasty-treated patients ( 223 of 276 ) and 75 % of the control patients ( 198 of 265 ) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery . Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group . The arthroplasty group also had a statistically significant higher rate of neurological success ( p = 0.005 ) as well as a lower rate of secondary revision surgeries ( p = 0.0277 ) and supplemental fixation ( p = 0.0031 ) . The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months , as was relief of neck pain . The patients in the investigational group returned to work 16 days sooner than those in the control group , and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well ( p = 0.0492 , log-rank test ) . The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees . In the investigational group , there were no cases of implant failure or migration . CONCLUSIONS The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success , improved clinical outcomes , and a reduced rate of secondary surgeries compared with ACDF OBJECT There are now 3 r and omized , multicenter , US FDA investigational device exemption , industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion ( ACDF ) for single-level cervical disease with 2 years of follow-up . These 3 studies evaluated the Prestige ST , Bryan , and ProDisc-C artificial discs . The authors analyzed the combined results of these trials . METHODS A total of 1213 patients with symptomatic , single-level cervical disc disease were r and omized into 2 treatment arms in the 3 r and omized trials . Six hundred twenty-one patients received an artificial cervical disc , and 592 patients were treated with ACDF . In the three trials , 94 % of the arthroplasty group and 87 % of the ACDF group have completed 2 years of follow-up . The authors analyzed the 2-year data from these 3 trials including previously unpublished source data . Statistical analysis was performed with fixed and r and om effects models . RESULTS The authors ' analysis revealed that segmental sagittal motion was preserved with arthroplasty ( preoperatively 7.26 ° and postoperatively 8.14 ° ) at the 2-year time point . The fusion rate for ACDF at 2 years was 95 % . The Neck Disability Index , 36-Item Short Form Health Survey Mental , and Physical Component Summaries , neck pain , and arm pain scores were not statistically different between the groups at the 24-month follow-up . The arthroplasty group demonstrated superior results at 24 months in neurological success ( RR 0.595 , I(2 ) = 0 % , p = 0.006 ) . The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point ( RR 0.44 , I(2 ) = 0 % , p = 0.004 ) . At the 2-year time point , the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model ( RR 0.460 , I(2 ) = 2.9 % , p = 0.030 ) , but this finding was not significant using a r and om effects model . Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis . CONCLUSIONS Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy . Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years . Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years , but further follow-up and analysis are needed to confirm this finding Purpose Heterotopic ossification is a phenomenon in cervical arthroplasty . Previous reports have mainly focused on various semiconstrained devices and only a few publications have focused on ossification around devices that are nonconstrained . The purpose of this study was to assess the occurrence of heterotopic ossification around a nonconstrained cervical device and how it affects clinical outcome 2 years after surgery . Methods Thirty-seven patients were included from a larger cohort of a r and omized controlled trial ( NORCAT ) which compared single-level cervical arthroplasty with fusion . The occurrence of heterotopic ossification was assessed with a CT scan and two neuroradiologists determined its degree . For grading , we used the Mehren/Suchomel classification system ( grade 0–4 ) . The patients were divided by level of ossification , low grade ( 0–2 ) or high grade ( 3–4 ) , and clinical outcomes were compared . Self-rated disability for neck and arm pain ( Neck Disability Index ) , health-related quality of life ( the Short Form-36 and EuroQol-5D ) , and pain ( the Numeric Rating Scale 11 ) were used as clinical outcome measures . Results Heterotopic ossification was encountered in all patients 2 years after surgery . Complete fusion ( grade 4 ) was found in 16 % of participants , and high- grade ossification ( grade 3–4 ) occurred in 62 % . The remaining patients were classified as having low- grade ossification ( grade 2 ) . There were no differences in the clinical outcomes of patients with low- and high- grade ossification . Conclusion High- grade heterotopic ossification and spontaneous fusion 2 years after surgery were seen in a significant number of patients . However , the degree of ossification did not influence the clinical outcome Purpose St and ard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion , but the use of arthroplasty , design ed to preserve motion , has increased , and most studies report clinical outcome in its favor . Few of these trials , however , blinded the patients . We , therefore , conducted the Norwegian Cervical Arthroplasty Trial , and present 2-year clinical outcome after arthroplasty or fusion . Methods This multicenter trial included 136 patients with single-level cervical disc disease . The patients were r and omized to arthroplasty or fusion , and blinded to the treatment modality . The surgical team was blinded to r and omization until nerve root decompression was completed . Primary outcome was the self-rated Neck Disability Index . Secondary outcomes were the numeric rating scale for pain and quality of life question naires Short Form-36 and EuroQol-5Dimension-3 Level . Results There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion ( P < 0.001 ) , and no observed significant between-group differences at any follow-up times . However , linear mixed model analyses , correcting for baseline values , dropouts and missing data , revealed a difference in Neck Disability Index ( P = 0.049 ) , and arm pain ( P = 0.027 ) in favor of fusion at 2 years . The duration of surgery was longer ( P < 0.001 ) , and the frequency of reoperations higher ( P = 0.029 ) with arthroplasty . Conclusion The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up . However , the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty
Output:
| Conclusions : There is a lack of consistency in reporting of AEs among RCTs of cervical arthroplasty .
FDA IDE trials scored better in AE event reporting compared to other studies . |
MS211926 | ***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: Hunger during school may prevent children in developing countries from benefiting from education . Although many countries have implemented school feeding programs , few programs have been rigorously evaluated . We conducted a r and omized , controlled trial of giving breakfast to undernourished and adequately nourished children . The undernourished group comprised 407 children in grade s 2 - 5 in 16 rural Jamaican schools ( weights-for-age < or = -1 SD of the National Center for Health Statistics references ) and the adequately nourished group comprised 407 children matched for school and class ( weights-for-age > -1 SD ) . Both groups were stratified by class and school , then r and omly assigned to breakfast or control groups . After the initial measurements , breakfast was provided every school day for 1 school year . Children in the control group were given one-quarter of an orange and the same amount of attention as children in the breakfast group . All children had their heights and weights measured and were given the Wide Range Achievement Test before and after the intervention . School attendance was taken from the schools ' registers . Compared with the control group , height , weight , and attendance improved significantly in the breakfast group . Both groups made poor progress in Wide Range Achievement Test scores . Younger children in the breakfast group improved in arithmetic . There was no effect of nutritional group on the response to breakfast . In conclusion , the provision of a school breakfast produced small benefits in children 's nutritional status , school attendance , and achievement . Greater improvements may occur in more undernourished population s ; however , the massive problem of poor achievement levels requires integrated programs including health and educational inputs as well as school meals OBJECTIVE To examine the long-term effects of an intervention combining teacher training , parent education , and social competence training for children during the elementary grade s on adolescent health-risk behaviors at age 18 years . DESIGN Nonr and omized controlled trial with follow-up 6 years after intervention . SETTING Public elementary schools serving high-crime areas in Seattle , Wash. PARTICIPANTS Of the fifth- grade students enrolled in participating schools , 643 ( 76 % ) were given written parental consent for the longitudinal study and 598 ( 93 % ) were followed up and interviewed at age 18 years . INTERVENTIONS A full intervention provided in grade s 1 through 6 of 5 days of in-service training for teachers each intervention year , developmentally appropriate parenting classes offered to parents when children were in grade s 1 through 3 and 5 through 6 , and developmentally adjusted social competence training for children in grade s 1 and 6 . A late intervention , provided in grade s 5 and 6 only , paralleled the full intervention at these grade s. MAIN OUTCOME MEASURES Self-reported violent and nonviolent crime , substance use , sexual activity , pregnancy , bonding to school , school achievement , grade repetition and school dropout , suspension and /or expulsion , and school misbehavior ; delinquency charges from court records ; grade point average ; California Achievement Test scores : and disciplinary action reports from school records . RESULTS Fewer students receiving full intervention than control students reported violent delinquent acts ( 48.3 % vs 59.7 % ; P=.04 ) , heavy drinking ( 15.4 % vs 25.6 % ; P=.04 ) , sexual intercourse ( 72.1 % vs 83.0 % ; P=.02 ) , having multiple sex partners ( 49.7 % vs 61.5 % ; P=.04 ) , and pregnancy or causing pregnancy ( 17.1 % vs 26.4 % ; P=.06 ) by age 18 years . The full intervention student group reported more commitment ( P=.03 ) and attachment ( P=.006 ) to school , better academic achievement ( P=.01 ) , and less school misbehavior ( P=.02 ) than control students . Late intervention in grade s 5 and 6 only did not significantly affect health-risk behaviors in adolescence . CONCLUSIONS A package of interventions with teachers , parents , and children provided throughout the elementary grade s can have enduring effects in reducing violent behavior , heavy drinking , and sexual intercourse by age 18 years among multiethnic urban children . Results are consistent with the theoretical model guiding the intervention and support efforts to reduce health-risk behaviors through universal interventions in selected communities or schools serving high-crime neighborhoods This study evaluated the effect of Students for Peace , a multi-component violence-prevention intervention , on reducing aggressive behaviors among students of eight middle schools r and omly assigned into intervention or control conditions . The intervention , based on Social Cognitive Theory , included the formation of a School Health Promotion Council , training of peer mediators and peer helpers , training of teachers in conflict resolution , a violence-prevention curriculum , and newsletters for parents . All students were evaluated in the spring of 1994 , 1995 and 1996 ( approximately 9000 students per evaluation ) . Sixth grade rs in 1994 were followed through seventh grade in 1995 or eighth grade in 1996 or both ( n = 2246 ) . Cohort and cross-sectional evaluations indicated little to no intervention effect in reducing aggressive behaviors , fights at school , injuries due to fighting , missing classes because of feeling unsafe at school or being threatened to be hurt . For all variables , the strongest predictors of violence in eighth grade were violence in sixth grade and low academic performance . Although ideal and frequently recommended , the holistic approach to prevention in schools in which teachers , administrators and staff model peaceful conflict resolution is difficult to implement , and , in this case , proved ineffective . The Students for Peace experience suggests that interventions begin prior to middle school , explore social environmental intervention strategies , and involve parents and community members OBJECTIVE To examine the long-term effects of the Seattle Social Development Project intervention in promoting positive adult functioning and preventing mental health problems , crime , and substance use ( including tobacco , alcohol , and other drugs ) at 21 years of age . DESIGN This nonr and omized controlled trial followed up participants to 21 years of age , 9 years after the intervention ended . We compared the following 3 intervention conditions : a full 6-year intervention ( grade s 1 through 6 ) ; a late 2-year intervention ( grade s 5 and 6 only ) ; and a no-treatment control condition . SETTING Eighteen public elementary schools serving diverse neighborhoods , including high-crime neighborhoods , of Seattle , Wash. PARTICIPANTS A sex-balanced , multiethnic sample of 605 participants across the 3 conditions who completed interviews at 21 years of age ( 94 % of the original sample in these conditions ) . INTERVENTIONS Teacher training in classroom instruction and management , child social and emotional skill development , and parent training . MAIN OUTCOME MEASURES Self-reports of functioning in school and work , emotional and mental health , and crime and substance use at 21 years of age and official court records . RESULTS Broad significant effects on functioning in school and work and on emotional and mental health were found . Fewer significant effects on crime and substance use were found at 21 years of age . Most outcomes had a consistent dose effect , with the strongest effects in subjects in the full-intervention group and effects in the late-intervention group between those in the full-intervention and control groups . CONCLUSIONS A theory-guided preventive intervention that strengthened teaching and parenting practice s and taught children interpersonal skills during the elementary grade s had wide-ranging beneficial effects on functioning in early adulthood The effects of a 2-year health-related school physical education program on st and ardized academic achievement scores was assessed in 759 children who completed Metropolitan Achievement Tests before and after the program . Schools were r and omly assigned to condition : ( a ) Specialists taught the Sports , Play , and Active Recreation for Kids curriculum ; ( b ) classroom teachers were trained to implement the curriculum ; and ( c ) controls continued their usual programs . The Trained Teacher condition was superior to Control on Language , Reading , and Basic Battery . The Specialist condition was superior to Control on Reading , but inferior on Language . Despite devoting twice as many minutes per week to physical education as Controls , the health-related physical education program did not interfere with academic achievement . Health-related physical education may have favorable effects on students ' academic achievement STUDY OBJECTIVE This study assessed the impact of a comprehensive school-based asthma program on symptoms , grade s , and school absences in children , and parents ' asthma management practice s. DESIGN R and omized controlled trial . SETTING Fourteen elementary schools in low-income neighborhoods in Detroit , MI . PARTICIPANTS Eight hundred thirty-five children with asthma in grade s 2 through 5 and their parents . INTERVENTION The intervention entailed six components for children , their parents , classmates , and school personnel to encourage and enable disease management . MEASUREMENTS AND RESULTS Parents completed telephone interviews and the schools provided data at baseline and 24 months after intervention . At follow-up , treatment children with persistent disease had significant declines in both daytime ( 14 % fewer , p < 0.0001 ) and nighttime ( 14 % fewer , p < 0.0001 ) symptoms . Among children with both mild intermittent and persistent disease , those in the treatment group had 17 % fewer daytime symptoms ( p < 0.0001 ) but 40 % more nighttime symptoms . Treatment children had higher grade s for science ( p < 0.02 ) but not reading , mathematics , or physical education . No differences in school absences for all causes between groups were noted in school records . However , parents of treatment group children reported fewer absences attributable to asthma in the previous 3 months ( 34 % fewer , p < 0.0001 ) and 12 months ( 8 % fewer , p < 0.05 ) . Parents of treatment children had higher scores ( 2.19 greater , p = 0.02 ) on an asthma management index . The program may have stimulated attention to symptoms at night by parents of children with mild intermittent disease . Overall , the intervention provided significant benefits , particularly for children with persistent asthma The authors examined the effectiveness of a school-based prevention program on reducing binge drinking in a sample of minority , inner-city , middle-school students . Rates of binge drinking were compared among youth who received the program beginning in the 7th grade ( n = 1,713 ) and a control group ( n = 1,328 ) that did not . The prevention program had protective effects in terms of binge drinking at the 1-year ( 8th grade ) and 2-year ( 9th grade ) follow-up assessment s. The proportion of binge drinkers was over 50 % lower in the intervention group relative to the control group at the follow-up assessment s. There were also several significant program effects on proximal drinking variables , including drinking knowledge , pro-drinking attitudes , and peer drinking norms . These findings indicate that a school-based drug abuse prevention approach previously found to be effective among White youth significantly reduced binge drinking among urban minority youth A six-year , school-based prevention program , which modified classroom teacher practice s , offered parent training , and provided child social skills training , was evaluated for its effects on school failure , drug abuse , and delinquency among low-income urban children . Compared to a low-income control group , children in the intervention group showed enhanced school commitment and class participation . The girls in the group also evidence d lower rates of substance use initiation , while the boys exhibited increased social and school work skills Objectives . This study evaluated the long-term effectiveness of Safer Choices , a theory-based , multi-component educational program design ed to reduce sexual risk behaviors and increase protective behaviors in preventing HIV , other STDs , and pregnancy among high school students . Methods . The study used a r and omized controlled trial involving 20 high schools in California and Texas . A cohort of 3869 ninth- grade students was tracked for 31 months from fall semester 1993 ( baseline ) to spring semester 1996 ( 31-month follow-up ) . Data were collected using self-report surveys administered by trained data collectors . Response rate at 31-month follow-up was 79 % . Results . Safer Choices had its greatest effect on measures involving condom use . The program reduced the frequency of intercourse without a condom during the three months prior to the survey , reduced the number of sexual partners with whom students had intercourse without a condom , and increased use of condoms and other protection against pregnancy at last intercourse . Safer Choices also improved 7 of 13 psychosocial variables , many related to condom use , but did not have a significant effect upon rates of sexual initiation . Conclusions . The Safer Choices program was effective in reducing important risk behaviors for HIV , other STDs , and pregnancy and in enhancing most psychosocial determinants of such behavior OBJECTIVES An earlier report described desirable 1-month follow-up effects of the Safe Date s program on psychological , physical , and sexual dating violence . Mediators of the program-behavior relationship also were identified . The present report describes the 1-year follow-up effects of the Safe Date s program . METHODS Fourteen schools were in the r and omized experiment . Data were gathered by question naires in schools before program activities and 1 year after the program ended . RESULTS The short-term behavioral effects had disappeared at 1 year , but effects on mediating variables such as dating violence norms , conflict management skills , and awareness of community services for dating violence were maintained . CONCLUSIONS The findings are considered in the context of why program effects might have decayed and the possible role of boosters for effect maintenance OBJECTIVE This prospect i ve study is focused on the characteristics leading to alcohol use disorders in early adulthood among a cohort of black children . The principal aim of this work is to examine the impact of educational attainment , school dropout and early school adaptation on the development of alcohol abuse and dependence in adulthood . METHOD From a population that consisted of 1,242 first grade rs in 1966 - 67 , a total of 953 were interviewed at age 32 - 33 about their current alcohol and drug use , educational attainment ,
Output:
| RESULTS The strongest evidence from scientifically rigorous evaluations exists for a positive effect on some academic outcomes from school health programs for asthmatic children that incorporate health education and parental involvement .
Strong evidence also exists for a lack of negative effects of physical education programs on academic outcomes .
Limited evidence from scientifically rigorous evaluations support the effect of nutrition services , health services , and mental health programs , but no such evidence is found in the literature to support the effect of staff health promotion programs or school environment interventions on academic outcomes .
However , school health programs hold promise for improving academic outcomes for children |
MS211927 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Although patients with chronic kidney disease ( CKD ) are at increased risk of cardiovascular disease ( CVD ) , the roles of lipid-modifying therapies in decreasing CVD risk are unclear . Our aim is to compare the effects of statin and fibrate therapy on arterial function as a risk marker of CVD . STUDY DESIGN Double-blind , r and omized , placebo-controlled , parallel-group study . SETTING & PARTICIPANTS Ambulatory patients with stages 3 to 5 CKD . INTERVENTION 6 weeks of atorvastatin , 40 mg/d , or gemfibrozil , 600 mg twice daily , with placebo . OUTCOMES & MEASUREMENTS Primary outcome was arterial function assessed by means of endothelial-dependent flow-mediated dilatation ( FMD ) and small-artery compliance ( C2 ) . Secondary outcomes included endothelial-independent glyceryl trinitrate-mediated dilatation ( GTNMD ) , large-artery compliance ( C1 ) , and levels of lipids , lipoproteins , and oxidized low-density lipoprotein , as well as markers of insulin resistance and inflammation . RESULTS Compared with placebo , atorvastatin significantly decreased low-density lipoprotein ( -52 % ) , triglyceride ( -30 % ) , and oxidized low-density lipoprotein levels ( -41 % ; P < 0.0001 ) . Gemfibrozil significantly decreased triglyceride levels ( -40 % ) and increased high-density lipoprotein levels ( + 20 % ; P < 0.0001 ) . Neither atorvastatin nor gemfibrozil had a significant effect on markers of insulin resistance or inflammation . There was no significant change in FMD , GTNMD , or C1 with either atorvastatin or gemfibrozil . There was improvement in C2 with atorvastatin ( + 1.1 mL/mm Hg x 100 ) compared with placebo ( P = 0.024 ) , but not with gemfibrozil compared with placebo . LIMITATIONS Small sample size leading to inadequate power , short duration of therapy , and use of a heterogeneous group of patients with CKD and dialysis patients . CONCLUSION In patients with advanced CKD , atorvastatin is associated with improvement in dyslipidemia and small-artery stiffness , but not endothelial function . Gemfibrozil improves dyslipidemia , but has no effect on arterial function Background Patients with end-stage renal disease ( ESRD ) are at high risk of cardiovascular events . Multiple risk factors for atherosclerosis are present in ESRD and may contribute to the increased risk of cardiovascular mortality in this population . In contrast to patients with normal renal function , the benefits of modifying lipid levels on cardiovascular outcomes in patients with ESRD on haemodialysis have yet to be confirmed in large prospect i ve r and omised trials . A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis : an Assessment of survival and cardiovascular events ( AURORA ) will be the first large-scale international trial to assess the effects of statin therapy on cardiovascular morbidity and mortality in ESRD patients on chronic haemodialysis . Methods More than 2,750 ESRD patients who have been receiving chronic haemodialysis treatment for at least 3 months have been r and omised ( 1:1 ) , irrespective of baseline lipid levels , to treatment with rosuvastatin 10 mg or placebo . The primary study endpoint is the time to a major cardiovascular event ( first occurrence of cardiovascular death , non-fatal myocardial infa rct ion or non-fatal stroke ) . Secondary endpoints include all-cause mortality , major cardiovascular event-free survival time , time to cardiovascular death , time to non-cardiovascular death , cardiovascular interventions , tolerability of treatment and health economic costs per life-year saved . Study medication will be given until 620 subjects have experienced a major cardiovascular event . Conclusion Our hypothesis is that results from AURORA will establish the clinical efficacy and tolerability of rosuvastatin in patients with ESRD receiving chronic haemodialysis and guide the optimal management of this exp and ing population Statins have multiple effects , including anti-inflammatory actions , lowering C-reactive protein levels , and reducing coronary events . We performed a post hoc analysis of the r and omized placebo-controlled 4D Study that had evaluated the efficacy and safety of atorvastatin in 1255 patients with type 2 diabetes mellitus who were on maintenance hemodialysis . Here we determined the relationship between atorvastatin treatment , C-reactive protein , and the outcome of patients who had pre-specified and adjudicated endpoints of all-cause mortality , composite vascular endpoint , myocardial infa rct ion , sudden death , and stroke . Atorvastatin had no significant effect on the risk of composite vascular endpoint or death relative to placebo in any quartile of baseline C-reactive protein . These baseline levels were not significantly different between the treated and placebo group and remained stable at 6 months on atorvastatin but significantly increased in those patients on placebo . All of the patients with baseline C-reactive protein in the fourth quartile had a significantly increased risk of deaths and in composite vascular endpoint compared to patients in the first quartile . The mean value of two consecutive C-reactive protein measurements was associated with significant increases in the risk of sudden death , stroke , all-cause mortality and composite vascular endpoint . Our results show that C-reactive protein was highly predictive of outcome , but atorvastatin treatment was not associated with reduced relative risks in the composite vascular endpoint or mortality in patients on hemodialysis with or without inflammation Background The high incidence of cardiovascular disease in patients with end stage renal disease ( ESRD ) is related to the accumulation of uremic toxins in the middle and large-middle molecular weight range . As online hemodiafiltration ( HDF ) removes these molecules more effectively than st and ard hemodialysis ( HD ) , it has been suggested that online HDF improves survival and cardiovascular outcome . Thus far , no conclusive data of HDF on target organ damage and cardiovascular morbidity and mortality are available . Therefore , the CONvective TRAnsport STudy ( CONTRAST ) has been initiated . Methods CONTRAST is a Dutch multi-center r and omised controlled trial . In this trial , approximately 800 chronic hemodialysis patients will be r and omised between online HDF and low-flux HD , and followed for three years . The primary endpoint is all cause mortality . The main secondary outcome variables are fatal and non-fatal cardiovascular events . Conclusion The study is design ed to provide conclusive evidence whether online HDF leads to a lower mortality and less cardiovascular events as compared to st and ard HD The efficacy , tolerability and safety of simvastatin in the treatment of hyperlipemia in uremic patients undergoing hemodialysis were evaluated in 6 patients ; a further 6 patients were treated with placebo and represented the control group . All patients treated completed the study . No clinical or laboratory side-effects were noted during the entire period of observation . Simvastatin caused a significant 26 % reduction in total cholesterol , a 36 % reduction in LDL cholesterol and a 28 % reduction in triglycerides ; HDL cholesterol and Apolipoprotein A increased by 19 % and 12 % respectively Summary Background Lowering LDL cholesterol with statin regimens reduces the risk of myocardial infa rct ion , ischaemic stroke , and the need for coronary revascularisation in people without kidney disease , but its effects in people with moderate-to-severe kidney disease are uncertain . The SHARP trial aim ed to assess the efficacy and safety of the combination of simvastatin plus ezetimibe in such patients . Methods This r and omised double-blind trial included 9270 patients with chronic kidney disease ( 3023 on dialysis and 6247 not ) with no known history of myocardial infa rct ion or coronary revascularisation . Patients were r and omly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo . The key prespecified outcome was first major atherosclerotic event ( non-fatal myocardial infa rct ion or coronary death , non-haemorrhagic stroke , or any arterial revascularisation procedure ) . All analyses were by intention to treat . This trial is registered at Clinical Trials.gov , NCT00125593 , and IS RCT N54137607 . Findings 4650 patients were assigned to receive simvastatin plus ezetimibe and 4620 to placebo . Allocation to simvastatin plus ezetimibe yielded an average LDL cholesterol difference of 0·85 mmol/L ( SE 0·02 ; with about two-thirds compliance ) during a median follow-up of 4·9 years and produced a 17 % proportional reduction in major atherosclerotic events ( 526 [ 11·3 % ] simvastatin plus ezetimibe vs 619 [ 13·4 % ] placebo ; rate ratio [ RR ] 0·83 , 95 % CI 0·74–0·94 ; log-rank p=0·0021 ) . Non-significantly fewer patients allocated to simvastatin plus ezetimibe had a non-fatal myocardial infa rct ion or died from coronary heart disease ( 213 [ 4·6 % ] vs 230 [ 5·0 % ] ; RR 0·92 , 95 % CI 0·76–1·11 ; p=0·37 ) and there were significant reductions in non-haemorrhagic stroke ( 131 [ 2·8 % ] vs 174 [ 3·8 % ] ; RR 0·75 , 95 % CI 0·60–0·94 ; p=0·01 ) and arterial revascularisation procedures ( 284 [ 6·1 % ] vs 352 [ 7·6 % ] ; RR 0·79 , 95 % CI 0·68–0·93 ; p=0·0036 ) . After weighting for subgroup-specific reductions in LDL cholesterol , there was no good evidence that the proportional effects on major atherosclerotic events differed from the summary rate ratio in any subgroup examined , and , in particular , they were similar in patients on dialysis and those who were not . The excess risk of myopathy was only two per 10 000 patients per year of treatment with this combination ( 9 [ 0·2 % ] vs 5 [ 0·1 % ] ) . There was no evidence of excess risks of hepatitis ( 21 [ 0·5 % ] vs 18 [ 0·4 % ] ) , gallstones ( 106 [ 2·3 % ] vs 106 [ 2·3 % ] ) , or cancer ( 438 [ 9·4 % ] vs 439 [ 9·5 % ] , p=0·89 ) and there was no significant excess of death from any non-vascular cause ( 668 [ 14·4 % ] vs 612 [ 13·2 % ] , p=0·13 ) . Interpretation Reduction of LDL cholesterol with simvastatin 20 mg plus ezetimibe 10 mg daily safely reduced the incidence of major atherosclerotic events in a wide range of patients with advanced chronic kidney disease . Funding Merck/Schering-Plough Pharmaceuticals ; Australian National Health and Medical Research Council ; British Heart Foundation ; UK Medical Research Council BACKGROUND Cardiovascular disease as a result of accelerated atherogenesis is common in patients with end-stage renal disease ( ESRD ) . Dyslipidemia may be a major contributor in this process and can be influenced by lipid-lowering drugs ( statins ) . Moreover , statins may exhibit additional inhibitory effects on the atherogenesis , such as a modulation of the immune system as triggered by oxidatively modified LDL and a reduction of the inflammatory marker C-reactive protein ( CRP ) . METHODS We evaluated in a single-blind r and omized trial of 28 ESRD patients on hemodialysis , the dose-depending effects of both atorvastatin and simvastatin on lipids , lipoproteins , LDL particle heterogeneity , high sensitive-CRP , and markers of in vivo LDL oxidation . RESULTS Both statin therapies significantly lowered total plasma cholesterol and LDL-cholesterol concentrations to the same extent , whereas reduction in the concentrations of triglyceride-rich particles was less pronounced . Furthermore , statin therapy reduced LDL cholesterol in all LDL subfractions , without altering the overall LDL particle density . After both statins plasma hs-CRP concentrations were not significantly reduced ; parameters of in vivo LDL oxidation ( plasma ox-LDL concentration and the oxidation level of isolated LDL ) , were significantly decreased . Autoantibodies against ox-LDL , however , did not change during this trial period . CONCLUSIONS These results show that atorvastatin and simvastatin exhibit comparable favourable effects on lipid profiles in ESRD . Moreover , the reduction of in vivo oxidatively modified LDL as shown in this ESRD population , may indicate that these statins exhibit favourable effects on oxidative stress in vivo Objective . There have been no endpoint studies with statins for patients with severe renal failure . The purpose of this prospect i ve , open , r and omized , controlled study
Output:
| Statins have little or no beneficial effects on mortality or cardiovascular events and uncertain adverse effects in adults treated with dialysis despite clinical ly relevant reductions in serum cholesterol levels |
MS211928 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background and the Purpose of the Study Patients undergoing high-dose chemotherapy for hematological malignancies are susceptible to development of oral mucositis , and no effective modality has been reported for its prophylaxis and treatment . The aim of this study was to evaluate the effectiveness of zinc mouthwash on chemotherapy-induced oral mucositis lesions . Methods In this double-blind r and omized trial , patients under chemotherapy for acute leukemia were divided into two test and control groups of 15 patients each . The groups were homogeneous with respect to medical history , tumor characteristics , and therapeutic details . The test group received 10ml 0.2 % zinc sulfate mouthwash , and the control group received 10ml 0.2 % chlorhexidine gluconate mouthwash , twice a day for a period of two weeks . Spijkervet scale was used to grade the severity of mucositis at every other week during eight weeks . The severity scores were analyzed with repeated measure ANOVA using SPSS 13.0 computer software . Results Mean severity scores were generally lower in the test group compared to the controls at all four time intervals evaluated ; but only , the differences in weeks of 2 and 3 were statistically significant ( P=0.025 ) . Conclusion Zinc mouthwash used in conjunction with chemotherapy may reduce the severity of oral mucositis lesions in patients with leukaemia The purpose of this study was to evaluate the effect of oral zinc sulfate in the prevention of chemotherapy‐induced mucositis in patients undergoing hematopoietic stem‐cell transplantation ( HSCT ) . This study was a double‐blind , r and omized , placebo‐controlled design , with 60 patients undergoing HSCT , divided proportionally in experimental group who received zinc sulfate , and in placebo group . They all had received high‐dose chemotherapy conditioning regimen for allogenic transplantation . Oral mucositis assessed was based on World Health Organization ( WHO ) oral mucositis scale . There were no significant differences in the development of mucositis between the two groups . Severity of mucositis was not significantly different between the two groups either . The same result was obtained regarding the duration of mucositis . Zinc sulfate did not show any significant adverse effects in experimental group . In conclusion , Zinc sulfate did not have any clinical benefits in prevention or reduction of severity , and duration of high‐dose chemotherapy‐induced mucositis in patients undergoing HSCT . Copyright © 2011 John Wiley & Sons , Oral mucositis ( OM ) is a complication of high-dose chemotherapy ( HDC ) followed by hematopoietic SCT ( HSCT ) with few effective treatments . Selenium has a cytoprotective role via the glutathione peroxidase ( Glu . Px ) enzyme and prevents chemotherapy-induced toxicities . We performed a double‐blind , r and omized , placebo-controlled study to evaluate the efficacy of selenium on the prevention of OM in 77 patients with leukemia , undergoing allogeneic HSCT . Thirty-seven patients received oral selenium tablets ( 200 mcg twice daily ) from the starting day of HDC to 14 days after transplantation . OM was evaluated daily for 21 days after transplantation according to World Health Organization oral toxicity scale . The incidence of severe OM ( grade s 3–4 ) was significantly lower in the selenium group ( 10.8 % vs 35.1 % , P<0.05 ) . We noted that the duration of objective OM ( grade s 2–4 ) , excluding patient ’s self-declaration ( grade 1 ) , was significantly shorter in the selenium group ( 3.6±1.84 vs 5.3±2.2 days , P=0.014 ) . Significant elevations in serum selenium level and plasma Glu . Px activity were observed 7 and 14 days after transplantation compared with baseline in the selenium group . We conclude that selenium can reduce the duration and severity of OM after HDC . Clinical trial.org ID : NCT01432873 PURPOSE To determine the effect of oral zinc sulphate supplementation on radiation-induced oropharyngeal mucositis in patients with head- and -neck cancer . MATERIAL S AND METHODS Thirty patients with head- and -neck cancer were r and omly assigned to receive either zinc sulfate or placebo . Primary tumors were localized in the larynx in 14 patients , in the nasopharynx in 4 , in the oral cavity in 4 , in a salivary gl and in 1 , in the maxillary sinus in 1 , in neck nodes ( lymphoma presenting primarily ) in 3 and in neck metastases from an unknown primary in 3 . In the placebo group , 3 patients were excluded ; 1 patient died during treatment , 1 left the study , and 1 did not come to the 6 week control visit . The patients were treated with telecobalt radiotherapy at conventional fractionation ( 2 Gy/fraction , five fractions weekly , for 20 - 35 fractions within 4 - 7 weeks ) . The median radiation dose was 6400 cGy ( 4000 - 7000 cGy ) . Oral mucositis was assessed by two independent physicians , experts in radiation oncology , using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring criteria . RESULTS In the zinc sulfate group , Grade 3 - 4 mucositis was not detected in any patient ; Grade 0 mucositis was detected in 2 , and Grade 1 in 8 , and Grade 2 in 5 patients . In the placebo group , Grade 2 mucositis was detected in 4 and Grade 3 in 8 patients . We observed that the degree of mucositis in the patients in the zinc sulfate group was significantly lower than that in the placebo group ( p < 0.05 ) . Confluent mucositis developed earlier in the placebo group than in the zinc sulfate group after the onset of treatment ( p < 0.05 ) and started to improve sooner in the zinc sulfate group than in the placebo group ( p < 0.05 ) . CONCLUSIONS Zinc sulfate is beneficial in decreasing the severity of radiation-induced mucositis and oral discomfort . These results should be confirmed by additional evaluation in r and omized studies with a larger number of patients Objectives Mucosal damage is an important and debilitating side effect when treating head and neck cancer patients with (chemo-)radiation . The aim of this r and omized clinical trial was to investigate whether the addition of a neutral , supersaturated , calcium phosphate ( CP ) mouth rinse benefits the severity and duration of acute mucositis in head and neck cancer patients treated with (chemo)radiation . Material s and methods A total of 60 patients with malignant neoplasms of the head and neck receiving (chemo)radiation were included in this study . Fifty-eight patients were r and omized into two treatment arms : a control group receiving st and ard of care ( n = 31 ) and a study group receiving st and ard of care + daily CP mouth rinses ( n = 27 ) starting on the first day of (chemo-)radiation . Oral mucositis and dysphagia were assessed twice a week using the National Cancer Institute common toxicity criteria scale version 3 , oral pain was scored with a visual analogue scale . Results No significant difference in grade III mucositis ( 59 vs. 71 % ; p = 0.25 ) and dysphagia ( 33 vs. 42 % , p = 0.39 ) was observed between the study group compared to the control group . Also no significant difference in time until development of peak mucositis ( 28.6 vs. 28.7 days ; p = 0.48 ) , duration of peak mucositis ( 22.7 vs. 24.6 days ; p = 0.31 ) , recuperation of peak dysphagia ( 20.5 vs 24.2 days ; p = 0.13 ) and occurrence of severe pain ( 56 vs. 52 % , p = 0.5 ) . Conclusion In this r and omized study , the addition of CP mouth rinse to st and ard of care did not improve the frequency , duration or severity of the most common acute toxicities during and early after (chemo)radiation . There is currently no evidence supporting its st and ard use in daily practice Purpose Of patients undergoing allogeneic hematopoietic stem cell transplantation ( HSCT ) , 75 % or more experience oral mucositis , a painful acute complication that can delay discharge , interrupt treatment , and threaten life . To evaluate the efficacy of a supersaturated calcium phosphate rinse ( SCPR ) , we compared it with customary care — topical mouth solutions — on measures of severity and consequent interventions and complications . Methods In this r and omized controlled trial , 40 patients undergoing allogeneic HSCT were r and omized : 20 to SCPR four times daily and 20 to solutions made with salvia leaf extract , iodine-povidine , and fluconazole . Treatment extended from initiation of conditioning treatment until the granulocyte count was ≥0.2 g/L. Mucositis severity was measured daily by a hematologist according to a World Health Organization ( WHO ) scale and self-assessed by patients . Need for interventions [ analgesics , total parenteral nutrition ( TPN ) , and granulocyte colony-stimulating factor ] and complications ( acute graft-versus-host disease and infections ) were also assessed . Results In comparison with the control group , the SCPR group had significantly lower mean measures of WHO oral toxicity ( 0.9 vs. 1.8 ; P = 0.02 ) , disease course ( 3.2 vs. 7.1 days ; P = 0.02 ) , and peak mouth pain ( 0.85 vs. 1.75 ; P = 0.005 ) . Analgesic need was significantly shorter ( 1.1 vs. 3.4 days ; P = 0.047 ) and the need for TPN significantly lower ( 0 vs. 6 patients ; P = 0.02 ; 0 vs. 1.9 mean days ; P = 0.009 ) . Measures of complications were lower in the SCPR group , but not significantly so . Trial limitations include the impracticality of achieving double blinding with agents so different in appearance and in preadministration preparation . Conclusions Compared with the control group , the SCPR group had significantly lower mean measures of oral toxicity , peak mouth pain , and disease course duration . These results warrant confirmation in controlled , multicenter , r and omized trials The purpose of this study was to determine the effect of zinc supplementation on radiation-induced mucositis in patients with nasopharyngeal carcinoma ( NPC ) and those with oral cancers ( OC ) . A total of 100 patients with head and neck cancers engaged in a r and omized double blind study . All participants were placed into two r and omized groups ( experimental and control ) . The experimental group received a st and ard dose of zinc supplements , and the control group was given a placebo . Subgroup analyses were performed between 40 NPC and 43 OC patients . It was found that patients with OC in the control group developed Grade 2 and Grade 3 mucositis sooner than those in the experimental group . However , the benefits were not found to extend to patients with NPC . The results indicated that zinc supplementation prescribed in conjunction with radiotherapy postponed the development of severe mucositis solely for patients with OC . The pretreatment oral mucosa condition and areca chewing habit might account for such discrepancy Changes in the microflora on oral carcinoma surfaces may lead to both local and systemic infections , which may complicate the morbidity of the patient suffering from oral malignant neoplasms . Thus , anticancer therapy , irradiation , chemotherapy or surgery impairs the defence mechanism of the oral mucosa and is accompanied by proliferation of the mucosal biofilm with overgrowth of yeast and bacteria . This study investigates the inhibition of the biofilm present on the surface of oral squamous cell carcinomas . Biofilm sample s were obtained from the central surface ( 1 cm2 ) of each lesion in 10 patients ( eight male , two female ; mean age : 47.6 years ; SD + /- 7.6 ) before any antibiotherapy or tumour treatment . Patients were r and omly divided into two groups and were rinsed with Meridol mouthrinse ( amine fluoride ) or placebo ( saline solution ) for 7 days . Sample s were repeatedly taken from the same site after rinsing . Sample s were transported in pre-reduced brain heart infusion broth and cultured within 1 h of removal , using aerobic and anaerobic complete and selective media . Total aerobic and anaerobic counts were determined and isolated bacteria were identified . The median counts of colony forming units ( CFU/ml ) after rinsing with Meridol were significantly lower for both aerobes and anaerobes than before rinsing with Meridol . ( For aerobes before rinsing : 1.35 x 10(6 ) , after rinsing : 7.55 x 10(5 ) ; p = 0.025 ; for anaerobes before rinsing : 1.39 x 10(6 ) , after rinsing : 7.15 x 10(5 ) ; p = 0.011 . Rinsing with placebo : no significant difference was found . Aerobe median counts before rinsing : 1.17 x 10(6 ) , after rinsing : 1.03 x 10(5 ) , and for anaer
Output:
| The general positive effect trend suggests individuals taking mineral derivatives during cancer therapies are less likely to experience peak OM than those without . |
MS211929 | ***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 A pilot study of high dose coenzyme Q(10 ) ( CoQ(10))/vitamin E therapy in Friedreich 's ataxia ( FRDA ) patients result ed in significant clinical improvements in most patients . This study investigated the potential for this treatment to modify clinical progression in FRDA in a r and omized double blind trial . METHODS Fifty FRDA patients were r and omly divided into high or low dose CoQ(10)/ vitamin E groups . The change in International Co-operative Ataxia Ratings Scale ( ICARS ) was assessed over 2 years as the primary end-point . A post hoc analysis was made using cross-sectional data . RESULTS At baseline serum CoQ(10 ) and vitamin E levels were significantly decreased in the FRDA patients ( P < 0.001 ) . During the trial CoQ(10 ) and vitamin E levels significantly increased in both groups ( P < 0.01 ) . The primary and secondary end-points were not significantly different between the therapy groups . When compared to cross-sectional data 49 % of all patients demonstrated improved ICARS scores . This responder group had significantly lower baseline serum CoQ(10 ) levels . CONCLUSIONS A high proportion of FRDA patients have a decreased serum CoQ(10 ) level which was the best predictor of a positive clinical response to CoQ(10)/vitamin E therapy . Low and high dose CoQ(10)/vitamin E therapies were equally effective in improving ICARS scores Background : Friedreich ’s ataxia ( FRDA ) , the most common genetic cause of ataxia , is characterised by progressive neurodegeneration and cardiomyopathy . Initial treatments are likely to slow progression rather than reverse morbidity . An appropriate and sensitive scale to measure disease progress is critical to detect the benefit of treatments . Objective : To compare the Friedreich Ataxia Rating Scale ( FARS ) with other scales proposed as outcome measures for FRDA . Methods : 76 participants were assessed with the FARS and the International Cooperative Ataxia Rating Scale ( ICARS ) and 72 of these participants were also assessed with the Functional Independence Measure and the Modified Barthel Index . 43 participants had repeat measures at an interval of 12 months . Sensitivity and responsiveness were assessed using the effect size for each measure and the sample size required for a placebo-controlled clinical trial . Results : The FARS showed a high correlation with the other three measures . A significant change in the score over 12 months was detected by the FARS , the International Cooperative Ataxia Rating Scale and the Functional Independence Measure . The FARS had the greatest effect size and requires fewer patients for an equivalently powered study . Conclusions : Of the scales assessed , the FARS is the best to use in clinical trials of FRDA . This is based on effect size , and power calculations that show that fewer participants are required to demonstrate the same effect of an intervention . Further work is required to develop more sensitive and responsive instruments Objective : To examine the potential validity of performance measures and examination-based scales in Friedreich ataxia ( FA ) by examining their correlation with disease characteristics . Methods : The authors assessed the properties of a c and i date clinical outcome measure , the Friedreich Ataxia Rating Scale ( FARS ) , and simple performance measures ( 9-hole peg test , the timed 25-foot walk , PATA test , and low-contrast letter acuity ) in 155 patients with FA from six institutions , and correlated the scores with disease duration , functional disability , activity of daily living scores , age , and shorter GAA repeat length to assess whether these measures capture the severity of neurologic dysfunction in FA . Results : Scores for the FARS and performance measures correlated significantly with functional disability , activities of daily living scores , and disease duration , showing that these measures meet essential criteria for construct validity for measuring the progressive nature of FA . In addition , the FARS and transformed performance measures scores were predicted by age and shorter GAA repeat length in linear regression models accounting for sex and testing site . Correlations between performance measures were moderate in magnitude , suggesting that each test captures separate yet related dimensions of neurologic function in FA and that a composite measure might better predict disease status . Composite measures created using cohort means and st and ard deviations predicted disease status better than or equal to single performance measures or examination-based measures . Conclusions : The Friedreich Ataxia Rating Scale , performance measures , and performance measure composites provide valid assessment s of disease progression in Friedreich ataxia Background : The pleiotropic effects of riluzole may antagonize common mechanisms underlying chronic cerebellar ataxia , a debilitating and untreatable consequence of various diseases . Methods : In a r and omized , double-blind , placebo-controlled pilot trial , 40 patients presenting with cerebellar ataxias of different etiologies were r and omly assigned to riluzole ( 100 mg/day ) or placebo for 8 weeks . The following outcome measures were compared : proportion of patients with a decrease of at least 5 points in the International Cooperative Ataxia Rating Scale ( ICARS ) total score after 4 and 8 weeks compared with the baseline score ; mean changes from the baseline to posttreatment ICARS ( total score and subscores at 8 weeks ) ; and occurrence of adverse events . Results : Riluzole and placebo groups did not differ in baseline characteristics . The number of patients with a 5-point ICARS drop was significantly higher in the riluzole group than in the placebo group after 4 weeks ( 9/19 vs 1/19 ; odds ratio [ OR ] = 16.2 ; 95 % confidence interval [ CI ] 1.8–147.1 ) and 8 weeks ( 13/19 vs 1/19 ; OR = 39.0 ; 95 % CI 4.2–364.2 ) . The mean change in the riluzole group ICARS after treatment revealed a decrease ( p < 0.001 ) in the total score ( −7.05 [ 4.96 ] vs 0.16 [ 2.65 ] ) and major subscores ( −2.11 [ 2.75 ] vs 0.68 [ 1.94 ] for static function , −4.11 [ 2.96 ] vs 0.37 [ 2.0 ] for kinetic function , and −0.74 [ 0.81 ] vs 0.05 [ 0.40 ] for dysarthria ) . Sporadic , mild adverse events occurred . Conclusions : These findings indicate the potential effectiveness of riluzole as symptomatic therapy in diverse forms of cerebellar ataxia . Classification of evidence : This study provides Class I evidence that riluzole reduces , by at least 5 points , the ICARS score in patients with a wide range of disorders that cause cerebellar ataxia ( risk difference 63.2 % , 95 % CI 33.5%–79.9 % ) OBJECTIVE To assess the efficacy of idebenone on neurological function in patients with Friedreich ataxia . DESIGN R and omized , double-blind , placebo-controlled intervention trial . SETTING Children 's Hospital of Philadelphia and the University of California at Los Angeles . PARTICIPANTS Seventy ambulatory pediatric patients ( age , 8 - 18 years ) with a baseline International Cooperative Ataxia Rating Scale ( ICARS ) score of 10 to 54 . INTERVENTIONS Participants were r and omized into 1 of 3 treatment arms : 450 or 900 mg of idebenone per day ( in those with a body weight < or = or > 45 kg , respectively ; n = 22 ) ; 1350 or 2250 mg of idebenone per day ( n = 24 ) ; or placebo ( n = 24 ) . MAIN OUTCOME MEASURES Mean change from baseline to week 24 in ICARS score was the primary efficacy variable . Mean change in Friedreich Ataxia Rating Scale ( FARS ) score , performance measures , and activities of daily living were the secondary efficacy variables . RESULTS Patients who received idebenone improved by 2.5 points on mean ICARS score compared with baseline , while patients in the placebo group improved by 1.3 points . Patients who took idebenone also improved by 1.6 points on the FARS , while patients taking placebo declined by 0.6 points . For both end points , the difference between the idebenone and placebo groups was not statistically different . CONCLUSIONS Idebenone did not significantly alter neurological function in Friedreich ataxia during the 6-month study . Larger studies of longer duration may be needed to assess the therapeutic potential of drug c and i date s on neurological function in Friedreich ataxia . Trial Registration clinical trials.gov Identifier : NCT00537680 Objective – To preliminarily compare the efficacy of pregabalin with that of placebo on the cerebellar signs caused by cortical cerebellar atrophy ( CCA ) . A deficiency of gamma‐aminobutyric acid ( GABA ) has been described in the cerebellum in CCA , and pregabalin has been shown to enhance GABA release in rat hippocampus BACKGROUND Olivopontocerebellar atrophy ( OPCA ) is a chronic neurodegenerative disease with symptoms of cerebellar ataxia , parkinsonism , autonomic disturbances and ophthalmoplegia . Buspirone , a 5-HT1(A ) agonist could constitute a symptomatic improvement in cerebellar dysfunction whereas estrogen has been investigated for neuroprotection . We conducted an open-labeled pilot trial to assess the efficacy of estrogen with buspirone treatment . PATIENTS AND METHODS Eighteen patients ( 7 male and 11 female ) with OPCA were r and omized into the buspirone ( 15 mg/day , n=9 ) , or the combined treatment group ( estrogen , 0.625 mg/d plus buspirone , n=9 ) . For the clinical rating , International Cooperative Ataxia Rating Scale ( ICARS ) was used and dysarthria , gaze evoked nystagmus , finger to nose , pronation-supination alternating movement , knee-tibia test , and gait speed were evaluated for 12 months . RESULTS Buspirone-treated group showed improvements in finger to nose and pronation-supination alternating movement test ( p=0.046 and p=0.025 , respectively ) . The combination group ( Estrogen+buspirone ) , however , showed no improvement in cerebellar sub-scales compared to the baseline . CONCLUSIONS Buspirone treatment showed feasible efficacies for OPCA , while the combined treatment of estrogen and buspirone failed to improve , suggesting estrogen may not have further benefit in cerebellar dysfunction Abstract . The aim of this study was to assess the efficacy and the safety of ondansetron administered orally in patients with a cerebellar disorder . The study was a r and omised , multi-center , double-blind trial . The patients were r and omised either to oral ondansetron 8 mg or to placebo twice daily for seven days . Cerebellar dysfunction was quantified before and after treatment using the International Cooperative Ataxia Rating Scale ( ICARS ) . We performed a global analysis ( total scores ) , we analysed by subscores ( 4 subscores : oculomotor , speech , kinetic , postural ) and subgroups ( 4 subgroups : Cerebellar Cortical Atrophy ( CCA ) , Multiple Systemic Atrophy ( MSA ) , Familial Cerebellar Degeneration ( FCD ) and miscellaneous cerebellar disorders ) , and we also performed an analysis by individual test items . We investigated whether ondansetron and placebo had different effects upon ICARS total scores and subscores in the 4 subgroups considered together or separately . For p values < 0.05 , we subsequently applied the Mann-Whitney test to compare ondansetron and placebo effect for each individual item . We evaluated 45 of the 46 patients included . No effect was found in global analysis . We found no difference in the analysis of the ICARS subscores . Concerning the individual test items , there was a significant difference between the placebo and ondansetron for the finger-to-nose test ( p = 0.049 ) , the Heel-to-Knee test ( HK ) ; ( p = 0.03 ) , the Body Sway Eyes Closed ( p = 0.017 ) and the Body Sway Eyes Open ( BSEO ) ; ( p = 0.014 ) . There was no significant difference for tremor in upper limbs ( p = 0.32 ) or for gait ( p = 0.49 ) . The Mann-Whitney test showed a greater effect of ondansetron than placebo for BSEO in miscellaneous disorders ( p = 0.013 ) and for HK in FCD ( p = 0.036 ) , but ondansetron was deleterious for HK in CCA ( p = 0.019 ) . Our study showed no effect of oral ondansetron on global cerebellar dysfunction . The analysis by subgroups showed that the oral form of ondansetron ( a ) is deleterious for coordination in patients with CCA , ( b ) has no effect upon tremor in upper limbs , and ( c ) has a mild effect upon posture and coordination in lower limbs in some subgroups of ataxic diseases BACKGROUND Friedreich 's ataxia ( FA ) is a progressive , multisystem , degenerative disorder caused by a reduction in frataxin . Loss of frataxin results in mitochondrial dysfunction and oxidative damage in patients and model systems . Previous studies have indicated that the antioxidant idebenone ( 5 mg/kg daily ) reduces cardiac hypertro
Output:
| SARA and ICARS were the best studied and vali date d so far , and their reliability sustain their use .
Ataxia and non-ataxia scores will probably provide a better view of the overall disability in long-term trials and studies of natural history . |
MS211930 | ***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 The prevalence of medical disorders is high among substance abuse patients , yet medical services are seldom provided in coordination with substance abuse treatment . OBJECTIVE To examine differences in treatment outcomes and costs between integrated and independent models of medical and substance abuse care as well as the effect of integrated care in a subgroup of patients with substance abuse-related medical conditions ( SAMCs ) . DESIGN R and omized controlled trial conducted between April 1997 and December 1998 . SETTING AND PATIENTS Adult men and women ( n = 592 ) who were admitted to a large health maintenance organization chemical dependency program in Sacramento , Calif. INTERVENTIONS Patients were r and omly assigned to receive treatment through an integrated model , in which primary health care was included within the addiction treatment program ( n = 285 ) , or an independent treatment-as-usual model , in which primary care and substance abuse treatment were provided separately ( n = 307 ) . Both programs were group based and lasted 8 weeks , with 10 months of aftercare available . MAIN OUTCOME MEASURES Abstinence outcomes , treatment utilization , and costs 6 months after r and omization . RESULTS Both groups showed improvement on all drug and alcohol measures . Overall , there were no differences in total abstinence rates between the integrated care and independent care groups ( 68 % vs 63 % , P = .18 ) . For patients without SAMCs , there were also no differences in abstinence rates ( integrated care , 66 % vs independent care , 73 % ; P = .23 ) and there was a slight but nonsignificant trend of higher costs for the integrated care group ( $ 367.96 vs $ 324.09 , P = .19 ) . However , patients with SAMCs ( n = 341 ) were more likely to be abstinent in the integrated care group than the independent care group ( 69 % vs 55 % , P = .006 ; odds ratio [ OR ] , 1.90 ; 95 % confidence interval [ CI ] , 1.22 - 2.97 ) . This was true for both those with medical ( OR , 3.38 ; 95 % CI , 1.68 - 6.80 ) and psychiatric ( OR , 2.10 ; 95 % CI , 1.04 - 4.25 ) SAMCs . Patients with SAMCs had a slight but nonsignificant trend of higher costs in the integrated care group ( $ 470.81 vs $ 427.95 , P = .14 ) . The incremental cost-effectiveness ratio per additional abstinent patient with an SAMC in the integrated care group was $ 1581 . CONCLUSIONS Individuals with SAMCs benefit from integrated medical and substance abuse treatment , and such an approach can be cost-effective . These findings are relevant given the high prevalence and cost of medical conditions among substance abuse patients , new developments in medications for addiction , and recent legislation on parity of substance abuse with other medical benefits Objective : The objective of this study was to determine if receipt of revascularization was similar among commercially insured adults with mental disorders compared with people without mental disorders . Methods : This was a retrospective analysis of a 100 % sample of Blue Cross/Blue Shield of Iowa administrative cl aims data , 1996 to 2001 . Logistic regression was used to calculate unadjusted and adjusted odds ratios ( OR ) for receipt of angioplasty ( PTCA ) and bypass graft surgery ( CABG ) within 30 days of discharge . Results : A total of 3368 adults , aged 18 to 64 years , were hospitalized for myocardial infa rct ion ( MI ) and 40 % ( n = 1342 ) had a mental disorder . Subjects with mental disorders were more likely to be younger , female , urban residents , and to have increased cardiovascular and medical comorbidity . They were similarly likely as subjects without mental disorders to have received PTCA ( OR , 1.10 ; 95 % confidence interval [ CI ] , 0.95–1.29 ) and CABG ( OR , 0.89 ; 95 % CI , 0.71–1.11 ) in analyses adjusted for demographic and clinical characteristics . Revascularization rates did not differ by mental disorder type , with few exceptions . Conclusions : Receipt of revascularization was similar for patients with and without mental disorders . Our results may differ from previous findings as a result of the younger population studied and increased comorbidity in people with mental disorders , which may have result ed in a contraindication for surgical intervention . Conversely , the increased burden of comorbidity could suggest that these patients should have received PTCA at higher rates because of the better prognosis associated with revascularization as compared with medical management . Prospect i ve analyses with review of clinical data and behavioral risk factors are necessary to determine why some patients with mental illness may be less likely to receive cardiac interventions . MI = myocardial infa rct ion ; CVD = cardiovascular disease ; MHD = mental health disorders ; PTCA = percutaneous transluminal coronary angioplasty ; CABG = coronary artery bypass graft surgery ; CPT = Common Procedural Terminology ; ICD = International Classification of Diseases ; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ; OR = odds ratio ; COPD = chronic obstructive pulmonary disease ; CI = confidence interval Abstract BACKGROUND : Persons with persistent mental illness are at risk for failure to receive medical services . In order to deliver appropriate preventive and primary care for this population , it is important to determine which chronic medical conditions are most common . OBJECTIVE : We examined chronic medical comorbidity in persons with schizophrenia using vali date d method ologies . DESIGN : Retrospective analysis of longitudinal administrative cl aims data from Wellmark Blue Cross/Blue Shield of Iowa . PARTICIPANTS : Subjects with schizophrenia or schizoaffective disorder ( N=1,074 ) , and controls ( N=726,262 ) who filed at least 1 cl aim for medical services , 1996 to 2001 . MEASUREMENTS : Case subjects had schizophrenia as the most clinical ly predominant psychotic disorder , based on psychiatric hospitalization , psychiatrist diagnoses , and outpatient care . Controls had no cl aims for any psychiatric comorbidity . Using a modified version of the Elixhauser Comorbidity Index , inpatient and outpatient cl aims were used to determine the prevalence of 46 common medical conditions . Odds ratios ( ORs ) were adjusted for age , gender , residence , and nonmental health care utilization using logistic regression . RESULTS : Subjects with schizophrenia were significantly more likely to have 1 or more chronic conditions compared with controls . Adjusted OR ( 95 % confidence interval [ CI ] ) were 2.62 ( 2.09 to 3.28 ) for hypothyrodisim , 1.88 ( 1.51 to 2.32 ) for chronic obstructive pulmonary disease , 2.11 ( 1.36 to 3.28 ) for diabetes with complications , 7.54 ( 3.55 to 15.99 ) for hepatitis C , 4.21 ( 3.25 to 5.44 ) for fluid/electrolyte disorders , and 2.77 ( 2.23 to 3.44 ) for nicotine abuse/dependence . CONCLUSIONS : Schizophrenia is associated with substantial chronic medical burden . Familiarity with conditions affecting persons with schizophrenia may assist programs aim ed at providing medical care for the mentally ill Background / Objective .Somatic health care utilization was studied among individuals with serious mental illness who were receiving community-based psychiatric services . Research Design .Cross-sectional study . SubjectsA total of 200 out patients , 100 with schizophrenia and 100 with affective disorder , were recruited from r and omly selected sample s receiving care at two psychiatric centers . Measures . Patients were interviewed using questions from national health surveys . Multiple logistic regression analyses were used to compare responses from each sample to those of matched subsets of individuals from the general population . Results .The psychiatric sample s were more likely to report receiving some medical care services in the past year than were individuals in the general population including having visited a general medical doctor ( Odds ratio , schizophrenia sample = 2.04 ; Odds ratio , affective disorder sample = 2.37 ) and having a complete physical examination ( Odds ratio , schizophrenia sample = 2.69 ; Odds ratio , affective disorder sample = 1.74 ) . However , our sample s were less likely to receive routine dental care ( Odds ratio , schizophrenia sample = 0.46 ; Odds ratio , affective disorder sample = 0.60 ) . Perceived barriers to receiving medical care were reported significantly more often by the patient groups than the comparison groups ( Odds ratios > 3 ) . Conclusions . General health services are widely utilized by individuals with serious mental illness who are in outpatient psychiatric care . Dental services remain underutilized , however , and there is a high rate of perceived barriers to receiving medical care in this population OBJECTIVE In this secondary data analysis of Primary Care Research in Substance Abuse and Mental Health for the Elderly ( PRIMSe ) study , we hypothesized that older minorities who receive mental health services integrated in primary care setting s would have greater service use and better mental health outcomes than older minorities referred to community services . METHOD We identified 2,022 ( 48 % minorities ) primary care patients 65 years and older , who met study inclusion criteria and had either alcohol misuse , depression , and /or anxiety . They were r and omized to receive treatment for these disorders in the primary care clinic or to a brokerage case management model that linked patients to community-based services . Service use and clinical outcomes were collected at baseline , three months and six months post r and omization on all participants . RESULTS Access to and participation in mental health /substance abuse services was greater in the integrated model than in referral ; there were no treatment by ethnicity effects . There were no treatment effects for any of the clinical outcomes ; Whites and older minorities in both integrated and referral groups failed to show clinical ly significant improvement in symptoms and physical functioning at 6 months . CONCLUSIONS While providing services in primary care results in better access to and use of these services , accessing these services is not enough for assuring adequate clinical outcomes We determined whether patients with serious mental illness ( SMI ) were less likely than non-SMI to self-report having a medical condition that was recorded in their medical record . We included all patients from the VA National Psychosis Registry diagnosed with SMI and a r and om sample of non-SMI patients in fiscal year 1999 who completed the Large Health Survey of Veteran Enrollees ( N = 35,837 ) . Among patients with diagnoses for any of 11 conditions recorded in administrative data , we evaluated whether patients reported having that same condition in the survey , using multivariable logistic regression and generalized estimating equations . Among patients diagnosed with a given condition , those with SMI were less likely to report being told by providers that they had seven of the 11 conditions examined : heart disease ( OR = 0.68 , p < 0.001 ) , arthritis ( OR = 0.79 , p < 0.001 ) , cancer ( OR = 0.69 , p < 0.001 ) , diabetes ( OR = 0.79 , p < 0.001 ) , back pain ( OR = 0.81 , p < 0.001 ) , congestive heart failure ( OR = 0.71 , p < 0.001 ) , and hypertension ( OR = 0.77 , p < 0.001 ) . Patients with SMI were less aware of co-occurring medical conditions OBJECTIVE The aim of this study was to examine patterns of use of general medical services among persons with a severe and persistent mental illness enrolled in Medicaid from 1996 to 1998 . METHODS A total of 669 persons with a severe and persistent mental illness were identified by using statewide clinical criteria . A three-year data base of Medicaid cl aims was developed to examine service use . The main outcome measures were use of outpatient services for a general medical problem , use of dental and vision services , and use of screening tests for women . Service use was examined by primary psychiatric diagnosis ( schizophrenic , affective , paranoid , and anxiety disorders ) , and analyses controlled for the presence of a chronic medical condition , age , race , and sex . RESULTS This study found high levels of service use for outpatient services but very low levels for primary and preventive services . Although 78 percent of persons with a schizophrenic disorder had an office-based visit during the three-year period , all persons with an anxiety disorder had such a visit . Sixty-nine percent of persons with a schizophrenic disorder had at least one emergency department visit , whereas 83 percent of those with an anxiety disorder had such a visit . Dental and vision visits and the use of mammograms and pap tests followed the same pattern ; persons with a schizophrenic disorder had fewer visits and had less overall use than the other diagnostic groups . The use patterns across the four groups were significantly different in outpatient service use , dental and vision service use , and screening tests for women . Compared with persons with a schizophrenic disorder , those with an anxiety disorder were more likely to have had an office-based visit and to have received vision services , those with a paranoid disorder were more likely to have used dental services or received a mammogram , and those with an affective disorder were more likely to have had a pap
Output:
| Nevertheless , indirect evidence supports the observation that deficits in quality of care are contributing to higher than expected mortality in those with severe mental illness ( SMI ) and schizophrenia .
The quality of medical treatment provided to those with cardiac conditions and comorbid schizophrenia is often suboptimal and may be linked with avoidable excess mortality . |
MS211931 | ***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: & NA ; The purpose of the present study was to determine whether gender differences exist in the forebrain cerebral activation patterns of the brain during pain perception . Accordingly , positron emission tomography ( PET ) with intravenous injection of H2 15O was used to detect increases in regional cerebral blood flow ( rCBF ) in normal right‐h and ed male and female subjects as they discriminated differences in the intensity of innocuous and noxious heat stimuli applied to the left forearm . Each subject was instructed in magnitude estimation based on a scale for which 0 indicated ‘ no heat sensation ’ ; 7 , ‘ just barely painful ’ and 10 , ‘ just barely tolerable ’ . Thermal stimuli were 40 ° C or 50 ° C heat , applied with a thermode as repetitive 5‐s contacts to the volar forearm . Both male and female subjects rated the 40 ° C stimuli as warm but not painful and the 50 ° C stimuli as painful but females rated the 50 ° C stimuli as significantly more intense than did the males ( P=0.0052 ) . Both genders showed a bilateral activation of premotor cortex in addition to the activation of a number of contralateral structures , including the posterior insula , anterior cingulate cortex and the cerebellar vermis , during heat pain . However , females had significantly greater activation of the contralateral prefrontal cortex when compared to the males by direct image subtraction . Volume of interest comparison ( t‐statistic ) also suggested greater activation of the contralateral insula and thalamus in the females ( P<0.05 ) . These pain‐related differences in brain activation may be attributed to gender , perceived pain intensity , or to both factors OBJECTIVE To determine the prevalence and characteristics of fibromyalgia in the general population . METHODS A r and om sample of 3,006 persons in Wichita , KS , were characterized according to the presence of no pain , non-widespread pain , and widespread pain . A sub sample of 391 persons , including 193 with widespread pain , were examined and interviewed in detail . RESULTS The prevalence of fibromyalgia was 2.0 % ( 95 % confidence interval [ 95 % CI ] 1.4 , 2.7 ) for both sexes , 3.4 % ( 95 % CI 2.3 , 4.6 ) for women , and 0.5 % ( 95 % CI 0.0 , 1.0 ) for men . The prevalence of the syndrome increased with age , with highest values attained between 60 and 79 years ( > 7.0 % in women ) . Demographic , psychological , dolorimetry , and symptom factors were associated with fibromyalgia . CONCLUSION Fibromyalgia is common in the population , and occurs often in older persons . Characteristic features of fibromyalgia -- pain threshold and symptoms -- are similar in community and clinic population s , but overall severity , pain , and functional disability are more severe in the clinic population UNLABELLED Pain catastrophizing is among the most robust predictors of pain outcomes , and a disruption in endogenous pain-inhibitory systems is 1 potential mechanism that may account for increased pain among individuals who report higher pain catastrophizing . Pain catastrophizing may negatively influence diffuse noxious inhibitory controls ( DNIC ) , a measure of endogenous pain inhibition , through complex anatomical circuitry linking cortical responses to pain with processes that modulate pain . The current study examined whether DNIC mediated the relationship between catastrophizing and pain among 35 healthy young adults and examined the moderating effects of sex to determine whether the magnitude or direction of associations differed among men and women . DNIC was assessed using pressure pain thresholds on the forearm before and during a cold pressor task . Using bias-corrected bootstrapped confidence intervals , results showed that diminished DNIC was a significant partial mediator of the relation between greater pain-related catastrophizing and more severe pain ratings . Participant sex moderated these associations ; higher catastrophizing predicted lower DNIC for men and women , however , the effect of catastrophizing on pain ratings was partially mediated by DNIC for women only . These findings further support the primary role of pain catastrophizing in modulation of pain outcomes . PERSPECTIVE These findings support the hypothesis that the heightened pain reported by individuals higher in pain catastrophizing may be related to a disruption in the endogenous modulation of pain , operationalized by assessing DNIC . Whether interventions that reduce pain catastrophizing affect pain outcomes via effects on DNIC is in need of investigation In this study we tested the hypothesis that hypoalgesia in individuals at risk for hypertension is related to enhanced activation of supraspinal pain modulation systems . Supraspinal inhibition of pain signals was assessed using a diffuse noxious inhibitory control paradigm , in which a noxious conditioning stimulus was used to suppress pain in response to a noxious test stimulus applied to a remote area of the body . Specifically , the nociceptive flexion reflex ( NFR ) was assessed in 113 healthy young adults before , during , and after exposure to forearm tourniquet ischemia . Consistent with previous evidence of hypoalgesia in individuals at risk for hypertension , offspring of hypertensive individuals exhibited significantly higher NFR thresholds than offspring of normotensive persons . Although NFR activity was significantly decreased in all participants during concomitant application of forearm ischemia , the degree of attenuation of NFR activity was not significantly different as a function of risk for hypertension We present the first prevalence study of specific headache entities using the operational diagnostic criteria of the International Headache Society . One thous and 25 - 64 year old men and women , who lived in the western part of Copenhagen County were r and omly drawn from the Danish National Central Person Registry . All subjects were invited to a general health examination focusing on headache and including : a self-administered question naire concerning sociodemographic variables , a structured headache interview and a general physical and neurological examination . The participation rate was 76 % . Information about 79 % of the non- participants showed a slightly differing headache prevalence which was not quantitatively important . The following results in participants are therefore representative of the total sample . The lifetime prevalences of headache ( including anybody with any form of headache ) , migraine , and tension-type headache were 93 , 8 and 69 % in men ; and 99 , 25 and 88 % in women . The point prevalence of headache was 11 % in men and 22 % in women . Prevalence of migraine in the previous year was 6 % in men and 15 % in women and the corresponding prevalences of tension-type headache were 63 and 86 % . Differences according to sex were significant with a male : female ratio of 1:3 in migraine , and 4:5 in tension-type headache . The prevalence of tension-type headache decreased with increasing age , whereas migraine showed no correlation to age within the studied age interval . Headache disorders are extremely prevalent and represent a major health problem , which merits increased attention Objective Sex differences in pain sensitivity and stress reactivity have been well documented . Little is known about the role of the endogenous opioid system in these differences . This study was conducted to compare adrenocortical , pain sensitivity , and blood pressure responses to opioid blockade using naltrexone in men and women . Methods Twenty-six participants completed 2 sessions during which placebo or 50 mg of naltrexone was administered , using a double-blind , counterbalanced design . Thermal pain threshold and heat tolerance were assessed . Participants also rated pain during a 90-second cold pressor test ( CPT ) and completed the McGill Pain Question naire ( MPQ ) after each pain challenge . Blood and saliva sample s and cardiovascular and mood measures were obtained throughout the sessions . Results Plasma cortisol , adrenocorticotropin , beta endorphin , prolactin , and salivary cortisol levels increased similarly in men and women after naltrexone administration compared with placebo . Women reported more pain during both pain procedures and had lower thermal pain tolerance . In response to naltrexone , women exhibited reduced blood pressure responses and reduced MPQ pain ratings after CPT . No effects of naltrexone on these measures were found in men . Conclusions Although men and women exhibited similar hormonal responses to opioid receptor blockade , women reported less pain and showed smaller blood pressure responses during CPT . Results suggest differential effects of the endogenous opioid system on pain perception and blood pressure in men and women OBJECTIVE To examine possible deficiencies in endogenous pain modulating mechanisms in fibromyalgia patients compared with matched pain-free control subjects . DESIGN /SUBJECTS/ METHODOLOGY : Pain reduction was investigated in 25 female patients with fibromyalgia and 26 age-matched healthy women using the diffuse noxious inhibitory controls ( DNIC ) paradigm . Tonic thermal stimuli at painful and nonpainful intensities , tailored to individual heat pain thresholds , were employed to induce pain inhibition . The anticipated effect was assessed by measuring the electrical pain threshold and detection threshold , using a double staircase method . Only nontender control points were stimulated ( thermode on the foot , electrodes on the inner forearm ) . RESULTS The patients with fibromyalgia had significantly lower heat pain thresholds than the healthy subjects , but similar electrical detection and pain thresholds . The repeatedly applied electrical stimuli result ed in a degree of perceptual adaptation that was similar between the two groups . However , concurrent tonic thermal stimuli , at both painful and nonpainful levels , significantly increased the electrical pain threshold in the healthy subjects but not in the fibromyalgia patients . The electrical detection threshold was not affected in either group . CONCLUSIONS Pain modulation , produced by a concurrent tonic stimulus in healthy persons , was not seen in the fibromyalgia group . The patients either had deficient pain modulation or were unable to tolerate a tonic stimulus intense enough to engage a modulatory process . It remains to be established whether the pain reduction found in the healthy subjects was the conventional DNIC effect , another effect ( e.g. , distraction ) , or a combination of both & NA ; The aim of this study was to investigate the effects of diffuse noxious inhibitory controls ( DNICs ) on the temporal summation of the nociceptive flexion reflex ( RIII reflex ) in humans . Recordings were obtained from 36 healthy adults ( 16 M , 20 F ) , and the area and temporal summation threshold ( TST ) of the RIII reflex were measured . The subjective intensity of the painful sensation was rated on an 11‐point visual analogue scale ( VAS ) . Neurophysiological and VAS measurements were recorded after activation of DNICs by means of the cold pressor test ( CPT ) , which involved immersing the h and in cold water ( 2–4 ° C ) . A slight significant lower TST was found in the females versus the males . In all the subjects , the CPT induced a significant TST increase and RIII area reduction compared with the control session . The VAS results paralleled those of the RIII reflex area and TST . During the CPT , a significant difference in the percentage TST increase emerged between females and males , being lower in the former . Similarly , we found a significantly lower percentage reduction of the RIII area in women than in men during the CPT . To summarize , activation of DNICs through the CPT significantly increased the TST of the RIII reflex in healthy subjects . This inhibitory effect was gender‐specific . Whereas other findings are based on psychophysical evaluations , the results of this experimental study provide an objective neurophysiological demonstration that DNICs attenuate temporal summation in humans and confirm the presence of significant differences in pain modulation mechanisms between men and women & NA ; Little is known about sex differences in the temporal pattern of descending inhibitory mechanisms , such as descending noxious inhibitory control ( DNIC ) . Sex differences in temporal characteristics of DNIC were investigated by measuring pressure pain thresholds ( PPTs ) over time in the trapezius muscles ( local pain areas ) and the posterolateral neck muscles ( referred pain areas ) following repeated bilateral injection of hypertonic versus isotonic saline into both trapezius muscles . Ten females and 11 males received two consecutive bilateral injections , with 15 min interval , of either 5.8 % hypertonic saline ( 0.5 ml in each side for each bilateral injection ) or isotonic saline as a control in a r and omized manner . Following hypertonic saline injection , the maximal pain intensities of the first and second bilateral injections were significantly higher in females than in males . The PPTs in the trapezius muscles were significantly lower in females than in males . Significantly higher PPTs ( hypoalgesia ) in men than in women were shown 15 min after the first bilateral injection , and 7.5 and 15 min after the second bilateral injection in the referred pain areas . Importantly , the second bilateral injection failed to further increase the PPTs for both sexes . These results showed that there were sex differences in temporal characteristics of descending inhibition with long‐lasting hypoalgesia in men than in women . Repeated noxious muscular stimuli may inhibit further build‐up of DNIC , which may reflect a mechanism of plasticity of the descending inhibitory systems following recurrent nociceptive barrage for both sexes & NA ; The aims of this study were to investigate possible sex differences in ( a ) intraoral pain evoked by topical application of capsaicin to the gingiva , and ( b ) the modulation of this pain by diffuse noxious inhibitory controls ( DNIC ) . Three groups with a total of fifty‐four healthy volunteers ( 20 men , 20 women using oral contraceptives ( W+OC ) , 14 women not using ( W−OC ) ) completed the study . In two sessions , intraoral pain was evoked by topical application of 30 μL 5 % capsaicin to the gingiva . Conditioning stimuli were applied with three min h and immersion in ice water in one session and 30 ° C
Output:
| Studies evaluating pain thresholds and nociceptive flexion reflex indicated the opposite when simply averaged across studies ; however , weighted analyses of threshold found more efficient DNIC in males .
Gender differences in DNIC effect depend on both the experimental methodology and the modes of measurement of the effect |
MS211932 | ***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 Modafinil was tested for efficacy in decreasing use in methamphetamine-dependent participants , compared to placebo . METHODS This was a r and omized , double-blind , placebo-controlled study , with 12 weeks of treatment and a 4-week follow-up . Eight outpatient substance abuse treatment clinics participated in the study . There were 210 treatment-seekers r and omized , who all had a DSM-IV diagnosis of methamphetamine dependence ; 68 participants to placebo , 72 to modafinil 200 mg , and 70 to modafinil 400 mg , taken once daily on awakening . Participants came to the clinic three times per week for assessment s , urine drug screens , and group psychotherapy . The primary outcome measure was a methamphetamine non-use week , which required all the week 's qualitative urine drug screens to be negative for methamphetamine . RESULTS Regression analysis showed no significant difference between either modafinil group ( 200 or 400 mg ) or placebo in change in weekly percentage having a methamphetamine non-use week over the 12-week treatment period ( p=0.53 ) . Similarly , a number of secondary outcomes did not show significant effects of modafinil . However , an ad-hoc analysis of medication compliance , by urinalysis for modafinil and its metabolite , did find a significant difference in maximum duration of abstinence ( 23 days vs. 10 days , p=0.003 ) , between those having the top quartile of compliance ( > 85 % of urines were positive for modafinil , N=36 ) , and the lower three quartiles of modafinil 200 and 400 mg groups ( N=106 ) . CONCLUSIONS Although these data suggest that modafinil , plus group behavioral therapy , was not effective for decreasing methamphetamine use , the study is probably inconclusive because of inadequate compliance with taking medication The safety and tolerability of modafinil ( 400 mg/day , n = 14 ) and mirtazapine ( 60 mg/day , n = 13 ) in inpatient methamphetamine withdrawal treatment were compared to a historical comparison group receiving treatment as usual ( pericyazine , 2.5 - 10 mg/day , n = 22 ) . Modafinil and mirtazapine were well tolerated , producing minimal positive subjective effects and no discontinuation effects in this open-label study . Side effects were mild and transient . Aches and pains were most commonly reported by participants receiving mirtazapine , whereas headache was reported by modafinil-treated participants . Modafinil-treated participants had a milder withdrawal syndrome as measured by the Amphetamine Cessation Symptom Assessment and less sleep disturbance in comparison to mirtazapine . Pericyazine was associated with a more severe withdrawal syndrome in comparison to mirtazapine and modafinil . Both modafinil and mirtazapine were safe and well tolerated in methamphetamine withdrawal treatment . However , these early findings of efficacy in symptom amelioration should be replicated in an adequately powered , r and omized , placebo-controlled double-blind design AIM To investigate the safety and efficacy of once-daily supervised oral administration of sustained-release dexamphetamine in people dependent on methamphetamine . DESIGN R and omized , double-blind , placebo-controlled trial . PARTICIPANTS Forty-nine methamphetamine-dependent drug users from Drug and Alcohol Services South Australia ( DASSA ) clinics . INTERVENTION Participants were assigned r and omly to receive up to 110 mg/day sustained-release dexamphetamine ( n = 23 ) or placebo ( n = 26 ) for a maximum of 12 weeks , with gradual reduction of the study medication over an additional 4 weeks . Medication was taken daily under pharmacist supervision . MEASUREMENTS Primary outcome measures included treatment retention , measures of methamphetamine consumption ( self-report and hair analysis ) , degree of methamphetamine dependence and severity of methamphetamine withdrawal . Hair sample s were analysed for methamphetamine using liquid chromatography-mass spectrometry . FINDINGS Treatment retention was significantly different between groups , with those who received dexamphetamine remaining in treatment for an average of 86.3 days compared with 48.6 days for those receiving placebo ( P = 0.014 ) . There were significant reductions in self-reported methamphetamine use between baseline and follow-up within each group ( P < 0.0001 ) , with a trend to a greater reduction among the dexamphetamine group ( P = 0.086 ) . Based on hair analysis , there was a significant decrease in methamphetamine concentration for both groups ( P < 0.0001 ) . At follow-up , degree of methamphetamine dependence was significantly lower in the dexamphetamine group ( P = 0.042 ) . Dexamphetamine maintenance was not associated with serious adverse events . CONCLUSIONS The results of this preliminary study have demonstrated that a maintenance pharmacotherapy programme of daily sustained-release amphetamine dispensing under pharmacist supervision is both feasible and safe . The increased retention in the dexamphetamine group , together with the general decreases in methamphetamine use , degree of dependence and withdrawal symptom severity , provide preliminary evidence that this may be an efficacious treatment option for methamphetamine dependence OBJECTIVE To compare bupropion to placebo for reducing methamphetamine ( MA ) use , increasing retention , and reducing the severity of depressive symptoms and MA-cravings . A secondary objective compared bupropion to placebo for reducing cigarette smoking among MA dependent participants . METHODS Following a 2-week , non-medication baseline screening period , 73 treatment-seeking MA dependent participants were r and omly assigned to bupropion sustained release ( 150 mg twice daily ; N=36 ) or placebo ( twice daily ; N=37 ) for 12-weeks under double-blind conditions . Participants attended clinic thrice weekly to provide urine sample s analyzed for MA-metabolite , to complete research measures and assessment s , and to receive contingency management and weekly cognitive behavioral therapy sessions . RESULTS There were no statistically significant effects for bupropion relative to placebo on MA use verified by urine drug screens , for reducing the severity of depressive symptoms or MA-cravings , or on study retention . In a post hoc analysis , there was a statistically significant effect of bupropion treatment on MA use among participants with lighter ( 0 - 2 MA-positive urines ) , but not heavier ( 3 - 6 MA-positive urines ) MA use during baseline ( OR=2.81 , 95 % CI=1.61 - 4.93 , p<0.001 for MA-free week with bupropion among light users ) . Bupropion treatment was also associated with significantly reduced cigarette smoking , by almost five cigarettes per day ( p=0.0002 ) . CONCLUSION Bupropion was no more effective than placebo in reducing MA use in planned analyses , though bupropion did reduce cigarette smoking . Post hoc findings of an effect for bupropion among baseline light , but not heavy , MA users suggests further evaluation of bupropion for light-MA users is warranted The efficacy of stimulant treatment in patients with substance use disorders and comorbid attention deficit hyperactivity disorder ( ADHD ) has been tested for cocaine and alcohol dependence but so far no studies have been conducted in amphetamine dependent individuals . The present trial was a pilot study aim ing to test the feasibility of treating amphetamine dependent patients with comorbid ADHD with central stimulant medication . The study was a double-blind , placebo controlled trial with parallel groups design comparing the efficacy of a fixed dose ( 72 mg ) of OROS methylpheni date ( MPH ) with placebo ( PL ) in reducing ADHD symptoms in currently abstinent adults with amphetamine dependence and ADHD . Twenty-four treatment seeking patients who met the DSM IV criteria for amphetamine dependence and ADHD were r and omized to MPH/PL . The trial was conducted at an outpatient facility with twice weekly visits , measuring ADHD symptoms and drug use . Patients rated their ADHD symptoms on a weekly basis and provided supervised urine specimens for drug toxicology twice weekly . All patients participated in weekly sessions of a skills training programme . Both the groups significantly reduced their self-rated ADHD symptoms during the 12-week treatment but there was no difference between the two treatment arms . Drug use , both measured by urine toxicology and self-report did not differ between the groups . No difference was found between the two groups with regards to craving for amphetamine or in retention in treatment . Larger studies with higher doses combined with individual dosage and longer follow-up periods are warranted Methamphetamine is a highly addictive stimulant and long-term exposure leads to reductions in dopamine . One therapeutic strategy is to develop and test compounds that normalize dopamine . The primary aim of this study was to determine the safety of modafinil treatment during methamphetamine exposure in a controlled clinical setting . Methamphetamine-dependent volunteers ( N=13 ) , who were not seeking treatment , were r and omized to receive either modafinil ( 200 mg , PO ) or matching placebo over three days ( Days 1 - 3 or Days 8 - 10 ) . On Day 1 , subjects were r and omized to modafinil or placebo in the morning , and then 3 and 6h later received infusions of methamphetamine ( 0 and 30 mg , i.v . ) , after which cardiovascular and subjective effects were assessed . On Day 3 , participants completed i.v . self-administration sessions during which they made 10 choices for low doses of methamphetamine ( 3 mg , i.v . ) or saline . Days 4 - 7 were used as a washout period . On Day 8 participants were assigned to the alternate study medication ( placebo or modafinil ) , and the same testing procedures were repeated through Day 10 . The data reveal that modafinil treatment was well-tolerated and not associated with increased incidence of adverse events . In general , modafinil reduced by approximately 25 % ratings of methamphetamine-induced " Any Drug Effect " , " High " , and " Want Methamphetamine " , and reduced total number of choices for methamphetamine and monetary value of methamphetamine , though none of these measures reached statistical significance . Given these encouraging , though non-significant trends , the primary conclusion is that it appears safe to proceed with modafinil in further clinical evaluations of therapeutic efficacy AIM To examine the safety and efficacy of modafinil ( 200 mg/day ) compared to placebo in the treatment of methamphetamine dependence and to examine predictors of post-treatment outcome . PARTICIPANTS AND DESIGN Eighty methamphetamine-dependent subjects in Sydney , Australia were allocated r and omly to modafinil ( 200 mg/day ) ( n = 38 ) or placebo ( n = 42 ) under double-blind conditions for 10 weeks with a further 12 weeks post-treatment follow-up . MEASURES Comprehensive drug use data ( urine specimens and self-report ) and other health and psychosocial data were collected weekly during treatment and research interviews at baseline , week 10 and week 22 . RESULTS Treatment retention and medication adherence were equivalent between groups . There were no differences in methamphetamine abstinence , craving or severity of dependence . Medication-compliant subjects tended to provide more methamphetamine-negative urine sample s over the 10-week treatment period ( P = 0.07 ) . Outcomes were better for methamphetamine-dependent subjects with no other substance dependence and those who accessed counselling . There were statistically significant reductions in systolic blood pressure ( P = 0.03 ) and weight gain ( P = 0.05 ) in modafinil-compliant subjects compared to placebo . There were no medication-related serious adverse events . Adverse events were generally mild and consistent with known pharmacological effects . CONCLUSIONS Modafinil demonstrated promise in reducing methamphetamine use in selected methamphetamine-dependent patients . The study findings support definitive trials of modafinil in larger multi-site trials OBJECTIVE Problems related to illegal amphetamine use have become a major public health issue in many developed countries . To date , evidence on the effectiveness of psychosocial treatments has remained modest , and no pharmacotherapy has proven effective for amphetamine dependence . METHOD Individuals meeting DSM-IV criteria for intravenous amphetamine dependence ( N=53 ) were r and omly assigned to receive aripiprazole ( 15 mg/day ) , slow-release methylpheni date ( 54 mg/day ) , or placebo for 20 weeks . The study was terminated prematurely due to unexpected results of interim analysis . An intention-to-treat analysis was used . The primary outcome measure was the proportion of amphetamine-positive urine sample s. RESULTS Patients allocated to aripiprazole had significantly more amphetamine-positive urine sample s than patients in the placebo group ( odds ratio=
Output:
| No significant differences were found between psychostimulants and placebo for any of the studied efficacy outcomes .
Results of this review do not support the use of psychostimulant medications at the tested doses as a replacement therapy for amphetamine abuse or dependence . |
MS211933 | ***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 1987 I contributed a commentary that seriously evaluated the method ologic quality of studies promulgating the assumption that exercise has a role in the prevention of osteoporosis [ l ] . Along with a more comprehensive review published separately in 1989 121 , that commentary recommended r and omized controlled trials to confirm the well-recognized association between above average levels of physical activity and higher bone mineral density ( BMD ) [ l-4 ] . A recent literature search revealed eight reports published since 1989 that utilized a r and omized study design to determine the potential effects of various types of exercise interventions on BMD 15 - 121 . These studies had equivocal results ; some showed mild positive effects but others showed virtually no effect of exercise on BMD ( Table 1 ) . What is most disturbing about these studies is the generalIy high level of subject attrition reported . Indeed , subject dropout rates ranged from 4 % to 50 % . Five of the studies had attrition rates above 20 % ( Table 1 ) . Such high levels of attrition have serious implication s for analyzing and interpreting the results of these trials . In fact , not a single study presented a valid intention-to-treat ( ITT ) analysis to adjust statistically for significant subject attrition . Interestingly , a recent position statement on exercise and osteoporosis made no mention of this problem , its potential impact on the results of r and omized trials , or its statistical implication s 1131 . As articulated by a working group of the American Statistical Association , ITT analysis includes all r and omized subjects in the groups to which they were r and omly assigned , regardless of their compliance to the intervention and regardless of subsequent withdrawal from treatment or deviation from the protocol 1141 . ITT requires that all subjects initially r and omized into the study be included in the primary test statistics . Because this type of analysis may require imputation of data , its consequences can be profound in studies with attrition rates as high as many of these exercise studies . Some study reports stated that withdrawal rates were similar between groups ill ] , that reasons for withdrawal were not study related [ 9,11 ] , or that dropouts were not dissimilar to subjects who remained in the study on selected baseline variables 1121 . While these findings may To assess the effect of an exercise intervention using a weighted vest on perceived health status and bone density in older persons , we enrolled 36 seniors in a r and omized controlled trial . The vest-use group met weekly for 1 h for a low level exercise class . They wore a weighted vest during the class and as tolerated at home . The discussion controls met for 1 h weekly . At baseline and follow-up ( 20 weeks ) , subjects completed a question naire that incuded the 20 item MOS Short-Form Health Survey , Multidimensional Health Locus of Control Scale , and Philadelphia Geriatric Center Morale Scale , and bone density was measured by dual energy X-ray absorptiometry . Subjects also completed daily activity diaries . Subjects in the vest group reported a statistically significant dicrease in bodily pain , improved physical functioning , and increased internal health locus of control . Bone density increased by 1 % in the vest group and decreased by 0.6 % in the controls ( p=0.12 ) . We conclude that our exercise intervention had a positive effect on some measures of perceived health in older persons The objectives of this study were to evaluate ( 1 ) the effect of spinal muscle strengthening by loading exercises on the bone mineral density ( BMD ) of the spine , and ( 2 ) the effect of upper extremity loading exercises on the BMD of the midradius and femur in healthy , premenopausal women . The study design was a r and omized , controlled trial of 3 years ' duration . Ninety-six healthy , premenopausal , white women aged 30 - 40 years participated ; 67 completed the study . All subjects were in good health ( normal menses ) and were active , but not athletic ( that is , not involved in a regular sport activity ) . Subjects were r and omized to an exercise or control group . The exercise group performed a supervised , non-strenuous , weight-lifting exercise program . Exercise performance was supervised once a week at the medical facility . In addition , the subjects performed the exercises twice a week on their own . Dietary calcium intake was to be maintained at 1,500 mg/day in both groups . Bone density was measured at the lumbar spine and hip with dual-energy X-ray absorptiometry at 0 , 1 , and 3 years . BMD of the midradius was measured with single photon absorptiometry . Measurements of muscle strength were obtained at baseline and every 3 months for 3 years . Maximal oxygen uptake was measured , and the level of physical activity was recorded . Compliance with the exercise program was excellent during the first year of the study , but decreased thereafter . At the end of 3 years , subject withdrawal was about 34 % from the exercise group and about 22 % from the control group ( total subject withdrawal was about 30 % ) . Muscle strength in the exercise group increased significantly at all involved skeletal sites ( p values all < 0.001 ) . There was a modest positive correlation between the BMD of Ward 's triangle with spinal flexor strength ( r = 0.32 , p = 0.008 ) and with grip strength ( r = 0.38 , p = 0.001 ) . Comparing study groups , we found no significant effect of the loading and nonstrenuous strengthening exercises in the exercise group or free physical activity group ( our control group ) on BMD at the spine , hip , or midradius measurement sites . In active , but not athletic premenopausal women , additional moderate weight-lifting exercises showed no significant effect on BMD Summary The purpose of this study was to determine the optimal intensity of exercise necessary to prevent the postmenopausal bone loss on the basis of anaerobic threshold ( AT ) . Thirty-three postmenopausal women were r and omized to control ( group C : n=12 ) or two exercise groups ( group H and group M ) . All women performed a treadmill exercise test , and the AT was measured by expired gas analysis . The exercise regimen consisted mainly of walking at a speed that kept the exercise heart rate above the AT ( group H : n=12 ) or below the AT ( group M : n=9 ) . Exercise was performed for 30 minutes , three times a week for 7 months . The bone mineral density ( BMD ) of the lumbar vertebrae was measured using dual energy X-ray absorptiometry . The BMD level in group C decreased by 1.7±2.7 % , but there was a significant increase of 1.1±2.9 % in group H. In group M there was a decrease of 1.0±3.1 % which did not differ from group C. In group C , serum osteocalcin and urinary hydroxyproline excretion were significantly increased , but no changes were seen in either of the exercise groups . Urinary calcium significantly decreased in the exercise groups . We conclude that short-term ( 7 months ) exercise with intensity above the AT is safe and effective in preventing postmenopausal bone loss OBJECTIVE The purpose of the study was to determine the effect of six months of heavy resistance training ( weightlifting ) on the bone density of premenopausal women . EXPERIMENTAL DESIGN A 6-month prospect i ve design with r and om assignment to groups . SETTING Measurements of bone mineral density ( BMD ) were obtained from the Radiology Clinic at North Carolina Memorial Hospital . Exercise sessions were completed in the Physical Education Department facilities at the University of North Carolina , Chapel Hill , NC . PARTICIPANTS Thirty-five premenopausal women , 40 - 50 years of age , were r and omly assigned to either a resistance training ( RT ) and sedentary control ( CON ) group . The study finished with 12 women exercising and 14 in the control group . INTERVENTION The resistance training consisted of three days per week of high-intensity weightlifting specifically design ed to place strain on the spine and hips . MEASURES Bone density of the lumbar vertebrae , femoral neck , and distal radius , were determined prior to and at the end of the exercise program using dual energy X-ray absorptiometry ( DEXA ) . RESULTS Resistance-training produced strength gains : overhead press = 125 % , leg press = 86 % , and calf raises = 91 % ( p < 0.001 ) . RT tended to increased lumbar BMD 1.03 % , while the CON decreased 0.36 % ( p = 0.072 ) . Both groups lost radial BMD ( CON = -0.45 % ; RT = -1.04 % ) . Both groups gained femoral neck BMD ( CON = 1.26 % ; RT = 1.22 % ) . CONCLUSIONS These results suggest that even a short-term weight training program can either maintain or improve the BMD of the femoral neck and lumbar vertebrae in premenopausal women A substantial body of cross-sectional data and a smaller number of intervention trials generally justify optimism that regular physical activity benefits the skeleton . We conducted an 8 month controlled exercise trial in a group of healthy college women ( mean age = 19.9 years ) who were r and omly assigned to a control group or to progressive training in jogging or weight lifting . We measured the following variables : bone mineral density ( BMD ) of the spine ( L2 - 4 ) and right proximal femur using dual-energy x-ray absorptiometry , dynamic muscle strength using the 1-RM method , and endurance performance using the 1.5 mile walk/run field test . A total of 31 women completed the 8 month study . For women completing the study , compliance , defined as the percentage of workout sessions attended , was 97 % for the runners ( range 90 - 100 % ) and 92 % ( range 88 - 100 % ) for the weight trainers . Body weight increased by approximately 2 kg in all groups ( p less than 0.05 ) . Weight training was associated with significant increases ( p less than 0.01 ) in muscle strength in all muscle groups . Improvement ranged from 10 % for the deep back to 54 % for the leg . No significant changes in strength scores were observed in the control or running groups . Aerobic performance improved only in the running group ( 16 % , p less than 0.01 ) . Lumbar BMD increased ( p less than 0.05 ) in both runners ( 1.3 + /- 1.6 % ) and weight trainers ( 1.2 + /- 1.8 % ) . These results did not differ from each other but were both significantly greater than results in control subjects , in whom bone mineral did not change . ( ABSTRACT TRUNCATED AT 250 WORDS A r and omized controlled trial was carried out to determine whether calcium supplementation and load-bearing exercise can increase or maintain bone mass in the elderly . Fifty Chinese women , aged 62–92 years , living in a hostel for the elderly in Hong Kong were r and omized to enter one of four treatment groups : ( I ) calcium supplementation of 800 mg ( as calcium lactate gluconate ) daily ; ( II ) load-bearing exercise four times a week plus a daily placebo tablet ; ( III ) calcium supplementation daily and load-bearing exercise four times a week ; ( IV ) a placebo tablet daily . The interventions went on for 10 months . The bone mineral density ( BMD ) was measured at three sites in the hip ( femoral neck , Ward 's triangle and intertrochanteric area ) and the L2–4 level of the spine . The percentage change in BMD in 10 months was used as the main outcome measurement . The parathyroid hormone level and indices of bone metabolism were also measured before and after 10 months of intervention . The BMD at Ward 's triangle and the intertrochanteric area increased significantly in subjects on calcium supplement ( p<0.05 ) , but there was no significant change at the spine and femoral neck . Exercise had no effect on bone loss at any site . However , the results of two-way analysis of variance showed a significant joint effect of calcium supplements and exercise at the femoral neck ( p<0.05 ) , but not at the other sites . The parathyroid hormone levels fell significantly in subjects on calcium supplements (p<0.01).Calcium supplement in the form of calcium lactate gluconate was adequately absorbed in elderly Chinese women with a calcium intake of less than 300 mg per day . It was effective in reducing bone loss at the hip , and there may be interaction effects with exercise in maintaining bone density The effect of two structured exercise programmes on the bone mass of 48 healthy postmenopausal white women aged 50 - 62 was studied after one year . Volunteers were r and omised to group 1 ( control ) , group 2 ( aerobic exercise ) , or group 3 ( aerobic and strengthening exercises ) . Before and after the training programme each subject had evaluations of bone mass ( determined by neutron activation analysis and expressed as calcium bone index ) and maximum oxygen uptake attained on a multistage exercise treadmill test . After one year both exercise groups had higher levels of fitness and greater bone mass than controls . Mean values ( 2 SEM ) for changes in the calcium bone index were -0.011 ( 0.037 ) , 0.039 ( 0.035 ) , and 0.066 ( 0.036 ) for groups 1 , 2 , and 3 , respectively . Analysis of variance on the observed data and analysis of covariance adjusting changes to the initial mean value for the whole group showed significant differences between each exercise group and the controls but no difference between the exercise groups themselves . Both exercise groups showed a significant improvement in maximum oxygen uptake . This study suggests that exercise may modify bone loss in healthy postmenopausal women OBJECTIVE to evaluate the effects of brisk walking on bone mineral density in women who had suffered an upper limb fracture . DESIGN r and omized placebo-controlled trial . Assessment s of bone mineral density were made before and at
Output:
| This systematic review of r and omized trials shows that both impact and non-impact exercise have a positive effect at the lumbar spine in pre- and postmenopausal women .
Impact exercise probably has a positive effect at the femoral neck . |
MS211934 | ***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 AND AIMS Homelessness is associated with increased prevalence of mental health disorders , substance use disorders and mental health/substance use disorder comorbidity in the United States of America . Gay , bisexual and other men who have sex with men ( MSM ) living in the United States are at increased risk for homelessness , and have also evidence d elevated mental health and substance use disorder prevalence relative to their non-MSM male counterparts . DESIGN AND METHODS Secondary analysis of data from a r and omised controlled trial estimating the diagnostic prevalence of substance use/mental health disorder comorbidity among a sample of homeless , substance-dependent MSM ( DSM-IV verified ; n = 131 ) . RESULTS The most prevalent substance use/mental health disorder comorbidities were stimulant dependence comorbid with at least one depressive disorder ( 28 % ) , alcohol dependence comorbid with at least one depressive disorder ( 26 % ) and stimulant dependence comorbid with antisocial personality disorder ( 25 % ) . DISCUSSION AND CONCLUSIONS Diagnostic depression and antisocial personality disorder both demonstrated high rates of prevalence among homeless , substance-dependent ( particularly stimulant and alcohol dependent ) MSM . [ Fletcher JB , Reback CJ . Mental health disorders among homeless , substance-dependent men who have sex with men . Drug Alcohol Rev 2016;36:555 - 559 ] Metholodogy This study examined the prevalence and correlates of mental illness in homeless people in Hong Kong and explored the barriers preventing their access to health care . Ninety-seven Cantonese-speaking Chinese who were homeless during the study period were selected at r and om from the records of the three organisations serving the homeless population . The response rate was 69 % . Seventeen subjects could not give valid consent due to their poor mental state , so their responses were excluded from the data analysis . A psychiatrist administered the Structured Clinical Interview for DSM-IV Axis-I disorders ( SCID-I ) and the Mini -Mental State Examination . Consensus diagnoses for subjects who could not complete the SCID-I were established by three independent psychiatrists . Findings The point prevalence of mental illness was 56 % . Seventy-one percent of the subjects had a lifetime history of mental illness , 30 % had a mood disorder , 25 % had an alcohol use disorder , 25 % had a substance use disorder , 10 % had a psychotic disorder , 10 % had an anxiety disorder and 6 % had dementia . Forty-one percent of the subjects with mental illness had undergone a previous psychiatric assessment . Only 13 % of the subjects with mental illness were receiving psychiatric care at the time of interview . The prevalence of psychotic disorders , dementia and the rate of under treatment are hugely underestimated , as a significant proportion ( 18 % ) of the subjects initially selected were too ill to give consent to join the study . Conclusion The low treatment rate and the presence of this severely ill and unreached group of homeless people reflect the fact that the current mode of service delivery is failing to support the most severely ill homeless individuals BACKGROUND Very little is known about the mental health of homeless women . The present study is one of the first to focus on psychiatric diagnosis and comorbidity in a population of homeless women systematic ally interviewed with a structured instrument . METHOD Three hundred homeless women r and omly selected from St. Louis shelters were interviewed using the Diagnostic Interview Schedule ( DIS ) . RESULTS The population of homeless women in St. Louis is predominantly young adult , single , and black ; most have young children and average nearly a high school education . Schizophrenia and bipolar affective disorder account for only a small portion of the mental illness in these women . Nearly one in three has a history of substance abuse , with drug abuse being more prevalent than alcoholism . One third of the sample met lifetime criteria for posttraumatic stress disorder . One fourth of the women have received inpatient psychiatric care , and the majority with a nonsubstance Axis I diagnosis have received some mental health treatment . CONCLUSION Although major mental illness is overrepresented among these homeless women , the majority do not suffer from major mental illness . Despite the severity of the stressors these women face , the large numbers escaping psychiatric disorders speak to their resilience and to the likelihood that important factors other than mental illness contribute to their homelessness . Future studies to examine positive outcomes and investigate protective factors might provide a valuable source of information on coping with the stresses associated with homelessness and point to more effective interventions Introduction Quality assessment of included studies is an important component of systematic review s. Objective The authors investigated inter-rater and test – retest reliability for quality assessment s conducted by inexperienced student raters . Design Student raters received a training session on quality assessment using the Jadad Scale for r and omised controlled trials and the Newcastle – Ottawa Scale ( NOS ) for observational studies . Raters were r and omly assigned into five pairs and they each independently rated the quality of 13–20 articles . These articles were drawn from a pool of 78 papers examining cognitive impairment following electroconvulsive therapy to treat major depressive disorder . The articles were r and omly distributed to the raters . Two months later , each rater re-assessed the quality of half of their assigned articles . Setting McMaster Integrative Neuroscience Discovery and Study Program . Participants 10 students taking McMaster Integrative Neuroscience Discovery and Study Program courses . Main outcome measures The authors measured inter-rater reliability using κ and the intraclass correlation coefficient type 2,1 or ICC(2,1 ) . The authors measured test – retest reliability using ICC(2,1 ) . Results Inter-rater reliability varied by scale question . For the six-item Jadad Scale , question -specific κs ranged from 0.13 ( 95 % CI −0.11 to 0.37 ) to 0.56 ( 95 % CI 0.29 to 0.83 ) . The ranges were −0.14 ( 95 % CI −0.28 to 0.00 ) to 0.39 ( 95 % CI −0.02 to 0.81 ) for the NOS cohort and −0.20 ( 95 % CI −0.49 to 0.09 ) to 1.00 ( 95 % CI 1.00 to 1.00 ) for the NOS case – control . For overall scores on the six-item Jadad Scale , ICC(2,1)s for inter-rater and test – retest reliability ( accounting for systematic differences between raters ) were 0.32 ( 95 % CI 0.08 to 0.52 ) and 0.55 ( 95 % CI 0.41 to 0.67 ) , respectively . Corresponding ICC(2,1)s for the NOS cohort were −0.19 ( 95 % CI −0.67 to 0.35 ) and 0.62 ( 95 % CI 0.25 to 0.83 ) , and for the NOS case – control , the ICC(2,1)s were 0.46 ( 95 % CI −0.13 to 0.92 ) and 0.83 ( 95 % CI 0.48 to 0.95 ) . Conclusions Inter-rater reliability was generally poor to fair and test – retest reliability was fair to excellent . A pilot rating phase following rater training may be one way to improve agreement Background : Homelessness is a growing problem in the cities of the western world , and homeless people have a plethora of mental health and social difficulties . These are , nevertheless , difficult to evaluate epidemiologically . Method : In this paper we present a population survey using the Composite International Diagnostic Interview ( CIDI ) conducted in the city of Paris in winter 1996 on a representative sample of 838 homeless people . Night shelters as well as food kitchens were r and omly sample d , and the mean response rate was around 65 % . Results : The sample was relatively young and predominantly male ( 85 % ) . Forty percent were born outside France , 96 % had worked at some time , and one-third reported no re sources at all . The lifetime prevalence of psychiatric disorders was 57.9 % , while the 1-year prevalence was 29.1 % . For definite psychotic disorders , prevalence was 16 % ( lifetime ) and 6 % ( 1-year ) . Generally , this Parisian homeless population had some access to care : in the preceding 6 months 57.7 % of them had been medically attended and 14.2 % of these had been hospitalised . The survey was cross-sectional , and did not evaluate regular access to care or the quality of care . Conclusions : The implication s for health and social systems are discussed in the light of comparisons with European and North American data Objective : To determine whether the prevalence of schizophrenia among the homeless population of Edinburgh resident in hostels has changed between 1966 and 1992 . Design : Comparison of two cross sectional surveys . Setting s -- Hostels for homeless people in Edinburgh . Subjects -- In 1966 a r and om sample of 98 residents of three common lodging houses . In 1992 a r and om sample of 198 residents of nine hostels . Main outcome measure -- Prevalence of schizophrenia . Results : The prevalence of schizophrenia in 1992 was 12/136 ( 9 % ) compared with 20/79 ( 25 % ) in 1966 ( odds ratio 0.29 ; 95 % confidence interval 0.13 to 0.62 ; P=0.001 ) . Adjustment for confounding by age , current hostel , and duration of unemployment by means of logistic regression produced an adjusted odds ratio of 0.22 ( 0.08 to 0.58 ) . Conclusions : The prevalence of schizophrenia was lower in 1992 even after other changes in the population resident in hostels occurring between 1966 and 1992 were taken into account . The findings are not consistent with an increase in the prevalence of schizophrenia among homeless people despite a 66 % reduction in adult psychiatric beds in the region during 1966 - 92 Objective : International studies indicate high prevalence rates of post-traumatic stress disorder within homeless population s. In Australia , studies indicate high rates of trauma among homeless adults , yet post-traumatic stress disorder has not been investigated in homeless Australian adults . The primary aim of this project was to determine the prevalence of post-traumatic stress disorder among homeless adults in Sydney . Further , another aim of the study was to determine whether the onset of post-traumatic stress disorder preceded the first episode of homelessness or was a consequence of homelessness . Method : The sample consisted of 70 homeless men and women aged 18–73 years , who were r and omly sample d through eight homeless services . A computer-assisted face-to-face structured clinical interview was conducted with each participant . Lifetime prevalence of post-traumatic stress disorder was determined via the Composite International Diagnostic Interview . Results : The majority of the sample had experienced at least one traumatic event in their lifetime ( 98 % ) . Indeed , the mean number of traumas per person was six . The 12 month prevalence of post-traumatic stress disorder was higher among homeless adults in Sydney in comparison to the Australian general population ( 41 % vs 1.5 % ) . But 79 % of the sample had a lifetime prevalence of post-traumatic stress . In 59 % of cases , the onset of post-traumatic stress disorder preceded the age of the first reported homeless episode . Conclusions : Homeless adults in Sydney frequently experience trauma and post-traumatic stress disorder . The study found that trauma and post-traumatic stress disorder more often precede homelessness , but re-victimization is common . These findings highlight the high mental health needs among homeless people and have implication s for services for homeless people A study of homeless people in Baltimore , Md , focused on their health and other characteristics , with special emphasis on their needs for services . In the first stage , 298 men and 230 women were r and omly selected from the missions , shelters , and jail in Baltimore to respond to a baseline interview that provided extensive sociodemographic and health-related data . In the second stage , a sub sample of 203 subjects was r and omly selected from the baseline survey respondents to have systematic psychiatric and physical examinations . Data are presented from both stages . Data from the first stage demonstrate , among other things , the high levels of disaffiliation of this population and their heavy involvement in substance abuse . Data from the clinical examinations demonstrate the high prevalence of mental illnesses and other psychiatric disorders and of a wide range of physical disorders and confirm the high prevalence of alcohol abuse disorders . The high rates of comorbidity of these conditions is demonstrated and data are provided on the subjects ' needs for mental health and substance abuse services Purpose Previous cross-sectional studies have indicated that homeless individuals may present with high rates of suicidal ideation , which are strongly associated with completed suicide . We conducted the first known longitudinal study of suicidal ideation in the homeless . Methods We used data collected over 24 months in the Vancouver At Home project ( N = 497 ) , comprised two r and omized-controlled trials of housing interventions for homeless individuals with mental disorders . Presence of suicidal ideation was determined using the Colorado symptom index . Results Suicidal ideation significantly decreased over time [ odds ratio ( OR ) = 0.31 at 24 months , 95 % confidence interval ( CI ) 0.21–0.46 ] . Baseline diagn
Output:
| Conclusion This systematic review and meta- analysis revealed that schizophrenia and other psychotic disorders are highly prevalent among homeless people , indicating an urgent need for studies to help develop better mechanisms of prevention , detection as well as treatment of those disorders among homeless people |
MS211935 | ***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 — Intravenous thrombolysis is an approved treatment for anterior ( ACS ) and posterior ( PCS ) circulation stroke . However , no r and omized controlled trial has investigated safety and efficacy of intravenous thrombolysis according to stroke territory , although PCS is assumed to differ from ACS in many ways . We aim ed to compare the safety and clinical outcome of intravenous thrombolysis applied to patients with PCS and ACS . Methods — Prospect ively collected data of 883 consecutive patients with acute ischemic stroke ( 788 ACS , 95 PCS ) treated with intravenous thrombolysis in 3 Swiss stroke centers were analyzed . Presenting characteristics , symptomatic intracranial hemorrhage , mortality , and favorable outcome ( modified Rankin scale 0 or 1 ) at 3 months were compared between patients with PCS and ACS . Results — As compared with patients with ACS , those with PCS were younger ( mean age , 63 versus 67 years , P=0.012 ) and had a lower mean baseline National Institutes of Health Stroke Scale score ( 9 versus 12 , P<0.001 ) . Patients with PCS less often had symptomatic intracranial hemorrhage ( 0 % versus 5 % , P=0.026 ) and had more often a favorable outcome ( 66 % versus 47 % , P<0.001 ) . Mortality was similar in the 2 groups ( PCS , 9 % ; ACS , 13 % ; P=0.243 ) . After multivariable adjustment , PCS was an independent predictor of lower symptomatic intracranial hemorrhage frequency ( P=0.001 ) , whereas stroke territory was not associated either with favorable outcome ( P=0.177 ) or with mortality ( P=0.251 ) . Conclusions — Our study suggests that PCS is associated with a lower risk of symptomatic intracranial hemorrhage after intravenous thrombolysis as compared with ACS , whereas favorable outcome and mortality were similar in the 2 stroke territories Background and Purpose — Early reperfusion is a predictor of good outcome in acute ischemic stroke . We investigated whether middle cerebral artery ( MCA ) occlusions have a better clinical outcome and proportion of recanalization compared with internal carotid artery ( ICA ) occlusion after st and ard treatment with intravenous ( IV ) tissue plasminogen activator ( tPA ) . Patients — In a retrospective analysis of our prospect i ve stroke data base between January 7 , 1998 , and January 30 , 2002 , we identified 36 consecutive patients who were treated with IV tPA within 3 hours after symptom onset of a stroke in the distribution of a documented ICA or MCA occlusion . The National Institutes of Health Stroke Scale ( NIHSS ) score was recorded before tPA , at 24 hours , 3 days , and 3 months after stroke . Three-month outcome was recorded by modified Rankin scale . Magnetic resonance angiography or computed tomographic angiography was obtained before tPA . The presence of recanalization was assessed by transcranial Doppler and /or magnetic resonance angiography within 3 days after stroke onset . Results — Nineteen patients had MCA occlusion , and 17 had ICA-plus-MCA occlusion before tPA . Although there was no difference in age and NIHSS at day 0 between the 2 groups , the MCA group had a lower day 3 NIHSS score compared with the ICA group ( P = 0.006 ) in an ANCOVA . In addition , patients who had a MCA occlusion had lower day 1 and 3 NIHSS scores compared with the ICA group ( P = 0.04 and P = 0.03 , respectively ; Wilcoxon rank sum ) . Similarly , NIHSS was significantly lower in patients who recanalized on days 1 and 3 ( P = 0.004 and P = 0.003 respectively , Wilcoxon rank sum ) . When we adjusted for NIHSS score at day 0 in an ANCOVA , the adjusted mean was lower in the group that recanalized compared with the group that did not recanalize ( P < 0.001 ) . There was a significant difference between the proportion of recanalization in the MCA group ( 15 of 17 recanalized , 88 % ) at 3 days after tPA compared with that of the ICA group ( 5 of 16 recanalized , 31%;P = 0.001 , Fisher exact test ) . The 3-month modified Rankin scale was not different between the 2 groups . Conclusions — Despite comparable age and NIHSS scores before IV tPA , MCA occlusions have lower day 1 and 3 NIHSS scores and higher proportion of recanalization compared with ICA occlusions . A combined IV/intra-arterial or mechanical thrombolysis may be needed to achieve early recanalization in ICA occlusions Background and Purpose — Thrombolytic therapy is licensed for use in highly selected patients with acute ischemic stroke . We aim ed to model the health economic impact of limited use of thrombolytic therapy and to assess whether it was likely to be cost-effective when used more widely in the UK National Health Service ( NHS ) . Methods — The authors formed a discussion panel to develop the decision- analysis model of acute stroke care . It consisted of Markov state-transition processes , with probabilities of different health states determined by certain key variables . The range of estimates of efficacy of recombinant tissue plasminogen activator ( rt-PA ) was taken from an up date to a Cochrane systematic review of r and omized trials of thrombolysis . Data on outcome after stroke were taken from our hospital-based stroke register , supplemented by data derived from relevant literature sources . Results — The model suggested that compared with st and ard care , if eligible patients were treated with rt-PA up to 6 hours , there was a 78 % probability of a gain in quality -adjusted survival during the first year , at a cost of £ 13 581 per quality -adjusted life-year ( QALY ) gained . Over a lifetime , rt-PA was associated with cost-savings of £ 96 565 per QALY . However , the estimates were imprecise and highly susceptible to the assumptions used in the economic model ; under several plausible assumptions , rt-PA was much less cost-effective than st and ard care , and under others , a great deal more cost-effective . Conclusions — The estimates of effectiveness and cost-effectiveness were imprecise . Although the benefits appeared promising , the data did not support the widespread use of thrombolytic therapy outside the terms of the current restricted license in routine clinical practice in the NHS . There is a case for new large-scale r and omized trials comparing thrombolytic therapy with control up to 6 hours to determine more precisely the effects of rt-PA on short-term and long-term survival and its cost-effectiveness when used in a wider range of patients BACKGROUND Trials of endovascular therapy for ischemic stroke have produced variable results . We conducted this study to test whether more advanced imaging selection , recently developed devices , and earlier intervention improve outcomes . METHODS We r and omly assigned patients with ischemic stroke who were receiving 0.9 mg of alteplase per kilogram of body weight less than 4.5 hours after the onset of ischemic stroke either to undergo endovascular thrombectomy with the Solitaire FR ( Flow Restoration ) stent retriever or to continue receiving alteplase alone . All the patients had occlusion of the internal carotid or middle cerebral artery and evidence of salvageable brain tissue and ischemic core of less than 70 ml on computed tomographic ( CT ) perfusion imaging . The co primary outcomes were reperfusion at 24 hours and early neurologic improvement ( ≥8-point reduction on the National Institutes of Health Stroke Scale or a score of 0 or 1 at day 3 ) . Secondary outcomes included the functional score on the modified Rankin scale at 90 days . RESULTS The trial was stopped early because of efficacy after 70 patients had undergone r and omization ( 35 patients in each group ) . The percentage of ischemic territory that had undergone reperfusion at 24 hours was greater in the endovascular-therapy group than in the alteplase-only group ( median , 100 % vs. 37 % ; P<0.001 ) . Endovascular therapy , initiated at a median of 210 minutes after the onset of stroke , increased early neurologic improvement at 3 days ( 80 % vs. 37 % , P=0.002 ) and improved the functional outcome at 90 days , with more patients achieving functional independence ( score of 0 to 2 on the modified Rankin scale , 71 % vs. 40 % ; P=0.01 ) . There were no significant differences in rates of death or symptomatic intracerebral hemorrhage . CONCLUSIONS In patients with ischemic stroke with a proximal cerebral arterial occlusion and salvageable tissue on CT perfusion imaging , early thrombectomy with the Solitaire FR stent retriever , as compared with alteplase alone , improved reperfusion , early neurologic recovery , and functional outcome . ( Funded by the Australian National Health and Medical Research Council and others ; EXTEND-IA Clinical Trials.gov number , NCT01492725 , and Australian New Zeal and Clinical Trials Registry number , ACTRN12611000969965 . ) BACKGROUND Among patients with acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , less than 40 % regain functional independence when treated with intravenous tissue plasminogen activator ( t-PA ) alone . Thrombectomy with the use of a stent retriever , in addition to intravenous t-PA , increases reperfusion rates and may improve long-term functional outcome . METHODS We r and omly assigned eligible patients with stroke who were receiving or had received intravenous t-PA to continue with t-PA alone ( control group ) or to undergo endovascular thrombectomy with the use of a stent retriever within 6 hours after symptom onset ( intervention group ) . Patients had confirmed occlusions in the proximal anterior intracranial circulation and an absence of large ischemic-core lesions . The primary outcome was the severity of global disability at 90 days , as assessed by means of the modified Rankin scale ( with scores ranging from 0 [ no symptoms ] to 6 [ death ] ) . RESULTS The study was stopped early because of efficacy . At 39 centers , 196 patients underwent r and omization ( 98 patients in each group ) . In the intervention group , the median time from qualifying imaging to groin puncture was 57 minutes , and the rate of substantial reperfusion at the end of the procedure was 88 % . Thrombectomy with the stent retriever plus intravenous t-PA reduced disability at 90 days over the entire range of scores on the modified Rankin scale ( P<0.001 ) . The rate of functional independence ( modified Rankin scale score , 0 to 2 ) was higher in the intervention group than in the control group ( 60 % vs. 35 % , P<0.001 ) . There were no significant between-group differences in 90-day mortality ( 9 % vs. 12 % , P=0.50 ) or symptomatic intracranial hemorrhage ( 0 % vs. 3 % , P=0.12 ) . CONCLUSIONS In patients receiving intravenous t-PA for acute ischemic stroke due to occlusions in the proximal anterior intracranial circulation , thrombectomy with a stent retriever within 6 hours after onset improved functional outcomes at 90 days . ( Funded by Covidien ; SWIFT PRIME Clinical Trials.gov number , NCT01657461 . ) Background and Purpose — The frequent use of a longer time window for recanalization therapy in patients with basilar artery occlusion ( BAO ) in daily practice is not supported by any scientific evidence . We investigated the relationship between time to recanalization therapy and functional outcome in BAO with data from the Basilar Artery International Cooperation Study ( BASICS ) . Methods — BASICS is a prospect i ve multicenter registry of patients ( n=619 ) with radiologically confirmed BAO . We analyzed patients receiving intravenous thrombolysis or intra-arterial treatment . Patients were divided into 4 groups based on the interval between estimated time of BAO and start of recanalization therapy : ⩽3 hours ( n=134 ) , > 3 to ⩽6 hours ( n=151 ) , > 6 to ⩽9 hours ( n=56 ) , and > 9 hours ( n=68 ) . Primary outcome measure was poor functional outcome ( modified Rankin scale score 4–6 ) after 1 month . We calculated adjusted risk ratios with 95 % CIs using Poisson regression analyses with the ⩽3 hours group as the reference group . Results — Patients had an increased risk of poor functional outcome as time to recanalization therapy became longer ( ⩽3 hours : 62 % ; > 3 to ⩽6 hours : 67 % [ adjusted risk ratio , 1.06 ; 0.91–1.25 ] ; > 6 to ⩽9 hours : 77 % [ adjusted risk ratio , 1.26 ; 1.06–1.51 ] ; > 9 hours : 85 % [ adjusted risk ratio , 1.47 ; 1.26–1.72 ] ) . Conclusions — Early recanalization therapy in patients with BAO is associated with a more favorable outcome with a significant increased chance of a poor outcome when recanalization therapy is started > 6 hours after estimated time of BAO B
Output:
| Regarding intra-arterial treatment , the symptomatic intracerebral hemorrhage and post-procedural recanalization rates were comparable between the two groups , although the posterior circulation stroke group had a higher mortality risk and lower tendency for a favorable functional outcome .
CONCLUSIONS Safety and efficacy of thrombolysis in posterior circulation stroke depends on involvement of large vessel occlusion and reperfusion modality such that intravenous thrombolytics is more effective and safer than in anterior circulation stroke ; the safety and efficacy of intra-arterial treatment is comparable or lower than anterior circulation stroke . |
MS211936 | ***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 contribution of immune activation to accelerated HIV-disease progression in older individuals has not been delineated . Methods : Prospect i ve multicenter cohort of older ( ≥45 years ) and younger ( 18–30 years ) HIV-infected adults initiating 192 weeks of antiretroviral therapy ( ART ) . Longitudinal models of CD4 cell restoration examined associations with age-group , thymic volume , immune activation , and viral load . Results : Forty-five older and 45 younger adults ( median age 50 and 26 years , respectively ) were studied . Older patients had fewer naive CD4 cells ( P < 0.001 ) and higher HLA-DR/CD38 expression on CD4 ( P = 0.05 ) and CD8 cells ( P = 0.07 ) than younger patients at any time on ART . The rate of naive and total CD4 cell increase was similar between age groups , but older patients had a faster mean rate of B-cell increase ( by + 0.7 cells/week ; P = 0.01 ) , to higher counts than healthy controls after 192 weeks ( P = 0.003 ) . Naive CD4 increases from baseline were associated with immune activation reductions ( as declines from baseline of % CD8 cells expressing HLA-DR/CD38 ; P < 0.0001 ) , but these increases were attenuated in older patients , or in those with small thymuses . A 15 % reduction in activation was associated with naive gains of 29.9 and 6.2 cells/&mgr;l in younger , versus older patients , or with gains of 25.7 , 23.4 , and 2.1 cells/&mgr;l in patients with the largest , intermediate , and smallest thymuses , respectively ( P < 0.01 for interactions between activation reduction and age-group or thymic volume ) . Conclusion : Older patients had significant B-cell expansion , higher levels of immune activation markers , and significantly attenuated naive CD4 cell gains associated with activation reduction Objective : To prospect ively examine differences in baseline characteristics and study outcomes between HIV‐infected women and men during a clinical trial of nucleoside analogue therapy . Methods : ACTG 175 r and omized HIV‐infected patients with CD4 + counts between 200 and 500 cells/mm3 to one of four nucleoside analogue regimens : zidovudine ( ZDV ) , didanosine ( ddl ) , ZDV + ddI , or ZDV + zalcitabine ( ddC ) . Differences in time to first dose modification , voluntary withdrawal , development of toxicity and symptomatology , and AIDS progression were compared by gender . Results : The study included 438 women and 2029 men . Baseline values of HIV RNA plasma concentrations were significantly lower for women ( 0.3 log10 ) than men in a subset of patients in whom assays were taken and this difference persisted after adjustment for CD4 + count . Women reported reducing dosage and discontinue ddI‐containing regimens more frequently than men did ; adjustment for weight did not completely explain this difference . Women were at lower risk than men for progression to a study endpoint ( 19 % of women versus 24 % of men ; p < .0001 ) . Among those antiretroviral‐naive study subjects receiving ZDV , men were four times more likely to progress to a study endpoint than women . Conclusions : Differences in pretreatment characteristics and on study experiences were demonstrated between women and men enrolled in this clinical trial . The suggestion of a gender difference in response to ZDV monotherapy by antiretroviral‐naive study subjects and the lower baseline values for HIV RNA in women compared with those in men provides evidence for gender differences in the relationship between virus replication , CD4 + decline , and responses to nucleoside analogue therapy Objective : To determine the impact of age and initial HAART regimen class on virologic and immunologic response within 24 months after initiation . Design : Pooled analysis of data from 19 prospect i ve cohort studies in the North American AIDS Cohort Collaboration on Research and Design ( NA-ACCORD ) . Methods : Twelve thous and , one hundred and ninety-six antiretroviral-naive adults who initiated HAART between 1998 and 2008 using a boosted protease inhibitor-based regimen or a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen were included in our study . Discrete time-to-event models estimated adjusted hazard odds ratios ( aHOR ) and 95 % confidence intervals ( CIs ) for suppressed viral load ( ≤500 copies/ml ) and , separately , at least 100 cells/μl increase in CD4 cell count . Truncated , stabilized inverse probability weights accounted for selection biases from discontinuation of initial regimen class . Results : Among 12 196 eligible participants ( mean age = 42 years ) , 50 % changed regimen classes after initiation ( 57 and 48 % of whom initiated protease inhibitor and NNRTI-based regimens , respectively ) . Mean CD4 cell count at initiation was similar by age . Virologic response to treatment was less likely in those initiating using a boosted protease inhibitor [ aHOR = 0.77 ( 0.73 , 0.82 ) ] , regardless of age . Immunologic response decreased with increasing age [ 18–<30 : ref ; 30–<40 : aHOR = 0.92 ( 0.85 , 1.00 ) ; 40–<50 : aHOR = 0.85 ( 0.78 , 0.92 ) ; 50–<60 : aHOR = 0.82 ( 0.74 , 0.90 ) ; ≥60 : aHOR = 0.74 ( 0.65 , 0.85 ) ] , regardless of initial regimen . Conclusion : We found no evidence of an interaction between age and initial antiretroviral regimen on virologic or immunologic response to HAART ; however , decreased immunologic response with increasing age may have implication s for age-specific when-to-start guidelines BACKGROUND Individuals infected with human immunodeficiency virus ( HIV ) have higher risk than HIV-negative individuals for diseases associated with aging . T-cell senescence , characterized by expansion of cells lacking the costimulatory molecule CD28 , has been hypothesized to mediate these risks . METHODS We measured the percentage of CD28(-)CD4(+ ) and CD8(+ ) T cells from HIV-infected treatment-naive adults from 5 Adult Clinical Trials Group ( ACTG ) antiretroviral therapy ( ART ) studies and the ALLRT ( ACTG Longitudinal Linked R and omized Trials ) cohort , and from 48 HIV-negative adults . Pretreatment and 96-week posttreatment % CD28(- ) cells were assessed using linear regression for associations with age , sex , race/ethnicity , CD4 count , HIV RNA , ART regimen , and hepatitis C virus ( HCV ) infection . RESULTS In total , 1291 chronically HIV-infected adults were studied . Pretreatment , lower CD4 count was associated with higher % CD28(-)CD4(+ ) and % CD28(-)CD8(+ ) cells . For CD8(+ ) cells , younger age and HCV infection were associated with a lower % CD28(- ) . ART reduced % CD28(- ) levels at week 96 among virally suppressed individuals . Older age was strongly predictive of higher % CD28(-)CD8(+ ) . Compared to HIV-uninfected individuals , HIV-infected individuals maintained significantly higher % CD28(- ) . CONCLUSIONS Effective ART reduced the proportion of CD28(- ) T cells . However , levels remained abnormally high and closer to levels in older HIV-uninfected individuals . This finding may inform future research of increased rates of age-associated disease in HIV-infected adults Background Higher plasma D-dimer levels are strong predictors of mortality in HIV+ individuals . The factors associated with D-dimer levels during HIV infection , however , remain poorly understood . Methods In this cross-sectional study , participants in three r and omized controlled trials with measured D-dimer levels were included ( N = 9,848 ) . Factors associated with D-dimer were identified by linear regression . Covariates investigated were : age , gender , race , body mass index , nadir and baseline CD4 + count , plasma HIV RNA levels , markers of inflammation ( C-reactive protein [ CRP ] , interleukin-6 [ IL-6 ] ) , antiretroviral therapy ( ART ) use , ART regimens , co-morbidities ( hepatitis B/C , diabetes mellitus , prior cardiovascular disease ) , smoking , renal function ( estimated glomerular filtration rate [ eGFR ] and cystatin C ) and cholesterol . Results Women from all age groups had higher D-dimer levels than men , though a steeper increase of D-dimer with age occurred in men . Hepatitis B/C co-infection was the only co-morbidity associated with higher D-dimer levels . In this subgroup , the degree of hepatic fibrosis , as demonstrated by higher hyaluronic acid levels , but not viral load of hepatitis viruses , was positively correlated with D-dimer . Other factors independently associated with higher D-dimer levels were black race , higher plasma HIV RNA levels , being off ART at baseline , and increased levels of CRP , IL-6 and cystatin C. In contrast , higher baseline CD4 + counts and higher high-density lipoprotein cholesterol were negatively correlated with D-dimer levels . Conclusions D-dimer levels increase with age in HIV+ men , but are already elevated in women at an early age due to reasons other than a higher burden of concomitant diseases . In hepatitis B/C co-infected individuals , hepatic fibrosis , but not hepatitis viral load , was associated with higher D-dimer levels There is intense interest in developing curative interventions for HIV . How such a cure will be quantified and defined is not known . We applied a series of measurements of HIV persistence to the study of an HIV-infected adult who has exhibited evidence of cure after allogeneic hematopoietic stem cell transplant from a homozygous CCR5Δ32 donor . Sample s from blood , spinal fluid , lymph node , and gut were analyzed in multiple laboratories using different approaches . No HIV DNA or RNA was detected in peripheral blood mononuclear cells ( P BMC ) , spinal fluid , lymph node , or terminal ileum , and no replication-competent virus could be cultured from P BMC s. However , HIV RNA was detected in plasma ( 2 laboratories ) and HIV DNA was detected in the rectum ( 1 laboratory ) at levels considerably lower than those expected in ART-suppressed patients . It was not possible to obtain sequence data from plasma or gut , while an X4 sequence from P BMC did not match the pre-transplant sequence . HIV antibody levels were readily detectable but declined over time ; T cell responses were largely absent . The occasional , low-level PCR signals raise the possibility that some HIV nucleic acid might persist , although they could also be false positives . Since HIV levels in well-treated individuals are near the limits of detection of current assays , more sensitive assays need to be developed and vali date d. The absence of recrudescent HIV replication and waning HIV-specific immune responses five years after withdrawal of treatment provide proof of a clinical cure BACKGROUND Short-course antiretroviral therapy ( ART ) in primary human immunodeficiency virus ( HIV ) infection may delay disease progression but has not been adequately evaluated . METHODS We r and omly assigned adults with primary HIV infection to ART for 48 weeks , ART for 12 weeks , or no ART ( st and ard of care ) , with treatment initiated within 6 months after seroconversion . The primary end point was a CD4 + count of less than 350 cells per cubic millimeter or long-term ART initiation . RESULTS A total of 366 participants ( 60 % men ) underwent r and omization to 48-week ART ( 123 participants ) , 12-week ART ( 120 ) , or st and ard care ( 123 ) , with an average follow-up of 4.2 years . The primary end point was reached in 50 % of the 48-week ART group , as compared with 61 % in each of the 12-week ART and st and ard-care groups . The average hazard ratio was 0.63 ( 95 % confidence interval [ CI ] , 0.45 to 0.90 ; P=0.01 ) for 48-week ART as compared with st and ard care and was 0.93 ( 95 % CI , 0.67 to 1.29 ; P=0.67 ) for 12-week ART as compared with st and ard care . The proportion of participants who had a CD4 + count of less than 350 cells per cubic millimeter was 28 % in the 48-week ART group , 40 % in the 12-week group , and 40 % in the st and ard-care group . Corresponding values for long-term ART initiation were 22 % , 21 % , and 22 % . The median time to the primary end point was 65 weeks ( 95 % CI , 17 to 114 ) longer with 48-week ART than with st and ard care . Post hoc analysis identified a trend toward
Output:
| Participation of demographic subgroups differed by intervention type and study location .
Rates of participation of demographic groups of interest did not vary with time .
Limited data suggest efficacy , particularly of early therapy initiation followed by treatment interruption , may vary by demographic variables , in this case sex . |
MS211937 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Study Design . A prospect i ve r and omized controlled trial . Objectives . To examine the effectiveness of combined manipulative treatment , stabilizing exercises , and physician consultation compared with physician consultation alone for chronic low back pain . Summary of Background Data . Strong evidence exists that manual therapy provides more effective short-term pain relief than does placebo treatment in the management of chronic low back pain . The evidence for long-term effect is lacking . Methods . Two hundred four chronic low back pain patients , whose Oswestry disability index was at least 16 % , were r and omly assigned to either a manipulative-treatment group or a consultation group . All were clinical ly examined , informed about their back pain , provided with an educational booklet , and were given specific instructions based on the clinical evaluation . The treatment included four sessions of manipulation and stabilizing exercises aim ing to correct the lumbopelvic rhythm . Question naires inquired about pain intensity , self-rated disability , mental depression , health-related quality of life , health care costs , and production costs . Results . At the baseline , the groups were comparable , except for the percentage of employees ( P = 0.01 ) . At the 5- and 12-month follow-ups , the manipulative-treatment group showed more significant reductions in pain intensity ( P < 0.001 ) and in self-rated disability ( P = 0.002 ) than the consultation group . However , we detected no significant difference between the groups in health-related quality of life or in costs . Conclusions . The manipulative treatment with stabilizing exercises was more effective in reducing pain intensity and disability than the physician consultation alone . The present study showed that short , specific treatment programs with proper patient information may alter the course of chronic low back pain STUDY DESIGN A r and omized controlled comparative trial with an 8-month follow-up period was conducted . OBJECTIVE To compare the effect of the McKenzie treatment method with that of intensive dynamic strengthening training in patients with subacute or chronic low back pain . SUMMARY OF BACKGROUND DATA R and omized studies indicate that the efficacy of the McKenzie method in the treatment of patients with acute or subacute low back pain is debatable . Currently , no r and omized studies examining the effects of this method for patients with chronic low back pain have been published . METHODS For this study , 260 consecutive patients with low back pain and at least 8 weeks duration of symptoms ( 85 % of the patients had more than 3 months duration of symptoms ) were r and omized into two groups : Group A was treated with the McKenzie method ( n = 132 ) , and Group B was treated with intensive dynamic strengthening training ( n = 128 ) . The treatment period for both groups was 8 weeks at an outpatient clinic , followed by 2 months of self-training at home . Treatment results were recorded at the end of the treatment period at the clinic , then 2 and 8 months after . In both groups , 30 % of the patients were lost to follow-up evaluation . An intention-to-treat analysis of the main effect variables , disability , and pain was performed for all the patients included in the study . A supplementary analysis of the 180 patients who completed the full treatment program also was undertaken . RESULTS Intention-to-treat analysis showed a tendency toward a difference in reduction of disability in favor of the McKenzie group at the 2-month follow-up assessment ( P = 0.04 ) , but no differences at the end of treatment and at the 8-month follow-up evaluation . No differences in reduction of pain were observed at any time between the groups . The supplementary analysis of the patients who had completed the full intervention showed a tendency toward a difference in favor of the McKenzie method in reduction of pain at the end of treatment ( P = 0.02 ) . This difference reached statistical significance at the 2-month follow-up assessment ( P = 0.01 ) , but no difference was found after 8 months . The supplementary analysis showed no differences between the groups with regard to reduction of disability . CONCLUSION The McKenzie method and intensive dynamic strengthening training seem to be equally effective in the treatment of patients with subacute or chronic low back pain Study Design . A r and omized controlled trial with a 6-month follow-up period was conducted . Objective . To compare lumbar extension exercise and whole-body vibration exercise for chronic lower back pain . Summary of Background Data . Chronic lower back pain involves muscular as well as connective and neural systems . Different types of physiotherapy are applied for its treatment . Industrial vibration is regarded as a risk factor . Recently , vibration exercise has been developed as a new type of physiotherapy . It is thought to activate muscles via reflexes . Methods . In this study , 60 patients with chronic lower back pain devoid of “ specific ” spine diseases , who had a mean age of 51.7 years and a pain history of 13.1 years , practice d either isodynamic lumbar extension or vibration exercise for 3 months . Outcome measures were lumbar extension torque , pain sensation ( visual analog scale ) , and pain-related disability ( pain disability index ) . Results . A significant and comparable reduction in pain sensation and pain-related disability was observed in both groups . Lumbar extension torque increased significantly in the vibration exercise group ( 30.1 Nm/kg ) , but significantly more in the lumbar extension group ( + 59.2 Nm/kg ; SEM 10.2;P < 0.05 ) . No correlation was found between gain in lumbar torque and pain relief or pain-related disability ( P > 0.2 ) . Conclusions . The current data indicate that poor lumbar muscle force probably is not the exclusive cause of chronic lower back pain . Different types of exercise therapy tend to yield comparable results . Interestingly , well-controlled vibration may be the cure rather than the cause of lower back pain BACKGROUND AND PURPOSE The prescriptive validity of a treatment-oriented extension-mobilization category for patients with low back syndrome ( LBS ) was examined . SUBJECTS Of a total of 39 patients with LBS referred for physical therapy , 24 patients ( 14 male , 10 female ) , aged 14 to 50 years ( means = 31.3 , SD = 11.6 ) , were classified as having signs and symptoms indicating treatment with an extension-mobilization approach . The remaining subjects were dismissed from the study . Patients in the extension-mobilization category were r and omly assigned to either an experimental ( treatment ) group ( n = 14 ) or a comparison group ( n = 10 ) . METHODS The experimental and comparison group subjects were treated with either mobilization and extension ( a treatment matched to the category ) or a flexion exercise regimen ( an unmatched treatment ) . Outcome was assessed with a modified Oswestry Low Back Pain Question naire administered initially and at 3 and 5 days after initiation of treatment . Data were analyzed with a 2 x 3 ( treatment group x treatment period ) analysis of variance . RESULTS The subjects ' rate of improvement , as indicated by the Oswestry question naire scores , was dependent on the treatment group to which they were assigned . Subjects treated with extension and mobilization positively responded at a faster rate than did those treated with a flexion-oriented program . CONCLUSION AND DISCUSSION This study illustrates that a priori classification of selected patients with LBS into a treatment category of extension and mobilization and subsequently treating the patients accordingly with specified interventions can be an effective approach to conservative management of selected patients BACKGROUND Chiropractic manipulation and strenuous exercise therapy have been shown effective in the treatment of nonspecific back pain . Bone- setting , the predecessor of modern manual therapies , still survives in some parts of Finl and and was compared with a light exercise therapy and non-manipulative , pragmatic physiotherapy in a year-long r and omized controlled trial on patients with long-term back pain . METHODS One hundred fourteen ambulatory patients of working age with back pain for 7 weeks or more were r and omly assigned to the therapies , which were offered in up to 10 sessions during a 6-week treatment period . The outcome was measured by the Oswestry Disability Question naire . Sick-leaves and visits to health centers were recorded for 1 year before and after the therapy . RESULTS The Oswestry disability scores improved most in the bone- setting group ( P = .02 , Kruskall-Wallis test ) . Visits to health centers for back pain were reduced only in the physiotherapy group ( P = .01 , Wilcoxon test ) . Sick-leaves were not significantly different between groups . A secondary analysis based on the use of additional therapies after the intervention showed a possible subgroup with an enhanced effect from bone- setting . CONCLUSIONS Traditional bone- setting seemed more effective than exercise or physiotherapy on back pain and disability , even 1 year after therapy Abstract Objective : To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities . Design : R and omised controlled trial of progressive exercise programme compared with usual primary care management . Patients ' preferences for type of management were elicited independently of r and omisation . Participants : 187 patients aged 18 - 60 years with mechanical low back pain of 4 weeks to 6 months ' duration . Interventions : Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups , stretching exercises , relaxation session , and brief education on back care . A cognitive-behavioural approach was used . Main outcome measures : Assessment s of debilitating effects of back pain before and after intervention and at 6 months and 1 year later . Measures included Rol and disability question naire , Aberdeen back pain scale , pain diaries , and use of healthcare services . Results : At 6 weeks after r and omisation , the intervention group improved marginally more than the control group on the disability question naire and reported less distressing pain . At 6 months and 1 year , the intervention group showed significantly greater improvement in the disability question naire score ( mean difference in changes 1.35 , 95 % confidence interval 0.13 to 2.57 ) . At 1 year , the intervention group also showed significantly greater improvement in the Aberdeen back pain scale ( 4.44 , 1.01 to 7.87 ) and reported only 378 days off work compared with 607 in the control group . The intervention group used fewer healthcare re sources . Outcome was not influenced by patients ' preferences . Conclusions : The exercise class was more clinical ly effective than traditional general practitioner management , regardless of patient preference , and was cost effective . Key messages Patients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmful An exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year later Patients ' preferences for type of management did not affect outcome Patients in the intervention group tended to use fewer healthcare re sources and took fewer days off work This type of exercise programme should be more widely BACKGROUND The effectiveness of massage therapy for low-back pain has not been documented . This r and omized controlled trial compared comprehensive massage therapy ( soft-tissue manipulation , remedial exercise and posture education ) , 2 components of massage therapy and placebo in the treatment of subacute ( between 1 week and 8 months ) low-back pain . METHODS Subjects with subacute low-back pain were r and omly assigned to 1 of 4 groups : comprehensive massage therapy ( n = 25 ) , soft-tissue manipulation only ( n = 25 ) , remedial exercise with posture education only ( n = 22 ) or a placebo of sham laser therapy ( n = 26 ) . Each subject received 6 treatments within approximately 1 month . Outcome measures obtained at baseline , after treatment and at 1-month follow-up consisted of the Rol and Disability Question naire ( RDQ ) , the McGill Pain Question naire ( PPI and PRI ) , the State Anxiety Index and the Modified Schober test ( lumbar range of motion ) . RESULTS Of the 107 subjects who passed screening , 98 ( 92 % ) completed post-treatment tests and 91 ( 85 % ) completed follow-up tests . Statistically significant differences were noted after treatment and at follow-up . The comprehensive massage therapy group had improved function ( mean RDQ score 1.54 v. 2.86 - 6.5 , p < 0.001 ) , less intense pain ( mean PPI score 0.42 v. 1.18 - 1.75 , p < 0.001 ) and a decrease in the quality of pain ( mean PRI score 2.29 v. 4.55 - 7.71 , p = 0.006 ) compared with the other 3 groups . Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function . At 1-month follow-up 63 % of subjects in the comprehensive massage therapy group reported no pain as compared with 27 % of the soft-tissue manipulation group , 14 % of the remedial exercise group and 0 % of the sham laser therapy group . INTERPRETATION Patients with subacute low-back pain were shown to benefit from massage therapy , as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists OBJECTIVE To determine if the use of an isokinetic device for trunk exercise is more effective than st and ard physiotherapy in promoting motor disinhibition for patients with chronic low back pain . POPULATION chronic low back pain out patients who are treated in a Rheumatology or PM & R unit within an academic hospital . METHODOLOGY This is a prospect i ve , controlled , r and omized study , with two groups of treatment : one treated with isokinetic techniques and the other with st and ard physiotherapy , six sessions for each treatment during 2 weeks . Outcome measures include pain ( VSA ) , trunk mobility ( Schöber index , distance from fingers to floor ) , muscle extensibility and muscle strength ( Biering
Output:
| Exercise therapy decreased pain and improved physical function by modest amounts in adults with chronic low back pain .
In adults with acute low back pain , exercise therapy , conservative management , and no treatment had similar effects on pain .
They synthesized the evidence by using a levels-of- evidence approach because of the heterogeneity and insufficiency of the literature and concluded that the evidence did not support effectiveness of exercises for acute low back pain but that exercises may be helpful for chronic low back pain .
We considered studies to provide evidence that the exercise therapy was ineffective if the comparison group statistically significantly improved and the exercise group did not statistically significantly improve . |
MS211938 | ***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 appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p < 0.022 ) . HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p < 0.002 ) . The reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control The influence of the source of dietary fat on postpr and ial thermogenesis and substrate oxidation rates , was examined in twelve postmenopausal women aged 57 - 73 years , with BMI 21.9 - 38.3 kg/m(2 ) . A single blind , r and omised , paired comparison of two high-fat , isoenergetic , mixed test meals was conducted . The major source of fat was either cream ( CREAM ) or extra virgin olive oil ( EVOO ) . RMR , diet-induced thermogenesis ( DIT ) and substrate oxidation rates over 5 h were measured by indirect calorimetry . There were no differences in body weight , RMR , fasting carbohydrate or fat oxidation rates between the two occasions . DIT ( EVOO 97 ( SD 46 ) v. CREAM 76 ( SD 69 ) kJ/5 h and EVOO 5.2 ( SD 2.5 ) v. CREAM 4.1 ( SD 3.7)% energy ) did not differ between the two test meals . The postpr and ial increase in carbohydrate oxidation rates , relative to their respective fasting values ( DeltaCOX ) , was significantly lower following the EVOO meal ( EVOO 10.6 ( SD 8.3 ) v. CREAM 17.5 ( SD 10 ) g/5 h ; paired t test , P=0.023 ) , while postpr and ial fat oxidation rates ( DeltaFOX ) were significantly higher ( EVOO 0.0 ( SD 4.4 ) v. CREAM -3.6 ( sd 4.0 ) g/5 h ; P=0.028 ) . In the eight obese subjects , however , DIT was significantly higher following the EVOO meal ( EVOO 5.1 ( SD 2.0 ) v. CREAM 2.5 ( sd 2.9 ) % ; P=0.01 ) . This was accompanied by a significantly lower DeltaCOX ( EVOO 10.9 ( SD 9.9 ) v. CREAM 17.3 ( SD 10.5 ) g/5 h ; P=0.03 ) and significantly higher DeltaFOX ( EVOO 0.11 ( SD 4.4 ) v. CREAM -4.1 ( SD 4.5 ) g/5 h , P=0.034 ) . The present study showed that olive oil significantly promoted postpr and ial fat oxidation and stimulated DIT in abdominally obese postmenopausal women The aim of this dynamic prospect i ve follow-up study was to assess the association between olive oil consumption and the likelihood of weight gain or the incidence of overweight or obesity in a large Mediterranean cohort of 7,368 male and female Spanish university graduates ( the SUN Project ) who were followed for a median period of 28.5 mon . A vali date d Food Frequency Question naire was administered at baseline , and respondents also completed a follow-up question naire after 28.5 mon . Changes in participants ' consumption of olive oil and their weight were assessed during follow-up . A higher baseline consumption of olive oil was associated with a lower likelihood of weight gain , although the differences were not statistically significant . The adjusted difference in weight gain ( kg ) was −0.16 [ 95 % confidence interval ( C1 ) : −0.42 to + 0.11 ] for participants in the upper quintile of olive oil consumption ( median : 46 g/d ) compared with those in the lowest quintile ( median : 6 g/d ) . For participants with a high baseline consumption of olive oil whose olive oil consumption also increased during follow-up , we found a slightly increased but nonsignificant risk of incidence of over-weight or obesity ( adjusted odds ratio=1.19 , 95 % C1 : 0.73 to 1.95 ) . Our study , carried out in a sample of free-living people , shows that a high amount of olive oil consumption is not associated with higher weight gain or a significantly higher risk of developing overweight or obesity in the context of the Mediterranean food pattern Six healthy adult males were fed four different diets to determine the effects of the quantity of fat ( 30 % or 40 % of energy as fat ) and type of fat ( polyunsaturated or saturated ) on utilization of fatty acids . Each diet was fed for 15 d. The ratio of dietary polyunsaturated to saturated fat ( P : S ) was formulated at either 0.2 or 1.0 at both fat intakes . Subjects provided breath tests to measure background 13C and response to [1 - 13C]10:0 and [1 - 13C]16:0 fed with a test meal . Increasing the P : S increased whole-body oxidation of labeled 10:0 by 30 % after consumption of both low- and high-fat diets . When labeled 16:0 was fed , the amount of 13C excreted in breath increased by a factor of 2.4 after the low-fat diet with a high P : S compared with the diet with a low P : S. The results suggest that the amount and type of fat in the diet affect utilization of individual fatty acids in normal subjects A r and omised crossover study of eight overweight or obese men ( aged 24 - 49 years , BMI 25.5 - 31.3 kg/m(2 ) ) , who followed two diets for 4 weeks each , was performed to determine whether substitution of saturated fat with monounsaturated fat affects body weight and composition . Subjects were provided with all food and beverages as modules ( selected ad libitum ) of constant macronutrient composition , but differing energy content . The % total energy from saturated fat , monounsaturated fat and polyunsaturated fat was 24 , 13 and 3 % respectively on the saturated fatty acid (SFA)-rich diet and 11 , 22 and 7 % respectively on the monounsaturated fatty acid (MUFA)-rich diet . MUFA accounted for about 80 % of the unsaturated fats consumed on both diets . Body composition , blood pressure , energy expenditure ( resting and postpr and ial metabolic rates , substrate oxidation rate , physical activity ) , serum lipids , the fatty acid profile of serum cholesteryl esters and plasma glucose and insulin concentrations were measured before and after each diet period . Significant ( P < or = 0.05 ) differences in total cholesterol and the fatty acid composition of serum cholesteryl esters provided evidence of dietary adherence . The men had a lower weight ( -2.1 ( SE 0.4 ) kg , P=0.0015 ) and fat mass ( -2.6 ( SE 0.6 ) kg , P=0.0034 ) at the end of the MUFA-rich diet as compared with values at the end of the SFA-rich diet . No significant differences were detected in energy or fat intake , energy expenditure , substrate oxidation rates or self-reported physical activity . Substituting dietary saturated with unsaturated fat , predominantly MUFA , can induce a small but significant loss of body weight and fat mass without a significant change in total energy or fat intake OBJECTIVE We examined associations between two Mediterranean diet ( MD ) adherence indexes ( the MD index , MDI , and the MD score , MDS ) and several blood biomarkers of diet and disease . SUBJECTS We studied 328 individuals from Catalonia ( Northeastern Spain ) , ages 18 - 75 , who provided fasting blood sample s , a subset of the 2346 individuals as part of a larger representative and r and om sample from the 1992 - 1993 Catalan Nutritional Survey . DESIGN AND METHOD Diet was measured using 24-h recalls . Biomarkers studied were plasma levels of beta-carotene , alpha-tocopherol , retinol , vitamins B12 , C and folates as well as serum total cholesterol , HDL cholesterol , LDL cholesterol and triglycerides . Multivariate linear regression was used to analyse associations of the nutrient biomarkers with the dietary pattern indexes , adjusting for potential confounders . RESULTS AND CONCLUSIONS Subjects with higher MD adherence , as measured by the two dietary indexes , had significantly higher plasma concentrations of beta-carotene , folates , vitamin C , alpha-tocopherol and HDL cholesterol . The most highly significant relationship was that between folates and the adherence to the MD Pattern , as determined by both indexes . These research findings suggest the potential usefulness of biomarkers as complementary tools for assessing adherence to a dietary pattern . This type of data not only informs the development of robust dietary adherence indexes , but it also provides specific clues about the potential physiological mechanisms that explain the beneficial effects of the MD pattern on chronic disease risk BACKGROUND Several studies have shown that adherence to the Mediterranean Diet measured by using the Mediterranean diet score ( MDS ) is associated with lower obesity risk . The newly proposed Nordic Diet could hold similar beneficial effects . Because of the increasing focus on the interaction between diet and genetic predisposition to adiposity , studies should consider both diet and genetics . OBJECTIVE We investigated whether FTO rs9939609 and TCF7L2 rs7903146 modified the association between the MDS and Nordic diet score ( NDS ) and changes in weight ( Δweight ) , waist circumference ( ΔWC ) , and waist circumference adjusted for body mass index ( BMI ) ( ΔWC BMI ) . DESIGN We conducted a case-cohort study with a median follow-up of 6.8 y that included 11,048 participants from 5 European countries ; 5552 of these subjects were cases defined as individuals with the greatest degree of unexplained weight gain during follow-up . A r and omly selected subcohort included 6548 participants , including 5496 noncases . Cases and noncases were compared in analyses by using logistic regression . Continuous traits ( ie , Δweight , ΔWC , and ΔWC BMI ) were analyzed by using linear regression models in the r and om subcohort . Interactions were tested by including interaction terms in models . RESULTS A higher MDS was significantly inversely associated with case status ( OR : 0.98 ; 95 % CI : 0.96 , 1.00 ) , ΔWC ( β = -0.010 cm/y ; 95 % CI : -0.020 , -0.001 cm/y ) , and ΔWC BMI ( β = -0.008 ; 95 % CI:-0.015 , -0.001 ) per 1-point increment but not Δweight ( P = 0.53 ) . The NDS was not significantly associated with any outcome . There was a borderline significant interaction between the MDS and TCF7L2 rs7903146 on weight gain ( P = 0.05 ) , which suggested a beneficial effect of the MDS only in subjects who carried 1 or 2 risk alleles . FTO did not modify observed associations . CONCLUSIONS A high MDS is associated with a lower ΔWC and ΔWC BMI , regardless of FTO and TCF7L2 risk alleles . For Δweight , findings were less clear , but the effect may depend on the TCF7L2 rs7903146 variant . The NDS was not associated with anthropometric changes during follow-up BACKGROUND AND AIMS Diets high in monounsaturated fatty acids ( MUFA ) such as a Mediterranean diet may reduce the risk of cardiovascular diseases by improving insulin sensitivity and serum lipids . Besides being high in MUFA , a Mediter
Output:
| This systematic review highlights the potential for a Mediterranean diet intervention to reduce central obesity and in turn reduce obesity-related chronic disease risk and associated public health burden |
MS211939 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Purpose . The purpose of this study was to test the feasibility and assess outcomes of health care adherence based on whether participants engage in particular risky behaviors relevant to general health or living with human immunodeficiency virus ( HIV ) infection and the frequency of these adherent behaviors . Health adherent behaviors include both self-advocacy and decreased stigma as underlying key components . Design . A r and omized control trial comparing peer-led attention control support and intervention groups . Setting . Community-based women 's drop-in center in an urban , black neighborhood of Boston , Massachusetts . Subjects . Aging , low-income , black women living with HIV infection . Intervention . Peer-led , small-group , structured writing using film clips from Women 's Voices Women 's Lives as a writing prompt . Measures . Demographic and outcome data that included adherence , self-advocacy , and stigma ; collected at baseline , 6 weeks , and 6 months . Analysis . Repeated- measures analysis of variance scores were examined between groups and waves . Paired- sample t-tests were used to examine mean differences across time . Results . Sample included 110 women ( intervention , n = 56 ; comparison , n = 54 ) . Retention was 85.5 % . Repeated- measures analysis indicated intervention group condom use ( n = 69 , F = 8.02 , df = 1 , p < .01 ) and safe sex ( n = 71 , F = 13.02 , df = 1 , p < .01 ) was higher than that of comparison group . A time effect was also found in the Silencing the Self Scale ( n = 91 , Pillai 's trace = 7.21 , df = 2 , p < .01 ) . Conclusion . This study demonstrates the feasibility of a tailored , peer-led , and culturally relevant interventions and tentative efficacy in population s affected by health disparities . Key limitations include no comparison intervention format with women who ca n't write and the need to test generalizability Abstract Multimedia technologies offer powerful tools to increase capacity of health workers to deliver st and ardized , effective , and engaging antiretroviral medication adherence counseling . Masivukeni — is an innovative multimedia-based , computer-driven , lay counselor-delivered intervention design ed to help people living with HIV in re source -limited setting s achieve optimal adherence . This pilot study examined medication adherence and key psychosocial outcomes among 55 non-adherent South African HIV+ patients , on antiretroviral therapy ( ART ) for at least 6 months , who were r and omized to receive either Masivukeni or st and ard of care ( SOC ) counseling for ART non-adherence . At baseline , there were no significant differences between the SOC and Masivukeni groups on any outcome variables . At post-intervention ( approximately 5–6 weeks after baseline ) , -clinic-based pill count adherence data available for 20 participants ( 10 per intervention arm ) showed a 10 % improvement for— participants and a decrease of 8 % for SOC participants . Masivukeni participants reported significantly more positive attitudes towards disclosure and medication social support , less social rejection , and better clinic – patient relationships than did SOC participants . Masivukeni shows promise to promote optimal adherence and provides preliminary evidence that multimedia , computer-based technology can help lay counselors offer better adherence counseling than st and ard approaches 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 Introduction Hope is an essential dimension of successful coping in the context of illnesses such as HIV/AIDS , because positive expectations for the future alleviate emotional distress , enhance quality of life and have been linked to the capacity for behavioural change . The social environment ( e.g. family , peers ) is a regulator of hope for people living with HIV/AIDS ( PLWHA ) . In this regard , the dual aim of this article is ( 1 ) to analyze the influence of a peer adherence support ( PAS ) intervention and the family environment on the state of hope in PLWHA and ( 2 ) to investigate the interrelationship between the two determinants . Methods The Effective AIDS Treatment and Support in the Free State study is a prospect i ve r and omized controlled trial . Participants were recruited from 12 public antiretroviral treatment ( ART ) clinics across five districts in the Free State Province of South Africa . Each of these patients was assigned to one of the following groups : a control group receiving st and ard care , a group receiving additional biweekly PAS or a group receiving PAS and nutritional support . Latent cross-lagged modelling ( Mplus ) was used to analyse the impact of PAS and the family environment on the level of hope in PLWHA . Results The results of the study indicate that neither PAS nor the family environment has a direct effect on the level of hope in PLWHA . Subsequent analysis reveals a positive significant interaction between family functioning and PAS at the second follow-up , indicating that better family functioning increases the positive effect of PAS on the state of hope in PLWHA . Conclusions The interplay between well-functioning families and external PAS generates higher levels of hope , which is an essential dimension in the success of lifelong treatment . This study provides additional insight into the important role played by family dynamics in HIV/AIDS care , and it underscores the need for PAS interventions that are sensitive to the context s in which they are implemented Summary Background The treatment of perinatal depression is a public-health priority because of its high prevalence and association with disability and poor infant development . We integrated a cognitive behaviour therapy-based intervention into the routine work of community-based primary health workers in rural Pakistan and assessed the effect of this intervention on maternal depression and infant outcomes . Methods We r and omly assigned 40 Union Council clusters in rural Rawalpindi , Pakistan , in equal numbers to intervention or control . Married women ( aged 16–45 years ) in their third trimester of pregnancy with perinatal depression were eligible to participate . In the intervention group , primary health workers were trained to deliver the psychological intervention , whereas in the control group untrained health workers made an equal number of visits to the depressed mothers . The primary outcomes were infant weight and height at 6 months and 12 months , and secondary outcome was maternal depression . The interviewers were unaware of what group the participants were assigned to . Analysis was by intention to treat . The study is registered as IS RCT N65316374 . Findings The number of clusters per group was 20 , with 463 mothers in the intervention group and 440 in the control group . At 6 months , 97 ( 23 % ) of 418 and 211 ( 53 % ) of 400 mothers in the intervention and control groups , respectively , met the criteria for major depression ( adjusted odds ratio ( OR ) 0·22 , 95 % CI 0·14 to 0·36 , p<0·0001 ) . These effects were sustained at 12 months ( 111/412 [ 27 % ] vs 226/386 [ 59 % ] , adjusted OR 0·23 , 95 % CI 0·15 to 0·36 , p<0·0001 ) . The differences in weight-for-age and height-for-age Z scores for infants in the two groups were not significant at 6 months ( −0·83 vs −0·86 , p=0·7 and −2·03 vs −2·16 , p=0·3 , respectively ) or 12 months ( −0·64 vs −0·8 , p=0·3 and −1·10 vs −1·36 , p=0·07 , respectively ) . Interpretation This psychological intervention delivered by community-based primary health workers has the potential to be integrated into health systems in re source -poor setting s. Funding Wellcome Trust Background Among people living with HIV ( PLHIV ) on antiretroviral therapy ( ART ) , it is important to determine how quality of life ( QOL ) may be improved and HIV-related stigma can be lessened over time . This study assessed the effect of peer support on QOL and internal stigma during the first year after initiating ART among a cohort of PLHIV in north-eastern Vietnam . Methods A sub- sample study of a r and omised controlled trial was implemented between October 2008 and November 2010 in Quang Ninh , Vietnam . In the intervention group , participants ( n = 119 ) received adherence support from trained peer supporters who visited participants ’ houses biweekly during the first two months , thereafter weekly . In the control group , participants ( n = 109 ) were treated according to st and ard guidelines , including adherence counselling , monthly health check and drug refills . Basic demographics were measured at baseline . QOL and internal stigma were measured using a Vietnamese version of the WHOQOL-HIVBREF and Internal AIDS-related Stigma Scale instruments at baseline and 12 months . T-tests were used to detect the differences between mean values , multilevel linear regressions to determine factors influencing QOL . Results Overall , QOL improved significantly in the intervention group compared to the control group . Among participants initiating ART at clinical stages 3 and 4 , education at high school level or above and having experiences of a family member dying from HIV were also associated with higher reported QOL . Among participants at clinical stage 1 and 2 , there was no significant effect of peer support , whereas having children was associated with an increased QOL . Viral hepatitis was associated with a decreased QOL in both groups . Lower perceived stigma correlated significantly but weakly with improved QOL , however , there was no significant relation to peer support . Conclusion The peer support intervention improved QOL after 12 months among ART patients presenting at clinical stages 3 and 4 at baseline , but it had no impact on QOL among ART patients enrolled at clinical stages 1 and 2 . The intervention did not have an effect on Internal AIDS-related stigma . To improve QOL for PLHIV on ART , measures to support adherence should be context ualized in accordance with individual clinical and social needs OBJECTIVE To evaluate the effectiveness of a culturally adapted , primary care – based nurse – community health worker ( CHW ) team intervention to support diabetes self-management on diabetes control and other biologic measures . RESEARCH DESIGN AND METHODS Two hundred sixty-eight Samoan participants with type 2 diabetes were recruited from a community health center in American Samoa and were r and omly assigned by village clusters to the nurse-CHW team intervention or to a wait-list control group that received usual care . RESULTS Participants had a mean age of 55 years , 62 % were female , mean years of education were 12.5 years , 41 % were employed , and mean HbA1c was 9.8 % at baseline . At 12 months , mean HbA1c was significantly lower among CHW participants , compared with usual care , after adjusting for confounders ( b = −0.53 ; SE = 0.21 ; P = 0.03 ) . The odds of making a clinical ly significant improvement in HbA1c of at least 0.5 % in the CHW group was twice the odds in the usual care group after controlling for confounders ( P = 0.05 ) . There were no significant differences in blood pressure , weight , or waist circumference at 12 months between groups . CONCLUSIONS A culturally adapted nurse-CHW team intervention was able to significantly improve diabetes control in the U.S. Territory of American Samoa . This represents an important translation of an evidence -based model to a high-risk population and a re source -poor setting In the current context of human re source shortages in South Africa , various community support interventions are being implemented to provide long-term psychosocial care to persons living with HIV/AIDS ( PLWHA ) . However , it is important to analyze the unintended social side effects of such interventions in regards to the stigma felt by PLWHA , which might threaten the successful management of life-long treatment . Latent cross-lagged modeling was used to analyze longitudinal data on 294 PLWHA from a r and omized controlled trial ( 1 ) to determine whether peer adherence support ( PAS ) and treatment buddying influence the stigma experienced by PLWHA ; and ( 2 ) to analyze the interrelationships between each support form and stigma . Results indicate that having a treatment buddy decreases felt stigma scores , while receiving PAS increases levels of felt stigma at the second follow up . However , the PAS intervention was also found to have a positive influence on having a treatment buddy at this time . Furthermore , a treatment buddy mitigates the stigmatizing effect of PAS , result ing in a small negative indirect effect on stigma . The study indicates the importance of looking beyond the intended effects of an intervention , with the goal of minimizing any adverse consequences that might threaten the successful long-term management of HIV/AIDS and maximizing the opportunities created by such support OBJECTIVE To evaluate the acceptability , practicality , and short-term efficacy of a health education program to improve disease self-management in patients with symptomatic HIV/AIDS . DESIGN R and omized controlled trial , baseline and 3-month follow-up question naire assessment s. SETTING San Francisco Bay communities . PARTICIPANTS Seventy-one men with symptomatic HIV or AIDS were r and omly assigned to a seven-session group educational intervention ( N=34 ) or a usual-care control group ( N=37 ) . INTERVENTION Interactive health education groups were used to teach wide-ranging disease self-management skills and information : symptom assessment and management , medication use , physical exercise , relaxation , doctor-patient communication , and nutrition . Each group was led by two trained peer-leaders ( one of whom was HIV-positive ) recruited from the community . MAIN OUTCOME MEASURES The primary outcome
Output:
| Evidence partially supported the use of CHWs in promoting psychosocial outcomes in PLWH . |
MS211940 | ***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 need to provide high quality prenatal care services , which take account of women ’s views and specifically address their need for information , support and communication , has been advocated and group prenatal care , had been suggested as one of the ways to achieve this objective . The purpose of this study was to examine the impact of group versus individual prenatal care on satisfaction and prenatal care use . Methods : This was a cluster-r and omized controlled trial with the health center as the r and omization unit that conducted in 2007 . Satisfaction was measured through a st and ardized question naire , and the Kotelchuck Adequacy of Prenatal Care Utilization Index was used to measure prenatal care utilization . Results : We recruited 678 women ( group prenatal care , ( N= 344 ) and individual prenatal care , ( N=334 ) in the study . Women in group prenatal care model were more satisfied than women in individual prenatal care model in all areas evaluated , including information , communication , co-ordination and quality of care . Group care women were significantly more likely to have adequate prenatal care than individual care women were ( OR=1.35 95 % CI=1.26–1.44 ) . Conclusions : Group prenatal care was associated with a significant improvement in client satisfaction and prenatal care utilization . This model of care has implication s for the planning and provision of prenatal services within public health system , which is moving toward a better quality health care , and increasing use of services OBJECTIVES To estimate the impact of the Integrated Management of Childhood Illness ( IMCI ) strategy on early-childhood mortality , we evaluated a malaria-control project in Benin that implemented IMCI and promoted insecticide-treated nets ( ITNs ) . METHODS We conducted a before- and -after intervention study that included a nonr and omized comparison group . We used the preceding birth technique to measure early-childhood mortality ( risk of dying before age 30 months ) , and we used health facility surveys and household surveys to measure process indicators . RESULTS Most process indicators improved in the area covered by the intervention . Notably , because ITNs were also promoted in the comparison area children 's ITN use increased by about 20 percentage points in both areas . Regarding early-childhood mortality , the trend from baseline ( 1999 - 2001 ) to follow-up ( 2002 - 2004 ) for the intervention area ( 13.0 % decrease ; P < .001 ) was 14.1 % ( P < .001 ) lower than was the trend for the comparison area ( 1.3 % increase ; P = .46 ) . CONCLUSIONS Mortality decreased in the intervention area after IMCI and ITN promotion . ITN use increased similarly in both study areas , so the mortality impact of ITNs in the 2 areas might have canceled each other out . Thus , the mortality reduction could have been primarily attributable to IMCI 's effect on health care quality and care-seeking BACKGROUND Evidence about the best methods with which to accelerate progress towards achieving the Millennium Development Goals is urgently needed . We assessed the effect of performance-based payment of health-care providers ( payment for performance ; P4P ) on use and quality of child and maternal care services in health-care facilities in Rw and a. METHODS 166 facilities were r and omly assigned at the district level either to begin P4P funding between June , 2006 , and October , 2006 ( intervention group ; n=80 ) , or to continue with the traditional input-based funding until 23 months after study baseline ( control group ; n=86 ) . R and omisation was done by coin toss . We surveyed facilities and 2158 households at baseline and after 23 months . The main outcome measures were prenatal care visits and institutional deliveries , quality of prenatal care , and child preventive care visits and immunisation . We isolated the incentive effect from the re source effect by increasing comparison facilities ' input-based budgets by the average P4P payments made to the treatment facilities . We estimated a multivariate regression specification of the difference-in-difference model in which an individual 's outcome is regressed against a dummy variable , indicating whether the facility received P4P that year , a facility-fixed effect , a year indicator , and a series of individual and household characteristics . FINDINGS Our model estimated that facilities in the intervention group had a 23 % increase in the number of institutional deliveries and increases in the number of preventive care visits by children aged 23 months or younger ( 56 % ) and aged between 24 months and 59 months ( 132 % ) . No improvements were seen in the number of women completing four prenatal care visits or of children receiving full immunisation schedules . We also estimate an increase of 0·157 st and ard deviations ( 95 % CI 0·026 - 0·289 ) in prenatal quality as measured by compliance with Rw and an prenatal care clinical practice guidelines . INTERPRETATION The P4P scheme in Rw and a had the greatest effect on those services that had the highest payment rates and needed the least effort from the service provider . P4P financial performance incentives can improve both the use and quality of maternal and child health services , and could be a useful intervention to accelerate progress towards Millennium Development Goals for maternal and child health . FUNDING World Bank 's Bank-Netherl and s Partnership Program and Spanish Impact Evaluation Fund , the British Economic and Social Research Council , Government of Rw and a , and Global Development Network OBJECTIVE To compare the maternal outcome , in terms of postpartum infection , of deliveries conducted by trained traditional birth attendants ( TBAs ) with those conducted by untrained birth attendants . METHODS The study took place in a rural area of Bangladesh where a local NGO ( BRAC ) had previously undertaken TBA training . Demographic surveillance in the study site allowed the systematic identification of pregnant women . Pregnant women were recruited continuously over a period of 18 months . Data on the delivery circumstances were collected shortly after delivery while data on postpartum morbidity were collected prospect ively at 2 and 6 weeks . All women with complete records who had delivered at home with a non-formal birth attendant ( 800 ) were included in the analysis . The intervention investigated was TBA training in hygienic delivery comprising the ' three cleans ' ( h and -washing with soap , clean cord care , clean surface ) . The key outcome measure was maternal postpartum genital tract infection diagnosed by a symptom complex of any two out of three symptoms : foul discharge , fever , lower abdominal pain . RESULTS Trained TBAs were significantly more likely to practice hygienic delivery than untrained TBAs ( 45.0 vs. 19.3 % , p < 0.0001 ) . However , no significant difference in levels of postpartum infection was found when deliveries by trained TBAs and untrained TBAs were compared . The practice of hygienic delivery itself also had no significant effect on postpartum infection . Logistic regression models confirmed that TBA training and hygienic delivery had no independent effect on postpartum outcome . Other factors , such as pre-existing infection , long labour and insertion of h and s into the vagina were found to be highly significant . CONCLUSIONS Trained TBAs are more likely to practice hygienic delivery than those that are untrained . However , hygienic delivery practice s do not prevent postpartum infection in this community . Training TBAs to wash their h and s is not an effective strategy to prevent maternal postpartum infection . More rigorous evaluation is needed , not only of TBA training programmes as a whole , but also of the effectiveness of the individual components of the training OBJECTIVE To determine the effects of hospital quality assurance interventions on compliance with clinical st and ards , availability of essential drugs , client satisfaction , and utilization . DESIGN Quasi-experimental , prospect i ve study with four intervention hospitals and four control hospitals . All eight facilities were purposively selected and of comparable complexity . SETTING Ministry of Health secondary care facilities in Ecuador . INTERVENTIONS Facility-based quality improvement teams , job clarification , st and ards communication , refresher training , strengthening hospital pharmacy committees , monthly monitoring of compliance indicators , and formation of users ' committees . MEASURES Compliance with input and process st and ards , utilization of services , and patient satisfaction were measured monthly in both groups through review of clinical and administrative records , exit interviews , and patient satisfaction surveys . RESULTS After 12 months , the quality assurance interventions produced rapid increases in compliance with clinical st and ards in the intervention hospitals as compared with the control group . These improvements appeared as early as 2 months after the onset of the interventions . No differences were found between intervention and control groups in terms of trends in utilization patterns or client satisfaction . CONCLUSION Quality assurance interventions made a difference in technical quality of care . Patient satisfaction and utilization do not appear to be directly associated with short-term improvements in compliance with clinical st and ards . Quality improvement interventions may require longer periods and a specific aim at clients ' needs to demonstrate effects on utilization and satisfaction outcome variables Prenatal and delivery care are critical both for maternal and newborn health . Using the Demographic and Health Surveys ( DHS ) data for thirty-two low-income countries across Asia , sub-Saharan Africa and Latin America , and employing a two-level r and om-intercept model , this paper empirically assesses the influence of prenatal attendance and a wide array of observed individual- , household- and community-level characteristics on a woman 's decision to give birth at a health facility or at home . The results show that prenatal attendance does appreciably influence the use of facility delivery in all three geographical regions , with women having four visits being 7.3 times more likely than those with no prenatal care to deliver at a health facility . These variations are more pronounced for Sub-Saharan Africa . The influence of the number of prenatal visits , maternal age and education , parity level , and economic status of the birthing women on the place of delivery is found to vary across the three geographical regions . The results also indicate that obstetrics care is geographically and economically more accessible to urban and rural women from the non-poor households than those from the poor households . The strong influence of number of visits , household wealth , education and regional poverty on the site of delivery setting suggests that policies aim ed at increasing the use of obstetric care programs should be linked with the objectives of social development programs such as poverty reduction , enhancing the status of women , and increasing primary and secondary school enrollment rate among girls BACKGROUND We report the preliminary findings from a continuing cluster r and omised evaluation of the Integrated Management of Childhood Illness ( IMCI ) strategy in Bangladesh . METHODS 20 first-level outpatient facilities in the Matlab sub-district and their catchment areas were r and omised to either IMCI or st and ard care . Surveys were done in households and in health facilities at baseline and were repeated about 2 years after implementation . Data on use of health facilities were recorded . IMCI implementation included health worker training , health systems support , and community level activities guided by formative research . FINDINGS 94 % of health workers in the intervention facilities were trained in IMCI . Health systems supports were generally available , but implementation of the community activities was slow . The mean index of correct treatment for sick children was 54 in IMCI facilities compared with 9 in comparison facilities ( range 0 - 100 ) . Use of the IMCI facilities increased from 0.6 visits per child per year at baseline to 1.9 visits per child per year about 21 months after IMCI introduction . 19 % of sick children in the IMCI area were taken to a health worker compared with 9 % in the non-IMCI area . INTERPRETATION 2 years into the assessment , the results show improvements in the quality of care in health facilities , increases in use of facilities , and gains in the proportion of sick children taken to an appropriate health care provider . These findings are being used to strengthen child health care nationwide . They suggest that low levels of use of health facilities could be improved by investing in quality of care and health systems support BACKGROUND WHO and UNICEF launched the Integrated Management of Childhood Illness ( IMCI ) strategy in the mid-1990s to reduce deaths from diarrhoea , pneumonia , malaria , measles , and malnutrition in children younger than 5 years . We assessed the effect of IMCI on health and nutrition of children younger than 5 years in Bangladesh . METHODS In this cluster r and omised trial , 20 first-level government health facilities in the Matlab subdistrict of Bangladesh and their catchment areas ( total population about 350 000 ) were paired and r and omly assigned to either IMCI ( intervention ; ten clusters ) or usual services ( comparison ; ten clusters ) . All three components of IMCI-health-worker training , health-systems improvements , and family and community activities-were implemented beginning in February , 2002 . Assessment included household and health facility surveys tracking intermediate outputs and outcomes , and nutrition and mortality changes in intervention and comparison areas . Primary endpoint was mortality in children aged between 7 days and 59 months . Analysis was by intention to treat . This study is registered , number IS RCT N52793850 . FINDINGS The yearly rate of mortality reduction in children younger than 5 years ( excluding deaths in first week of life ) was similar in IMCI and comparison areas ( 8.6%vs 7.8 % ) . In the last 2 years of the study , the mortality rate was 13.4 % lower in IMCI than in comparison areas ( 95 % CI -14.2 to 34.3 ) , corresponding to 4.2 fewer deaths per 1000 livebirths ( 95 % CI -4.1 to 12.4 ; p=0.30 ) . Implementation of IMCI led to improved health-worker skills , health-system support , and family and community practice s , translating into increased care-seeking for illnesses . In IMCI areas , more children younger than 6 months were exclusively breastfed ( 76%vs 65 % , difference of differences 10.1 % ,
Output:
| Studies relied heavily on service utilisation as a measure of strategy success , which did not always correspond to improved quality . |
MS211941 | ***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 This paper presents a prospect i ve examination of sociodemographic , psychosocial , and physiologic characteristics associated with positive change in cardiovascular disease risk factors during a 6-year multiple risk factor intervention study . METHODS Data are presented on 221 women and 190 men ( aged 25 through 74 years ) who participated in four cohort surveys ( 1979 through 1985 ) . A signal detection model was used to identify baseline variables that best divide the sample into subgroups on the basis of the probability of positive change in a composite risk factor score . RESULTS Sixty-nine percent of the respondents showed a positive change in risk factor score during the intervention . The subgroup with the highest proportion of positive changers ( 83 % ) was composed of older adults ( > 55 years ) with the highest perceived risk , highest health media use , and highest blood pressure and cholesterol levels . The subgroup with the lowest proportion of positive changers ( 42 % ) was the least educated , was the most likely to be Hispanic , and had the lowest health knowledge and self-efficacy scores . CONCLUSIONS The differing composition of subgroups who respond or do not respond to community cardiovascular disease interventions illustrates the need to develop specific interventions that target different age , socioeconomic , and cultural subgroups A comprehensive community based programme to control cardiovascular diseases was started in North Karelia , Finl and , in 1972 . Reductions in smoking , serum cholesterol concentrations , and blood pressure were among the central intermediate objectives . The effect of the programme during the 10 year period 1972 - 82 was evaluated by examining independent r and om population sample s at the outset ( 1972 ) and five ( 1977 ) and 10 ( 1982 ) years later both in the programme and in a matched reference area . Over 10 000 subjects were studied in 1972 and 1977 ( participation rate about 90 % ) and roughly 8000 subjects in 1982 ( participation rate about 80 % ) . Analyses were conducted of the estimated effect of the programme on the risk factor population means by comparing the baseline and five year and 10 year follow up results in the age range 30 - 59 years . The effect of the programme ( net reduction in North Karelia ) at 10 years among the middle aged male population was estimated to be a 28 % reduction in smoking ( p less than 0.001 ) , a 3 % reduction in mean serum cholesterol concentration ( p less than 0.001 ) , a 3 % fall in mean systolic blood pressure ( p less than 0.001 ) , and a 1 % fall in mean diastolic blood pressure ( p less than 0.05 ) . Among the female population the reductions were respectively , 14 % ( NS ) , 1 % ( NS ) , 5 % ( p less than 0.001 ) , and 2 % ( p less than 0.05 ) . During the first five years of the project ( 1972 - 7 ) the programme effectively reduced the population mean values of the major coronary risk factors . At 10 years the effects had persisted for serum cholesterol concentrations and blood pressure and were increased for smoking The National Research Program 1 A on " Primary Prevention of cardiovascular disease in Switzerl and ' was design ed to determine whether community health education can reduce cardiovascular risk factors in the population . Two communities ( 12,000 inhabitants each ) in the French speaking and two ( 16,000 inhabitants each ) in the German speaking part of the country were selected either for intervention or comparison . Following baseline screening in 1977 ( stratified r and om sample s ) and the community intervention program ( 1978 - 1980 ) , a final assessment on the initial participants was performed at the end of 1980 . Amongst the regular smokers , 26,2 % stopped during this period in the intervention communities whereas 18,1 % did so in the reference cities . 4,7 % of non-smokers began to smoke during the same period in the intervention communities whereas 7,8 % did so in the reference cities . Plasma thiocyanate measurement suggested reliable answers on smoking status . These results suggest that community health education may be effective in preventing harmful health consequence of smoking Abstract Objectives : To estimate the extent to which changes in the main coronary risk factors ( serum cholesterol concentration , blood pressure , and smoking ) explain the decline in mortality from ischaemic heart disease and to evaluate the relative importance of change in each of these risk factors . Design : Predicted changes in ischaemic heart disease mortality were calculated by a ligistic regression model using the risk factor levels assessed by cross sectional population surveys , in 1972 , 1977 , 1982 , 1987 , and 1992 . These predicted changes were compared with observed changes in mortality statistics . Setting : North Karelia and Kuopio provinces , Finl and . Subjects : 14 257 men and 14 786 women aged 30–59 r and omly selected from the national population register . Main outcome measures : Levels of the risk factors and predicted and observed changes in mortality from ischaemic heart disease . Results — The observed changes in the risk factors in the population from 1972 to 1992 predicted a decline in mortality from ischaemic heart disease of 44 % ( 95 % confidence interval 37 % to 50 % ) in men and 49 % ( 37 % to 59 % ) in women . The observed decline was 55 % ( 51 % to 58 % ) and 68 % ( 61 to 74 ) respectively . Conclusion : An assessment of the data on the risk factors for ischaemic heart disease and mortality suggests that most of the decline in mortality from ischaemic heart disease can be explained by changes in the three main coronary risk factors BACKGROUND This article provides a descriptive overview of the implementation process of the Heart , Body , and Soul program . The program objective was to test strategies to reduce the prevalence of cigarette smoking among urban African Americans in East Baltimore . METHOD This study constitutes a prospect i ve r and omized trial among inner-city African Americans design ed to improve quit rates among church attenders . A r and om-digit-dialing survey was conducted to establish baseline levels of self-reported cigarette smoking , examine attendant attitudes , and determine the presence of known cardiovascular risk factors among community residents of the catchment area . A similar survey was conducted among churchgoers to establish a baseline . Twenty-two churches were recruited and r and omly assigned to either intensive or minimal ( self-help ) intervention strategies . Baseline health screenings were held in all participating churches . Innovative culturally specific smoking cessation strategies mediated through lay volunteers from participating churches were implemented in the intensive intervention churches . RESULTS Pastors of all churches were directly involved in all aspects of the planning and implementation process . A total of 29 volunteer lay smoking-cessation specialists were trained and successfully implemented the intensive interventions in churches . An additional 272 church members were trained to conduct their church 's health screenings . CONCLUSION The essential component of this successful implementation process were building trust and acceptance and providing the technical support to encourage smoking-cessation strategies . This description of the project is presented to assist others involved in church-based trials in urban African American communities The Belgian Heart Disease Prevention Project is a controlled , multifactorial prevention trial involving 19,390 males aged 40–59 years employed by 30 Belgian industries . These industries were paired and r and omized into a control or intervention unit . In each intervention factory , the subjects from the two highest deciles of a coronary risk-score distribution curve were given individual advice twice a year . A health education campaign was also organized in each intervention factory . In the control group , 10 % of r and omly chosen subjects had the same baseline examination as the whole of the intervention group . After 2 years , high-risk subjects and r and om sample s of the control and intervention group were compared regarding the coronary risk profile by means of a multiple logistic function ( MLF ) . In the intervention high-risk group , the MLF showed a decrease of 20 % , and in the control group there was an increment of 12.5 % ( p < 0.001 ) . Comparing the r and om sample s an increment of 25 % was found in the control group vs a drop of 2.26 in the intervention group ( p < 0.001 ) . The coronary risk profile can be altered in a middle-aged male working population through mass media health education supplemented by face-to-face counseling in high-risk subjects Purpose . To present an evaluation of a 5-year , community-based , chronic disease prevention project managed by a state health department to determine whether the department could replicate similar previous projects that had received more funding and other re sources . Design . The evaluation used a matched comparison design and a review of archive and interview data . Setting . Florence , South Carolina ( population : 56,240 ) . Subjects . A r and om sample of 1642 persons in Florence ( and 1551 in the comparison ) who responded to a risk factor question naire and underwent a physical assessment ; 70 . 7 % of baseline subjects participated in the postintervention . Forty key persons were interviewed concerning project effectiveness . Interventions by Project . Walk-a-thons , a speakers ' bureau , media messages , restaurant food labeling , and cooking seminars . More than 31,000 participants were involved in 585 activities . Measures . Question naires focused on hypertension , obesity , high cholesterol , smoking , and exercise . Physical assessment s determined lipid , lipoprotein , apolipoprotein , and blood pressure levels . Analysis of covariance was used for baseline and postintervention comparisons . Content analysis was used on archive and interview data . Results . The project had a slightly favorable intervention effect on cholesterol and smoking , but failed to have an effect on other risk factors for cardiovascular disease . The project influenced community awareness , enlisted influential community members , and fostered linkages among local health services . Conclusions . Health departments can be instrumental in community risk reduction programming ; however , they may not replicate projects having greater re sources Few studies have prospect ively examined the characteristics associated with worksite adoption of tobacco-control initiatives . Data were collected as part of the Community Intervention Trial ( COMMIT ) for Smoking Cessation , which conducted interventions in 11 communities . This smoking cessation intervention was based on community organization principles and delivered through multiple community channels , including worksites , health care providers , the media , and cessation re sources . This article reports results from telephone interviews of intervention community worksites having 50 or more employees , conducted at baseline and the end of the intervention period . Among worksites that responded to both baseline and final surveys , 83 % had not adopted a smoke-free policy at baseline , and 61 % did not offer any cessation aid or quitting re sources at baseline . By the final survey , 34 % of those with no smoking ban at baseline had become smoke-free , and 36 % of those offering no cessation assistance at baseline were offering cessation re sources at the follow-up . The prevalence of policy adoption was higher among worksites employing more female employees and offering other health-promotion activities ; manufacturing businesses were significantly less likely than businesses other than service and wholesale/retail businesses to adopt policies . Adoption of cessation programs was significantly more likely among worksites employing 100 to 249 workers , compared with those employing 50 to 99 workers ; those predominantly employing men ; those offering other types of health-promotion activities ; and those with a higher rate of turnover . These results provide important information about the characteristics of worksites likely to engage in tobacco-control efforts . Health educators and others may choose to target those worksites most ready for adoption of tobacco control policies and programs , as indicated by these findings Since 1985 a small-scale community-based cardiovascular disease ( CVD ) preventive programme has been in operation in an inl and municipality , Norsjö , in Northern Sweden . The aim of this study was to assess the development of the relationship between social position and CVD risk factors in repeated cross-sectional surveys ( 1985 - 1990 ) among all men and women aged 30 , 40 , 50 and 60 years in the study area , using an age-stratified r and om sample from the Northern Sweden MONICA Study of 1986 and 1990 as reference population . These multiple cross-sectional surveys comprised a self-administered question naire and a health examination . Of the study population 95 % ( n = 1499 ) and 80 % of those in the reference area ( n = 3208 ) participated . Subjects were classified with regard to demographic , structural and social characteristics in relation to CVD risk factors and self-reported health status . Time trends in classical risk factor occurrence were assessed in terms of age- and sex- adjusted odds ratios using Mantel-Haenszel procedures . When simultaneously adjusting for several potential confounders we used a logistic regression analysis . Initially , more than half of the study population , both males and females , had and elevated ( > or = 6.5 mmol/l ) serum cholesterol level . After adjustments had been made for age and social factors it was found that the relative risk of hypercholesterolaemia dropped substantially and significantly among both sexes during the 6 years of CVD intervention in the study area . However , the probability of being a smoker was significantly reduced only in highly educated groups . Among other risk factors no single statistically significant change over time could be found . In the reference area there were no changes over time for the selected CVD risk factors . People in the study area had a less favourable perception of their health than those in the reference area . Social differences were found when perceived good health was measured , especially in variables indicating emotional and social support . When sex , age and social factors had been accounted for there was not clear change over the years in perceived good health INTRODUCTION Our objectives were ( 1 ) to examine the
Output:
| The two most rigorous studies showed limited evidence of an effect on prevalence .
In the US COMMIT study there was no differential decline in prevalence between intervention and control communities , and there was no significant difference in the quit rates of heavier smokers who were the target intervention group .
In the Australian CART study there was a significantly greater quit rate for men but not women .
REVIEW ER 'S CONCLUSIONS The failure of the largest and best conducted studies to detect an effect on prevalence of smoking is disappointing . |
MS211942 | ***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 the United Kingdom ( UK ) over the last 10 years , there has been a significant increase in the use of vacuum-formed retainers ( VFRs ) rather than conventional Hawley retainers . There are currently no data to compare the cost-effectiveness of this change in practice . The two aims of this study were to compare ( 1 ) the cost-effectiveness of VFRs and Hawley retainers over 6 months , from the perspective of the National Health Service , orthodontic practice , and the patient and ( 2 ) patient satisfaction in the two retainer groups . A r and omized controlled trial ( RCT ) was carried out in a specialist orthodontic practice . Three hundred and ninety-seven eligible patients were r and omized to one of two retainer groups , and followed up for 6 months . All subjects were invited to complete patient satisfaction question naires . Additional data were collected for the cost analysis from the patient records and national data bases . Descriptive and bivariate analyses were used to compare patient satisfaction between retainer groups . In all , 196 subjects were r and omized to the Hawley group ( mean age 14 years 8 months , 63 per cent female , 37 per cent male ) and 201 to the VFR group ( mean age 15 years , 59 per cent female , 41 per cent male ) . VFRs were more cost-effective than Hawley retainers from all perspectives . The majority of subjects showed a preference for VFRs compared with Hawley retainers . There were also fewer breakages than in the Hawley group Background Retention is an important component of orthodontic treatment ; however , poor compliance with retainer use is often encountered , especially in adolescents . The purpose of this study was to prove the hypothesis that verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use . Methods This study was a r and omized controlled trial . The sample was recruited from Wenzhou , People ’s Republic of China , between February 2013 and May 2014 , and 326 participants were r and omized into three groups . Patients and parents in Group A ( n=106 ) were given routine retainer wear instructions only ; in Group B ( n=111 ) , images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients , combined with routine instructions ; and in Group C ( n=109 ) , images illustrating the severe consequences of poor compliance with Hawley retainer use were shown to patients and parents , combined with routine instructions . Three months after debonding , question naires were used to investigate daily wear time and the reasons for poor compliance . Differences in means between the groups were tested by one-way analysis of variance . Results The mean daily wear time in Group C ( 15.09±4.13 hours ) was significantly greater than in Group A ( 12.37±4.58 hours , P<0.01 ) or Group B ( 13.50±4.22 hours , P<0.05 ) ; the mean daily wear time in Group B was greater than in Group A , but was not significant ( P=0.67 ) . Reasons for nonusage were forgetting to wear the retainer ( 51 % ) and finding the retainer bothersome to frequently insert and remove ( 42 % ) . Conclusion Verbal instructions combined with images showing the severe consequences of poor compliance can increase retainer use . Parents play an important role in compliance with retainer use in adolescent patients INTRODUCTION Intraoral elastics are commonly used in orthodontics and require regular changing to be effective . Unfortunately , poor compliance with elastics is often encountered , especially in adolescents . Intention for an action and its implementation can be improved using " if-then " plans that spell out when , where , and how a set goal , such as elastic wear , can be put into action . Our aim was to determine the effect of if-then plans on compliance with elastics . METHODS To identify common barriers to compliance with recommendations concerning elastic wear , semistructured interviews were carried out with 14 adolescent orthodontic patients wearing intraoral elastics full time . Emerging themes were used to develop if-then plans to improve compliance with elastic wear . A prospect i ve pilot study assessed the effectiveness of if-then planning aim ed at overcoming the identified barriers on compliance with elastic wear . Twelve participants were r and omized equally into study and control groups ; the study group received information about if-then planning . The participants were asked to collect used elastics , and counts of these were used to assess compliance . RESULTS A wide range of motivational and volitional factors were described by the interviewed participants , including the perceived benefits of elastics , cues to remember , pain , eating , social situations , sports , loss of elastics , and breakages . Compliance with elastic wear was highly variable among patients . The study group returned more used elastics , suggesting increased compliance , but the difference was not significant . CONCLUSIONS The use of if-then plans might improve compliance with elastic wear when compared with routine clinical instructions Both r and omized and nonr and omized studies are integral to orthodontic research and practice because they permit evaluation of relationships between exposures and outcomes , allowing the efficacy , effectiveness , and safety of interventions to be assessed . These design s allow clinical decisions to be informed . Nonr and omized design s include nonr and omized clinical trials , cohort studies , case-control studies , cross-sectional studies , case series , and ecological studies . There is debate surrounding the optimal research design ; however , both r and omized and nonr and omized design s are important to build a broad , informative evidence base . The design s are therefore complementary , with unique advantages and limitations . The applicability of either approach hinges on the clinical question posed , the feasibility of study ing it , and ethical considerations Early treatment for Class II malocclusion is frequently undertaken with the objective of correcting skeletal disproportion by altering the growth pattern . Because the majority of previous studies of growth modification for Class II malocclusion have been based on retrospective record review s , the efficacy of such an approach has not been well established . In this controlled clinical trial , patients in the mixed dentition with overjet > or = 7 mm were r and omly assigned to either early treatment with headgear , or modified bionator , or to observation . All patients were observed for 15 months with no other appliances used during this phase of the trial . The three groups , who were equivalent initially , experienced statistically significant differences ( p < 0.01 ) in skeletal change . There was considerable variation in the pattern of change within all three groups , with about 80 % of the treated children responding favorably . Although patients in both early treatment groups had approximately the same reduction in Class II severity , as reflected by change in the ANB angle , the mechanism of this change was different . The headgear group showed restricted forward movement of the maxilla , and the functional appliance group showed a greater increase in m and ibular length . The permanence of these skeletal changes and their impact on the subsequent treatment remains to be evaluated Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more In the first phase of a r and omized clinical trial of early versus late Class II treatment , statistically significant differences were observed between the treatment and observation groups . However , there were wide variations in response . The change in jaw relationship ( categorized as the annualized reduction in ANB angle ) was favorable or highly favorable in 76 % of the headgear , 83 % of the functional appliance , and 31 % of control ( observation only ) groups . The patient 's initial skeletal severity , age/maturity at the outset of treatment , growth pattern , and cooperation with treatment were examined as possible influences on early growth modification treatment . Correlations between the annualized change in the ANB angle and any of the possible influences were close to zero and not statistically significant . We conclude that there is little to be gained from precisely timing early treatment to specific age/maturity markers and that a favorable reduction in Class II skeletal problems can occur for patients in a broad range of skeletal severity and growth patterns . Cooperation , measured as the number of hours of reported wear , or the clinical assessment of compliance , explained little of the variation in treatment response . The wide variation in growth seen in the untreated patients highlights the importance of well-controlled studies if clinicians are to improve their ability to select children with the greatest chances of a favorable treatment response INTRODUCTION The aim of this study was to compare the effectiveness of Twin-block and Dynamax appliances for the treatment of Class II Division 1 malocclusion . METHODS This was a r and omized controlled trial involving 32 boys and 32 girls aged 10 to 14 years with Class II Division 1 malocclusion . They were r and omly allocated to either the Dynamax appliance group or the Twin-block appliance group . Treatment was provided by 4 clinicians at 2 centers . Records were taken at the start and the end of the functional phase and after all treatment . In addition , incisal overjet , the number of appliance breakages , and adverse events or side effects of the treatment were recorded at each patient visit . RESULTS The data monitoring committee in an interim analysis at 18 months after the start of the trial found significantly greater overjet reduction in the Twin-block group than in the Dynamax group and more breakages and adverse events with the Dynamax appliance . As a result , treatment with the Dynamax appliance was terminated , and those patients completed treatment with the Twin-block or a fixed appliance . Regression analysis showed a statistically significant difference in the performance over time between the Twin-block and Dynamax appliances in terms of reduction in overjet , with the Twin-block appliance performing significantly better than the Dynamax . The incidence of adverse events was greater in the Dynamax group ( 82 % ) than in the Twin-block group ( 16 % ) , with a statistically significant difference ( P < 0.001 ) between the 2 groups . CONCLUSIONS The Twin-block appliance was more effective than the Dynamax appliance when overjet was evaluated and the Dynamax appliance patients reported greater incidence of adverse events with their appliance than those who were treated with the Twin-block appliance Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies The aim of this controlled trial was to identify and quantify skeletal , soft tissue and dental changes during treatment , and immediately post-treatment with Twin Block ( TB ) or Dynamax appliance using the techniques of three-dimensional (3D)optical surface laser scanning , cephalometric , and clinical measurements . Sixty-two Caucasian subjects , 36 males aged 11 - 14 years and 26 females aged 10 - 13 years were enrolled in the study . The patients were placed in two groups , matched for gender and age and subsequently allocated r and omly for treatment with either a TB or Dynamax appliance . Active treatment lasted 9 months followed by 3 months ' post-treatment observation . Laser scanning and clinical measurements were taken at 3-monthly intervals and final cephalometric records after 12 months . Statistical analysis was performed using Wilcoxon 's matched-pairs signed-rank tests . The non-compliance rates were the same for both groups ( 9 per cent ) , but a greater incidence of breakages was found in the Dynamax group . The TB was found to produce slightly more antero-posterior skeletal change , median ANB reduction , TB=2 degrees , Dynamax 1.1 degree ( P=0.006 ) , and similar forward movements of the chin and was associated with larger increases in the vertical facial dimension , median total anterior face height increase ; TB=3.2 mm , Dynamax = 2.8 mm ( P=0.03 ) . The soft tissue vertical cephalometric increases were 3.6 mm with the TB , 2.0 mm with the Dynamax ( P=0.036 ) , and with laser scanning 5.05 and 2.6 mm , respectively , a difference which is likely to be more clinical ly relevant . The median post-treatment changes in soft tissue pogonion were -0.65 mm in the TB and + 0.22 mm in the Dynamax group . The optical surface scanning mark and measure system is a valid method for quantifying soft tissue changes The aim of this study was to evaluate the effectiveness of Herbst and Twin-block appliances for established Class II Division I malocclusion . The study was a multicenter , r and omized clinical trial carried out in orthodontic departments in the United Kingdom . A total of 215 patients ( aged 11 - 14 years ) were r and omized to receive treatment with either the Herbst or the Twin-block appliance . Treatment with the Herbst appliance result ed in a lower failure-to-complete rate for the functional appliance phase of treatment ( 12.9 % ) than did treatment with Twin-block ( 33.6 % ) . There were no differences in treatment time between appliances , but significantly more appointments ( 3 ) were needed for repair of the Herbst appliance than for the Twin-block . There were no differences in skeletal and dental changes between the appliances ; however , the final occlusal result and skeletal discrepancy were better for girls than for boys . Because of the high cooperation rates of patients using it , the Herbst appliance could be the appliance of choice for treating adolescents with Class II Division 1 malocclusion . The trade-off for use of the Herbst is more appointments for appliance repair The aim of this study was to evaluate the effectiveness of a fixed Twin-block appliance by using a study with a prospect i ve cohort design . Thirty-two children were included in the study over a 2-year period . Cephalometric data were analyzed with the Pancherz cephalometric analysis . Study models were analyzed with the PAR index ,
Output:
| Conclusions : Compliance with removable orthodontic appliances and adjuncts is suboptimal , and patients routinely overestimate duration of wear .
HighlightsSuboptimal compliance is typical with all types of orthodontic appliances .
Actual wear time is approximately 5 hours per day less than stipulated .
Overreporting of appliance wear was found with all types of appliances . |
MS211943 | ***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 examine the effectiveness of switching patients to lurasidone using 3 different dosing strategies . METHOD Adults with DSM-IV-defined schizophrenia or schizoaffective disorder in a nonacute phase of illness were r and omized to 1 of 3 lurasidone dosing regimens for the initial 2 weeks of the study : ( 1 ) 40 mg/d for 2 weeks ; ( 2 ) 40 mg/d for 1 week , increased to 80 mg/d on day 8 for week 2 ( up-titration group ) ; and ( 3 ) 80 mg/d for 2 weeks . Lurasidone was then flexibly dosed ( 40 - 120 mg/d ) for the subsequent 4 weeks of the study . The preswitch antipsychotic agent was tapered by day 7 to 50 % of the original dose and discontinued by the end of week 2 . Subjects were stratified on the basis of whether the primary preswitch antipsychotic medication was classified as " sedating " ( olanzapine or quetiapine ) or " nonsedating " ( all other antipsychotics ) . The primary outcome measure was time to treatment failure , defined as any occurrence of insufficient clinical response , exacerbation of underlying disease , or discontinuation due to an adverse event . The study was conducted from June 2010 to May 2011 . RESULTS Of 240 subjects treated in this study , 86 ( 35.8 % ) were treated with an antecedent sedating antipsychotic , and 154 ( 64.2 % ) were treated with an antecedent nonsedating antipsychotic . Nineteen ( 7.9 % ) of the 240 patients experienced treatment failure . No clinical ly relevant differences were observed when the 3 r and omized switch groups were compared . Treatment failure rates were 10/86 ( 11.6 % ) versus 9/154 ( 5.8 % ) among subjects who had been receiving a preswitch sedating versus nonsedating antipsychotic medication , respectively . Consistent with prior studies of lurasidone , there was no signal for clinical ly relevant adverse changes in body weight , glucose , insulin , lipids , or prolactin ; mean improvements in weight and lipids were observed . Movement disorder rating scales did not demonstrate meaningful changes . The incidence of akathisia as an adverse event was 12.5 % ; only 1 subject ( 0.4 % ) discontinued due to akathisia . CONCLUSIONS Switching patients to lurasidone can be successfully accomplished by starting at 40 mg/d for 2 weeks , or 80 mg/d for 2 weeks , or 40 mg/d for 1 week followed by 80 mg/d the second week . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01143077 Aripiprazole is a D2 and D3 receptor partial agonist that is unlike other second generation antipsychotics . The effectiveness of aripiprazole with regard to neurocognitive function and its adverse effects is unclear . The present study evaluates the comparative efficacy , effects on neurocognitive function , and adverse effects of aripiprazole and risperidone in the treatment of hospitalized patients with schizophrenia . This double-blind , cross-over study included 23 patients with schizophrenia who were r and omly assigned to be treated first with either aripiprazole or risperidone . After eight weeks on one medication , the patients were switched to the other medication for eight weeks . The patient assessment included the Positive and Negative Syndrome Scale ( PANSS ) , neurocognitive assessment s , and adverse events including extrapyramidal symptoms , vital signs , electrocardiogram , and clinical laboratory tests . The study findings indicated that psychopathology assessed with the PANSS , extrapyramidal symptoms and other adverse effects did not differ between aripiprazole and risperidone for the subjects remaining in treatment . In the neurocognitive assessment s , the score for disinhibition with aripiprazole was significantly lower than with risperidone ( p < 0.05 ) . In addition , serum prolactin levels were significantly lower with aripiprazole ( p < 0.001 ) . The treatment drop-out rate was higher for patients receiving aripiprazole than risperidone . In comparing aripiprazole and risperidone , risperidone is better from the viewpoint of treatment continuation . On the other h and , some adverse effects , such as hyperprolactinemia and disinhibition , are less severe with aripiprazole . Thus , for certain applications , aripiprazole may be a beneficial new treatment option for schizophrenia Few pharmacological intervention studies have examined the impact of medication on social cognition , particularly emotion perception . The goal of this r and omized , double-blind study is to compare the effects of several second generation antipsychotics and a first generation antipsychotic , perphenazine , on emotion perception in individuals with schizophrenia . Patients were assigned to receive treatment with olanzapine , queitapine fumarate , risperidone , ziprasidone or perphenazine for up to 18 months . Eight hundred and seventy three patients completed an emotion perception test immediately prior to r and omization and after 2 months of treatment . We also examined baseline predictors of emotion perception change . Most treatments were associated with a small , non-statistically significant improvement in emotion perception at two months , although they did not differ from one another . Greater improvement in emotion perception at 2 months was significantly predicted by lower baseline emotion perception and higher baseline neurocognitive functioning , and marginally predicted by less time on an antipsychotic Rationale The relative effectiveness of the atypical antipsychotic drugs and conventional agents in patients with early-stage schizophrenia has not been comprehensively determined . Objectives The aim of our study was to evaluate the efficacy and safety of seven antipsychotic drugs for the maintenance treatment in patients with early-stage schizophrenia . Methods In a 12-month open-label , prospect i ve observational , multicenter study , 1,133 subjects with schizophrenia or schizophreniform disorder within 5 years of onset were monotherapy with chlorpromazine , sulpiride , clozapine , risperidone , olanzapine , quetiapine , or aripiprazole . The primary measure was the rate of treatment discontinuation for any reason . Secondary outcomes included measures for clinical and functional outcomes and tolerability . Results The percentage of patients discontinued treatment within 12 months was 41.4 % for chlorpromazine , 39.5 % for sulpiride , 36.7 % for clozapine , 40.2 % for risperidone , 39.6 % for olanzapine , 46.9 % for quetiapine , and 40.2 % for aripiprazole , a nonsignificant difference ( p = 0.717 ) ; there were no significant differences among these seven treatments on discontinuation due to relapse , intolerability , patient decision , or nonadherence ( all p values ≥ 0.260 ) . Extrapyramidal symptoms were more prominent in chlorpromazine and sulpiride treatment groups . Anticholinergic side effects were most common with clozapine and chlorpromazine . Weight gain was most common with olanzapine and clozapine . Conclusions The efficacy of seven antipsychotic medications for the maintenance treatment appeared similar in early-stage schizophrenia . With regard to the high dropout rate and side effects , special programs are needed to keep efficacy and safety of antipsychotics maintenance treatment for schizophrenia with early ABSTRACT Objective : The Health Outcomes of a Canadian Community Cohort ( HOCCC ) study is a 1-year prospect i ve observational study of out patients with schizophrenia or related psychotic disorders . The purpose of the study was to compare effectiveness of antipsychotic treatment as measured by 1-year treatment completion rates . Design and methods : Patients ( N = 929 ) were enrolled if in the course of usual clinical practice they switched to a second-generation antipsychotic ( SGA ) . Observational data were collected for up to 1 year . The primary analysis compared 1-year treatment-completion rates for the olanzapine cohort with the other SGA cohort ( quetiapine , risperidone , clozapine ) , using a chi-squared test . Results : Of 929 patients enrolled , 64.8 % ( 516/796 ) of evaluable patients completed 1 year of treatment . There was no statistically significant difference in the proportion of treatment completers between the olanzapine cohort ( 67.4 % , 256/380 ) and the other SGA cohort ( 62.5 % , 260/416 ) . Treatment-completion rates were risperidone 62.0 % ( 127/205 ) , quetiapine 63.7 % ( 123/193 ) and clozapine 55.6 % ( 10/18 ) . Antipsychotic polypharmacy was common . Patients treated with olanzapine or risperidone had significantly higher increases in BMI than quetiapine-treated patients . There were no major differences between olanzapine monotherapy and pooled other SGA monotherapy groups in status of extrapyramidal symptoms from baseline to endpoint . Conclusions : Olanzapine and other SGAs exhibited similar rates of 1-year treatment completion . Further study of medication combinations is needed , given their perceived clinical value , and the high frequency of antipsychotic polypharmacy in clinical practice . Limitations : As most patients received several psychotropics and power was reduced in monotherapy analyses , comparisons between cohorts must be interpreted cautiously . Comparisons between individual antipsychotics were post hoc and not powered a priori . Accuracy and completeness of adverse event information for drugs other than olanzapine is limited Thomas SHL , Drici MD , Hall GC , Crocq MA , Everitt B , Lader MH , Le Jeunne C , Naber D , Priori S , Sturkenboom M , Thibaut F , Peuskens J , Mittoux A , Tanghøj P , Toumi M , Moore ND , Mann RD . Safety of sertindole versus risperidone in schizophrenia : principal results of the sertindole cohort prospect i ve study ( SCoP Abstract Objective : Although the use of innovative drug delivery systems , like orally disintegrating antipsychotic tablets ( ODT ) , may facilitate medication adherence and help reduce the risk of relapse and hospitalization , no information is available about the comparative cost-effectiveness of st and ard oral tablets ( SOT ) vs ODT formulations in the treatment of schizophrenia . This study compared the cost-effectiveness of olanzapine ODT and olanzapine SOT in the usual treatment of out patients with schizophrenia from a US healthcare perspective . The study also compared olanzapine ODT with risperidone and aripiprazole , two other atypical antipsychotics available in both ODT and SOT formulations . Methods : Published medical literature and a clinical expert panel were used to populate a 1-year Monte Carlo Micro-simulation model . The model captures clinical and cost parameters including adherence levels , treatment discontinuation by reason , relapse with and without inpatient hospitalization , quality -adjusted life years ( QALYs ) , treatment-emergent adverse events , healthcare re source utilization , and associated costs . Key outcomes were total annual direct cost per treatment , QALY , and incremental cost-effectiveness ( ICER ) per 1 QALY gained . Results : Based on model projections , olanzapine ODT therapy was more costly ( $ 9808 vs $ 9533 ) , but more effective in terms of a lower hospitalization rate ( 15 % vs 16 % ) and better QALYs ( 0.747 vs 0.733 ) than olanzapine SOT therapy . Olanzapine ODT was more cost-effective than olanzapine SOT ( ICER : $ 19,643 ) , more cost-effective than risperidone SOT therapy ( ICER : $ 39,966 ) , and dominant ( meaning less costly and more effective ) than risperidone ODT and aripiprazole in ODT or SOT formulations . Limitations : Lack of head-to-head r and omized studies comparing the three studied atypical antipsychotics required making input assumptions that need further study . Conclusions : This micro-simulation found that the utilization of olanzapine ODT for the treatment of schizophrenia is predicted to be more cost-effective than any other ODT or SOT formulations of the studied atypical antipsychotic medications Abstract Differences among antipsychotics in effectiveness have turned out to be a topic of increasing research interest , although comparisons between the different second-generation antipsychotics are scarce . From October 2005 to March 2011 , a prospect i ve , r and omized , open-label study comparing the effectiveness of aripiprazole , ziprasidone , and quetiapine in the short-term treatment of first-episode schizophrenia-spectrum disorders was undertaken . Two hundred two patients were r and omly assigned to aripiprazole ( n = 78 ) , ziprasidone ( n = 62 ) , or quetiapine ( n = 62 ) and followed up for 6 weeks . The primary effectiveness measure was all-cause of treatment discontinuation . In addition , an analysis based on per protocol population s was conducted in the analysis for clinical efficacy . The overall dropout rate at 6 weeks was small ( 6.4 % ) . The treatment discontinuation rate differed significantly between treatment groups ( aripiprazole , 15 % ; zipras
Output:
| RCTs , which are the primary study type for regulatory su bmi ssions , showed a lack of bias .
Studies aim ed at HTA were not as well performed .
As a group , cross-sectional studies scored poorly for bias , with a primary failure to identify a representative sample . |
MS211944 | ***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 A complete remission is essential for prolonging survival in patients with acute myeloid leukemia ( AML ) . Daunorubicin is a cornerstone of the induction regimen , but the optimal dose is unknown . In older patients , it is usual to give daunorubicin at a dose of 45 to 50 mg per square meter of body-surface area . METHODS Patients in whom AML or high-risk refractory anemia had been newly diagnosed and who were 60 to 83 years of age ( median , 67 ) were r and omly assigned to receive cytarabine , at a dose of 200 mg per square meter by continuous infusion for 7 days , plus daunorubicin for 3 days , either at the conventional dose of 45 mg per square meter ( 411 patients ) or at an escalated dose of 90 mg per square meter ( 402 patients ) ; this treatment was followed by a second cycle of cytarabine at a dose of 1000 mg per square meter every 12 hours [ DOSAGE ERROR CORRECTED ] for 6 days . The primary end point was event-free survival . RESULTS The complete remission rates were 64 % in the group that received the escalated dose of daunorubicin and 54 % in the group that received the conventional dose ( P=0.002 ) ; the rates of remission after the first cycle of induction treatment were 52 % and 35 % , respectively ( P<0.001 ) . There was no significant difference between the two groups in the incidence of hematologic toxic effects , 30-day mortality ( 11 % and 12 % in the two groups , respectively ) , or the incidence of moderate , severe , or life-threatening adverse events ( P=0.08 ) . Survival end points in the two groups did not differ significantly overall , but patients in the escalated-treatment group who were 60 to 65 years of age , as compared with the patients in the same age group who received the conventional dose , had higher rates of complete remission ( 73 % vs. 51 % ) , event-free survival ( 29 % vs. 14 % ) , and overall survival ( 38 % vs. 23 % ) . CONCLUSIONS In patients with AML who are older than 60 years of age , escalation of the dose of daunorubicin to twice the conventional dose , with the entire dose administered in the first induction cycle , effects a more rapid response and a higher response rate than does the conventional dose , without additional toxic effects . ( Current Controlled Trials number , IS RCT N77039377 ; and Netherl and s National Trial Register number , NTR212 . Cytogenetics is considered one of the most valuable prognostic determinants in acute myeloid leukemia ( AML ) . However , many studies on which this assertion is based were limited by relatively small sample sizes or varying treatment approach , leading to conflicting data regarding the prognostic implication s of specific cytogenetic abnormalities . The Medical Research Council ( MRC ) AML 10 trial , which included children and adults up to 55 years of age , not only affords the opportunity to determine the independent prognostic significance of pretreatment cytogenetics in the context of large patient groups receiving comparable therapy , but also to address their impact on the outcome of subsequent transplantation procedures performed in first complete remission ( CR ) . On the basis of response to induction treatment , relapse risk , and overall survival , three prognostic groups could be defined by cytogenetic abnormalities detected at presentation in comparison with the outcome of patients with normal karyotype . AML associated with t(8;21 ) , t(15;17 ) or inv(16 ) predicted a relatively favorable outcome . Whereas in patients lacking these favorable changes , the presence of a complex karyotype , -5 , del(5q ) , -7 , or abnormalities of 3q defined a group with relatively poor prognosis . The remaining group of patients including those with 11q23 abnormalities , + 8 , + 21 , + 22 , del(9q ) , del(7q ) or other miscellaneous structural or numerical defects not encompassed by the favorable or adverse risk groups were found to have an intermediate prognosis . The presence of additional cytogenetic abnormalities did not modify the outcome of patients with favorable cytogenetics . Subgroup analysis demonstrated that the three cytogenetically defined prognostic groups retained their predictive value in the context of secondary as well as de novo AML , within the pediatric age group and furthermore were found to be a key determinant of outcome from autologous or allogeneic bone marrow transplantation ( BMT ) in first CR . This study highlights the importance of diagnostic cytogenetics as an independent prognostic factor in AML , providing the framework for a stratified treatment approach of this disease , which has been adopted in the current MRC AML 12 trial Cytogenetic classification by the revised international prognostic scoring system ( IPSS‐R ) and the prognostic value of monosomal karyotype ( MK ) were assessed in 783 patients with primary myelodysplastic syndromes ( MDS ) . At 22 months median follow‐up , 562 ( 72 % ) deaths were recorded . Percentages of patients with IPSS‐R “ very good , ” “ good , ” “ intermediate , ” “ poor , ” and “ very poor ” cytogenetic categories was 5 , 63 , 18 , 4 , and 10 % , respectively . The corresponding median survivals were 21 , 40 , 24 , 18 , and 6.5 months and the inter‐group differences ( good vs. very good/intermediate/poor vs. very poor ; P < 0.01 ) or similarities ( very good vs. intermediate vs. poor ; P = 0.79 ) were not significantly modified in multivariable analysis . Results were similar when analysis was restricted to 602 patients managed by supportive care . MK adversely affected survival in both poor and very poor karyotype groups ( P < 0.01 ) . In conclusion , we were unable to confirm the prognostic superiority of IPSS‐R‐very good karyotype or prognostically distinguish between very good , intermediate and poor karyotypes . Furthermore , we show additional prognostic information from MK in poor/very poor karyotype . Am . J. Hematol . 88:690–693 , 2013 . © 2013 Wiley Periodicals , BACKGROUND Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage . In this trial , we aim ed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens . METHODS In a phase III , international , multicentre , controlled , parallel-group , open-label trial , patients with higher-risk myelodysplastic syndromes were r and omly assigned one-to-one to receive azacitidine ( 75 mg/m(2 ) per day for 7 days every 28 days ) or conventional care ( best supportive care , low-dose cytarabine , or intensive chemotherapy as selected by investigators before r and omisation ) . Patients were stratified by French-American-British and international prognostic scoring system classifications ; r and omisation was done with a block size of four . The primary endpoint was overall survival . Efficacy analyses were by intention to treat for all patients assigned to receive treatment . This study is registered with Clinical Trials.gov , number NCT00071799 . FINDINGS Between Feb 13 , 2004 , and Aug 7 , 2006 , 358 patients were r and omly assigned to receive azacitidine ( n=179 ) or conventional care regimens ( n=179 ) . Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis . After a median follow-up of 21.1 months ( IQR 15.1 - 26.9 ) , median overall survival was 24.5 months ( 9.9-not reached ) for the azacitidine group versus 15.0 months ( 5.6 - 24.1 ) for the conventional care group ( hazard ratio 0.58 ; 95 % CI 0.43 - 0.77 ; stratified log-rank p=0.0001 ) . At last follow-up , 82 patients in the azacitidine group had died compared with 113 in the conventional care group . At 2 years , on the basis of Kaplan-Meier estimates , 50.8 % ( 95 % CI 42.1 - 58.8 ) of patients in the azacitidine group were alive compared with 26.2 % ( 18.7 - 34.3 ) in the conventional care group ( p<0.0001 ) . Peripheral cytopenias were the most common grade 3 - 4 adverse events for all treatments . INTERPRETATION Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care A monosomal karyotype ( MK ) , defined as ≥2 autosomal monosomies or a single monosomy in the presence of additional structural abnormalities , was recently identified as an independent prognostic factor conveying an extremely poor prognosis in patients with acute myeloid leukemia ( AML ) . In the present study , after excluding patients with t(15;17 ) , t(8;21 ) , inv(16 ) and normal karyotypes , 324 AML patients with cytogenetic abnormalities were the main subject of analysis . The incidences of MK were 13 % in patients aged 15 to 60 years and 18 % in those between 15 and 88 years old . MK was much more prevalent among elderly patients ( p<0.001 ) and was significantly associated with the presence of -7 , -5 , del(5q ) , abn12p , abn17p , -18 or 18q- , -20 or 20q- and CK ( for all p<0.001 except for abn12p p=0.009 ) , and + 8 or + 8q was less frequent in MK+ AML(p=0.007 ) . No correlation was noted between monosomal karyotype and FAB subtype ( p>0.05 ) ; MK remained significantly associated with worse overall survival among patients with complex karyotype ( p=0.032 ) ; A single autosomal monosomy contributed an additional negative effect in OS of patients with structural cytogenetic abnormalities ( P=0.008 ) . This report presents the prevalence , feature and prognostic impact of MK among a large series of Chinese AML patients from a single center for the first time Diagnostic karyotype provides the framework for risk-stratification schemes in acute myeloid leukemia ( AML ) ; however , the prognostic significance of many rare recurring cytogenetic abnormalities remains uncertain . We studied the outcomes of 5876 patients ( 16 - 59 years of age ) who were classified into 54 cytogenetic subgroups and treated in the Medical Research Council trials . In multivariable analysis , t(15;17)(q22;q21 ) , t(8;21)(q22;q22 ) , and inv(16)(p13q22)/t(16;16)(p13;q22 ) were the only abnormalities found to predict a relatively favorable prognosis ( P < .001 ) . In patients with t(15;17 ) treated with extended all-trans retinoic acid and anthracycline-based chemotherapy , additional cytogenetic changes did not have an impact on prognosis . Similarly , additional abnormalities did not have a significant adverse effect in t(8;21 ) AML ; whereas in patients with inv(16 ) , the presence of additional changes , particularly + 22 , predicted a better outcome ( P = .004 ) . In multivariable analyses , various abnormalities predicted a significantly poorer outcome , namely abn(3q ) ( excluding t(3;5)(q25;q34 ) ) , inv(3)(q21q26)/t(3;3)(q21;q26 ) , add(5q)/del(5q ) , -5 , -7 , add(7q)/del(7q ) , t(6;11)(q27;q23 ) , t(10;11)(p11 approximately 13;q23 ) , other t(11q23 ) ( excluding t(9;11)(p21 approximately 22;q23 ) and t(11;19)(q23;p13 ) ) , t(9;22)(q34;q11 ) , -17 , and abn(17p ) . Patients lacking the aforementioned favorable or adverse aberrations but with 4 or more unrelated abnormalities also exhibited a significantly poorer prognosis ( design ated " complex " karyotype group ) . These data allow more reliable prediction of outcome for patients with rarer abnormalities and may facilitate the development of consensus in reporting of karyotypic information in clinical trials involving younger adults with AML . This study is registered at http://www.is rct n.org as IS RCT N55678797 and IS RCT N17161961 Metaphase karyotyping is an established diagnostic st and ard in acute myeloid leukemia ( AML ) for risk stratification . One of the cytogenetic findings in AML is structurally highly abnormal marker chromosomes . In this study , we have assessed frequency , cytogenetic characteristics , prognostic
Output:
| This analysis of the literature confirms the negative prognostic impact on survival of the MK in myeloid neoplasias . |
MS211945 | ***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 exponential growth of image-based diagnostic and minimally invasive interventions requires a detailed three-dimensional anatomical knowledge and increases the dem and towards the undergraduate anatomical curriculum . This r and omized controlled trial investigates whether musculoskeletal ultrasound ( MSUS ) or arthroscopic methods can increase the anatomical knowledge uptake . Methods Second-year medical students were r and omly allocated to three groups . In addition to the compulsory dissection course , the ultrasound group ( MSUS ) was taught by eight , didactically and professionally trained , experienced student-teachers and the arthroscopy group ( ASK ) was taught by eight experienced physicians . The control group ( CON ) acquired the anatomical knowledge only via the dissection course . Exposure ( MSUS and ASK ) took place in two separate lessons ( 75 minutes each , shoulder and knee joint ) and introduced st and ard scan planes using a 10-MHz ultrasound system as well as arthroscopy tutorials at a simulator combined with video tutorials . The theoretical anatomic learning outcomes were tested using a multiple-choice question naire ( MCQ ) , and after cross-over an objective structured clinical examination ( OSCE ) . Differences in student ’s perceptions were evaluated using Likert scale-based items . Results The ASK-group ( n = 70 , age 23.4 ( 20–36 ) yrs . ) performed moderately better in the anatomical MC exam in comparison to the MSUS-group ( n = 84 , age 24.2 ( 20–53 ) yrs . ) and the CON-group ( n = 88 , 22.8 ( 20–33 ) yrs . ; p = 0.019 ) . After an additional arthroscopy teaching 1 % of students failed the MC exam , in contrast to 10 % in the MSUS- or CON-group , respectively . The benefit of the ASK module was limited to the shoulder area ( p < 0.001 ) . The final examination ( OSCE ) showed no significant differences between any of the groups with good overall performances . In the evaluation , the students certified the arthroscopic tutorial a greater advantage concerning anatomical skills with higher spatial imagination in comparison to the ultrasound tutorial ( p = 0.002 ; p < 0.001 ) . Conclusions The additional implementation of arthroscopy tutorials to the dissection course during the undergraduate anatomy training is profitable and attractive to students with respect to complex joint anatomy . Simultaneous teaching of basic-skills in musculoskeletal ultrasound should be performed by medical experts , but seems to be inferior to the arthroscopic 2D-3D-transformation , and is regarded by students as more difficult to learn . Although arthroscopy and ultrasound teaching do not have a major effect on learning joint anatomy , they have the potency to raise the interest in surgery The birth of the intermittent injectate-based conventional pulmonary artery catheter ( fondly nicknamed PAC ) was proudly announced in the New Engl and Journal of Medicine in 1970 by his parents HJ Swan and William Ganz . PAC grew rapidly , reaching manhood in 1986 where , in the US , he was shown to influence the management of over 40 % of all ICU patients . His reputation , however , was tarnished in 1996 when Connors and colleagues suggested that he harmed patients . This was followed by r and omized controlled trials demonstrating he was of little use . Furthermore , reports surfaced suggesting that he was unreliable and inaccurate . It also became clear that he was poorly understood and misinterpreted . Pretty soon after that , a posse of rivals ( bedside echocardiography , pulse contour technology ) moved into the neighborhood and cl aim ed they could assess cardiac output more easily , less invasively and no less reliably . To make matter worse , dynamic assessment of fluid responsiveness ( pulse pressure variation , stroke volume variation and leg raising ) made a mockery of his ‘ wedge ’ pressure . While a h and ful of die-hard followers continued to promote his mission , the last few years of his existence were spent as a castaway until his death in 2013 . His cousin ( the continuous cardiac output PAC ) continues to eke a living mostly in cardiac surgery patients who need central access anyway . This paper review s the rise and fall of the conventional PAC This study compared the efficacy of two cardiac anatomy teaching modalities , ultrasound imaging and cadaveric prosections , for learning cardiac gross anatomy . One hundred and eight first‐year medical students participated . Two weeks prior to the teaching intervention , students completed a pretest to assess their prior knowledge and to ensure that groups were equally r and omized . Students , divided into pre‐existing teaching groups , were assigned to one of two conditions ; “ cadaver ” or “ ultrasound . ” Those in the cadaver group received teaching on the heart using prosections , whereas the ultrasound group received teaching using live ultrasound images of the heart . Immediately after teaching , students sat a post‐test . Both teaching modalities increased students ' test scores by similar amounts but no significant difference was found between the two conditions , suggesting that both prosections and ultrasound are equally effective methods for teaching gross anatomy of the heart . Our data support the inclusion of either cadaveric teaching or living anatomy using ultrasound within the undergraduate anatomy curriculum , and further work is needed to compare the additive effect of the two modalities . Anat Sci Educ . © 2011 American Association of Anatomists Purpose We analyzed the efficacy of a point-of-care ultrasonographic protocol , based on a focused multiorgan examination , for the diagnostic process of symptomatic , non-traumatic hypotensive patients in the emergency department . Methods We prospect ively enrolled 108 adult patients complaining of non-traumatic symptomatic hypotension of uncertain etiology . Patients received immediate point-of-care ultrasonography to determine cardiac function and right/left ventricle diameter rate , inferior vena cava diameter and collapsibility , pulmonary congestion , consolidations and sliding , abdominal free fluid and aortic aneurysm , and leg vein thrombosis . The organ-oriented diagnoses were combined to formulate an ultrasonographic hypothesis of the cause of hemodynamic instability . The ultrasonographic diagnosis was then compared with a final clinical diagnosis obtained by agreement of three independent expert physicians who performed a retrospective hospital chart review of each case . Results Considering the whole population , concordance between the point-of-care ultrasonography diagnosis and the final clinical diagnosis was interpreted as good , with Cohen ’s k = 0.710 ( 95 % CI , 0.614–0.806 ) , p < 0.0001 and raw agreement ( Ra ) = 0.768 . By eliminating the 13 cases where the final clinical diagnosis was not agreed upon ( indefinite ) , the concordance increased to almost perfect , with k = 0.971 ( 95 % CI , 0.932–1.000 ) , p < 0.0001 and Ra = 0.978 . Conclusions Emergency diagnostic judgments guided by point-of-care multiorgan ultrasonography in patients presenting with undifferentiated hypotension significantly agreed with a final clinical diagnosis obtained by retrospective chart review . The integration of an ultrasonographic multiorgan protocol in the diagnostic process of undifferentiated hypotension has great potential in guiding the first-line therapeutic approach Ultrasound simulation allows students to virtually explore internal anatomy by producing accurate , moving , color , three‐dimensional rendered slices from any angle or approach leaving the organs and their relationships intact without requirement for consumables . The aim was to determine the feasibility and efficacy of self‐directed learning of cardiac anatomy with an ultrasound simulator compared to cadavers and plastic models . After a single cardiac anatomy lecture , fifty university anatomy students participated in a three‐hour supervised self‐directed learning exposure in groups of five , r and omized to an ultrasound simulator or human cadaveric specimens and plastic models . Pre‐ and post‐tests were conducted using pictorial and non‐pictorial multiple‐choice questions ( MCQs ) . Simulator students completed a survey on their experience . Four simulator and seven cadaver group students did not attend after r and omization . Simulator use in groups of five students was feasible and feedback from participants was very positive . Baseline test scores were similar ( P = 0.9 ) between groups . After the learning intervention , there was no difference between groups in change in total test score ( P = 0.37 ) , whether they were pictorial ( P = 0.6 ) or non‐pictorial ( P = 0.21 ) . In both groups there was an increase in total test scores ( simulator + 19.8 ±12.4%% and cadaver : + 16.4 % ± 10.2 , P < 0.0001 ) , pictorial question scores ( + 22.9 ±18.0 % , 19.7 ±19.3 % , P < 0.001 ) and non‐pictorial question scores ( + 16.7 ±18.2 % , + 13 ±15.4 % , P = 0.002 ) . The ultrasound simulator appears equivalent to human cadaveric prosections for learning cardiac anatomy . Anat Sci Educ 8 : 21–30 . © 2014 American Association of Anatomists Existing guidelines for the number of ultrasounds required before clinical competency are based not on scientific study but on consensus opinion . The objective of this study was to describe the learning curve of limited right upper quadrant ultrasound . This was a prospect i ve descriptive study . Ultrasounds collected over 1 year were review ed for interpretive and technical errors . Possible errors during bedside ultrasound of the gallbladder include incorrect interpretation , incomplete image acquisition , and improper or poor imaging techniques result ing in poor image quality . The ultrasound image quality was rated on a 4-point scale , with 1 = barely interpretable and 4 = excellent image quality . Required images were rated on an additional 4-point scale , with 4 = all required images were included and 1 = minimal images were recorded . There were 352 patients enrolled by 42 emergency physicians ( 35 residents and 7 attendings ) . Gallstones were identified in 13.9 % of the patients , and 4.3 % of the ultrasounds were indeterminate . Interpretive and technical error rates decreased as the clinician gained experience . The number of poor quality ultrasounds decreased after an average of seven ultrasounds . Inclusion of all required images increased after 25 ultrasounds . Sonographers who had performed over 25 ultrasounds showed excellent agreement with the expert over-read , with only two disagreements , both from a single individual . It was concluded that clinicians are clinical ly competent after performing 25 ultrasounds of the gallbladder OBJECTIVES We aim ed to investigate the potential benefit of adding goal -directed ultrasound examinations performed by on-call medical residents using a pocket-size imaging device in patients admitted to a medical department . METHODS A total of 992 emergency admissions to the medical department at a nonuniversity hospital in Norway were included . Patients admitted on date s with an on-call medical resident r and omized to use a pocket-size imaging device were eligible for pocket-size cardiac and abdominal ultrasound examinations or st and ard care . The cardiac examination included estimation of right and left ventricular sizes and global systolic function and regional left ventricular systolic function , evaluation for pleural and pericardial effusion , and valvular disease . The abdominal examination looked for signs of gross abnormalities of the liver , gallbladder , abdominal aorta , inferior vena cava , and urinary system . Six of 12 medical residents with limited ultrasound experience were r and omized to perform the examinations . Diagnostic corrections were made , and findings were confirmed by reference st and ard diagnostics . RESULTS A total of 199 patients were examined . Median times used were 5.7 minutes for the cardiac examination and 4.7 minutes for the abdominal examination . In 13 patients ( 6.5 % ) , the examination result ed in a major change in the primary diagnosis . In 21 patients ( 10.5 % ) , the diagnosis was verified , and in 48 ( 24.0 % ) , an additional important diagnosis was made . CONCLUSIONS By implementing pocket-size ultrasound examinations that took less than 11 minutes to the usual care , we corrected , verified , or added important diagnoses in more than 1 of 3 emergency medical admissions . Point-of-care examinations with a pocket-size imaging device increased medical residents ' diagnostic accuracy and capability Introduction : This study compared ultrasonography-guided ( USG ) placement with anatomic placement during internal jugular ( IJ ) central venous catheter ( CVC ) insertion by novice practitioners using a simulation model . Methods : A prospect i ve , r and omized , crossover study of 28 fourth year medical students was conducted with institutional review board approval . Participants viewed an instructional material before participation , and supervision was st and ardized . Participants were r and omly assigned to either USG or traditional l and mark method first , and each group served as its own crossover comparison . Paired t tests and & khgr;2 analysis were performed on matched-pair data . Results : Fifty-four percent of participants had at least one arterial stick without USG compared with 0 % when using USG . Significant differences were shown in the USG versus no-USG groups in number of needle advances until successful cannulation of the vein : mean with USG = 1.5 advances ( 95 % CI , 1.0–1.9 ) , mean without USG = 10.4 advances ( 95 % CI , 7.8–13 ) , P < 0.001 ; time to successful cannulation : mean with USG = 58 seconds ( 95 % CI , 48–72 seconds ) , mean without USG = 338 seconds ( 95 % CI , 286–390 seconds
Output:
| The use of ultrasound was not demonstrated to improve students ' underst and ing of anatomy .
The benefit of ultrasound in teaching physical examination was inconsistent and rests on minimal evidence .
With POCUS , students ' diagnostic accuracy was improved for certain pathologies , but findings were inconsistent for others . |
MS211946 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A prospect i ve r and omised single-blind study of the effects of real and sham acupuncture on exercise-induced asthma was conducted in nineteen children . Forced expiratory flow in 1st second ( FEV1 ) , forced vital capacity ( FVC ) , and peak expiratory flow rate ( PEFR ) were measured throughout acupuncture and after treadmill exercise . Neither real nor sham acupuncture affected the basal bronchomotor tone but both , when applied 20 min before exercise , attenuated exercise induced asthma : mean maximum percentage falls in FEV1 , FVC , and PEFR were 44.4 % , 33.3 % , and 49.5 % without acupuncture ; 23.8 % , 15.8 % , and 25.9 % after real acupuncture ; and 32.6 % , 26.1 % , and 34.3 % after sham acupuncture . Real acupuncture provided better protection against exercise-induced asthma than did sham acupuncture ( p less than 0.05 ) The present multicentre study evaluates the differences in efficacy between a 3 month rehabilitation programme including drug treatment , and a 3 month control period of drug treatment only , for asthmatic patients and patients with chronic obstructive pulmonary disease ( COPD ) . The programme was run by physiotherapists in eight local practice s , and included exercise training , patient education , breathing retraining , evacuation of mucus , relaxation techniques , and recreational activities . In a r and omized controlled trial with a cross-over design , the effects of rehabilitation were evaluated 3 and 6 months after baseline measurements in terms of exercise tolerance and quality of life ( QOL ) . Exercise tolerance was assessed using submaximal cycle ergometer tests and 6 min walking tests . QOL was evaluated by means of the Chronic Respiratory Disease Question naire ( CRDQ ) . After 3 months , the patients who started with rehabilitation showed significant improvements in endurance time ( 421 s ) and cardiac frequency ( 6 beats.min-1 ) during cycling , walking distance ( 39 m ) , and total CRDQ score ( 17 points ) compared to the control group . These improvements were still significant after 6 months . Additional analysis indicated that the asthmatic patients and the patients with COPD responded to rehabilitation in a similar way , with the exception that there was a greater improvement in walking distance for asthmatics . Improvements in exercise tolerance were not significantly correlated with improvements in QOL . Rehabilitation of patients with asthma or chronic obstructive pulmonary disease in local physiotherapy practice s improves exercise tolerance and quality of life A small , controlled trial of joint treatment of childhood asthma by a doctor , a physiotherapist , a psychologist , and a social worker , working together in the family setting , demonstrated an improvement in ventilatory capacity . The limited scope of this trial does not permit more general conclusions as to the effect of such treatment on the severity and frequency of attacks , but the observation that some measurable physiological improvement occurred suggests that the place of multidisciplinary nonpharmaceutical management of childhood asthma should be investigated in more detail Many asthma patients seek alternative or adjunctive therapies . One such modality is reflexology , whereby finger pressure is applied to certain parts of the body . The aim of the study was to examine the popular cl aim that reflexology treatment benefits bronchial asthma . Ten weeks of active or simulated ( placebo ) reflexology given by an experienced reflexologist , were compared in an otherwise blind , controlled trial of 20 + 20 out patients with asthma . Objective lung function tests ( peak flow morning and evening , and weekly spirometry at the clinic ) did not change . Subjective scores ( describing symptoms , beta2-inhalations and quality of life ) and also bronchial sensitivity to histamine improved on both regimens , but no differences were found between groups receiving active or placebo reflexology . However , a trend in favour of reflexology became significant when a supplementary analysis of symptom diaries was carried out . It was accompanied by a significant pattern compatible with subconscious unblinding , in that patients tended to guess which treatment they had been receiving . No evidence was found that reflexology has a specific effect on asthma beyond placebo influence The effects of chest physical therapy in acute severe asthma in children have been studied in 38 children aged 6 to 13 years in a r and omized placebo controlled trial . The study began between 6 and 24 hours after admission to hospital ; 19 children received chest physical therapy ( PT ) and 19 children received placebo visits . Each child had 4 treatments over 2 days which were preceded by nebulized salbutamol . Lung volumes and flow rates were measured in a body plethysmograph before salbutamol and before and after either PT or placebo on the first and fourth treatments . Throughout the study st and ard asthma drug therapy was given . In both groups characteristics such as sex , race , age , height , weight , severity , and baseline lung function were similar . Taking into account the baseline , lung function at the end of the study was similar in both groups . Three 12 year old children in the PT group showed improvements in flows above those seen in any children in the placebo group . We conclude that chest PT , when combined with asthma drug therapy , does not improve lung function in most children in this age group with acute severe asthma The purpose of this r and omized patient‐ and observer‐blinded cross‐over trial was to evaluate the efficacy of chiropractic treatment in the management of chronic asthma when combined with pharmaceutical maintenance therapy . The trial was conducted at the National University Hospital 's Out‐patient Clinic in Copenhagen , Denmark . Thirty‐one patients aged 18–44 years participated , all suffering from chronic asthma controlled by bronchodilators and /or inhaled steroids . Patients , or who had received chiropractic treatment for asthma within the last 5 years , who received oral steroids and immunotherapy , were not eligible . Patients were r and omized to receive either active chiropractic spinal manipulative treatment or sham chiropractic spinal manipulative treatment twice weekly for 4 weeks , and then crossed over to the alternative treatment for another 4 weeks . Both phases were preceded and followed by a 2‐week period without chiropractic treatment . The main outcome measurements were forced expiratory volume in the first second ( FEV1 ) , forced vital capacity ( FVC ) , daily use of inhaled bronchodilators , patient‐rated asthma severity and non‐specific bronchial reactivity ( n‐BR ) . Using the cross‐over analysis , no clinical ly important or statistically significant differences were found between the active and sham chiropractic interventions on any of the main or secondary outcome measures . Objective lung function did not change during the study , but over the course of the study , non‐specific bronchial hyperreactivity ( n‐BR ) improved by 36 % ( P= 0.01 ) and patient‐rated asthma severity decreased by 34 % ( P= 0.0002 ) compared with the baseline values . The results do not support the hypothesis that chiropractic spinal manipulative therapy is superior to sham spinal manipulation in the management of pharmaceutically controlled chronic asthma in adults when administered twice weekly for 4 weeks The therapeutic effectiveness of classic Chinese acupuncture was compared with " placebo " acupuncture in 15 patients with stable bronchial asthma . The patients received treatments with real and placebo acupuncture in a r and omly ordered , subject and evaluator-blind crossover fashion twice weekly for five weeks . Both real and placebo treatment periods were preceded by three week periods when no acupuncture was administered . Five patients felt better on real treatment , five patients preferred placebo and five did not feel any improvement on either of the two treatments . Treatment with real acupuncture when compared with no treatment and placebo treatment failed to provide any improvement in daily peak flow rates , asthma symptom scores , number of puffs of beta 2-agonist aerosol use , and pulmonary function results Physiotherapy is an established treatment in asthmatic children . One purpose is to increase tolerance towards physical activity , decrease broncho-obstruction and promote elimination of secretions . A positive effect of physical training in asthmatic children has been reported in many studies . An improved working capacity has e.g. been shown after supervised physical training at least twice a week for a period of three months ( 1 ) . This was not a realistic level of training intensity in our clinical practice . Therefore , the goal of this study was to test whether physiotherapy combined with physical training once a week had any effect on working capacity or lung function tests in asthmatic children Thirty patients with proved bronchial asthma receiving treatment with inhaled steroid in dosages of less than 1,000 micrograms daily were subdivided at r and om into two groups of 15 patients . One group received foot zone therapy and the other merely uniform clinical care but without " placebo foot zone therapy " . The " active " group received a total of ten foot zone therapy sessions of one hour at intervals of one week . The asthmatic symptoms , consumption of medicine and the objective pulmonary function parameters were followed-up during the subsequent six months . Decrease in consumption of beta-2-agonists and increase in peak-flow levels were observed in the group which had received foot zone therapy , but the same changes were observed in the control group . The authors do not find that this investigation demonstrates that foot zone therapy is of effect on the disease bronchial asthma . They conclude , however , that the favourable effect in both of the groups are due to increased care and control which occurred in both patient groups BACKGROUND Chiropractic spinal manipulation has been reported to be of benefit in nonmusculoskeletal conditions , including asthma . METHODS We conducted a r and omized , controlled trial of chiropractic spinal manipulation for children with mild or moderate asthma . After a three-week base-line evaluation period , 91 children who had continuing symptoms of asthma despite usual medical therapy were r and omly assigned to receive either active or simulated chiropractic manipulation for four months . None had previously received chiropractic care . Each subject was treated by 1 of 11 participating chiropractors , selected by the family according to location . The primary outcome measure was the change from base line in the peak expiratory flow , measured in the morning , before the use of a bronchodilator , at two and four months . Except for the treating chiropractor and one investigator ( who was not involved in assessing outcomes ) , all participants remained fully blinded to treatment assignment throughout the study . RESULTS Eighty children ( 38 in the active-treatment group and 42 in the simulated-treatment group ) had outcome data that could be evaluated . There were small increases ( 7 to 12 liters per minute ) in peak expiratory flow in the morning and the evening in both treatment groups , with no significant differences between the groups in the degree of change from base line ( morning peak expiratory flow , P=0.49 at two months and P=0.82 at four months ) . Symptoms of asthma and use of 3-agonists decreased and the quality of life increased in both groups , with no significant differences between the groups . There were no significant changes in spirometric measurements or airway responsiveness . CONCLUSIONS In children with mild or moderate asthma , the addition of chiropractic spinal manipulation to usual medical care provided no benefit A 5-day , non-residential exercise and living course for children with asthma is described as a feature of a programme of outpatient physiotherapy . Eleven children undertaking such a course were compared with 10 asthmatic children in a control group . The subject group showed , in the short term at least , an improvement in bronchial lability , peak flow rates , nocturnal and daytime wheeze , and activity compared with the controls . These findings were statistically significant . There was no difference between the groups in the number of days on which extra medication was taken . A short , sharp course is of benefit physically , socially and psychologically to children with asthma In this pilot study , the authors evaluated the immediate effects of osteopathic manipulative procedures compared with sham procedures on 10 subjects who were diagnosed with chronic asthma . The research followed a pretest-posttest crossover design wherein each subject served as her own control . Blinded examiners recorded respiratory excursion , peak expiratory flow rates , and subjective measures of asthma symptoms . Measurements of both upper thoracic and lower thoracic forced respiratory excursion statistically increased after osteopathic manipulative procedures compared with sham procedures . Changes in peak expiratory flow rates and asthma symptoms were not statistically significant OBJECTIVES The first objective was to determine if chiropractic spinal manipulative therapy ( SMT ) in addition to optimal medical management result ed in clinical ly important changes in asthma-related outcomes in children . The second objective was to assess the feasibility of conducting a full-scale , r and omized clinical trial in terms of recruitment , evaluation , treatment , and ability to deliver a sham SMT procedure . STUDY DESIGN Prospect i ve clinical case series combined with an observer-blinded , pilot r and omized clinical trial with a 1-year follow-up period . SETTING Primary contact , college outpatient clinic , and a pediatric hospital . PATIENTS A total of 36 patients aged 6 to 17 years with mild and moderate persistent asthma were admitted to the study . OUTCOME MEASURES Pulmonary function tests ; patient- and parent- or guardian-rated asthma-specific quality of life , asthma severity , and improvement ; am and pm peak expiratory flow rates ; and diary-based day and nighttime symptoms . INTERVENTIONS Twenty chiropractic treatment sessions were scheduled during the 3-month intervention phase . Patients were r and omly assigned to receive either active SMT or sham SMT in addition to their st and ardized ongoing medical management . RESULTS It is possible to blind the participants to the nature of the SMT intervention , and a full-scale trial with the described design is feasible to conduct . At the end of the 12-week intervention phase , objective lung function
Output:
| REVIEW ER 'S CONCLUSIONS There is insufficient evidence to support the use of manual therapies for patients with asthma .
Currently , there is insufficient evidence to support or refute the use of manual therapy for patients with asthma |
MS211947 | ***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 Persons with human immunodeficiency virus ( HIV ) infection are at risk for premature cardiovascular disease ( CVD ) . Predictors of atherosclerotic disease progression in contemporary patients have not been well described . METHODS Using data from a prospect i ve observational cohort of adults infected with HIV ( Study to Underst and the Natural History of HIV/AIDS in the Era of Effective Therapy ) , we assessed common carotid artery intima-media thickness ( CIMT ) at baseline and year 2 by ultrasound . We examined HIV-associated predictors of CIMT progression after adjusting for age , sex , race/ethnicity , body mass index , smoking , hypertension , diabetes , low-density lipoprotein cholesterol level , and baseline CIMT using linear regression . RESULTS Among 389 participants ( median age at baseline , 42 years ; male sex , 77 % ; median CD4 + cell count at baseline , 485 cells/mm³ ; 78 % receiving antiretroviral therapy ) , the median 2-year CIMT change was 0.016 mm ( interquartile range , -0.003 to 0.033 mm ; P < .001 ) . Lesser CIMT progression was associated with a suppressed viral load at baseline ( -0.009 mm change ; P = .015 ) and remaining virologically suppressed throughout follow-up ( -0.011 mm change ; P < .001 ) . After adjusting for additional risk factors and a suppressed viral load during follow-up , nonnucleoside reverse transcriptase inhibitor versus protease inhibitor exposure was associated with lesser CIMT progression ( -0.011 mm change ; P = .02 ) . CONCLUSIONS Suppressing HIV replication below clinical thresholds was associated with less progression of atherosclerosis . The proatherogenic mechanisms of HIV replication and the net CVD benefit of different antiretroviral drugs should be a focus of future research BACKGROUND Human immunodeficiency virus (HIV)-infected patients are at increased risk of cardiovascular disease , which may be related to chronic inflammation and endothelial dysfunction despite virological control with antiretroviral therapy . The relationship between carotid intima-media thickness ( IMT ) , a surrogate marker for cardiovascular disease , proinflammatory cytokines , and endothelial activation markers has not been fully explored in HIV-infected patients who are receiving antiretroviral therapy . METHODS We conducted a prospect i ve , cross-sectional , observational study of treated HIV-infected patients and healthy control subjects to evaluate the relationship between carotid IMT , proinflammatory cytokines , endothelial activation biomarkers , and metabolic parameters in treated HIV-infected patients , compared with healthy control subjects . RESULTS We enrolled 73 HIV-infected patients and 21 control subjects . Common carotid artery and internal carotid artery IMT measurements , as well as tumor necrosis factor-alpha , high-sensitivity C-reactive protein , interleukin-6 , myeloperoxidase , and soluble vascular cell adhesion molecule-1 levels were higher in the HIV-infected group . High-sensitivity C-reactive protein was the only biomarker that was positively correlated with carotid IMT in both groups . In the HIV-infected group , soluble vascular cell adhesion molecule-1 was positively correlated with all inflammatory cytokine levels . In multiple regression analysis , soluble vascular cell adhesion molecule-1 , myeloperoxidase , and tumor necrosis factor-alpha levels were all associated with internal carotid artery IMT in the HIV-infected group , whereas age was associated with both common carotid artery and internal carotid artery IMT . CONCLUSIONS Enhanced endothelial activation , inflammation , and increased carotid IMT occur in HIV-infected patients despite antiretroviral therapy . Inflammatory markers are associated with endothelial activation , and both are associated with internal carotid artery IMT , supporting a potential role of inflammation in endothelial activation and cardiovascular disease in HIV infection OBJECTIVE Combined antiretroviral therapy ( cART ) has significantly improved the survival rate and quality of life for HIV-infected subjects , but it contributes to the development of metabolic complications including coronary artery disease ( CAD ) . Recent studies have reported that high plasma levels of the soluble receptor for advanced glycation end products ( sRAGE ) were associated with a lower incidence of CAD in non-HIV infected patients . However , there has been no report of an association of sRAGE and sub clinical carotid atherosclerosis in HIV-infected patients receiving cART . METHODS We examined the association of circulating sRAGE in HIV-infected patients with carotid intima-media thickness ( IMT ) and other metabolic variables . We prospect ively enrolled 76 HIV-infected patients receiving cART for ≥ 6 months . RESULTS sRAGE had a significantly negative correlation with body mass index ( r = -0.324 , p = 0.005 ) , waist-to-hip ratio ( r = -0.335 , p = 0.003 ) , systolic blood pressure ( BP ) ( r=-0.359 , p=0.002 ) , diastolic BP ( r = -0.343 , p = 0.004 ) , total cholesterol ( r = -0.240 , p = 0.037 ) , low-density lipoprotein-cholesterol ( r=-0.284 , p=0.024 ) , log(homeostasis model assessment of insulin resistance [ HOMA-IR ] ) ( r = -0.380 , p = 0.002 ) and carotid IMT including max-IMT and mean-IMT ( r = -0.358 , p = 0.001 and r = -0.329 , p = 0.004 , respectively ) . By the use of multiple stepwise regression analyses , systolic BP ( p=0.001 ) and log[HOMA-IR ] ( p = 0.001 ) remained significant independently . CONCLUSIONS These results suggest that sRAGE may have a protective effect against sub clinical atherosclerosis by preventing inflammatory responses mediated by the activation of cell surface RAGE in HIV-infected patients receiving cART BACKGROUND Marked changes in the prevalence of noncommunicable diseases such as obesity , diabetes , and cardiovascular disease have occurred in developed and developing countries in recent decades . The overarching aim of the study is to examine the relationship of societal influences on human lifestyle behaviors , cardiovascular risk factors , and incidence of chronic noncommunicable diseases . METHODS The Prospect i ve Urban Rural Epidemiology ( PURE ) study is a large-scale epidemiological study that plans to recruit approximately 140,000 individuals residing in > 600 communities in 17 low- , middle- , and high-income countries around the world . Individual data collection includes medical history , lifestyle behaviors ( physical activity and dietary profile ) , blood collection and storage for biochemistry and future genetic analysis , electrocardiogram , and anthropometric measures . In addition , detailed information is being collected with respect to 4 environmental domains of interest-the built environment , nutrition and associated food policy , psychosocial/socioeconomic factors , and tobacco environment . A minimum follow-up of 10 years is currently planned . RESULTS This report describes the design , justification , and methodology of the PURE study . The PURE study has been recruiting since 2002 and has enrolled 139,506 individuals by March 31 , 2009 . CONCLUSIONS The PURE study builds on the work and experience gained through conduct of the INTERHEART study . Its design and extensive data collection are geared toward addressing major questions on causation and development of the underlying determinants of cardiovascular disease in population s at varying stages of epidemiologic transition Rosiglitazone may be useful for the treatment of antiretroviral therapy-associated lipoatrophy , but an association with cardiovascular disease ( CVD ) has been question ed in diabetics . We evaluated rosiglitazone 's effect on surrogate markers of CVD in HIV-infected individuals with lipoatrophy . HIV(+ ) patients with lipoatrophy on thymidine-sparing regimens were r and omized to rosiglitazone vs. placebo for 48 weeks . We serially assessed carotid IMT , fasting metabolic profiles , tumor necrosis factor (TNF)-α , soluble receptors ( sTNFRI and II ) , interleukin (IL)-6 , high-sensitivity C-reactive protein ( hsCRP ) , myeloperoxidase ( MPO ) , and endothelial activation markers [ von Willebr and factor ( vWF ) , soluble intercellular cell adhesion molecules-1 ( sICAM-1 ) , and vascular cell adhesion molecules-1 ( sVCAM-1 ) ] . Seventy-one subjects enrolled : 17 % were female and 51%were white . Baseline characteristics were similar between groups except for higher total cholesterol in the placebo group ( p = 0.04 ) . At 48 weeks , common carotid artery ( CCA ) IMT changed significantly ( p ≤ 0.05 ) within but not between the groups ( p = 0.36 ) : the median ( IQR ) increase was 0.10 ( 0.05 , 0.25 ) mm and 0.15 ( 0 , 0.25 ) mm in the rosiglitazone and placebo groups , respectively . hsCRP , sTNFRI and II , sVCAM-1 , and vWF changed significantly ( p ≤ 0.02 ) within but not between groups . Total cholesterol increased significantly in the rosiglitazone group ( p = 0.008 ) . In our study of virologically controlled subjects with lipoatrophy , rosiglitazone did not independently increase carotid IMT , endothelial activation , and inflammatory cytokines Chronic HIV infection is associated with increased risk of cardiovascular disease ( CVD ) , including in patients with virological suppression . Persistent innate immune activation may contribute to the development of CVD via activation of monocytes in these patients . We investigated whether changes in monocyte phenotype predict sub clinical atherosclerosis in virologically suppressed HIV-positive individuals with low cardiovascular risk . We enroled 51 virologically suppressed HIV-positive individuals not receiving protease inhibitors or statins and 49 age-matched uninfected controls in this study . Carotid artery intima-media thickness ( cIMT ) was used as a surrogate marker for CVD , and traditional risk factors , including Framingham risk scores , were recorded . Markers of monocyte activation ( CD14 , CD16 , CCR2 , CX3CR1 , CD38 , HLA-DR and CD11b ) were measured in whole-blood sample s by flow cytometry . Associations were assessed using univariate and multivariate median regressions . Median cIMT was similar between HIV-positive and HIV-negative participants ( P=0.3 ) , although HIV-positive patients had significantly higher Framingham risk score ( P=0.009 ) and systemic inflammation . Expression of two monocyte markers , CD11b and CX3CR1 , independently predicted carotid artery thickness in HIV-positive individuals after controlling for Framingham risk score ( P=0.025 and 0.015 , respectively ) . These markers were not predictive of carotid artery thickening in controls . Our study indicates that monocyte surface markers may serve as novel predictors of CVD in HIV-positive individuals and is consistent with an important role for monocyte activation in the progression of HIV-related cardiovascular pathology BACKGROUND The relationships between soluble CD14 ( sCD14 ) , endotoxin ( lipopolysaccharide [ LPS ] ) , and progression of atherosclerosis have not been defined in human immunodeficiency virus ( HIV ) infection . METHODS We retrospectively assessed serum sCD14 and LPS levels of 91 subjects in a prospect i ve 3-year study of carotid artery intima-media thickness ( CIMT ) ( AIDS Clinical Trials Group [ ACTG ] 5078 ) , where subjects were enrolled as risk factor-controlled triads of HIV-uninfected ( n = 36 ) and HIV-infected individuals with ( n = 29 ) or without ( n = 26 ) protease inhibitor (PI)-based therapy for ≥2 years . The primary end point was the yearly rate of change of CIMT ( ΔCIMT ) . RESULTS In multivariate analysis of the HIV-infected subjects , each 1 µg/mL above the mean of baseline serum sCD14 corresponded to an additional 1.52 µm/y ( 95 % confidence interval , .07 - 2.98 ; P = .04 ) in the ΔCIMT . Every 100 pg/mL above the mean of baseline serum LPS corresponded to an additional 0.49 µm/y ( 95 % confidence interval , .18-.81 ; P = .003 ) in the ΔCIMT . However , in univariate
Output:
| CRP , IL-6 and soluble vascular cell adhesion molecule ( sVCAM-1 ) were the most studied markers in relation to CIMT .
None of the inflammatory markers showed an association with CIMT .
Interpretation This review showed a relation between some inflammatory markers and CVD , however , no consistent relation is observed for CIMT . |
MS211948 | ***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 the prefrontal cortex of subjects with schizophrenia , markers of the synthesis and re-uptake of GABA appear to be selectively altered in a subset of interneurons that includes ch and elier cells . Determining the effect of these disturbances in presynaptic GABA markers on inhibitory signaling requires knowledge of the status of GABA(A ) receptors at the postsynaptic targets of ch and elier cells , the axon initial segments ( AIS ) of pyramidal neurons . Because the alpha(2 ) subunit of the GABA(A ) receptor is preferentially localized at pyramidal neuron AIS , we quantified alpha(2 ) subunit immunoreactive AIS in tissue sections containing prefrontal cortex area 46 from 14 matched triads of subjects with schizophrenia , subjects with major depression and control subjects . Systematic , r and om sampling revealed that the mean number of alpha(2)-labeled AIS per mm(2 ) in subjects with schizophrenia was significantly ( P = 0.007 ) increased by 113 % compared to control subjects and non-significantly increased compared to subjects with major depression . Furthermore , within subjects with schizophrenia , the density of alpha(2)-labeled AIS was negatively correlated ( r = -0.49 , P = 0.038 ) with the density of ch and elier axon terminals immunoreactive for the GABA membrane transporter . These data suggest that GABA(A ) receptors are up-regulated at pyramidal neuron AIS in response to deficient GABA neuro-transmission at ch and elier axon terminals in schizophrenia . Thus , disturbances in inhibition at the ch and elier neuron-pyramidal neuron synapse may be a critical component of prefrontal cortical dysfunction in schizophrenia BACKGROUND The role of the inhibitory neurotransmitter gamma aminobutyric acid ( GABA ) in schizophrenia has previously been investigated using postmortem material . Recently , using single photon emission tomography ( SPET ) with the selective benzodiazepine antagonist 123I-Iomazenil as the radiolig and , we have demonstrated an in vivo relationship between reduced GABAA/benzodiazepine receptor binding and the severity of positive symptomatology in schizophrenia . The present study aim ed to build on this using the same in vivo scanning techniques , and relating findings to cognitive functioning . METHODS Ten nonpsychiatric control subjects and 15 schizophrenic patients , matched for age and h and edness , were scanned . A battery of neuropsychologic tests was also administered . RESULTS Correlational analysis revealed a pattern of increased correlations between GABAA/benzodiazepine receptor binding and task performance , in the schizophrenic group compared to the control group . CONCLUSIONS Findings are preliminary but suggest a relationship between reduced GABAA/benzodiazepine receptor binding and poorer cognitive functioning , involving memory and visual attention processes , in the schizophrenic group but not in the control group . A role for GABA in the pathophysiology of schizophrenia is suggested . Limitations of the present study and suggestions for future research are discussed
Output:
| There were insufficient PET/SPECT receptor availability studies for meta-analyses , but a systematic review did not suggest replicable group differences in regional GABAA/BZR availability .
The current literature does not reveal consistent alterations in in vivo GABA neuroimaging measures in schizophrenia , as might be hypothesized from animal models and postmortem data . |
MS211949 | ***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 a matrix for determining the predominant type , cause category , and rate of medication prescribing errors , and to explore the effectiveness of hospital-based improvement initiatives among pediatric intensive care units ( PICUs ) . Design This study involved the prospect i ve identification of medication errors for categorization and evaluation by using a matrix methodology . A pretest-posttest design without a control group was used to explore the impact of initiatives employed to reduce medication error rates and severity . Setting PICUs in nine freest and ing , collaborating tertiary care children ’s hospitals that participated in both baseline and postintervention analyses . Methods We evaluated 12,026 PICU medication orders at baseline and 9,187 orders postintervention for prescribing errors , excluding resuscitation orders . A st and ardized tool and process captured error type , cause category , and severity for 2 wks before and after intervention . Three levels of error detection were used and included pharmacy order entry , PICU nurse order transcription , and team-based overview . Site-specific interventions were implemented , which included predominantly provider education as well as informational ( 47 % ) and dosing “ assists ” via preprinted orders , forcing functions , or prompts ( 39 % ) . Results Of baseline orders , 11.1 % had at least one prescribing error . The interception of prescribing errors improved 30.9 % ( 1.6 % of all orders at baseline , 2.0 % post intervention ) . Preventable adverse drug events were uncommon ( 0.6 % of all medication errors ) and of low severity at baseline ; most were wrong dose errors . The implementation of improvement initiatives , specific for each facility , result ed in a 31.6 % reduction in prescribing errors from 11.1 % to 7.6 % . However , site results varied considerably . Conclusions A benchmark for medication prescribing errors in the PICU was identified among nine children ’s hospitals . The methodology was successful in accounting for site-specific differences with regard to identifying and documenting errors as well as reporting results of improvement initiatives . Furthermore , the methodology employed was generalizable in the identification of predominant prescribing error types , which helped to track individual hospital improvement initiative development and implementation . Overall improvement in prescribing error rates was noted ; however , considerable variation in the success of improvement initiatives was noted and bears further attention BACKGROUND The adherence to evidence -based treatment guidelines for acute myocardial infa rct ion ( AMI ) is still suboptimal . Therefore , we design ed a study to evaluate the effects of a collaborative quality improvement ( QI ) intervention on the adherence to AMI guidelines . The intervention used a national web-based quality registry to generate local and regular real-time performance feedback . METHODS A 12-month baseline measurement of the adherence rates was retrospectively collected , comprising the period July 1 , 2001 , through June 30 , 2002 . During the intervention period of November 1 , 2002 , through April 30 , 2003 , multidisciplinary teams from 19 nonr and omized intervention hospitals were subjected to a multifaceted QI-oriented intervention . Another 19 hospitals , unaware of their status as controls , were matched to the intervention hospitals . During the postintervention measurement period of May 1 , 2003 , through April 30 , 2004 , a total of 6726 consecutive patients were included at the intervention ( n = 3786 ) and control ( n = 2940 ) hospitals . The outcome measures comprised 5 Swedish national guideline -derived quality indicators , compared between baseline and postintervention levels in the control and QUICC intervention hospitals . RESULTS In the control and QI intervention hospitals , the mean absolute increase of patients receiving angiotensin-converting enzyme inhibitors was 1.4 % vs 12.6 % ( P = .002 ) , lipid-lowering therapy 2.3 % vs 7.2 % ( P = .065 ) , clopidogrel 26.3 % vs 41.2 % ( P = .010 ) , heparin/low-molecular weight heparin 5.3 % vs 16.3 % ( P = .010 ) , and coronary angiography 6.2 % vs 16.8 % ( P = .027 ) , respectively . The number of QI intervention hospitals reaching a treatment level of at least 70 % in 4 or 5 of the 5 indicators was 15 and 5 , respectively . In the control group , no hospital reached 70 % or more in just 4 of the 5 indicators . CONCLUSIONS By combining a systematic and multidisciplinary QI collaborative with a web-based national quality registry with functionality allowing real-time performance feedback , major improvements in the adherence to national AMI guidelines can be achieved Abstract Objective To test a multifaceted collaborative quality improvement intervention design ed to promote evidence based surfactant treatment for preterm infants of 23 - 29 weeks ' gestation . Design Cluster r and omised controlled trial Setting and participants 114 neonatal intensive care units ( which treated 6039 infants of 23 - 29 weeks gestation born in 2001 ) . Main outcome measures Process of care measures : proportion of infants receiving first surfactant in the delivery room , proportion receiving first surfactant more than two hours after birth , and median time from birth to first dose of surfactant . Clinical outcomes : death before discharge home , and pneumothorax . Intervention Multifaceted collaborative quality improvement advice including audit and feedback , evidence review s , an interactive training workshop , and ongoing faculty support via conference calls and email . Results Compared with those in control hospitals , infants in intervention hospitals were more likely to receive surfactant in the delivery room ( adjusted odds ratio 5.38 ( 95 % confidence interval 2.84 to 10.20 ) ) , were less likely to receive the first dose more than two hours after birth ( adjusted odds ratio 0.35 ( 0.24 to 0.53 ) ) , and received the first dose of surfactant sooner after birth ( median of 21 minutes v 78 minutes , P < 0.001 ) . The intervention effect on timing of surfactant was larger for infants born in the participating hospitals than for infants transferred to a participating hospital after birth . There were no significant differences in mortality or pneumothorax . Conclusion A multifaceted intervention including audit and feedback , evidence review s , quality improvement training , and follow up support changed the behaviour of health professionals and promoted evidence based practice OBJECTIVES In August 1993 a group of house staff and nursing staff at MetroHealth Medical Center formed a quality improvement team to evaluate the process of medical care on the inpatient wards . Using st and ard continuous quality improvement ( CQI ) methods , a team of medical interns , nurses , and other health professionals involved in patient care on the medicine inpatient service design ed interdisciplinary , daily work rounds to improve the care of patients on the inpatient wards . METHODS The authors conducted a r and omized , controlled firm trial of the impact of interdisciplinary rounds on the inpatient medicine services . The trial lasted 6 months ( November 1993-April 1994 ) and included 1,102 admissions r and omly assigned to experimental or control teams by the pre-existing firm system . Of the 1,102 admissions included in the study , 535 were r and omized to medical services with traditional rounds and 567 to medical services with interdisciplinary rounds . The outcomes studied included length of stay ( LOS ) , total hospital charges , provider satisfaction , and ancillary service efficiency . RESULTS Unadjusted analysis for log-transformed data showed lower length of stay and total charges for the interdisciplinary group . The mean LOS for interdisciplinary rounds was 5.46 days , compared with 6.06 days for traditional care ( P = 0.006 ) , whereas mean total charges were $ 6,681 and $ 8,090 ( P = 0.002 ) for the two groups , respectively . After multivariate regression analysis using a propensity score that included gender , age , marital status , admission source , diagnosis-related group ( DRG ) weight , and primary diagnosis by International Classification of Diseases , Ninth Revision ( ICD-9 ) cluster , these differences remained statistically significant . CONCLUSIONS Previous studies of interdisciplinary teams have failed to show statistically significant cost savings . This study involving more patients shows both cost and LOS decreases with the use of interdisciplinary teams . At the end of the 6-month trial , interdisciplinary rounds were instituted on all medicine inpatient services Background : Research into adverse events ( AEs ) has highlighted the need to improve patient safety . AEs are unintended injuries or complications result ing in death , disability or prolonged hospital stay that arise from health care management . We estimated the incidence of AEs among patients in Canadian acute care hospitals . Methods : We r and omly selected 1 teaching , 1 large community and 2 small community hospitals in each of 5 provinces ( British Columbia , Alberta , Ontario , Quebec and Nova Scotia ) and review ed a r and om sample of charts for nonpsychiatric , nonobstetric adult patients in each hospital for the fiscal year 2000 . Trained review ers screened all eligible charts , and physicians review ed the positively screened charts to identify AEs and determine their preventability . Results : At least 1 screening criterion was identified in 1527 ( 40.8 % ) of 3745 charts . The physician review ers identified AEs in 255 of the charts . After adjustment for the sampling strategy , the AE rate was 7.5 per 100 hospital admissions ( 95 % confidence interval [ CI ] 5.7– 9.3 ) . Among the patients with AEs , events judged to be preventable occurred in 36.9 % ( 95 % CI 32.0%–41.8 % ) and death in 20.8 % ( 95 % CI 7.8%–33.8 % ) . Physician review ers estimated that 1521 additional hospital days were associated with AEs . Although men and women experienced equal rates of AEs , patients who had AEs were significantly older than those who did not ( mean age [ and st and ard deviation ] 64.9 [ 16.7 ] v. 62.0 [ 18.4 ] years ; p = 0.016 ) . Interpretation : The overall incidence rate of AEs of 7.5 % in our study suggests that , of the almost 2.5 million annual hospital admissions in Canada similar to the type studied , about 185 000 are associated with an AE and close to 70 000 of these are potentially preventable In an era of chronic re source scarcity it is critical that quality improvement professionals have confidence that their project activities cause measured change . A commonly used research design , the single group pre-test/post-test design , provides little insight into whether quality improvement interventions cause measured outcomes . A re-evaluation of a quality improvement programme design ed to reduce the percentage of bilateral cardiac catheterisations for the period from January 1991 to October 1996 in three catheterisation laboratories in a north eastern state in the USA was performed using an interrupted time series design with switching replications . The accuracy and causal interpretability of the findings were considerably improved compared with the original evaluation design . Moreover , the re-evaluation provided tangible evidence in support of the suggestion that more rigorous design s can and should be more widely employed to improve the causal interpretability of quality improvement efforts . Evaluation design s for quality improvement projects should be constructed to provide a reasonable opportunity , given available time and re sources , for causal interpretation of the results . Evaluators of quality improvement initiatives may infrequently have access to r and omised design s. Nonetheless , as shown here , other very rigorous research design s are available for improving causal interpretability . Unilateral method ological surrender need not be the only alternative to r and omised experiments BACKGROUND Brigham and Women 's Hospital , in Boston , and its major health maintenance organization ( HMO ) , Harvard Community Health Plan , collected data in spring 1994 which revealed that patients were less satisfied with hospital discharge planning than with other elements of care . PROBLEM IDENTIFICATION PROCESS An interdisciplinary team , formed in November 1994 and composed of eight members from the hospital and HMO , used data from the hospital 's Patient Satisfaction Survey , flowcharting , and phone interviews with patients to identify discharge planning-related problems . For example , follow-up contact with patients after discharge was erratic and no clear signal of the successful " h and off " of care from the hospital team to the community team existed . IMPROVEMENT CYCLE 1 Eighty-three percent of the payer 's patients that received the improvement strategy developed by the interdisciplinary team-a concierge service-rated discharge planning as excellent or very good , compared to 63 % of control patients . IMPROVEMENT CYCLE 2 : PLAN SOLUTIONS/STRATEGIES FOR IMPROVING HOSPITAL DISCHARGE PLANNING : The results of the team 's Cycle 1 improvement provided information for the team to use in design ing a second cycle of incremental improvement activity . For example , to address the lack of clarity about who was responsible for making decisions about discharge and follow-up care , the attending physician was design ated the transition-of-care coordinator . Once all the improvements were implemented , Cycle 2 patients who received the intervention rated satisfaction with discharge higher ( 83 % versus 73 % ) than the control group . CONCLUSIONS Implication s of hospitalwide implementation of discharge planning-related services attempted on one unit are being considered OBJECTIVE To determine the effects of hospital quality assurance interventions on compliance with clinical st and ards , availability of essential drugs , client satisfaction , and utilization . DESIGN Quasi-experimental , prospect i ve study with four intervention hospitals
Output:
| Findings revealed limited information about attributes of successful and unsuccessful team initiatives , barriers and facilitators to team initiatives , unique or combined contribution of selected interventions , or how to effectively establish these teams .
Conclusions Not unlike systematic review s of quality improvement collaboratives , this broad review revealed that while teams reported a number of positive results , there are many method ological issues . |
MS211950 | ***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: PGD ( preimplantation genetic diagnosis ) of aneuploidy for chromosomes X , Y , 13 , 18 and 21 was carried out on 196 embryos from 36 infertile patients classified with a poor prognosis due to ( i ) maternal age , ( ii ) repeated in-vitro fertilization ( IVF ) failures and ( iii ) mosaic karyotype . The percentage of abnormal embryos was comparable in the three groups of patients : maternal age 63 % , repeated IVF failure 57 % , and mosaic karyotype 62 % . The analysis of the overall data revealed an increased incidence of abnormal embryos in the older age categories ( predominantly due to aneuploidy ) , even in embryos at the 7- to 8-cell stage . In addition , the percentage of chromosomally abnormal embryos was directly proportional to the number of IVF failures , where the increase in chromosomal abnormalities was not correlated to aneuploidy but to other aberrations such as mosaicism and polyploidy . Following PGD , 28 patients had at least one embryo transferred that appeared normal by fluorescent in-situ hybridization ( FISH ) . Four clinical pregnancies result ed , with an implantation rate of 10 % per normal embryo . In conclusion , the high rate of chromosomally abnormal embryos in poor prognosis patients may have been the cause of implantation failure in their previous IVF cycles . Therefore , the possibility of transferring embryos with a normal FISH complement could improve the chance of pregnancy in this category of patients OBJECTIVE To assess the potential benefit of preimplantation aneuploidy testing on the outcome of in vitro fertilization ( IVF ) for women of advanced maternal age ( AMA ) . DESIGN Prospect i ve r and omized clinical trial . SETTING Private IVF clinic . PATIENT(S ) Sixty-two infertile AMA couples undergoing fertility treatment . INTERVENTION(S ) Fluorescent in situ hybridization ( FISH ) for chromosomes X , Y , 13 , 15 , 16 , 17 , 18 , 21 , and 22 . MAIN OUTCOME MEASURE(S ) Preimplantation aneuploidy testing of biopsied blastomeres on day 3 of development . RESULT ( S ) Fertilization and blastocyst developmental rates were similar for the test and control groups : 80 % versus 77.4 % and 49 % versus 48.2 % , respectively . The average number of embryos transferred was comparable at 2.2 for the test group and 2.7 for the control group . Implantation rates were also equivalent across the two groups : 37.3 % in the control group versus 36.5 % in the test group . Nevertheless , the spontaneous abortion rate was observed to be lower for the test group : 25.9 % versus 32.26 % in the control group . This result ed in an observed increase in delivery rates for the test group : 78 % versus 67.74 % in the control group . CONCLUSION ( S ) Preimplantation aneuploidy testing does not appear to statistically significantly improve outcome parameters in infertile AMA patients ; however , a trend toward a decrease in the spontaneous abortion rate with a subsequent higher delivery rate was observed BACKGROUND Single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies in an assisted reproductive technology ( ART ) programme . Besides the morphological quality and embryo kinetics up to the blastocyst stage , preimplantation genetic screening ( PGS ) of aneuploidy has been advocated as an adjuvant approach to select the embryo . METHODS Couples with a female partner younger than 36 were r and omly assigned to undergo transfer of a single blastocyst in a cycle with or without PGS using FISH for the chromosomes X , Y , 13 , 16 , 18 , 21 , 22 . RESULTS After the enrolment of 120 of the projected 447 patients in each group , study recruitment was terminated prematurely on the basis of futility . The observed live birth delivery rates after ART were 30.8 versus 30.8 % per r and omized patient , 34.6 versus 34.6 % per cycle initiated , 37.8 versus 37.0 % per aspirated cycle and 41.6 versus 43.5 % per embryo transfer for the control versus the PGS group , respectively , with absolute between-group differences ( 95 % CI ; P value ) of 0 % ( -11.7 to 11.7 ; P = 1.00 ) , 0 % ( -12.7 to 12.7 ; P = 1.00 ) , -0.8 % ( -14.2 to 12.7 ; P = 0.91 ) and 2.1 % ( -12.7 to 16.7 ; P = 0.79 ) , respectively . Even in this younger age group , only 61 % of the embryos had a normal diploid status . CONCLUSIONS The absence of a beneficial treatment effect in this r and omized clinical trial provides no arguments in favour of PGS to improve live birth delivery rate following single-embryo transfer in women under the age 36 . Clinical Trials.gov : NCT00670059 BACKGROUND The data are compiled from two multicentre , prospect ively r and omized studies on the effect of follicular fluid meiosis-activating sterol ( FF-MAS ) on human oocytes . The donated oocytes were exposed either to test doses of FF-MAS or to control solutions . The data from the control groups are presented with chromosomal status of the embryos correlated to embryo morphology . METHODS The study includes 144 r and omly selected donated human oocytes . The nucleus from each blastomere was fixed separately and fluorescence in-situ hybridization ( FISH ) using seven probes ( 13 , 16 , 18 , 21 , 22 , X and Y ) was performed . RESULTS Analysis of 103 pre-embryos containing 479 blastomeres result ed in 424 blastomeres with clear FISH signals . Of these blastomeres , 55 % were normal diploid and 45 % were abnormal . At a pre-embryonic level , 53 % were classified as normal containing > or=50 % normal blastomeres while 31 % of the pre-embryos were classified as uniformly normal . Abnormality rate was significantly increased in the pre-embryos with unevenly sized blastomeres and with increasing degree of fragmentation at 68 h after fertilization . Applying criteria for good embryo quality significantly increased the rate of chromosomally normal pre-embryos from 53 to 75 % . CONCLUSIONS The data demonstrate the high degree of genetic heterogeneity in a r and omly selected pool of donated pre-embryos from an IVF programme . Further , we found that uniformity of blastomere size , degree of fragmentation and cleavage kinetics reflect the cytogenetic status of the pre-embryo and are therefore important in the selection of pre-embryos OBJECTIVE To select chromosomally euploid embryos for transfer by analyzing single biopsied blastomeres using either fluorescence in situ hybridization ( FISH ) for chromosomes 13 , 16 , 18 , 21 , and 22 or comparative genomic hybridization ( CGH ) , which provides a full karyotype . DESIGN Prospect i ve observational study . SETTING A large IVF unit and the research laboratory of a hospital clinical genetics unit . PATIENT(S ) Twenty patients with recurrent implantation failure . INTERVENTION(S ) Ovarian stimulation and IVF by intracytoplasmic sperm injection ( ICSI ) , embryo biopsy , and embryo transfer . MAIN OUTCOME MEASURE(S ) Chromosome normality of biopsied blastomeres and implantation and clinical pregnancy rates . RESULT ( S ) Comparative genomic hybridization was able to identify many chromosomal abnormalities that would have been missed if those cells had been analyzed by FISH . The clinical pregnancy rate per transfer and implantation rate was 11 % and 7 % for embryos analyzed by FISH and 21 % and 15 % for embryos analyzed by CGH . CONCLUSION ( S ) Comparative genomic hybridization is more effective than FISH for identifying chromosomally normal embryos , which may result in a higher clinical pregnancy rate and implantation rate after embryo transfer BACKGROUND It is generally accepted that the age-related increased aneuploidy rate is correlated with reduced implantation and a higher abortion rate . Therefore , advanced maternal age ( AMA ) couples are a good target group to assess the possible benefit of preimplantation genetic diagnosis for aneuploidy screening ( PGD-AS ) on the outcome after assisted reproductive technology ( ART ) . METHODS A prospect i ve r and omized controlled clinical trial ( RCT ) was carried out comparing the outcome after blastocyst transfer combined with PGD-AS using fluorescence in situ hybridization ( FISH ) for the chromosomes X , Y , 13 , 16 , 18 , 21 and 22 in AMA couples ( aged > or = 37 years ) with a control group without PGD-AS . From the 400 ( 200 for PGD-AS and 200 controls ) couples that were allocated to the trial , an oocyte pick-up was performed effectively in 289 cycles ( 148 PGD-AS cycles and 141 control cycles ) . RESULTS Positive serum HCG rates per transfer and per cycle were the same for PGD-AS and controls : 35.8 % ( 19.6 % ) [ % /per embryo transfer ( per cycle ) ] and 32.2 % ( 27.7 % ) , respectively ( NS ) . Significantly fewer embryos were transferred in the PGD-AS group than in the control group ( P<0.001 ) . The implantation rate ( with fetal heart beat ) was 17.1 % in the PGD-AS group versus 11.5 % in the control group ( not significant ; P=0.09 ) . We observed a normal diploid status in 36.8 % of the embryos . CONCLUSIONS This RCT provides no arguments in favour of PGD-AS for improving clinical outcome per initiated cycle in patients with AMA when there are no restrictions in the number of embryos to be transferred Blastocysts more commonly have a normal karyotype than cleavage-stage embryos do . Moreover , blastocysts have also made a metabolic transition from catabolism and recycling of the oocyte 's reserves and re sources , processes that fuel the first 3 days of cleavage . Although not all blastocysts are karyotypically equal , it is still to be determined to what extent a mosaic karyotype might be a normal feature among embryos , both at the cleavage stage and the blastocyst stage-- and when looking for karyotypic abnormalities by embryo biopsy might help the chance of implantation rather than harm it . It is also still impractical to look at all the chromosomes that can , through their aneuploidy , st and in the way of successful embryonic and fetal development . We report a r and omized clinical trial of blastocyst biopsy followed by preimplantation genetic screening ( PGS ) for aneuploidy using 5-colour FISH . The trial was suspended and then terminated early when we were unable to show an advantage for PGS . If we are correct in assuming that mitotic non-disjunction is common by the stage of the blastocyst ( and that it is much less ominous than meiotic non-disjunction ) , then further studies of effective PGS of blastocysts for aneuploidy require methods of analysis that cover all the chromosomes and can differentiate the triallelic and monoallelic states of meiotically derived aneuploidies from the biallelic state of mitotic aneuploidies OBJECTIVE The purpose of this study was to determine the positive predictive value ( PPV ) and negative predictive value ( NPV ) of FISH analysis and to determine which chromosomal abnormalities are most frequently confirmed . DESIGN Prospect i ve observational . SETTING IVF laboratory . PATIENT(S ) Two hundred forty-one embryos were analyzed from 98 patients . INTERVENTION(S ) FISH re analysis . MAIN OUTCOME MEASURE(S ) Embryos that would have been discarded in patients undergoing preimplantation genetic diagnosis ( PGD ) were fixed and FISH re analysis was performed . Results of re analysis were compared with the day 3 diagnosis while PPV and NPV were calculated . RESULT ( S ) Among the 241 embryos , 198 embryos were abnormal and 43 were normal by day 3 FISH analysis . The PPV was 83 % and the NPV was 81 % . PPV was also determined for specific categories of aneuploidy , and certain abnormalities such as monosomies , trisomies , tetrasomies , and polyploidies were frequently confirmed on re analysis ( PPV > 80 % ) , whereas Turner syndrome diagnosis was not ( PPV = 17 % ) . CONCLUSION ( S ) FISH analysis offers a PPV of 83 % and NPV of 81 % when evaluating a single blastomere in conjunction with PGD . FISH errors and mosaicism are primarily responsible for
Output:
| Discussion With currently available technology , and taking into account the number of embryos to be transferred , the clinical validity of PGS-FISH , although superior to that of morphological criteria , does not appear to be clinical ly relevant |
MS211951 | ***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: Schnitzler syndrome is a rare plasma cell disorder the pathogenesis of which is still not fully understood . We evaluated the circulating levels of four major angiogenic cytokines ( VEGF , angiogenin , angiopoietin-1 and angiopoietin-2 ) and six bone remodeling markers ( sRANKL , osteoprotegerin , dickkopf-1 , CTX , osteocalcin and bone-specific alkaline phosphatase-bALP ) in 13 patients with Schnitzler syndrome . At diagnosis , patients had elevated angiogenic cytokines . The mean VEGF levels were almost 3.5-fold higher in Schnitzler syndrome compared to controls , while 10 of 13 patients had higher VEGF than the upper control value . Successful treatment led to a significant reduction in VEGF . Patients with Schnitzler syndrome had increased bone formation ( high bALP , osteocalcin and osteoprotegerin ) which was not balanced by an increase in bone resorption ( normal CTX and sRANKL ) . These data support a role for VEGF as a new minor criterion in the diagnosis and follow up of Schnitzler syndrome , while the uncoupling of bone remodeling in favor of bone formation justifies the presence of bone densification More than half of all cases of preeclampsia occur in healthy first-time pregnant women . Our aim was to develop a method to predict those at risk by combining clinical factors and measurements of biomarkers in women recruited to the Screening for Pregnancy Endpoints ( SCOPE ) study of low-risk nulliparous women . Forty-seven biomarkers identified on the basis of ( 1 ) association with preeclampsia , ( 2 ) a biological role in placentation , or ( 3 ) a role in cellular mechanisms involved in the pathogenesis of preeclampsia were measured in plasma sample d at 14 to 16 weeks ’ gestation from 5623 women . The cohort was r and omly divided into training ( n=3747 ) and validation ( n=1876 ) cohorts . Preeclampsia developed in 278 ( 4.9 % ) women , of whom 28 ( 0.5 % ) developed early-onset preeclampsia . The final model for the prediction of preeclampsia included placental growth factor , mean arterial pressure , and body mass index at 14 to 16 weeks ’ gestation , the consumption of ≥3 pieces of fruit per day , and mean uterine artery resistance index . The area under the receiver operator curve ( 95 % confidence interval ) for this model in training and validation cohorts was 0.73 ( 0.70–0.77 ) and 0.68 ( 0.63–0.74 ) , respectively . A predictive model of early-onset preeclampsia included angiogenin/placental growth factor as a ratio , mean arterial pressure , any pregnancy loss < 10 weeks , and mean uterine artery resistance index ( area under the receiver operator curve [ 95 % confidence interval ] in training and validation cohorts , 0.89 [ 0.78–1.0 ] and 0.78 [ 0.58–0.99 ] , respectively ) . Neither model included pregnancy-associated plasma protein A , previously reported to predict preeclampsia in population s of mixed parity and risk . In nulliparous women , combining multiple biomarkers and clinical data provided modest prediction of preeclampsia Aim /hypothesisLeptin has been shown to regulate angiogenesis in animal and in vitro studies by upregulating the production of several pro-angiogenic factors , but its role in regulating angiogenesis has never been studied in humans . Methods The potential angiogenic effect of two doses of metreleptin ( 50 and 100 ng/ml ) was evaluated in vitro , using a novel three-dimensional angiogenesis assay . Fifteen healthy , normoleptinaemic volunteers were administered both a physiological ( 0.1 mg/kg ) and a pharmacological ( 0.3 mg/kg ) single dose of metreleptin , in vivo , on two different inpatient admissions separated by 1–12 weeks . Serum was collected at 0 , 6 , 12 and 24 h after metreleptin administration . Twenty lean women , with leptin levels < 5 ng/ml , were r and omised in a 1:1 fashion to receive either physiological replacement doses of metreleptin ( 0.04–0.12 mg/kg q.d . ) or placebo for 32 weeks . Serum was collected at 0 , 8 , 20 and 32 weeks after r and omisation . Proteomic angiogenesis array analysis was performed to screen for angiogenic factors . Circulating concentrations of angiogenin , angiopoietin-1 , platelet derived endothelial factor (PDGF)-AA , matrix metalloproteinase ( MMP ) 8 and 9 , endothelial growth factor ( EGF ) and vascular EGF ( VEGF ) were also measured . Results Both metreleptin doses failed to induce angiogenesis in the in vitro model . Although leptin levels increased significantly in response to both short-term and long-term metreleptin administration , circulating concentrations of angiogenesis markers did not change significantly in vivo . Conclusions /interpretationsThis is the first study that examines the effect of metreleptin administration in angiogenesis in humans . Metreleptin administration does not regulate circulating angiogenesis related factors in humans . Clinical trial registration : Clinical Trials.gov NCT00140205 and NCT00130117 . Funding : This study was supported by National Institutes of Health-National Center for Research Re sources grant M01-RR-01032 ( Harvard Clinical and Translational Science Center ) and grant number UL1 RR025758 . Funding was also received from the National Institute of Diabetes and Digestive and Kidney Diseases grants 58785 , 79929 and 81913 , and AG032030 PURPOSE Accurate urine assays for bladder cancer detection would benefit patients and health care systems . Through extensive genomic and proteomic profiling of urine components we previously identified a panel of 8 biomarkers that can facilitate the detection of bladder cancer in voided urine sample s. In this study we confirmed this diagnostic molecular signature in a diverse multicenter cohort . MATERIAL S AND METHODS We performed a case-control , phase II study in which we analyzed voided urine from 102 subjects with bladder cancer and 206 with varying urological disorders . The urinary concentration of 8 biomarkers ( IL-8 , MMP-9 and 10 , PAI-1 , VEGF , ANG , CA9 and APOE ) was assessed by enzyme-linked immunosorbent assay . Diagnostic performance of the panel of tested biomarkers was evaluated using ROCs and descriptive statistical values , eg sensitivity and specificity . RESULTS Seven of the 8 urine biomarkers were increased in subjects with bladder cancer relative to those without bladder cancer . The 7 biomarkers were assessed in a new model , which had an AUROC of 0.88 ( 95 % CI 0.84 - 0.93 ) , and 74 % sensitivity and 90 % specificity . In contrast , the sensitivity of voided urine cytology and the UroVysion ® cytogenetic test in this cohort was 39 % and 54 % , respectively . Study limitations include analysis performed on banked urine sample s and the lack of voided urine cytology and cytogenetic test data on controls . CONCLUSIONS The study provides further evidence that the reported panel of diagnostic biomarkers can reliably achieve the noninvasive detection of bladder cancer with higher sensitivity than currently available urine based assays OBJECTIVE To investigate whether elevated urinary levels of vascular endothelial growth factor ( VEGF ) , carbonic anhydrase 9 ( CA9 ) , and angiogenin are associated with bladder cancer ( BCa ) . METHODS This was a case-control study in which voided urine sample s from 127 patients ( 63 control subjects and 64 patients with BCa ) were analyzed . The urinary concentrations of VEGF , CA9 , angiogenin , and bladder tumor antigen ( BTA ) were assessed using enzyme-linked immunosorbent assays . We used the area under the curve of receiver operating characteristic curves to determine the ability of VEGF , CA9 , and angiogenin to detect BCa in voided urine sample s. Data were also compared with the findings from a commercial enzyme-linked immunosorbent assay-based BCa detection assay ( BTA-Trak ) . The sensitivity , specificity , and positive and negative predictive values were calculated . RESULTS The urinary concentrations of VEGF , CA9 , angiogenin , and BTA were significantly elevated in those with BCa . VEGF was the most accurate urinary biomarker ( area under the curve 0.886 , 95 % confidence interval 0.8301 - 0.9418 ) . Furthermore , multivariate regression analysis highlighted VEGF ( odds ratio 5.90 , 95 % confidence interval 2.60 - 13.40 , P < .0001 ) as an independent variable . The sensitivity and specificity for VEGF ( 83 % sensitivity and 87 % specificity ) outperformed those for BTA ( 80 % sensitivity and 84 % specificity ) . CONCLUSION VEGF could be a valuable addition to voided urine sample analysis for the detection of BCa . Larger , prospect i ve studies are needed to determine the clinical utility of urinary VEGF and angiogenin as biomarkers in the noninvasive evaluation of patients with BCa OBJECTIVE Angiogenin ( ANG ) , a potent inducer of neovascularization , is secreted by some types of human tumor cells and appears crucial for their growth . This study was design ed with the aim to investigate any correlation between the serum angiogenin and the clinicopathological variables and furthermore evaluate the prognostic value of serum angiogenin in patients with breast cancer . MATERIAL AND METHODS Sixty-four consecutive patients with invasive breast cancer undergoing surgery were prospect ively included and evaluated . Venous blood sample s were collected before surgery . Sera were obtained by centrifugation and stored at -70 degrees C until assayed . The control group consisted of 16 patients with benign breast tumor ( 8 with fibrocystic disease and 8 with fibroadenoma ) . Serum concentration of angiogenin was measured by the quantitative s and wich enzyme immunoassay technique . The data on primary tumor staging , age , estrogen receptor , lymph node status , distant metastases and TNM staging were review ed and recorded . RESULTS The mean value of serum angiogenin in patients with invasive breast cancer was 2123.95 + /- 324.34 pg/ml and that of control group were 2108.16 + /- 398.20 pg/ml ( fibrocystic disease ) and 2010.27 + /- 318.40 pg/ml ( fibroadenoma ) . The difference was not significant ( p = 0.66 ) . Furthermore , with univariate analysis , there were no significant differences in serum angiogenin levels between the subgroups of the above-mentioned clinicopathological variables . CONCLUSION Serum angiogenin levels did not appear as a meaningful prognostic parameter for invasive breast cancer OBJECTIVE Our purpose was to compare angiogenin , lactate dehydrogenase ( LDH ) and fibronectin levels in mid-trimester amniotic fluid of patients with preterm and term deliveries and to find out their predictive values for preterm birth . STUDY DESIGN A prospect i ve cohort study was conducted in 55 pregnancies with singleton gestations that underwent amniocentesis at 15 - 20 weeks for st and ard genetic indications . Amniotic fluid angiogenin , lactate dehydrogenase and fibronectin levels were measured by enzyme-linked immunosorbent assay ( ELISA ) , radial immundiffusion technic and automated analyzer , respectively . RESULTS Five patients delivered preterm , five developed signs or symptoms of threatened preterm labor and 45 had term delivery after an uneventful pregnancy . Demographic data were not significantly different . Amniotic fluid angiogenin and lactate dehydrogenase levels were significantly higher in patients with preterm than term deliveries ( P<0.001 and 0.02 , respectively ) . Receiver-operator characteristic curve analysis showed that the amniotic fluid angiogenin had the best screening efficiency in predicting preterm delivery . An angiogenin level of 35ng/ml was the optimal cut-off value for the prediction of preterm delivery , with a sensitivity of 100 % and specificity of 91 % . CONCLUSION Second-trimester angiogenin is found to be quite effective in the prediction of preterm delivery . Preexisting intrauterine ischemia may be an important risk factor for preterm delivery and already be present in the early mid-trimester OBJECTIVE To investigate the role of the angiogenic factors , vascular endothelial growth factor ( VEGF ) and angiogenin in the pathophysiology of preeclampsia and how their concentrations correlate with the severity of the disease and fetal outcome . PATIENTS AND METHODS A prospect i ve study was carried out on 71 pregnant patients with preeclampsia and 20 pregnant normotensive controls . Maternal serum levels of VEGF and angiogenin were determined in all cases by enzyme imm
Output:
| We noted no significant differences in serum ANG levels between patients and healthy controls , except in cases in which patients suffered from cancer or cardiovascular diseases .
The serum ANG concentrations were significantly higher in patients who developed colorectal cancer , acute myeloid leukemia , multiple myeloma , myelodysplastic syndromes , and heart failure than those in healthy controls .
Conclusion ANG has the potential of being a serum biomarker for cancers and cardiovascular diseases |
MS211952 | ***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 Spin represents specific reporting strategies , either intentional or unintentional , to convince the reader that the beneficial effect of the experimental intervention in terms of efficacy and safety is greater than that shown by the results . The objectives of this study were to 1 ) develop a classification of spin specific to non-r and omized studies assessing an intervention and 2 ) estimate the prevalence of spin in abstract s of reports of such studies . Methods In a first step , we developed a specific classification of spin for non-r and omized studies by a literature review and pilot study . In a second step , 2 research ers trained in the field of methodology evaluated the prevalence of spin in the abstract of all non-r and omized studies assessing an intervention published in the BioMed Central Medical Series journals between January 1 , 2011 and December 31 , 2013 . All disagreements were resolved by consensus . We also determined whether the level of spin in abstract conclusions was high ( spin reported without uncertainty or recommendations for further trials ) , moderate ( spin reported with some uncertainty or recommendations for further trials ) or low ( spin reported with uncertainty and recommendations for further trials ) . Results Among the 128 assessed articles assessed , 107 ( 84 % ) had at least one example of spin in their abstract . The most prevalent strategy of spin was the use of causal language , identified in 68 ( 53 % ) abstract s. Other frequent strategies were linguistic spin , inadequate implication s for clinical practice , and lack of focus on harm , identified in 33 ( 26 % ) , 25 ( 20 % ) , and 34 ( 27 % ) abstract s respectively . Abstract conclusions of 61 ( 48 % ) articles featured a high level of spin . Conclusion Abstract of reports of non-r and omized studies assessing an intervention frequently includes spin . Efforts to reduce the prevalence of spin in abstract for such studies are needed Publication of medical research has high stakes : the communication and legitimization of medical research , the advancement of authors ' careers , priorities in funding decisions , the direction of future research , and the visibility and prestige of journals themselves . Peer review and editing play central roles in the publication process , affecting the acceptance of a manuscript and the form in which it appears . The most commonly heard justification of peer review is that it is an indispensable aid to an editor in assessing the importance of a scientific question and in assessing how well that question has been answered [ 1 , 2 ] . However , it has also been criticized as being inherently conservative , censorial , and , perhaps worst of all , arbitrary [ 3 ] . A frequently heard charge is that peer review delays the dissemination of crucial medical information without commensurate benefit [ 4 - 7 ] . During the last several years , some medical journal editors decided that the value of peer- review and editing practice s should be examined with the same rigor dem and ed for testing medical hypotheses [ 8 , 9 ] . The First International Congress on Peer Review was organized in 1989 [ 10 ] , bringing together medical journal editors and other interested scholars to present and discuss research on peer review ; a second Congress was held in 1993 . The peer- review process has two components : the assessment s by external review ers and the decisions and actions taken by editors , which are partially affected by comments from the review ers . To our knowledge , no study has evaluated the effects of peer review and editing on manuscript quality once the decision to accept has been made , and a computerized search of Index Medicus back to 1966 failed to locate any such studies . In this paper , we present the results of such a study , assessing the change in a manuscript between the times of provisional acceptance and final publication . We studied whether the quality of accepted manuscripts was improved by peer- review and editorial processes and , if it was , which aspects were most improved . Methods Setting The study was conducted at the editorial offices of Annals of Internal Medicine . Annals , a specialty journal in internal medicine , is published twice monthly and has a circulation of approximately 100 000 . Annals receives approximately 2400 manuscripts annually , of which half are reports of original research . During the period of this study , the investigators included the editors of Annals ( RHF and SWF ) and a statistical associate editor ( SNG ) . The Review Process No change was noted in the usual review and editing procedures at Annals during the time of this study . All manuscripts received at Annals were initially review ed by one of two full-time editors or one of two half-time deputy editors , as well as by one of seven associate editors , all of whom are faculty members of medical schools in Philadelphia and have subspecialty interests ( for example , infectious disease , gastroenterology ) . Half of the su bmi ssions were returned to authors without further review and half were sent to at least 2 outside review ers , selected by the associate editor from a data base of about 7000 review ers . After comments from the review ers were received , the original editor and associate editor reassessed each manuscript and chose which ones would be discussed at a weekly editorial conference of editors , deputy editors , medical associate editors , and two statistical associate editors . Factors that affected acceptance decisions included the quality of the research , the importance of the question , the contribution of the finding to its field , the utility and interest for Annals readers , the quality of the presentation , the priority relative to other articles , and available space . Authors were notified either that the editors would not accept the paper , that the editors were willing to reconsider the paper after major revisions , or that the paper was provisionally accepted , pending satisfactory revision . Approximately one third of the articles evaluated by outside review ers were accepted , 15 % of su bmi tted original research articles . Papers to be considered further were sent to authors , along with the comments of the two outside review ers , comments of one of the statistical editors , and a letter from one of the editors or deputy editors ( which summarized the discussion at the weekly conference , the ideas of the associate editor , and suggestions from the editor ) . In addition , each manuscript was review ed by a production editor , and directions for changes in manuscript wording or layout of figures and tables were included . All revised manuscripts were review ed by the editor or deputy editor in charge of the manuscript , the appropriate associate editor , the statistical editor , and the production editor . Some revised manuscripts were also reassessed by the original outside review ers . Approximately half of the revised manuscripts were returned to authors for further revision . Most revised manuscripts ( > 95 % ) were ultimately published . The time taken by this process was approximately 2 weeks for the initial decision to review or reject , 8 additional weeks to review and make an acceptance decision , 8 weeks until final acceptance , and about 4 months until publication . More than 95 % of manuscripts su bmi tted to Annals had a provisional acceptance or rejection decision sent to the authors within 3 months . The average time from su bmi ssion to publication was about 7 months , with initial peer review accounting for approximately 6 weeks . Manuscript Selection and Study Design All original research manuscripts ( articles ) accepted for publication by Annals from March 1992 to March 1993 were entered into the study after obtaining the author 's consent . Commentaries , review s , expository pieces , editorials , and brief reports were not included . This study had a beforeafter design , in which two versions of each manuscript were evaluated : the version originally su bmi tted and the version sent to the printer for publication after all modifications based on peer review , editors ' comments , and copyediting . All before and after manuscripts were in electronic form and were reformatted to make the appearance of the two versions identical . Authors ' names and affiliations were removed . The design of the study was approved by the Institutional Review Board of the University of Pennsylvania School of Medicine . Definition of Quality Manuscript quality can be separated conceptually into two components : the quality of the research itself , and the quality of the research report . The quality of the research report was evaluated in this study . It was defined as follows on the cover sheet of the quality assessment instrument : Whether the authors have described their research in enough detail and with sufficient clarity so a reader could make an independent judgment about the strengths and weaknesses of their data and conclusions . Manuscript Quality Assessment Instrument A 34- question instrument was developed to structure the assessment of the quality of a manuscript ( Appendix ) . Items were derived from published checklists [ 11 - 14 ] , articles about the contents of journal articles [ 15 - 18 ] , the authors ' editorial experience , and the comments of journal editors and method ologists who review ed drafts of the instrument . Each question could be answered on a 5-point ordinal scale , where 1 was worst and 5 was best . The instrument was organized along the same dimensions as a st and ard journal article : Title and Abstract ( 2 items ) , Introduction ( 2 items ) , Methods ( 7 items ) , Results ( 15 items ) , Discussion and Conclusions ( 4 items ) , and General Evaluation ( 4 items ) . An additional question asked for a subjective assessment of the manuscript 's overall quality on a 10-point scale . The instrument differed from previously published quality scoring schemes in several ways . It was not a checklist but rather was a set of structured judgments , grade d ordinally , allowing users the discretion not to penalize a manuscript if a detail was omitted that was not critical to the study 's interpretation . Also , in keeping with the definition of quality given above , each question was about the adequacy of the reporting rather than the quality of the research itself . Assessment A panel of 44 physicians and epidemiologists with training in research methods and in critically assessing the medical literature was recruited to serve as an independent panel of expert assessors ( experts ) . They did not receive any formal training in the use of the assessment instrument , although general guidelines were given on the cover sheet ( Appendix ) . The panel was masked to the design and aims of the study ; they were told only that they were participating in a study of manuscript quality for Annals . Before and after versions of each manuscript were r and omly assigned to different experts to prevent the bias that might have been introduced if they could infer the design of the study and thereby which manuscript had been through the editorial process . Thirty-two manuscript versions were given to two or three experts to assess the reliability of the instrument ; all others were assessed by only one expert . Statistical Analyses The study was design ed to have 90 % power to detect a 0.5 unit change in average score , assuming a within-manuscript st and ard deviation of 1 scale unit , using = 0.05 . The main outcome measure was the percentage of items that were scored 3 or higher on the 5-point scales ( percentage score ) . The average of all score components ( average score ) was also analyzed . Linear regression was used to assess the effect of revision on each of these outcome measures , with terms controlling for manuscript and review er . Item-specific analyses were done on dichotomized item scores ( 0 for ratings 2 and 1 for ratings 3 ) . The change from before revision to after revision in individual items was statistically assessed with conditional logistic regression , which allowed for variable group Objective To investigate the effectiveness of open peer review as a mechanism to improve the reporting of r and omised trials published in biomedical journals . Design Retrospective before and after study . Setting BioMed Central series medical journals . Sample 93 primary reports of r and omised trials published in BMC -series medical journals in 2012 . Main outcome measures Changes to the reporting of method ological aspects of r and omised trials in manuscripts after peer review , based on the CONSORT checklist , corresponding peer review er reports , the type of changes requested , and the extent to which authors adhered to these requests . Results Of the 93 trial reports , 38 % ( n=35 ) did not describe the method of r and om sequence generation , 54 % ( n=50 ) concealment of allocation sequence , 50 % ( n=46 ) whether the study was blinded , 34 % ( n=32 ) the sample size calculation , 35 % ( n=33 ) specification of primary and secondary outcomes , 55 % ( n=51 ) results for the primary outcome , and 90 % ( n=84 ) details of the trial protocol . The number of changes between manuscript versions was relatively small ; most involved adding new information or altering existing information . Most changes requested by peer review ers had a positive impact on the reporting of the final manuscript — for example , adding or clarifying r and omisation and blinding ( n=27 ) , sample size ( n=15 ) , primary and secondary outcomes ( n=16 ) , results for primary or secondary outcomes ( n=14 ) , and toning down conclusions to reflect the results ( n=27 ) . Some changes requested by peer review ers , however , had a negative impact , such as adding additional unplanned analyses ( n=15 ) . Conclusion Peer review ers fail to detect important deficiencies in reporting of the methods and results of r and omised trials . The number of these changes requested by peer review ers was relatively small . Although most had a positive impact , some were inappropriate and could have a negative impact on reporting in the final publication Background The analysis of clinical trials with dropout usually assumes the missing data are ` missing at r and om ' , i.e. given an individual 's past observed data , their probability of dropout does not depend on their present outcome . However , in many setting s this assumption is implausible , so it is sensible to assess the robustness of conclusions to departures from missing at r and om . Purpose To develop a practical , accessible , approach that allows expert opinions about the degree of departure from missing at r and om in the analysis of a clinical trial to be meaningfully and accurately elicited and incorporated in sensitivity analysis . Methods We elicit experts ' prior beliefs about the mean difference between missing and observed outcomes in each trial arm . Then we perform a Bayesian synthesis of the information in the trial data with that in the experts ' prior , using ( i ) a full Bayesian analysis for which we give WinBUGS code , and ( ii ) a simple approximate formula for the estimated treatment effect and its st and ard error . We illustrate our approach by re-analysing a recent trial of interventions to improve the quality of peer review . Results In the peer review trial , the approximate formula agreed well with the full Bayesian analysis , and both showed substantially larger st and ard errors than an analysis assuming missing at r and om . Limitations Strictly , the method is only applicable if the outcome is normally distributed . We did not elicit the full bivariate prior distribution , and instead used a sensitivity analysis . Our approach is not design ed to incorporate prior beliefs about the intervention effect itself . Conclusions Our proposed approach allows for the greater uncertainty introduced by missing data that are potentially informatively missing
Output:
| As compared with the st and ard peer review process , training did not improve the quality of the peer review report and use of a checklist did not improve the quality of the final manuscript .
Blinded peer review did not affect the quality of the peer review report or rejection rate . |
MS211953 | ***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 African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans The effect of pharmaceutical care on the prevention , detection , and resolution of medication-related problems in high-risk patients in a rural community was studied . Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were r and omly assigned to a control group or an intervention group . The control group received st and ard medical care , and the intervention group received pharmaceutical care , including a medical record review , a medication history review , pharmacotherapeutic evaluation , and patient medication education and monitoring over a one-year period . A total of 69 patients completed the study ( 33 in the intervention group and 36 in the control group ) . The percentage of patients responding to hypertension , diabetes , dyslipidemia , and anticoagulation therapy increased significantly in the intervention group and declined in the control group . Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group . There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures . Medication compliance scores improved in the intervention group but not in the control group . Medication knowledge increased in the intervention group and decreased in the control group . Pharmaceutical care in a rural , community-based setting appeared to reduce inappropriate prescribing , enhance disease management , and improve medication compliance and knowledge without adversely affecting health-related quality of life A decision support system for the management of oral hypoglycaemic therapy in type II diabetes was evaluated . The ruleset contained therein forms the basis of a prototype computer programme , but in order to assess the robustness of the individual rules , it was decided it was necessary to use a paper-based form of the ruleset . A nurse with no previous experience of managing type II diabetes was trained to use the system and then undertook the exclusive management of half of all new type II diabetics , from a district population of 300,000 , over a 16-month period . General practice s within this area were divided into two groups , study and control , matching for size , geographical area and st and ards of existing diabetes care . Patients ( n = 102 ) from the study group practice s were then assigned to her care . Those patients ( n = 116 ) in the control group of practice s were treated according to their normal procedures . The decision support system for oral hypoglycaemic therapy was based on the following criteria : the current type of treatment ( six levels ) ; current glycaemic control ( HbA1 and FBS)-whether improving , steady or worsening ; and weight-%IBW , whether rising , steady or falling . Each of these parameters was carefully defined on the basis of established practice and clinical experience . Patients after initial education were seen at their usual clinic by the nurse only , on a monthly basis , until satisfactory glycaemic control was established and thereafter review ed 3 monthly . She was also responsible for ensuring the organisation of Diabetes Annual Review procedures . The medical records of the control group patients were examined at the end of the study and data on glycaemic control and Annual Review s extracted . In the study group 98 % patients achieved HbA1 levels within the normal range and all patients had full annual review s performed . The control practice s achieved much poorer degrees of metabolic control ( P < 0.01 ) and completed fewer annual review s. The study group did not demonstrate a significantly increased frequency of clinical hypoglycaemia consequent upon better blood sugar control . No exceptions to the ruleset , as initially defined , were detected . In conclusion , this decision support system was successful at achieving st and ards of diabetes control and care equal to or better than conventional structures of diabetes care . Implementation of such a system , on a simple computer platform , could greatly assist and possibly improve diabetes management in general practice PURPOSE This study was conducted to evaluate the impact of a provider problem-based learning ( PBL ) intervention on screening for complications of diabetes in community health centers . METHODS A successive sampling design was used to compare selected st and ards of diabetes care delivered preintervention with the care delivered postintervention at 2 community health centers and 1 comparison centers . Two r and omly assigned intervention sites received a PBL intervention focused on care guidelines for prevention of diabetes complications , with telephone follow-up over 12 months . Effects of the intervention were determined from an audit of 200 charts from each site . RESULTS The odds of having a glycosylated hemoglobin test more than doubled from preintervention to postintervention , and the odds of having a foot examination more than tripled across centers . Measurement of creatinine and glycosylated hemoglobin were associated ; the odds of having one test tripled when the other had been measured . Rates for documentation of patient education were significantly lower at the intervention site where free patient education booklets were distributed . CONCLUSIONS Improvements in diabetes care were not consistent among community health centers . Interventions involving system and policy changes may be more effective in implementing and sustaining improvements than just provider education STUDY OBJECTIVE : To study the clinical and cost outcomes of providing nutritional counselling to patients with one or more of the following conditions : overweight , hypertension and type 2 diabetes . DESIGN : The study was design ed as a r and om controlled trial . Consecutive patients were screened opportunistically for one or more of the above conditions and r and omly allocated to one of two intervention groups ( doctor/dietitian or dietitian ) or a control group . Both intervention groups received six counselling sessions over 12 months from a dietitian . However , in the doctor/dietitian group it was the doctor and not the dietitian who invited the patient to join the study and the same doctor also review ed progress at two of the six counselling sessions . SETTING : The study was conducted in a university group general practice set in a lower socioeconomic outer suburb of Perth , Western Australia . PATIENTS : Of the 273 patients r and omly allocated to a study group , 198 were women . Age ranged from 25 to 65 years . Seventy eight per cent of patients resided in the lower two socioecnomic quartiles , 56 per cent described their occupation as home duties and 78 per cent were partnered . RESULTS : Both intervention groups reduced weight and blood pressure compared with the control group . Patients in the doctor/dietitian group were more likely to complete the 12 month programme than those in the dietitian group . Patients in the doctor/dietitian group lost an average of 6.7 kg at a cost of $ A9.76 per kilogram , while the dietitian group lost 5.6 kg at a cost of $ A7.30 per kilogram . CONCLUSION : General practitioners , in conjunction with a dietitian , can produce significant weight and blood pressure improvement by health promotion methods Prerequisites for translating intervention research findings into practice are maintenance of results , generalization of effects and consistency of implementation . This report presents 12 months follow-up information on a r and omized 2x2 factorial trial evaluating the incremental effects of adding ( 1 ) telephone follow-up or ( 2 ) a community re sources utilization component to a basic touchscreen computer-assisted dietary goal - setting intervention for 320 type 2 diabetes patients . All conditions evidence d significant improvement from baseline to the 12 months follow-up across behavioral , biological and psychosocial measures . There were few consistent differences between conditions , but results were robust across interventionists and clinics . The telephone follow-up component appeared to enhance long-term results on some measures . When considered along with earlier results from a r and omized trial that included a control condition without goal setting , it is concluded that this basic goal - setting intervention can be consistently implemented by a variety of interventionists and produce lasting improvements BACKGROUND Despite clear evidence for the efficacy of lowering cholesterol levels , there is a deficiency in its real-world application . There is a need to explore alternative strategies to address this important public health problem . This study aim ed to determine the effect of a program of community pharmacist intervention on the process of cholesterol risk management in patients at high risk for cardiovascular events . METHODS A r and omized controlled trial conducted in 54 community pharmacies ( 1998 - 2000 ) included patients at high risk for cardiovascular events ( with atherosclerotic disease or diabetes mellitus with another risk factor ) . Patients r and omized to pharmacist intervention received education and a brochure on risk factors , point-of-care cholesterol measurement , referral to their physician , and regular follow-up for 16 weeks . Pharmacists faxed a simple form to the primary care physician identifying risk factors and any suggestions . Usual care patients received the same brochure and general advice only , with minimal follow-up . The primary end point was a composite of performance of a fasting cholesterol panel by the physician or addition or increase in dose of cholesterol-lowering medication . RESULTS The external monitoring committee recommended early study termination owing to benefit . Of the 675 patients enrolled , approximately 40 % were women , and the average age was 64 years . The primary end point was reached in 57 % of intervention patients vs 31 % in usual care ( odds ratio , 3.0 ; 95 % confidence interval , 2.2 - 4.1 ; P<.001 ) . CONCLUSIONS A community-based intervention program improved the process of cholesterol management in high-risk patients . This program demonstrates the value of community pharmacists working in collaboration with patients and physicians OBJECTIVE To evaluate the effectiveness of a managed care approach to health care delivery , group visits , in the management of uninsured or inadequately insured patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 120 patients with uncontrolled type 2 diabetes were r and omly assigned to receive their care in group visits or usual care for 6 months . After 6 months , concordance with 10 process-of-care indicators recommended by the American Diabetes Association ( ADA ) st and ards of care was evaluated through chart abstract ion . The 10 items evaluated were up-to- date HbA(1c ) levels and lipid profiles , urine for microalbumin , appropriate use of ACE inhibitor or angiotensin receptor blockers , use of lipid-lowering agents where indicated , daily aspirin use , annual foot examinations , annual referrals for retinal examinations , and immunizations against streptococcal pneumonia and influenza . RESULTS Patients who received care in group visits showed statistically significant improvement in concordance with these 10 process-of-care indicators ( P < 0.001 ) . Of the patients , 76 % who received care in group visits had at least 9 of these 10 items up to date , as compared with 23 % of control patients ; 86 % of patients in group visits had at least 8 of the 10 indicators compared with 47 % of control patients . CONCLUSIONS Group visits proved more effective in promoting concordance with ADA st and ards of care than usual care in the treatment of uninsured or inadequately insured patients with type 2 diabetes OBJECTIVE To evaluate the impact of primary care group visits ( chronic care clinics ) on the process and outcome of care for diabetic patients . RESEARCH DESIGN AND METHODS We evaluated the intervention in primary care practice s r and omized to intervention and control groups in a large-staff model health maintenance organization ( HMO ) . Patients included diabetic patients > or = 30 years of age in each participating primary care practice , selected at r and om from an automated diabetes registry . Primary care practice s were r and omized within clinics to either a chronic care clinic ( intervention ) group or a usual care ( control ) group . The intervention group conducted periodic one-half day chronic care clinics for groups of approximately 8 diabetic patients in their respective doctor 's practice . Chronic care clinics consisted of st and ardized assessment s ; visits with the primary care physician , nurse , and clinical pharmacist ; and a group education/peer support meeting . We collected self-report question naires
Output:
| Conclusion The significant association between CAS characteristics and effectiveness of reported outcomes for patients with Type II diabetes suggests that complexity science may provide an effective framework for design ing and implementing interventions that lead to improved patient outcomes |
MS211954 | ***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: Context Hepatocellular carcinoma often follows hepatitis C virus infection . Currently available treatments for hepatocellular carcinoma are unsatisfactory . Percutaneous ethanol injection therapy into tumor nodules shows some promise , but recurrence rates are high . Contribution In a carefully selected group of 74 patients with multicentric hepatocellular carcinoma , mild hepatitis C , and mild cirrhosis , patients r and omly assigned to receive interferon in addition to ethanol injections showed improved survival at 5 and 7 years , particularly among patients with a sustained virologic response . Caution s Combined treatment of multicentric hepatocellular carcinoma offers the possibility of enhanced survival for carefully selected patients ; this study is small , however , and enrolled only patients with low virus levels and mild cirrhosis . The Editors Chronic hepatitis C virus ( HCV ) infection is a common , frequently asymptomatic disease . Despite the clinical ly quiescent course of HCV infection , it may slowly progress to cirrhosis and , eventually , to hepatocellular carcinoma ( 1 , 2 ) . Cirrhosis is a major risk factor for the development of hepatocellular carcinoma ( 3 , 4 ) , and 70 % to 80 % of patients with hepatocellular carcinoma in Japan have HCV infection ( 5 ) . Current strategies for treating hepatocellular carcinoma include surgical resection , transarterial embolization , percutaneous ethanol injection therapy , radiofrequency wave ablation , and chemotherapy ( 6 - 9 ) . Recent studies have shown that percutaneous ethanol injection therapy is effective for hepatocellular carcinoma when the tumors are small ( <3 to 5 cm in diameter ) and limited in number ; survival rates are similar to those obtained with surgery ( 10 - 12 ) . Five-year survival rates , however , are poor ( 30 % to 60 % for both hepatectomy and percutaneous ethanol injection therapy ) . Poor prognosis may be the result of the high incidence of tumor recurrence ; the cumulative recurrence rate at 5 years is 60 % to 100 % ( 10 - 13 ) . Several studies have evaluated the factors that contribute to the recurrence of hepatocellular carcinoma ( 12 , 13 ) . Occasionally , early recurrence develops adjacent to the treated lesion ( local recurrence , 6 % to 33 % depending on tumor size ) ( 14 ) , but most tumors ( 80 % to 90 % ) recur at different sites ( 15 ) . Because hepatocellular carcinoma recurrence and decompensation of underlying liver disease are major problems after medical or surgical treatment , liver transplantation is another option for treating small , unresectable hepatocellular carcinomas in patients with cirrhosis . Studies report 5-year survival rates as high as 75 % with liver transplantation ( 16 - 18 ) . Interferon therapy has beneficial effects in chronic HCV infection ( 19 , 20 ) . In long-term follow-up studies , sustained virologic responders have remained in remission with normal liver function and improved histologic features of inflammation ; in some of these responders , fibrosis even regresses ( 21 , 22 ) . Recently , the frequency of hepatocellular carcinoma in patients receiving interferon therapy has substantially decreased , especially in patients with sustained virologic and biochemical responses ( 23 - 25 ) . This decreased frequency has occurred even in patients with cirrhosis ( 25 , 26 ) . Our study evaluated whether complete ablation of neoplastic nodules and administration of antiviral therapy could increase survival rates . Methods Study Design Our prospect i ve study was design ed by an eight-member committee in December 1992 . The Ethics Committee of the University of Tokyo approved the study . We obtained informed consent from each patient in accordance with the Helsinki declaration . Patients with compensated cirrhosis , three or fewer nodules of hepatocellular carcinoma , and low HCV RNA loads were recruited after complete ablation of the lesions . Eligibility Criteria Inclusion Criteria Hepatitis C virus infection was diagnosed on the basis of identification of anti-HCV antibody using the passive hemagglutination test ( Dinabbot , Tokyo , Japan ) or enzyme-linked immunosorbent assay ( ELISA ; Ortho Diagnostic Systems , Tokyo , Japan ) . Hepatitis C virus RNA was identified by reverse transcriptase polymerase chain reaction ( RT-PCR ) . The serum HCV RNA level was measured by competitive reverse transcriptase (CRT)-PCR according to the method of Kato and colleagues ( 27 ) ; HCV genotype was determined by the method of Okamoto and colleagues ( 28 ) . Hepatocellular carcinoma was suspected on the basis of several imaging methods , including abdominal ultrasonography , dynamic computed tomography ( CT ) , magnetic resonance imaging ( MRI ) , and arteriography . We confirmed the diagnosis by histologic examination of tumor biopsy specimens obtained from all patients . Evaluation was based on the criteria of the International Working Party ( 29 ) . In addition , we obtained and evaluated biopsy specimens from non-neoplastic lesions according to the methods of Desmet and colleagues ( 30 ) . Hepatocellular carcinoma was treated with percutaneous ethanol injection therapy ( 7 , 8 , 10 ) . Real-time linear-array scanners were used with 3.5-MHz transducers for the sonographic guidance of needles [ 21-gauge with a 15-cm or 20-cm needle ; Hanako , Tokyo , Japan ] into the tumors . Two to 10 mL of 99.5 % ethanol was injected into each lesion . Ethanol injection was repeated several times at different sessions . Complete destruction of the nodules was confirmed on dynamic CT 1 month after ethanol injection according to the following criteria : 1 ) The destructive area was larger than the area of the tumor nodule shown on pretreatment dynamic CT and 2 ) dynamic CT showed no early-phase contrast enhancement of nodules ( 7 , 8 , 10 ) . Inclusion criteria were as follows : 1 ) hepatocellular carcinoma with three or fewer lesions [ verified by histologic examination ] and dynamic CTconfirmed complete ablation of hepatocellular carcinoma lesions by percutaneous ethanol injection therapy , 2 ) detection of HCV RNA by RT-PCR and an HCV RNA load of 2 106 copies/mL or less by CRT-PCR ( the cutoff value was based on unpublished data indicating that interferon treatment was effective in patients with HCV RNA loads of 105 copies/50 L of serum by CRT-PCR [ 27 ] ] , 3 ) platelet count of 50 109 cells/L , 4 ) leukocyte count of 3 109 cells/L or greater , 5 ) compensated cirrhosis in ChildPugh stage A , 6 ) age younger than 70 years , 7 ) no previous treatment with interferon , and 8) su bmi ssion of informed consent . Exclusion Criteria Exclusion criteria were as follows : 1 ) liver diseases due to other causes , such as hepatitis B or primary biliary cirrhosis ; 2 ) HCV RNA load of 2 106 copies/mL or greater by CRT-PCR ; 3 ) severe comorbid diseases , such as heart disease , lung disease , or diabetes mellitus ; 4 ) decompensated cirrhosis in ChildPugh stage B or C ; and 5 ) failure to obtain informed consent . R and omization Patients who enrolled in the study were r and omly assigned in a 2:1 ratio to the interferon group or the control group by the controller . We assigned patients to the treatment group or control group by using a r and omization list . Interferon Therapy and Follow-up of Patients Interferon Therapy We started interferon therapy with natural interferon- ( Sumitomo Pharmaceuticals , Tokyo , Japan ) 2 to 3 months after tumor ablation was confirmed . Patients received 6 million U of interferon by intramuscular injection three times weekly for 48 weeks as out patients . If patients could not tolerate this dose , the interferon dose was reduced to 3 million U. If HCV RNA in serum was still detected by RT-PCR ( detection limit , 102 copies/mL ) after 24 weeks of interferon therapy and serum alanine aminotransferase ( ALT ) levels were higher than pretreatment ALT levels , therapy was discontinued . Criteria for Interferon Response We defined the efficacy of interferon therapy virologically and biochemically . Patients who were negative for HCV RNA ( as determined by RT-PCR ; detection limit , 102 copies/mL ) more than 6 months after the completion of interferon therapy were classified as showing a sustained virologic response . Patients with persistently normal ALT levels after the completion of interferon therapy were classified as showing a sustained biochemical response ; patients with abnormal ALT levels were classified as showing a nonsustained biochemical response . Follow-up Patients attended a monthly medical consultation at the University of Tokyo Hospital outpatient clinic . Blood biochemical measures , including -fetoprotein ( AFP ) tumor markers , were measured every 1 to 2 months ; ultrasonography was performed every 2 to 3 months ; and dynamic CT was performed every 6 months . Recurrence of hepatocellular carcinoma was detected by the finding of abnormal nodules with low or high echogenic appearance on abdominal ultrasonography or by the finding of abnormal density on dynamic CT . The diagnosis was confirmed histologically through ultrasonography-guided fine-needle biopsy of the tumor . Recurrent nodules were divided into two categories [ 14 , 15 ] : 1 ) local recurrence , in which the nodule appeared adjacent to the previously treated nodules , suggesting that residual tumor cells had not been completely ablated by percutaneous ethanol injection therapy , or 2 ) new foci developing at a distant site . New foci of hepatocellular carcinoma , as well as local recurrent nodules at tumor , node , metastasis ( TNM ) stage I , II , and III , were mainly treated by a second course of percutaneous ethanol injection therapy ; local recurrent nodules at TNM stage IV were treated with transarterial chemoembolization or chemotherapy . New development of hepatocellular carcinoma and survival of the patients ( tumor recurrence rate and survival rate ) were analyzed in relation to the time interval after initial treatment . Statistical Analysis When estimating the sample size , we assumed that 5-year survival in the control group would be 40 % according to the data of our previous unpublished study . We predicted that 5-year survival would be increased by 35 % as a result of Lamivudine is widely used to treat patients with hepatitis B. However , the outcomes in patients with hepatocellular carcinoma ( HCC ) treated with lamivudine have not been established . This study was conducted to evaluate the outcomes of lamivudine treatment for patients with HCC using an untreated , matched control group . Thirty patients with controlled HCC orally received lamivudine . As controls , 40 patients with HCC who were not treated with lamivudine and matched for clinical features were selected . The lamivudine-treated and untreated groups were compared with respect to changes in liver function , HCC recurrence , survival , and cause of death . In the lamivudine-treated group , there was significant improvement in the Child-Pugh score at 24 months after starting treatment , while no improvement was observed in the untreated group . There was no significant difference in the cumulative incidence of HCC recurrence and survival between the groups . However , there was a significant difference in the cumulative incidence of death due to liver failure ( P= 0.043 ) . A significant improvement in liver function was achieved by lamivudine treatment , even in patients with HCC . These results suggest that lamivudine treatment for patients with HCC may prevent death due to liver failure . Further prospect i ve r and omized studies using a larger number of patients are required BACKGROUND / AIMS Recurrence after resection of hepatocellular carcinoma ( HCC ) is a frequent event . This study evaluated the effect of postoperative interferon alpha ( IFN alpha ) treatment on recurrence and survival in patients with hepatitis B virus (HBV)-related HCC . METHOD Two hundred and thirty six patients were r and omized after resection into IFN alpha treatment ( 5 micro i.m . tiw for 18 months ) and control groups . Treatment was terminated if recurrence was diagnosed , and recurrence was managed the same way in both groups . Statistical analysis was based on the method of intent-to-treat . RESULTS The two groups were comparable in all clinicopathological parameters . The median overall survival was 63.8 months in the treatment group and 38.8 months in the control group ( P=0.0003 ) ; the median disease-free survival period was 31.2 versus 17.7 months ( P=0.142 ) . Fever , leucocytopenia , and thrombocytopenia were adverse effects in the treatment group , but were mostly manageable . CONCLUSIONS IFN alpha treatment improved the overall survival of patients with HBV-related HCC after curative resection , probably by postponing recurrence Because hepatocellular carcinoma often recurs after surgical resection or ethanol injection therapy , we conducted a prospect i ve r and omized controlled trial of interferon ( IFN ) in patients with chronic liver disease caused by hepatitis C virus ( HCV ) . Twenty eligible patients with cirrhosis were r and omized into two groups : 10 patients treated with 6 million units of natural IFN-beta twice a week for 36 months and 10
Output:
| Conclusions Adjuvant IFN therapy may significantly reduce the recurrence rates of patients with viral hepatitis-related HCC and improve the survival of patients after surgical resection or TACE .
The ideal dose mostly selected is 3 MIU/ml , three times per week , which can make patients tolerate the adverse reactions of IFN better and maintain effective concentrations for a long time |
MS211955 | ***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: L-Theanine is an amino acid found naturally in tea . Despite the common consumption of L-theanine , predominantly in combination with caffeine in the form of tea , only one study to date has examined the cognitive effects of this substance alone , and none have examined its effects when combined with caffeine . The present r and omised , placebo-controlled , double-blind , balanced crossover study investigated the acute cognitive and mood effects of L-theanine ( 250 mg ) , and caffeine ( 150 mg ) , in isolation and in combination . Salivary caffeine levels were co-monitored . L-Theanine increased ' headache ' ratings and decreased correct serial seven subtractions . Caffeine led to faster digit vigilance reaction time , improved Rapid Visual Information Processing ( RVIP ) accuracy and attenuated increases in self-reported ' mental fatigue ' . In addition to improving RVIP accuracy and ' mental fatigue ' ratings , the combination also led to faster simple reaction time , faster numeric working memory reaction time and improved sentence verification accuracy . ' Headache ' and ' tired ' ratings were reduced and ' alert ' ratings increased . There was also a significant positive caffeine x L-theanine interaction on delayed word recognition reaction time . These results suggest that beverages containing L-theanine and caffeine may have a different pharmacological profile to those containing caffeine alone Recent neuropharmacological research has suggested that certain constituents of tea may have modulatory effects on brain state . The bulk of this research has focused on either L-theanine or caffeine ingested alone ( mostly the latter ) and has been limited to behavioral testing , subjective rating , or neurophysiological assessment s during resting . Here , we investigated the effects of both L-theanine and caffeine , ingested separately or together , on behavioral and electrophysiological indices of tonic ( background ) and phasic ( event-related ) visuospatial attentional deployment . Subjects underwent 4 d of testing , ingesting either placebo , 100 mg of L-theanine , 50 mg of caffeine , or these treatments combined . The task involved cued shifts of attention to the left or right visual hemifield in anticipation of an imperative stimulus requiring discrimination . In addition to behavioral measures , we examined overall , tonic attentional focus as well as phasic , cue-dependent anticipatory attentional biasing , as indexed by scalp-recorded alpha-b and ( 8 - 14 Hz ) activity . We found an increase in hit rate and target discriminability ( d ' ) for the combined treatment relative to placebo , and an increase in d ' but not hit rate for caffeine alone , whereas no effects were detected for L-theanine alone . Electrophysiological results did not show increased differential biasing in phasic alpha across hemifields but showed lower overall tonic alpha power in the combined treatment , similar to previous findings at a larger dosage of L-theanine alone . This may signify a more generalized tonic deployment of attentional re sources to the visual modality and may underlie the facilitated behavioral performance on the combined ingestion of these 2 major constituents of tea OBJECTIVE L-theanine is a unique amino acid present almost exclusively in the tea plant . It possesses neuroprotective , mood-enhancing , and relaxation properties . This is a first study design ed to evaluate the efficacy and tolerability of L-theanine augmentation of antipsychotic treatment of patients with chronic schizophrenia and schizoaffective disorder . METHOD 60 patients with DSM-IV schizophrenia or schizoaffective disorder participated in an 8-week , double-blind , r and omized , placebo-controlled study . 400 mg/d of L-theanine was added to ongoing antipsychotic treatment from February 2006 until October 2008 . The outcome measures were the Positive and Negative Syndrome Scale ( PANSS ) , the Hamilton Anxiety Rating Scale ( HARS ) , the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) for neurocognitive functioning , and additional measures of general functioning , side effects , and quality of life . RESULTS 40 patients completed the study protocol . Compared with placebo , L-theanine augmentation was associated with reduction of anxiety ( P = .015 ; measured by the HARS scale ) and positive ( P = .009 ) and general psychopathology ( P < .001 ) scores ( measured by the PANSS 3-dimensional model ) . According to the 5-dimension model of psychopathology , L-theanine produced significant reductions on PANSS positive ( P = .004 ) and activation factor ( P = .006 ) scores compared to placebo . The effect sizes ( Cohen d ) for these differences ranged from modest to moderate ( 0.09 - 0.39 ) . PANSS negative and CANTAB task scores , general functioning , side effect , and quality of life measures were not affected by L-theanine augmentation . L-theanine was found to be a safe and well-tolerated medication . CONCLUSIONS L-theanine augmentation of antipsychotic therapy can ameliorate positive , activation , and anxiety symptoms in schizophrenia and schizoaffective disorder patients . Further long-term studies of L-theanine are needed to substantiate the clinical ly significant benefits of L-theanine augmentation Tea ingredients L-theanine and caffeine have repeatedly been shown to deliver unique cognitive benefits when consumed in combination . The current r and omized , placebo-controlled , double-blind , cross-over study compared a combination of L-theanine ( 97 mg ) and caffeine ( 40 mg ) to a placebo on two attention tasks and a self-report question naire before , and 10 and 60 min after consumption . The combination of L-theanine and caffeine significantly improved attention on a switch task as compared to the placebo , while subjective alertness and intersensory attention were not improved significantly . The results support previous evidence that L-theanine and caffeine in combination can improve attention 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 Objective : Ingestion of the nonproteinic amino acid theanine ( 5-N-ethylglutamine ) has been shown to increase oscillatory brain activity in the so-called alpha b and ( 8 - 14 Hz ) during resting electroencephalographic recordings in humans . Independently , alpha b and activity has been shown to be a key component in selective attentional processes . Here , we set out to assess whether theanine would cause modulation of anticipatory alpha activity during selective attentional deployments to stimuli in different sensory modalities , a paradigm in which robust alpha attention effects have previously been established . Methods : Electrophysiological data from 168 scalp electrode channels were recorded while participants performed a st and ard intersensory attentional cuing task . Results : As in previous studies , significantly greater alpha b and activity was measured over parieto-occipital scalp for attentional deployments to the auditory modality than to the visual modality . Theanine ingestion result ed in a substantial overall decrease in background alpha levels relative to placebo while subjects were actively performing this dem and ing attention task . Despite this decrease in background alpha activity , attention-related alpha effects were significantly greater for the theanine condition . Conclusion : This increase of attention-related anticipatory alpha over the right parieto-occipital scalp suggests that theanine may have a specific effect on the brain 's attention circuitry . We conclude that theanine has clear psychoactive properties , and that it represents a potentially interesting , naturally occurring compound for further study , as it relates to the brain 's attentional system OBJECTIVE The aim of this study was to investigate green tea flavan-3-ol catabolism and plasma pharmacokinetic and urinary excretion by high-performance liquid chromatography with t and em mass spectrometry to evaluate their absolute bioavailability by taking into account all known and some unknown catabolites deriving from their interaction with the gastrointestinal tract and its host microflora . METHODS A feeding study was carried out in 20 healthy human volunteers who ingested 400 mL of a ready-to-drink green tea containing approximately 400 μmol of flavan-3-ols . Urine and plasma were collected for 4 and 24h , respectively , and 39 relevant catabolites were identified in these biological fluids by t and em mass spectrometry . RESULTS In biological fluids , 39 relevant flavan-3-ol catabolites were identified . In plasma , (-)-epigallocatechin-3-gallate was the only unmetabolized compound and the highest in absolute concentration compared with (-)-epigallocatechin and (-)-epicatechin conjugates . Colonic microflora-derived polyhydroxyphenyl-γ-valerolactones were by far the main urinary catabolites , averaging 10 times greater concentratin than flavan-3-ol conjugates . The calculated bioavailability was equal to 39 % and it is interesting to notice the great variability in urinary excretion of colonic metabolites among participants , probably related to differences in their own colonic microflora . CONCLUSION This study demonstrates that green tea catechins are more bioavailable than previously observed when colonic ring fission metabolites are taken into consideration . Regular consumption of ready-to-drink green tea containing flavan-3-ols allows a non-marginal exposure of the human body to these catabolites , somehow justifying the numerous beneficial actions described as linked to green tea intake
Output:
| The effects of green tea can not be attributed to a single constituent of the beverage .
This is exemplified in the finding that beneficial green tea effects on cognition are observed under the combined influence of both caffeine and l-theanine , whereas separate administration of either substance was found to have a lesser impact |
MS211956 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract In a non-r and omized , comparative prospect i ve study ( 416 patients ) we compared the outcome of IVF/ICSI in two parallel control groups : one in which patients were followed up using combined monitoring ( ultrasound plus serum estradiol monitoring , the UHM group ) and one in which only ultrasound monitoring was used ( the UM group ) . This study has taken the number of mature oocytes at the moment of egg retrieval as its primary end variable . After adjustment for age , gravidity , antagonist protocol , AMH and infertility diagnosis , the average difference in number of mature oocytes between the UHM group and the UM group was −0.4 ( 95 % CI : −1.7 to 1.0 ) , which met our definition of clinical equivalence ( 95 % CI for the adjusted mean difference between −2 and 2 ) . Larger studies are still needed to evaluate the differences in the live birth rates per cycle and to further confirm that blood sampling definitively has no added value in monitoring ovarian stimulation for IVF/ICSI . Chinese abstract 我们在一项非随机、对照、前瞻性研究中（416例患者）比较了IVF/ICSI中两个平行对照组的结果：一组患者应用超声联合血雌二醇进行监测（ultrasound plus serum estradiol monitoring，UHM），一组患者仅应用超声监测（ultrasound monitoring，UM）。本研究以取卵时成熟卵母细胞的数量为主要研究终点。在对年龄、孕次、拮抗剂方案、AMH水平、不孕症诊断进行校正后，UHM组和UM组的成熟卵母细胞数量的平均差异是-0.4（(95 % CI ： -1.7- 1.0），这与临床等效的定义相符（调整后的平均差的95 % CI介于-2到2之间）。仍需要更大型的研究来评估周期活产率及进一步确定IVF/ICSI中采血检测对卵巢刺激监测的最终结果无附加价值 St and ard monitoring of controlled ovarian hyperstimulation ( COH ) includes hormone assays ( estradiol , LH , progesterone ) and regular pelvic ultrasound examination . We report a r and omized study on an attempt to simplify monitoring of COH . Ultrasound monitoring of the cycle alone did not affect pregnancy rates and did not increase the risks of OHSS . These results encourage the future simplification of stimulation protocol Objective : To evaluate if monitoring patients by ultrasound ( US ) only during in vitro fertilization ( IVF ) treatment is safe . Design : R and omized prospect i ve study . Intervention : Patients undergoing their first IVF treatment were r and omized into two groups . The ultrasound only group ( study group ) was monitored by US for follicle size and endometrial thickness without blood tests . In this group , only one blood test was taken before human chorionic gonadotropin ( hCG ) injection , to ensure a safe level of estradiol ( E2 ) regarding ovarian hyperstimulation syndrome ( OHSS ) risk . The control group was monitored by ultrasound plus serum estradiol and progesterone concentration at each visit . Main outcome measure : Clinical pregnancy rate . Results : No differences were found between the groups in the parameters of IVF treatment , induction days , number of ampoules , E2 level of hCG , as well as embryo quality . The clinical pregnancy rate was not statistically different between the groups , 57.5 % vs. 40.0 % , respectively ( p = 0.25 ) . No OHSS cases were found among the study or control groups . Conclusion : Ultrasound as a single monitoring tool for IVF cycles is reliable , safe , patient friendly , and reduces treatment expenses . In an era of cost effectiveness awareness , this regimen should be considered for routine management in IVF programs OBJECTIVE To determine if there is an optimum time for the administration of human chorionic gonadotropin ( hCG ) after pituitary desensitization with gonadotropin-releasing hormone agonists ( GnRH-a ) has been achieved before ovarian stimulation for in vitro fertilization ( IVF ) . DESIGN Prospect i ve r and omized study . PATIENTS Two hundred forty-seven patients undergoing an IVF treatment cycle who were r and omly divided into three groups . INTERVENTIONS All patients were administered subcutaneously buserelin acetate 500 micrograms/d from day 1 of the menstrual cycle . After pituitary desensitization had been achieved at least 14 days later , ovarian stimulation with human menopausal gonadotropin was commenced . Ovarian stimulation , cycle monitoring , oocyte recovery , and IVF and embryo transfer ( ET ) techniques were identical in all three groups . Patients in group 1 ( n = 79 ) had hCG administered when the mean diameter of the largest follicle had reached 18 mm , at least two other follicles were greater than 14 mm , and serum estradiol ( E2 ) levels were consistent with the number of follicles observed on ultrasound . Patients in groups 2 ( n = 84 ) and 3 ( n = 84 ) had hCG administered 1 day and 2 days , respectively , after the above criteria had been reached . RESULTS The mean day of hCG administration ( P less than 0.01 ) , maximum serum E2 concentration ( P = 0.06 ) , number of days of serum E2 rise ( P = 0.03 ) , and mean diameter of the largest follicle ( P less than 0.0001 ) were significantly different . There were , however , no significant differences in the mean number of preovulatory and medium size follicles , number of oocytes recovered or embryos transferred . There were also no significant differences in the oocyte recovery , fertilization and cleavage rates , in the number of embryos frozen , or in the pregnancy rates per initiated cycle and per ET . CONCLUSIONS There is no significant advantage in the precise timing of hCG administration after pituitary desensitization with GnRH-a OBJECTIVE To determine whether cycle monitoring using both serum E(2 ) and ultrasound findings yields superior clinical pregnancy rates during IVF-embryo transfer ( ET ) compared to monitoring with ultrasound alone . DESIGN Prospect i ve , r and omized , multicenter , patient-blinded study . SETTING Four assisted conception units in the United Kingdom . PATIENT(S ) Two hundred ninety-seven women believed to be normal responders undergoing IVF treatment . INTERVENTION(S ) Patients were r and omly allocated on day 7 of stimulation to one of the two hCG administration criteria : [ 1 ] the E(2)-to-follicle > or = 11 mm ratio was between 250 and 500 pmol/L/follicle and at least 2 follicles reached a mean diameter of 18 mm or [ 2 ] at least 2 follicles reached a mean diameter of 18 mm and the endometrium thickness was > or = 8 mm . MAIN OUTCOME MEASURE(S ) Duration and cumulative dose of recombinant human FSH , total number of growing follicles , oocytes retrieved , number and quality of embryos , pregnancy rates , and ovarian hyperstimulation syndrome ( OHSS ) rates . RESULT ( S ) Two hundred ninety-seven patients were r and omized to one of the two criteria groups . Of these , 288 ( 97 % ) received urinary (u)-hCG ( 143 in group A and 145 in group B ) . One hundred three women in group A ( 72 % ) met both criteria for hCG administration . Pregnancy and OHSS rates were similar ( 34.3 % vs. 31.4 % and 4.9 % vs. 4.1 % , respectively ) . CONCLUSION ( S ) The addition of E(2)/follicle criteria to ultrasound monitoring of IVF cycles in normal responders seldom changes the timing of hCG , and does not increase pregnancy rates or the risk of OHSS OBJECTIVE To evaluate the effect of a new automated technique of follicle measurement ( Sono automated volume calculation [ SonoAVC ] ) on the timing of oocyte maturation and subsequent oocyte retrieval . DESIGN Prospect i ve r and omized controlled trial . SETTING University-based Assisted Conception Unit . PATIENT(S ) Seventy-two women undergoing their first cycle of assisted reproduction treatment . INTERVENTION(S ) The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of either conventional two-dimensional ( 2D ) ultrasound or SonoAVC . MAIN OUTCOME MEASURE(S ) The number of mature oocytes retrieved and clinical pregnancy rate . RESULT ( S ) The number of the mature oocytes collected ( 10.70 + /- 6.08 vs. 11.43 + /- 6.17 ) , the number of fertilized oocytes ( 7.27 + /- 4.78 vs. 7.97 + /- 5.25 ) , and the clinical pregnancy rates ( 42 % vs. 43 % ) were similar with both 2D ultrasound and SonoAVC methods . CONCLUSION ( S ) Automated follicle tracking using SonoAVC identifies a comparable number of follicles to real-time 2D ultrasound in this preliminary study . Timing final follicle maturation and egg retrieval on the basis of these automated measures does not appear to improve the clinical outcome of assisted reproduction treatment OBJECTIVE To investigate the feasibility of IVF treatment with minimal monitoring during ovarian hyperstimulation . DESIGN Retrospective analysis and prospect i ve study with real-time control group . SETTING Transport IVF program with transport clinic and satellite clinics . PATIENTS One hundred consecutive IVF cycles monitored at a transport clinic and 100 concurrent consecutive cycles monitored at satellite clinics , using the same stimulation-monitoring protocol and result ing in oocyte aspiration , are compared retrospectively for the number of ultrasound ( US ) measurements carried out during monitoring and for results of IVF treatment . No patient selection took place . After introduction of a minimal monitoring protocol at a transport clinic , a prospect i ve study was started comparing 100 minimal monitoring cycles at a transport clinic with 100 concurrent conventional monitoring cycles at satellite clinics , all result ing in oocyte aspiration . Patients entered the retrospective or prospect i ve study only once . In all cases the same laboratory facility was used . Monitoring of ovarian hyperstimulation was done with US measurements only . Cycles were canceled for impending ovarian hyperstimulation syndrome ( OHSS ) when > 35 follicles were seen to develop during hyperstimulation . RESULTS Retrospective analysis shows no difference for the average number of US measurements at transport and satellite clinics ( 2.8 + /- 0.9 and 3.0 + /- 1.0 ; mean + /- SD ) . No differences were found in the number of ongoing pregnancies obtained in the two groups : 22 and 18 , respectively . One case of severe OHSS occurred in the satellite clinic group . Introduction of minimal monitoring at the transport clinic gives a significant reduction of the average number of US measurements at the transport clinic compared with satellite clinics , where conventional monitoring continued to be used ( 1.5 + /- 0.8 versus 2.8 + /- 0.9 ) . Ongoing pregnancies at transport and satellite clinics numbered 33 and 26 , respectively . In both groups one patient developed severe OHSS . Sixty-two percent of cycles at the transport clinic were monitored with one US measurement only . No cancellations for impending OHSS occurred during the study period . CONCLUSION A large group of patients need only one US measurement during monitoring of ovarian hyperstimulation . Minimal monitoring gives a useful further simplification of the clinical phase of IVF treatment , without adverse effects on treatment outcome and incidence of OHSS OBJECTIVE To assess prospect ively the appropriateness of follicular sonography alone for monitoring ovarian stimulation and to compare it to ovarian monitoring with both follicular sonography and hormone level determinations . STUDY DESIGN Prospect i ve , blind , clinical study in which the investigator made cycle management decisions based on follicular sonography only . RESULTS Follicular sonography alone predicted 88 % of the decisions made by the combination of follicular sonography , luteinizing hormone ( LH ) , estradiol ( E2 ) and progesterone measurements . Follicular sonography was unable to predict abnormal E2 patterns in eight ( 8 % ) of the patients ' scans . Follicular sonography did not detect three ( 3 % ) patients with a premature LH surge . CONCLUSION Follicular sonograms alone performed during ovarian stimulation predicted 88 % of cycle decisions . One could argue that hormone measurements could be either reduced or eliminated during ovarian stimulation for assisted reproductive technology and that follicular sonography only would be a cost-effective compromise . The effect of such simplified monitoring on pregnancy rates would require further prospect i ve evaluation A total of 114 patients admitted to an in-vitro fertilization-embryo transfer programme for the first time , were r and omly assigned to the study group or controls . Gonadotrophin-releasing hormone analogue ( GnR
Output:
| This review up date found no evidence from r and omised trials to suggest that combined monitoring by TVUS and serum estradiol is more efficacious than monitoring by TVUS alone with regard to clinical pregnancy rates and the incidence of OHSS .
The number of oocytes retrieved appeared similar for both monitoring protocol s. The data suggest that both these monitoring methods are safe and reliable . |
MS211957 | ***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 previous studies have examined the health of carers , but they have usually focused on elderly subjects and have often not had representative control sample s. AIM To determine whether caring for a partner with Parkinson 's disease is associated with a worsening social , psychological and physical well-being than people with partners who do not suffer with Parkinson 's disease . METHOD One hundred and fifty-four carer spouses of subjects with Parkinson 's disease , and 124 non-carer spouses of r and omly selected population controls recruited from a national case-control study of early-onset Parkinson 's disease in the Republic of Irel and , between 1992 - 1994 , were studied . Outcome was measured along three dimensions : social functioning , assessed by the frequency of social contacts , outings and holidays ; psychological well-being , measured by the General Health Question naire ; and physical health , measured by the career 's use of medical services , medications and episodes of chronic illness . RESULTS Carer spouses were less likely to get out of the house once a week at least ( odds ratio 1.79 , 95 % confidence intervals 1.00 - 3.20 ) or to have had a holiday in the last year ( odds ratio 1.71 , 95 % confidence intervals 1.01 - 2.90 ) . Contact with friends and neighbours decreased with increasing care provision . For spouses providing a lot of care , there was an almost fivefold increase in psychiatric morbidity ( odds ratio 4.86 , 95 % confidence intervals 1.5 - 15.9 ) after adjusting for other variables . Most of the medical outcomes were less favourable among carers , but only the use of tranquilizers ( odds ratio 3.73 , 95 % confidence intervals 1.18 - 11.8 ) and episodes of chronic illness ( odds ratio 2.96 , 95 % confidence intervals 1.27 - 6.94 ) were significant . CONCLUSIONS Overall , career spouses have slightly worse social , psychological and physical profiles . For social outcomes , increasing care provision is associated with fewer contacts , outings and holidays . For psychological and physical measures , carers providing a lot of care experience worse health . These results have implication s for targeting appropriate interventions The aim of this study was to evaluate the effects of orofacial physiotherapeutic treatment ( OPT ) on the facial mobility of Parkinson 's disease ( PD ) sufferers . Sixteen participants with PD were allocated r and omly to either the Treatment group or the Control group . A short interview between the physiotherapist and each subject was videotaped , and 10 r and om frames of the videotape were selected to be used in the facial expression assessment . The quantification of facial expressions was achieved by using an objective microcomputer-based measurement system , based on a mathematical model of the face ( FACEM ) . A facial outline is obtained , as well as 12 facial measures , which represent distances between key facial l and marks . The facial assessment was performed on 3 separate occasions , that is , baseline ( pretreatment ) , posttreatment , and follow-up ( 4 weeks later ) . A repeated measures analysis of variance ( MANOVA ) revealed a significant main effect of Time and a significant interaction effect between Time and Group for the Mouth-Opening Measure , suggesting that after treatment , members of the Treatment group opened their mouths to a greater degree than members of the Control group . Within the Treatment group , significant differences between pretreatment and posttreatment scores ( MANOVA ) were found for Mouth-Opening Measure and Mid-Top-Lip Measure . Similarly , Mouth-Opening Measure , Mid-Top-Lip Measure , Lower-Lip Thickness Measure , Top Eyelid/Iris Intersect Measure and Lower Eyelid/Iris Intersect Measure were significant across time from baseline to follow-up in the Treatment group only . No significant differences were found on any of the facial measures during the same period for members of the Control group . These findings suggest that OPT can improve facial movement and that this benefit extends in time , beyond the period of OPT itself . Such an increase in facial mobility can be expected to modify the " Parkinsonian facies " and facilitate the display of facial expressions Respiratory symptoms are recognized as sequelae of motor dysfunction in idiopathic Parkinson 's disease ( IPD ) and these symptoms have the potential to cause problems with swallow , cough , voice and speech . Specifically , maneuvers that require rapid activation and coordination of upper airway and chest wall musculature become progressively impaired as motor dysfunction progresses during the natural course of the disease . This study reports on the maximum inspiratory and expiratory pressures produced by 28 participants ( average age 64 ) diagnosed with moderate to severe IPD ( average stage 2.5 with a range of 2.0 - 3.0 ) . All measures were collected during the " medication on " state . Outcomes of a specific respiratory muscle strength training technique for improving maximum expiratory pressure are reported for three of the patients in this study . Techniques that focus on strengthening the respiratory muscles in patients with IPD ( other than with low load breathing exercises ) , have not been previously reported . The results of this pilot study demonstrate that respiratory muscle weakness may be an important factor in the respiratory complications in IPD and that respiratory muscle strength training has the potential to improve expiratory muscle strength for this population . This improvement has the potential to positively impact high forced respiratory activities , such as forced breathing maneuvers , swallow , cough and speech functions that require greater magnitude and duration of expiration We studied the effect of clonazepam in a double-blind trial on 12 parkinsonian patients with hypokinetic dysarthria . Speech sample s were judged on 14 of the dimensions used in the Mayo Clinic dysarthria study . Of the 11 patients who completed the study , 10 showed improvement . The effective dosage of clonazepam was 0 . 25 to 0 . 5 mg/d with higher dosage than that less effective . Clonazepam has a definite role in the management of perkinsonian dysarthria A study was set up to judge the efficacy and long term effects of intensive speech therapy in patients with Parkinson 's Disease . A total of 22 patients entered the study but only 18 completed it . Twelve patients were r and omly allocated to a treatment group and participated in a two week intensive speech therapy programme . Ten patients were r and omly allocated to a control group and received no therapy . Six of the control group and all twelve of the treatment group patients were available for follow-up assessment s . It is concluded that a course of intensive speech therapy is of value to patients with speech and voice problems arising out of their Parkinson 's Disease and that the effects of speech therapy can be maintained for up to a period of three months at least
Output:
| Some measures of speech monotoni city and articulation were investigated ; however , all these results were non-significant .
Although improvements in speech impairments were noted in these studies , due to the small number of patients examined , method ological flaws , and the possibility of publication bias , there is insufficient evidence to conclusively support or refute the efficacy of SLT for speech problems in Parkinson 's disease . |
MS211958 | ***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: Ninety‐seven parturients undergoing elective Caesarean section were allocated r and omly to have their legs elevated to approximately 30 ° on pillows or elevated and wrapped with elasticated Esmarch b and ages or neither ( controls ) following spinal anaesthesia . All patients received intravenous crystalloid ( 20 ml.kg−1 over 20 min ) prior to spinal injection and were placed in the left lateral tilt position . Significant hypotension was treated with intravenous ephedrine in 5 mg bolus doses . Leg wrapping result ed in a significant reduction in the incidence ofpostspinal hypotension in comparison to the control group ( 18 % compared to 53 % , p = 0.004 ) . This represents a five‐fold reduction in the likelihood ofpostspinal hypotension ( odds ratio 5.3 , 95 % CI 1.7–16.3 ) . Leg elevation alone did not significantly reduce the incidence of hypotension ( 39 % ) . There was no significant difference in the time of onset of hypotension between the groups . For those patients requiring ephedrine , there was no significant difference in mean dose requirements between the groups . The use of leg compression immediately postspinal provides a simple means of reducing the accompanying hypotension and should be used more widely Seventy-eight pregnant women at term , scheduled for elective cesarean section , were enrolled in this multicenter trial to compare the analgesic efficacy and side effect profile of a spinal block with hyperbaric bupivacaine alone ( Group B ) or combined with 75 [ micro sign]g of clonidine ( Group BC ) or with clonidine 75 [ micro sign]g and fentanyl 12.5 [ micro sign]g ( Group BCF ) . Intraoperatively , clonidine increased the spread of the sensory block and decreased pain ( pain scores 23 + /- 7 mm vs 17 + /- 6 and 2 + /- 1 mm for Group B versus Groups BC and BCF ; P < 0.05 ) and analgesic supplementation . This improved analgesia was best with the clonidine-fentanyl combination ( Group BC versus Group BCF ; P < 0.05 ) . Postoperative analgesia was prolonged only in Group BCF ( 215 + /- 79 min vs 137 + /- 35 and 183 + /- 80 min for Group BCF versus Groups B and BC ; P < 0.05 ) . Blood pressure and heart rate changes were not significantly different among groups , whereas sedation and pruritus were significantly more frequent in Group BCF . Nausea and vomiting were decreased in Groups BC and BCF . Apgar scores and umbilical artery blood pH were not different among groups . We conclude that adding a small dose of intrathecal clonidine to bupivacaine increases the quality of intraoperative analgesia and decreases pain during cesarean section . Combining clonidine with fentanyl further improved analgesia . Implication s : In this study , we demonstrate improved intraoperative spinal analgesia by adding 75 [ micro sign]g of clonidine to bupivacaine ; side effects were not increased . The combination of clonidine and fentanyl further improved analgesia but moderately increased sedation and pruritus . ( Anesth Analg 1998;87:609 - 13 Abstract Purpose . This study aim ed to compare low-molecular weight hydroxyethyl starch containing 1 % dextrose ( HES ) infusion and lactated Ringer 's solution ( LR ) in the prevention of hypotension associated with spinal anesthesia for cesarean section . Methods . Sixty-seven patients scheduled for cesarean section under spinal anesthesia were r and omly allocated to receive either LR ( n= 35 ) or HES ( n= 32 ) infusion before cesarean delivery . Infusion of the fluid was started immediately after arrival at the operating room , through two fully open i.v . routes of 18 or 16 gauge . The two groups were compared in terms of the incidence of hypotension ; ephedrine dose ; cord and maternal blood gas , hemoglobin , and glucose ; and Apgar scores . Results . Intravenous fluid volume until delivery in the LR group was significantly greater than that in the HES group ( 1298 ± 503 and 973 ± 339 ml , respectively ) in spite of the similar periods of intravenous infusion ( 18.1 ± 3.9 and 18.2 ± 4.1 min ) . The incidence of hypotension , and the ephedrine dose , blood gas analyses , and Apgar scores were not significantly different between the groups . The ephedrine dose correlated with the anesthesia level by spinal anesthesia ( P < 0.05 ) . Conclusion . This study did not show an advantage of HES compared with LR in the prevention of hypotension or in the reduction of ephedrine dose during cesarean section under spinal anesthesia . The anesthesia level , rather than the choice of intravenous fluid solution , might be related to the ephedrine dose We r and omized women having elective Caesarean section to receive either no preload ( control group , n=33 ) or 4 % gelatin solution ( Gelofusine ) 15 ml kg(-1 ) ( colloid group , n=35 ) i.v . before spinal anaesthesia . Intravenous metaraminol was titrated at 0.25 - 0.75 mg min(-1 ) to maintain systolic arterial pressure ( SAP ) in the target range 90 - 100 % of baseline after the spinal injection . The control group required more vasopressor in the first 10 min [ median 1.7 ( range 0 - 2.9 ) mg vs 1.4 ( 0 - 2.8 ) , P=0.02 ] at a greater maximum infusion rate [ 0.5 ( 0 - 0.75 ) vs 0.25 ( 0 - 0.5 ) mg min(-1 ) , P=0.0005 ] and had a lower minimum SAP [ 90 ( 51 - 109 ) vs 101 ( 75 - 127 ) mm Hg , P=0.006 ] than the colloid group . Nausea was less frequent in the colloid group ( 6 vs 24 % ) but neonatal outcome was similar in the two groups . Colloid preload improved haemodynamic stability but did not affect neonatal outcome when arterial pressure was maintained with an infusion of metaraminol during spinal anaesthesia for Caesarean section Abstract We have routinely applied an extra-strong graduated compression stocking to cesarean section patients to reduce the incidence of spinal anesthesia hypotension . Because bupivacaine has recently become available in Japan , we compared the incidence of spinal hypotension using either 2.0 ml of hyperbaric 0.3 % dibucaine or 0.5 % bupivacaine . There were 98 full-term parturients wearing the stocking who received 2.0 ml injection of dibucaine or bupivacaine for elective cesarean section . When systolic blood pressure decreased to 90–100 mm Hg or to less than 70 % of the pre-anesthesia value , ephedrine was injected intravenously . There was no significant difference in systolic blood pressure or heart rate during spinal anesthesia between the dibucaine and bupivacaine groups . Although the demographic data and various data related to anesthesia or surgery were similar in the groups , the fluid volume and the dose and incidence of ephedrine injection during anesthesia showed significant differences : the mean dose was 3.6 and 1.5 mg and the incidence was 41 % and 19 % in the dibucaine and bupivacaine groups , respectively . Spinal anesthesia using bupivacaine results in a lower incidence of spinal hypotension compared with dibucaine and , in combination with fitting the extra-strong stockings onto both legs , is clinical ly useful for cesarean sections Maternal and neonatal catecholamine concentrations , following the use of either phenylephrine or ephedrine to treat a drop in maternal blood pressure after spinal anaesthesia for caesarean delivery , were compared . Patients were r and omly assigned to one of two groups : Group 1 patients ( n = 20 ) were treated with ephedrine given as 5 mg intravenous bolus injections ; Group 2 patients ( n = 20 ) were treated with phenylephrine given as 40 μg intravenous bolus injections , for decreases in maternal systolic blood pressure to maintain maternal systolic blood pressure above 100 mmHg . Maternal vein ( MV ) , umbilical vein ( UV ) , and umbilical artery ( UA ) blood sample s were taken at the time of delivery . Sample s were analyzed for catecholamine concentrations and blood gas values The value of intravenous crystalloid administration in preventing spinal-induced hypotension in the parturient has recently been question ed . Also , the association between increasing crystalloid volume and decreasing postpartum colloid osmotic pressure ( COP ) raises concern regarding the risk of maternal and fetal pulmonary edema . To study the dose-response effect of varying amounts of crystalloid volume prior to spinal anesthesia , we measured maternal hemodynamic variables and maternal and fetal COP in three groups of healthy parturients receiving spinal anesthesia for elective cesarean delivery . Fifty-five parturients were r and omized in a double-blind fashion to receive one of 10 , 20 , or 30 mL/kg of crystalloid volumes prior to induction of spinal anesthesia . Measurements included mean arterial blood pressure ( MAP ) , cardiac index ( CI ) , and systemic vascular resistance index ( SVRI ) recorded using noninvasive thoracic impedance monitoring until delivery . Maternal and neonatal COP were measured . All groups showed declines in MAP and SVRI from baseline at 5 min after spinal anesthesia , but the amount of decline did not differ among groups . Total ephedrine and additional intravenous ( IV ) fluid administered did not differ among groups . The 20- and 30- mL/kg groups showed a larger decline in maternal COP than the 10-mL/kg group ; no differences in neonatal COP were seen with varying preload . We conclude that increasing the amount of IV crystalloid administered to 30 mL/kg in the healthy parturient does not significantly alter maternal hemodynamics or ephedrine requirements after spinal anesthesia and has no apparent benefit . ( Anesth Analg 1996;83:299 - 303 Purpose To study how the body h and les fluid given intravenously during the onset of spinal anaesthesia in women scheduled for Caesarean section . Methods The effect of spinal anaesthesia on the volume kinetics of a constant-rate infusion of 25 ml · kg−1 of Ringer ’s solution ( n = 11 ) and 10 ml · kg−1 of dextran 3 % 60 ( n = 8) was studied before elective Caesarean section , Measurements of the blood haemoglobin concentration and urine excretion served as input variables in calculations of the size(s ) of the body fluid spaces exp and ed by the infused fluid . The blood glucose level was also monitored . Results When a one-volume kinetic model were fitted to the data , spinal anaesthesia reduced the size of the exp and ed body fluid space by 30 % ( Ringer ’s ) and 58 % ( dextran ) ( P < 0.02 ) When a two-volume model was statistically justified , anaesthesia reduced the rate of fluid equilibration between the two exp and ed body fluid spaces by 47 % and 19 % , respectively ( P < 0.04 ) The baseline volume for the primary ( central ) fluid space was smaller than the expected plasma volume ; 1.5 l for Ringer ’s solution and 0.9 l for dextran . Only small changes in the blood glucose concentration were found . Conclusion The onset of spinal anaesthesia induces acute changes in the body ’s h and ling of infused fluid that can be described by volume kinetic analysis .RésuméObjectifÉtudier le devenir des liquides administrés par voie intraveineuse durant l’induction de l’anesthésie rachidienne chez des parturientes subissant une césarienne . MéthodesLes effets de la rachianesthésie sur la cinétique volumétrique d’une infusion à débit constant de 25 ml · kg−1 de solution de Ringer ( n= 11 ) ou de 10 ml · kg−1 de dextran 60 en solution à 3 % ( n = 8) ont été étudiés avant la césarienne élective . Les mesures du taux d’hémoglobine sanguin et du débit urinaire ont servi comme entrées variables dans le calcul de l’expansion volémique par le liquide infusé des différents compartiments corporels . La glycémie a aussi été mesurée . RésultatsLorsque les données étaient rapportées à un modèle cinétique à un seul compartiment , l’anesthésie rachidienne entraînait une réduction du compartiment corporel déjà distendu de 30 % pour le Ringer et de 58 % pour le dextran ( P 0.02 ) . Lorsqu’un modèle à deux compartiments apparaissait justifié d’un point de vue statistique , l’anesthésie entraînait une réduction du taux d’équilibration entre les deux compartiments corporels déjà distend
Output:
| REVIEW ER 'S CONCLUSIONS No studied intervention has been shown to eliminate the need to treat maternal hypotension during spinal anaesthesia for caesarean section .
We are unable to draw any conclusions regarding adverse effects of the studied interventions , due to their probable low incidence and the small number of women studied . |
MS211959 | ***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 Effects of pump treatment vs. four times daily injections were explored in children with diabetes with regard to quality of life and impact of disease as well as adverse effects and parameters of metabolic control . METHODS An open , parallel , r and omized controlled prospect i ve comparative study lasting 14 months was completed by 38 type 1 children with diabetes ( age 4 - 16 yr ) following a 3.5-months run-in phase . St and ardized quality -of-life Pediatric Quality of life Inventory ( PedsQL ) and impact of disease scores were obtained every 3.5 months as well as regular medical parameters . Parallel treatment group data and longitudinal within-patient data were analysed for each treatment modality . RESULTS Within-patient comparisons of the two treatment modalities showed significant improvement in PedsQL and impact scores after pump treatment . Treatment group comparisons did not show significant improvement . Pump treatment result ed in decreased symptomatic hypoglycaemia and lowered haemoglobin A1c by 0.22 % after run in . CONCLUSIONS Within-patient comparison suggests that metabolic control , frequency of severe hypoglycaemia ( a threefold decrease ) , quality of life and impact of disease scores are improved by pump treatment in comparison to regular treatment with four daily insulin injections BACKGROUND The management of diabetes in preschool children poses unique difficulties for both the families and the medical team . OBJECTIVE To test the feasibility and safety of insulin pump therapy in the 1 - 6 year age group in order to improve quality of life and metabolic control . METHODS The study group comprised 15 type 1 diabetic children aged 1 - 6 years old ( mean + /- SD , 3.8 + /- 1.2 years ) from three diabetes centers . Insulin pump therapy was applied for 12 months . Data , including insulin dose , hemoglobin A1c , hypoglycemic events , as well as scores on the Diabetes Quality of Life Measure Question naire and the Diabetes Treatment Satisfaction Question naire , were collected and compared with the multiple daily injection treatment prior to entry into the study , RESULTS HbA1c was measured at the beginning of the study and at 2 , 4 , 8 and 12 months later ; the respective levels ( mean + /- SD ) were 8.82 + /- 0.98 , 8.45 + /- 1.05 , 8.37 + /- 0.85 , 8.32 + /- 0.71 , 8.18 + /- 0.90 % . HbA1c measurements after 12 months were significantly lower than at the beginning of the study ( P < 0.05 ) . There were no significant differences in insulin dose and the total number of hypoglycemic events . In both the DQOL and DTSQ scales there were significant differences in scores in favor of the insulin pump period ( 43.7 + /- 8.0 versus 33.7 + /- 7.9 , P < 0.001 ; and 10.9 + /- 2.3 versus 14.5 + /- 2.3 , P < 0.001 ) , respectively . CONCLUSIONS For very young diabetic children , insulin pump therapy improves quality of life and is feasible and safe . It should be considered as an optional mode of therapy for this age group OBJECTIVE Our goals were to determine if continuous subcutaneous insulin infusion ( CSII ) , compared with those continuing multiple daily injections ( MDIs ) , can be safely used in young children , if those on CSII will have superior glycemic control , if subjects using CSII will have less hypoglycemia for their level of control , and if families using CSII will report an improved quality of life . RESEARCH DESIGN AND METHODS We conducted a r and omized 1-year feasibility trial comparing CSII with continuing MDIs in preschool children with a history of type 1 diabetes for at least 6 months ' duration . Prospect i ve outcomes included measures of overall glycemic control ( HbA1c and continuous glucose monitoring system ) , the incidence of severe hypoglycemia and diabetic ketoacidosis , the percent of glucose values below 3.9 mmol/l , and the parents ' report of quality of life . RESULTS The 19 subjects ' ages ranged from 1.7 to 6.1 ( mean 3.6 ) years , duration of diabetes ranged from 0.6 to 2.6 ( mean 1.4 ) years , and baseline HbA1c ranged from 6.7 to 9.6 % ( mean 7.9 % ) . Seven subjects were male . Nine subjects were r and omized to start CSII and 10 to continue on MDI . All baseline characteristics were well balanced . Overall metabolic control , diabetes quality of life , and the incidence of hypoglycemia were similar in the two groups . No subject had diabetic ketoacidosis , while one subject in each group had an episode of severe hypoglycemia . No CSII subject discontinued using the pump during or after the study . CONCLUSIONS CSII can be a safe and effective method to deliver insulin in young children BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Intensive therapy for type 1 diabetes mellitus ( DM ) is usually provided by either multiple daily injections of insulin ( MDI ) or by insulin pump ( continuous subcutaneous insulin infusion CSII ) . We design ed an open , r and omized , crossover trial to compare CSII with MDI for glycemic control , dose requirements , weight change , incidence of adverse events , quality of life and satisfaction in adolescents Purpose : To review research design s for rehabilitation . Summary of Key Points : Single-case , observational , and qualitative design s are highlighted in terms of recent advances and ability to answer important scientific questions about rehabilitation . Statement of Conclusions : Single-case , observational , and qualitative design s can be conducted in a systematic and rigorous manner that provides important information that can not be acquired using more common design s , such as r and omized controlled trials . These less commonly used design s may be more feasible and effective in answering many research questions in the field of rehabilitation . Recommendations for Clinical Practice : Research ers should consider these design s when selecting the optimal design to answer their research questions . We should improve education about the advantages and disadvantages of existing research design s to enable more critical analysis of the scientific literature we read and review to avoid undervaluing studies not within more commonly used categories OBJECTIVE To compare the efficacy and feasibility of continuous subcutaneous insulin infusion ( CSII ) with multiple daily insulin injections ( MDI ) in children with type 1 diabetes . METHODS The study sample included 23 children ( 10 males ) aged 9.4 to 13.9 years with type 1 diabetes . An open r and omized crossover design was used to compare 3.5 months of CSII to 3.5 months of MDI therapy for the following variables : diabetic control , incidence of adverse events , daily insulin requirement , body mass index st and ard deviation scores , treatment satisfaction , and quality of life . RESULTS The changes in HbA(1c ) and fructoseamine values were similar in the 2 arms over time . At the end of the study , mean HbA(1c ) level measured 8.05 + /- 0.78 % . There were no differences between the treatment modes in frequency of symptomatic hypoglycemic or hyperglycemic events . There was 1 event of severe hypoglycemia during pump therapy and 3 during MDI , yielding a rate of 0.26 events per patient-year . There were no episodes of diabetic ketoacidosis . Body mass index st and ard deviation scores decreased during CSII and increased during MDI , as did mean insulin dose . Patients expressed a higher treatment satisfaction from CSII than MDI , although there was no difference in quality of life between the 2 modes . CONCLUSIONS Intensive insulin therapy by either insulin pump or MDI is safe in children and young adolescents with type 1 diabetes , with similar diabetes control and a very low rate of adverse events . We suggest that both modes be available to the diabetic team to better tailor therapy BACKGROUND The risk of developing long-term complications of type 1 diabetes ( T1D ) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens : multiple daily injections ( MDI ) ( ≥ 4 ) and continuous subcutaneous insulin infusion ( CSII ) . Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI , both treatments are used widely within the NHS . OBJECTIVES ( 1 ) To compare glycaemic control during treatment with CSII and MDI and ( 2 ) to determine safety and cost-effectiveness of the treatment , and quality of life ( QoL ) of the patients . DESIGN A pragmatic , open-label r and omised controlled trial with an internal pilot and 12-month follow-up with 1 : 1 web-based block r and omisation stratified by age and centre . SETTING Fifteen diabetes clinics in hospitals in Engl and and Wales . PARTICIPANTS Patients aged 7 months to 15 years . INTERVENTIONS Continuous subsutaneous insulin infusion or MDI initiated within 14 days of diagnosis of T1D . DATA SOURCES Data were collected at baseline and at 3 , 6 , 9 and 12 months using paper forms and were entered central ly . Data from glucometers and CSII were downloaded . The Health Utilities Index Mark 2 was completed at each visit and the Pediatric Quality of Life Inventory ( PedsQL , diabetes module ) was completed at 6 and 12 months . Costs were estimated from hospital patient administration system data . OUTCOMES The primary outcome was glycosylated haemoglobin ( HbA1c ) concentration at 12 months . The secondary outcomes were ( 1 ) HbA1c concentrations of < 48 mmol/mol , ( 2 ) severe hypoglycaemia , ( 3 ) diabetic ketoacidosis ( DKA ) , ( 4 ) T1D- or treatment-related adverse events ( AEs ) , ( 5 ) change in body mass index and height st and ard deviation score , ( 6 ) insulin requirements , ( 7 ) QoL and ( 8) partial remission rate . The economic outcome was the incremental cost per quality -adjusted life-year ( QALY ) gained . RESULTS A total of 293 participants , with a median age of 9.8 years ( minimum 0.7 years , maximum 16 years ) , were r and omised ( CSII , n = 149 ; MDI , n = 144 ) between May 2011 and January 2015 . Primary outcome data were available for 97 % of participants ( CSII , n = 143 ; MDI , n = 142 ) . At 12 months , age-adjusted least mean squares HbA1c concentrations were comparable between groups : CSII , 60.9 mmol/mol [ 95 % confidence interval ( CI ) 58.5 to 63.3 mmol/mol ] ; MDI , 58.5 mmol/mol ( 95 % CI 56.1 to 60.9 mmol/mol ) ; and the difference of CSII - MDI , 2.4 mmol/mol ( 95 % CI -0.4 to 5.3 mmol/mol ) . For HbA1c concentrations of < 48 mmol/mol ( CSII , 22/143 participants ; MDI , 29/142 participants ) , the relative risk was 0.75 ( 95 % CI 0.46 to 1.25 ) , and for partial remission rates ( CSII , 21/86 participants ; MDI , 21/64 ) , the relative risk was 0.74 ( 95 % CI 0.45 to 1.24 ) . The incidences of severe hypoglycaemia ( CSII , 6/144 ; MDI , 2/149 participants ) and DKA ( CSII , 2/144 participants ; MDI , 0/149 participants ) were low . In total , 68 AEs ( 14 serious ) were reported during CSII treatment and 2
Output:
| RESULTS QoL and glycaemic control was significantly better in CSII subjects at baseline and follow-up .
No significant differences in adverse events were found between study groups .
No significant changes over time could be shown for either QoL or glycaemic control .
CONCLUSION CSII proved to provide similar or slightly better outcomes in all analysed fields .
This is consistent with previous research . |
MS211960 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To determine whether antioxidant therapy alters the disease process in severe early onset pre‐eclampsia , in support of the hypothesis that increased lipid peroxides and reactive oxygen species production play an important role in the pathogenesis of the disease To study the effect of calcium and vitamin D supplementation on the incidence of toxaemia of pregnancy , 200 r and omly selected pregnant women ( supplemented group ) , were put on calcium ( 375 mg/day ) and vitamin D ( 1,200 IU/day ) supplements at 20 - 24 weeks of pregnancy onwards . Another 200 pregnant women constituted the non-supplemented group . At 32 and 36 weeks of pregnancy the systolic and diastolic blood pressure of non-toxemic women was significantly lower in the supplemented group than in the non-supplemented group . However , the incidence of toxaemia in the supplemented group ( 6 % ) was not significantly different from that in the non-supplemented group ( 9 % ) Hypertension during pregnancy increases fetal growth retardation , preterm deliveries , and perinatal deaths , and yet its causes remain unclear . In HIV-infected women , preterm birth additionally increases the risk of HIV transmission to the infant . Oxidative stress and endothelial cell dysfunction of the placenta have been implicated in the development of hypertension during pregnancy . Vitamin intake can reduce oxidative stress and improve endothelial function . We therefore evaluated the effect of multivitamin ( 20 mg thiamine , 20 mg riboflavin , 25 mg B-6 , 50 microg B-12 , 500 mg C , 30 mg E , and 0.8 mg folic acid ) and vitamin A supplements ( 30 mg beta-carotene plus 5000 IU preformed vitamin A ) in relation to hypertension during pregnancy ( systolic blood pressure > or = 140 mm Hg or diastolic blood pressure > or = 90 mm Hg at any time during pregnancy ) . In a double-blind , placebo-controlled , r and omized , clinical trial , conducted among 1078 HIV-positive pregnant Tanzanian women , those who received multivitamins were 38 % less likely to develop hypertension during pregnancy than those who did not [ relative risk ( RR ) = 0.62 , 95 % CI 0.40 - 0.94 , P = 0.03 ] . There was no overall effect of vitamin A on hypertension during pregnancy ( RR = 1.00 , 95 % CI 0.66 - 1.51 , P = 0.98 ) . Hypertension during pregnancy was more likely in women with high baseline systolic blood pressure ( > 120 vs. < or = 120 mm Hg ) ( RR = 6.02 , 95%CI 2.59 - 13.97 , P < 0.001 ) , and those with higher mid-upper arm circumference ( RR = 1.12 , 95 % CI 1.04 - 1.19 , P = 0.002 ) . Taking multivitamins containing vitamins B , C , and E during pregnancy may be an inexpensive and effective strategy to improve the health of the mother and baby BACKGROUND Vitamin C is involved in the synthesis and degradation of collagen and is important for maintenance of the chorioamniotic membranes . Inadequate availability of ascorbic acid during pregnancy has been proposed as a risk factor for premature rupture of the chorioamniotic membranes ( PROM ) . OBJECTIVE The objective of the study was to evaluate the effectiveness of 100 mg vitamin C/d in preventing PROM . DESIGN A controlled double-blind trial was performed . Pregnant women ( n = 126 ) in their 20th wk of gestation were invited ; 120 accepted and were r and omly assigned to 2 groups ( 100 mg vitamin C/d or placebo ) . Every 4 wk , plasma and leukocyte vitamin C concentrations were measured , and each subject was evaluated for cervicovaginal infection . The incidence of PROM was recorded for each group as an indicator of the protective effect of vitamin C supplementation . RESULTS One hundred nine patients finished the study . Mean plasma vitamin C concentrations decreased significantly throughout the pregnancy in both groups ( P = 0.001 ) , and there were no significant differences between groups . Between weeks 20 and 36 , mean leukocyte vitamin C concentrations decreased from 17.5 to 15.23 microg/10(8 ) cells in the placebo group and increased from 17.26 to 22.17 microg/10(8 ) cells in the supplemented group ( within- and between-group differences : P = 0.001 ) . The incidence of PROM was 14 per 57 pregnancies ( 24.5 % ) in the placebo group and 4 per 52 pregnancies ( 7.69 % ) in the supplemented group ( relative risk : 0.26 ; 95 % CI : 0.078 , 0.837 ) . CONCLUSION Daily supplementation with 100 mg vitamin C after 20 wk of gestation effectively lessens the incidence of PROM CONTEXT Pregnant women who are positive for thyroid peroxidase antibodies [ TPOAb(+ ) ] are prone to develop postpartum thyroid dysfunction ( PPTD ) and permanent hypothyroidism . Selenium ( Se ) decreases thyroid inflammatory activity in patients with autoimmune thyroiditis . OBJECTIVE We examined whether Se supplementation , during and after pregnancy , influences the thyroidal autoimmune pattern and function . DESIGN This was a prospect i ve , r and omized , placebo-controlled study . SETTING The study was conducted in the Department of Obstetrics and Gynecology and Department of Endocrinology . PATIENTS A total of 2143 euthyroid pregnant women participated in the study ; 7.9 % were TPOAb(+ ) . INTERVENTIONS During pregnancy and the postpartum period , 77 TPOAb(+ ) women received selenomethionine 200 microg/d ( group S1 ) , 74 TPOAb(+ ) women received placebo ( group S0 ) , and 81 TPOAb(- ) age-matched women were the control group ( group C ) . MAIN OUTCOME MEASURES We measured the prevalence of PPTD and hypothyroidism . RESULTS PPTD and permanent hypothyroidism were significantly lower in group S1 compared with S0 ( 28.6 vs. 48.6 % , P<0.01 ; and 11.7 vs. 20.3 % , P<0.01 ) . CONCLUSION Se supplementation during pregnancy and in the postpartum period reduced thyroid inflammatory activity and the incidence of hypothyroidism OBJECTIVE Rates of pre-eclampsia in women with type 1 diabetes are two to four times higher than in normal pregnancies . Diabetes is associated with antioxidant depletion and increased free radical production , and an increasing body of evidence suggests that oxidative stress and endothelial cell activation may be relevant to disease pathogenesis in pre-eclampsia . The Diabetes and Pre-eclampsia Intervention Trial ( DAPIT ) aims to establish if pregnant women with type 1 diabetes supplemented with vitamins C and E have lower rates of pre-eclampsia and endothelial activation compared with placebo treatment . METHODS DAPIT is a r and omised multicentre double-blind placebo-controlled trial that will recruit 756 pregnant women with type 1 diabetes from 20 metabolic-antenatal clinics in the UK over 4 years . Women are r and omised to daily vitamin C ( 1000 mg ) and vitamin E ( 400 IU ) or placebo at 8 - 22 weeks of gestation until delivery . Maternal venous blood is obtained at r and omisation , 26 and 34 weeks , for markers of endothelial activation and oxidative stress and to assess glycaemic control . The primary outcome of DAPIT is pre-eclampsia . Secondary outcomes include endothelial activation ( PAI-1/PAI-2 ) and birthweight centile In a previous study from this institution , patients at high risk for preterm labour were screened for the presence of bacterial vaginosis ( BV ) . When BV was present , they were r and omised to receive either treatment ( metronidazole ) or placebo ( vitamin C ) . There were significantly more patients with preterm labour in the metronidazole group . The aim of this double-blind r and omised placebo-controlled trial study was to determine whether vitamin C could indeed reduce the recurrence risk of preterm labour . Patients with a history of preterm labour in a preceding pregnancy were r and omised to receive 250 mg vitamin C or a matching placebo twice daily until 34 weeks ' gestation . They attended a dedicated premature labour clinic . Significantly more women delivered before term in the group that received vitamin C , but there was no difference in the outcome of the babies between the two groups . Supplementation with vitamin C did not prevent premature labour We studied the effect of VIBOVITmama ( Polfa Kutno S.A. ) supplementation on the course of pregnancy duration , delivery and puerperium and also the status of zinc , copper and selenium in the blood of matched maternal-cord pairs . Healthy pregnant women ( n=138 ) were divided by a double blinded trial into a test group taking vitamin and mineral supplementation containing 15 mg of zinc , 2 mg of copper and 20 microg of selenium and a control group taking placebo . Course of pregnancy , delivery and puerperium were analyzed , as well as concentration of bioelements in the blood serum of pregnant women in the I , II , and II trimester and in umbilical cord blood of their children . In the study group we noted fewer by 1.45 % cases of pregnancy induced hypertension and a much higher rate of natural deliveries ( 75 % ) in comparison to the control group ( 53 % ) . During pregnancy in the supplemented group a 1 % increase of zinc serum concentration was found . In the control group zinc concentration decreased by 7 % ( p < 0.005 ) . Insignificant differences in serum concentration of copper and selenium was observed between the study group and controls . In umbilical cord blood the differences in the concentration of the above microelements were also insignificant . The results allow for the statement that VIBOVITmama supplementation stabilizes the zinc , copper and selenium levels in blood of pregnant women without the risk of overdosing , especially with reference to selenium OBJECTIVE To determine whether supplementation with vitamins C and E after preterm premature rupture of membranes ( PPROM ) is associated with an increased latency period . METHODS In this double-blind , r and omized , controlled trial , 60 women with singleton pregnancies of 26 to 34 weeks ' duration and PPROM were r and omly assigned to vitamin C ( 500 mg/day ) and vitamin E ( 400 IU/day ) or placebo until delivery . All women received 2 doses of betamethasone in the first 24 h after admission as well as broad-spectrum antibiotic prophylaxis . RESULTS Important demographic , as well as clinical characteristics such as number of cases of chorioamnionitis , early neonatal sepsis , and respiratory distress syndrome , were similar in the 2 groups . A statically significant difference in the mean+/-S.D. number of days of latency was found between the groups ( 10.5+/-5.2 days vs. 3.5+/-4.0 days ( P = 0.03 ) . CONCLUSION Vitamins C and E supplementation of after PPROM is associated with a longer latency before delivery BACKGROUND Oxidative stress could play a part in pre-eclampsia , and there is some evidence to suggest that vitamin C and vitamin E supplements could reduce the risk of the disorder . Our aim was to investigate the potential benefit of these antioxidants in a cohort of women with a range of clinical risk factors . METHODS We did a r and omised , placebo-controlled trial to which we enrolled 2410 women identified as at increased risk of pre-eclampsia from 25 hospitals . We assigned the women 1000 mg vitamin C and 400 IU vitamin E ( RRR alpha tocopherol ; n=1199 ) or matched placebo ( n=1205 ) daily from the second trimester of pregnancy until delivery . Our primary endpoint was pre-eclampsia , and our main secondary endpoints were low birthweight ( < 2.5 kg ) and small size for gestational age ( < 5th customised birthweight centile ) . Analyses were by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N 62368611 . FINDINGS Of 2404 patients treated , we analysed 2395 ( 99.6 % ) . The incidence of pre-eclampsia was similar in treatment placebo groups ( 15 % [ n=181 ] vs 16 % [ n=187 ] , RR 0.97 [ 95 % CI 0.80 - 1.17 ] ) . More low birthweight babies were born to women who took antioxidants than to controls ( 28 % [ n=387 ] vs 24 % [
Output:
| However , for the latter two outcomes , this was not clearly reflected in an increase in any other hypertensive complications .
AUTHORS ' CONCLUSIONS Evidence from this review does not support routine antioxidant supplementation during pregnancy to reduce the risk of pre-eclampsia and other serious complications in pregnancy |
MS211961 | ***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 only r and omised controlled trial to test high-fidelity assertive community treatment ( ACT ) in the UK ( the R and omised Evaluation of Assertive Community Treatment ( REACT ) study ) found no advantage over usual care from community mental health teams in reducing the need for in-patient care and in other clinical outcomes , but participants found ACT more acceptable and engaged better with it . One possible reason for the lack of efficacy of ACT might be the short period of follow-up ( 18 months in the REACT study ) . This paper reports on participants ' service contact , in-patient service use and adverse events 36 months after r and omisation Integrated mental health and substance abuse treatment within an assertive community treatment ( ACT ) approach was compared to that within a st and ard case management approach for 223 patients with dual disorders over three years . ACT patients showed greater improvements on some measures of substance abuse and quality of life , but the groups were equivalent on most measures , including stable community days , hospital days , psychiatric symptoms , and remission of substance use disorder BACKGROUND The significant reductions in hospital admission demonstrated in US assertive community treatment ( ACT ) studies have not been replicated in the UK . Explanations cite poor UK ' model fidelity ' and /or better UK st and ard care . No international model-fidelity comparisons exist . AIMS To compare high-fidelity US ACT teams with a UK team . METHOD The UK 700 's ACT team ( n=97 ) was compared with high-fidelity US ACT teams ( n=73 ) by using two measures : a forerunner of the Dartmouth Assertive Community Treatment schedule ( to assess adherence to ACT principles ) and 2-year prospect i ve activity data . RESULTS The UK and US teams had similar high-fidelity scores . Although significant differences were found in the amount and type of activity , practice differences in areas central to ACT were not great . CONCLUSIONS The failure of UK ACT studies to demonstrate the outcome differences of early US studies can not be attributed entirely to the lack of ACT fidelity Abstract Objective To compare outcomes of care from assertive community treatment teams with care by community mental health teams for people with serious mental illnesses . Design Non-blind r and omised controlled trial . Setting Two inner London boroughs . Participants 251 men and women under the care of adult secondary mental health services with recent high use of inpatient care and difficulties engaging with community services . Interventions Treatment from assertive community treatment team ( 127 participants ) or continuation of care from community mental health team ( 124 participants ) . Main outcome measures Primary outcome was inpatient bed use 18 months after r and omisation . Secondary outcomes included symptoms , social function , client satisfaction , and engagement with services . Results No significant differences were found in inpatient bed use ( median difference 1 , 95 % confidence interval −16 to 38 ) or in clinical or social outcomes for the two treatment groups . Clients who received care from the assertive community treatment team seemed better engaged ( adapted homeless engagement acceptance schedule : difference in means 1.1 , 1.0 to 1.9 ) , and those who agreed to be interviewed were more satisfied with services ( adapted client satisfaction question naire : difference in means 7.14 , 0.9 to 13.4 ) . Conclusions Community mental health teams are able to support people with serious mental illnesses as effectively as assertive community treatment teams , but assertive community treatment may be better at engaging clients and may lead to greater satisfaction with services BACKGROUND The aim was to compare the efficacy of intensive clinical case management ( ICM ) with st and ard community care in the management of ' hard to treat ' patients with a severe mental illness . METHOD A r and omised controlled trial was carried out in East Lambeth , a deprived area of inner London . Seventy people with psychosis design ated as ' hard to treat ' by referring teams were included ; 35 were r and omised to ICM ( case load eight patients per worker ) , and 35 to st and ard care , which offered follow-up by a community psychiatric nursing service ( 30 patients per worker ) . Outcome measures were admissions and hospital bed utilisation ; contact with services ; symptomatology ; social behaviour ; social functioning ; quality of life ; patients ' satisfaction with care at 9 and 18 months . RESULTS There were no differences in patients ' symptoms , social behaviour or social functioning . Quality of life was significantly improved in patients receiving ICM at 9 months . Satisfaction with care was significantly greater among case-managed patients . All ICM patients remained in contact with services throughout the study , while six control patients were refusing all contact with services at 18 months . CONCLUSIONS ICM failed to improve the clinical outcome of ' hard to treat ' patients . The service was successful in maintaining contact with patients , was greatly appreciated and had a positive effect on their perceived quality of life BACKGROUND The PRiSM Psychosis Study investigated the outcomes of community mental health services for epidemiologically representative cases of psychosis in London . METHOD The results presented in the preceding nine papers are interpreted . RESULTS ( a ) The health and social gains reported in experimental studies of community health services are replicable in ordinary clinical setting s , and are more effective than hospital-oriented services which they replace . ( b ) Dilution does occur -- these gains are less pronounced than in experimental ( efficacy ) studies . ( c ) Both models of community services produced a range of improved outcomes . ( d ) Some limited extra advantages ( in terms of met needs , improved quality of life , and social networks ) were found in the intensive sector . ( e ) There is no consistent evidence that community-oriented services ( which include in-patient beds ) fail service users , their families or the wider public . On balance the results weigh slightly in favour of the two-team model ( for acute and continuing care ) in terms of clinical effectiveness , but the general model is almost as effective and is less expensive . CONCLUSIONS The evidence supports a community-oriented rather than a hospital-oriented approach and there is little difference between the community mental health team models OBJECTIVE The study examined the association between fidelity of programs to the assertive community treatment model and client outcomes in dual disorders programs . METHODS Assertive community treatment programs in the New Hampshire dual disorders study were classified as low-fidelity programs ( three programs ) or high-fidelity programs ( four programs ) based on extensive longitudinal process data . The study included 87 clients with a dual diagnosis of severe mental illness and a comorbid substance use disorder . Sixty-one clients were in the high-fidelity programs , and 26 were in the low-fidelity programs . Client outcomes were examined in the domains of substance abuse , housing , psychiatric symptoms , functional status , and quality of life , based on interviews conducted every six months for three years . RESULTS Clients in the high-fidelity assertive community treatment programs showed greater reductions in alcohol and drug use and attained higher rates of remission from substance use disorders than clients in the low-fidelity programs . Clients in high-fidelity programs had higher rates of retention in treatment and fewer hospital admissions than those in low-fidelity programs . No differences between groups were found in length of hospital stays and other residential measures , psychiatric symptoms , family and social relations , satisfaction with services , and overall life satisfaction . CONCLUSIONS Faithful implementation of , and adherence to , the assertive community treatment model for persons with dual disorders was associated with superior outcomes in the substance use domain . The findings underscore the value of measures of model fidelity , and they suggest that local modifications of the assertive community treatment model or failure to comply with it may jeopardize program success A 2-year experimental cost study of 10 Intensive Psychiatric Community Care ( IPCC ) programs was conducted at Department of Veterans Affairs ( VA ) medical centers in the Northeast . High hospital users were r and omly assigned to either IPCC ( n = 454 ) or st and ard VA care ( n = 419 ) at four neuropsychiatric ( NP ) and six general medical and surgical ( GMS ) hospitals . National computerized data were used to track all VA health care service usage and costs for 2 years following program entry . At 9 of the 10 sites , IPCC treatment result ed in reduced inpatient service usage . Overall , for IPCC patients compared with control patients , average inpatient usage was 89 days ( 33 % ) less while average cost per patient ( for IPCC inpatient , and outpatient services ) was $ 15,556 ( 20 % ) less . Additionally , costs for IPCC patients compared with control patients were $ 33,295 ( 29 % ) less at NP sites but were $ 6,273 ( 15 % ) greater at GMS sites . At both NP and GMS sites , costs were lower for IPCC patients in two subgroups : veterans over age 45 and veterans with high levels of inpatient service use before program entry . No interaction was noted between the impact of IPCC on costs and other clinical or sociodemographic characteristics . Similarly , no linear relationship was observed between the intensity of IPCC services and the impact of IPCC on VA costs , although the two sites that did not fully implement the IPCC program had the poorest results . With these sites excluded , the total cost of care for IPCC patients at GMS sites was $ 579 ( 3 % ) more per year than that for the control patients One hundred and twenty patients presenting for admission to a state psychiatric hospital were r and omly allocated into two groups . Control patients received st and ard hospital care and after-care . Experimental patients were not admitted if this could be avoided ; instead they and their relatives were provided with comprehensive community treatment and a 24-hour crisis service . Patients with a primary diagnosis of alcohol or drug dependence , organic brain disorder or mental retardation were excluded . Most patients were suffering from psychotic disorders -- more than half specifically from schizophrenia . During the 12 months study period 96 % of the control patients were admitted--51 % more than once . Of the experimental patients 60 % were not admitted at all and only 8 % were admitted more than once . Control patients spent an average of 53.5 days in psychiatric hospital , experimental patients spent an average of 8.4 days . Community treatment did not increase the burden upon the community , was considered to be significantly more satisfactory and helpful by patients and their relatives , achieved a clinical ly superior outcome , and cost less than st and ard care and after-care . The ingredients differentiating comprehensive community-based care from prevailing methods of psychiatric care are discussed BACKGROUND The costs and the effectiveness of mental health services need to be evaluated if provision is to be efficient . Service use and costs are described for two geographical areas in south London . METHOD Service use was measured comprehensively for clients in both sectors for two six-month time periods using the Client Service Receipt Interview . This information was combined with unit costs to calculate service costs . The ' hidden ' costs of informal care and unsupported accommodation were also calculated . RESULTS At baseline significantly more intensive sector clients had in-patient stays but by the follow-up this difference had disappeared . There was significantly more use of supported accommodation in the intensive sector during both time periods . Baseline and follow-up total service costs were significantly higher for the intensive sector . Costs were spread disproportionately and a small number of services accounted for a large proportion of cost . CONCLUSIONS While the cost at Time 2 was significantly greater in the intensive sector , this was largely due to the high use of supported accommodation . There was some convergence in cost between the sectors over time BACKGROUND Case management has increasingly been the recommended approach to care for severely mentally ill patients since the number of psychiatric beds has decreased . Despite equivocal results , in the UK and Europe , this approach is becoming accepted policy . We assessed the effect of smaller case loads . METHODS We r and omly assigned 708 psychotic patients in four centres st and ard case management ( 355 patients , case load 30 - 35 per case manager ) or intensive case management ( 353 patients , case load 10 - 15 per case manager ) . We measured clinical symptoms and social functioning at baseline , 1 year , and 2 years . The impact of treatment on hospital use was assessed at 2 years by subgroup analyses for Afro-Caribbean and for severely socially disabled patients . Analysis was by intention to treat . FINDINGS There was no significant decline in overall hospital use among intensive-case-management patients ( mean 73.5 vs 73.1 days in those who received st and ard care [ SD 0.4 , 95 % CI -17.4 to 18.1 ] ) , nor were there any significant gains in clinical or social functioning . There was no evidence of differential effect in Afro-Caribbean patients or the most socially disabled patients . INTERPRETATION In well-coordinated mental-health services , a decline in case load alone does not improve outcome for these patients . Mental-health planners may need to pay more attention to the content of treatment rather than changes in service organisation
Output:
| Variation in reduced hospitalization was found to be mainly due to variation in control service practice but model fidelity to team organization principles was also associated with reduced hospitalization .
Low caseloads and specified ACT staffing , however , had no effect at all on outcome . '
Ordinary CMHTs ' share most of the organizational aspects of ACT and appear to deliver equal outcomes with much reduced re sources . |
MS211962 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES The purpose of this study was to compare the effects of N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided therapy with those of intensive clinical management and with usual care ( UC ) on clinical outcomes in chronic symptomatic heart failure . BACKGROUND Initial trial results suggest titration of therapy guided by serial plasma B-type natriuretic peptide levels improves outcomes in patients with chronic heart failure , but the concept has not received widespread acceptance . Accordingly , we conducted a longer-term study comparing the effects of NT-proBNP-guided therapy with those of intensive clinical management and with UC of patients with heart failure . METHODS Three hundred sixty-four patients admitted to a single hospital with heart failure were r and omly allocated 1:1:1 ( stratified by age ) to therapy guided by NT-proBNP levels or by intensive clinical management , or according to UC . Treatment strategies were applied for 2 years with follow-up to 3 years . RESULTS One-year mortality was less in both the hormone- ( 9.1 % ) and clinical ly-guided ( 9.1 % ) groups compared with UC ( 18.9 % ; p = 0.03 ) . Three-year mortality was selectively reduced in patients < or=75 years of age receiving hormone-guided treatment ( 15.5 % ) compared with their peers receiving either clinical ly managed treatment ( 30.9 % ; p = 0.048 ) or UC ( 31.3 % ; p = 0.021 ) . CONCLUSIONS Intensive management of chronic heart failure improves 1-year mortality compared with UC . Compared with clinical ly guided treatment and UC , hormone-guided treatment selectively improves longer-term mortality in patients < or=75 years of age . ( NT-proBNP-Assisted Treatment To Lessen Serial Cardiac Readmissions and Death [ BATTLESCARRED ] ; Australian New Zeal and Clinical Trials Registry 12605000735651 ) Background —The prognostic value of serum sodium in patients hospitalized for worsening heart failure has not been well defined . Methods and Results —The Outcomes of a Prospect i ve Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure ( OPTIME-CHF ) study r and omized 949 patients with systolic dysfunction hospitalized for worsening heart failure to receive 48 to 72 hours of intravenous milrinone or placebo in addition to st and ard therapy . In a retrospective analysis , we investigated the relationship between admission serum sodium and the primary end point of days hospitalized for cardiovascular causes within 60 days of r and omization , as well as the secondary end points of in-hospital mortality , 60-day mortality , and 60-day mortality/rehospitalization . The number of days hospitalized for cardiovascular causes was higher in the lowest sodium quartile : 8.0 ( 4.5 , 18.5 ) versus 6 ( 4 , 13 ) versus 6 ( 4 , 11.5 ) versus 6 ( 4 , 12 ) days ( P<0.015 for comparison with the lowest quartile ) . Lower serum sodium was associated with higher in-hospital and 60-day mortality : 5.9 % versus 1 % versus 2.3 % versus 2.3 % ( P<0.015 ) and 15.9 % versus 6.4 % versus 7.8 % versus 7 % ( P=0.002 ) , respectively . There was a trend toward higher mortality/rehospitalization for patients who were in the lowest sodium quartile . Multivariable-adjusted Cox proportional hazards analysis showed that serum sodium on admission , when modeled linearly , predicted increased 60-day mortality : sodium ( per 3-mEq/L decrease ) had a hazard ratio of 1.18 with a 95 % CI of 1.03 to 1.36 ( P=0.018 ) . Conclusions —In patients hospitalized for worsening heart failure , admission serum sodium is an independent predictor of increased number of days hospitalized for cardiovascular causes and increased mortality within 60 days of discharge OBJECTIVES This study was design ed to investigate whether selected baseline variables and early response markers predict the effects of cardiac resynchronization therapy ( CRT ) on long-term mortality . BACKGROUND Cardiac resynchronization therapy reduces long-term morbidity and mortality in patients with moderate or severe heart failure and markers of cardiac dyssynchrony , but not all patients respond to a similar extent . METHODS In the CARE-HF ( Cardiac Resynchronization in Heart Failure ) study , 813 patients with heart failure and markers of cardiac dyssynchrony were r and omly assigned to receive or not receive CRT in addition to pharmacological treatment and were followed for a median of 37.6 months . A model including assigned treatment , 15 pre-specified baseline variables , and 8 markers of response at 3 months was constructed to predict all-cause mortality . RESULTS On multivariable analysis , plasma concentration of amino terminal pro-brain natriuretic peptide ( univariate and multivariable model chi-square test : 105.0 and 48.4 ; both p < 0.0001 ) and severity of mitral regurgitation ( chi-square test : 44.0 and 17.9 ; both p < 0.0001 ) at 3 months , regardless of assigned treatment , were the strongest predictors of mortality . Ischemic heart disease as the cause of ventricular dysfunction ( chi-square test : 34.9 and 7.4 ; p < 0.0001 and p = 0.0066 ) , being in New York Heart Association functional class IV ( chi-square test : 18.8 and 9.6 ; p < 0.0001 and p = 0.0020 ) , or having less interventricular mechanical delay ( chi-square test : 29.8 and 8.8 ; p < 0.0001 and p = 0.0029 ) at baseline all predicted a worse outcome . However , the reduction in mortality in patients assigned to CRT was similar before ( hazard ratio : 0.602 ; 95 % confidence interval : 0.468 to 0.774 ) and after ( hazard ratio : 0.679 ; 95 % confidence interval : 0.494 to 0.914 ) adjustment for variables measured at baseline and at 3 months . CONCLUSIONS Patients who have more severe mitral regurgitation or persistently elevated amino terminal pro-brain natriuretic peptide despite treatment for heart failure , including CRT , have a higher mortality . However , patients assigned to CRT had a lower mortality even after adjusting for variables measured before and 3 months after intervention . The effect of CRT on mortality can not be usefully predicted using such information . ( CARE-HF CArdiac Resynchronization in Heart Failure ; NCT00170300 ) Brain natriuretic peptide ( BNP ) is a cardiac ventricular hormone that may be a sensitive and specific marker of changes in ventricular function . In a prospect i ve , r and omised open trial with 16 patients followed for 6 months after first Q wave anterior myocardial infa rct ion we set out to determine : whether BNP concentrations are raised acutely , the effect on circulating BNP of angiotensin-converting enzyme ( ACE ) inhibition , how BNP and atrial natriuretic peptide ( ANP ) concentrations compared as correlates of left-ventricular ejection fraction , and whether plasma BNP concentrations could distinguish patients with low ( < 40 % ) and relatively preserved ( > 40 % ) ejection fractions . Plasma concentrations of BNP measured on days 2 , 7 , 8 , 42 , and 180 postinfa rct ion were significantly raised in patients compared with normal controls and to a proportionately greater degree than ANP concentrations . Treatment with placebo ( n = 8) or oral captopril ( n = 8) from day 8 result ed in significantly lower BNP concentrations at days 42 ( p = 0.05 ) and 180 ( p < 0.05 ) in the captopril-treated group . Compared with ANP , BNP concentrations were much more strongly correlated with radionuclide-measured left-ventricular ejection fraction at days 2 , 42 , and 180 . All 8 patients with baseline ( day 2 ) ejection fractions of 40 % or above had plasma BNP concentrations less than 10 pmol/L , whereas the 8 patients with ejection fractions less than 40 % had BNP concentrations greater than 10 pmol/L. Our findings suggest that measurements of circulating BNP may identify those patients with significant left-ventricular dysfunction who have been highlighted by the Survival and Ventricular Enlargement study as likely to benefit from long-term ACE inhibition after myocardial infa rct ion AIMS Plasma levels of individual neurohormones ( NH ) have been proposed as reliable indicators for risk stratification of patients with heart failure ( HF ) . Mainly because of small sample size , the predictive value of different NH has never been compared , while taking into account demographic , clinical and echocardiographic markers of risk in HF . METHODS AND RESULTS Plasma brain natriuretic peptide ( BNP ) , norepinephrine ( NE ) , renin activity ( PRA ) , aldosterone ( aldo ) and endothelin were measured in 4300 patients before r and omization in Val-HeFT . Univariate and multivariate Cox proportional hazard analyses were performed to investigate the relationship between NH and two primary study outcomes , mortality and combined mortality and morbidity ( M/M ) . Higher baseline values for all NH were related to mortality and M/M , with univariate hazard ratios ranging from 1.13 [ 95 % CI 0.99 - 1.30 ] ( aldo ) to 2.47 [ 2.13 - 2.87 ] ( BNP ) for mortality , and from 1.24 [ 1.11 - 1.39 ] ( aldo ) to 2.56 [ 2.28 - 2.89 ] ( BNP ) for M/M. In multivariate analyses , BNP had the strongest association with outcome , followed by NE and PRA . Patients with more activation of renin-angiotensin-aldosterone system tended to show greater benefit from valsartan ; but the trend was not statistically significant . CONCLUSION All the NHs evaluated in 4300 patients with stable moderate to severe HF were found to be significant markers of outcome , despite therapy with ACEi , BB and r and omization to an angiotensin receptor blocker or placebo . Several of these markers have been implicated as contributors to progression of HF , but BNP , which is thought to be protective , was the most powerful indicator for poor outcome OBJECTIVES We investigated whether plasma amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , a marker of cardiac dysfunction and prognosis measured in CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) , could be used to identify the severity of heart failure at which statins become ineffective . BACKGROUND Statins reduce cardiovascular morbidity and mortality in many patients with ischemic heart disease but not , overall , those with heart failure . There must be a transition point at which treatment with a statin becomes futile . METHODS In CORONA , patients with heart failure , reduced left ventricular ejection fraction , and ischemic heart disease were r and omly assigned to 10 mg/day rosuvastatin or placebo . The primary composite outcome was cardiovascular death , nonfatal myocardial infa rct ion , or stroke . RESULTS Of 5,011 patients enrolled , NT-proBNP was measured in 3,664 ( 73 % ) . The midtertile included values between 103 pmol/l ( 868 pg/ml ) and 277 pmol/l ( 2,348 pg/ml ) . Log NT-proBNP was the strongest predictor ( per log unit ) of every outcome assessed but was strongest for death from worsening heart failure ( hazard ratio [ HR ] : 1.99 ; 95 % confidence interval [ CI ] : 1.71 to 2.30 ) , was weaker for sudden death ( HR : 1.69 ; 95 % CI : 1.52 to 1.88 ) , and was weakest for atherothrombotic events ( HR : 1.24 ; 95 % CI : 1.10 to 1.40 ) . Patients in the lowest tertile of NT-proBNP had the best prognosis and , if assigned to rosuvastatin rather than placebo , had a greater reduction in the primary end point ( HR : 0.65 ; 95 % CI : 0.47 to 0.88 ) than patients in the other tertiles ( heterogeneity test , p = 0.0192 ) . This reflected fewer atherothrombotic events and sudden deaths with rosuvastatin . CONCLUSIONS Patients with heart failure due to ischemic heart disease who have NT-proBNP values < 103 pmol/l ( 868 pg/ml ) may benefit from rosuvastatin OBJECTIVES The aim of this multicenter study was to evaluate the prognostic impact of a therapeutic strategy using plasma brain natriuretic peptide ( BNP
Output:
| Natriuretic peptides , including B-type natriuretic peptide ( BNP ) and N-terminal-proBNP ( NT-proBNP ) , have emerged as powerful markers of cardiovascular risk in patients with heart failure.1 Circulating natriuretic peptide ( NP ) levels add incremental prognostic value to st and ard clinical risk stratification algorithms for both ambulatory and hospitalized heart failure patients , with a steady increase in the risk of mortality and recurrent heart failure hospitalization as NT-proBNP levels rise above 1000 pg/mL.2–5 A systematic review of 19 studies of patients with heart failure demonstrated that for every 100-pg/mL rise in BNP concentration , there was a corresponding 35 % increase in the relative risk of death.6 Response by Januzzi and Troughton on p 516 Beyond the prognostic value of a single NP measurement , changes in NP concentrations over time may help to further stratify risk.2,7 Reductions in NP levels , whether achieved spontaneously or through application of appropriate medical therapy , appear to be associated with improvement in clinical outcomes .8,9 In the Valsartan Heart Failure Trial , subjects with the largest proportional reductions in BNP levels at 4 months after r and omization experienced the best outcomes , whereas those with the greatest increase in BNP levels experienced the highest event rates.7 Among patients hospitalized with decompensated heart failure , both predischarge NP levels and the relative change in NP levels during hospital treatment are strong predictors of the risk for death or hospital readmission at 6 months.8,10,11 In addition to their association with risk for adverse cardiovascular outcomes , circulating levels of NP appear to vary in relationship to the biology of heart failure progression .
NP levels tend to rise during acute heart failure decompensation and to fall with successful treatment in a pattern that mirrors reductions in filling pressure , improvements in left ventricular structure and function , |
MS211963 | ***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 The short- and long-term effects of anti-hepatitis C treatment on mortality in the HIV-HCV-coinfected population have not been evaluated in observational cohorts . Such evaluations must use methods that allow for time-varying prognostic factors that both predict treatment and are affected by prior treatment . We aim ed to study immunological changes in HIV-HCV-coinfected individuals during HCV treatment and to estimate the effect of HCV-treatment on mortality . METHODS Patients were included if they were aged ≥16 years , were HIV-HCV-coinfected and were enrolled in the COHERE cohort . Data were pooled within COHERE in December 2009 in EuroCoord . R and om-effects models were used to model immunological changes during HCV treatment . Marginal structural models were used to estimate the effect of HCV treatment on mortality , allowing for time-dependent confounders affected by prior treatment . RESULTS In total , 780/6,433 ( 12 % ) HIV-HCV-coinfected patients initiated HCV treatment ( interferon [ IFN ] and ribavirin n=692 , IFN alone n=88 ) . CD4(+ ) T-cell counts decreased during the first 12 weeks of treatment ( P<0.0001 ) and stabilized from week 24 onwards . The estimated mortality hazard ratio for comparing HCV-treated with -untreated individuals was 0.72 ( 95 % CI 0.43 , 1.21 ) . The estimated hazard ratio for liver-related death was 0.57 ( 95 % CI 0.21 , 1.55 ) . CONCLUSIONS Despite its effect in reducing CD4(+ ) T-cell counts , the effect of HCV treatment on mortality was in the direction of benefit and our results excluded a substantial increase in mortality . Such benefit may be related to a lower risk of liver-related death . New HCV treatment strategies might contribute to a further reduction in mortality Background Hepatitis C virus ( HCV ) is an RNA virus which has been known to cause acute and chronic necro-inflammatory disease of the liver . It is the leading cause of end-stage liver disease and hepatocellular carcinoma . HIV is known to have a negative impact on the natural disease outcome and immune response of HCV infection , whereas the reverse remains unclear . We evaluated the impact of HCV co-infection on recovery of CD4 + and CD8 + T-cells and liver enzyme levels before and after initiation of highly active antiretroviral therapy ( HAART ) in HIV/HCV co-infected patients . Methods A hospital-based , observational , prospect i ve cohort study design was used for this study . Pre-antiretroviral treatment ( Pre-ART ) and under HAART HIV mono-infected and HCV/HIV co-infected individuals who are under regular follow-up were recruited for this study . 387 blood sample s were collected from volunteer , known HIV positive Ethiopian patients and screened for HCV . Twenty five HCV/HIV co-infected patients were prospect ively followed for four years . CD4 + and CD8 + T-cells and liver enzyme levels were determined annually for each of the participant . Results The prevalence of HCV/HIV co-infection in this study was 6.5 % . Both HCV/HIV co-infected and HIV mono-infected under HAART groups showed CD4 + recovery ( 343 Vs 426 ; P < 0.004 , OR = 4.97 , 95 % CI = 2.41 to 10.27 ) respectively ; but , the recovery rate was higher in mono-infected ( 80 Vs 426 ) than co-infected group ( 148 Vs 343 ) . The recovery and /or decline pattern of CD8 + T-cells was the same with that of CD4 + . In 75 % of co-infected groups , the mean alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) levels were above the upper limit of normal reference range . Analyses restricted to individuals who initiated HAART and pre-ART showed similar results . Conclusion We found that CD4 + T-cell recovery was negatively affected by the presence of ongoing HCV replication in under HAART co-infected individuals and fast decline of CD4 + T-cells in pre-ART patients . It was also associated with increased ALT and AST enzyme levels in both HAART initiated and treatment naïve co-infected patients Background The purpose of this study was to evaluate the efficacy and safety of three nevirapine-based antiretroviral treatments for adult antiretroviral-naïve Chinese patients with HIV-1 infection . Methodology This was a prospect i ve , multicenter study . 198 antiretroviral-naïve HIV-1 positive subjects with CD4 lymphocyte counts between 100/ul and 350/ul and plasma HIV-1 RNA levels more than 500 copies/ml were r and omized to start three NVP-based antiretroviral treatments : group A , NVP+AZT+ddI ; group B , NVP+3TC+d4 T ; group C , NVP+AZT+3TC . Viral responses , immunologic responses , adverse events and drug resistence were monitored at baseline and the end of week 4 , 12 , 24 , 36 , 52 . Viralogical response and immunological response were also comparaed in different strata of baseline CD4 T lymphocyte counts and plasma HIV-1 RNA concentrations . At baseline , the plasma HIV-1 RNA was 4.44±0.68 , 4.52±0.71 and 4.41±0.63 lg copies/ml in group A , B and C respectively ( p = 0.628 ) . At the end of the study , the plasma viral load reached 2.54±1.11 , 1.89±0.46 and 1.92±0.58 lg copies/ml in group A , B and C respectively ( p<0.001 ) . At week 52 , suppression of plasma HIV-1 RNA to less than 50 copies/ml was achieved in more patients in group B and C than in group A ( 68.2 % , 69 % vs. 39.7 % ; p<0.001 ) . In planned subgroup analyses , the decrease of viral response rate was seen in group A when CD4 cell count > 200/ul ( subgroup H ) . But in subgroup L , viral response rate of three groups has no significant statistic difference . There were no statistically significant differences among three groups in immunological response wthin any of the CD4 or pVL strata . 3 out of 193 patients with available genotype at baseline showed primary drug resistant . Of 26 patients with virologic failure , 17 patients showed secondary drug resistant , 16 subjects in group A and 1 subject in group B. Logistic regression analysis indicated that presence of hepatotoxicity was associated with HCV-Ab positive ( OR = 2.096 , 95%CI : 1.106–3.973 , P = 0.023 ) and higher CD4 baseline ( CD4 count > 250/ul)(OR = 2.096 , 95%CI : 1.07–4.107 , P = 0.031 ) . Conclusion Our findings strongly support the use of 3TC+d4 T and 3TC+AZT as the nucleoside analogue combination in NVP-based antiretroviral therapy . The regimen of AZT+ddI+NVP produced poor virological response especially in the stratum of CD4 count more than 200/ul . More patients showed secondary drug resistant in this arm too . Patients with HCV-Ab+ and CD4 count > 250/ul appear to have significantly high risk of hepatoxicity . Trial Registration Clinical Trials.gov IMPORTANCE Patients co-infected with human immunodeficiency virus ( HIV ) and hepatitis C virus ( HCV ) are at high risk for liver disease progression . However , interferon-based treatments for HCV infection have significant toxicities , limiting treatment uptake . OBJECTIVE To assess the all-oral 3 direct-acting antiviral ( 3D ) regimen of ombitasvir , paritaprevir ( co-dosed with ritonavir [ paritaprevir/r ] ) , dasabuvir , and ribavirin in HCV genotype 1-infected adults with HIV-1 co-infection , including patients with cirrhosis . DESIGN , SETTING , AND PARTICIPANTS TURQUOISE-I is a r and omized , open-label study . Part 1a of this pilot study was conducted at 17 sites in the United States and Puerto Rico between September 2013 and August 2014 and included 63 patients with HCV genotype 1 and HIV-1 co-infection who were HCV treatment-naive or had history of prior treatment failure with peginterferon plus ribavirin therapy . The study allowed enrollment of patients , including those with cirrhosis , with a CD4 + count of 200/mm3 or greater or CD4 + percentage of 14 % or more and plasma HIV-1 RNA suppressed while taking a stable atazanavir- or raltegravir-inclusive antiretroviral regimen . INTERVENTIONS Ombitasvir/paritaprevir/r , dasabuvir , and ribavirin for 12 or 24 weeks of treatment as r and omized . MAIN OUTCOMES AND MEASURES The primary assessment was the proportion of patients with sustained virologic response ( HCV RNA < 25 IU/mL ) at posttreatment week 12 ( SVR12 ) . RESULTS Among patients receiving 12 or 24 weeks of 3D and ribavirin , SVR12 was achieved by 29 of 31 ( 94 % ; 95 % CI , 79%-98 % ) and 29 of 32 patients ( 91 % ; 95 % CI , 76%-97 % ) , respectively . Of the 5 patients who did not achieve SVR , 1 withdrew consent , 2 had confirmed virologic relapse or breakthrough , and 2 patients had clinical history and phylogenetic evidence consistent with HCV reinfection . The most common treatment-emergent adverse events were fatigue ( 48 % ) , insomnia ( 19 % ) , nausea ( 18 % ) , and headache ( 16 % ) . Adverse events were generally mild , with none reported as serious or leading to discontinuation . No patient had a confirmed HIV-1 breakthrough of 200 copies/mL or greater during treatment . CONCLUSIONS AND RELEVANCE In this open-label , r and omized uncontrolled study , treatment with the all-oral , interferon-free 3D-plus-ribavirin regimen result ed in high SVR rates among patients co-infected with HCV genotype 1 and HIV-1 whether treated for 12 or 24 weeks . Further phase 3 studies of this regimen are warranted in patients with co-infection . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01939197 BACKGROUND Hepatitis C virus ( HCV ) infection is highly prevalent among HIV-1-infected individuals , but its contribution to the morbidity and mortality of coinfected patients who receive potent antiretroviral therapy is controversial . We used data from the ongoing Swiss HIV Cohort Study to analyse clinical progression of HIV-1 , and the virological and immunological response to potent antiretroviral therapy in HIV-1-infected patients with or without concurrent HCV infection . METHODS We analysed prospect i ve data on survival , clinical disease progression , suppression of HIV-1 replication , CD4-cell recovery , and frequency of changes in antiretroviral therapy according to HCV status in 3111 patients starting potent antiretroviral therapy . RESULTS 1157 patients ( 37.2 % ) were coinfected with HCV , 1015 of whom ( 87.7 % ) had a history of intravenous drug use . In multivariate Cox 's regression , the probability of progression to a new AIDS-defining clinical event or to death was independently associated with HCV seropositivity ( hazard ratio 1.7 [ 95 % CI 1.26 - 2.30 ] ) , and with active intravenous drug use ( 1.38 [ 1.02 - 1.88 ] ) . Virological response to antiretroviral therapy and the probability of treatment change were not associated with HCV serostatus . In contrast , HCV seropositivity was associated with a smaller CD4-cell recovery ( hazard ratio for a CD4-cell count increase of at least 50 cells/microL=0.79 [ 0.72 - 0.87 ] ) . INTERPRETATION HCV and active intravenous drug use could be important factors in the morbidity and mortality among HIV-1-infected patients , possibly through impaired CD4-cell recovery in HCV seropositive patients receiving potent antiretroviral therapy . These findings are relevant for decisions about optimum timing for HCV treatment in the setting of HIV infection IMPORTANCE There is an unmet need for interferon- and ribavirin-free treatment for chronic hepatitis C virus ( HCV ) infection in patients co-infected with human immunodeficiency virus ( HIV
Output:
| A meta- analysis found no evidence of increased HIV VL associated with HCV co-infection or between HIV VL and HCV treatment with pegylated interferon-alpha-2a/b and ribavirin .
CONCLUSIONS This finding is in contrast to the substantial increases in HIV VL observed with several other systemic infections . |
MS211964 | ***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 Coronary artery bypass surgery with cardiopulmonary bypass carries a significant risk of perioperative brain injury . At least 1 % to 5 % will suffer a stroke , and at 3-months postoperatively approximately 30 % are reported to have cognitive impairment assessed by neuropsychologic testing . In off-pump surgery cardiopulmonary bypass is not used and instrumentation on the ascending aorta is reduced . The main aim of this study was to assess if off-pump surgery reduces intraoperative cerebral embolization . METHODS This was a prospect i ve and r and omized study of two comparable groups with regard to age , sex , years of education , preoperative cognitive functioning , and surgical characteristics . Fifty-two patients ( 29 off-pump ) were monitored by the use of transcranial Doppler ultrasound for cerebral microembolization during surgery . Preoperative and postoperative clinical , cerebral magnetic resonance imaging , and neuropsychologic examinations were also carried out . RESULTS There was a significant reduction in the number of cerebral microemboli during off-pump compared with on-pump surgery ( 16.3 [ range 0 to 131 ] versus 90.0 [ range 15 to 274 ] , p < 0.0001 ) . No significant difference with regard to the incidence of neuropsychologic performance ( decline in 29 % off-pump , 35 % on-pump ) or neuroradiologic findings at 3 months was found , and there was no association between the number of cerebral microemboli and cognitive outcome . CONCLUSIONS This study clearly demonstrates that off-pump surgery leads to a reduction in intraoperative cerebral microembolization . A significant reduction in the number of off-pump patients with cognitive decline or ischemic brain lesions on cerebral magnetic resonance imaging could not be demonstrated in this relatively small patient population Background and Purpose — The aim of this study was to assess the first multifrequency transcranial Doppler system that was specially developed to automatically detect and discriminate between solid and gaseous cerebral microemboli . Methods — The multifrequency transcranial Doppler instrumentation insonates simultaneously with 2.5 and 2.0 MHz . Differentiation between solid and gaseous microemboli is based on the principle that solid microemboli reflect more ultrasound at the higher than at the lower frequency , whereas the opposite is the case for gaseous microemboli . In the in vitro studies , 159 plastic spheres ( 50 or 80 & mgr;m in diameter ) and 105 gas bubbles ( 8 to 25 & mgr;m ) were studied in a pulsatile closed-loop system containing irodinium or pig blood . In vivo studies were carried out for 1 hour in 15 patients with mechanical heart valves and in 45 patients with carotid stenosis . This gave a total of 60 hours of online automatic monitoring in patients . Results — In the in vitro studies , 152 of the 159 ( 95.6 % ) plastic spheres were classified as solid , and 7 ( 4.4 % ) were classified as uncertain solid . Of the 105 gas bubbles , 99 ( 94.3 % ) were classified as gaseous and 6 ( 5.7 % ) as uncertain gaseous . Thus , correct classification was made for 251 ( 95.1 % ) of the 264 embolic events studied . A comparison between the automatic multifrequency discrimination and the known embolic classification gave a & kgr ; value of 0.897 ( P < 0.0001 ) . The multifrequency Doppler classified 433 ( 84.2 % ) of the 514 emboli detected in the mechanical heart valve patients as gaseous , 74 ( 14.4 % ) as solid , and 7 ( 1.4 % ) as uncertain ( 3 uncertain solid , 4 uncertain gas ) . Thirty-two emboli were detected in 17 ( 38 % ) of the 45 carotid stenosis patients ; 30 ( 93.7 % ) were classified as solid and 2 ( 6.3 % ) as uncertain solid . Conclusions — This study has shown that multifrequency transcranial Doppler can be used to automatically differentiate between solid and gaseous microemboli online . Most detected microemboli in this initial study of mechanical heart valves were classified as gaseous , whereas most were classified as solid in the patients with carotid stenosis OBJECTIVE To analyze the frequency and severity of sub clinical cerebral complications associated with coronary artery bypass grafting ( CABG ) . DESIGN A prospect i ve controlled study using preoperative and postoperative magnetic resonance imaging ( MRI ) of the brain , quantitative electroencephalography ( QEEG ) , and detailed neuropsychological and neurologic examinations as potentially sensitive indicators of sub clinical cerebral injury associated with CABG . SETTING Multimodality evaluation in a tertiary care unit ( Kuopio University Hospital , Kuopio , Finl and ) . PATIENTS Thirty-eight patients undergoing elective CABG and 20 control patients undergoing other major vascular surgery , mostly operations on the abdominal aorta . MAIN OUTCOME MEASURES Coronary artery bypass grafting-associated cerebral complications assessed preoperatively and postoperatively by brain MRI , QEEG , detailed neurologic examination , and a neuropsychological test battery that evaluates cognitive functions in major areas known to be vulnerable to organic impairment ( learning and memory , attention , flexible mental processing , and psychomotor speed ) . RESULTS There were no major neurologic complications . A mild hemisyndrome developed in 1 patient who underwent CABG and in 1 control patient . Overall , there was no decline in mean cognitive performance 3 months after surgery . Electroencephalographic slowing of 0.5 Hz or more in at least 2 channels occurred in 11 patients who underwent CABG and in 1 control patient ( P=.03 ) . The postoperative brain MRI scan revealed new small ischemic lesions in 8 patients ( 21 % ) in the CABG group but in none of the control group ( P=.03 ) . These new cerebral MRI lesions did not explain deterioration in neuropsychological test performance or the QEEG slowing . CONCLUSIONS Coronary artery bypass grafting causes more QEEG alterations and small ischemic cerebral lesions that are detectable by MRI than does other major vascular surgery . The effect is mainly sub clinical , because no statistically significant deterioration in mean neuropsychological test performance was detected Background and Purpose Microemboli have been implicated in the etiology of neuropsychological deficits after cardiopulmonary bypass . This study examined the incidence of high‐intensity transcranial signals ( microemboli ) and their relation to changes in neuropsychological performance after surgery . Methods Transcranial Doppler ultrasonography was used to measure middle cerebral artery blood flow velocity and detect microemboli . The number of high‐intensity transcranial signals was determined and related to a neurological examination and absolute changes in neuropsychological performance as well as the number of patients considered to exhibit a neuropsychological deficit . Data were available on 100 consenting patients undergoing routine cardiopulmonary bypass . Fifty of the patients were r and omly assigned to a procedure that included a 40‐&mgr;m arterial line filter , and 50 had the procedure without any arterial line filter . Results Significantly more patients were found to have neuropsychological deficits in the group without the arterial line filter at both 8 days ( P<.05 ) and 8 weeks ( P<.03 ) after surgery . In addition , more “ soft ” neurological signs were found in the nonfiltered group 24 hours after surgery ( P<.05 ) . More high‐intensity transcranial signals were found in the nonfiltered group , and the number of high‐intensity transcranial signals was found to be related to the likelihood of a patient having a neuropsychological deficit at 8 weeks . Conclusions These data suggest that neuropsychological deficits after routine cardiopulmonary bypass are related to the number of microemboli delivered during surgery . Furthermore , the numbers of microemboli may be reduced by including a 40‐&mgr;m filter on the arterial line . ( Stroke . 1994;25:1393‐1399 . BACKGROUND Neurologic and clinical morbidity after coronary artery bypass grafting ( CABG ) can be significant . By avoiding cardiopulmonary bypass , off-pump CABG ( OPCAB ) may reduce morbidity . METHODS Sixty patients ( 30 CABG and 30 OPCAB ) were prospect ively r and omized . Neurocognitive testing was performed before the operation and 2 weeks and 1 year after the operation . Neurologic testing to detect stroke and (99m)Tc-HMPAO whole-brain single photon emission computed tomography scanning to assess cerebral perfusion were performed before the operation and 3 days afterward . Bilateral middle cerebral artery transcranial Doppler scanning was performed intraoperatively to detect cerebral microemboli . All examiners were blinded to treatment group . Clinical morbidity and costs were compared . RESULTS Coronary artery bypass grafting was associated with more cerebral microemboli ( 575 + /- 278.5 CABG versus 16.0 + /- 19.5 OPCAB ( median + /- semiinterquartile range ) and significantly reduced cerebral perfusion after the operation to the bilateral occipital , cerebellar , precunei , thalami , and left temporal lobes ( p < or = 0.01 ) . Cerebral perfusion with OPCAB was unchanged . Compared with base line , OPCAB patients performed better on the Rey Auditory Verbal Learning Test ( total and recognition scores ) at both 2 weeks and at 1 year ( p < or = 0.05 ) , whereas CABG performance was statistically unchanged for all cognitive measures . Patients who underwent CABG had more chest tube drainage ( 1389 + /- 1256 mL CABG versus 789 + /- 586 mL OPCAB , p = 0.02 ) and required more blood ( 3.9 + /- 5.8 U CABG versus 1.2 + /- 2.2 U OPCAB , p = 0.02 ) , fresh frozen plasma ( 3.0 + /- 6.0 U CABG versus 0.5 + /- 2.2 U OPCAB , p = 0.03 ) , and hours of postoperative use of dopamine ( 16.3 + /- 21.2 hours CABG versus 7.3 + /- 9.7 hours OPCAB , p = 0.04 ) . These differences culminated in higher costs for CABG ( $ 23,053 + /- $ 5,320 CABG versus $ 17,780 + /- $ 4,390 OPCAB , p < 0.0001 ) . One stroke occurred with CABG , compared with none with OPCAB ( p = NS ) . One OPCAB patient died because of a pulmonary embolus ( p = NS ) . CONCLUSIONS Compared with CABG , OPCAB may reduce neurologic and clinical morbidity as well as cost Background and Purpose — Improvements in cardiac surgery mortality and morbidity have focused interest on the neurological injury such as stroke and cognitive decline that may accompany an otherwise successful operation . We aim ed to investigate ( 1 ) the rate of stroke , new ischemic change on MRI , and cognitive impairment after cardiac valve surgery ; and ( 2 ) the controversial relationship between perioperative cerebral ischemia and cognitive decline . Methods — Forty patients ( 26 men ; mean [ SD ] age 62.1 [ 13.7 ] years ) undergoing intracardiac surgery ( 7 also with coronary artery bypass grafting ) were studied . Neurological , neuropsychological , and MRI examinations were performed 24 hours before surgery and 5 days ( MRI and neurology ) and 6 weeks ( neuropsychology and neurology ) after surgery . Cognitive decline from baseline was determined using the Reliable Change Index . Results — Two of 40 ( 5 % ) patients had perioperative strokes and 22 of 35 ( 63 % ) tested had cognitive decline in at least one measure ( range , 1 to 4 ) . Sixteen of 37 participants ( 43 % ) with postoperative imaging had new ischemic lesions ( range , 1 to 17 lesions ) with appearances consistent with cerebral embolization . Cognitive decline was seen in all patients with , and 35 % of those without , postoperative ischemic lesions ( P<0.001 ) , and there was an association between the number of abnormal cognitive tests and ischemic burden ( P<0.001 ) . Conclusion — We have provided a reliable estimate of the rate of stroke , postoperative ischemia , and cognitive impairment at 6 weeks after cardiac valve surgery . Cognitive impairment is associated with perioperative ischemia and is more severe with greater ischemic load Background — Reinfusion of unprocessed cardiotomy blood during cardiac surgery can introduce particulate material into the cardiopulmonary bypass circuit , which may contribute to postoperative cognitive d
Output:
| Conclusion : This systematic review could neither confirm nor rule out a causal link between emboli from CPB and postoperative cognitive decline |
MS211965 | ***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 study the feasibility and effectiveness of a discharge planning intervention . DESIGN Quasi-experimental pre-post study design . SETTING General medicine wards at three hospitals : an academic medical center , a community teaching hospital , and a community-based nonteaching hospital . PARTICIPANTS All patients aged 65 and older admitted to the hospitalist services . INTERVENTION The intervention toolkit had five core elements : admission form with geriatric cues , facsimile to the primary care provider , interdisciplinary worksheet to identify barriers to discharge , pharmacist-physician collaborative medication reconciliation , and predischarge planning appointments . MEASUREMENTS Thirty-day readmission and return to emergency department rates and patient satisfaction with discharge . Odds ratios were determined , and site effects were examined accordig to interaction terms and Breslow Day statistics . RESULTS Two hundred thirty-seven patients were followed during the preintervention period , and 185 were exposed to the intervention . Patients characteristics were similar across the two time periods . The proportion of patients with high- quality transitions home , measured according to Coleman 's Care Transition Measures , increased from 68 % to 89 % ( odds ratio (OR)=3.49 , 95 % confidence interval (CI)=2.06 - 5.92 ) . Return to the emergency department within 3 days of discharge was lower in the intervention period ( 10 % vs 3 % , OR=0.25 , 95 % CI=0.10 - 0.62 ) . At 30 days , there was a lower rate of readmission ( 22 % vs 14 % , OR=0.59 , 95 % CI=0.34 - 0.97 ) and fewer visits to the emergency department ( 21 % vs 14 % , OR=0.61 , 95 % CI=0.36 - 1.03 ) ( P=.06 ) . CONCLUSION When hospitalized elderly patients are treated with consideration of their specific needs , healthcare outcomes can be improved Background : Hospital discharge is an interlace of care when patients are at a high risk of medication discrepancies as they transition from hospital to home . These discrepancies are important , as they may contribute to drug-related problems , medication errors , and adverse drug events . Objective : To Identify , characterize , and assess the clinical impact of unintentional medication discrepancies at hospital discharge . Methods : All consecutive general internal medicine patients admitted for at least 72 hours to a tertiary care teaching hospital were prospect ively assessed . Patients were excluded if they were discharged with verbal prescriptions ; died during hospitalization ; or transferred from or to a nursing home , another institution , or another unit within the same hospital . The primary endpoint was to determine the number of patients with at least one unintended medication discrepancy on hospital discharge . Medication discrepancies were assessed through comparison of a best possible medication discharge list with the actual discharge prescriptions . Secondary objectives were to characterize and assess the potential clinical impact of the unintentional discrepancies . Results : From March 14,2006 , to June 2,2006,430 patients were screened for eligibility ; 150 patients were included in the study . Overall , 106 ( 70.7 % ) patients had at least one actual or potential unintentional discrepancy . Sixty-two patients ( 41.3 % ) had at least one actual unintentional medication discrepancy al hospital discharge and 83 patients ( 55.3 % ) had at least one potential unintentional discrepancy . The most common unintentional discrepancies were an incomplete prescription requiring clarification , which could result in a patient delay in obtaining medications ( 49.5 % ) , and the omission of medications ( 22.9 % ) . Of the 105 unintentional discrepancies , 31 ( 29.5 % ) had the potential to cause possible or probable patient discomfort and /or clinical deterioration . Conclusions : Medication discrepancies occur commonly on hospital discharge . Underst and ing the type and frequency of discrepancies can help clinicians better underst and ways to prevent them . Structured medication reconciliation may help to prevent discharge medication discrepancies Objective Heart failure patients are regularly admitted to hospital and frequently use multiple medication . Besides intentional changes in pharmacotherapy , unintentional changes may occur during hospitalisation . The aim of this study was to investigate the effect of a clinical pharmacist discharge service on medication discrepancies and prescription errors in patients with heart failure . Setting A general teaching hospital in Tilburg , the Netherl and s. Method An open r and omized intervention study was performed comparing an intervention group , with a control group receiving regular care by doctors and nurses . The clinical pharmacist discharge service consisted of review of discharge medication , communicating prescribing errors with the cardiologist , giving patients information , preparation of a written overview of the discharge medication and communication to both the community pharmacist and the general practitioner about this medication . Within 6 weeks after discharge all patients were routinely scheduled to visit the outpatient clinic and medication discrepancies were measured . Main outcome measure The primary endpoint was the frequency of prescription errors in the discharge medication and medication discrepancies after discharge combined . Results Forty-four patients were included in the control group and 41 in the intervention group . Sixty-eight percent of patients in the control group had at least one discrepancy or prescription error against 39 % in the intervention group ( RR 0.57 ( 95 % CI 0.37–0.88 ) ) . The percentage of medications with a discrepancy or prescription error in the control group was 14.6 % and in the intervention group it was 6.1 % ( RR 0.42 ( 95 % CI 0.27–0.66 ) ) . Conclusion This clinical pharmacist discharge service significantly reduces the risk of discrepancies and prescription errors in medication of patients with heart failure in the 1st month after discharge BACKGROUND Prior studies suggest that unintended medication discrepancies that represent errors are common at the time of hospital admission . These errors are particularly worthy of attention because they are not likely to be detected by computerized physician order entry systems . METHODS We prospect ively studied patients reporting the use of at least 4 regular prescription medications who were admitted to general internal medicine clinical teaching units . The primary outcome was unintended discrepancies ( errors ) between the physicians ' admission medication orders and a comprehensive medication history obtained through interview . We also evaluated the potential seriousness of these discrepancies . All discrepancies were review ed with the medical team to determine if they were intentional or unintentional . All unintended discrepancies were rated for their potential to cause patient harm . RESULTS After screening 523 admissions , 151 patients were enrolled based on the inclusion criteria . Eighty-one patients ( 53.6 % ; 95 % confidence interval , 45.7%-61.6 % ) had at least 1 unintended discrepancy . The most common error ( 46.4 % ) was omission of a regularly used medication . Most ( 61.4 % ) of the discrepancies were judged to have no potential to cause serious harm . However , 38.6 % of the discrepancies had the potential to cause moderate to severe discomfort or clinical deterioration . CONCLUSIONS Medication errors at the time of hospital admission are common , and some have the potential to cause harm . Better methods of ensuring an accurate medication history at the time of hospital admission are needed BACKGROUND Hospitalization and subsequent discharge home often involve discontinuity of care , multiple changes in medication regimens , and inadequate patient education , which can lead to adverse drug events ( ADEs ) and avoidable health care utilization . Our objectives were to identify drug-related problems during and after hospitalization and to determine the effect of patient counseling and follow-up by pharmacists on preventable ADEs . METHODS We conducted a r and omized trial of 178 patients being discharged home from the general medicine service at a large teaching hospital . Patients in the intervention group received pharmacist counseling at discharge and a follow-up telephone call 3 to 5 days later . Interventions focused on clarifying medication regimens ; review ing indications , directions , and potential side effects of medications ; screening for barriers to adherence and early side effects ; and providing patient counseling and /or physician feedback when appropriate . The primary outcome was rate of preventable ADEs . RESULTS Pharmacists observed the following drug-related problems in the intervention group : unexplained discrepancies between patients ' preadmission medication regimens and discharge medication orders in 49 % of patients , unexplained discrepancies between discharge medication lists and postdischarge regimens in 29 % of patients , and medication nonadherence in 23 % . Comparing trial outcomes 30 days after discharge , preventable ADEs were detected in 11 % of patients in the control group and 1 % of patients in the intervention group ( P = .01 ) . No differences were found between groups in total ADEs or total health care utilization . CONCLUSIONS Pharmacist medication review , patient counseling , and telephone follow-up were associated with a lower rate of preventable ADEs 30 days after hospital discharge . Medication discrepancies before and after discharge were common targets of intervention Purpose To examine the impact of systematic medication reconciliations upon hospital admission and of a medication review while in hospital on the number of inappropriate medications and unscheduled drug-related hospital revisits in elderly patients . Methods This was a prospect i ve , controlled study in 210 patients , aged 65 years or older , who were admitted to one of three internal medicine wards at a University Hospital in Sweden . Intervention patients received the complete Lund Integrated Medicines Management model ( medication reconciliation upon admission and discharge , and medication review and monitoring ) provided by a multi-professional team , including a clinical pharmacist . Control patients received st and ard care and medication reconciliation upon discharge . Blinded review ers evaluated the appropriateness of the prescribing ( using the Medication Appropriateness Index ) on admission and discharge , and assessed the probability that a drug-related problem was the reason for any patient readmitted to hospital or visiting the emergency department within 3 months of discharge ( using World Health Organisation causality criteria ) . Results There was a greater decrease in the number of inappropriate drugs in the intervention group than in the control group for both the intention-to-treat population { 51 % [ 95 % confidence interval ( CI ) 43–58 % ] vs. 39 % ( 95 % CI 30–48 % ) ; p = 0.0446 } and the per- protocol population [ 60 % ( 95 % CI 51–67 % ) vs. 44 % ( 95 % CI 34–52 % ) ; p = 0.0106 ) ] . There were six revisits to hospital in the intervention group which were judged as ‘ possibly , probably or certainly drug-related ’ , compared with 12 in the control group ( p = 0.0469 ) . Conclusions In this study , medication reconciliation and review provided by a clinical pharmacist in a multi-professional team significantly reduced the number of inappropriate drugs and unscheduled drug-related hospital revisits among elderly patients OBJECTIVE To quantify admission medication discrepancies in a tertiary-care , general pediatric population , to describe their clinical importance and associated factors , and to assess a screening approach to pharmacist involvement . METHODS A total of 272 patients were studied prospect ively at hospital admission . The study pharmacist performed a medication history and compared it to physicians ' admission medication orders . Discrepancies between the 2 were coded as intentional but undocumented or unintentional . Unintentional discrepancies were rated for potential to cause harm by 3 physicians . Additional data collected included patients ' reason for admission and presence of chronic conditions , whether physicians used a medication reconciliation form , the characteristics of patients ' home medication regimen , and the time required to perform a pharmacist history and reconciliation . Interrater reliability and associations between baseline characteristics and discrepancy rates were explored . RESULTS Eighty patients ( 30 % ) had at least one undocumented intentional discrepancy ( range , 0 - 7 ) . At least one unintentional discrepancy ( range , 0 - 9 ) was found in 59 patients ( 22 % ) . Of the unintentional discrepancies , 23 % had moderate and 6 % had severe potential to cause discomfort or deterioration . Ratings were similar among the 3 physicians . Characteristics associated with higher risk of clinical ly important discrepancies were : use of the medication reconciliation form , > or = 4 prescription medications , and antiepileptic drug use . Logistic regression revealed that only the variable > or = 4 medications was independently associated with clinical ly important discrepancies . CONCLUSIONS Admission medication errors are common in this tertiary-care , general pediatric population , and nearly a third represent potential adverse events . The use of a medication reconciliation form by physicians without pharmacist involvement does not appear to reduce errors . A cutoff of > or = 4 prescription medications is highly sensitive for identifying patients at risk of clinical ly important discrepancies Background Medication reconciliation has been m and ated by the Irish government at transfer of care . Research is needed to determine the contribution of clinical pharmacists to the process . Objective To describe the contribution of emergency department based clinical pharmacists to admission medication reconciliation in Irel and . Main Outcome Measure Frequency of clinical pharmacist ’s activities . Setting Two public university teaching hospitals . Methodology Adults admitted via the accident and emergency department , from a non-acute setting , reporting the use of at least three regular prescription medic
Output:
| Pharmacist-led medication reconciliation programmes are effective at improving post-hospital healthcare utilisation .
This review supports the implementation of pharmacist-led medication reconciliation programmes that include some component aim ed at improving medication safety |
MS211966 | ***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: Declined balance functions have adverse effects on elderly population . Lower limbs muscle power training is currently an emerging concept in rehabilitation on individuals with decreased balance and mobility . In this prospect i ve , controlled study , we used a human-computer interactive video-game-based rehabilitation device ( LLPR ) for training of lower limb muscle power in the elderly . Forty ( aged > 65 years ) individuals were recruited from the community . Twenty participants in the exercise group received 30-min training , twice a week , using the LLPR system . The LLPR system allows participants to perform fast speed sit-to-st and ( STS ) movements . Twenty age-matched participants in the control group performed slow speed STS movements , as well as strengthening and balance exercises , with the same frequency and duration . The results were compared after 12 sessions ( 6 weeks ) of training . The mechanical and time parameters during STS movement were measured using the LLPR system . Modified falls efficacy scale ( MFES ) , Tinetti Performance-Oriented Mobility Assessment ( POMA ) , function reach test , five times sit to st and ( FTSS ) and Timed Up and Go ( TUG ) were administered to participants as clinical assessment s. Results showed that in the exercise group , all the mechanical and time parameters showed significant improvement . In control group , only the maximal vertical ground reaction force ( MVGRF ) improved significantly . For clinical assessment s ( balance , mobility , and self-confidence ) , exercise group showed significantly better scores . The STS movements in video-game-based training mimic real life situations which may help to transfer the training effects into daily activities . The effectiveness of lower limb muscle training is worthy of further investigation Background Stepping impairments are associated with physical and cognitive decline in older adults and increased fall risk . Exercise interventions can reduce fall risk , but adherence is often low . A new exergame involving step training may provide an enjoyable exercise alternative for preventing falls in older people . Purpose To assess the feasibility and safety of unsupervised , home-based step pad training and determine the effectiveness of this intervention on stepping performance and associated fall risk in older people . Design Single-blinded two-arm r and omized controlled trial comparing step pad training with control ( no-intervention ) . Setting / Participants Thirty-seven older adults residing in independent-living units of a retirement village in Sydney , Australia . Intervention Intervention group ( IG ) participants were provided with a computerized step pad system connected to their TVs and played a step game as often as they liked ( with a recommended dose of 2–3 sessions per week for 15–20 minutes each ) for eight weeks . In addition , IG participants were asked to complete a choice stepping reaction time ( CSRT ) task once each week . Main Outcome Measures CSRT , the Physiological Profile Assessment ( PPA ) , neuropsychological and functional mobility measures were assessed at baseline and eight week follow-up . Results Thirty-two participants completed the study ( 86.5 % ) . IG participants played a median 2.75 sessions/week and no adverse events were reported . Compared to the control group , the IG significantly improved their CSRT ( F31,1 = 18.203 , p<.001 ) , PPA composite scores ( F31,1 = 12.706 , p = 0.001 ) , as well as the postural sway ( F31,1 = 4.226 , p = 0.049 ) and contrast sensitivity ( F31,1 = 4.415 , p = 0.044 ) PPA sub-component scores . In addition , the IG improved significantly in their dual-task ability as assessed by a timed up and go test/verbal fluency task ( F31,1 = 4.226 , p = 0.049 ) . Conclusions Step pad training can be safely undertaken at home to improve physical and cognitive parameters of fall risk in older people without major cognitive and physical impairments . Trial Registration Australian New Zeal and Clinical Trials Registry ACTRN12611001081909 BACKGROUND Dementia cases may reach 100 million by 2050 . Interventions are sought to curb or prevent cognitive decline . Exercise yields cognitive benefits , but few older adults exercise . Virtual reality-enhanced exercise or " exergames " may elicit greater participation . PURPOSE To test the following hypotheses : ( 1 ) stationary cycling with virtual reality tours ( " cybercycle " ) will enhance executive function and clinical status more than traditional exercise ; ( 2 ) exercise effort will explain improvement ; and ( 3 ) brain-derived neurotrophic growth factor ( BDNF ) will increase . DESIGN Multi-site cluster r and omized clinical trial ( RCT ) of the impact of 3 months of cybercycling versus traditional exercise , on cognitive function in older adults . Data were collected in 2008 - 2010 ; analyses were conducted in 2010 - 2011 . SETTING / PARTICIPANTS 102 older adults from eight retirement communities enrolled ; 79 were r and omized and 63 completed . INTERVENTIONS A recumbent stationary ergometer was utilized ; virtual reality tours and competitors were enabled on the cybercycle . MAIN OUTCOME MEASURES Executive function ( Color Trails Difference , Stroop C , Digits Backward ) ; clinical status ( mild cognitive impairment ; MCI ) ; exercise effort/fitness ; and plasma BDNF . RESULTS Intent-to-treat analyses , controlling for age , education , and cluster r and omization , revealed a significant group X time interaction for composite executive function ( p=0.002 ) . Cybercycling yielded a medium effect over traditional exercise ( d=0.50 ) . Cybercyclists had a 23 % relative risk reduction in clinical progression to MCI . Exercise effort and fitness were comparable , suggesting another underlying mechanism . A significant group X time interaction for BDNF ( p=0.05 ) indicated enhanced neuroplasticity among cybercyclists . CONCLUSIONS Cybercycling older adults achieved better cognitive function than traditional exercisers , for the same effort , suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline . TRIAL REGISTRATION This study is registered at Clinical trials.gov NCT01167400 BACKGROUND Gait and cognitive disturbances are common in Parkinson 's disease ( PD ) . These deficits exacerbate fall risk and difficulties with mobility , especially during complex or dual-task walking . Traditional gait training generally fails to fully address these complex gait activities . Virtual reality ( VR ) incorporates principles of motor learning while delivering engaging and challenging training in complex environments . We hypothesized that VR may be applied to address the multifaceted deficits associated with fall risk in PD . METHODS Twenty patients received 18 sessions ( 3 per week ) of progressive intensive treadmill training with virtual obstacles ( TT + VR ) . Outcome measures included gait under usual-walking and dual-task conditions and while negotiating physical obstacles . Cognitive function and functional performance were also assessed . RESULTS Patients were 67.1 ± 6.5 years and had a mean disease duration of 9.8 ± 5.6 years . Posttraining , gait speed significantly improved during usual walking , during dual task , and while negotiating overground obstacles . Dual-task gait variability decreased ( ie , improved ) and Trail Making Test times ( parts A and B ) improved . Gains in functional performance measures and retention effects , 1 month later , were also observed . CONCLUSIONS To our knowledge , this is the first time that TT + VR has been used for gait training in PD . The results indicate that TT + VR is viable in PD and may significantly improve physical performance , gait during complex challenging conditions , and even certain aspects of cognitive function . These findings have important implication s for underst and ing motor learning in the presence of PD and for treating fall risk in PD , aging , and others who share a heightened risk of falls The combination of active video gaming and exercise ( exergaming ) is suggested to improve elderly people 's balance , thereby decreasing fall risk . Exergaming has been shown to increase motivation during exercise therapy , due to the enjoyable and challenging nature , which could support long-term adherence for exercising balance . However , scarce evidence is available of the direct effects of exergaming on postural control . Therefore , the aim of the study was to assess the effect of a six-week videogame-based exercise program aim ed at improving balance in elderly people . Task performance and postural control were examined using an interrupted time series design . Results of multilevel analyses showed that performance on the dot task improved within the first two weeks of training . Postural control improved during the intervention . After the intervention period task performance and balance were better than before the intervention . Results of this study show that healthy elderly can benefit from a videogame-based exercise program to improve balance and that all subjects were highly motivated to exercise balance because they found gaming challenging and enjoyable Background While many studies confirm the positive effect of cognitive and physical training on cognitive performance of older adults , only little is known about the effects of simultaneously performed cognitive and physical training . In the current study , older adults simultaneously performed a verbal working memory and a cardiovascular training to improve cognitive and motor-cognitive dual task performance . Twenty training sessions of 30 minutes each were conducted over a period of ten weeks , with a test session before , in the middle , and after the training . Training gains were tested in measures of selective attention , paired-associates learning , executive control , reasoning , memory span , information processing speed , and motor-cognitive dual task performance in the form of walking and simultaneously performing a working memory task . Results Sixty-three participants with a mean age of 71.8 ± 4.9 years ( range 65 to 84 ) either performed the simultaneous training ( N = 21 ) , performed a single working memory training ( N = 16 ) , or attended no training at all ( N = 26 ) . The results indicate similar training progress and larger improvements in the executive control task for both training groups when compared to the passive control group . In addition , the simultaneous training result ed in larger improvements compared to the single cognitive training in the paired-associates task and was able to reduce the step-to-step variability during the motor-cognitive dual task when compared to the single cognitive training and the passive control group . Conclusions The simultaneous training of cognitive and physical abilities presents a promising training concept to improve cognitive and motor-cognitive dual task performance , offering greater potential on daily life functioning , which usually involves the recruitment of multiple abilities and re sources rather than a single one BACKGROUND there are few longitudinal studies of the prognosis of falling at home . OBJECTIVE to determine outcomes in older people who fall once and more than once . DESIGN longitudinal prospect i ve cohort study . SETTING primary care in the UK . SUBJECTS 1815 subjects over 75 who had a st and ardized and vali date d health check . METHOD annual interviews over 4 years . Practice records were used to establish death and admission to institutions . RESULTS risk of death was increased at 1 year [ odds ratio ( OR ) 2.6 , 95 % confidence interval ( CI ) 1.4 - 4.7 ] and 3 years ( OR 1.9 , 95 % CI 1.2 - 3.0 ) for recurrent fallers but not single fallers ( OR 0.9 , 95 % CI 0.5 - 1.6 at 1 year ; OR 0.97 , 95 % CI 0.7 - 1.4 at 3 years ) . Risk of admission to long-term care over 1 year was markedly increased both for single fallers ( OR 3.8 , 95 % CI 1.8 - 8.3 ) and recurrent fallers ( OR 4.5 , 95 % CI 1.7 - 12 ) . Functional decline was not related to faller status , the latter being very variable from one year to the next . CONCLUSIONS the stronger relationship between falling and admission to long-term care rather than mortality supports the hypothesis that the perceived risks for those who fall only once are exaggerated Background Computer-based interventions have demonstrated consistent positive effects on various physical abilities in older adults . This study aims to compare two training groups that achieve similar amounts of strength and balance exercise where one group receives an intervention that includes additional dance video gaming . The aim is to investigate the different effects of the training programs on physical and psychological parameters in older adults . Methods Thirty-one participants ( mean age ± SD : 86.2 ± 4.6 years ) , residents of two Swiss hostels for the aged , were r and omly assigned to either the dance group ( n = 15 ) or the control group ( n = 16 ) . The dance group absolved a twelve-week cognitive-motor exercise program twice weekly that comprised progressive strength and balance training supplemented with additional dance video gaming . The control group performed only the strength and balance exercises during this period . Outcome measures were foot placement accuracy , gait performance under single and dual task conditions , and falls efficacy . Results After the intervention between-group comparison revealed significant differences for gait velocity ( U = 26 , P = .041 , r = .45 ) and for single support time ( U = 24 , P = .029 , r = .48 ) during the fast walking dual task condition in favor of the dance group . No significant between-group differences were observed either in the foot placement accuracy test or in falls efficacy . Conclusions There was a significant interaction in favor of the dance video game group for improvements in step time . Significant improved fast walking performance under dual task conditions ( velocity , double support time , step length ) was observed for the dance video game group only . These findings suggest that in older adults a cognitive-motor intervention may result in more improved gait under dual task conditions in comparison to a traditional strength and balance exercise program . Trial registration This trial has been registered under IS RCT N05350123 ( http://www.controlled-trials.com OBJECTIVES To evaluate the learning , retention and transfer of performance improvements after Nintendo Wii Fit ™ training in patients with Parkinson 's disease and healthy elderly people . DESIGN Longitudinal ,
Output:
| One pilot study found balance board training reduced falls and most studies reported training improved physical ( e.g. balance and strength ) and cognitive ( e.g. attention , executive function ) measures .
Inconsistent results were found for psychological measures related to falls-efficacy .
Very few between-group differences were evident when interactive cognitive-motor interventions were compared to traditional training programs .
Conclusions The review findings provide preliminary evidence that interactive cognitive-motor interventions can improve physical and cognitive fall risk factors in older people , but that the effect of such interventions on falls has not been definitively demonstrated .
Interactive cognitive-motor interventions appear to be of equivalent efficacy in ameliorating fall risk as traditional training programs . |
MS211967 | ***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 Studies have shown that treatment of hyperlipidemia , especially lowering of plasma LDL levels , retards the progression of coronary atherosclerosis and prevents clinical cardiovascular events . No such studies have focused on subjects with low levels of HDL cholesterol . METHODS AND RESULTS We r and omly assigned 395 post-coronary bypass men , who had an HDL cholesterol concentration < or = 1.1 mmol/L and LDL cholesterol < or = 4.5 mmol/L , to receive gemfibrozil 1200 mg/d or placebo . Coronary angiography was performed at baseline and after , on average , 32 months of therapy . Changes in coronary dimensions were assessed by computer-assisted analysis . Average on-trial serum triglyceride concentrations were 1.69+/-0.68 and 1.02+/-0.37 , total cholesterol 5.48+/-0.68 and 4.83+/-0.63 , LDL cholesterol 3.84+/-0.59 and 3.39+/-0.56 , and HDL cholesterol 0.88+/-0.15 and 0.98+/-0.17 mmol/L in the placebo and gemfibrozil groups , respectively ( mean+/-SD , each P<.001 ) . The change in per-patient means of average diameters of native coronary segments was -0.04+/-0.11 mm in the placebo group and -0.01+/-0.10 mm in the gemfibrozil group ( P=.009 ) . The equivalent changes in minimum luminal diameters of stenoses were -0.09+/-0.18 and -0.04+/-0.15 mm , respectively ( P=.002 ) . A similar , albeit nonsignificant , trend toward treatment benefit was found in the predefined primary study end point , segments unaffected by grafts and those distal to graft insertions . In aortocoronary bypass grafts , 23 subjects ( 14 % ) assigned to placebo had new lesions in the follow-up angiogram , compared with 4 subjects ( 2 % ) assigned to gemfibrozil ( P<.001 ) . CONCLUSIONS Gemfibrozil therapy retarded the progression of coronary atherosclerosis and the formation of bypass-graft lesions after coronary bypass surgery in men with low HDL cholesterol as their main lipid abnormality In a double-blind clinical trial of clofibrate versus identical quantity of corn oil 497 patients with ischaemic heart disease were observed over a period of five years . The death rate and the rate of non-fatal infa rcts were significantly less among the clofibrate group , and the difference was greatest in respect of sudden deaths and among patients who had previously suffered from angina rather than infa rct ion . The cholesterol- and triglyceride-reducing properties of clofibrate were maintained throughout the period of the trial and side effects were very few . But the protective action of the drug against new infa rcts and death bore no apparent relation to these properties Objective : To assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease . Design : Double blind placebo controlled r and omised trial . Setting : 85 general practice s and nine hospital vascular clinics . Participants : 1568 men , mean age 68.2 years ( range 35 to 92 ) at recruitment . Interventions : Bezafibrate 400 mg daily ( 783 men ) or placebo ( 785 men ) . Main outcome measures : Combination of coronary heart disease and of stroke . All coronary events , fatal and non-fatal coronary events separately , and strokes alone ( secondary end points ) . Results : Bezafibrate did not reduce the incidence of coronary heart disease and stroke . There were 150 and 160 events in the active and placebo groups respectively ( relative risk 0.96 , 95 % confidence interval 0.76 to 1.21 ) . There were 90 and 111 major coronary events in the active and placebo groups respectively ( 0.81 , 0.60 to 1.08 ) , of which 64 and 65 were fatal ( 0.95 , 0.66 to 1.37 ) and 26 and 46 non-fatal ( 0.60 , 0.36 to 0.99 ) . Beneficial effects on non-fatal events were greatest in men aged < 65 years at entry , in whom benefit was also seen for all coronary events ( 0.38 , 0.20 to 0.72 ) . There were no significant effects in older men . There were 60 strokes in those on active treatment and 49 in those on placebo ( 1.34 , 0.80 to 2.01 ) . There were 204 and 195 deaths from all causes in the two groups respectively ( 1.03 , 0.83 to 1.26 ) . Bezafibrate reduced the severity of intermittent claudication for up to three years . Conclusions : Bezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events , particularly in those aged < 65 years at entry , in whom all coronary events may also be reduced Background We studied the joint effect of baseline triglyceride and lipoprotein cholesterol levels on the incidence of cardiac end points in the trial group ( n = 4,081 ) of the Helsinki Heart Study , a 5-year r and omized coronary primary prevention trial among dyslipidemic middle-aged men . The relative risks ( RR ) were calculated using Cox proportional hazards models with a dummy variable technique that allows simultaneous study of subgroup combinations from the placebo and treatment groups . Methods and Results In the placebo group ( n = 2,045 ) , the low density lipoprotein cholesterol (LDL-C)/high density lipoprotein cholesterol ( HDL-C ) ratio was the best single predictor of cardiac events . This ratio in combination with the serum triglyceride level revealed a high-risk subgroup : subjects with LDL-C/HDL-C ratio > 5 and triglycerides > 2.3 mmol/1 had a RR of 3.8 ( 95 % CI , 2.2 - 6.6 ) compared with those with LDL-C/HI)L-C ratio ≤5 and triglyceride concentration ≤2.3 mmol/1 . In subjects with triglyceride concentration > 2.3 mmol/l and LDL-C/H1)L-C ratio ≤5 , RR was close to unity ( 1.1 ) , whereas in those with triglyceride level ≤2.3 mmoVIl and LDL-C/HDL-C ratio > 5 , RR was 1.2 . The high-risk group with LDL-C/HDL-C ratio > 5 and triglyceride level > 2.3 mmol/1 profited most from treatment with gemfibrozil , with a 71 % lower incidence of coronary heart disease events than the corresponding placebo subgroup . In all other subgroups , the reduction in CHD incidence was substantially smaller Conclusions Serum triglyceride concentration has prognostic value , both for assessing coronary heart disease risk and in predicting the effect of gemfibrozil treatment , especially when used in combination with HDL-C and OBJECTIVE To determine whether serum lipid intervention , in addition to conventional diabetes treatment , could alter cardiovascular outcomes in type 2 diabetes . RESEARCH DESIGN AND METHODS There were 164 type 2 diabetic subjects ( 117 men , 47 women ) without a history of clinical cardiovascular disease r and omized to receive either bezafibrate or placebo daily on a double-blind basis in addition to routine diabetes treatment and followed prospect ively for a minimum of 3 years . Serial biochemical and noninvasive vascular assessment s , carotid and femoral artery B-mode ultrasound measurements , and those pertaining to coronary heart disease (CHD)— clinical history , the World Health Organization ( WHO ) cardiovascular question naire , and resting and exercise electrocardiogram (ECG)—were recorded . RESULTS Bezafibrate treatment was associated with significantly greater reductions over 3 years in median serum triglyceride ( −32 vs. 4 % , P = 0.001 ) , total cholesterol ( −7 vs. −0.3 % , P = 0.004 ) , and total−to-HDL cholesterol ratio ( −12 vs. −0.0 % , P = 0.001 ) , and an increase in HDL cholesterol ( 6 vs. −2 % , P = 0.02 ) as compared with placebo . There was a trend toward a greater reduction of fibrinogen ( −18 vs. −6 % , P = 0.08 ) at 3 years . No significant differences between the two groups were found in the progress of ultrasonically measured arterial disease . In those treated with bezafibrate , there was a significant reduction ( P = 0.01 , log-rank test ) in the combined incidence of Minnesota-coded probable ischemic change on the resting ECG and of documented myocardial infa rct ion . CONCLUSIONS Improving dyslipidemia in type 2 diabetic subjects had no effect on the progress of ultrasonically measured arterial disease , although the lower rate of “ definite CHD events ” in the treated group suggests that this might result in a reduction in the incidence of coronary heart disease BACKGROUND We investigated whether combination therapy with a statin plus a fibrate , as compared with statin monotherapy , would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus who were at high risk for cardiovascular disease . METHODS We r and omly assigned 5518 patients with type 2 diabetes who were being treated with open-label simvastatin to receive either masked fenofibrate or placebo . The primary outcome was the first occurrence of nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes . The mean follow-up was 4.7 years . RESULTS The annual rate of the primary outcome was 2.2 % in the fenofibrate group and 2.4 % in the placebo group ( hazard ratio in the fenofibrate group , 0.92 ; 95 % confidence interval [ CI ] , 0.79 to 1.08 ; P=0.32 ) . There were also no significant differences between the two study groups with respect to any secondary outcome . Annual rates of death were 1.5 % in the fenofibrate group and 1.6 % in the placebo group ( hazard ratio , 0.91 ; 95 % CI , 0.75 to 1.10 ; P=0.33 ) . Prespecified subgroup analyses suggested heterogeneity in treatment effect according to sex , with a benefit for men and possible harm for women ( P=0.01 for interaction ) , and a possible interaction according to lipid subgroup , with a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol ( P=0.057 for interaction ) . CONCLUSIONS The combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events , nonfatal myocardial infa rct ion , or nonfatal stroke , as compared with simvastatin alone . These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes . ( Clinical Trials.gov number , NCT00000620 . Objective In a r and omized 5-yr multi-intervention trial , we tested the efficacy of intensified health education ( IHE ) in improving metabolic control and reducing the level of coronary risk factors and incidence of ischemic heart disease ( IHD ) . Research Design and Methods Within the intervention group , the benefit of clofibric acid was evaluated in a double-blind study . One thous and one hundred thirty-nine newly diagnosed middle-aged ( 30- to 55-yr-old ) patients with non-insulindependent diabetes mellitus ( NIDDM ) entered the study . They were classified as diet controlled after a 6- wk screening phase with conventional dietary treatment . During the follow-up , the control group ( n = 378 ) was cared for at different diabetes outpatient clinics with a st and ardized surveillance . The intervention group ( n = 761 ) had a structured IHE that included dietary advice , antismoking and antialcohol education , and ways to enhance physical activity . Results R and omly , 379 of the IHE patients received 1.6 g clofibric acid/day , and the others received placebo . IHE result ed in improved glucose control ( adjusted fasting blood glucose ) levels after 5 yr ( control subjects 9.27 mM , IHE group 8.71 mM , and IHE plus clofibric acid group 8.60 mM , P < 0.01 ) . The better glycemic control was achieved with fewer antidiabetic drugs . After 5 yr , antidiabetic drugs were prescribed to 47 % of the control subjects , 28 % of the IHE group , and 34 % of the IHE plus clofibric acid group ( cutoff limit for drug application was postpr and ial blood glucose of ≥13.87 mM ) . The ratio of polyunsaturated to saturated fatty acids ( 0.26 vs. 0.40 , P
Output:
| INTERPRETATION Fibrates can reduce the risk of major cardiovascular events predominantly by prevention of coronary events , and might have a role in individuals at high risk of cardiovascular events and in those with combined dyslipidaemia . |
MS211968 | ***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 efficacy of the skin self-examination ( SSE ) to detect artificial changes in the size of nevi has not been evaluated in a controlled setting . OBJECTIVE Our purpose was to determine the sensitivity and specificity of the SSE in detecting artificial changes in mole size in patients at high risk for melanoma . METHODS In a single-center , single-blinded cross-over study , patients who had been performing the SSE confidently for at least 1 year examined their backs after the diameter of an existing mole was increased artificially in r and om order by 0 , 2 , or 4 mm . RESULTS The specificity of the SSE was 62 % ( 95 % confidence interval [ CI ] , 53%-72 % ) ( N = 103 ) . The sensitivity of the 2 mm change was 58 % ( 95 % CI , 49%-68 % ) and that of the 4 mm change was 75 % ( 95 % CI , 66%-83 % ) . SSE performance was not related to perceived risk , number of moles , gender , age , or frequency of self-examination . CONCLUSION Even in our highly motivated and selected group of high-risk patients , 25 % could not detect an obvious increase in the diameter of an existing nevus , whereas 38 % incorrectly identified a change when none was made . The SSE is only a moderately effective tool for the detection of acute , large , changes in mole size . The usefulness of the SSE in detection of new lesions or changes in existing lesions is likely due to a combination of factors or due to factors other than size , such as color , border irregularity , and texture , among others OBJECTIVE To determine the sensitivity and specificity of skin self-examination ( SSE ) to detect new and changing moles with and without the aid of baseline digital photographs in patients with dysplastic nevi . DESIGN AND INTERVENTION Patients had baseline digital photography and mole counts of their back , chest , and abdomen and were instructed to perform a baseline SSE . Print copies of the images were provided to the patient . Following the baseline examination , the appearance of existing moles was altered and new moles were created using cosmetic eyeliner . The number of moles altered and /or created totaled approximately 10 % of each patients ' absolute mole count . SETTING AND PATIENTS Fifty patients with 5 or more dysplastic nevi from the outpatient clinic at Memorial Sloan-Kettering Cancer Center , New York , NY . MAIN OUTCOME MEASURE Skin self-examinations with and without access to the baseline photographs to identify the number of new and altered moles . RESULTS The sensitivity and specificity of SSE for detection of both altered and new moles without photography were 60.2 % and 96.2 % , respectively . Skin self-examination with photography yielded a sensitivity and specificity of 72.4 % and 98.4 % , respectively . The findings were similar when stratified by site ( back vs chest or abdomen ) . The sensitivity and specificity for new moles were higher compared with altered moles . CONCLUSIONS Access to baseline photography improved the diagnostic accuracy of SSE on the back and chest or abdomen and improved detection of changing and new moles . Our results suggest that baseline digital photography in t and em with SSE may be effective in improving the diagnostic accuracy of patients performing SSE Objectives : Melanoma is a significant cause of morbidity and mortality worldwide and incidence is increasing . Survival after treatment is inversely related to the thickness of the tumour at diagnosis . Population screening has the potential to reduce mortality but there is no conclusive evidence of benefit . Such evidence can come best from a r and omised trial . Here we describe the design of a community based r and omised trial of a population screening programme for melanoma in Queensl and , Australia and early results of the first phase of the trial . Methods : A total of 44 communities ( aggregate population 560 000 adults aged 30 years or more ) will be r and omised to receive either a community based screening programme for 3 years or normal practice . The screening programme promotes thorough skin self examination and whole body skin examination by a doctor and provides open access skin cancer screening clinics . In its first phase , the trial is underway in nine intervention and nine control communities . The primary outcome measure is mortality from melanoma during 15 years of follow up . Results : The first phase of the trial has shown the feasibility of implementing a population skin screening programme including regular skin cancer screening clinics , and has shown the strong support of communities and doctors for the programme . There has been a significant 2.5-fold increase in participation in screening in the intervention communities in this first phase after the first 12 months of the trial and no significant increase in participation in screening in control communities during this period . Conclusions : The design of a community based r and omised trial of screening for melanoma has been successfully peer review ed and the intervention has been shown to be feasible in practice . This r and omised trial may be one of the last opportunities to develop the evidence required for public health recommendations for population screening for melanoma Background : Malignant melanoma is rising quickly in incidence and mortality rates . Family physicians ( FPs ) have been reported to lack confidence in diagnosing skin cancers . Objective : The aim of this study was to determine whether an educational intervention can improve FPs ’ abilities to diagnose skin cancers . Methods : The design was a prospect i ve , r and omized trial which included a skin cancer question naire , a video intervention , and a skin biopsy review . Results : Pre-intervention , FPs answered 57 % of the questions correctly on the skin cancer question naire . Post-intervention , the video intervention group scored higher than did the control group . The video intervention group removed 10 % fewer benign lesions and almost 3 times more malignant lesions compared with their pre-intervention biopsy rate . No findings were statistically significant . Conclusion : An educational intervention may improve FPs ’ knowledge and diagnosis of skin cancer . Our results may guide future studies with larger sample sizes in developing a skin cancer continuing medical education ( CME ) course for FPs . Antécédents : L’incidence des mélanomes et le taux de mortalité qui y est associé augmentent rapidement , ce qui laisse suggérer que les médecins de famille n’ont pas la confiance nécessaire pour diagnostiquer le cancer de la peau . Objectif : Déterminer si une campagne d’éducation peut améliorer la capacité des médecins de famille à diagnostiquer les cancers de la peau . Méthodes : Une étude prospect i ve r and omisée a été menée , comprenant un question naire sur le cancer de la peau , une séance éducative sur vidéo et un aperçu d’une biopsie de la peau . Résultats : Avant la séance , les médecins de famille ont obtenu de bonnes réponses à 57 % des questions figurant sur le question naire du cancer de la peau . Le groupe qui a assisté à la séance vidéo a eu un meilleur résultat que le groupe précédent . Le groupe a enlevé 10 % de moins de tumeurs bénignes et 3 fois plus de tumeurs malignes après l’aperçu de la biopsie . Toutefois , ces résultats ne représentent pas des statistiques significatives . Conclusion : Des mesures éducatives pourront améliorer les connaissances des médecins de famille et leurs capacités de diagnostiquer les mélanomes . Nos résultats pourront orienter de futures études , avec un plus large nombre de participants , dans la mise au point d’une stratégie d’éducation médicale continue ( EMC ) sur le cancer de la peau , destinée aux médecins de famille
Output:
| Results Key Question Does screening in asymptomatic persons with whole-body examination by a primary care clinician or by self-examination reduce morbidity and mortality from skin cancer ?
We found no new evidence on the effectiveness of skin examination by a physician in reducing the morbidity or mortality of skin cancer .
Context ual Question 1 Can screening with whole-body examination by primary care clinicians or by self-examination accurately detect skin cancers ? |
MS211969 | ***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 appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p < 0.022 ) . HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p < 0.002 ) . The reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control OBJECTIVE To test the effects of two Mediterranean diet ( MedDiet ) interventions versus a low-fat diet on incidence of diabetes . RESEARCH DESIGN AND METHODS This was a three-arm r and omized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center ( PREDIMED-Reus , northeastern Spain ) of the Prevención con Dieta Mediterránea [ PREDIMED ] study , a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk . Participants were r and omly assigned to education on a low-fat diet ( control group ) or to one of two MedDiets , supplemented with either free virgin olive oil ( 1 liter/week ) or nuts ( 30 g/day ) . Diets were ad libitum , and no advice on physical activity was given . The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria . RESULTS After a median follow-up of 4.0 years , diabetes incidence was 10.1 % ( 95 % CI 5.1–15.1 ) , 11.0 % ( 5.9–16.1 ) , and 17.9 % ( 11.4–24.4 ) in the MedDiet with olive oil group , the MedDiet with nuts group , and the control group , respectively . Multivariable adjusted hazard ratios of diabetes were 0.49 ( 0.25–0.97 ) and 0.48 ( 0.24–0.96 ) in the MedDiet supplemented with olive oil and nuts groups , respectively , compared with the control group . When the two MedDiet groups were pooled and compared with the control group , diabetes incidence was reduced by 52 % ( 27–86 ) . In all study arms , increased adherence to the MedDiet was inversely associated with diabetes incidence . Diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity . CONCLUSIONS MedDiets without calorie restriction seem to be effective in the prevention of diabetes in subjects at high cardiovascular risk Aims /hypothesis . The amount and quality of fat in the diet could be of importance for development of insulin resistance and related metabolic disorders . Our aim was to determine whether a change in dietary fat quality alone could alter insulin action in humans . Methods . The KANWU study included 162 healthy subjects chosen at r and om to receive a controlled , isoenergetic diet for 3 months containing either a high proportion of saturated ( SAFA diet ) or monounsaturated ( MUFA diet ) fatty acids . Within each group there was a second assignment at r and om to supplements with fish oil ( 3.6 g n-3 fatty acids/d ) or placebo . Results . Insulin sensitivity was significantly impaired on the saturated fatty acid diet ( -10 % , p = 0.03 ) but did not change on the monounsaturated fatty acid diet ( + 2 % , NS ) ( p = 0.05 for difference between diets ) . Insulin secretion was not affected . The addition of n-3 fatty acids influenced neither insulin sensitivity nor insulin secretion . The favourable effects of substituting a monounsaturated fatty acid diet for a saturated fatty acid diet on insulin sensitivity were only seen at a total fat intake below median ( 37E % ) . Here , insulin sensitivity was 12.5 % lower and 8.8 % higher on the saturated fatty acid diet and monounsaturated fatty acid diet respectively ( p = 0.03 ) . Low density lipoprotein cholesterol ( LDL ) increased on the saturated fatty acid diet ( + 4.1 % , p < 0.01 ) but decreased on the monounsaturated fatty acid diet ( MUFA ) ( –5.2 , p < 0.001 ) , whereas lipoprotein ( a ) [ Lp(a ) ] increased on a monounsaturated fatty acid diet by 12 % ( p < 0.001 ) . Conclusions /interpretation . A change of the proportions of dietary fatty acids , decreasing saturated fatty acid and increasing monounsaturated fatty acid , improves insulin sensitivity but has no effect on insulin secretion . A beneficial impact of the fat quality on insulin sensitivity is not seen in individuals with a high fat intake ( > 37E % ) . [ Diabetologia ( 2001 ) 44 : 312–319 Objective To assess the relation between adherence to a Mediterranean diet and the incidence of diabetes among initially healthy participants . Design Prospect i ve cohort study with estimates of relative risk adjusted for sex , age , years of university education , total energy intake , body mass index , physical activity , sedentary habits , smoking , family history of diabetes , and personal history of hypertension . Setting Spanish university department . Participants 13 380 Spanish university graduates without diabetes at baseline followed up for a median of 4.4 years . Main outcome measures Dietary habits assessed at baseline with a vali date d 136 item food frequency question naire and scored on a nine point index . New cases of diabetes confirmed through medical reports and an additional detailed question naire posted to those who self reported a new diagnosis of diabetes by a doctor during follow-up . Confirmed cases of type 2 diabetes . Results Participants who adhered closely to a Mediterranean diet had a lower risk of diabetes . The incidence rate ratios adjusted for sex and age were 0.41 ( 95 % confidence interval 0.19 to 0.87 ) for those with moderate adherence ( score 3 - 6 ) and 0.17 ( 0.04 to 0.75 ) for those with the highest adherence ( score 7 - 9 ) compared with those with low adherence ( score < 3 ) . In the fully adjusted analyses the results were similar . A two point increase in the score was associated with a 35 % relative reduction in the risk of diabetes ( incidence rate ratio 0.65 , 0.44 to 0.95 ) , with a significant inverse linear trend ( P=0.04 ) in the multivariate analysis . Conclusion Adherence to a Mediterranean diet is associated with a reduced risk of diabetes Background The effects of fish consumption and n-3 fatty acids on type 2 diabetes mellitus ( T2DM ) have recently been debated . Objective We explored the risk of T2DM in relation to consumption of lean fish , fatty fish , fish products and total fish as well as cod liver oil supplements in a representative sample of Norwegian women . Design This was a prospect i ve population based cohort study in 33740 women free of T2DM , stroke , angina or heart attack and with detailed information on important co-variates and dietary intake at baseline . Risk ratios and corresponding 95 % CI were estimated using Poisson regression with log-person time as offset . Results Lean fish consumption was inversely associated with T2DM compared to zero intake . Risk ratios and 95 % CI for intake of 75 and 100 g lean fish per day were 0.71 ( 0.51 , 0.98 ) and 0.67 ( 0.46 , 0.98 ) , respectively . There was no effect of intake of fatty fish , fish products , total fish or use of cod liver oil supplements on the risk of T2DM . Conclusion Lean fish consumption of 75–100 g/d had a beneficial effect on T2DM . It remains unclear whether lean fish in itself has a protective effect on T2DM or that lean fish consumers have a protective life-style that we were not able to take into account in this study . Unfavorable effects of fatty fish consumption or use of cod liver oil supplements on T2DM were not observed BACKGROUND Obesity is a strong risk factor for type 2 diabetes . However , few studies have compared the predictive power of overall obesity with that of central obesity . The cutoffs for waist circumference ( WC ) and waist-to-hip ratio ( WHR ) as measures of abdominal adiposity remain controversial . OBJECTIVE The objective was to compare body mass index ( BMI ) , WC , and WHR in predicting type 2 diabetes . DESIGN A prospect i ve cohort study ( Health Professionals Follow-Up Study ) of 27 270 men was conducted . WC , WHR , and BMI were assessed at baseline . Covariates and potential confounders were assessed repeatedly during the follow-up . RESULTS During 13 y of follow-up , we documented 884 incident type 2 diabetes cases . Age-adjusted relative risks ( RRs ) across quintiles of WC were 1.0 , 2.0 , 2.7 , 5.0 , and 12.0 ; those of WHR were 1.0 , 2.1 , 2.7 , 3.6 , and 6.9 ; and those of BMI were 1.0 , 1.1 , 1.8 , 2.9 , and 7.9 ( P for trend < 0.0001 for all ) . Multivariate adjustment for diabetes risk factors only slightly attenuated these RRs . Adjustment for BMI substantially attenuated RRs for both WC and WHR . The receiver operator characteristic curve analysis indicated that WC and BMI were similar and were better than WHR in predicting type 2 diabetes . The cumulative proportions of type 2 diabetes cases identified according to medians of BMI ( > /=24.8 ) , WC ( > /=94 cm ) , and WHR ( > /=0.94 ) were 82.5 % , 83.6 % , and 74.1 % , respectively . The corresponding proportions were 78.9 % , 50.5 % , and 65.7 % according to the recommended cutoffs . CONCLUSIONS Both overall and abdominal adiposity strongly and independently predict risk of type 2 diabetes . WC is a better predictor than is WHR . The currently recommended cutoff for WC of 102 cm for men may need to be reevaluated ; a lower cutoff may be more appropriate BACKGROUND The long-term relations between specific types of dietary fat and risk of type 2 diabetes remain unclear . OBJECTIVE Our objective was to examine the relations between dietary fat intakes and the risk of type 2 diabetes . DESIGN We prospect ively followed 84204 women aged 34 - 59 y with no diabetes , cardiovascular disease , or cancer in 1980 . Detailed dietary information was assessed at baseline and up date d in 1984 , 1986 , and 1990 by using vali date d question naires . Relative risks of type 2 diabetes were obtained from pooled logistic models adjusted for nondietary and dietary covariates . RESULTS During 14 y of follow-up , 2507 incident cases of type 2 diabetes were documented . Total fat intake , compared with equivalent energy intake from carbohydrates , was not associated with risk of type 2 diabetes ; for a 5 % increase in total energy from fat , the relative risk ( RR ) was 0.98 ( 95 % CI : 0.94 , 1.02 ) . Intakes of saturated or monounsaturated fatty acids were also not significantly associated with the risk of diabetes . However , for a 5 % increase in energy from polyunsaturated fat , the RR was 0.63 ( 0.53 , 0.76 ; P <
Output:
| RESULTS Based on several studies , Mediterranean diet is inversely related to type 2 diabetes and plays important roles in the management of type 2 diabetes .
Based on the evidence gathered and evaluated from various studies , we concluded combination and interaction of Mediterranean diet components , such as fruits , vegetables , nuts , legumes , whole grains , fish and moderate intakes of red wine , which contain essential nutrients and health promoting properties , including high fibers , high magnesium , high anti-oxidant and high monounsaturatal fatty acids ( MUFA ) .
Interaction and combination of these essential nutrients and health promoting properties found to lower body weight , hemoglobin A1C ( HbA1c ) , low density lipoprotein ( LDL ) , oxidative-stress and improve high density lipoprotein ( HDL ) level ; which are beneficial for prevention and prognosis improvement of type 2 diabetes .
In the modern society , poor dietary habits accompanied by inadequate physical activity are associated with the risk of having obesity and type 2 diabetes . |
MS211970 | ***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: Thirteen out of 49 patients suspected of having specific food intolerance after withdrawal and re introduction of specific foods , were further subjected to double blind placebo controlled food challenges . Only three of these subjects were thus shown to have proven specific food intolerance . Of the remaining 10 , nine were strong ' placebo reactors ' . The study suggests that a small number of patients with gastrointestinal symptoms have verifiable specific food intolerance but that a greater number have symptoms attributable to psychogenic causes BACKGROUND Although previous studies have shown that psychological disturbances are frequently associated with the irritable bowel syndrome ( IBS ) , the relation was not necessarily cause and effect . The development of chronic bowel symptoms after an episode of acute gastroenteritis has allowed us to examine prospect ively the role of psychological factors . METHODS Seventy-five patients with acute gastroenteritis completed a series of psychometric tests soon after admission to hospital . Of these , 22 had persistent symptoms compatible with IBS after the acute illness , and in 20 of these the symptoms were still present at six months . FINDINGS At the time of their initial illness , patients who subsequently developed IBS had higher scores for anxiety , depression , somatization and neurotic trait than those who returned to normal bowel function . The psychometric scores had not changed when remeasured after the acute illness . Lactose malabsorption was not an important factor . INTERPRETATION These results support the hypothesis that psychological factors are important in IBS Food hypersensitivity as a cause of abdominal symptoms was investigated by means of exclusion diets and double-blind food provocation in patients with irritable bowel syndrome . Twenty-seven patients entered the study ; nineteen complied with dietary manipulation . Food hypersensitivity as a cause of their presenting symptoms was confirmed by double-blind food provocation in only three patients , who also had evidence of associated atopic disease and positive skin tests to common inhalant allergens . Evidence of minor psychiatric disorder was found in twelve of fourteen patients examined by an independent psychiatrist Specific foods were found to provoke symptoms of irritable bowel syndrome ( IBS ) in 14 of 21 patients . In 6 patients who were challenged double blind the food intolerance was confirmed . No difference was detected in changes in plasma glucose , histamine , immune complexes , haematocrit , eosinophil count , or breath hydrogen excretion produced after challenge or control foods . Rectal prostagl and in E2 ( PGE2 ) , however , increased significantly , and in a further 5 patients rectal PGE2 correlated with wet faecal weight . Food intolerance associated with prostagl and in production is an important factor in the pathogenesis of IBS
Output:
| Milk , wheat , and eggs were most frequently identified to cause symptom exacerbation ; of the foods identified the most common trait was a high salicylate content .
Foods high in amines were also identified .
Studies of diarrhea-predominant IBS identified a higher percentage of adverse food reactions .
Conclusion : Whether adverse reactions to foods are a key factor in exacerbating IBS symptoms or whether dietary manipulation is a valid treatment option is unclear . |
MS211971 | ***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 Sedentary activities such as video gaming are independently associated with obesity . Active video games , in which players physically interact with images on screen , may help increase physical activity and improve body composition . OBJECTIVE The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight , body composition , physical activity , and physical fitness . DESIGN We conducted a 2-arm , parallel , r and omized controlled trial in Auckl and , New Zeal and . A total of 322 overweight and obese children aged 10 - 14 y , who were current users of sedentary video games , were r and omly assigned at a 1:1 ratio to receive either an active video game up grade package ( intervention , n = 160 ) or to have no change ( control group , n = 162 ) . The primary outcome was the change from baseline in body mass index ( BMI ; in kg/m(2 ) ) . Secondary outcomes were changes in percentage body fat , physical activity , cardiorespiratory fitness , video game play , and food snacking . RESULTS At 24 wk , the treatment effect on BMI ( -0.24 ; 95 % CI : -0.44 , -0.05 ; P = 0.02 ) favored the intervention group . The change ( ±SE ) in BMI from baseline increased in the control group ( 0.34 ± 0.08 ) but remained the same in the intervention group ( 0.09 ± 0.08 ) . There was also evidence of a reduction in body fat in the intervention group ( -0.83 % ; 95 % CI : -1.54 % , -0.12 % ; P = 0.02 ) . The change in daily time spent playing active video games at 24 wk increased ( 10.03 min ; 95 % CI : 6.26 , 13.81 min ; P < 0.0001 ) with the intervention accompanied by a reduction in the change in daily time spent playing nonactive video games ( -9.39 min ; 95 % CI : -19.38 , 0.59 min ; P = 0.06 ) . CONCLUSION An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children . This trial was registered in the Australian New Zeal and Clinical Trials Registry at http://www.anzctr.org.au/ as ACTRN12607000632493 Physical inactivity among children is a serious public health problem . It has been suggested that high levels of screen time are contributory factors that encourage sedentary lifestyles in young people . As physical inactivity and obesity levels continue to rise in young people , it has been proposed that new-generation active computer- and video-console games ( otherwise known as “ exergaming ” ) may offer the opportunity to contribute to young people 's energy expenditure during their free time . Although studies have produced some encouraging results regarding the energy costs involved in playing active video-console games , the energy costs of playing the authentic versions of activity-based video games are substantially larger , highlighting that active gaming is no substitute for real sports and activities . A small number of exergaming activities engage children in moderate-intensity activity , but most do not . Only 3 very small trials have considered the effects of exergaming on physical activity levels and /or other health outcomes in children . Evidence from these trials has been mixed ; positive trends for improvements in some health outcomes in the intervention groups were noted in 2 trials . No adequately powered r and omized , controlled trial has been published to date , and no trial has assessed the long-term impact of exergaming on children 's health . We now need high- quality r and omized , controlled trials to evaluate the effectiveness and sustainability of exergaming , as well as its clinical relevance ; until such studies take place , we should remain cautious about its ability to positively affect children 's health BACKGROUND The rising prevalence of obesity in children has been linked in part to the consumption of sugar-sweetened drinks . Our aim was to examine this relation . METHODS We enrolled 548 ethnically diverse schoolchildren ( age 11.7 years , SD 0.8 ) from public schools in four Massachusetts communities , and studied them prospect ively for 19 months from October , 1995 , to May , 1997 . We examined the association between baseline and change in consumption of sugar-sweetened drinks ( the independent variables ) , and difference in measures of obesity , with linear and logistic regression analyses adjusted for potentially confounding variables and clustering of results within schools . FINDINGS For each additional serving of sugar-sweetened drink consumed , both body mass index ( BMI ) ( mean 0.24 kg/m2 ; 95 % CI 0.10 - 0.39 ; p=0.03 ) and frequency of obesity ( odds ratio 1.60 ; 95 % CI 1.14 - 2.24 ; p=0.02 ) increased after adjustment for anthropometric , demographic , dietary , and lifestyle variables . Baseline consumption of sugar-sweetened drinks was also independently associated with change in BMI ( mean 0.18 kg/m2 for each daily serving ; 95 % CI 0.09 - 0.27 ; p=0.02 ) . INTERPRETATION Consumption of sugar-sweetened drinks is associated with obesity in children The primary objective of this pilot study was to evaluate the effect of active video games on children 's physical activity levels . Twenty children ( mean ± SD age = 12 ± 1.5 years ; 40 % female ) were r and omised to receive either an active video game up grade package or to a control group ( no intervention ) . Effects on physical activity over the 12-week intervention period were measured using objective ( Actigraph accelerometer ) and subjective ( Physical Activity Question naire for Children [ PAQ-C ] ) measures . An activity log was used to estimate time spent playing active and non-active video games . Children in the intervention group spent less mean time over the total 12-week intervention period playing all video games compared to those in the control group ( 54 versus 98 minutes/day [ difference = -44 minutes/day , 95 % CI [ -92 , 2 ] ] , p = 0.06 ) . Average time spent in all physical activities measured with an accelerometer was higher in the active video game intervention group compared to the control group ( difference at 6 weeks = 194 counts/min , p = 0.04 , and at 12 weeks = 48 counts/min , p = 0.06).This preliminary study suggests that playing active video games on a regular basis may have positive effects on children 's overall physical activity levels . Further research is needed to confirm if playing these games over a longer period of time could also have positive effects on children 's body weight and body mass index . Trial Registration OBJECTIVES The effects of a Boy Scout Five-A-Day Badge program on fruit juice ( FJ ) and low-fat vegetable ( LV ) consumption were evaluated using a two-condition ( treatment , active-attention-placebo-control ) group r and omized trial , with three data collection periods ( baseline , immediate post , 6-month post ) . METHODS Forty-two Boy Scout troops ( n=473 , 10- to 14-year-old Scouts ) in Houston , TX , were r and omly assigned to condition . The 9-week program included approximately 30 min of weekly troop time , plus approximately 25 min of weekly Internet programming . The intervention was delivered in two waves ( Spring and Fall ) . Data were collected in 2003 - 2004 , and analyses were completed in 2008 . Main outcomes were FJ and LV consumption ( vali date d food frequency question naire ) . FV self-efficacy , preferences , and home availability were also measured . RESULTS Significant increases in FJ consumption ( p=.003 ) , FJ home availability ( p=.009 ) , and LV self-efficacy ( p=.004 ) were observed among the intervention group immediately following the intervention but were not maintained 6 months later . CONCLUSION A Boy Scout troop-plus-Internet intervention promoting FJ and LV consumption result ed in short-term changes in FJ consumption among U.S. Boy Scouts . Future research should investigate ways to extend these results to LV and maintain the increases over time Objective . To evaluate the efficacy and feasibility of a multifaceted , community-based weight intervention program for children using exergaming technology ( activity-promoting video gaming ) . Design and Methods . This is a prospect i ve observational pilot study . Forty-eight children , between the ages of 8 and 16 years , who are overweight or obese , enrolled in Exergaming for Health , a multidisciplinary weight management program , which used active video gaming . Primary outcome measures were change in body mass index ( BMI ) z scores . Results . Most children ( n = 40 , 83 % ) completed the program and participated in outcome evaluations . The average BMI change was −0.48 kg/m2 ( SD = 0.93 ) , P < .002 ( BMI z-score change was −0.072 , SD = 0.14 , P < .0001 ) . The average Global Self-Worth score improved , screen time and soda intake reduced , and exercise hours per week increased . Conclusions . The Exergaming for Health program may be an effective weight management intervention that is feasible with high participation rates . A larger r and omized controlled trial is needed to confirm these results OBJECTIVE We examined the feasibility of Dance Dance Revolution ( DDR ) , a dance video game , in participants ' homes , to increase physical activity ( PA ) and to decrease sedentary screen time ( SST ) . METHODS AND PROCEDURES Sixty children ( 7.5 + /- 0.5 years ) were r and omized in a 2:1 ratio to DDR or to wait-list control ( 10-week delay ) . DDR use was logged , PA was measured objective ly by accelerometry . SST was self-reported at weeks 0 and 10 . At week 28 , after both groups had access to DDR , accelerometry and SST were repeated . RESULTS Mean use of DDR was 89 + /- 82 ( range 0 - 660 min ) min per week ( mpw ) . The DDR group showed increased vigorous PA and a reduction in light PA ; the control group showed no increase in moderate and /or vigorous PA ( MVPA ) although they also had a reduction in light PA . Differences between the groups were not observed . The DDR group also reported a decrease in SST of -1.2 + /- 3.7 h per week ( hpw ) ( P < 0.05 ) , whereas the controls reported an increase of + 3.0 + /- 7.7 hpw ( nonsignificant ) . The difference in SST between the groups was significant , with less SST in the DDR group . Between weeks 10 and 28 , numeric reductions in SST were reported in both groups . In the DDR group , SST at week 28 ( 8.8 + /- 6.0 hpw ) was lower than baseline ( 10.5 + /- 5.5 hpw ; P < 0.03 ) . DISCUSSION This pilot study suggests that DDR reduces SST and may facilitate slight increases in vigorous PA . Further study is needed to better characterize children and context s in which DDR may promote a healthy lifestyle BACKGROUND There is a paucity of research investigating the effects of innovative physical activity programs on physical health and academic performance in the Latino population . PURPOSE To examine the impact of Dance Dance Revolution [DDR]-based exercise on Latino children 's physical fitness and academic achievement . DESIGN A repeated- measures crossover design was used . In Year 1 , Grade -4 students were assigned to the intervention group and offered 30 minutes of exercise ( DDR , aerobic dance ) three times per week . Grade -3 and Grade -5 students made up the comparison group and were offered no structured exercise at school . In Year 2 , the Grade -4 students were again assigned to the intervention , whereas Grade -5 and Grade -6 students were in the comparison group . SETTING / PARTICIPANTS Assessment s were conducted with 208 Latino school children . MAIN OUTCOME MEASURES The baseline measures included time to complete a 1-mile run , BMI , and reading and math scores . Data were collected again 9 months later . Overall , data were collected in 2009 - 2011 and analyzed in 2012 . RESULTS Data yielded significant differences between the intervention and comparison groups in differences in 1-mile run and math scores in Year 1 and Year 2 . The results also revealed net differences in the intervention versus comparison group scores on the 1-mile run for Grade 3 ( p<0.01 ) . Additionally , children 's yearly pre-test and post-test BMI group changes differed ( χ(2)((2 ) ) = 6.6 , p<0.05 ) only for the first year of intervention . CONCLUSIONS The DDR-based exercise intervention improved children 's cardiorespiratory endurance and math scores over time . Professionals should consider integrating exergaming at schools to achieve the goals of promoting a physically active lifestyle and enhancing academic success among Latino children OBJECTIVE We evaluated in a prospect i ve study microcomputer nutritional teaching games and their contribution to the children 's acquisition of nutritional knowledge and improvement of eating habits . MATERIAL AND METHODS One thous and eight hundred seventy-six children aged 7 - 12 years took part in this study at school . All 16 schools of the same school district were r and omized into two groups : games group and control group , both receiving conventional nutritional teaching by their teachers . The children in the games group played computer games during the conventional nutritional teaching period ( 2 hours a week for 5 weeks ) . At completion of the study , dietetic knowledge and dietary records were evaluated in both groups . RESULTS Dietary knowledge tests results were better in the games group ( p<0.001 ) . The children in the games group had
Output:
| Results indicated that academic interest in using health videogames for childhood obesity prevention has increased during this time . |
MS211972 | ***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: Using the isolated arm technique , the frequency of awareness was evaluated in 50 full-term patients undergoing elective Caesarean section under general anaesthesia . In 20 patients , anaesthesia was induced with thiopentone 4 mg kg-1 , and in the other 30 patients , induction was with ketamine 1.5 mg kg-1 . Following suxamethonium 1.5 mg kg-1 and tracheal intubation , anaesthesia was supplemented during the induction-delivery period in the thiopentone group with 50 % nitrous oxide and 0.5 % halothane in oxygen in 10 patients , and with 1 % halothane in 100 % oxygen in the other 10 patients . In the ketamine group , the patients underwent ventilation with 50 % nitrous oxide and 0.5 % halothane in oxygen in 10 patients , with 1 % halothane in 100 % in 10 patients , and with 100 % oxygen only in the last 10 patients . Awareness was significantly greater after induction with thiopentone ( 14/20 ) than after ketamine ( 4/30 ) . There were no significant differences in Apgar scores or umbilical vein blood-gas values in the newborns Background : Intraoperative awareness with explicit recall occurs in approximately 0.15 % of all surgical cases . Efficacy trials based on the Bispectral Index ® ( BIS ) monitor ( Covidien , Boulder , CO ) and anesthetic concentrations have focused on high-risk patients , but there are no effectiveness data applicable to an unselected surgical population . Methods : We conducted a r and omized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center . Surgical cases were r and omized to alerting algorithms based on either BIS values or anesthetic concentrations . The primary outcome was the incidence of definite intraoperative awareness ; prespecified secondary outcomes included postanesthetic recovery variables . Results : The study was terminated because of futility . At interim analysis the incidence of definite awareness was 0.12 % ( 11/9,376 ) ( 95 % CI : 0.07–0.21 % ) in the anesthetic concentration group and 0.08 % ( 8/9,460 ) ( 95 % CI : 0.04–0.16 % ) in the BIS group ( P = 0.48 ) . There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting . By post hoc secondary analysis , the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared with a cohort receiving no intervention ( P = 0.001 ; 95 % CI : 1.7–13.1 ) . Conclusion : This negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocol s based on either BIS values or anesthetic concentration . By post hoc analysis , a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared with routine care We examined the feasibility of administering nearly 100 % oxygen throughout the induction-delivery period of general anaesthesia for 113 Caesarean sections . Isoflurane 1.25 % was compared with 1.5 % enflurane for maintenance of anaesthesia . The level of anaesthesia was monitored by use of the isolated forearm technique . There was a greater amount of isolated forearm movement when enflurane was used . The three main criteria for a satisfactory general anaesthetic technique for Caesarean section were fulfilled , namely no maternal awareness , no undue depression of the fetus and no adverse effect on uterine contractility . Isoflurane and enflurane appear to be suitable anaesthetic agents for facilitating hyperoxygenation during Caesarean section 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 Patients who are given general anaesthesia are not guaranteed to remain unconscious during surgery . Knowledge about the effectiveness of current protective measures is scarce , as is our underst and ing of patients ' responses to this complication . We did a prospect i ve case study to assess conscious awareness during anaesthesia . METHODS 11785 patients who had undergone general anaesthesia were interviewed for awareness on three occasions : before they left the post-anaesthesia care unit , and 1 - 3 days and 7 - 14 days after the operation . FINDINGS We identified 18 cases of awareness and one case of inadvertent muscle blockade that had occurred before unconsciousness . Incidence of awareness was 0.18 % in cases in which neuromuscular blocking drugs were used , and 0.10 % in the absence of such drugs . 17 cases of awareness were identified at the final interview , but no more than 11 would have been detected if an interview had been done only when the patients left the post-anaesthesia care unit . Four non-paralysed patients recalled intraoperative events , but none had anxiety during wakefulness or had delayed neurotic symptoms . This finding contrasts with anaesthesia with muscle relaxants , during which 11 of 14 patients had pain , anxiety , or delayed neurotic symptoms . After repeated discussion and information , the delayed neurotic symptoms resolved within 3 weeks in all patients . Analysis of individual cases suggests that a reduced incidence of recall of intraoperative events would not be achieved by monitoring of end-tidal anaesthetic gas concentration or by more frequent use of benzodiazepines . INTERPRETATION The inability to prevent awareness by conventional measures may advocate monitoring of cerebral activity by neurophysiological techniques . However , the sensitivity of such techniques is not known , and in the light of our findings , at least 861 patients would need to be monitored to avoid one patient from suffering due to awareness during relaxant anaesthesia Failure of general anesthesia to render a patient insensate , termed " awareness , " is estimated to affect between 40,000 and 140,000 patients in the US each year . This study investigated the occurrence of post-traumatic stress disorder ( PTSD ) in subjects who reported a past episode of intraoperative awareness . We inquired about intraoperative and postoperative experiences and studied the relationship between various surgical experiences and currently meeting the diagnosis of PTSD . Sixteen postawareness subjects and 10 postgeneral anesthesia controls completed the Clinician Administered PTSD Scale ( CAPS ) , a st and ardized clinical rating scale for PTSD , and a question naire about peri-operative experiences . Nine of 16 subjects ( 56.3 % ) , a mean of 17.9 postoperative years , and no controls met diagnostic criteria for current PTSD ( X(2)= 8.6 , df = 1 , P<.01 ) . Common intraoperative experiences included an inability to communicate , helplessness , terror , and pain . Postawareness patients had significant postoperative distress related to feeling unable to communicate , unsafe , terrified , ab and oned and betrayed . Perioperative dissociative experiences predicted having current PTSD . Being conscious during surgery is a traumatic event that may result in developing chronic PTSD . Further studies should include prospect i ve design s of prevalence and long-term psychological , social , and overall health effects , and ways of preventing and treating awareness-induced PTSD Using the isolated forearm technique ( IFT ) , we wished to determine if patients known to be unresponsive to comm and s during general anaesthesia with nitrous oxide , halothane and neuromuscular blocking agents had any evidence of explicit or implicit recall . Two groups of women , studied in a single-blind sequential block design , heard different tapes , either a comm and and information tape ( n = 34 ) or radio static ( n = 34 ) , throughout surgery . Four women ( two radio static , two comm and ) had unequivocal evidence of explicit recall for a period near the beginning or end of the procedure , at a time when the IFT was not being used . With or without hypnosis , category generation , serial position of category exemplars and word association tests did not reveal evidence of priming . We conclude that during light general anaesthesia with nitrous oxide , halothane and atracurium , patients had neither explicit nor implicit memory for information presented during a period when they are known to be unresponsive to comm and Background : The isolated forearm technique allows assessment of consciousness of the external world ( connected consciousness ) through a verbal comm and to move the h and ( of a tourniquet-isolated arm ) during intended general anesthesia . Previous isolated forearm technique data suggest that the incidence of connected consciousness may approach 37 % after a noxious stimulus . The authors conducted an international , multicenter , pragmatic study to establish the incidence of isolated forearm technique responsiveness after intubation in routine practice . Methods : Two hundred sixty adult patients were recruited at six sites into a prospect i ve cohort study of the isolated forearm technique after intubation . Demographic , anesthetic , and intubation data , plus postoperative question naires , were collected . Univariate statistics , followed by bivariate logistic regression models for age plus variable , were conducted . Results : The incidence of isolated forearm technique responsiveness after intubation was 4.6 % ( 12/260 ) ; 5 of 12 responders reported pain through a second h and squeeze . Responders were younger than nonresponders ( 39 ± 17 vs. 51 ± 16 yr old ; P = 0.01 ) with more frequent signs of sympathetic activation ( 50 % vs. 2.4 % ; P = 0.03 ) . No participant had explicit recall of intraoperative events when question ed after surgery ( n = 253 ) . Across groups , depth of anesthesia monitoring values showed a wide range ; however , values were higher for responders before ( 54 ± 20 vs. 42 ± 14 ; P = 0.02 ) and after ( 52 ± 16 vs. 43 ± 16 ; P = 0.02 ) intubation . In patients not receiving total intravenous anesthesia , exposure to volatile anesthetics before intubation reduced the odds of responding ( odds ratio , 0.2 [ 0.1 to 0.8 ] ; P = 0.02 ) after adjustment for age . Conclusions : Intraoperative connected consciousness occurred frequently , although the rate is up to 10-times lower than anticipated . This should be considered a conservative estimate of intraoperative connected consciousness BACKGROUND Awareness during anesthesia is foremost assessed with postoperative interviews , which may underestimate its incidence . On-line monitors such as the Bispectral Index and patient response to verbal comm and are not necessarily commonly used . This study investigated response to comm and during deep sedation ( Bispectral Index 60 - 70 ) and the ability of prevailing monitoring techniques to indicate awareness and predict recall . METHODS The authors systematic ally assessed the response to comm and using the isolated forearm technique while monitoring electroencephalographic and hemodynamic variables . Fifty-six elective surgical patients were repeatedly given verbal instructions to squeeze the observer 's h and during target-controlled infusion with propofol and alfentanil . After recovery , conscious recall was assessed with a short structured interview . RESULTS Overall , 1,082 comm and s were given . No response was observed to 887 ( 82 % ) comm and s , an equivocal response was observed to 56 ( 5 % ) comm and s , and an unequivocal response was observed to 139 ( 13 % ) comm and s. Of the 37 patients ( 66 % ) with an unequivocal response to comm and ( " awareness " ) , nine ( 25 % ) reported conscious recall after recovery . Their reports provided valuable insights as to how awareness may be adequately addressed . Hemodynamic variables poorly predicted awareness , whereas parameters derived from the encephalogram , especially the Bispectral Index , were highly significant predictors ( P < 0.0001 ) . Electroencephalographic parameters did not discriminate between patients with or without conscious recall , whereas heart rate and responsiveness to comm and did . CONCLUSIONS The incidence of awareness is underestimated when conscious recall is taken as evidence . Awareness can be monitored on-line with behavioral and modern neurophysiologic measures . Providing feedback during intra-anesthetic awareness helps patients to cope with a potentially stressful situation Little is known about the effect of anesthetic management on long-term outcomes . We design ed a prospect i ve observational study of adult patients undergoing major noncardiac surgery with general anesthesia to determine if mortality in the first year after surgery is associated with demographic , preoperative clinical , surgical , or intraoperative variables . One-year mortality was 5.5 % in all patients ( n = 1064 ) and 10.3 % in patients ≥65 yr old ( n = 243 ) . Multivariate Cox Proportional Hazards modeling identified three variables as significant independent predictors of mortality : patient comorbidity ( relative risk , 16.116 ; P < 0.0001 ) , cumulative deep hypnotic time ( Bispectral Index ® < 45 ) ( relative risk = 1.244/h ; P = 0.0121 ) and intraoperative systolic hypotension ( relative risk = 1.0
Output:
| Proportions of IFT‐positive patients decreased significantly with increasing age and premedication use .
Conclusions St and ard general anaesthesia regimens might not prevent connected consciousness . |
MS211973 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary Background The rising number of young people going to university has led to concerns about an increasing dem and for student mental health services . We aim ed to assess whether provision of mindfulness courses to university students would improve their resilience to stress . Methods We did this pragmatic r and omised controlled trial at the University of Cambridge , UK . Students aged 18 years or older with no severe mental illness or crisis ( self-assessed ) were r and omly assigned ( 1:1 ) , via remote survey software using computer-generated r and om numbers , to receive either an 8 week mindfulness course adapted for university students ( Mindfulness Skills for Students [ MSS ] ) plus mental health support as usual , or mental health support as usual alone . Participants and the study management team were aware of group allocation , but allocation was concealed from the research ers , outcome assessors , and study statistician . The primary outcome was self-reported psychological distress during the examination period , as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure ( CORE – OM ) , with higher scores indicating more distress . The primary analysis was by intention to treat . This trial is registered with the Australia and New Zeal and Clinical Trials Registry , number ACTRN12615001160527 . Findings Between Sept 28 , 2015 , and Jan 15 , 2016 , we r and omly assigned 616 students to the MSS group ( n=309 ) or the support as usual group ( n=307 ) . 453 ( 74 % ) participants completed the CORE – OM during the examination period and 182 ( 59 % ) MSS participants completed at least half of the course . MSS reduced distress scores during the examination period compared with support as usual , with mean CORE – OM scores of 0·87 ( SD 0·50 ) in 237 MSS participants versus 1·11 ( 0·57 ) in 216 support as usual participants ( adjusted mean difference −0·14 , 95 % CI −0·22 to −0·06 ; p=0·001 ) , showing a moderate effect size ( β −0·44 , 95 % CI −0·60 to −0·29 ; p<0·0001 ) . 123 ( 57 % ) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 ( 37 % ) of 235 participants in the MSS group . On average , six students ( 95 % CI four to ten ) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress . No participants had adverse reactions related to self-harm , suicidality , or harm to others . Interpretation Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy . Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional , effective interventions to increase resilience to stress in university students . Funding University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of Engl and Objective : Both Mindfulness Based Cognitive Therapy ( MBCT ) and Cognitive Therapy ( CT ) enhance self-management of prodromal symptoms associated with depressive relapse , albeit through divergent therapeutic procedures . We evaluated rates of relapse in remitted depressed patients receiving MBCT and CT . Decentering and dysfunctional attitudes were assessed as treatment-specific process markers . Method : Participants in remission from Major Depressive Disorder ( MDD ; N = 166 ) were r and omized to 8 weeks of either MBCT ( N = 82 ) or CT ( N = 84 ) and were followed for 24 months , with process markers measured every 3 months . Attendance in both treatments was high ( 6.3/8 session ) and treatment fidelity and competence were evaluated . Relapse was defined as a return of symptoms meeting the criteria for major depression on Module A of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders ( SCID ) . Results : Intention-to-treat analyses indicated no differences between MBCT and CT in either rates of relapse to MDD or time to relapse across 24 months of follow up . Both groups experienced significant increases in decentering and participants in CT reported greater reductions in dysfunctional attitudes . Within both treatments , participants who relapsed evidence d lower decentering scores than those who stayed well over the follow up . Conclusions : This is the first study to directly compare relapse prophylaxis following MBCT and CT directly . The lack of group differences in time to relapse supports the view that both interventions are equally effective and that increases in decentering achieved via either treatment are associated with greater protection . These findings lend credence to Teasdale et al. ’s ( 2002 ) contention that , even though they may be taught through dissimilar methods , CT and MBCT help participants develop similar metacognitive skills for the regulation of distressing thoughts and emotions This study evaluated mindfulness-based cognitive therapy ( MBCT ) , a group intervention design ed to train recovered recurrently depressed patients to disengage from dysphoria-activated depressogenic thinking that may mediate relapse/recurrence . Recovered recurrently depressed patients ( n = 145 ) were r and omized to continue with treatment as usual or , in addition , to receive MBCT . Relapse/recurrence to major depression was assessed over a 60-week study period . For patients with 3 or more previous episodes of depression ( 77 % of the sample ) , MBCT significantly reduced risk of relapse/recurrence . For patients with only 2 previous episodes , MBCT did not reduce relapse/recurrence . MBCT offers a promising cost-efficient psychological approach to preventing relapse/recurrence in recovered recurrently depressed patients OBJECTIVES Alexithymia is common among psychiatric out patients and can complicate treatment . There has been little research into whether alexithymia can be modified by psychological intervention , and whether change in alexithymia is related to other areas of improvement . The purpose of the present study was to examine whether participation in an integrated group therapy program could effect change in alexithymia , and whether such change is related to improvement in interpersonal functioning . DESIGN AND METHODS Sixty-eight consecutively admitted psychiatric out patients to a comprehensive group therapy program were evaluated at baseline , post-therapy , and 3-month follow-up using the Toronto Alexithymia Scale 20 , the Beck Depression Inventory , and the Inventory of Interpersonal Problems-28 . Associations among variables were evaluated with correlations and among group comparisons with t test , ANOVA , chi-square tests , and logistic regression . Change in alexithymia was examined using repeated measures ANOVA , controlling for change in depressive symptoms . RESULTS Alexithymia , particularly difficulty identifying feelings , decreased significantly during the treatment period . Post-therapy levels of alexithymia were maintained during the 3 months following treatment completion . Changes in alexithymia were significantly associated with changes in interpersonal problems , both during therapy and during the follow-up period . CONCLUSIONS The results of our study suggest that a comprehensive , integrated group therapy program can affect change in alexithymia , and that such change can be maintained once therapy is completed . Also , modifying alexithymia may contribute to improvement in interpersonal functioning Background : Although there is preliminary evidence that alexithymia may influence the course of coronary heart disease ( CHD ) , there are no studies exploring attempts to modify alexithymic characteristics in cardiac patients . Method : Twenty post-myocardial infa rct ion ( MI ) patients ( 19 men and 1 woman ) were placed in a treatment group , which received weekly group psychotherapy for 4 months . Seventeen post-MI patients ( 16 men and 1 woman ) were placed in a comparison group which received two educational sessions over a period of 1 month . All subjects completed the Toronto Alexithymia Scale ( TAS ) before the start of group therapy , at the end of the 4-month period , and in follow-up assessment after 6-month , 1-year , and 2-year intervals . Results : In the psychotherapy treatment group , there was a significant reduction in the mean TAS score following group therapy , which was maintained over the 2-year follow-up period . In the educational group , there were no significant changes in mean TAS scores between the initial testing and any of the follow-up intervals . On an individual basis , a decrease to a lower level of TAS scores occurred in a higher percentage of patients in the treatment group than in the educational group . Over the 2-year follow-up period , patients with decreased alexithymia following group therapy experienced fewer cardiac events ( reinfa rct ion , sudden cardiac death , or rehospitalization for rhythm disorder or severe angina ) than patients whose alexithymia remained unchanged . Conclusions : The results indicate that group psychotherapy is able to decrease alexithymia and that for many patients this change can be maintained for at least 2 years . A reduction in the degree of alexithymia seems to influence favorably the clinical course of CHD
Output:
| Findings from our study should be replicated in further research with larger sample s ; however , the results indicate that mindfulness-based interventions may be an effective treatment in reducing alexithymia |
MS211974 | ***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 : Cognitive-behavioral treatment has proven efficacy for chronic temporom and ibular disorder ( TMD ) . However , most patients receive dental treatment that may not address psychological comorbidities often present in TMD . The aim of the present study was to evaluate the efficacy of biofeedback-based cognitive-behavioral treatment ( BFB-CBT ) versus dental treatment with occlusal splint ( OS ) . Moreover , changes in nocturnal masseter muscle activity ( NMMA ) were investigated . Methods : Fifty-eight patients with chronic TMD were r and omly assigned to receive either 8 weekly sessions of BFB-CBT or 8 weeks of OS treatment . Diagnoses were established using Research Diagnostic Criteria for TMD . Pain intensity and disability were defined as primary outcomes . Secondary outcomes included emotional functioning , pain coping , somatoform symptoms , treatment satisfaction , and adverse events . NMMA was assessed during 3 nights pretreatment and posttreatment with portable devices . Follow-up assessment took place 6 months after the treatment . Results : Both treatments result ed in significant reductions in pain intensity and disability , with similar amounts of clinical ly meaningful improvement ( 45 % for BFB-CBT and 48 % for OS ) . Patients receiving BFB-CBT showed significantly larger improvements in pain coping skills . Satisfaction with treatment and ratings of improvement were higher for BFB-CBT . Effects were stable over 6 months , and tended to be larger in the BFB-CBT group for all outcomes . No significant changes were observed in NMMA . Discussion : The fact that BFB-CBT result ed in larger improvements in pain coping skills , and was well accepted by the patients , underlines the importance and feasibility of psychological treatments in the clinical management of TMD Psychological characteristics potentially may be a cause or consequence of temporom and ibular disorder ( TMD ) . We hypothesized that psychological characteristics associated with pain sensitivity would influence risk of first-onset TMD , but the effect could be attributed to variation in the gene encoding catechol-O-methyltransferase ( COMT ) . We undertook a prospect i ve cohort study of healthy female volunteers aged 18–34 yrs . At baseline , participants were genotyped , they completed psychological question naires , and underwent quantitative sensory testing to determine pain sensitivity . We followed 171 participants for up to three years , and 8.8 % of them were diagnosed with first-onset TMD . Depression , perceived stress , and mood were associated with pain sensitivity and were predictive of 2- to 3-fold increases in risk of TMD ( P < 0.05 ) . However , the magnitude of increased TMD risk due to psychological factors remained unchanged after adjustment for the COMT haplotype . Psychological factors linked to pain sensitivity influenced TMD risk independently of the effects of the COMT haplotype on TMD risk Abstract Although cognitive – behavioral therapies ( CBT ) have been demonstrated to be effective for a variety of chronic pain problems , patients vary in their response and little is known about patient characteristics that predict or moderate treatment effects . Furthermore , although cognitive – behavioral theory posits that changes in patient beliefs and coping mediate the effects of CBT on patient outcomes , little research has systematic ally tested this . Therefore , we examined mediators , moderators , and predictors of treatment effects in a r and omized controlled trial of CBT for chronic temporom and ibular disorder ( TMD ) pain . Pre‐ to post‐treatment changes in pain beliefs ( control over pain , disability , and pain signals harm ) , catastrophizing , and self‐efficacy for managing pain mediated the effects of CBT on pain , activity interference , and jaw use limitations at one year . In individual mediator analyses , change in perceived pain control was the mediator that explained the greatest proportion of the total treatment effect on each outcome . Analyzing the mediators as a group , self‐efficacy had unique mediating effects beyond those of control and the other mediators . Patients who reported more pain sites , depressive symptoms , non‐specific physical problems , rumination , catastrophizing , and stress before treatment had higher activity interference at one year . The effects of CBT generally did not vary according to patient baseline characteristics , suggesting that all patients potentially may be helped by this therapy . The results provide further support for cognitive – behavioral models of chronic pain and point to the potential benefits of interventions to modify specific pain‐related beliefs in CBT and in other health care encounters ABSTRACT The purpose of this study was to determine whether cognitive – behavioral treatment ( CBT ) operates by effecting changes in cognitions , affects , and coping behaviors in the context of painful episodes . Patients were 54 men and women with temporom and ibular dysfunction‐related orofacial pain ( TMD ) enrolled in a study of brief ( 6 weeks ) st and ard conservative treatment ( STD ) or st and ard treatment plus CBT ( STD + CBT ) . Momentary affects , pain , and coping processes were recorded on a cell phone keypad four times per day for 7 days prior to treatment , and for 14 days after treatment had finished , in an experience sampling paradigm . Analyses indicated no treatment effects on general retrospective measures of pain , depression , or pain‐related interference with lifestyle at post‐treatment . However , mixed model analyses on momentary pain and coping recorded pre‐ and post‐treatment indicated that STD + CBT patients reported greater decreases in pain than did STD patients , significantly greater increases in the use of active cognitive and behavioral coping , and significantly decreased catastrophization . Analyses of experience sampling data indicated that post‐treatment momentary pain was negatively predicted by concurrent active coping , self‐efficacy , perceived control over pain , and positive‐high arousal affect . Concurrent catastrophization was strongly predictive of pain . Active behavioral coping and self‐efficacy reported at the prior time point ( about 3 h previously ) were also protective , while prior catastrophization and negative‐high arousal mood were predictive of momentary pain . The results suggest that CB treatment for TMD pain can help patients alter their coping behaviors , and that these changes translate into improved outcomes 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 AIMS To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain . METHODS A pilot r and omized controlled trial was conducted to compare the intervention with usual treatment . A total of 37 patients with chronic orofacial pain were r and omized into either the intervention group ( n = 19 ) or the usual treatment ( control ) group ( n = 18 ) . Vali date d outcome measures were used to measure the potential effectiveness of the intervention over a number of domains : physical and mental functioning ( Short Form 36 [ SF-36 ] ) ; anxiety and depression ( Hospital Anxiety and Depression Scale [ HADS ] ) ; pain intensity and interference with life ( Brief Pain Inventory [ BPI ] ) ; disability ( Manchester Orofacial Pain Disability Scale [ MOPDS ] ) ; and illness behavior ( Revised Illness Perceptions Question naire [ IPQr ] ) . Bootstrap confidence intervals were computed for the treatment effect ( ES ) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance . RESULTS At posttreatment and the 3-month follow-up , 11 participants in the intervention group and 7 in the control group failed to complete outcome measures . The intervention was acceptable and could be feasibly delivered face to face or over the telephone . Although the pilot trial was not powered to draw conclusions about the effectiveness , it showed significant ( P < .05 ) effects of the intervention on physical and mental functioning and treatment control . CONCLUSION The self-help intervention was acceptable to patients and allowed them to better underst and and self-manage chronic orofacial pain . It showed potential effectiveness on outcome domains related to functioning and illness perception . Further research is needed to underst and the cost effectiveness of the intervention for chronic orofacial pain There are few robust , evidence -based data about what constitutes the diagnosis of atypical facial pain and how it is best treated . We therefore aim ed to find out the current opinion of those on specialist lists in the United Kingdom ( UK ) on whether they use the term atypical facial pain , how they reach their diagnosis , and what treatment they offer . We sent out question naires to 240 specialists r and omly selected from the UK lists of those most likely to deal with atypical facial pain ( oral and maxillofacial surgeons , oral medical specialists , ear nose and throat surgeons , anaesthetists , psychiatrists and neurologists ) . We divided the replies according to whether the specialists were medically or dentally based . Of the 209 valid question naires , 143 were returned ( a response rate of 68 % ) ; 127 of the 143 used the term atypical facial pain , the others used various other terms . The two groups used significantly different criteria , mainly to exclude other conditions to achieve a diagnosis . About half used haematological tests and most used radiographic investigations routinely , and there were no significant differences among the specialities . No unified pattern of referral between different units was found . Treatment was mainly by antidepressant and anticonvulsant drugs , and counselling OBJECTIVES ( i ) To examine the association between self-reported mechanical factors and chronic oro-facial pain . ( ii ) To test the hypothesis that this relationship could be explained by : ( a ) reporting of psychological factors , ( b ) common association of self-reported mechanical factors with other unexplained syndromes . METHODS A population based cross-sectional study of 4200 r and omly selected adults registered with a General Medical Practice in North West , Engl and . The study examined the association of chronic oro-facial pain with a variety of self-reported mechanical factors : teeth grinding , facial trauma , missing teeth and the feeling that the teeth did not fit together properly . Information was also collected on demographic factors , psychological factors and the reporting of other frequently unexplained syndromes . RESULTS An adjusted response rate of 72 % was achieved . Only two mechanical factors : teeth grinding ( odds ratio ( OR ) 2.0 , 95 % CI 1.3 - 3.0 ) and facial trauma ( OR 2.0 ; 95 % CI 1.3 - 2.9 ) were independently associated with chronic oro-facial pain after adjusting for psychological factors . However , these factors were also commonly associated with the reporting of other frequently unexplained syndromes : teeth grinding ( odds ratio ( OR ) 1.8 , 95 % CI 1.5 - 2.2 ) , facial trauma ( OR 2.1 ; 95 % CI 1.7 - 2.6 ) . CONCLUSIONS Self-reported mechanical factors associated with chronic oro-facial pain are confounded , in part , by psychological factors and are equally common across other frequently unexplained syndromes . They may represent another feature of somatisation . Therefore the use of extensive invasive therapy such as occlusal adjustments and surgery to change mechanical factors may not be justified in many cases Previous research has suggested that a habit reversal treatment might be used effectively in a home-based minimal therapist contact ( MTC ) protocol to facilitate flexibility and increase treatment completion rates . Recent review s of MTC interventions have found it to be generally efficacious , cost-effective , and generalizable . While MTC has been used for certain health-related disorders ( e.g. , headache ) , almost no research has evaluated the effectiveness of a MTC protocol with a population suffering from temporom and ibular disorder ( TMD ) . The current study utilized an oral habit reversal treatment in a MTC format in an attempt to reduce attrition and increase treatment flexibility . Twenty females suffering from TMD were r and omly assigned to either a treatment ( n = 10 ) or a wait-list control ( n = 10 ) condition . Six individuals in each group used telephone contact while 4 used e-mail for weekly communication with the therapist . Results demonstrated that a habit reversal treatment in a MTC format led to statistically and clinical ly significant improvements in mean weekly pain ratings , number of pain-free days per week , and highest weekly pain ratings . Also , a significant reduction in maladaptive oral habits occurred from pre- to post-treatment and significant reductions in life stress and pain interference were observed . Results were maintained at follow-up . The implication s for the use of MTC for treatment of facial pain are discussed , as are the implication s of these findings for the role of oral habits in the etiology of TMD & NA ; Temporom and ibular disorders ( TMD ) are currently viewed as an interrelated set of clinical conditions presenting with signs and symptoms in masticatory and related muscles of the head and neck , and the soft tissue and bony components of the temporom and ibular joint . Epidemiologie and clinical studies of TMD confirm its status as a chronic pain problem . In this report we present results from a r and omized clinical trial which compared , at 3‐ and 12‐month
Output:
| Self-management interventions are effective for patients with chronic orofacial pain .
Packages of physical and psychosocial self-regulation and education appear beneficial .
SIGNIFICANCE This systematic review provides clear evidence for effectiveness of combined biomedical and psychological interventions ( incorporating self-management approaches ) on long-term outcomes in the management of chronic orofacial ( principally TMD ) pain . |
MS211975 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background : In the And ean Region , HIV and sexually transmitted infections ( STI ) are most prevalent among men who have sex with men ( MSM ) , but incidence estimates and associated factors have never been prospect ively assessed . Methods : A cohort of 1056 high-risk HIV-negative MSM in Lima , Peru , were recruited during 1998 - 2000 ( the ALASKA Cohort ) , and a nested case-control analysis was conducted between seroconverters and nonseroconverters , matched 1:3 by age and duration of follow-up for comparison of risk behaviors , acute retroviral symptoms , circumcision , and STI . Results : During average follow-up of 335 days , 34 men seroconverted , providing a HIV incidence estimate of 3.5 per 100 person-years [ 95 % confidence interval ( CI ) : 2.3 to 4.7 ] . High syphilis ( 8.4 per 100 person-years , 95 % CI : 6.7 to 10.1 ) and herpes simplex virus type 2 ( HSV-2 ) infection ( 10.4 per 100 person-years , 95 % CI : 8.6 to 11.9 ) incidence estimates were obtained . HIV seroconverters were more likely than men who remained seronegative to report fever ≥3 days ( 46 % vs. 7 % ) , to seek medical care ( 62 % vs. 27 % ) , and to have ≥1 casual partner ( 86.2 % vs. 74.1 % ) since their last visit . HIV seroconverters also were more likely to have acquired syphilis or HSV-2 infection ( 31 % vs. 8 % among initially HSV-2-seronegative men ) although they were less likely to be circumcised ( 4.2 % vs. 20.6 % , a nonsignificant difference ) . In multivariate analysis , incident syphilis or HSV-2 infection ( odds ratio [ OR ] : 5.9 , 95 % CI : 1.5 to 22.7 ) and sex with any casual partner ( OR : 4.8 , 95 % CI : 0.9 to 26.2 ) were associated with HIV seroconversion . Conclusions : STI that may cause anogenital ulcers are important risk factors for HIV acquisition among high-risk MSM in Lima , a population with a very high HIV incidence estimate . Synergistic interventions focusing in preventing both HIV and HSV-2 , like male circumcision , are warranted to be assessed , especially in MSM population s with low levels of circumcision and high incidence estimates of ulcerative STI BACKGROUND Observational data and non-human primate challenge studies suggest that cell-mediated immune responses might provide control of HIV replication . The Step Study directly assessed the efficacy of a cell-mediated immunity vaccine to protect against HIV-1 infection or change in early plasma HIV-1 levels . METHODS We undertook a double-blind , phase II , test-of-concept study at 34 sites in North America , the Caribbean , South America , and Australia . We r and omly assigned 3000 HIV-1-seronegative participants by computer-generated assignments to receive three injections of MRKAd5 HIV-1 gag/pol/nef vaccine ( n=1494 ) or placebo ( n=1506 ) . R and omisation was prestratified by sex , adenovirus type 5 ( Ad5 ) antibody titre at baseline , and study site . Primary objective was a reduction in HIV-1 acquisition rates ( tested every 6 months ) or a decrease in HIV-1 viral-load setpoint ( early plasma HIV-1 RNA measured 3 months after HIV-1 diagnosis ) . Analyses were per protocol and modified intention to treat . The study was stopped early because it unexpectedly met the prespecified futility boundaries at the first interim analysis . This study is registered with Clinical Trials.gov , number NCT00095576 . FINDINGS In a prespecified interim analysis in participants with baseline Ad5 antibody titre 200 or less , 24 ( 3 % ) of 741 vaccine recipients became HIV-1 infected versus 21 ( 3 % ) of 762 placebo recipients ( hazard ratio [ HR ] 1.2 [ 95 % CI 0.6 - 2.2 ] ) . All but one infection occurred in men . The corresponding geometric mean plasma HIV-1 RNA was comparable in infected male vaccine and placebo recipients ( 4.61 vs 4.41 log(10 ) copies per mL , one tailed p value for potential benefit 0.66 ) . The vaccine elicited interferon-gamma ELISPOT responses in 75 % ( 267 ) of the 25 % r and om sample of all vaccine recipients ( including both low and high Ad5 antibody titres ) on whose specimens this testing was done ( n=354 ) . In exploratory analyses of all study volunteers , irrespective of baseline Ad5 antibody titre , the HR of HIV-1 infection between vaccine and placebo recipients was higher in Ad5 seropositive men ( HR 2.3 [ 95 % CI 1.2 - 4.3 ] ) and uncircumcised men ( 3.8 [ 1.5 - 9.3 ] ) , but was not increased in Ad5 seronegative ( 1.0 [ 0.5 - 1.9 ] ) or circumcised ( 1.0 [ 0.6 - 1.7 ] ) men . INTERPRETATION This cell-mediated immunity vaccine did not prevent HIV-1 infection or reduce early viral level . Mechanisms for insufficient efficacy of the vaccine and the increased HIV-1 infection rates in subgroups of vaccine recipients are being explored BACKGROUND Male circumcision could provide substantial protection against acquisition of HIV-1 infection . Our aim was to determine whether male circumcision had a protective effect against HIV infection , and to assess safety and changes in sexual behaviour related to this intervention . METHODS We did a r and omised controlled trial of 2784 men aged 18 - 24 years in Kisumu , Kenya . Men were r and omly assigned to an intervention group ( circumcision ; n=1391 ) or a control group ( delayed circumcision , 1393 ) , and assessed by HIV testing , medical examinations , and behavioural interviews during follow-ups at 1 , 3 , 6 , 12 , 18 , and 24 months . HIV seroincidence was estimated in an intention-to-treat analysis . This trial is registered with Clinical Trials.gov , with the number NCT00059371 . FINDINGS The trial was stopped early on December 12 , 2006 , after a third interim analysis review ed by the data and safety monitoring board . The median length of follow-up was 24 months . Follow-up for HIV status was incomplete for 240 ( 8.6 % ) participants . 22 men in the intervention group and 47 in the control group had tested positive for HIV when the study was stopped . The 2-year HIV incidence was 2.1 % ( 95 % CI 1.2 - 3.0 ) in the circumcision group and 4.2 % ( 3.0 - 5.4 ) in the control group ( p=0.0065 ) ; the relative risk of HIV infection in circumcised men was 0.47 ( 0.28 - 0.78 ) , which corresponds to a reduction in the risk of acquiring an HIV infection of 53 % ( 22 - 72 ) . Adjusting for non-adherence to treatment and excluding four men found to be seropositive at enrollment , the protective effect of circumcision was 60 % ( 32 - 77 ) . Adverse events related to the intervention ( 21 events in 1.5 % of those circumcised ) resolved quickly . No behavioural risk compensation after circumcision was observed . INTERPRETATION Male circumcision significantly reduces the risk of HIV acquisition in young men in Africa . Where appropriate , voluntary , safe , and affordable circumcision services should be integrated with other HIV preventive interventions and provided as expeditiously as possible Background Black men who have sex with men ( MSM ) in the United States ( US ) are affected by HIV at disproportionate rates compared to MSM of other race/ethnicities . Current HIV incidence estimates in this group are needed to appropriately target prevention efforts . Methods From July 2009 to October 2010 , Black MSM reporting unprotected anal intercourse with a man in the past six months were enrolled and followed for one year in six US cities for a feasibility study of a multi-component intervention to reduce HIV infection . HIV incidence based on HIV seroconversion was calculated as number of events/100 person-years . Multivariate proportional hazards modeling with time-dependent covariates was used to identify correlates of HIV acquisition . Results Of 1,553 Black MSM enrolled , 1,164 were HIV-uninfected at baseline and included in follow-up . Overall annual HIV incidence was 3.0 % ( 95 % confidence interval ( CI ) : 2.0 , 4.4 % ) and 5.9 % among men ≤30 years old ( 95 % CI : 3.6 , 9.1 % ) . Men ≤30 years old reported significantly higher levels of sexual risk and were more likely to have a sexually transmitted infection diagnosed during follow-up . Younger men also were more likely to not have a usual place for health care , not have visited a health care provider recently , and to have unmet health care needs . In multivariate analysis , age ≤30 years ( hazard ratio ( HR ) : 3.4 ; 95 % CI : 1.4 , 8.3 ) and unprotected receptive anal intercourse with HIV-positive or unknown status partners ( HR : 4.1 ; 95 % CI : 1.9 , 9.1 ) were significantly associated with HIV acquisition . Conclusion In the largest cohort of prospect ively-followed Black MSM in the US , HIV incidence was high , particularly among young men . Targeted , tailored and culturally appropriate HIV prevention strategies incorporating behavioral , social and biomedical based interventions are urgently needed to lower these rates Background Observational studies suggest that male circumcision may provide protection against HIV-1 infection . A r and omized , controlled intervention trial was conducted in a general population of South Africa to test this hypothesis . Methods and Findings A total of 3,274 uncircumcised men , aged 18–24 y , were r and omized to a control or an intervention group with follow-up visits at months 3 , 12 , and 21 . Male circumcision was offered to the intervention group immediately after r and omization and to the control group at the end of the follow-up . The grouped censored data were analyzed in intention-to-treat , univariate and multivariate , analyses , using piecewise exponential , proportional hazards models . Rate ratios ( RR ) of HIV incidence were determined with 95 % CI . Protection against HIV infection was calculated as 1 − RR . The trial was stopped at the interim analysis , and the mean ( interquartile range ) follow-up was 18.1 mo ( 13.0–21.0 ) when the data were analyzed . There were 20 HIV infections ( incidence rate = 0.85 per 100 person-years ) in the intervention group and 49 ( 2.1 per 100 person-years ) in the control group , corresponding to an RR of 0.40 ( 95 % CI : 0.24%–0.68 % ; p < 0.001 ) . This RR corresponds to a protection of 60 % ( 95 % CI : 32%–76 % ) . When controlling for behavioural factors , including sexual behaviour that increased slightly in the intervention group , condom use , and health-seeking behaviour , the protection was of 61 % ( 95 % CI : 34%–77 % ) . Conclusion Male circumcision provides a degree of protection against acquiring HIV infection , equivalent to what a vaccine of high efficacy would have achieved . Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa . ( Preliminary and partial results were presented at the International AIDS Society 2005 Conference , on 26 July 2005 , in Rio de Janeiro , Brazil . Background The Step Study found that men who had sex with men ( MSM ) who received an adenovirus type 5 ( Ad5 ) vector – based vaccine and were uncircumcised or had prior Ad5 immunity , had a higher HIV incidence than MSM who received placebo . We investigated whether differences in HIV exposure , measured by reported sexual risk behaviors , may explain the increased risk . Methods Among 1764 MSM in the trial , 726 were uncircumcised , 994 had prior Ad5 immunity , and 563 were both uncircumcised and had prior Ad5 immunity . Analyses compared sexual risk behaviors and perceived treatment assignment among vaccine and placebo recipients , determined risk factors for HIV acquisition , and examined the role of insertive anal intercourse in HIV risk among uncircumcised men . Results Few sexual risk behaviors were significantly higher in vaccine versus placebo recipients at baseline or during follow-up . Among uncircumcised men , vaccine recipients at baseline were more likely to report unprotected insertive anal intercourse with HIV-negative partners ( 24.9 % vs. 18.1 % ; P = 0.03 ) . Among uncircumcised
Output:
| Our meta-analyses may suggest a protective effect of voluntary medical male circumcision against HIV infection among men who have sex with men , especially in setting s like Asia/Africa |
MS211976 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND AND OBJECTIVES CKD is characterized by remarkably high hospitalization and readmission rates . Our study aim was to test a medication therapy management intervention to reduce subsequent acute care utilization . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS The CKD Medication Intervention Trial was a single-blind ( investigators ) , r and omized clinical trial conducted at Providence Health Care in Spokane , Washington . Patients with CKD stages 3 - 5 not treated by dialysis who were hospitalized for acute illness were recruited . The intervention was design ed to improve posthospitalization care by medication therapy management . A pharmacist delivered the intervention as a single home visit within 7 days of discharge . The intervention included these fundamental elements : comprehensive medication review , medication action plan , and a personal medication list . The primary outcome was a composite of acute care utilization ( hospital readmissions and emergency department and urgent care visits ) for 90 days after hospitalization . RESULTS Baseline characteristics of participants ( n=141 ) included the following : age , 69±11 ( mean±SD ) years old ; women , 48 % ( 67 of 141 ) ; diabetes , 56 % ( 79 of 141 ) ; hypertension , 83 % ( 117 of 141 ) ; eGFR , 41±14 ml/min per 1.73 m2 ( serum creatinine-based Chronic Kidney Disease Epidemiology Collaboration equation ) ; and urine albumin-to-creatinine ratio median , 43 mg/g ( interquartile range , 8 - 528 ) creatinine . The most common primary diagnoses for hospitalization were the following : cardiovascular events , 36 % ( 51 of 141 ) ; infections , 18 % ( 26 of 141 ) ; and kidney diseases , 12 % ( 17 of 141 ) . The primary outcome occurred in 32 of 72 ( 44 % ) of the medication intervention group and 28 of 69 ( 41 % ) of those in usual care ( log rank P=0.72 ) . For only hospital readmission , the rate was 19 of 72 ( 26 % ) in the medication intervention group and 18 of 69 ( 26 % ) in the usual care group ( log rank P=0.95 ) . There was no between-group difference in achievement of guideline -based goals for use of renin-angiotensin system inhibition or for BP , hemoglobin , phosphorus , or parathyroid hormone . CONCLUSIONS Acute care utilization after hospitalization was not reduced by a pharmacist-led medication therapy management intervention at the transition from hospital to home Introduction Older people experience greater morbidity with a corresponding increase in medication use result ing in a potentially higher risk of adverse drug reactions ( ADRs ) . The aim of this study is to determine the prevalence and characteristics of ADR-related hospital admissions among older patients ( ≥65 years ) and their associated health and cost outcomes . Methods and analysis The proposed study will include a cross-sectional study of ADR prevalence in all patients aged ≥65 years admitted acutely to a large tertiary referral hospital in Irel and over a 9-month period ( 2016–2017 ) and a prospect i ve cohort study of patient-reported health outcomes and costs associated with ADR-related hospital admissions . All acute medical admissions will be screened for a suspected ADR-related hospital admission . A number of vali date d algorithms will be applied to assess the type , causative medications , preventability and severity of each ADR . ADRs will be determined , using a consensus method , by an expert panel . Patients who provide consent will be followed up 3 months post-discharge to establish patient-reported health outcomes ( health service use , health-related quality of life , adherence ) and costs associated with ADR-related hospital admissions . A r and om sample of patients admitted to hospital without a suspected ADR will be invited to take part in the study as a control group . Ethics and dissemination Ethical approval was obtained from Beaumont Hospital Ethics Committee . Findings will be disseminated through presentations and peer- review ed publications 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 Lack of information about medications coupled with high rates of utilization complicates compliance with medication regimens and increases the risk of adverse effects among older adults . We undertook a study of the efficacy of community-based interventions by pharmacists in a r and omly-allocated one-half of a sample of 284 older adults considered to be at high risk for medication-related problems . Information and attitudes towards prescription and over-the-counter medications did not differ significantly between the intervention and comparison groups , either before or after the pharmacist interventions . However , visits to physicians were significantly less in the intervention group , suggesting an important if unexpected impact on health-related behavior Objective To test whether a drug review and symptom self management and lifestyle advice intervention by community pharmacists could reduce hospital admissions or mortality in heart failure patients . Design R and omised controlled trial . Setting Home based intervention in heart failure patients . Participants 293 patients diagnosed with heart failure were included ( 149 intervention , 144 control ) after an emergency admission . Intervention Two home visits by one of 17 community pharmacists within two and eight weeks of discharge . Pharmacists review ed drugs and gave symptom self management and lifestyle advice . Controls received usual care . Main outcome measures The primary outcome was total hospital readmissions at six months . Secondary outcomes included mortality and quality of life ( Minnesota living with heart failure question naire and EQ-5D ) . Results Primary outcome data were available for 291 participants ( 99 % ) . 136 ( 91 % ) intervention patients received one or two visits . 134 admissions occurred in the intervention group compared with 112 in the control group ( rate ratio=1.15 , 95 % confidence interval 0.89 to 1.48 ; P=0.28 , Poisson model ) . 30 intervention patients died compared with 24 controls ( hazard ratio=1.18 , 0.69 to 2.03 ; P=0.54 ) . Although EQ-5D scores favoured the intervention group , Minnesota living with heart failure question naire scores favoured controls ; neither difference was statistically significant . Conclusion This community pharmacist intervention did not lead to reductions in hospital admissions in contrast to those found in trials of specialist nurse led interventions in heart failure . Given that heart failure accounts for 5 % of hospital admissions , these results present a problem for policy makers who are faced with a shortage of specialist provision and have hoped that skilled community pharmacists could produce the same benefits . Trial registration number IS RCT N59427925 PURPOSE The effect of pharmaceutical care services for home care patients with heart failure on death and rehospitalization rates was studied . METHODS Eligible patients had to be at least 21 years old and included those with a primary or secondary diagnosis of heart failure who were referred to receive skilled nursing services . Patients were then r and omized to receive usual care or pharmaceutical care . Patients assigned to the usual care group received the services typically provided by the visiting nurses association , while patients in the pharmaceutical care group received usual care plus st and ardized services from a clinical pharmacist . Pharmaceutical care services consisted of an initial comprehensive in home medication assessment and two follow-up visits . Throughout the three-week intervention period , the clinical pharmacist accessed and review ed all pertinent physician notes and laboratory test values and interacted with prescribers on behalf of the patients as necessary . RESULTS A total of 154 patients met all criteria and participated in the study . The pharmacist made 79 specific therapy recommendations , 47 ( 60 % ) of which were related directly to drug therapy for heart failure or cardiovascular disease . Overall , 14 therapy recommendations were fully implemented , and 10 heart failure-specific recommendations were fully implemented . Patients for whom the pharmacist had made recommendations that were followed by the prescriber had a reduced rate of the composite primary endpoint , but this difference did not reach statistical significance . CONCLUSION A home-based pharmaceutical care model for recently hospitalized patients with heart failure did not significantly improve the combined rate of death or rehospitalization OBJECTIVES A number of studies have reported that the risk of bleeding associated with warfarin is highest early in the course of therapy . This study examined the effect of a programme focused on the transition of newly anticoagulated patients from hospital to the community . DESIGN Open-label r and omized controlled trial . SETTING Home-based follow-up of patients discharged from acute care hospital in southern Tasmania , Australia . SUBJECTS A total of 128 patients initiated on warfarin in hospital and subsequently discharged to general practitioner ( GP ) care were enrolled in the study . Sixty were r and omized to home monitoring ( HM ) and 68 received usual care ( UC ) . INTERVENTIONS HM patients received a home-visit by the project pharmacist and point-of-care international normalized ratio ( INR ) testing on alternate days on 4 occasions , with the initial visit two days after discharge . The UC group was solely managed by the GP and only received a visit 8 days after discharge to determine anticoagulant control . RESULTS At discharge , 42 % of the HM group and 45 % of the UC group had a therapeutic INR . At day 8 , 67 % of the HM patients had a therapeutic INR , compared with 42 % of UC patients ( P < 0.002 ) . In addition , 26 % of UC patients had a high INR , compared with only 4 % of HM patients . Bleeding events were assessed 3 months after discharge and occurred in 15 % of HM patients , compared with 36 % of the UC group ( P < 0.01 ) . CONCLUSIONS This programme improved the initiation of warfarin therapy and result ed in a significant decrease in haemorrhagic complications in the first 3 months of therapy OBJECTIVE To assess whether home-based medication review by a pharmacist for at-risk older patients in a primary care setting can reduce hospital admissions . DESIGN R and omised controlled trial comparing home-based medication review with st and ard care . SETTING Home-based medication review of 136 patients registered with one general practice . METHOD Study participants were over 80 years of age , living at home , taking four or more medicines , and had at least one additional medicines-related risk factor . The intervention comprised two home visits by a community pharmacist who educated the patient/carer about their medicines , noted any pharmaceutical care issues , assessed need for an adherence aid , and subsequently met with the lead GP to agree on actions . MAIN OUTCOME MEASURE Total non-elective hospital admissions within 6 months . Secondary outcomes included number of deaths , care home admissions and quality of life ( EQ-5d ) . Impact on number of medicines prescribed was also assessed . RESULTS At 6 months , no difference in hospital admissions ( 21 intervention versus 20 control P = 0.80 ) , and no difference in care home admissions or deaths were detected between groups . There was a small ( non-significant ) decrease in quality of life in the intervention group . There was a statistically significant reduction in the mean number of medicines prescribed ( -0.87 items in favour of the intervention group , 95 % confidence interval -1.66 to -0.08 , P = 0.03 ) . CONCLUSIONS No positive impact on clinical outcomes or quality of life was demonstrated , however , this intervention did appear to reduce prescribing . This is in line with other evidence and suggests that this form of intervention may not have a clear health gain , but may lead to modest savings in terms of reduced prescribing . Future research should focus on whether such a prescribing effect would make this type of intervention cost effective Background Elderly polypharmacy patients may be more at risk of not adhering to medication . If so , the underlying reasons may be more readily disclosed during private discussion s with patients . Hence pharmaceutical care discussion s at home might improve treatment adherence . Objective The aim of this study was to investigate the impact of pharmaceutical care on medication adherence , hospitalisation and mortality in elderly patients prescribed polypharmacy . Setting Pharmaceutical care discussed at home . Methods A r and omised controlled trial with two arms ; pharmaceutical care ( n = 315 ) and controls ( n = 315 ) was design ed . It involved patients aged 65 + years living in Aarhus , Denmark who used five drugs or more without assistance . Pharmacists visited the pharmaceuticalcare patients at home , once only , and followed them during the subsequent year with three telephone calls . Non-adherence was measured by a pill-count . Patients were categorised as non-adherent if their mean adherence rate for all drugs consumed was < 80 % . The impact of pharmaceutical care on non-adherence and hospitalisation was analysed by 2 × 2 tables , and mortality by Cox regression . Main outcome measure Medication adherence , hospitalisation and mortality . Results The final analyses included 517 patients ( median age 74 years ; females 52 % ) . Dropouts were more frequent for the pharmaceutical-care group than for controls . Pharmacists encountered drug-related problems amongst 72 % of pharmaceutical-care patients . Pharmaceutical-care patients ( 11 % ) and control patients ( 10 % ) were similarly nonadherent ( Odds ratio 1.14 ; 95
Output:
| There was no consistent evidence of an effect on quality of life , medication adherence or knowledge .
Conclusion A systematic review of twelve RCTs assessing the impact of pharmacist home visits for individuals at risk of medication related problems found no evidence of effect on hospital admission or mortality rates , and limited evidence of effect on quality of life . |
MS211977 | ***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: Binge eating is a core clinical feature of bulimia nervosa ( BN ) . Enhanced reinforcing value of food may play a role in this behavioral disturbance , but a systematic behavioral assessment of objective measures of the rewarding value of binge eating is lacking . The purpose of this study was to quantify the reinforcing value of food in BN patients as compared with normal controls . A progressive ratio ( PR ) computerized work task was completed under binge and non-binge instruction . The task consisted of 12 trials . The first trial required 50 keyboard taps to earn one portion of yogurt shake , and subsequent trials required progressive work increments of 200 taps for each additional portion . Completion of all 12 trials required 13,800 taps to earn 2100ml of shake . The breakpoint , defined as the largest ratio completed before a participant stopped working , was the measure of reinforcing efficacy . Ten patients and 10 controls completed the experiment . Under binge instruction , patients completed more trials and taps , and had a higher breakpoint than controls . The non-binge instruction yielded opposite findings ; compared to controls , patients completed fewer trials and taps , and had a lower breakpoint . These results support the feasibility and potential utility of a PR task to quantify the reinforcing value of food in patients with BN Subjects with binge eating disorder ( BED ) regularly consume large amounts of food in short time periods . The neurobiology of BED is poorly understood . Brain dopamine , which regulates motivation for food intake , is likely to be involved . We assessed the involvement of brain dopamine in the motivation for food consumption in binge eaters . Positron emission tomography ( PET ) scans with [(11)C]raclopride were done in 10 obese BED and 8 obese subjects without BED . Changes in extracellular dopamine in the striatum in response to food stimulation in food-deprived subjects were evaluated after placebo and after oral methylpheni date ( MPH ) , a drug that blocks the dopamine reuptake transporter and thus amplifies dopamine signals . Neither the neutral stimuli ( with or without MPH ) nor the food stimuli when given with placebo increased extracellular dopamine . The food stimuli when given with MPH significantly increased dopamine in the cau date and putamen in the binge eaters but not in the nonbinge eaters . Dopamine increases in the cau date were significantly correlated with the binge eating scores but not with BMI . These results identify dopamine neurotransmission in the cau date as being of relevance to the neurobiology of BED . The lack of correlation between BMI and dopamine changes suggests that dopamine release per se does not predict BMI within a group of obese individuals but that it predicts binge eating BACKGROUND Several lines of evidence support the possibility that disturbances of dopamine ( DA ) function could contribute to alterations of weight , feeding , motor activity , and reward in anorexia nervosa ( AN ) . METHODS To assess possibly trait-related disturbances but avoid confounding effects of malnutrition , 10 women who were recovered from AN ( REC AN ) were compared with 12 healthy control women ( CW ) . Positron emission tomography with [(11)C]raclopride was used to assess DA D2/D3 receptor binding . RESULTS The women who were recovered from AN had significantly higher [(11)C]raclopride binding potential in the antero-ventral striatum than CW . For REC AN , [(11)C]raclopride binding potential was positively related to harm avoidance in the dorsal cau date and dorsal putamen . CONCLUSIONS These data lend support for the possibility that decreased intrasynaptic DA concentration or increased D2/D3 receptor density or affinity is associated with AN and might contribute to the characteristic harm avoidance or increased physical activity found in AN . Most intriguing is the possibility that individuals with AN might have a DA related disturbance of reward mechanisms contributing to altered hedonics of feeding behavior and their ascetic , anhedonic temperament
Output:
| The 5-HT transporter ( 5-HTT ) binding was increased or diminished in different specific cortical areas and in relation to Eating Disorder ( ED ) subtypes .
Some evidence s of blunted Dopamine ( DA ) release in the putamen in BN patients suggest that their DA function might be impaired as in addictive behaviours .
Studies estimating the regional Cerebral Blood Flow ( rCBF ) with SPECT demonstrated that temporal areas seem to play a key role in ED corroborating the hypothesis of a cingulate-temporal cortical dysfunction in AN .
In addition , alterations of both parietal and prefrontal cortex provide a possible common neural substrate in AN .
Studies included in this review are heterogeneous preventing robust conclusions , however , our findings add knowledge on some of the neurotransmitters involved in ED |
MS211978 | ***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 Interleukin (IL)-17 pathway is being clinical ly targeted in immune-mediated diseases , most of which are associated with a significant cardiovascular risk . We investigated the relationship between serum levels of IL-17 and the risk of cardiovascular events in patients with acute myocardial infa rct ion . METHODS AND RESULTS We used data from 981 patients enrolled in the prospect i ve , multicentre French registry of Acute ST elevation , or non-ST-elevation Myocardial Infa rct ion ( Fast-MI , NCT00673036 ) . Serum levels of IL-17 were associated with the risk of all-cause death and recurrent MI at 2 years , with levels of IL-17 below the median indicative of a worse outcome . The impact of IL-17 remained significant after adjustment for known cardiovascular risk factors , C-reactive protein , and treatments including statins : hazard ratio ( HR ) = 1.40 ( 1.03 - 1.91 ) ; P = 0.03 . IL-17 inhibited mononuclear cell adhesion to endothelium and reduced endothelial vascular cell adhesion molecule ( VCAM-1 ) expression . Patients with low ( below the median ) IL-17 levels and high ( above the median ) soluble VCAM-1 ( sVCAM-1 ) levels were at particularly increased risk of death and MI : adjusted HR = 2.22 ( 1.32 - 3.75 ) compared with the high IL-17/low sVCAM-1 group ( P = 0.002 ) . CONCLUSIONS Low serum levels of IL-17 are associated with a higher risk of major cardiovascular events in Caucasian patients with acute MI . Our results raise possible concern about the use of inhibitors of the IL-17 pathway in clinical setting s associated with a high cardiovascular risk . CLINICAL TRIALS REGISTRATION NCT00673036 BACKGROUND ACE inhibitors attenuate the detrimental effects of angiotensin II , and improve survival and reduce morbidity in patients with acute myocardial infa rct ion and evidence of heart failure or left-ventricular dysfunction . Selective antagonism of the angiotensin type 1 receptor represents an alternative approach to inhibition of the renin-angiotensin system . We did a multicentre , r and omised trial to test the hypothesis that the angiotensin II antagonist losartan would be superior or non-inferior to the ACE inhibitor captopril in decreasing all-cause mortality in high-risk patients after acute myocardial infa rct ion . METHODS 5477 patients 50 years of age or older ( mean age 67.4 years [ SD 9.8 ] ) , with confirmed acute myocardial infa rct ion and heart failure during the acute phase or a new Q-wave anterior infa rct ion or reinfa rct ion , were recruited from 329 centres in seven European countries . Patients were r and omly assigned and titrated to a target dose of losartan ( 50 mg once daily ) or captopril ( 50 mg three times daily ) as tolerated . The primary endpoint was all-cause mortality . Analysis was by intention to treat . FINDINGS There were 946 deaths during a mean follow-up of 2.7 ( 0.9 ) years : 499 ( 18 % ) in the losartan group and 447 ( 16 % ) in the captopril group ( relative risk 1.13 [ 95 % CI 0.99 - 1.28 ] , p=0.07 ) . The results for the secondary and tertiary endpoints were as follows : sudden cardiac death or resuscitated cardiac arrest 239 ( 9 % ) versus 203 ( 7 % ) , 1.19 ( 0.98 - 1.43 ) , p=0.07 , and fatal or non-fatal reinfa rct ion 384 ( 14 % ) versus 379 ( 14 % ) , 1.03 ( 0.89 - 1.18 ) , p=0.72 . The all-cause hospital admission rates were 1806 ( 66 % ) versus 1774 ( 65 % ) , 1.03 ( 0.97 - 1.10 ) , p=0.37 . Losartan was significantly better tolerated than captopril , with fewer patients discontinuing study medication ( 458 [ 17 % ] vs 624 [ 23 % ] , 0.70 [ 0.62 - 0.79 ] , p<0.0001 ) . INTERPRETATION Since we saw a non-significant difference in total mortality in favour of captopril , ACE inhibitors should remain first-choice treatment in patients after complicated acute myocardial infa rct ion . Losartan can not be generally recommended in this population . However , it was better tolerated than captopril , and was associated with significantly fewer discontinuations . Although the role of losartan in patients intolerant of ACE inhibition is not clearly defined , it can be considered in such patients BACKGROUND The aim of our study was to evaluate the clinical utility and prognostic significance of a cluster of 27 serum cytokines for risk stratification after myocardial infa rct ion . MATERIAL S AND METHODS We enrolled 33 consecutive patients admitted to our institution for acute myocardial infa rct ion and prospect ively followed . We evaluated traditional cardiovascular risk factors and assayed , during the acute phase , 27 serum cytokines ( IL-1 , IL-1ra , IL-2 , IL-4 , IL-5 , IL-6 , IL -7 , IL-8 , IL-9 , IL-10 , IL-12 , IL-13 , IL-15 , IL-17 , EOTAXIN , FGF , G-CSF , GM-CSF , IFN-γ , IP-10 , MCP-1 , MIP-1α , MIP-1β , PDGF , RANTES , TNF-α , VEGF ) potentially associated with cardiovascular risk . Patients were divided into two groups during follow-up according to the occurrence or absence of adverse cardiovascular events ( recurrence of angina , re-infa rct ion , death , need of new revascularization , occurrence of heart failure ) . We developed an additive risk score by assigning one point for each cytokine that had a value greater than the median value ( range 0 - 27 ) . Cytokines alone and the cytokines score were related to cardiovascular events . RESULTS Patients with and without major adverse cardiovascular events ( MACEs ) at follow up had a homogenous distribution of the main cardiovascular risk factors ; differences were detected only for sex and age . Patients who experienced MACE had a significantly different distribution of I troponin ( p=0.036 ) , IL-8 ( p=0.006 ) , IL-13 ( p=0.06 ) , IL-10 ( p=0.02 ) , IL-17 ( p=0.015 ) , IP-10 ( p=0.02 ) , MIP-1β ( p=0.05 ) . At univariate analysis , IL -8 ( p=0.046 OR 1.13 ) , IL-10 ( p=0.05 OR 1.14 ) and MIP-1β ( p=0.016 , OR 1.02 ) were significantly associated with the occurrence of MACE . This association was not confirmed at multivariate analysis . At the analysis of variance , a higher score was significantly associated with the occurrence of adverse events at follow up ( F=5.07 , p=0.03 ) . At ROC curve analysis , a score greater than 13 better predicted the occurrence of adverse events at follow-up ( AUC 0.72 , p=0.03 , sensibility 59.1 % , specificity 81.8 % ) . CONCLUSIONS In our study we did not identify a single inflammatory cytokine able to predict adverse events in a long term follow up , whereas the presence of more than 13 cytokines above the median value was useful for risk stratification Background The Proximity Extension Assay proteomics chip provides a large-scale analysis of 92 biomarkers linked to cardiovascular disease or inflammation . We aim ed to identify the biomarkers that best predicted long-term all-cause mortality in patients with acute myocardial infa rct ion . Methods In this prospect i ve cohort study , 92 biomarkers were analysed in 847 consecutive patients from the Västmanl and Myocardial Infa rct ion Study with a median follow-up of 6.9 years . Results The mean ( ± st and ard deviation ) age of the patients was 70 ( 11.8 ) years and 32.7 % were female . Two hundred and seven patients had died after follow-up . The biomarkers most strongly linked to all-cause mortality were growth differentiation factor 15 ( GDF-15 ) and tumour necrosis factor-related apoptosis-inducing lig and receptor 2 ( TRAIL-R2 ) . Cox regression analysis showed that GDF-15 ( hazard ratio 1.25 per unit change , 95 % confidence interval , 1.02–1.53 , p = 0.031 ) and TRAIL-R2 ( hazard ratio 1.37 per unit change , 95 % confidence interval 1.12–1.67 , p = 0.002 ) were independent predictors of long-term all-cause mortality after adjusting for age , gender , diabetes , previous myocardial infa rct ion , stroke , heart failure , hypertension , smoking , hypercholesterolaemia , body mass index , ST-elevation myocardial infa rct ion , left ventricular ejection fraction , troponin I , estimated glomerular filtration rate , N-terminal pro-brain natriuretic peptide and C-reactive protein . The combination of GDF-15 and TRAIL-R2 with established risk factors and biomarkers showed a discriminating accuracy of separating survivors from non-survivors with a cross-vali date d area under the receiving operating characteristics curve of 0.88 within five years . Conclusion GDF-15 and TRAIL-R2 were the most powerful Proximity Extension Assay chip biomarkers in predicting long-term all-cause mortality in patients with acute myocardial infa rct ion Objective : To investigate the relation between serum high sensitivity ( hs ) C reactive protein ( CRP ) , proinflammatory cytokine concentrations , proinflammatory to anti-inflammatory cytokine ratios and long-term prognosis in patients with non-ST elevation acute coronary syndrome ( NSTEACS ) . Design : Prospect i ve follow-up study for the first six months and then for the first year after admission to hospital . Setting : Tertiary referral centre . Patients : 80 patients ( 60 men , 20 women , mean age 60 ( SD 10 ) years ) with NSTEACS and moderate to high TIMI ( Thrombolysis In Myocardial Infa rct ion ) risk scores . Interventions : Blood sample s from patients with NSTEACS were obtained at the time of admission . Serum concentrations of hs-CRP , ( hs ) pro-inflammatory ( interleukin ( IL ) -1β , IL-6 , tumour necrosis factor α ) and ( hs ) anti-inflammatory ( IL-10 ) cytokines were analysed and proinflammatory to anti-inflammatory cytokine ratios were calculated by dividing proinflammatory cytokine concentrations by anti-inflammatory cytokine IL-10 . Main outcome measure : The primary end point of the study was new coronary events ( NCE ) defined as the combination of cardiac death , non-fatal myocardial infa rct ion and recurrent rest angina that required hospitalisation within 12 months of follow up . Results : During the one-year follow-up period , 23 patients ( 29 % ) met the NCE criteria . Concentrations of hs-CRP , IL-1β and IL-6 and ratios of IL-1β : IL-10 and IL-6:IL-10 were significantly higher in patients with NCE than in patients without NCE . In the logistic regression analysis , IL-6:IL-10 ratio was the most important predictor for NCE ( p = 0.006 ) with an odds ratio of 2.24 ( 95 % CI 1.26 to 3.97 ) . Conclusions : Cytokine concentrations and proinflammatory to anti-inflammatory cytokine ratios may be useful markers for predicting vascular risk in patients with NSTEACS BACKGROUND Inflammatory responses after intracoronary injection of autologous mononuclear bone marrow cells ( m BMC ) are not clarified . The aim of this study was to investigate the influence of intracoronary injection of m BMC on inflammatory mediators in patients with acute myocardial infa rct ion ( AMI ) . METHODS Patients with AMI in the ASTAMI trial ( N = 100 ) treated with percutaneous coronary intervention were r and omized to intracoronary injections of m BMC or control . Fasting blood sample s were drawn the day before stem cell transplantation ( baseline 4 - 5 days after AMI ) and 1 day , 3 days , 2 to 3 weeks , and 3 months after transplantation for determination of circulating levels of selected inflammatory markers and mRNA levels in whole blood sample s. RESULTS From
Output:
| Conclusion A combination of multiple cytokines had a better association with MACE than individual cytokines . |
MS211979 | ***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 Open-label , phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer . PATIENTS AND METHODS Patients were stratified and r and omly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day . Primary end point was overall survival ( OS ) . RESULTS Early trial termination occurred for futility and safety reasons . A total of 1,074 patients were r and omly assigned to the study ( sunitinib arm , n = 530 ; sorafenib arm , n = 544 ) . For sunitinib and sorafenib , respectively , median OS was 7.9 versus 10.2 months ( hazard ratio [ HR ] , 1.30 ; one-sided P = .9990 ; two-sided P = .0014 ) ; median progression-free survival ( PFS ; 3.6 v 3.0 months ; HR , 1.13 ; one-sided P = .8785 ; two-sided P = .2286 ) and time to progression ( TTP ; 4.1 v 3.8 months ; HR , 1.13 ; one-sided P = .8312 ; two-sided P = .3082 ) were comparable . Median OS was similar among Asian ( 7.7 v 8.8 months ; HR , 1.21 ; one-sided P = .9829 ) and hepatitis B-infected patients ( 7.6 v 8.0 months ; HR , 1.10 ; one-sided P = .8286 ) , but was shorter with sunitinib in hepatitis C-infected patients ( 9.2 v 17.6 months ; HR , 1.52 ; one-sided P = .9835 ) . Sunitinib was associated with more frequent and severe adverse events ( AEs ) than sorafenib . Common grade 3/4 AEs were thrombocytopenia ( 29.7 % ) and neutropenia ( 25.7 % ) for sunitinib ; h and -foot syndrome ( 21.2 % ) for sorafenib . Discontinuations owing to AEs were similar ( sunitinib , 13.3 % ; sorafenib , 12.7 % ) . CONCLUSION OS with sunitinib was not superior or equivalent but was significantly inferior to sorafenib . OS was comparable in Asian and hepatitis B-infected patients . OS was superior in hepatitis C-infected patients who received sorafenib . Sunitinib-treated patients reported more frequent and severe toxicity Objective : A phase II study was performed to evaluate the efficacy and tolerability of bevacizumab and erlotinib in advanced hepatocellular carcinoma ( HCC ) patients , and to investigate clinical and molecular predictors of outcome . Methods : 59 patients with advanced HCC received 10 mg/kg i.v . of bevacizumab every 14 days and 150 mg p.o . of erlotinib daily . The primary endpoint was progression-free survival ( PFS ) at 16 weeks . Clinical characteristics and plasma biomarkers expression levels were analyzed . Results : PFS at 16 weeks was 64 % ( 95 % CI 51–76 ) : 14 patients achieved partial response ( 24 % ) , 33 had stable disease ( 56 % ) , 6 progressed ( 10 % ) , and 6 were not evaluable ( 10 % ) . Median overall survival was 13.7 months ( 95 % CI 9.6–19.7 ) , and median PFS was 7.2 months ( 95 % CI 5.6–8.3 ) . Grade 3–4 adverse events included fatigue ( 30 % ) , diarrhea ( 17 % ) , hypertension ( 14 % ) , elevated transaminases ( 12 % ) , and gastrointestinal hemorrhage ( 10 % ) . High plasma angiopoietin-2 , epidermal growth factor receptor , and endothelin-1 , and lack of acneiform rash were associated with poor outcome . Conclusions : The combination of bevacizumab with erlotinib achieved encouraging results in patients with advanced HCC . Current correlatives may help to guide future HCC studies Summary Purpose The only drug that improves survival in hepatocellular carcinoma is sorafenib . FOLFOX-4 regimen is safe and widely used in patients with colorectal cancer , yielding interesting results with little toxicity . We conducted a retrospective study to evaluate the safety and the effectiveness of FOLFOX-4 in cirrhotic or liver transplanted patients with hepatocellular carcinoma ineligible for sorafenib . Methods Thirty seven patients were enrolled in the study . The medical record of either cirrhotic patients or liver transplanted patients with advanced hepatocellular carcinoma receiving FOLFOX-4 regimen between November 1999 and March 2006 were retrospectively analyzed . Patients received oxaliplatin 85 mg/m2 as a 2-hour infusion on day one , and leucovorin 200 mg/m2 as a 2-hour infusion followed by bolus 5-fluorouracil 400 mg/m2 and a 48-hours infusion of 5-fluorouracil 2400 mg/m2 . Treatment was repeated every 2 weeks until disease progression or unacceptable adverse effects occurred . Results Patients had a Child-Pugh class A ( n = 16 ) , class B cirrhosis ( n = 10 ) or a liver transplant ( n = 11 ) and received 2 to 37 cycles of chemotherapy ( total of 310 cycles ) . Two ( 5.4 % ) cirrhotic patients developed neutropenic sepsis and one ( 2.7 % ) toxic death occurred . At first assessment , five patients from Child-Pugh class A ( 33 % ) and two from Child-Pugh class B group ( 20 % ) achieved a radiological response and /or alpha foeto-protein decrease , and no patient achieved a complete response . Conclusions In conclusion , with a manageable toxicity profile in cirrhotic Child-Pugh class A-B or liver transplanted patients , the FOLFOX-4 regimen appears to be a feasible treatment option for patients with advanced hepatocellular carcinoma unfit for sorafenib . These data need to be confirmed in a prospect i ve study Purpose We design ed a phase II trial of the combination with oxaliplatin and doxorubicin for patients with unresectable HCC to evaluate the overall response rate ( ORR ) and the toxicity . Methods Forty patients with inoperable , systemic chemotherapy naive HCC were enrolled . Finally , 32 patients received oxaliplatin ( 130 mg/m2 ) and doxorubicin ( 60 mg/m2 ) every 3 weeks . Results Eighty-two treatment cycles were administered ( median 2 cycles , range 1–6 ) . There was no treatment-related mortality . The ORR was 15.6 % ( 95 % CI , 3.3–28.7 ) with five partial responses . The median overall survival and median overall progression free survival were 31 weeks ( 95 % CI , 22–40 weeks ) and 12 weeks ( 95 % CI , 5 - 19 weeks ) . Nausea and peripheral neuropathy were most frequent non-hematologic toxicities ( nausea , n = 15 ; peripheral neuropathy , n = 10 ) . The most frequent grade 3–4 hematologic adverse event was neutropenia ( 14 of 82 cycles ) including three cases of febrile neutropenia . Conclusions The combination of oxaliplatin and doxorubicin showed modest activity and a tolerable toxicity profile in advanced HCC patients Evaluation of new drug combinations is needed to improve patients ' prognosis in advanced hepatocellular carcinoma ( HCC ) . The purpose of this study was to evaluate the safety and efficacy of the capecitabine – oxaliplatine combination ( XELOX ) in HCC patients . First-line chemotherapy with XELOX regimen consisting of a 3-week cycle of intravenous oxaliplatin ( 130 mg m−2 ) on Day 1 , and oral capecitabine twice daily from Days 1–14 ( 1000 mg m−2 ) was administered in patients with measurable , unresectable HCC . Fifty patients ( male , 88 % ; median age , 68 years ) received a total of 295 cycles ( median , 6 ) of treatment . Disease control ( three partial responses , 29 stable diseases ) rate was 72 % ( 95 % CI 57–83 % ) . Median overall and median progression-free ( PFS ) survival was 9.3 months and 4.1 months , respectively . Progression-free survival rates at 6 and 12 months were 38 % ( 95 % CI 26–52 % ) and 14 % ( 95 % CI 7–26 % ) , respectively . Main grade 3–4 drug-related toxicities included diarrhoea ( 16 % ) , elevation of aminotransferases and /or bilirubin ( 16 % ) , thrombocytopenia ( 12 % ) , and neurotoxicity ( 6 % ) . Capecitabine plus oxaliplatin regimen showed modest anti-tumour activity with tolerable toxicities in patients with advanced HCC . However , the manageable toxicity profile and the encouraging disease control rate deserve further attention for this convenient , outpatient-based chemotherapy regimen PURPOSE Hepatocellular carcinoma ( HCC ) is a vascular tumor with poor prognosis . Given the reported activity of gemcitabine and oxaliplatin ( GEMOX ) in HCC and the potential benefits of targeting the vascular endothelial growth factor pathway with bevacizumab ( B ) , a phase II study of GEMOX-B was undertaken to define efficacy and toxicity profiles in HCC patients . PATIENTS AND METHODS Eligible patients had pathologically proven measurable unresectable or metastatic HCC . For cycle 1 ( 14 days ) , bevacizumab 10 mg/kg was administered alone intravenously on day 1 . For cycle 2 and beyond ( 28 days/cycle ) , bevacizumab 10 mg/kg was administered on days 1 and 15 , gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16 . RESULTS Thirty-three patients were enrolled and 30 patients were assessable for efficacy . The objective response rate was 20 % , and 27 % of patients had stable disease . Median overall survival was 9.6 months ( 95 % CI , 8.0 months to not available ) and median progression-free survival ( PFS ) was 5.3 months ( 95 % CI , 3.7 to 8.7 months ) ; the PFS rate at 3 and 6 months was 70 % ( 95 % CI , 54 % to 85 % ) and 48 % ( 95 % CI , 31 % to 65 % ) , respectively . The most common treatment-related grade 3 to 4 toxicities included leukopenia/neutropenia , transient elevation of aminotransferases , hypertension , and fatigue . CONCLUSION GEMOX-B could be safely administered with close monitoring and had moderate antitumor activity for patients with advanced HCC . The high 6-month PFS rate is encouraging , and this regimen is worthy of further investigation BACKGROUND Sorafenib has shown survival benefits in patients with advanced hepatocellular carcinoma ( HCC ) and Child-Pugh ( CP ) class A liver function . There are few prospect i ve data on sorafenib in patients with HCC and CP class B. PATIENTS AND METHODS A consecutive prospect i ve series of 300 patients with CP class A or B HCC were enrolled in a dual-phase trial to determine survival and safety data according to liver function ( class A or B ) in patients receiving oral sorafenib 800 mg daily . [ Results of this study were presented in part at the ASCO 2012 Gastrointestinal Cancers Symposium , 19 - 21 January 2012 . J Clin Oncol 2012 ; 30 ( Suppl 4 ) : abstract 306 . ] RESULTS Overall progression-free survival ( PFS ) , time to progression ( TTP ) and overall survival ( OS ) were 3.9 , 4.1 and 9.1 months , respectively . For patients with CP class A versus B status , PFS was 4.3 versus 2.1 months , TTP was 4.2 versus 3.8 months and OS was 10.0 versus 3 . 8 months . Extrahepatic spread was associated with worse outcomes but taken together with CP class , liver function played a greater role in reducing survival . Adverse events for the two CP groups were similar . CONCLUSION Although patients with HCC and CP class B liver function have poorer outcomes than those with CP class A function , data suggest that patients with CP class B liver function can tolerate treatment and may still benefit from sorafenib New systemic therapies are needed to improve the prognosis of patients with advanced‐stage hepatocellular carcinoma ( HCC ) . In a Phase II trial involving previously untreated patients with advanced HCC , the more favorable schedule from a previous pilot study was evaluated Purpose : Sorafenib impro
Output:
| OXA-based chemotherapy is effective in advanced HCC and represents a viable option in these patients . |
MS211980 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE --To assess the long term effect of early mobilisation exercises in patients with acute sprains of the neck after road accidents . DESIGN --Single blind r and omised prospect i ve study of patients receiving physiotherapy , advice on mobilisation , or on an initial period of rest followed up after two years by postal question naire . SETTING --Accident and emergency department in urban hospital . PATIENTS --247 Consecutive patients ( mean age at injury 30.6 years ) presenting within 48 hours after injury with no pre-existing disease of the neck or serious skeletal injury . Of these , 167 patients responded to the question naire ; 77 who responded but had not completed their treatment or review course were included in the analysis as a fourth group ( non-attenders ) . MAIN OUTCOME MEASURE -- Presence of symptoms after two years . RESULTS --Of the 167 patients ( 68 % ) responding , the percentage of patients still with symptoms was not significantly different in those receiving rest or physiotherapy ( 46 % , 12/26 v 44 % , 24/54 ) , but that in those receiving advice on early mobilisation was significantly lower ( 23 % , 11/48 , p = 0.02 ) . Of the 104 patients without symptoms , 94 ( 90 % ) recovered within six months and 62 ( 60 % ) within three months . Patients without symptoms who received advice or physiotherapy wore a collar for a significantly shorter time than those with persistent symptoms ( mean duration 1.4 ( SD 0.7 ) months v 2.8 ( 1.6 ) months , p = 0.005 and 1.6 ( 1.1 ) months v 1.8 ( 1.3 ) months , p = 0.006 respectively ) . CONCLUSIONS --Advice to mobilise in the early phase after neck injury reduces the number of patients with symptoms at two years and is superior to manipulative physiotherapy . Prolonged wearing of a collar is associated with persistence of symptoms Study Design . A question naire was mailed to 3000 r and omly selected 35‐45‐year‐old individuals in three communities in central Sweden . Objectives . To study the 1‐year prevalence of spinal pain and its ramifications in the form of pain , function , sick leave , and health care use . Summary of Background Data . Previous research ers have used a variety of definitions and population s , but primarily have investigated the occurrence of pain . Comprehensive data are needed concerning health care use , the degree of the pain problem , functional disturbances , and sick leave . Method . Participants in the study completed a question naire regarding spinal pain during the past year including the degree of their experienced pain , functional impairment , lost work days , and health care use . Results . A total of 2305 people ( 78.5 % ) responded to the question naire . Nonrespondents had similar characteristics but a slightly lower 1‐year prevalence rate than did respondents . For respondents , the prevalence of spinal pain during the past year was 66.3 % , with women having a slightly higher prevalence than men . Approximately 25 % of the respondents indicated that they had a substantial problem based on ratings of pain , functional impairment , and sick leave . Work absenteeism reported to the Public Social Insurance Office involved 19 % of those with pain , but an additional 15 % indicated unreported absenteeism . On average , those with pain visited health care providers three times during the past year , but a small number of those who experienced pain consumed large amounts of health care and illness benefits . An important gender difference was shown , such that when pain was at its worst , men took sick leave , whereas women sought health care . Conclusions . Taken together , these data indicate that spinal pain is common among 35‐45‐year‐old men and ‐ women , and that it is related to marked problems for approximately one fourth of those who experience pain . Gender differences exist in the pattern of sick leave and health care use , and a small proportion of those with pain consume very large amounts of the re sources . Consequently , there is a need for early , effective , preventive treatments Objectives The authors ' goals were to compare the effectiveness of manual therapy ( MT ; mainly spinal mobilization ) , physical therapy ( PT ; mainly exercise therapy ) , and continued care by the general practitioner ( GP ; analgesics , counseling and education ) over a period of 1 year . Methods One hundred eighty-three patients suffering for at least 2 weeks from nonspecific neck pain were r and omized to receive a 6-week treatment strategy of MT once a week , PT twice a week , or GP care once every 2 weeks . The primary outcome measures were perceived recovery , severity of physical dysfunctioning , pain intensity , and functional disability . Results The differences between groups considered over 1 year were statistically significant ( repeated measurements analyses P<0.001 to P=0.02 ) for all outcomes but borderline for the Neck Disability Index ( P=0.06 ) . Higher improvement scores were observed for MT for all outcomes , followed by PT and GP care . The success rate , based on perceived recovery after 13 weeks , was 72 % for MT , which was significantly higher than the success rate for continued GP care ( 42 % , P=0.001 ) but not significantly higher compared with PT treatment ( 59 % , P=0.16 ) . The difference between PT and GP approached statistical significance ( P=0.06 ) . After 1 year the success rates were 75 % , 63 % , and 56 % , respectively , and no longer significantly different . Conclusions Short-term results ( at 7 weeks ) have shown that MT speeded recovery compared with GP care and , to a lesser extent , also compared with PT . In the long-term , GP treatment and PT caught up with MT , and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up Abstract The inability to predict outcome in patients with low back/neck pain leads to inappropriate or unnecessary treatment . The aims of the study were to identify prognostic factors for disability at 1‐year follow‐up in patients with back pain visiting primary care , and to compare the effect of these in two treatment strategies – chiropractic and physiotherapy . Data were taken from a r and omised trial on patients with back/neck pain visiting the general practitioner , in which patients were allocated to chiropractic and physiotherapy as primary management . Three hundred and twenty‐three patients , aged 18–60 years , who had no contraindications to manipulation and who had not been treated within the previous month were included in the study . Multiple regression analysis was used to identify prognostic factors . Dependent variables were mean Oswestry score and mean change in Oswestry score at 12‐month follow‐up . The multiple regression analysis revealed five significant ( P<0.001–0.01 ) prognostic factors ; duration of current episode , Oswestry score at entry , expectations of treatment , number of localisations , and well‐being . Besides , the regression coefficients for the significant factors were compared between the two treatment strategies . No significant difference in effect or regression coefficients for the prognostic factors were seen between the two treatment strategies . Twelve per cent of the patients had poor prognostic factors ( duration ≥1 month , more than one localisation , low expectations of treatment and low well‐being ) at entry . These patients had a mean Oswestry score above 20 % at 1‐year follow‐up . Clinical decision models for the management of patients with back pain visiting primary care that consider prognostic factors need to be implemented and prospect ively evaluated PURPOSE To study whether the isolated intervention of high-speed , low-amplitude spinal manipulation in the cervical spine has any effect on cervicogenic headache . DESIGN Prospect i ve r and omized controlled trial with a blinded observer . SETTING Ambulatory outpatient facility in an independent research institution . PARTICIPANTS Fifty-three subjects suffering from frequent headaches who fulfilled the International Headache Society criteria for cervicogenic headache ( excluding radiological criteria ) . These subjects were recruited from 450 headache sufferers who responded to newspaper advertisements . INTERVENTION After r and omization , 28 of the group received high-velocity , low-amplitude cervical manipulation twice a week for 3 wk . The remaining 25 received low-level laser in the upper cervical region and deep friction massage ( including trigger points ) in the lower cervical/upper thoracic region , also twice a week for 3 wk . MAIN OUTCOME MEASURES The change from week 1 to week 5 in analgesic use per day , in headache intensity per episode and in number of headache hours per day , as registered in a headache diary . RESULTS The use of analgesics decreased by 36 % in the manipulation group , but was unchanged in the soft-tissue group ; this difference was statistically significant ( p = .04 , chi 2 for trend ) . The number of headache hours per day decreased by 69 % in the manipulation group , compared with 37 % in the soft-tissue group ; this was significant at p = .03 ( Mann-Whitney ) . Finally , headache intensity per episode decreased by 36 % in the manipulation group , compared with 17 % in the soft-tissue group ; this was significant at p = .04 ( Mann-Whitney ) . CONCLUSION Spinal manipulation has a significant positive effect in cases of cervicogenic headache OBJECTIVE To determine the relative effect of instrument-delivered thrust cervical manipulations in comparison with traditional manual-delivered thrust cervical manipulations in the treatment of cervical spine dysfunction . DESIGN Prospect i ve , r and omized , comparative clinical trial . SETTING Outpatient chiropractic clinic , Technikon Natal , South Africa . PATIENTS Thirty patients diagnosed with neck pain and restricted cervical spine range of motion without complicating pathosis for at least 1 month were included in the study . INTERVENTIONS The patients were r and omized into 2 groups . Those in one group received mechanical force , manually assisted ( MFMA ) manipulation to the cervical spine , delivered by means of a h and -held instrument ( Activator II Adjusting Instrument ) . Those in the other group received specific contact high-velocity , low-amplitude ( HVLA ) manipulation consisting of st and ard Diversified rotary/lateral break techniques to the cervical spine . Each group received only the specific therapeutic intervention , no other treatment modalities or interventions ( including medication ) being used , until asymptomatic status was achieved or a maximum of 8 treatments had been received . MAIN OUTCOME MEASURES Both treatment groups were assessed through use of subjective ( Numerical Pain Rating Scale 101 , McGill Short-Form Pain Question naire , and Neck Disability Index ) and objective ( goniometer cervical range of motion ) measurement parameters at specific intervals during the treatment period and at 1-month follow-up . The data were assessed through use of 2-tailed nonparametric paired and unpaired analysis , descriptive statistics , and power analysis of the data . RESULTS The results indicate that both treatment methods had a positive effect on the subjective and objective clinical outcome measures , no significant difference being observed between the 2 groups ( P < .025 ) . The subjective data from all 3 question naires showed statistically significant changes from initial to final consultations as well as from initial consultation to 1-month follow-up ( P < .025 ) . The objective range of motion measures showed statistically significant changes in the MFMA group for left and right rotation and left and right lateral flexion from initial consultation to final consultations and for right rotation and right lateral flexion from initial consultation to 1-month follow-up . The HVLA group showed only the change in left rotation from initial to final consultations and from initial consultation to 1-month follow-up to be statistically significant . CONCLUSIONS The results of this clinical trial indicate that both instrumental ( MFMA ) manipulation and manual ( HVLA ) manipulation have beneficial effects associated with reducing pain and disability and improving cervical range of motion in this patient population . A r and omized , controlled clinical trial in a similar patient base with a larger sample size is necessary to verify the clinical relevance of these findings Study Design . A multicenter , r and omized controlled trial with unblinded treatment and blinded outcome assessment was conducted . The treatment period was 6 weeks with follow-up assessment after treatment , then at 3 , 6 , and 12 months . Objectives . To determine the effectiveness of manipulative therapy and a low-load exercise program for cervicogenic headache when used alone and in combination , as compared with a control group . Summary of Background Data . Headaches arising from cervical musculoskeletal disorders are common . Conservative therapies are recommended as the first treatment of choice . Evidence for the effectiveness of manipulative therapy is inconclusive and available only for the short term . There is no evidence for exercise , and no study has investigated the effect of combined therapies for cervicogenic headache . Methods . In this study , 200 participants who met the diagnostic criteria for cervicogenic headache were r and omized into four groups : manipulative therapy group , exercise therapy group , combined therapy group , and a control group . The primary outcome was a change in headache frequency . Other outcomes included changes in headache intensity and duration , the Northwick Park Neck Pain Index , medication intake , and patient satisfaction . Physical outcomes included pain on neck movement , upper cervical joint tenderness , a craniocervical flexion muscle test , and a photographic measure of posture . Results . There were no differences in headache-related and demographic characteristics between the groups at baseline . The loss to follow-up evaluation was 3.5 % . At the 12-month follow-up assessment , both manipulative therapy and specific exercise had significantly reduced headache frequency and intensity , and the neck pain and effects were maintained ( P < 0.05 for all ) . The combined therapies was not significantly superior to either therapy alone , but 10 % more patients gained relief with the combination . Effect sizes were at least moderate and clinical ly relevant . Conclusion . Manipulative therapy and exercise can reduce the symptoms of cer
Output:
| Single or multiple ( 3 - 11 ) sessions of manipulation or mobilization showed no benefit in pain relief when assessed against placebo , control groups , or other treatments for acute/subacute/chronic mechanical neck disorders with or without headache .
Mobilization and /or manipulation when used with exercise are beneficial for persistent mechanical neck disorders with or without headache .
Done alone , manipulation and /or mobilization were not beneficial ; when compared to one another , neither was superior .
There was insufficient evidence available to draw conclusions for neck disorder with radicular findings .
Factorial design would help determine the active agent(s ) within a treatment mix |
MS211981 | ***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: Poor patency of synthetic grafts for infragenicular revascularization has led to use of distal vein patches or cuffs . The aim of this study was to compare the distally widened DistafloTM PTFE graft , which mimics a vein cuff , with a PTFE graft with distal vein modification . In this prospect i ve , r and omized , multicenter trial we compared use of a precuffed PTFE graft wit that of PTFE grafts with distal vein modification for infragenicular revascularization in patients with critical limb ischemia without saphenous vein . Study end points were primary and secondary patency and limb salvage rates at 2 years . From January 28,1999 to November 1 , 2000 , 104 patients were enrolled in 10 North American centers . Thirteen were excluded for protocol violation . Ninety-one bypasses were performed in 89 patients with a mean age of 73 years ( range 47 - 90 ) . By r and omization , 47 bypasses were done with the precuffed graft and 44 with PTFE graft with vein cuff . Both groups were comparable for comorbidities and operative variables , except for a higher incidence of acute ischemia in the precuffed group ( 19 % vs. 4.5 % , p = 0.03 ) . Bypass was a redo procedure in 53 % and was performed at the infrapopliteal vessels in 79 % . Operative mortality was 2.2 % ( 2/91 ) . Mean follow-up was 14 months ( range 1 - 30 ) . At 1 and 2 years , primary patency was 52 % and 49 % for the precuffed group and 62 % and 44 % for the vein cuffed group , respectively ( p = 0.53 ) . At 1 year and 2 years , the limb salvage rate was 72 % and 65 % for the precuffed group and 75 % and 62 % in the vein cuffed group ( p = 0.88 ) . Although numbers are small and follow-up short , this midterm analysis shows similar results for the Distaflo precuffed grafts and PTFE grafts with vein cuff . A precuffed graft is a reasonable alternative conduit for infragenicular reconstruction in the absence of saphenous vein and provides favorable limb salvage 1 . The activities of phosphofructokinase ( PFK ) , citrate synthetase ( CS ) , lactate dehydrogenase ( LDH ) , 3-hydroxyacyl-CoA dehydrogenase ( ACDH ) and cytochrome-c oxidase(Cyt-ox ) in the calf muscle tissue were compared in subjects with intermittent claudication ( n = 38 ) and controls ( n = 20 ) . The activities of CS , ACDH and Cyt-ox were increased and the activity of Cytox was positively correlated to the maximal walking distance ( MWD ) in the patients . 2 . Thirty-three patients with intermittent claudication were r and omized to three treatment groups : ( 1 ) operative surgery , ( 2 ) operative surgery supplemented with physical training and ( 3 ) physical training alone . Before and after 6 - 12 months of treatment , symptom-free walking distance ( SFWD ) , MWD , ankle-brachial blood pressure quotient ( ankle index ) , maximal plethysmographic calf blood flow ( MPBF ) and the activities of PFK , CS , LDH , ACDH and Cyt-ox were measured . 3 . SFWD and MWD increased in all three groups . Ankle index and MPBF increased in groups 1 and 2 , but were unchanged in group 3 . The activities of Cyt-ox and CS decreased with operation , but the activity of Cyt-ox was further augmented with training in group 3 . Overall , the change in ankle index explained 80 - 90 % of the variability in walking performance . In a separate analysis , the increased activity of Cyt-ox in group 3 was positively correlated to , and explained 31 % of the variability in , the improvement in SFWD . 4 . These findings indicate that both physical activity and a reduced calf blood flow are necessary conditions for the enzymatic adaptation to take place . A causal relationship between metabolic adaptation in the muscle tissue and walking performance is suggested . ( ABSTRACT TRUNCATED AT 250 WORDS Intermittent claudication is the primary symptom of peripheral arterial disease , affecting between 1 and 3 million Americans . Symptomatic improvement can be achieved by endovascular revascularization , but such procedures are invasive , expensive , and may be associated with procedural adverse events . Medical treatment options , including claudication medications and supervised exercise training , are also known to be effective , albeit also with associated limitations . The CLEVER ( Claudication : Exercise Vs . Endoluminal Revascularization ) study , funded by the Heart , Lung , and Blood Institute of the National Institutes of Health , is a prospect i ve , multicenter , r and omized , controlled clinical trial evaluating the relative efficacy , safety , and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication . The treatment arms are : ( 1 ) optimal medical care ( claudication pharmacotherapy ) ; ( 2 ) primary stent placement ; ( 3 ) supervised exercise rehabilitation ; and ( 4 ) combined stenting with supervised exercise rehabilitation . The CLEVER study is a 5-year r and omized , controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period . The primary end point is change in maximum walking duration on a grade d treadmill test . Secondary end points include the change at 18 months in maximum walking duration from baseline , comparisons of free-living daily activity levels assessed by pedometer , health-related quality of life , and cost-effectiveness . Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables , including body mass index , waist circumference , blood pressure , pulse pressure , and resting pulse as well as biochemical markers of cardiovascular health , including fasting lipids , fibrinogen , C-reactive protein , and hemoglobin A 1c values OBJECTIVE Despite many clinical studies , there is still uncertainty as to whether venous material is superior to prosthetic material s for femoropopliteal reconstruction proximal to the knee joint . A prospect ively r and omized clinical trial was design ed to evaluate the effectiveness of reversed saphenous vein in comparison with that of collagen impregnated woven polyester prosthesis in above-knee arterial reconstruction . METHODS In a 3-year period , 103 above-knee femoropopliteal bypass graft operations were performed and followed in 85 patients ( 52 male , 33 female ) . The indication for operation was severe claudication in 74 cases , rest pain in 7 cases , and ulceration in 4 cases . For the bypass graft , a reversed saphenous vein was used in each of 51 cases , and a collagen impregnated woven polyester prosthesis was used in each of 52 cases . Preoperative risk factors were diabetes ( 24 % ) , a history of myocardial infa rct ion ( 23 % ) , and current status with respect to smoking ( 74 % ) . There was no hospital mortality ; 5 % of patients had minor postoperative complications . RESULTS After 2 years of follow-up , the primary patency was 81 % for saphenous vein and 67 % for collagen impregnated woven polyester prosthesis ( P=0.065 ) ; the secondary patency was 81 % for saphenous vein and 77 % for collagen impregnated woven polyester prosthesis ( P=0.298 ) . During this follow-up period of 2 years , we found no statistically significant difference in primary and secondary patency between saphenous vein and collagen impregnated woven polyester prosthesis . We found no predictive factor for the occlusion of either bypass graft . CONCLUSION The use of collagen impregnated woven polyester prosthesis above the knee is a reasonable alternative in femoropopliteal bypass grafting that is associated with acceptable short-term patency rates OBJECTIVE To evaluate the feasibility and efficacy of simultaneous combined endovascular and open lower extremity arterial reconstruction . DESIGN Case series study with retrospective analysis of prospect ively collected non-r and omised data . METHODS Patients were divided into three groups : group 1 and group 2 included patients who underwent endovascular reconstruction proximal and distal to the site of open reconstruction , respectively , whereas group 3 included patients who underwent open surgery with both proximal and distal endoluminal procedures . Patency analyses were performed using Kaplan-Meier life tables . Univariate and multivariate analyses were used to assess the influence of various risk factors on primary patency . RESULTS Complete data were obtained from 60 patients who underwent 61 single-step hybrid procedures . Technical and haemodynamic success rates were 100 % and 95 % , respectively . The perioperative mortality rate was 3 % . The primary and assisted- primary patency rates at 12 months were 71 % and 98 % , respectively . Primary patency rates were lower in group 3 when compared with groups 1 and 2 ( log-rank test , p=0.006 ) . The presence of diabetes and dyslipidaemia were independent predictors of decreased primary patency ( p=0.003 and p=0.014 , respectively ) . CONCLUSIONS Hybrid procedures provide an effective treatment management of selected patients with multilevel lower extremity arterial disease . The extent of the disease , diabetes and dyslipidaemia are associated with worse outcome BACKGROUND An intention-to-treat analysis of r and omized Bypass versus Angioplasty in Severe Ischaemia of the Leg ( BASIL ) trial data showed that initial r and omization to a bypass surgery (BSX)-first strategy was associated with improvements in subsequent overall survival ( OS ) and amputation-free survival ( AFS ) of about 7 and 6 months , respectively . We describe the nature and timing of first , crossover , and re interventions and examine AFS and OS by first treatment received . We also compare vein with prosthetic BSX and transluminal with subintimal balloon angioplasty ( BAP ) and examine outcomes from BSX after failed BAP . METHODS We r and omly assigned 452 patients with SLI due to infrainguinal disease in 27 United Kingdom hospitals to a BSX first ( n = 228 ) or a BAP first ( n = 224 ) revascularization strategy . All patients have been monitored for 3 years and more than half for > 5 years . We prospect ively collected data on every procedure , major amputation , and death . RESULTS Patients r and omized to BAP were more likely to have their assigned treatment first ( 94 % vs 85 % , P = .01 , chi(2)test ) . BAP had a higher immediate technical failure rate of 20 % vs 2.6 % ( P = .01 , chi(2)test ) . By 12 weeks after r and omization 9 BAP ( 4 % ) vs 23 BSX ( 10 % ) patients had not undergone revascularization ; 3 BAP ( 1.3 % ) vs 13 BSX ( 5.8 % ) had undergone the opposite treatment first ; and 35 BAP ( 15.6 % ) and 2 ( 0.9 % ) BSX had received the assigned treatment and then undergone the opposite treatment . BSX distal anastomoses were divided approximately equally between the above and below knee popliteal and crural arteries ; most originated from the common femoral artery . About 25 % of the grafts were prosthetic and > 90 % of vein BSX used ipsilateral great saphenous vein . Most ( 80 % ) BAP patients underwent treatment of the SFA alone ( 38 % ) or combined with the popliteal artery ( 42 % ) and crural arteries ( 20 % ) . Outcome of vein BSX was better for AFS ( P = 0.003 ) but not OS ( P = 0.38 , log-rank tests ) than prosthetic BSX . There were no differences in outcome between approximately equal numbers of transluminal and subintimal BAP . AFS ( P = 0.006 ) but not OS ( P = 0.06 , log rank test ) survival was significantly worse after BSX after failed BAP than after BSX as a first revascularization attempt . CONCLUSIONS BAP was associated with a significantly higher early failure rate than BSX . Most BAP patients ultimately required surgery . BSX outcomes after failed BAP are significantly worse than for BSX performed as a first revascularization attempt . BSX with vein offers the best long term AFS and OS and , overall , BAP appears superior to prosthetic BSX Background Endovascular treatment options for the superficial femoral artery are evolving rapidly . For long lesions , the venous femoropopliteal bypass considered to be superior above the prosthetic bypass . An endoluminal bypass , however , may provide equal patency rates compared to the prosthetic above knee bypass . The introduction of heparin-bonded endografts may further improve patency rates . The SUrgical versus PERcutaneous Bypass ( SuperB ) study is design ed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life , related to a decreased complication rate , or not .
Output:
| The quality of the evidence for the most important outcomes of bypass surgery versus PTA was high except for clinical improvement and primary patency .
Our analysis has shown that PTA is associated with decreased peri-interventional complications in participants treated for CLI and shorter hospital stay compared with bypass surgery .
Surgical treatment seems to confer improved patency rates up to one year .
Endovascular treatment may be advisable in patients with significant comorbidity , rendering them high risk surgical c and i date s. No solid conclusions can be drawn regarding comparisons of bypass surgery with other treatments because of the paucity of available evidence . |
MS211982 | ***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: CONTEXT Of the 200 million adults worldwide who undergo noncardiac surgery each year , more than 1 million will die within 30 days . OBJECTIVE To determine the relationship between the peak fourth-generation troponin T ( TnT ) measurement in the first 3 days after noncardiac surgery and 30-day mortality . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , international cohort study that enrolled patients from August 6 , 2007 , to January 11 , 2011 . Eligible patients were aged 45 years and older and required at least an overnight hospital admission after having noncardiac surgery . MAIN OUTCOME MEASURES Patients ' TnT levels were measured 6 to 12 hours after surgery and on days 1 , 2 , and 3 after surgery . We undertook Cox regression analysis in which the dependent variable was mortality until 30 days after surgery , and the independent variables included 24 preoperative variables . We repeated this analysis , adding the peak TnT measurement during the first 3 postoperative days as an independent variable and used a minimum P value approach to determine if there were TnT thresholds that independently altered patients ' risk of death . RESULTS A total of 15,133 patients were included in this study . The 30-day mortality rate was 1.9 % ( 95 % CI , 1.7%-2.1 % ) . Multivariable analysis demonstrated that peak TnT values of at least 0.02 ng/mL , occurring in 11.6 % of patients , were associated with higher 30-day mortality compared with the reference group ( peak TnT ≤ 0.01 ng/mL ) : peak TnT of 0.02 ng/mL ( adjusted hazard ratio [ aHR ] , 2.41 ; 95 % CI , 1.33 - 3.77 ) ; 0.03 to 0.29 ng/mL ( aHR , 5.00 ; 95 % CI , 3.72 - 6.76 ) ; and 0.30 ng/mL or greater ( aHR , 10.48 ; 95 % CI , 6.25 - 16.62 ) . Patients with a peak TnT value of 0.01 ng/mL or less , 0.02 , 0.03 - 0.29 , and 0.30 or greater had 30-day mortality rates of 1.0 % , 4.0 % , 9.3 % , and 16.9 % , respectively . Peak TnT measurement added incremental prognostic value to discriminate those likely to die within 30 days for the model with peak TnT measurement vs without ( C index = 0.85 vs 0.81 ; difference , 0.4 ; 95 % CI , 0.2 - 0.5 ; P < .001 for difference between C index values ) . The net reclassification improvement with TnT was 25.0 % ( P < .001 ) . CONCLUSION Among patients undergoing noncardiac surgery , the peak postoperative TnT measurement during the first 3 days after surgery was significantly associated with 30-day mortality This study considered if N-terminal prohormone brain natriuretic peptide ( NT-proBNP ) is associated with increased risk for postoperative cardiac events in high-risk patients undergoing noncardiac surgery . In addition , this report describes how levels of NT-proBNP are affected by noncardiac surgery . The study design was a prospect i ve cohort study that enrolled 83 patients age > or = 50 years with > or = 1 risk factor for coronary artery disease having intermediate or high-risk noncardiac surgery . NT-proBNP levels were measured preoperatively and on postoperative days 1 and 3 . During the month following surgery , 25 patients ( 33 % ) had a combined 37 postoperative cardiac events including 15 episodes of heart failure ( 20 % ) , 12 episodes of new dysrhythmia ( 16 % ) , 7 myocardial infa rct ions ( 9 % ) , and 3 cardiac arrests ( 4 % ) . Preoperative NT-proBNP level > or = 457 pg/ml was significantly associated with occurrence of a postoperative cardiac event ( odds ratio 10.5 , 95 % confidence interval 1.9 to 56.6 , p = 0.006 ) . After surgery , 64 of 72 patients ( 89 % ) had an increase in NT-proBNP from their preoperative level . In conclusion , this study determined there was a significant association between elevated preoperative NT-proBNP and occurrence of a postoperative cardiac event . In addition , increased NT-proBNP after noncardiac surgery is not uncommon even in the absence of clinical ly identifiable heart failure Background — Postoperative atrial fibrillation ( AF ) is a complication of thoracic surgery for lung cancer , with a reported incidence that can run as high as 42 % . Recently , it has been observed retrospectively that B-type natriuretic peptide predicts AF after cardiac surgery . We performed a prospect i ve study to evaluate the role of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) as a marker for risk stratification of postoperative AF in patients undergoing thoracic surgery for lung cancer . Methods and Results — We measured NT-proBNP levels in 400 patients ( mean age , 62±10 years ; 271 men ) 24 hours before and 1 hour after surgery . The primary end point of the study was the incidence of postoperative AF . Overall , postoperative AF occurred in 72 patients ( 18 % ) . Eighty-eight patients ( 22 % ) showed an elevated perioperative NT-proBNP value . When patients with either preoperatively or postoperatively elevated NT-proBNP were pooled , a greater incidence of AF was observed compared with patients with normal values ( 64 % versus 5 % ; P<0.001 ) . At multivariable analysis , adjusted for age , gender , major comorbidities , echocardiography parameters , pneumonectomy , and medications , both preoperative and postoperative NT-proBNP values were independent predictors of AF ( relative risk , 27.9 ; 95 % CI , 13.2 to 58.9 ; P<0.001 for preoperative NT-proBNP elevation ; relative risk , 20.1 ; 95 % CI , 5.8 to 69.4 ; P<0.001 for postoperative NT-proBNP elevation ) . Conclusions — Elevation of perioperative NT-proBNP is a strong independent predictor of postoperative AF in patients undergoing thoracic surgery for lung cancer . This finding should facilitate studies of therapies to reduce AF in selected high-risk patients OBJECTIVES This study was design ed to evaluate B-type natriuretic peptide ( BNP ) for risk assessment and clinical decision making over a range of cut points , alone and with cardiac troponin I ( cTnI ) , in patients with non-ST-elevation acute coronary syndromes ( ACS ) . BACKGROUND B-type natriuretic peptide holds promise for risk stratification . Additional evidence regarding optimal decision limits , use in combination with troponin , and use in targeting therapy is needed before acceptance into clinical use for ACS . METHODS We evaluated BNP at baseline in 1,676 patients with non-ST-elevation ACS r and omized to early invasive versus conservative management . RESULTS Patients with elevated BNP ( > 80 pg/ml ; n = 320 ) were at higher risk of death at seven days ( 2.5 % vs. 0.7 % , p = 0.006 ) and six months ( 8.4 % vs. 1.8 % , p < 0.0001 ) . The association between BNP and mortality at six months ( adjusted odds ratio [ OR ] 3.3 ; 95 % confidence interval [ CI ] 1.7 to 6.3 ) was independent of important clinical predictors , including cTnI and congestive heart failure ( CHF ) . Patients with elevated BNP had a fivefold higher risk of developing new CHF by 30 days ( 5.9 % vs. 1.0 % , p < 0.0001 ) . B-type natriuretic peptide added prognostic information to cTnI , discriminating patients at higher mortality risk among those with negative ( OR 6.9 ; 95 % CI 1.9 to 25.8 ) and positive ( OR 4.1 ; 95 % CI 1.9 to 9.0 ) baseline cTnI results . No difference was observed in the effect of invasive versus conservative management when stratified by baseline levels of BNP ( p(interaction ) > or = 0.6 ) . CONCLUSIONS Elevated BNP ( > 80 pg/ml ) at presentation identifies patients with non-ST-elevation ACS who are at higher risk of death and CHF and adds incremental information to cTnI. Additional work is needed to identify therapies that may reduce the risk associated with increased BNP We performed a Monte Carlo study to evaluate the effect of the number of events per variable ( EPV ) analyzed in logistic regression analysis . The simulations were based on data from a cardiac trial of 673 patients in which 252 deaths occurred and seven variables were cogent predictors of mortality ; the number of events per predictive variable was ( 252/7 =) 36 for the full sample . For the simulations , at values of EPV = 2 , 5 , 10 , 15 , 20 , and 25 , we r and omly generated 500 sample s of the 673 patients , chosen with replacement , according to a logistic model derived from the full sample . Simulation results for the regression coefficients for each variable in each group of 500 sample s were compared for bias , precision , and significance testing against the results of the model fitted to the original sample . For EPV values of 10 or greater , no major problems occurred . For EPV values less than 10 , however , the regression coefficients were biased in both positive and negative directions ; the large sample variance estimates from the logistic model both overestimated and underestimated the sample variance of the regression coefficients ; the 90 % confidence limits about the estimated values did not have proper coverage ; the Wald statistic was conservative under the null hypothesis ; and paradoxical associations ( significance in the wrong direction ) were increased . Although other factors ( such as the total number of events , or sample size ) may influence the validity of the logistic model , our findings indicate that low EPV can lead to major problems Background : Postoperative cognitive dysfunction ( POCD ) is a significant cause of morbidity after noncardiac surgery . Identified risk factors are largely limited to demographic characteristics . We hypothesized that POCD was associated with apolipoprotein E4 ( APOE4 ) genotype and plasma biomarkers of brain injury and inflammation . Methods : Three hundred ninety-four patients older than 55 yr undergoing major elective noncardiac surgery were enrolled in this prospect i ve observational study . Apolipoprotein E genotyping was performed at baseline . Plasma was collected at baseline and end of surgery and at 4.5 , 24 , and 48-h postoperatively . Six protein biomarkers were assayed ( B-type natriuretic peptide , C-reactive protein , D-dimer , matrix metalloproteinase-9 , neuron-specific enolase , and S-100B ) . Neurocognitive testing was conducted at baseline and at 6 weeks and 1 yr after surgery ; scores were subjected to factor analysis . The association of APOE4 and biomarkers with POCD was tested using multivariable regression modeling . Results : Three hundred fifty patients ( 89 % ) completed 6-week neurocognitive testing . POCD occurred in 54.3 % of participants at 6 weeks and 46.1 % at 1 yr . There was no difference in POCD between patients with or without the APOE4 allele ( 56.6 vs. 52.6 % ; P = 0.58 ) . The continuous cognitive change score ( mean ± SD ) was similar between groups ( APOE4 : 0.05 ± 0.27 vs. non-APOE4 : 0.07 ± 0.28 ; P = 0.53 ) . Two hundred ninety-one subjects ( 74 % ) completed testing at 1 yr . POCD occurred in 45.9 % of APOE4 subjects versus 46.3 % of non-APOE4 subjects ( P = 0.95 ) . The cognitive score was again similar ( APOE4 : 0.08 ± 0.27 vs. non-APOE4 : 0.05 ± 0.25 ; P = 0.39 ) . Biomarker levels were not associated with APOE4 genotype or cognition at 6 weeks or 1 yr . Conclusion : Cognitive decline after major noncardiac surgery is not associated with APOE4 genotype or plasma biomarker levels OBJECTIVES The aim of this study was to evaluate whether chronic heart failure ( HF ) therapy guided by concentrations of amino-terminal pro-B-type natriuretic peptide ( NT-proBNP ) is superior to st and ard of care ( SOC ) management . BACKGROUND It is unclear whether st and ard HF treatment plus a goal of reducing NT-proBNP concentrations improves outcomes compared with st and ard management alone . METHODS In a prospect i ve single-center trial , 151 subjects with HF due to left ventricular ( LV ) systolic dysfunction were r and omized to receive either st and ard
Output:
| Increased postoperative BNPs are independently associated with adverse cardiac events after noncardiac surgery |
MS211983 | ***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: Among severely mentally ill ( SMI ) substance abusers , HIV rates are elevated and HIV risk reduction interventions have been shown to be less effective . An enhanced cognitive behavioral HIV risk reduction intervention ( E-CB ) for SMI was compared to a health promotion condition ( HPC ) in 222 psychiatric out patients at 6 months postintervention . Compared to females , males in the E-CB improved on intention to practice safer sex and in condom use skills and in unprotected vaginal sex , but did not differ in HIV knowledge , perceived susceptibility , anxiety , condom attitudes , safer sex self-efficacy , unprotected vaginal sex acts , or sex partners . Across intervention groups , there were improvements in all areas except self-efficacy and number of partners . Risk reduction among SMI may be facilitated by increasing awareness of health related behaviors and HIV-targeted content . However , meaningful changes in critical risk reduction skills and intentions may require a more focused intervention and may vary by gender Objective : The objective of this study was to assess the validity of women ’s reports of recent unprotected sex by testing for prostate-specific antigen ( PSA ) in vaginal sample s. Study Design : The authors conducted prospect i ve research with 332 female sex workers attending 2 public dispensaries in Madagascar . Results : Among women who reported no sex or protected sex only within the past 48 hours , 21 % and 39 % , respectively , tested positive for PSA . Among those testing positive for PSA , no differences in PSA concentrations were found among those reporting no sex , protected sex only , or at least one unprotected act . Conclusions : The substantial disagreement between self-reports and measurement of a biologic marker of semen exposure in vaginal specimens substantiates that self-reports of sexual behavior can not be assumed to be valid measures . Future sexually transmitted infection/HIV and pregnancy prevention studies should confirm the validity of self-reports or use end points that do not rely on self-reported data In a pilot study , young people in slums in Kampala , Ug and a received an HIV prevention program ( Street Smart ) and were r and omized to receive vocational training immediately ( Immediate ) or four months later ( Delayed ) . Youth were monitored at recruitment , 4 months ( 85 % retention ) , and 24 months ( 74 % retention ) . Employment increased dramatically : Only 48 % had ever been employed at recruitment , 86 % were employed from months 21 to 24 post recruitment . Over two years , decreases were recorded in the number of sexual partners , mental health symptoms , delinquent acts , and drug use ; condom use increased . Providing employment in low income countries , in conjunction with HIV prevention , may provide sustained support to young people to prevent HIV acquisition . ResumenEn un estudio piloto , los jóvenes en los barrios bajos de Kampala , Ug and a recibieron un programa de prevención del VIH ( Street Smart ) y fueron aleatorizados para recibir la formación profesional inmediatamente ( inmediato ) o cuatro meses más tarde ( en diferido ) . La juventud fue vigilada en el reclutamiento , 4 meses ( 85 % de retención ) , y 24 meses ( 74 % de retención ) . El empleo aumentó dramáticamente : sólo el 48 % había sido empleado en la contratación , el 86 % fue empleado de 21 a 24 meses después de la contratación . Más de dos años , se registraron disminuciones en el número de parejas sexuales , los síntomas de la salud mental , los actos delictivos y el consumo de drogas ; el uso del condón aumentó . La creación de empleo en los países de bajos ingresos , en conjunción con la prevención del VIH , puede proporcionar un apoyo sostenido a los jóvenes para prevenir la adquisición del VIH Challenges in the accurate measurement of sexual behavior in human immunodeficiency virus ( HIV ) prevention research are well documented and have prompted discussion about whether valid assessment s are possible . Audio computer-assisted self-interviewing ( ACASI ) may increase the validity of self-reported behavioral data . In 2006 - 2007 , Zimbabwean women participated in a r and omized , cross-sectional study that compared self-reports of recent vaginal sex and condom use collected through ACASI or face-to-face interviewing ( FTFI ) with a vali date d objective biomarker of recent semen exposure ( prostate-specific antigen ( PSA ) levels ) . Of 910 study participants , 196 ( 21.5 % ) tested positive for PSA , an indication of semen exposure during the previous 2 days . Of these 196 participants , 23 ( 11.7 % ) reported no sex in the previous 2 days , with no difference in reported sexual activity between interview modes ( 12.5 % ACASI vs. 10.9 % FTFI ; Fisher 's exact test : P = 0.72 ) . In addition , 71 PSA-positive participants ( 36.2 % ) reported condom-protected vaginal sex only ; their reports also indicated no difference between interview modes ( 33.7 % ACASI vs. 39.1 % FTFI ; P = 0.26 ) . Only 52 % of PSA-positive participants reported unprotected sex during the previous 2 days . Self-report was a poor predictor of recent sexual activity and condom use in this study , regardless of interview mode , providing evidence that such data should be interpreted cautiously A partner study was conducted in northern Thail and between March 1992 and June 1996 which included data that allowed an assessment of the reliability of self-reports of sexual behavior and contraceptive use among heterosexual couples . The authors enrolled 529 couples among whom all male subjects were human immunodeficiency virus ( HIV ) seropositive voluntary blood donors and their female sexual partners were either HIV infected ( n=246 ) or HIV seronegative ( n=283 ) . The levels of agreement within couples were assessed for recency of last sexual intercourse , sexual activity in the prior year , and contraceptive practice s. For HIV discordant couples , a prospect i ve study was conducted to examine risk factors for HIV transmission , the primary goal of the study . This allowed assessment of reliability of inter-partner reports over 6 - 12 months . Overall , agreement among couples was good for common sexual practice s , especially vaginal intercourse and time since last intercourse , but was lower for condom use . Anal and oral sex were infrequently reported by these couples and there was greater disagreement for the occurrence of these practice s. Partner agreement for contraceptive histories was good to excellent . Prospect i ve data showed less frequent intercourse and more condom use but reliability remained good . Common sexual practice s may be reliable for both HIV concordant and discordant couples in studies estimating prevalent infection . Estimates of incident heterosexually transmitted HIV may be made with greater reliability by studies which include assessment of reports of risk behavior by each member of a couple than studies of individuals This r and omized , controlled trial , conducted among out-of-treatment heroin/cocaine users at an emergency department visit , tests the impact on sexual risk of adding brief motivational intervention ( B-MI ) to point-of-service testing , counseling and drug treatment referral . 1,030 enrollees aged 18–54 received either voluntary counseling/testing ( VC/T ) with drug treatment referral , or VC/T , referral , and B-MI , delivered by an outreach worker . We measured number and proportion of non-protected sex acts ( last 30 days ) at 6 and 12 months ( n = 802 ) . At baseline , 70 % of past-30-days sex acts were non-protected ; 35 % of sex acts occurred while high ; 64 % of sexual acts involved main , 24 % casual and 12 % transactional sex partners ; 1.7 % tested positive for an STI , and 8.8 % for HIV . At six or 12 month follow-up , 20 enrollees tested positive for Chlamydia and /or Gonorrhea , and 6 enrollees HIV sero-converted . Self-reported high-risk behaviors declined in both groups with no significant between-group differences in behaviors or STI/HIV incidence Abstract This study assessed and compared the efficacy of culturally tailored behavioral interventions to increase use and acceptability of sexual barrier products among HIV-positive women in Zambia . It also sought to evaluate cultural preferences as facilitators or impediments to potential use of vaginal chemical barriers for sexual risk reduction within the Zambian context . Women ( N=240 ) , recruited from the University Teaching Hospital HIV Voluntary Counseling and Testing Center , were r and omized into group or individual intervention arms . Participants attended a baseline assessment , three intervention sessions and follow up assessment s at six and 12 months . All participants increased use and acceptability of female condoms and vaginal products and maintained male condom use at six and 12 months . Preliminary data indicated that group participants increased male condom use at six months and trial use and acceptability of female condoms and lubricants predicted their use in the group condition . Results support group interventions to increase sexual barrier use and acceptability in HIV-positive women within the Zambian context . From a public health st and point , groups may represent a cost-effective and culturally congruent intervention This article compares cross-sectional measures of condom use among 2,269 female sex workers in Cameroon r and omly assigned to receive one of five different question naires measuring condom use . We found that the level of reported condom use varied depending on the type of survey questions used . Measures based on 2-week coital logs or the past 10 acts categorized more women as " 100 % " or " 0 % " users than always-to-never scales categorized women as " always " or " never " users . Consistency of use also varied by type of partner . Internal consistency of responses was high . Future studies should assess differences in prospect i ve measures of condom use and the level of association between various measures and infection with sexually transmitted disease Research has established that voluntary medical male circumcision ( VMMC ) reduces HIV acquisition in heterosexual men by approximately 60 % ; however , engaging in sexual activity before the wound is healed may attenuate this protective effect . This prospect i ve study included VMMC clients who were circumcised in Kenya between November , 2008 and March , 2010 , aged ≥18 years , and r and omly selected for an interview and genital examination 28–45 days post-VMMC ( N = 1,344 ) . At the time of the interview , 91.3 % participants were healed . Overall , 30.7 % reported engaging in early sexual activity , usually 3–4 weeks post-VMMC . In a multivariable analysis , being married or cohabitating was the strongest predictor of engaging in early sexual activity . Strategies to reduce engaging in sexual activity during the recommended 42-day abstinence period following VMMC should be explored including re-energizing the effort to include female partners in counseling , mass education campaigns , and targeted text messaging programs for VMMC clients Culturally-specific HIV risk reduction interventions for Hispanic women are needed . SEPA ( Salud/Health , Educación/Education , Promoción/Promotion , y/ and Autocuidado/Self-care ) is a culturally-specific and theoretically-based group intervention for Hispanic women . The SEPA intervention consists of five sessions covering STI and HIV prevention ; communication , condom negotiation and condom use ; and violence prevention . A r and omized trial tested the efficacy of SEPA with 548 adult U.S. Hispanic women ( SEPA n = 274 ; delayed intervention control n = 274 ) who completed structured interviews at baseline and 3 , 6 , and 12 months post-baseline . Intent-to-treat analyses indicated that SEPA decreased positive urine sample s for Chlamydia ; improved condom use , decreased substance abuse and IPV ; improved communication with partner , improved HIV-related knowledge , improved intentions to use condoms , decreased barriers to condom use , and increased community prevention attitudes . Culturally-specific interventions have promise for preventing HIV for Hispanic women in the U.S. The effectiveness of SEPA should be tested in a translational community trial . ResumenIntervenciones culturalmente específicas son necesarias para la reducción de riesgo de contraer VIH en las mujeres hispanas . SEPA ( Salud/Health , Educación/Education , Promoción/Promotion , y Autocuidado/Self-care ) es una intervención grupal culturalmente específica con bases teóricas diseñada para mujeres Hispanas . La intervención SEPA consiste en cinco sesiones que cubren temas relacionados con la prevención de ITS - VIH , comunicación , negociación y uso del condón ; y prevención de la violencia . Utiliz and o un estudio r and omizado se probó la eficacia de SEPA con una muestra de 548 mujeres hispanas que viven en los Estados Unidos de Norteamérica ( SEPA n = 274 ; grupo control n = 274 ) . Las participantes respondieron una entrevistas estructuradas al inicio del estudio y a los 3 , 6 , y 12 meses posteriores a la intervención . Los result ados del análisis señalan que las mujeres que participaron en SEPA disminuyeron las muestras positivas de Chlamydia en orina , aumentaron el uso del condón , disminuyeron el abuso de sustancias y los episodios de violencia de pareja , mejoraron la comunicación de pareja , aumentaron el conocimiento sobre VIH , mejoraron la intención de utilizar condón , percibieron menores barreras para uso del condón , y mejoraron las actividades de preven
Output:
| Desarrollar y utilizar normas para medición del uso de condón ampliaría comparabilidad de result ados a través de estudios y beneficiaría investigación de la prevención de VIH . |
MS211984 | ***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: Although evidence -based practice ( EBP ) improves health care quality , decreases costs , and empowers nurses , there is a paucity of intervention studies design ed to test models of how to enhance nurses ' use of EBP . Therefore , the specific aim of this study was to determine the preliminary effects of implementing the Advancing Research and Clinical practice through close Collaboration ( ARCC ) model on nurses ' EBP beliefs , EBP implementation behaviors , group cohesion , productivity , job satisfaction , and attrition/turnover rates . A 2-group r and omized controlled pilot trial was used with 46 nurses from the Visiting Nurse Service of New York . The ARCC group versus an attention control group had stronger EBP beliefs , higher EBP implementation behaviors , more group cohesion , and less attrition/turnover . Implementation of the ARCC model in health care systems may be a promising strategy for enhancing EBP and improving nurse and cost outcomes Background Little is known about the impact of implementing nursing-oriented best practice guidelines on the delivery of patient care in either hospital or community setting s. Methods A naturalistic study with a prospect i ve , before and after design documented the implementation of six newly developed nursing best practice guidelines ( asthma , breastfeeding , delirium-dementia-depression ( DDD ) , foot complications in diabetes , smoking cessation and venous leg ulcers ) . Eleven health care organisations were selected for a one-year project . At each site , clinical re source nurses ( CRNs ) worked with managers and a multidisciplinary steering committee to conduct an environmental scan and develop an action plan of activities ( i.e. education sessions , policy review ) . Process and patient outcomes were assessed by chart audit ( n = 681 pre-implementation , 592 post-implementation ) . Outcomes were also assessed for four of six topics by in-hospital/home interviews ( n = 261 pre-implementation , 232 post-implementation ) and follow-up telephone interviews ( n = 152 pre , 121 post ) . Interviews were conducted with 83/95 ( 87 % ) CRN 's , nurses and administrators to describe recommendations selected , strategies used and participants ' perceived facilitators and barriers to guideline implementation . Results While statistically significant improvements in 5 % to 83 % of indicators were observed in each organization , more than 80 % of indicators for breastfeeding , DDD and smoking cessation did not change . Statistically significant improvements were found in > 50 % of indicators for asthma ( 52 % ) , diabetes foot care ( 83 % ) and venous leg ulcers ( 60 % ) . Organizations with > 50 % improvements reported two unique implementation strategies which included h and s-on skill practice sessions for nurses and the development of new patient education material s. Key facilitators for all organizations included education sessions as well as support from champions and managers while key barriers were lack of time , workload pressure and staff resistance . Conclusion Implementation of nursing best practice guidelines can result in improved practice and patient outcomes across diverse setting s yet many indicators remained unchanged . Mobilization of the nursing workforce to actively implement guidelines and to monitor the delivery of their care is important so that patients may learn about and receive recommended healthcare Background . The influence of an opinion leader intervention on adherence to Unstable Angina ( UA ) guidelines compared with a traditional quality improvement model was investigated . Research Design . A group-r and omized controlled trial with 2210 patients from 21 hospitals was design ed . There were three intervention arms : ( 1 ) no intervention ( NI ) ; ( 2 ) a traditional Health Care Quality Improvement Program ( HCQIP ) ; and ( 3 ) a physician opinion leader in addition to the HCQIP model ( OL ) . Quality indicators included : electrocardiogram within 20 minutes , antiplatelet therapy within 24 hours and at discharge , and heparin and & bgr;-blockers during hospitalization . Hospitals could determine the specific indicators they wished to target . Potential cases of UA were identified from Medicare cl aims data . UA confirmation was determined by a clinical algorithm based on data abstract ed from medical records . Data analyses included both hospital level analysis ( analysis of variance ) and patient level analysis ( generalized linear models ) . Results . The only statistically significant postintervention difference in percentage compliant was greater improvement for the OL group in the use of antiplatelet therapy at 24 hours in both hospital level ( P = 0.01 ) and patient level analyses ( P < 0.05 ) compared with the HCQIP and NI groups . When analyses were confined to hospitals that targeted specific indicators , compared with the HCQIP hospitals , the OL hospitals showed significantly greater change in percentage compliant postintervention in both antiplatelet therapy during the first 24 hours ( 20.2 % vs. −3.9 % , P = 0.02 ) and heparin ( 31.0 % vs.9.1 % , P = 0.05 ) . Conclusions . The influence of physician opinion leaders was unequivocally positive for only one of five quality indicators . To maximize adherence to best practice s through physician opinion leaders , more research on how these physicians influence health care delivery in their organizations will be required BACKGROUND Very little effort has been directed to enable GPs to better informed decisions about PSA screening among their male patients . OBJECTIVES To evaluate an innovative programme design ed to enhance GPs ' capacity to promote informed decision making by male patients about PSA screening . METHODS The study design was a cluster r and omised controlled trial set in New South Wales , Australia 's most populous state . 277 GPs were recruited through a major pathology laboratory . The interventions were three telephone-administered ' peer coaching ' sessions integrated with educational re sources for GPs and patients and the main outcome measures were : GP knowledge ; perceptions of patient involvement in informed decision making ; GPs ' own decisional conflict ; and perceptions of medicolegal risk . RESULTS Compared with GPs allocated to the control group , GPs allocated to our intervention gained significantly greater knowledge about PSA screening and related information [ Mean 6.1 out of 7 ; 95 % confidence interval ( CI ) = 5.9 - 6.3 versus 4.8 ; 95 % CI = 4.6 - 5.0 ; P < 0.001 ] . They were less likely to agree that patients should remain passive when making decisions about PSA screening [ Odds ratio ( OR ) = 0.11 ; 95 % CI = 0.04 - 0.31 ; P < 0.001 ] . They perceived less medicolegal risk when not acceding to an ' uninformed ' patient request for a PSA test ( OR = 0.31 ; 95 % CI 0.19 - 0.51 ) . They also demonstrated lower levels of personal decisional conflict about the PSA screening ( Mean 25.4 ; 95 % CI 24.5 - 26.3 versus 27.8 ; 95 % CI 26.6 - 29.0 ; P = 0.0002 ) . CONCLUSION A ' peer coaching ' programme , supplemented by education material s , holds promise as a strategy to equip GPs to facilitate informed decision making amongst their patients Studies at area hospitals revealed many gaps between research evidence and intrapartum nursing practice s. A r and omized controlled trial involving 20 hospitals was used to evaluate the effectiveness of a marketing strategy to promote research -based nursing care . It was hypothesized that the strategy would result in lower rates of epidural analgesia , through increasing the amount of support nurses provided to their patients . Other outcomes included rates of narcotic analgesia , episiotomy , and operative delivery . The marketing strategy was unsuccessful in improving intrapartum nursing care . Much more research is needed about the factors that facilitate improvements in nursing practice Background . As familial cancer genetic services moves into community practice increased numbers of trained health professionals are needed to counsel individuals seeking cancer risk information . Nurses have been targeted to provide cancer risk assessment and counseling . To help prepare nurses for this role , a 5-day training in familial cancer risk assessment and counseling followed by a long-distance mentorship to support continued skill development in the work environment was conducted by Fox Chase Cancer Center , Philadelphia , PA . Methods . Four cohorts ( N = 41 ) have completed the training and were r and omized to either an immediate or delayed mentorship . A formative evaluation assessed the nurse ’s ability to consult with other genetic health professionals and build self-efficacy in counseling skills via responses to question naire . A post-mentorship interview evaluated the usefulness , timing and length of the mentorship . Results . For both groups , there was a statistically significant improvement in self-efficacy for all skills from baseline to 6 months and an increased number of nurses consulting with genetic health professionals . All the nurses reported the value of the mentorship and those with less cancer risk counseling experience prior to the training needed support and re sources for further skill and program development . Lessons learned from this formative evaluation are provided Pain in children is infrequently assessed and managed by nurses . One-on-one coaching based on audit with feedback and the use of opinion leaders have been effective in changing professional health care practice s. Coaching by an opinion leader for changing pediatric nurses ' pain practice s was tested in a clustered r and omized trial in six Canadian pediatric hospitals . The rate of pain assessment s , nurses ' knowledge , and nonpharmacological interventions increased in the coaching group . However , there were significant site differences that could not be attributed to the coaching but to factors inherent in the sites . The context in which interventions are implemented will influence the effectiveness of individualized interventions A r and omized controlled trial with 76 physicians in 16 community hospitals evaluated audit and feedback and local opinion leader education as methods of encouraging compliance with a guideline for the management of women with a previous cesarean section . The guideline recommended clinical actions to increase trial of labor and vaginal birth rates . Charts for all 3552 cases in the study groups were audited . After 24 months the trial of labor and vaginal birth rates in the audit and feedback group were no different from those in the control group , but rates were 46 % and 85 % higher , respectively , among physicians educated by an opinion leader . Duration of hospital stay was lower in the opinion leader education group than in the other two groups . The overall cesarean section rate was reduced only in the opinion leader education group . There were no adverse clinical outcomes attributable to the interventions . The use of opinion leaders improved the quality of care BACKGROUND The paradigm shift to evidence -based nursing practice in the United States has been slow . Although multiple barriers to evidence -based practice ( EBP ) have been identified through prior studies , there is a gap in the literature specifically identifying key variables ( e.g. , belief that EBP produces quality outcomes ) that are correlated with the extent to which nurses engage in EBP . AIM The primary aims of this study were to ( 1 ) describe nurses ' knowledge , beliefs , skills , and needs regarding EBP ; ( 2 ) determine whether relationships exist among these variables ; and ( 3 ) describe major barriers and facilitators to EBP . METHODS A descriptive survey was conducted with a convenience sample of 160 nurses who were attending EBP conferences or workshops in four states located within the Eastern Region of the United States . RESULTS Although participant beliefs about the benefit of EBP were high , knowledge of EBP was relatively low . Significant relationships were found between the extent to which the nurses ' practice is evidence -based and ( 1 ) nurses ' knowledge of EBP , ( 2 ) nurses ' beliefs about the benefits of EBP , ( 3 ) having an EBP mentor , and ( 4 ) using the Cochrane Data base of Systematic Review s and the National Guideline Clearinghouse . CONCLUSION AND IMPLICATION S Health care systems need to implement interventions that not only increase nurses ' EBP knowledge and skills , but also strengthen their beliefs about the benefit of evidence -based care . EBP mentors may be key in accelerating a more rapid shift toward evidence -based nursing practice . Theoretically driven r and omized controlled trials are urgently needed to test the effectiveness of interventions on advancing evidence -based care CONTEXT The effectiveness of recruiting local medical opinion leaders to improve quality of care is poorly understood . OBJECTIVE To evaluate a guideline -implementation intervention of clinician education by local opinion leaders and performance feedback to ( 1 ) increase use of lifesaving drugs ( aspirin and thrombolytics in eligible elderly patients , beta-blockers in all eligible patients ) for acute myocardial infa rct ion ( AMI ) , and ( 2 ) decrease use of a potentially harmful therapy ( prophylactic lidocaine ) . DESIGN R and omized controlled trial with hospital as the unit of r and omization , intervention , and analysis . SETTING Thirty-seven community hospitals in Minnesota . PATIENTS All patients with AMI admitted to study hospitals over 10 months before ( 1992 - 1993 , N=2409 ) or after ( 1995 - 1996 , N=2938 ) the intervention . INTERVENTION Using a vali date d survey , we identified opinion leaders at 20 experimental hospitals who influenced peers through small and large group discussion s , informal consultations , and revisions of protocol s and clinical pathways . They focused on ( 1 ) evidence ( drug efficacy ) , ( 2 ) comparative performance , and ( 3 ) barriers to change . Control hospitals received mailed performance feedback . MAIN OUTCOME MEASURES Hospital-specific changes before and after the intervention in the proportion of eligible patients receiving each study drug . RESULTS Among experimental hospitals , the median change in the proportion of eligible elderly patients receiving aspirin was + 0.13 ( 17 % increase from 0.77 at baseline ) ,
Output:
| There were mixed findings for changes in professionals ' behaviors and impact on practitioners ' and patients ' outcomes : some outcomes improved , while others showed no difference . |
MS211985 | ***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 impact of improved water , sanitation , and hygiene ( WASH ) access on mitigating illness is well documented , although impact of school-based WASH on school-aged children has not been rigorously explored . We conducted a cluster-r and omized trial in Nyanza Province , Kenya to assess the impact of a school-based WASH intervention on diarrhoeal disease in primary -school pupils . Two study population s were used : schools with a nearby dry season water source and those without . Pupils attending ' water-available ' schools that received hygiene promotion and water treatment ( HP&WT ) and sanitation improvements showed no difference in period prevalence or duration of illness compared to pupils attending control schools . Those pupils in schools that received only the HP&WT showed similar results . Pupils in ' water-scarce ' schools that received a water-supply improvement , HP&WT and sanitation showed a reduction in diarrhoea incidence and days of illness . Our study revealed mixed results on the impact of improvements to school WASH improvements on pupil diarrhoea BACKGROUND The promotion of household water treatment and h and washing with soap has led to large reductions in child diarrhoea in r and omized efficacy trials . Currently , we know little about the health effectiveness of behaviour-based water and hygiene interventions after the conclusion of intervention activities . METHODS We present an extension of previously published design ( propensity score matching ) and analysis ( targeted maximum likelihood estimation ) methods to evaluate the behavioural and health impacts of a pre-existing but non-r and omized intervention ( a 3-year , combined household water treatment and h and washing campaign in rural Guatemala ) . Six months after the intervention , we conducted a cross-sectional cohort study in 30 villages ( 15 intervention and 15 control ) that included 600 households , and 929 children < 5 years of age . RESULTS The study design created a sample of intervention and control villages that were comparable across more than 30 potentially confounding characteristics . The intervention led to modest gains in confirmed water treatment behaviour [ risk difference = 0.05 , 95 % confidence interval ( CI ) 0.02 - 0.09 ] . We found , however , no difference between the intervention and control villages in self-reported h and washing behaviour , spot-check hygiene conditions , or the prevalence of child diarrhoea , clinical acute lower respiratory infections or child growth . CONCLUSIONS To our knowledge this is the first post-intervention follow-up study of a combined household water treatment and h and washing behaviour change intervention , and the first post-intervention follow-up of either intervention type to include child health measurement . The lack of child health impacts is consistent with unsustained behaviour adoption . Our findings highlight the difficulty of implementing behaviour-based household water treatment and h and washing outside of intensive efficacy trials Background H and hygiene is considered as an important means of infection control . We explored whether guided h and hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-r and omized 3-arm intervention trial . Methods A total of 21 clusters ( 683 persons ) were r and omized to implement h and hygiene with soap and water ( 257 persons ) , with alcohol-based h and rub ( 202 persons ) , or to serve as a control ( 224 persons ) . Participants in both intervention arms also received st and ardized instructions on how to limit the transmission of infections . The intervention period ( 16 months ) included the emergence of the 2009 influenza p and emic and the subsequent national h and hygiene campaign influencing also the control arm . Results In the total follow-up period there was a 6.7 % reduction of infection episodes in the soap- and water arm ( p = 0.04 ) . Before the onset of the anti-p and emic campaign , a statistically significant ( p = 0.002 ) difference in the mean occurrence of infection episodes was observed between the control ( 6.0 per year ) and the soap- and -water arm ( 5.0 per year ) but not between the control and the alcohol-rub arm ( 5.6 per year ) . Neither intervention had a decreasing effect on absence from work . Conclusions We conclude that intensified h and hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment . Surprisingly , the occurrence of reported sick leaves also increased in the soap- and water-arm . Trial Registration Clinical Trials.gov : NCT00981877 Source of funding The Finnish Work Environment Fund and the National Institute for Health and Welfare Elementary school-age children are particularly vulnerable to infections . While h and washing is the best method of preventing infections , many elementary schools are housed in buildings that have barriers to effective h and hygiene . The purpose of this study was to determine the effectiveness of an alcohol gel as an adjunct to h and washing in reducing absenteeism secondary to infectious illness . Two-hundred and fifty-three elementary school children were r and omized by classroom into an experimental or control group . With a crossover design , all children participated in both groups , with a one-week washout period between phases . A 45-minute “ Germ Unit ” was taught to all children as they started the experimental phase and a st and ard unit on h and hygiene was taught as they started the control phase . Sixty-nine children were absent due to illness while in the control group . Thirty-nine children became ill while in the experimental group . Alcohol gel as an adjunct to h and washing was shown to be effective in reducing absenteeism due to infectious illness by 43 % H and washing is thought to be effective for the prevention of transmission of diarrhoea pathogens . However it is not conclusive that h and washing with soap is more effective at reducing contamination with bacteria associated with diarrhoea than using water only . In this study 20 volunteers contaminated their h and s deliberately by touching door h and les and railings in public spaces . They were then allocated at r and om to ( 1 ) h and washing with water , ( 2 ) h and washing with non-antibacterial soap and ( 3 ) no h and washing . Each volunteer underwent this procedure 24 times , yielding 480 sample s overall . Bacteria of potential faecal origin ( mostly Enterococcus and Enterobacter spp . ) were found after no h and washing in 44 % of sample s. H and washing with water alone reduced the presence of bacteria to 23 % ( p < 0.001 ) . H and washing with plain soap and water reduced the presence of bacteria to 8 % ( comparison of both h and washing arms : p < 0.001 ) . The effect did not appear to depend on the bacteria species . H and washing with non-antibacterial soap and water is more effective for the removal of bacteria of potential faecal origin from h and s than h and washing with water alone and should therefore be more useful for the prevention of transmission of diarrhoeal diseases Background Day care center attendance has been recognized as a risk factor for acquiring gastrointestinal and respiratory infections , which can be prevented with adequate h and hygiene ( HH ) . Based on previous studies on environmental and sociocognitive determinants of caregivers ’ compliance with HH guidelines in day care centers ( DCCs ) , an intervention has been developed aim ing to improve caregivers ’ and children ’s HH compliance and decrease infections among children attending DCCs . The aim of this paper is to describe the design of a cluster r and omized controlled trial to evaluate the effectiveness of this intervention . Methods / design The intervention will be evaluated in a two-arm cluster r and omized controlled trial among 71 DCCs in the Netherl and s. In total , 36 DCCs will receive the intervention consisting of four components : 1 ) HH products ( dispensers and refills for paper towels , soap , alcohol-based h and sanitizer , and h and cream ) ; 2 ) training to educate about the Dutch national HH guidelines ; 3 ) two team training sessions aim ed at goal setting and formulating specific HH improvement activities ; and 4 ) reminders and cues to action ( posters/stickers ) . Intervention DCCs will be compared to 35 control DCCs continuing usual practice . The primary outcome measure will be observed HH compliance of caregivers and children , measured at baseline and one , three , and six months after start of the intervention . The secondary outcome measure will be the incidence of gastrointestinal and respiratory infections in 600 children attending DCCs , monitored over six months by parents using a calendar to mark the days their child has diarrhea and /or a cold . Multilevel logistic regression will be performed to assess the effect of the intervention on HH compliance . Multilevel poisson regression will be performed to assess the incidence of gastrointestinal and respiratory infections in children attending DCCs . Discussion This is one of the first DCC intervention studies to assess HH compliance of both caregivers and children , as well as the incidence of gastrointestinal and respiratory infections in children , as outcome measures . When an effect of the intervention on improving HH compliance and /or reducing incidence of infections is shown , (inter)national dissemination of the intervention in other DCCs may be considered . Trial registration Netherl and s trial registry : OBJECTIVES Improving school water , sanitation and hygiene ( WASH ) conditions reduces pupil absence and illness . However , these benefits may depend on the conditions of the latrines and availability of consumables . We sought to determine whether a low-cost , policy-relevant , environmental-level latrine cleaning intervention could improve latrine cleanliness , increase its use and reduce absenteeism . METHODS In a three-arm , cluster-r and omized trial we assessed absence via periodical roll-call among 17 564 pupils in 60 schools that had previously received WASH improvements as part of the SWASH+ project . Latrine conditions and use were also assessed using structured observation . Latrine cleanliness increased significantly during the post-intervention period among schools receiving the latrine cleaning package compared to controls , as did h and washing with soap . We found no difference in latrine use and absence across arms . CONCLUSIONS The additive impact of cleaning may not have been strong enough to impact absence above and beyond reductions attributable to the original WASH infrastructure improvements and basic hygiene education the schools previously received . Improving latrine conditions is important for the dignity and well-being of pupils , and investments and strategies are necessary to ensure that school toilets are clean and pupil-friendly Introduction Enteric infections are common during the first years of life in low-income countries and contribute to growth faltering with long-term impairment of health and development . Water quality , sanitation , h and washing and nutritional interventions can independently reduce enteric infections and growth faltering . There is little evidence that directly compares the effects of these individual and combined interventions on diarrhoea and growth when delivered to infants and young children . The objective of the WASH Benefits study is to help fill this knowledge gap . Methods and analysis WASH Benefits includes two cluster-r and omised trials to assess improvements in water quality , sanitation , h and washing and child nutrition — alone and in combination — to rural households with pregnant women in Kenya and Bangladesh . Geographically matched clusters ( groups of household compounds in Bangladesh and villages in Kenya ) will be r and omised to one of six intervention arms or control . Intervention arms include water quality , sanitation , h and washing , nutrition , combined water+sanitation+h and washing ( WSH ) and WSH+nutrition . The studies will enrol newborn children ( N=5760 in Bangladesh and N=8000 in Kenya ) and measure outcomes at 12 and 24 months after intervention delivery . Primary outcomes include child length-for-age Z-scores and caregiver-reported diarrhoea . Secondary outcomes include stunting prevalence , markers of environmental enteropathy and child development scores ( verbal , motor and personal/social ) . We will estimate unadjusted and adjusted intention-to-treat effects using semiparametric estimators and permutation tests . Ethics and dissemination Study protocol s have been review ed and approved by human subjects review boards at the University of California , Berkeley , Stanford University , the International Centre for Diarrheal Disease Research , Bangladesh , the Kenya Medical Research Institute , and Innovations for Poverty Action . Independent data safety monitoring boards in each country oversee the trials . This study is funded by a grant from the Bill & Melinda Gates Foundation to the University of California , Berkeley . Registration Trial registration identifiers ( http://www . clinical trials.gov ) : NCT01590095 ( Bangladesh ) , NCT01704105 ( Kenya ) OBJECTIVE To evaluate a simple low cost method for measuring h and contamination as an objective assessment of h and washing practice s. METHOD As part of a larger r and omized controlled trial of h and washing promotion with soap conducted in squatter settlements of Karachi , Pakistan , a r and omly selected subset of 52 mothers in households receiving soap and h and washing promotion and 28 mothers in control households directly pressed three fingers of their right h and onto MacConkey agar plates on weekly unannounced visits from April to September 2002 , and monthly from October 2002 to March 2003 . The MacConkey plates were incubated at 44 degrees C for 24 h , and evaluated for growth of thermotolerant coliform bacteria . RESULTS The proportion of sample s that had detectable thermotolerant coliforms ( 50 % ) was similar in households that received soap and control households ( 52 % , P = 0.40 ) . In the week after evaluation of the mothers ' h and s , the proportion of households that reported diarrhoea was similar regardless of whether or not the mother had thermotolerant coliforms detected by direct finger imprint ( 18
Output:
| Authors ' conclusions H and washing promotion probably reduces diarrhoea episodes in both child day‐care centres in high‐income countries and among communities living in LMICs by about 30 % .
However , less is known about how to help people maintain h and washing habits in the longer term . |
MS211986 | ***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: In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Background Few reports described outcomes of complete compared with infa rct -related artery (IRA)-only revascularisation in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multivessel coronary artery disease ( CAD ) . Moreover , no studies have compared the simultaneous treatment of non-IRA with the IRA treatment followed by an elective procedure for the other lesions ( staged revascularisation ) . Methods The outcomes of 214 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty were studied . Before the first angioplasty patients were r and omly assigned to three different strategies : culprit vessel angioplasty-only ( COR group ) ; staged revascularisation ( SR group ) and simultaneous treatment of non-IRA ( CR group ) . Results During a mean follow-up of 2.5 years , 42 ( 50.0 % ) patients in the COR group experienced at least one major adverse cardiac event ( MACE ) , 13 ( 20.0 % ) in the SR group and 15 ( 23.1 % ) in the CR group , p<0.001 . Inhospital death , repeat revascularisation and re-hospitalisation occurred more frequently in the COR group ( all p<0.05 ) , whereas there was no significant difference in re-infa rct ion among the three groups . Survival free of MACE was significantly reduced in the COR group but was similar in the CR and SR groups . Conclusions Culprit vessel-only angioplasty was associated with the highest rate of long-term MACE compared with multivessel treatment . Patients scheduled for staged revascularisation experienced a similar rate of MACE to patients undergoing complete simultaneous treatment of non-IRA BACKGROUND As compared with thrombolytic therapy , primary coronary angioplasty results in a higher rate of patency of the infa rct -related coronary artery , lower rates of stroke and reinfa rct ion , and higher in-hospital or 30-day survival rates . However , the comparative long-term efficacy of these two approaches has not been carefully studied . METHODS We r and omly assigned a total of 395 patients with acute myocardial infa rct ion to treatment with angioplasty or intravenous streptokinase . Clinical information was collected for a mean ( + /-SD ) of 5+/-2 years , and medical charges associated with the two treatments were compared . RESULTS A total of 194 patients were assigned to undergo primary angioplasty , and 201 to receive streptokinase . Mortality was 13 percent in the angioplasty group , as compared with 24 percent in the streptokinase group ( relative risk , 0.54 ; 95 percent confidence interval , 0.36 to 0.87 ) . Nonfatal reinfa rct ion occurred in 6 percent and 22 percent of the two groups , respectively ( relative risk , 0.27 ; 95 percent confidence interval , 0.15 to 0.52 ) . The combined incidence of death and nonfatal reinfa rct ion was also lower among patients assigned to angioplasty than among those assigned to streptokinase , with a relative risk of 0.13 ( 95 percent confidence interval , 0.05 to 0.37 ) for early events ( within the first 30 days ) and a relative risk of 0.62 ( 95 percent confidence interval , 0.43 to 0.91 ) for late events ( after 30 days ) . The rates of readmission for heart failure and ischemia were also lower among patients in the angioplasty group than among patients in the streptokinase group . Total medical charges per patient were lower in the angioplasty group ( 16,090 dollars ) than in the streptokinase group ( 16,813 dollars , P=0.05 ) . CONCLUSIONS During five years of follow-up , primary coronary angioplasty for acute myocardial infa rct ion was associated with lower rates of early and late death and nonfatal reinfa rct ion , fewer hospital readmissions for ischemia or heart failure , and lower total medical charges than treatment with intravenous streptokinase BACKGROUND Patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) and multivessel coronary disease have a worse prognosis compared with individuals with single-vessel disease . We aim ed to study the clinical outcome of patients with STEMI treated with fractional flow reserve (FFR)-guided complete revascularisation versus treatment of the infa rct -related artery only . METHODS We undertook an open-label , r and omised controlled trial at two university hospitals in Denmark . Patients presenting with STEMI who had one or more clinical ly significant coronary stenosis in addition to the lesion in the infa rct -related artery were included . After successful percutaneous coronary intervention ( PCI ) of the infa rct -related artery , patients were r and omly allocated ( in a 1:1 ratio ) either no further invasive treatment or complete FFR-guided revascularisation before discharge . R and omisation was done electronically via a web-based system in permuted blocks of varying size by the clinician who did the primary PCI . All patients received best medical treatment . The primary endpoint was a composite of all-cause mortality , non-fatal reinfa rct ion , and ischaemia-driven revascularization of lesions in non-infa rct -related arteries and was assessed when the last enrolled patient had been followed up for 1 year . Analysis was on an intention-to-treat basis . This trial is registered with Clinical Trials.gov , number NCT01960933 . FINDINGS From March , 2011 , to February , 2014 , we enrolled 627 patients to the trial ; 313 were allocated no further invasive treatment after primary PCI of the infa rct -related artery only and 314 were assigned complete revascularization guided by FFR values . Median follow-up was 27 months ( range 12–44 months ) . Events comprising the primary endpoint were recorded in 68 ( 22 % ) patients who had PCI of the infa rct -related artery only and in 40 ( 13 % ) patients who had complete revascularisation ( hazard ratio 0∙56 , 95 % CI 0∙38–0∙83 ; p=0∙004 ) . INTERPRETATION In patients with STEMI and multivessel disease , complete revascularisation guided by FFR measurements significantly reduces the risk of future events compared with no further invasive intervention after primary PCI . This effect is driven by significantly fewer repeat revascularisations , because all-cause mortality and non-fatal reinfa rct ion did not differ between groups . Thus , to avoid repeat revascularisation , patients can safely have all their lesions treated during the index admission . Future studies should clarify whether complete revascularization should be done acutely during the index procedure or at later time and whether it has an effect on hard endpoints . FUNDING Danish Agency for Science , Technology and Innovation and Danish Council for Strategic Research In the GRADE approach , r and omized trials are classified as high quality evidence and observational studies as low quality evidence but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted BACKGROUND In acute ST-segment elevation myocardial infa rct ion ( STEMI ) , the use of percutaneous coronary intervention ( PCI ) to treat the artery responsible for the infa rct ( infa rct , or culprit , artery ) improves prognosis . The value of PCI in noninfa rct coronary arteries with major stenoses ( preventive PCI ) is unknown . METHODS From 2008 through 2013 , at five centers in the United Kingdom , we enrolled 465 patients with acute STEMI ( including 3 patients with left bundle-branch block ) who were undergoing infa rct -artery PCI and r and omly assigned them to either preventive PCI ( 234 patients ) or no preventive PCI ( 231 patients ) . Subsequent PCI for angina was recommended only for refractory angina with objective evidence of ischemia . The primary outcome was a composite of death from cardiac causes , nonfatal myocardial infa rct ion , or refractory angina . An intention-to-treat analysis was used . RESULTS By January 2013 , the results were considered conclusive by the data and safety monitoring committee , which recommended that the trial be stopped early . During a mean follow-up of 23 months , the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI ( infa rct -artery-only PCI ) , which translated into rates of 9 events per 100 patients and 23 per 100 , respectively ( hazard ratio in the preventive-PCI group , 0.35 ; 95 % confidence interval [ CI ] , 0.21 to 0.58 ; P<0.001 ) . Hazard ratios for the three components of the primary outcome were 0.34 ( 95 % CI , 0.11 to 1.08 ) for death from cardiac causes , 0.32 ( 95 % CI , 0.13 to 0.75 ) for nonfatal myocardial infa rct ion , and 0.35 ( 95 % CI , 0.18 to 0.69 ) for refractory angina . CONCLUSIONS In patients with STEMI and multivessel coronary artery disease undergoing infa rct -artery PCI , preventive PCI in noninfa rct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events , as compared with PCI limited to the infa rct artery . ( Funded by Barts and the London Charity ; PRAMI Current Controlled Trials number , IS RCT N73028481 . ) DESIGN : Prospect i ve r and omized , multicentre study . RATIONALE : Recanalisation of the culprit lesion is the main goal of primary angioplasty for acute myocardial infa rct ion . With the exception of cardiogenic shock , staged procedures are performed in the presence of multivessel disease . The study hypothesis is that with modern non-thrombogenic stents ( heparin coated ) complete revascularization with multivessel treatment can be safely achieved during the primary angioplasty procedure with a lower need of subsequent revascularization procedures and at a lower cost . ENDPOINTS : PRIMARY : 12-month incidence of repeat revascularization ( any revascularization , infa rct related artery as well as non-infa rct -related artery ) . SECONDARY : ( 1 ) in hospital repeat revascularization , reinfa rct ion and death ; ( 2 ) total hospital cost ( including a 12 months follow-up period ) . METHODS : 69 patients with ST elevation Acute Myocardial Infa rct ion ( AMI ) , < 12 hours after symptoms onset , undergoing primary angioplasty , with documented multivessel disease and both culprit lesion and 1 to 3 other lesions suitable for stent implantation . Unbalanced r and omization between culprit lesion treatment only ( n = 17 ) and complete multivessel treatment ( n = 52 , with 71 additional lesions treated ) . RESULTS : The two groups were well balanced in terms of clinical characteristics , number of diseased vessels and angiographic characteristics of the culprit lesion . In the complete multivessel treatment group 2.36 ± 0.64 lesions per patient were treated using 2.73 ± 0.78 heparin coated stents ( 1.00 lesions and 1.29 ± 0.61 stents in the culprit treatment group , bothp < 0.001 ) . The duration of the procedure increased from 53 ± 21 min ( culprit treatment group ) to 69 ± 32 min ( p = 0.032 ) and the amount of contrast used from 242 ± 102 ml ( culprit treatment group ) to 341 ± 163 ml ( multivessel complete treatment),p = 0.025 . A similar low incidence of in-hospital major adverse cardiac events was observed in the 2 groups ( 0 and 3.8 % in culprit and
Output:
| CONCLUSIONS Pooled data provide moderate-certainty evidence that performance of multivessel PCI will provide an appreciable reduction in nonfatal MI and high-certainty evidence that it will reduce need for repeat revascularization .
Patients are likely to place a high value on these benefits |
MS211987 | ***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 population -based study , disease progression and survival were evaluated in untreated patients with newly diagnosed cancer of the prostate without distant metastases . Complete follow-up was achieved in 223 of 227 ( 98 % ) consecutively diagnosed , eligible patients of all ages . After 5 years , the cumulative progression-free survival ( with 95 % confidence interval ) was 71.8 (65.5 - 78.1)% and survival corrected for causes of death other than prostatic cancer was 93.8 (88.3 - 97.6)% . Univariate and multivariate analyses showed no association between age at diagnosis and the natural course . Local progression was less common in localised , non-palpable tumours than in larger tumours . The rate of progression was 18.7 ( 6.1 - 57.1 ) times higher and that of disease-specific death 216.0 ( 31.2 - 1496 ) times higher in patients with poorly than in those with highly differentiated tumours . It is concluded that tumour grade at diagnosis is an excellent predictor of local and distant progression . The low death rate , especially in patients with highly and moderately differentiated tumours , means that any local or systemic therapy intended for patients with early prostatic cancer must be evaluated in clinical trials with untreated controls for comparison Active surveillance followed by selective treatment for men who have evidence of disease progression may be an option for select patients with early‐stage prostate cancer . In this article , the authors report their experience in a contemporary cohort of men with prostate cancer who were managed with active surveillance BACKGROUND In 2008 , we reported that radical prostatectomy , as compared with watchful waiting , reduces the rate of death from prostate cancer . After an additional 3 years of follow-up , we now report estimated 15-year results . METHODS From October 1989 through February 1999 , we r and omly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy . Follow-up was complete through December 2009 , with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death . Relative risks , with 95 % confidence intervals , were estimated with the use of a Cox proportional-hazards model . RESULTS During a median of 12.8 years , 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died ( P=0.007 ) . In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting , death was due to prostate cancer . This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6 % and 20.7 % , respectively ( a difference of 6.1 percentage points ; 95 % confidence interval [ CI ] , 0.2 to 12.0 ) , and a relative risk with surgery of 0.62 ( 95 % CI , 0.44 to 0.87 ; P=0.01 ) . The survival benefit was similar before and after 9 years of follow-up , was observed also among men with low-risk prostate cancer , and was confined to men younger than 65 years of age . The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age . Among men who underwent radical prostatectomy , those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth ( relative risk , 6.9 ; 95 % CI , 2.6 to 18.4 ) . CONCLUSIONS Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer . Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment . ( Funded by the Swedish Cancer Society and the National Institutes of Health . ) OBJECTIVES Outcome data from a prospect i ve study of active surveillance of localised prostate cancer were analysed to identify factors , present at the time of diagnosis , that predict subsequent radical treatment . METHODS Eligible patients had clinical stage T1-T2a , N0-Nx , M0-Mx adenocarcinoma of the prostate with serum PSA<15 ng/ml , Gleason score < or= 7 , primary Gleason grade < or= 3 , and % positive biopsy cores ( pbc ) < or= 50 % . Monitoring included serial PSA measurement and repeat prostate biopsies . Radical treatment was initiated in the event of biochemical progression ( PSA velocity > 1 ng/ml/yr ) or histological progression ( primary Gleason grade > or= 4 , or % pbc > 50 % ) . Multivariate Cox regression analysis of baseline variables was performed with respect to time to radical treatment . RESULTS The 326 men recruited from 2002 to 2006 have been followed for a median of 22 mo . Median age was 67 yr , and median initial PSA ( iPSA ) 6.4 ng/ml . Sixty-five patients ( 20 % ) had deferred radical treatment , 16 ( 5 % ) changed to watchful waiting because of increasing comorbidity , 7 ( 2 % ) died of other causes , and 238 ( 73 % ) remain on surveillance . On multivariate Cox regression analysis , the free/total PSA ratio ( p<0.001 ) and clinical T stage ( p=0.006 ) were independent determinants of time to radical treatment . CONCLUSIONS In addition to established prognostic factors , the free/total PSA ratio may predict time to radical treatment in patients with untreated , localised prostate cancer managed by active surveillance . This possibility warrants further study
Output:
| Interestingly , only limited numbers of patients under active surveillance require additional treatment .
Recent data suggest that delayed treatment does not appear to alter the clinical outcome among those highly selected patients . |
MS211988 | ***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 Tests to determine serum antibody levels-the 2-tier sonicate immunoglobulin M ( IgM ) and immunoglobulin G ( IgG ) enzyme-linked immunosorbent assay ( ELISA ) and Western blot method or the IgG of the variable major protein-like sequence-expressed ( VlsE ) sixth invariant region ( C6 ) peptide ELISA method -are the major tests available for support of the diagnosis of Lyme disease . However , these tests have not been assessed prospect ively . METHODS We used these tests prospect ively to determine serologic responses in 134 patients with various manifestations of Lyme disease , 89 patients with other illnesses ( with or without a history of Lyme disease ) , and 136 healthy subjects from areas of endemicity and areas in which the infection was not endemic . RESULTS With 2-tier tests and the C6 peptide ELISA , only approximately one-third of 76 patients with erythema migrans had results that were positive for IgM or IgG seroreactivity with Borrelia burgdorferi in acute-phase sample s. During convalescence , 3 - 4 weeks later , almost two-thirds of patients had seroreactivity with the spirochete B. burgdorferi . The frequencies of seroreactivity were significantly greater among patients with spirochetal dissemination than they were among those who lacked evidence of disseminated disease . Of the 44 patients with Lyme disease who had neurologic , heart , or joint involvement , all had positive C6 peptide ELISA results , 42 had IgG responses with 2-tier tests , and 2 patients with facial palsy had only IgM responses . However , among the control groups , the IgG Western blot was slightly more specific than the C6 peptide ELISA . The differences between the 2 test systems ( 2-tier testing and C6 peptide ELISA ) with respect to sensitivity and specificity were not statistically significant . CONCLUSIONS Except in patients with erythema migrans , both test systems were sensitive for support of the diagnosis of Lyme disease . However , with current methods , 2-tier testing was associated with slightly better specificity BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences OBJECTIVE To determine if the early antibiotic treatment of deer tick bites prevented Lyme disease . DESIGN Prospect i ve , double-blind , placebo-controlled , antibiotic treatment . SETTING Private practice in an area endemic for Lyme disease . STUDY PARTICIPANTS Patients between 3 and 19 years of age who received antibiotic treatment within 3 days following a deer tick bite . INTERVENTIONS Patients received an antibiotic or placebo and were followed up for stage I and II disease . All patients had blood drawn at the time of presentation and 6 weeks later for immunofluorescent antibodies ( IFA ) . MEASUREMENTS /MAIN RESULTS One patient in the placebo group developed clinical Lyme disease associated with an IFA titer of 1:32 , considered weakly positive . Three other patients in the placebo group developed an IFA titer of 1:32 ; one had an influenzalike illness and two had no symptoms . None of the study patients developed any neurologic , cardiac , or arthritic symptoms in the 1- to 3-year follow-up . CONCLUSION Based on the low frequency of illness , the absence of stage II disease , and the inability to establish the efficacy of early antibiotic treatment , we suggest that physicians not routinely use prophylactic antibiotics for deer tick bites Animal studies have shown an exponential increase in the risk of Borrelia burgdorferi infection after 48 - 72 h of deer tick attachment . Persons with tick bites were prospect ively studied to determine if those with prolonged tick attachment constitute a high-risk group for infection . Ticks were identified , measured for engorgement , and assayed by polymerase chain reaction ( PCR ) for B. burgdorferi DNA . Duration of attachment was determined from the scutal index of engorgement . Of 316 su bmi ssions , 229 were deer ticks ; 14 % were positive by PCR . Paired sera and an intact tick for determination of duration of attachment were available for 105 subjects ( 109 bites ) . There were 4 human cases ( 3.7 % of bites ) of B. burgdorferi infection . The incidence was significantly higher for duration of attachment > or = 72 h than for < 72 h : 3 ( 20 % ) of 15 vs. 1 ( 1.1 % ) of 94 ( P = .008 ; odds ratio , 23.3 ; 95 % confidence interval , 2.2 - 242 ) . PCR was an unreliable predictor of infection . Tick identification and measurement of engorgement can be used to identify a small , high-risk subset of persons who may benefit from antibiotic prophylaxis BACKGROUND Tick-borne relapsing fever ( TBRF ) is an acute febrile illness . In Israel , TBRF is caused by Borrelia persica and is transmitted by Ornithodoros tholozani ticks . We examined the safety and efficacy of postexposure treatment to prevent TBRF . METHODS In a double-blind , placebo-controlled trial , 93 healthy subjects with suspected tick exposure ( 52 with signs of tick bites and 41 close contacts -- those without signs but with a similar risk of contact with ticks ) were r and omly assigned to receive either doxycycline ( Dexxon , in a dose of 200 mg the first day and then 100 mg per day for four days ) or placebo after presumed exposure to TBRF . Cases of TBRF were defined by fever and a positive blood smear . Serologic analysis for cross-reactivity to Borrelia burgdorferi and polymerase chain reaction ( PCR ) for the borrelia glpQ gene were also performed . RESULTS After r and omization , 47 subjects ( 26 with signs of tick bites and 21 close contacts ) received doxycycline . Forty-six other subjects ( 26 with signs of tick bites and 20 close contacts ) received placebo . All 10 cases of TBRF identified by a positive blood smear were in the placebo group of subjects with signs of a tick bite ( P<0.001 ) . These findings suggested a 100 percent efficacy of preemptive treatment ( 95 percent confidence interval , 46 to 100 percent ) . PCR for the borrelia glpQ gene was negative at baseline for all subjects and subsequently positive in all subjects with fever and a positive blood smear . Seroconversion was detected in eight of nine cases of TBRF . PCR and serum sample s were negative for all of the other subjects tested . No major treatment-associated adverse effects were identified . CONCLUSIONS Treatment with doxycycline is safe and efficacious in preventing TBRF after suspected exposure to ticks in a high-risk environment . ( Clinical Trials.gov number , NCT00237016 [ Clinical Trials.gov ] . ) We compared the efficacy of three antibiotics ( ceftriaxone , erythromycin and clarithromycin ) against Borrelia garinii infection in mice . The nymphal ticks of Ixodes persulcatus infected with the strain JEM6 of Japanese B. garinii were allowed to feed on female C3H mice . The mice were treated with each of the antibiotics for 5 consecutive days 1 , 3 , or 7 weeks after tick detachment . The doses of antibiotics per day were as follows : 5 mg intraperitoneal injection of ceftriaxone , 2 mg intraperitoneal injection of erythromycin and 1 mg peroral administration of clarithromycin . The infection status in treated mice was monitored by culturing their earlobes , hearts and urinary bladders in BSK II medium . Ceftriaxone eliminated borreliae completely ; however , a recurrence of infection was observed in mice treated with erythromycin and clarithromycin During 1980 and 1981 , we compared antibiotic regimens in 108 adult patients with early Lyme disease . Erythema chronicum migrans and its associated symptoms resolved faster in penicillin- or tetracycline-treated patients than in those given erythromycin ( mean duration , 5.4 and 5.7 versus 9.2 days , F = 3.38 , p less than 0.05 ) . None of 39 patients given tetracycline developed major late complications ( meningoencephalitis , myocarditis , or recurrent attacks of arthritis ) compared with 3 of 40 penicillin-treated patients and 4 of 29 given erythromycin ( chi square with 2 degrees of freedom = 5.33 , p = 0.07 ) . In 1982 , all 49 adult patients were given tetracycline ; again , none of them developed major complications . However , with all three antibiotic agents nearly half of the patients had minor late symptoms such as headache , musculoskeletal pain , and lethargy . These complications correlated significantly with the initial severity of illness . For patients with early Lyme disease , tetracycline appears to be the most effective drug , then penicillin , and finally erythromycin Summary A study on prevention of borreliosis in humans bitten by infected ticks was performed in 1992–1994 in the Perm ' region of Russia . AdultIxodes persulcatus ticks were removed from the study subjects , and live preparations made from the material obtained from the gut of each tick were microscopically analyzed ( up to 250 microscopic fields per preparation ) . Persons were divided into experimental and control groups ( 261 and 97 persons , respectively ) . The experimental group received doxycycline ( 100 mg twice daily ) for 3–5 days after the tick bite . In the control ( untreated ) group , 12 persons contracted borreliosis . In the experimental group , the disease was diagnosed in three subjects . Morbidity per 100 patients in the experimental group was 1.1 , i.e. 11 times lower than that in the control group . Identification ofBorrelia in ticks by microscopic analysis , followed by a short-term treatment with antibiotics according to microbiological indications , is an efficient method for preventing persons from contracting borreliosis . ZusammenfassungIn der Perm-Region , Rußl and , wurde von 1992–1994 eine Studie bei Personen , die von borrelieninfizierten Zecken gestochen worden waren , durchgeführt . Erwachsene Zecken der SpeziesIxodes persulcatus wurden abgenommen und nach Sektion auf Anwesenheit von Borrelien i m Darm mikroskopisch untersucht ( bis zu 250 Gesichtsfelder pro Präparat wurden untersucht ) . In der experimentellen Gruppe waren 261 und in der Kontrollgruppe 97 Personen eingeschlossen . Die experimentelle Gruppe erhielt eine Therapie mit 100 mg Doxycyclin zweimal täglich für 3–5 Tage nach dem Zeckenstich . In der unbeh and elten Kontrollgruppe zogen sich 12 Personen eine Borrelieninfektion zu . In der experimentellen Gruppe wurde bei drei Personen eine Borreliose diagnostiziert . Die Morbidität war in der beh and elten Gruppe mit 1,1/100 11 mal geringer als in der Kontrollgruppe . Identifizierung von Borrelien in den Zecken unter dem Mikroskop und kurzzeitige Antibiotikabeh and lung entsprechend dem mikroskopischen Befund erwies sich als effiziente Method e , um nach Zeckenstick eine Borrelia-Infektion zu verhüten Etude des mesures de prevention et du traitement au cours d'une etude faite dans le BACKGROUND Borrelia burgdorferi , which causes Lyme disease , is transmitted by deer ticks ( lxodes dammini ) in the northeastern and midwestern United States . Although deer-tick bites are common in areas in which the disease is endemic , there is uncertainty about how to manage the care of persons who are bitten . METHODS To assess the risk of infection with B. burgdorferi and the efficacy of prophylactic antimicrobial treatment after a deer-tick bite , we conducted a double-blind , placebo-
Output:
| The available evidence to date supports the use of antibiotic prophylaxis for the prevention of Lyme disease in endemic areas following an Ixodes tick bite . |
MS211989 | ***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 Increasing evidence supports the use of magnetic resonance (MR)-targeted prostate biopsy . The optimal method for such biopsy remains undefined , however . OBJECTIVE To prospect ively compare targeted biopsy outcomes between MR imaging (MRI)-ultrasound fusion and visual targeting . DESIGN , SETTING , AND PARTICIPANTS From June 2012 to March 2013 , prospect i ve targeted biopsy was performed in 125 consecutive men with suspicious regions identified on prebiopsy 3-T MRI consisting of T2-weighted , diffusion-weighted , and dynamic-contrast enhanced sequences . INTERVENTION Two MRI-ultrasound fusion targeted cores per target were performed by one operator using the ei-Nav|Artemis system . Targets were then blinded , and a second operator took two visually targeted cores and a 12-core biopsy . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Biopsy information yield was compared between targeting techniques and to 12-core biopsy . Results were analyzed using the McNemar test . Multivariate analysis was performed using binomial logistic regression . RESULTS AND LIMITATIONS Among 172 targets , fusion biopsy detected 55 ( 32.0 % ) cancers and 35 ( 20.3 % ) Gleason sum ≥7 cancers compared with 46 ( 26.7 % ) and 26 ( 15.1 % ) , respectively , using visual targeting ( p=0.1374 , p=0.0523 ) . Fusion biopsy provided informative nonbenign histology in 77 targets compared with 60 by visual ( p=0.0104 ) . Targeted biopsy detected 75.0 % of all clinical ly significant cancers and 86.4 % of Gleason sum ≥7 cancers detected on st and ard biopsy . On multivariate analysis , fusion performed best among smaller targets . The study is limited by lack of comparison with whole-gl and specimens and sample size . Furthermore , cancer detection on visual targeting is likely higher than in community setting s , where experience with this technique may be limited . CONCLUSIONS Fusion biopsy was more often histologically informative than visual targeting but did not increase cancer detection . A trend toward increased detection with fusion biopsy was observed across all study subsets , suggesting a need for a larger study size . Fusion targeting improved accuracy for smaller lesions . Its use may reduce the learning curve necessary for visual targeting and improve community adoption of MR-targeted biopsy PURPOSE We compared the accuracy of visual targeted biopsies vs computerized transrectal ultrasound-magnetic resonance imaging registration using a rigid ( Esaote ® , nondeformable ) or elastic ( Koelis ® , deformable ) approach . MATERIAL S AND METHODS A total of 391 consecutive patients with suspected localized prostate cancer were prospect ively included in analysis . All patients underwent prostate magnetic resonance imaging , followed by 10 to 12-core r and om prostate biopsies . When magnetic resonance imaging detected suspicious findings , targeted biopsy was performed , including visual , rigid system and elastic system targeted biopsies in the first 127 patients , the next 131 and the last 133 , respectively . Cancer detection rates were assessed by conditional logistic regression . Targeted biopsies alone and r and om biopsies were further compared for the amount of tissue sample d and microfocal cancer detection , the latter defined as a single core with 5 mm or less of Gleason 6 cancer . RESULTS Patient characteristics and r and om biopsy detection rates were similar among the groups . Magnetic resonance imaging detected at least 1 suspicious area in 54 ( 42 % ) , 78 ( 59 % ) and 82 patients ( 62 % ) in groups 1 , 2 and 3 , respectively . The cancer detection rates of rigid and elastic system targeted biopsies were significantly higher than the r and om biopsy rate ( p = 0.0065 and 0.0016 , respectively ) . Visual targeted biopsy did not perform better than r and om biopsy ( p = 0.66 ) . Rigid and elastic system targeted biopsies allowed for decreasing the number of cores and the detection of microfocal cancer , while increasing the detection of high grade cancer . CONCLUSIONS When performed with computerized magnetic resonance imaging-transrectal ultrasound image registration , targeted biopsy alone improved cancer detection over r and om biopsies , decreased the detection rate of microfocal cancer and increased the detection rate of cancer with a Gleason score of greater than 6 IMPORTANCE Targeted magnetic resonance (MR)/ultrasound fusion prostate biopsy has been shown to detect prostate cancer . The implication s of targeted biopsy alone vs st and ard extended-sextant biopsy or the 2 modalities combined are not well understood . OBJECTIVE To assess targeted vs st and ard biopsy and the 2 approaches combined for the diagnosis of intermediate- to high-risk prostate cancer . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1003 men undergoing both targeted and st and ard biopsy concurrently from 2007 through 2014 at the National Cancer Institute in the United States . Patients were referred for elevated level of prostate-specific antigen ( PSA ) or abnormal digital rectal examination results , often with prior negative biopsy results . Risk categorization was compared among targeted and st and ard biopsy and , when available , whole-gl and pathology after prostatectomy as the " gold st and ard . " INTERVENTIONS Patients underwent multiparametric prostate magnetic resonance imaging to identify regions of prostate cancer suspicion followed by targeted MR/ultrasound fusion biopsy and concurrent st and ard biopsy . MAIN OUTCOMES AND MEASURES The primary objective was to compare targeted and st and ard biopsy approaches for detection of high-risk prostate cancer ( Gleason score ≥ 4 + 3 ) ; secondary end points focused on detection of low-risk prostate cancer ( Gleason score 3 + 3 or low-volume 3 + 4 ) and the biopsy ability to predict whole-gl and pathology at prostatectomy . RESULTS Targeted MR/ultrasound fusion biopsy diagnosed 461 prostate cancer cases , and st and ard biopsy diagnosed 469 cases . There was exact agreement between targeted and st and ard biopsy in 690 men ( 69 % ) undergoing biopsy . Targeted biopsy diagnosed 30 % more high-risk cancers vs st and ard biopsy ( 173 vs 122 cases , P < .001 ) and 17 % fewer low-risk cancers ( 213 vs 258 cases , P < .001 ) . When st and ard biopsy cores were combined with the targeted approach , an additional 103 cases ( 22 % ) of mostly low-risk prostate cancer were diagnosed ( 83 % low risk , 12 % intermediate risk , and 5 % high risk ) . The predictive ability of targeted biopsy for differentiating low-risk from intermediate- and high-risk disease in 170 men with whole-gl and pathology after prostatectomy was greater than that of st and ard biopsy or the 2 approaches combined ( area under the curve , 0.73 , 0.59 , and 0.67 , respectively ; P < .05 for all comparisons ) . CONCLUSIONS AND RELEVANCE Among men undergoing biopsy for suspected prostate cancer , targeted MR/ultrasound fusion biopsy , compared with st and ard extended-sextant ultrasound-guided biopsy , was associated with increased detection of high-risk prostate cancer and decreased detection of low-risk prostate cancer . Future studies will be needed to assess the ultimate clinical implication s of targeted biopsy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00102544 PURPOSE Given the limitations of prostate specific antigen and st and ard biopsies for detecting prostate cancer , we evaluated the cancer detection rate and external validity of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system used at the National Institutes of Health . MATERIAL S AND METHODS We performed a phase III trial of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system with participants enrolled between 2012 and 2013 . A total of 153 men consented to the study and underwent 3 Tesla multiparametric magnetic resonance imaging with an endorectal coil for clinical suspicion of prostate cancer . Lesions were classified as low or moderate/high risk for prostate cancer . Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and st and ard 12-core prostate biopsy were performed and 105 men were eligible for analysis . RESULTS Mean patient age was 65.8 years and mean prostate specific antigen was 9.5 ng/ml . The overall cancer detection rate was 62.9 % ( 66 of 105 patients ) . The cancer detection rate in those with moderate/high risk on imaging was 72.3 % ( 47 of 65 ) vs 47.5 % ( 19 of 40 ) in those classified as low risk for prostate cancer ( p<0.05 ) . Mean tumor core length was 4.6 and 3.7 mm for fusion biopsy and st and ard 12-core biopsy , respectively ( p<0.05 ) . Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy detected prostate cancer that was missed by st and ard 12-core biopsy in 14.3 % of cases ( 15 of 105 ) , of which 86.7 % ( 13 of 15 ) were clinical ly significant . This biopsy up grade d 23.5 % of cancers ( 4 of 17 ) deemed clinical ly insignificant on 12-core biopsy to clinical ly significant prostate cancer necessitating treatment . CONCLUSIONS Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy can improve prostate cancer detection . The results of this trial support the external validity of this platform and may be the next step in the evolution of prostate cancer management PURPOSE We evaluated biochemical parameters and pathological features , as well as biopsy related morbidity of prostate cancer detected on biopsies 2 , 3 and 4 in men with total serum prostate specific antigen ( PSA ) between 4 and 10 ng./ml . These features were compared to those detected on prostate biopsy 1 . MATERIAL S AND METHODS In this prospect i ve European Prostate Cancer Detection study 1,051 men with total PSA between 4 and 10 ng./ml . underwent transrectal ultrasound guided sextant biopsy and 2 additional transition zone biopsies . All patients in whom biopsy sample s were negative for prostate cancer underwent biopsy 2 after 6 weeks . If also negative , biopsies 3 and even 4 were performed at 8-week intervals . Those patients with clinical ly localized cancer underwent radical prostatectomy . Pathological and clinical features of patients diagnosed with cancer on either biopsy 1 or 2 and clinical ly organ confined disease who agreed to undergo radical prostatectomy were compared . RESULTS Cancer detection rates on biopsies 1 , 2 , 3 and 4 were 22 % ( 231 of 1,051 ) , 10 % ( 83 of 820 ) , 5 % ( 36 of 737 ) and 4 % ( 4 of 94 ) , respectively . Overall , of the patients with clinical ly localized disease , which was 67 % of cancers detected , 86 % underwent radical prostatectomy and 14 % opted for watchful waiting or radiation therapy . Overall , 58.0 % , 60.9 % , 86.3 % and 100 % of patients had organ confined disease on biopsies 1 , 2 , 3 and 4 , respectively . Despite statistically significant differences in regard to multifocality ( p = 0.009 ) and cancer location ( p = 0.001 ) , including cancer on biopsy 2 showing a lower rate of multifocality and a more apico-dorsal location , there were no differences in regard to stage ( p = 0.2 ) , Gleason score ( p = 0.3 ) , percent Gleason grade 4/5 ( p = 0.2 ) , serum PSA and patient age between biopsies 1 and 2 . However , cancer detected on biopsies 3 and 4 had a significantly lower Gleason score ( p = 0.001 and 0.001 ) , lower rate of grade 4/5 ( p = 0.02 ) , and lower volume ( p = 0.001 and 0.001 ) and stage ( p = 0.001 ) , respectively . CONCLUSIONS Despite differences in location and multifocality , pathological and biochemical features of cancer detected on biopsies 1 and 2 were similar , suggesting comparable biological behaviors . Cancer detected on biopsies 3 and 4 had a lower grade , stage and volume compared with that on biopsies 1 and 2 . Morbidity on biopsies 1 and 2 was similar , whereas biopsies 3 and 4 had a slightly higher complication rate . Therefore , biopsy 2 in all cases of a negative finding on biopsy 1 appears justified . However , biopsies 3 and 4 should only be obtained in select patients with a high suspicion of cancer and /or poor prognostic factors on biopsy 1 or 2 Purpose : To evaluate multiparametric magnetic resonance imaging/transrectal ultrasound ( mpMRI/TRUS
Output:
| No clear advantage of MRI/US fusion-guided TBs was seen for cancer detection rates ( CDRs ) of all prostate cancers .
However , MRI/US fusion-guided TBs tended to give higher CDRs for clinical ly significant prostate cancers in our analysis .
Today , a limited number of prospect i ve studies have reported the CDRs of fusion platforms . |
MS211990 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract In the MM-015 trial , melphalan – prednisone – lenalidomide followed by lenalidomide maintenance ( MPR-R ) significantly prolonged progression-free survival versus melphalan – prednisone ( MP ) in newly diagnosed patients with multiple myeloma aged ≥ 65 years . Health-related quality of life ( HRQoL ) , a secondary endpoint of MM-015 , was also improved with MPR-R. This sub- analysis evaluated the impact of individual predictive factors on HRQoL. Patients completed HRQoL question naires at baseline , every third cycle and at progressive disease (PD)/treatment discontinuation . In a mixed-effects model female gender , advanced age and PD negatively affected HRQoL while better treatment responses showed positive effects . Compared to PD , HRQoL during MPR-R treatment was statistically significantly better in two of six preselected domains both of which were also clinical ly meaningful . HRQoL scores at end of treatment were all either improved or not statistically significantly different versus baseline . In conclusion , continuous treatment with MPR-R , which delays PD , appears to be associated with clinical ly meaningful improvements in We have carried out the largest r and omised trial to date of newly diagnosed myeloma patients , in which lenalidomide has been used as an induction and maintenance treatment option and here report its impact on second primary malignancy ( SPM ) incidence and pathology . After review , 104 SPMs were confirmed in 96 of 2732 trial patients . The cumulative incidence of SPM was 0.7 % ( 95 % confidence interval ( CI ) 0.4–1.0 % ) , 2.3 % ( 95 % CI 1.6–2.7 % ) and 3.8 % ( 95 % CI 2.9–4.6 % ) at 1 , 2 and 3 years , respectively . Patients receiving maintenance lenalidomide had a significantly higher SPM incidence overall ( P=0.011 ) . Age is a risk factor with the highest SPM incidence observed in transplant non-eligible patients aged > 74 years receiving lenalidomide maintenance . The 3-year cumulative incidence in this group was 17.3 % ( 95 % CI 8.2–26.4 % ) , compared with 6.5 % ( 95 % CI 0.2–12.9 % ) in observation only patients ( P=0.049 ) . There was a low overall incidence of haematological SPM ( 0.5 % ) . The higher SPM incidence in patients receiving lenalidomide maintenance therapy , especially in advanced age , warrants ongoing monitoring although the benefit on survival is likely to outweigh risk We compared thalidomide-dexamethasone ( TD ) with melphalan-prednisolone ( MP ) in 289 elderly patients with multiple myeloma ( MM ) . Patients received either thalidomide 200 mg plus dexamethasone 40 mg , days 1 to 4 and 15 to 18 on even cycles and days 1 to 4 on odd cycles , during a 28-day cycle or to melphalan 0.25 mg/kg and prednisolone 2 mg/kg orally on days 1 to 4 during a 28- to 42-day cycle . Patients achieving stable disease or better were r and omly assigned to maintenance therapy with either thalidomide 100 mg daily and 3 MU interferon alpha-2b thrice weekly or to 3 MU interferon alpha-2b thrice weekly only . TD result ed in a higher proportion of complete and very good remissions ( 26 % vs 13 % ; P= .006 ) and overall responses ( 68 % vs 50 % ; P= .002 ) compared with MP . Time to progression ( 21.2 vs 29.1 months ; P= .2 ) , and progression-free survival was similar ( 16.7 vs 20.7 months ; P= .1 ) , but overall survival was significantly shorter in the TD group ( 41.5 vs 49.4 months ; P= .024 ) . Toxicity was higher with TD , particularly in patients older than 75 years with poor performance status . The study was registered at Clinical Trials.gov as NCT00205751 Because interleukin-6 ( IL-6 ) is considered important in the proliferation of early multiple myeloma ( MM ) , we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone ( VMP ) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM . One hundred and six patients were r and omized to receive 9 cycles of VMP or VMP plus siltuximab ( 11 mg/kg every 3 weeks ) followed by siltuximab maintenance . Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions . With a complete response ( CR ) rate of 27 % on siltuximab plus VMP ( S+VMP ) and 22 % on VMP , the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10 % . Overall response rate was 88 % on S+VMP and 80 % on VMP , and at least very good partial response rates were 71 % and 51 % ( P = .0382 ) , respectively . Median progression-free survival ( 17 months ) and 1-year overall survival ( 88 % ) were identical in the 2 arms . Grade ≥3 adverse-event incidence was 92 % on S+VMP and 81 % on VMP ( P = .09 ) , with trends toward more hematologic events and infections on S+VMP . Maintenance therapy with siltuximab was well tolerated . In conclusion , the addition of siltuximab to VMP did not improve the CR rate or long-term outcomes . This study was registered at http:// clinical trials.gov as # NCT00911859 Oral melphalan and prednisone remain an effective and tolerable treatment for patients with multiple myeloma . For approximately 40 years , this combination has been the st and ard of care for patients not proceeding to stem cell transplant . Within the last 10 years , new agents have been found to be efficacious in the relapsed/refractory setting . Within the last year , two trials of added thalidomide in the newly diagnosed setting have demonstrated outcomes superior to those achieved with melphalan and prednisone alone . This improved outcome comes at the cost of increased toxicity . The National Cancer Institute of Canada Clinical Trials Group ( ncic ctg ) has recently developed a r and omized phase ii trial ( MY.11 ) that uses a combination of lenalidomide with melphalan for patients with newly diagnosed multiple myeloma . Lenalidomide is a thalidomide analogue and , like thalidomide , is thought to work through immunomodulatory effects . It was shown to have activity in patients with relapsed or refractory disease and , in combination with dexamethasone , is superior to dexamethasone alone . Lenalidomide holds promise as a more effective and potentially less toxic derivative of thalidomide . Experience with lenalidomide in combination with chemotherapy is very limited , and the purpose of MY.11 is to establish tolerability and to gain knowledge about efficacy . The information gained from MY.11 is expected to help inform dosing levels and schedules for a large phase iii trial being developed by the Eastern Cooperative Oncology Group that will include participation by the ncic ctg Purpose This analysis of the FIRST trial in patients with newly diagnosed multiple myeloma ( MM ) ineligible for stem-cell transplantation examined up date d outcomes and impact of patient age . Patients and Methods Patients with untreated symptomatic MM were r and omly assigned at a one-to-one-to-one ratio to lenalidomide plus low-dose dexamethasone until disease progression ( Rd continuous ) , Rd for 72 weeks ( 18 cycles ; Rd18 ) , or melphalan , prednisone , and thalidomide ( MPT ; 72 weeks ) , stratified by age ( ≤ 75 v > 75 years ) , disease stage ( International Staging System stage I/II v III ) , and country . The primary end point was progression-free survival . Rd continuous and MPT were primary comparators . Results Between August 21 , 2008 , and March 7 , 2011 , 1,623 patients were enrolled ( Rd continuous , n = 535 ; Rd18 , n = 541 ; MPT , n = 547 ) , including 567 ( 35 % ) age older than 75 years . Higher rates of advanced-stage disease and renal impairment were observed in patients older than 75 versus 75 years of age or younger . Rd continuous reduced the risk of progression or death compared with MPT by 31 % ( hazard ratio [ HR ] , 0.69 ; 95 % CI , 0.59 to 0.80 ; P < .001 ) overall , 36 % ( HR , 0.64 ; 95 % CI , 0.53 to 0.77 ; P < .001 ) in patients age 75 years or younger , and 20 % ( HR , 0.80 ; 95 % CI , 0.62 to 1.03 ; P = .084 ) in those age older than 75 years . Median overall survival was longer with Rd continuous than with MPT , including a 14-month difference in patients age older than 75 years . Progression-free survival with Rd18 was similar to that with MPT , and overall survival with Rd18 was marginally inferior to that with Rd continuous . Rates of grade 3 to 4 treatment-emergent adverse events were similar for Rd continuous-treated patients age 75 years or older and those age older than 75 years ; however , older patients had more frequent lenalidomide dose reductions . Conclusion Results support Rd continuous treatment as a new st and ard of care for stem-cell transplantation-ineligible patients with newly diagnosed MM of all ages Bortezomib plus melphalan and prednisone ( VMP ) and lenalidomide plus low-dose dexamethasone ( Rd ) are 2 st and ards of care for elderly untreated multiple myeloma ( MM ) patients . We planned to use VMP and Rd for 18 cycles in a sequential or alternating scheme . Patients ( 233 ) with untreated MM , > 65 years , were r and omized to receive 9 cycles of VMP followed by 9 cycles of Rd ( sequential scheme ; n = 118 ) vs 1 cycle of VMP followed by 1 cycle of Rd , and so on , up to 18 cycles ( alternating scheme ; n = 115 ) . VMP consisted of one 6-week cycle of bortezomib using a biweekly schedule , followed by eight 5-week cycles of once-weekly VMP . Rd included nine 4-week cycles of Rd . The primary end points were 18-month progression free survival ( PFS ) and safety profile of both schemes . The 18-month PFS was 74 % and 80 % in the sequential and alternating arms , respectively ( P = .21 ) . The sequential and alternating groups exhibited similar hematologic and nonhematologic toxicity . Both arms yielded similar complete response rate ( 42 % and 40 % ) , median PFS ( 32 months vs 34 months , P = .65 ) , and 3-year overall survival ( 72 % vs 74 % , P = .63 ) . The benefit of both schemes was remarkable in patients aged 65 to 75 years . In addition , achieving complete and immunophenotypic response was associated with better outcome . The present approach , based on VMP and Rd , is associated with high efficacy and acceptable toxicity profile with no differences between the sequential and alternating regimens . This trial was registered at www . clinical trials.gov as # NCT00443235 Thalidomide with melphalan/prednisone ( MPT ) was defined as st and ard treatment in elderly patients with multiple myeloma ( MM ) based on five r and omized trials . In one of these trials , HOVON49 , a prospect i ve health-related quality -of-life ( HRQoL ) study was initiated in order to assess the impact of thalidomide on QoL. Patients aged > 65 years with newly diagnosed MM were r and omized to receive melphalan plus prednisone ( MP ) or MPT , followed by thalidomide maintenance in the MPT arm . Two hundred eighty-four patients were included in this side study ( MP , n = 149 ; MPT n = 135 ) . HRQoL was assessed with the EORTC Core QoL Question naire ( QLQ-C30 ) and the myeloma-specific module ( QLQ-MY24 ) at baseline and at predetermined intervals during treatment . The QLQ-C30 subscales physical function ( P = 0.044 ) and constipation ( P < 0.001 ) showed an improvement during induction in favour of the MP arm . During thalidomide maintenance , the scores for the QLQ-MY24 paraesthesia became significantly higher in the MPT arm ( P<0.001 ) . The QLQ-C30 subscales pain ( P = 0.12 ) , insomnia ( P = 0.068 ) , appetite loss ( P = 0.074 ) and the QLQ-MY24 item sick ( P = 0.086 ) scored marginally better during thalidomide maintenance . The overall QoL-scale QLQ-C30-HR
Output:
| Based on our four pre-selected comparisons of interest , continuous treatment with VRD had the largest survival benefit compared with MP , while RD and TMP also probably considerably increase survival .
However , treatment combinations of V , R , and T also substantially increase the incidence of AEs , and lead to a higher risk of treatment discontinuation . |
MS211991 | ***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 virologically confirmed hospitalization rates associated with respiratory syncytial virus ( RSV ) , adenovirus , and parainfluenza viruses in Hong Kong children . Methods : All patients < 18 years of age living on Hong Kong Isl and ( within Hong Kong SAR ) admitted for a febrile acute respiratory infection to 1 of the 2 public hospitals on 1 fixed day of the week between October 2003 and September 2006 were prospect ively recruited . Hong Kong Isl and has a known population denominator and these 2 hospitals managed 72.5 % of all general pediatric admissions for this population . Nasopharyngeal aspirates were tested for RSV , adenovirus , and parainfluenzae types 1 , 2 , and 3 by direct antigen detection and culture . Results : The annual hospitalization rate for RSV in infants < 6 months of age was 233.4 to 311.2 per 10,000 . Parainfluenza type 3 had a hospitalization rate of 27.3 to 122.8 per 10,000 in the 1 to < 2 years group . Adenovirus was associated with significant hospitalization in those 6 months to 1 year ( 25.9–77.8 per 10,000 ) , and in those 2 to < 5 years ( 38.1–59.2 per 10,000 ) . The mean duration of hospitalization for RSV was 4.04 ± 2.61 days , significantly longer than the 3.12 ± 1.41 days for adenovirus and the 2.93 ± 2.54 days for parainfluenza infections ( P = 0.013 and P = 0.038 , respectively ) . Conclusion : We documented that the overall pediatric hospitalization burden of RSV was high and comparable to that of influenza . The burden for all the studied viruses was mainly in previously healthy children < 5 years of age OBJECTIVE To explore the distribution and clinical manifestations of rhinovirus infection in wheezing children , and compare the clinical differences between rhinovirus- and respiratory syncytial virus-induced wheezing . MATERIAL S AND METHODS This prospect i ve cohort study was carried out in Children 's Hospital of Soochow University from Dec 2012 to Nov 2014 . We enrolled consecutive hospitalized children < 60 months of age presented with wheezing . Clinical data including cough , fever , dyspnea , crackles were recorded by pediatricians on the first day of admission . Meanwhile , nasopharyngeal aspirates were obtained to test for respiratory viruses , by using polymerase chain reaction method for rhinovirus , human bocavirus , and human metapneumovirus , and direct immunofluorescence assay to test for respiratory syncytial virus , adenovirus , parainfluenza virus types 1 - 3 , and influenza virus types A and B. RESULTS Rhinovirus was a main causative agent isolated in 14.7 % of the hospitalized wheezing children in Suzhou , China , being second to respiratory syncytial virus ( 21.0 % ) . Different from respiratory syncytial virus infection , which peaked in winter months , rhinovirus could be detected all year round , peaked between July and September , and in November . Children with rhinovirus infection were older and presented with more often allergic sensitizations , blood eosinophilia , and leukocytosis than those of respiratory syncytial virus infection . Logistic regression analysis revealed that rhinovirus-infected children experienced earlier wheezing more often than respiratory syncytial virus children ( odds ratio , 3.441 ; 95 % confidence interval , 1.187 - 9.979 ; p=0.023 ) . CONCLUSION Rhinovirus was a main viral pathogen in wheezing children , especially in summer time . Rhinovirus-induced wheezing was different from respiratory syncytial virus , apart from seasonal epidemics ; these two groups differed with regard to age , allergic sensitizations , laboratory test , and history of wheezing episodes Background Human respiratory syncytial virus ( RSV ) is an important community and nosocomial pathogen in developed countries but data regarding the importance of RSV in developing countries are relatively scarce . Methods During a 1-year surveillance study in 2010 , we took serial sample s from children admitted to the Emergency Unit of the Respiratory Ward of Children 's Hospital 1 in Ho Chi Minh City , Vietnam . RSV was detected within 72 hours of admission to the ward in 26 % ( 376/1439 ; RSV A : n = 320 ; RSV B : n = 54 ; and RSV A and B : n = 2 ) . Among those negative in the first 72 hours after admission , 6·6 % ( 25/377 ) acquired nosocomial RSV infection during hospitalization ( RSV A : n = 22 ; and RSV B : n = 3 ) . Results Children with nosocomial RSV infection were younger ( P = 0·001 ) and had a longer duration of hospitalization ( P < 0·001 ) . The rate of incomplete recovery among children with nosocomial RSV infection was significantly higher than among those without ( P < 0·001 ) . Phylogenetic analysis of partial G gene sequences obtained from 79 % ( 316/401 ) of positive specimens revealed the co-circulation of multiple genotypes with RSV A NA1 being predominant ( A NA1 : n = 275 ; A GA5 : n = 5 ; B BA3 : n = 3 ; B BA9 : n = 26 ; and B BA10 : n = 7 ) . The RSV A GA5 and RSV B BA3 genotypes have not been reported from Vietnam , previously . Conclusion Besides emphasizing the importance of RSV as a cause of respiratory infection leading to hospitalization in young children and as a nosocomial pathogen , data from this study extend our knowledge on the genetic diversity of RSV circulating in Vietnam Background and objective Clinical characteristics of human bocavirus ( HBoV ) infection have been studied worldwide , but their importance of those characteristics remains unknown . We investigated distinctive clinical features of HBoV-positive children with lower respiratory tract infection ( LRTI ) . Methods and results During April 2007–July 2009 , for 402 hospitalized children younger than 2 years with LRTI , we prospect ively examined virus genomes in nasopharyngeal swabs for HBoV , respiratory syncytial virus ( RSV ) , rhinovirus , metapneumovirus , parainfluenzavirus , and adenovirus . The HBoV genomes were identified in 34 patients ( 8.5 % ) . Clinical and laboratory data of HBoV-positive and other virus/bacteria-negative patients ( n = 18 ) were analyzed and compared with data of RSV-single positive patients ( n = 99 ) . The seasonal distribution of HBoV exhibits a concentration of cases during March – September , with most RSV cases occurring during winter in Japan . The minimum age of HBoV-positive patients was 5 months , although 44 patients ( 44 % ) with RSV were younger than 6 months . The main clinical features were respiratory distress and hypoxia . Hypoxia advances within 3 days after onset . The mean oxygen saturation on arrival was 92.8 % , which was significantly lower than that in patients with RSV ( p < 0.001 ) . White blood cell counts were similar among groups . However , the percentage of neutrophils in white blood cells were significantly higher in HBoV-positive patients ( 62 vs. 45 % , p < 0.001 ) . Their prognoses were good . Their hospital stays were 6.6 days . Conclusions HBoV-single positive patients show several clinical characteristics , such as seasonality , age , hypoxia , and neutrophilia , which differ from those with RSV infection Summary In a multicenter , prospect i ve case-control study involving 1758 children aged < 5 years in developing and emerging countries , the main microorganisms associated with pneumonia were Streptococcus pneumoniae , human metapneumovirus , rhinovirus , and respiratory syncytial virus Background The dominant viral etiologies responsible for acute respiratory infections ( ARIs ) are poorly understood , particularly among hospitalized children in re source -limited tropical countries where morbidity and mortality caused by ARIs are highest . Improved etiological insight is needed to improve clinical management and prevention . Objectives We conducted a three-year prospect i ve descriptive study of severe respiratory illness among children from 2 months to 13 years of age within the largest referral hospital for infectious diseases in southern Vietnam . Methods Molecular detection for 15 viral species and subtypes was performed on three types of respiratory specimens ( nose , throat swabs and nasopharyngeal aspirates ) using a multiplex RT-PCR kit ( Seeplex ™ RV detection , Seegene ) and additional monoplex real-time RT-PCRs . Results A total of 309 children were enrolled from November 2004 to January 2008 . Viruses were identified in 72 % ( 222/309 ) of cases , including respiratory syncytial virus ( 24 % ) , influenza virus A and B ( 17 % ) , human bocavirus ( 16 % ) , enterovirus ( 9 % ) , human coronavirus ( 8 % ) , human metapneumovirus ( 7 % ) , parainfluenza virus 1–3 ( 6 % ) , adenovirus ( 5 % ) , and human rhinovirus A ( 4 % ) . Co-infections with multiple viruses were detected in 20 % ( 62/309 ) of patients . When combined , diagnostic yields in nose and throat swabs were similar to nasopharyngeal aspirates . Conclusion Similar to other parts in the world , RSV and influenza were the predominant viral pathogens detected in Vietnamese hospitalized children . Combined nasal and throat swabs are the specimens of choice for sensitive molecular detection of a broad panel of viral agents . Further research is required to better underst and the clinical significance of single versus multiple viral coinfections and to address the role of bacterial (co-)infections involved in severe respiratory illness Since the initial discovery of RSV-A ON1 in Canada in 2010 , ON1 has been reported worldwide , yet information regarding its clinical impact and severity has been controversial . To investigate the clinical relevance of RSV-A ON1,acute respiratory infection ( ARI ) cases enrolled to our population -based prospect i ve pediatric ARI surveillance at Khanh Hoa General Hospital , Central Vietnam from January 2010 through December 2012 were studied . Clinical -epidemiological information and nasopharyngeal sample s were collected . Multiplex PCR assays were performed for screening 13 respiratory viruses . RSV-positive sample s were further tested for subgroups ( A/B ) and genotypes information by sequencing the G-glycoprotein 2nd hypervariable region . Statistical analysis was performed to evaluate the clinical -epidemiological characteristics of RSV-A ON1 . A total of 1854 ARI cases were enrolled and 426 ( 23.0 % ) of them were RSV-positive . During the study period , RSV-A and B had been co-circulating . NA1 was the predominant RSV-A genotype until the appearance of ON1 in 2012 . RSV-related ARI hospitalization incidence significantly increased after the emergence of ON1 . Moreover , multivariate analysis revealed that risk of lower respiratory tract infection was 2.26 ( 95 % CI : 1.37–3.72 ) times , and radiologically-confirmed pneumonia was 1.98 ( 95 % CI : 1.01–3.87 ) times greater in ON1 compared to NA1 cases . Our result suggested that ON1 ARI cases were clinical ly more severe than NA1 BACKGROUND Respiratory syncytial virus ( RSV ) is the most important viral pathogen in infants and children . It is important to analyze RSV epidemic patterns and related relevant factors in order to prevent further infections and related complications . OBJECTIVE To explore the relationship between RSV infection rate in hospitalized children from Suzhou area and climatic factors . STUDY DESIGN 42,664 nasopharyngeal specimens from hospitalized children with acute respiratory infections were screened for RSV antigens using direct immunofluorescence . 472 RSV positive sample s were r and omly selected and performed real-time PCR to identify RSV subtype . Monthly meteorological data in Suzhou area was collected ( average temperature , relative humidity , precipitation , total sunshine , and average wind speed ) from 2001 to 2011 . The relation between RSV infections and climatic factors was evaluated using correlation and stepwise regression analyses . RESULTS The annual RSV infection rate in hospitalized children in Suzhou from 2001 to 2011 varied between 11.85 % and 27.30 % . The highest monthly infection rates occurred from November to April . The time interval from November to April was considered the infection season . Seasonal RSV infection rates from 2001 to 2010 were 40.75 % , 22.72 % , 39.93 % , 27.37 % , 42.71 % , 21.28 % , 38.57 % , 19.86 % , and 29.73 % .
Output:
| The seasonality of RSV in the WPR countries follows the latitude , with the peak of RSV season occurring in the winter in temperate countries , and during the rainy season in tropical countries . |
MS211992 | ***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 a prior r and omized phase II trial comparing hyperthermic isolated limb perfusion ( HILP ) with four different doses of tumor necrosis factor alpha ( TNF-α ) , no dose effect was detected for response , but systemic toxicity was far lower with low-dose TNF-α . The objective of the present study was to confirm these data on a larger sample size of locally advanced or recurrent extremity soft tissue sarcomas with low-dose TNF-α . Methods We assessed a prospect i ve data base comprising 100 HILP ( 38–40 ° C ) with melphalan ( 10 mg/L ) and TNF-α ( 1 mg ) . The remnant tumor was resected 2 months later . Results Among 52 recurrences , 18 were in a previously irradiated field . Stages according to the American Joint Committee on Cancer classification were II ( 19 patients ) , III ( 78 patients ) , and IV ( 3 patients ) . The site/size were : 30 patients /57 mm and 70 patients /86 mm for the upper and lower limbs , respectively . Tumor grade s ( FNCLCC ) were 1 ( 23 patients ) , 2 ( 34 patients ) , and 3 ( 43 patients ) . Fifty-one patients had received systemic chemotherapy before HILP . Responses on magnetic resonance imaging were 30 % complete , 49 % partial , 9 % no change , and 12 % progression . No mortality or systemic toxicity occurred . Local toxicity ( Wieberdink ) attained grade 2 ( 16 patients ) , 3 ( 5 patients ) , and 4 ( 1 patient ) . Limbs were able to be saved in 87 % patients . Three-year overall survival and the local recurrence rate were 89 % and 18 % , respectively . Age , sex , tumor size , recurrence , uni- or multifocality , grade , preoperative chemotherapy , and a previously irradiated field were not predictive of response or local toxicity . Conclusions We confirm that 1 mg of TNF-α is as effective as the st and ard dose and results in no systemic toxicity Background Isolated limb perfusion with tumor necrosis factor alpha and melphalan ( TM-ILP ) has proven to be a successful option in treating advanced soft tissue sarcomas ( STS ) , where amputation otherwise is needed to achieve safe surgical margins . Methods From 2000 to 2009 , 54 patients with locally advanced STS , who all were c and i date s for amputation , were treated with totally 57 TM-ILP procedures and then followed prospect ively . The median follow-up time was 30 months . Median tumor size was 10 cm , and 94 % of the patients had high- grade tumors . Results The clinical overall response after TM-ILP was 71 % ( including 21 % CR ) , and 60 % of the patients underwent resection of the tumor remnant after a median of 2 months . The histopathologic response rate in the resected specimens was 76 % . Local recurrence/progress occurred in 37 % of the patients after a median of 7 months . Thirteen patients finally underwent amputation after a median of 11 months , giving a long-term limb salvage of 76 % . Conclusions TM-ILP of advanced soft tissue sarcoma of the extremities makes limb-sparing surgery possible in a high proportion of patients Isolated limb infusion ( ILI ) is a minimally invasive technique of delivering regional chemotherapy in patients with advanced melanoma or soft-tissue sarcoma of the limb . We report the final results of the first clinical trial of ILI in North America ( NCT00004250 ) . Eligible patients had recurrent melanoma or unresectable soft-tissue sarcoma of the limb . Angiographic catheters were positioned just above the knee or elbow of the extremity . General anesthesia was performed , a proximal tourniquet inflated , and a normothermic , low flow , hypoxic infusion of melphalan and dactinomycin circulated through the involved limb for 20 min . Tumor response and morbidity were assessed using st and ard criteria . Thirty-seven patients were accrued to the trial and 44 ILIs were performed ( eight patients had two ILIs ) ; one patient was not treated . Of the 32 evaluable patients , 17 ( 53 % ) had a significant response at 3 months : 25 % of patients had a complete response and 28 % of patients had a partial response . The median duration of complete response was 1 year ( 5–32 months ) . Morbidity was acceptable , with peak erythema , edema , and pain experienced at 2 weeks and considered ‘ moderate ’ in most patients . No patients developed compartment syndrome or required amputation because of ILI . ILI is well tolerated . More than half of the treated patients experienced a complete or partial response Between May 1975 and April 1981 , 43 adult patients with high- grade soft tissue sarcomas of the extremities were prospect ively r and omized to receive either amputation at or above the joint proximal to the tumor , including all involved muscle groups , or to receive a limb-sparing resection plus adjuvant radiation therapy . The limb-sparing resection group received wide local excision followed by 5000 rads to the entire anatomic area at risk for local spread and 6000 to 7000 rads to the tumor bed . Both r and omization groups received postoperative chemotherapy with doxorubicin ( maximum cumulative dose 550 mg/m2 ) , cyclophosphamide , and high-dose methotrexate . Twenty-seven patients r and omized to receive limb-sparing resection and radiotherapy , and 16 received amputation ( r and omization was 2:1 ) . There were four local recurrences in the limb-sparing group and none in the amputation group ( p1 = 0.06 generalized Wilcoxon test ) . However , there were no differences in disease-free survival rates ( 71 % and 78 % at five years ; p2 = 0.75 ) or overall survival rates ( 83 % and 88 % at five years ; p2 = 0.99 ) between the limb-sparing group and the amputation treatment groups . Multivariate analysis indicated that the only correlate of local recurrence was the final margin of resection . Patients with positive margins of resection had a higher likelihood of local recurrence compared with those with negative margins ( p1 less than 0.0001 ) even when postoperative radiotherapy was used . A simultaneous prospect i ve r and omized study of postoperative chemotherapy in 65 patients with high- grade soft-tissue sarcomas of the extremities revealed a marked advantage in patients receiving chemotherapy compared with those without chemotherapy in three-year continuous disease-free ( 92 % vs. 60 % ; p1 = 0.0008 ) and overall survival ( 95 % vs. 74 % ; p1 = 0.04 ) . Thus limb-sparing surgery , radiation therapy , and adjuvant chemotherapy appear capable of successfully treating the great majority of adult patients with soft tissue sarcomas of the extremity Background Isolated limb infusion ( ILI ) is a therapeutic option for patients with recurrent , unresectable extremity malignancies . Methods A prospect ively collected single-institution data base of patients undergoing ILI was analyzed for preoperative , intraoperative , and postoperative parameters and outcomes . Results From May 2007 to January 2012 , a total of 76 patients successfully underwent initial ILI , and 28 after either previous hyperthermic isolated limb perfusion or ILI . Seventy-nine patients ( 74 % ) had melanoma , 24 ( 22 % ) sarcoma , 3 ( 3 % ) Merkel cell , and 1 ( 1 % ) squamous cell carcinoma . There were 55 ( 72 % ) initial and 22 ( 79 % ) repeat lower extremity ( LE ) ILIs , and 21 ( 78 % ) initial and 6 ( 22 % ) repeat upper extremity ( UE ) ILIs . Serologic toxicity , measured by serum creatine kinase ( CK ) , peaked higher and later in LE ILIs , median 620 versus 124 IU/L , and postoperative day 4 versus 2 , respectively ( P < 0.05 ) . LE ILIs had a longer hospital length of stay ( LOS ) , median 6 versus 5 days ( P < 0.0001 ) . A median grade II Wieberdink regional toxicity was observed . Three-month follow-up was available in 94 ( 90 % ) . A response ( overall response rate , ORR ) was seen in 72 % of ILIs performed for melanoma and 58 % for sarcoma . No difference in response was observed between UE versus LE or between initial versus repeat ILIs . Repeat UE ILIs , however , appeared to have an improved ORR than repeat LE ILIs , 83 versus 64 % . Conclusions ILI may be successfully performed for cutaneous and soft tissue malignancies . LE ILIs have higher CK levels and slightly longer LOS . Repeat ILIs are not associated with increased toxicity and similar ORR . UE ILIs may have better ORR BACKGROUND Isolated limb perfusion ( TM-ILP ) achieves high response rates in soft tissue sarcomas ( STS ) . Some tumors show an insufficient association between radiological and pathological response . We investigated STS after TM-ILP with a primary emphasis on histologic regression patterns . METHODS In 53 patients with STS , TM-ILP with subsequent tumor resection was performed . Regression was assessed by the Salzer-Kuntschik regression scale . Microvessel density ( MVD ) of primary biopsies of 37 patients was determined by immunohistochemistry . Tumor regression was correlated with MVD of primary biopsies and other clinico-pathological parameters . RESULTS Regression presented mainly as necrosis or fibrosis/sclerosis upon histopathology . MFH , leiomyosarcoma , or clear cell sarcoma ( CCS ) responded well ; whereas liposarcomas , synovial sarcomas , or MPNST were poor responders . MFH often had abundant necrosis ; while other STS mainly presented with fibrosis/sclerosis . MVD had no influence on regression grade but modulated histologic regression patterns . Excellent regression demonstrated a trend toward an association with improved survival and local control . CONCLUSION TM-ILP yielded high response rates in STS . Regression after TM-ILP exhibits MVD-dependent histopathologic patterns and variable efficacy in different sarcoma types . Complete regression seems to be a favorable prognostic factor . A concerted consideration of histopathology and clinical findings may contribute to a better clinical assessment of regression after TM-ILP PURPOSE To determine in a r and omized prospect i ve multi-institutional trial whether the addition of tumor necrosis factor alpha ( TNF-alpha ) to a melphalan-based hyperthermic isolated limb perfusion ( HILP ) treatment would improve the complete response rate for locally advanced extremity melanoma . PATIENTS AND METHODS Patients with locally advanced extremity melanoma were r and omly assigned to receive melphalan or melphalan plus TNF-alpha during st and ard HILP . Patient r and omization was stratified according to disease/treatment status and regional nodal disease status . RESULTS The intervention was completed in 124 patients of the 133 enrolled . Grade 4 adverse events were observed in 14 ( 12 % ) of 129 patients , with three ( 4 % ) of 64 in the melphalan-alone arm and 11 ( 16 % ) of 65 in the melphalan-plus-TNF-alpha arm ( P = .0436 ) . There were two toxicity-related lower extremity amputations in the melphalan-plus-TNF-alpha arm , and one disease progression-related upper extremity amputation in the melphalan-alone arm . There was no treatment-related mortality in either arm of the study . One hundred sixteen patients were assessable at 3 months postoperatively . Sixty-four percent of patients ( 36 of 58 ) in the melphalan-alone arm and 69 % of patients ( 40 of 58 ) in the melphalan-plus-TNF-alpha arm showed a response to treatment at 3 months , with a complete response rate of 25 % ( 14 of 58 patients ) in the melphalan-alone arm and 26 % ( 15 of 58 patients ) in the melphalan-plus-TNF-alpha arm ( P = .435 and P = .890 , respectively ) . CONCLUSION In locally advanced extremity melanoma treated with HILP , the addition of TNF-alpha to melphalan did not demonstrate a significant enhancement of short-term response rates over melphalan alone by the 3-month follow-up , and TNF-alpha plus melphalan was associated with a higher complication rate Background Isolated limb infusion ( ILI ) is a minimally invasive technique for delivering high-dose regional chemotherapy . We report our experience with ILI for the treatment of soft tissue sarcoma ( STS ) . Methods From our prospect i ve data base , 21 patients with STS of the limb treated with ILI between 1994 and 2007 were identified . In all patients , a high-dose cytotoxic drug combination was used . Results There were 14 men , and the median age was 60 years ( range , 18–85 years ) . Eighteen patients ( 86 % ) had lower limb tumors . All patients had advanced local disease . The procedure was well tolerated . Fourteen patients ( 67 % ) received ILI before definitive surgery .
Output:
| Conclusion ILP and ILI for extremity STS can be safely performed with appreciable response rates and significant limb salvage rates . |
MS211993 | ***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 It has been hypothesized that the extent of acute anthracycline-induced cardiotoxicity reflects the risk for late development of heart failure . The aim of this study was to examine if short-term changes in cardiac function can be detected even after low-dose adjuvant epirubicin therapy for breast cancer when using Doppler tissue imaging of longitudinal left ventricular function . METHODS Eighty consecutive women in good cardiopulmonary health scheduled to undergo adjuvant treatment for breast cancer were included . They were examined using echocardiography and Doppler tissue imaging before and after three treatment series of epirubicin ( mean cumulative dose , 273.7 ± 46.6 mg/m(2 ) ; median time interval , 9 weeks ; range , 47 - 113 days ) . RESULTS Apart from a marginal reduction in E/A ratio , none of the conventional Doppler echocardiographic or Doppler tissue imaging indices of systolic and diastolic function were affected during epirubicin treatment . CONCLUSIONS In contrast to several previous studies using tissue Doppler and conventional echocardiography , this study did not document relevant short-term effects of low-dose epirubicin treatment on heart function Objectives To identify anthracycline-induced acute ( within 1 month ) and early-onset chronic progressive ( within 1 year ) cardiotoxicity in children younger than 16 years of age with childhood malignancies at a tertiary care centre of Pakistan . Design Prospect i ve cohort study . Setting Aga Khan University , Karachi , Pakistan . Participants 110 children ( aged 1 month–16 years ) . Intervention Anthracycline ( doxorubicin and /or daunorubicin ) . Outcome measurements All children who received anthracycline as chemotherapy and three echocardiographic evaluations ( baseline , 1 month and 1 year ) between July 2010 and June 2012 were prospect ively analysed for cardiac dysfunction . Statistical analysis including systolic and diastolic functions at baseline , 1 month and 1 year was carried out by repeated measures analysis of variance . Results Mean age was 74±44 months and 75 ( 68.2 % ) were males . Acute lymphoblastic leukaemia was seen in 70 ( 64 % ) patients . Doxorubicin alone was used in 59 ( 54 % ) and combination therapy was used in 35 ( 32 % ) . A cumulative dose of anthracycline < 300 mg/m2 was used in 95 ( 86 % ) . Fifteen ( 14 % ) children developed cardiac dysfunction within a month and 28 ( 25 % ) children within a year . Of these 10/15 ( 66.6 % ) and 12/28 ( 43 % ) had isolated diastolic dysfunction , respectively , while 5/15 ( 33.3 % ) and 16/28 ( 57 % ) had combined systolic and diastolic dysfunction . Seven ( 6.4 % ) patients expired due to severe cardiac dysfunction . Eight of 59 ( 13.5 % ) children showed dose-related cardiotoxicity ( p=<0.001 ) . Cardiotoxicity was also high when the combination of doxorubicin and daunorubicin was used ( p=0.004 ) . Conclusions Incidence of anthracycline-induced cardiotoxicity is high . Long-term follow-up is essential to diagnose its late manifestations 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 The benefits from anthracycline chemotherapy are undermined by potentially life-threatening cardiotoxicity . Transthoracic echocardiography is the most commonly used method for monitoring cardiotoxicity , and centres on the measurement of left ventricular systolic function . The aim of this study was to utilize two-dimensional speckle tracking echocardiography ( 2DSTE ) at baseline and immediately after anthracycline chemotherapy to investigate whether patients with significant changes in systolic function after anthracycline therapy would also develop alterations in diastolic parameters . METHODS AND RESULTS Fifty-two women with histologically confirmed breast cancer were prospect ively recruited . Echocardiograms were performed 1 week prior to and 1 week following chemotherapy ( always before adjuvant trastuzumab or thoracic radiotherapy ) . Conventional Doppler , tissue velocity imaging ( TVI ) , and 2DSTE were used to measure diastolic function . 2DSTE measurements included longitudinal diastolic strain , early ( E-Sr ) , and late ( A-Sr ) myocardial strain rate . 2DSTE and left ventricular ejection fraction ( LVEF ) were used to measure longitudinal systolic function . Altered LV diastolic function ( including E-Sr ) was observed in the entire cohort after chemotherapy , with a differential reduction in participants with a post therapy LVEF < 55 % . Pre-chemotherapy systolic strain was found to predict reduced E-Sr post therapy ( P = 0.04 ) . Univariate predictors of E-Sr were LVEF post therapy ( P = 0.049 ) and systolic strain post-therapy ( P = 0.01 ) . In a multivariate analysis , systolic strain after chemotherapy was the strongest independent predictor ( P = 0.001 ) . CONCLUSION Altered LV diastolic function was observed immediately after the administration of therapeutic doses of anthracycline chemotherapy . Furthermore , our analysis indicates that the changes in diastolic function are associated with reduced systolic function The aim of this study was to describe the acute effects of anthracyclines on left ventricular systolic and diastolic function using different echocardiographic modalities . Thirteen children scheduled to receive anthracyclines were prospect ively studied . They underwent complete 2-dimensional and Doppler echocardiographic evaluations , including tissue Doppler imaging , before the first dose and < 2 hours after each of the first 3 doses of anthracyclines ( dose range 30 to 75 mg/m2 ) . After the first dose , increased end-diastolic wall thickness , decreased wall thickening , and a prolonged myocardial performance index were noted . Parameters of diastolic function changed significantly , with a lower mitral E wave , a decreased E/A ratio , and prolonged isovolumic relaxation time . Also , reduced longitudinal early diastolic myocardial velocity and myocardial velocity acceleration during isovolumic contraction as well as reduced peak longitudinal and radial systolic strain rate and strain were noted . All these parameters remained significantly lower after subsequent doses . After the second dose , significant changes in the shortening fraction and the ejection fraction compared with baseline became apparent . After the third dose , further deterioration in radial peak systolic strain was seen . In conclusion , low to moderate doses of anthracyclines acutely induce cardiac diastolic and systolic dysfunction BACKGROUND To determine the normal range of left ventricular ( LV ) 2- dimensional ( 2-D ) strain and vendor-specific differences , a multicenter prospect i ve 2-D strain study endorsed by the Japanese Society of Echocardiography was conducted . METHODS AND RESULTS 2-D speckle tracking analysis was performed on 817 healthy subjects ( age range , 0 - 88 years ) ; the images included 3 LV short axis and 3 apical views using an ultrasound system from 1 of the 3 different vendors ( V(1 ) , n=333 ; V(2 ) , n=330 ; V(3 ) , n=337 ) . With the 2-D speckle tracking software from each vendor , radial , circumferential and longitudinal strain were measured using an 18-segment model . Inter-vendor variability was also assessed in a subset of subjects . The feasibility for 2-D strain measurements was different among the 3 vendors ( V(1 ) , 83 % ; V(2 ) , 70 % ; V(3 ) , 88 % , P<0.01 ) . The global radial ( V(1 ) , 54.6±12.6 % ; V(2 ) , 36.3±8.2 % ; V(3 ) , 51.4±8.0 % ) , circumferential ( V(1 ) , -22.8±2.9 % ; V(2 ) , -22.2±3.2 % ; V(3 ) , -30.5±3.8 % ) , and longitudinal ( V(1 ) , -21.3±2.1 % ; V(2 ) , -18.9±2.5 % ; V(3 ) , -19.9±2.4 % ) strain measurements were significantly different for each of the vendors . Segmental strain was also different between the 3 vendors . On inter-vendor analysis , vendor agreement ranged from mild to moderate . CONCLUSIONS Reference values are provided for normal 2-D strain for 3 different ultrasound vendors . Due to a low inter-vendor agreement , 2-D strain data are not interchangeable when conducting a longitudinal follow-up or a cross-sectional assessment of LV function The study aim ed to compare diastolic and systolic dysfunctions detected by echocardiography ( ECHO ) and multigated radionuclide angiography ( MUGA ) in patients with cancer in the first 3 months after anthracycline-comprising chemotherapy . Children with leukemia and solid tumors who had anthracycline-comprising chemotherapy were enrolled in the study . ECHO and MUGA were performed in all patients before the first chemotherapy course and in the first 3 month of completing anthracycline-comprising chemotherapy . Cumulative anthracycline doses per body surface were calculated . Left ventricular systolic and diastolic functions were measured by both techniques . Twenty-one patients with a median age of 6.9 ± 3.6 years were enrolled in the study . Mean cumulative anthracycline doses were equivalent to 276 ± 83 mg/m2 doxorubicin . After anthracycline chemotherapy , cardiac dysfunction was detected in 14 and 48 % of the patients by ECHO and MUGA , respectively . All dysfunctions detected by ECHO were systolic , whereas 29 % of the patients had diastolic and 38 % of the patients had systolic dysfunction in MUGA study . Although the study group is small , MUGA seems more sensitive in detecting anthracycline-induced systolic and diastolic cardiac dysfunctions compared to ECHO BACKGROUND Assessment of left ventricular systolic function is necessary during trastuzumab-based chemotherapy because of potential cardiotoxicity . Deformation indices have been proposed as an adjunct to clinical risk factors and ejection fraction ( EF ) , but the optimal parameter and optimal cutoffs are undefined . The aim of this study was to determine the best means of early detection of subsequent reduction of EF in patients with breast cancer treated with trastuzumab . METHODS Eighty-one consecutive women ( mean age , 50 ± 11 years ) receiving trastuzumab were prospect ively studied , 37 of whom received concurrent anthracyclines . Conventional echocardiographic indices ( mitral annular systolic [ s ' ] and diastolic [ e ' ] velocities ) and myocardial deformation indices ( global longitudinal peak systolic strain [ GLS ] , global longitudinal peak systolic strain rate [ GLSR-S ] , and global longitudinal early diastolic strain rate [ GLSR-E ] ) were measured at baseline and at 6 and 12 months . Cardiotoxicity was defined as a > 10 % decline as a percentage of baseline EF in 12 months . RESULTS In the 24 patients ( 30 % ) who later developed cardiotoxicity , myocardial deformation indices decreased at 6 months ( GLS , P < .001 ; GLSR-S , P = .009 ; GLSR-E , P = .002 vs baseline ) , but e ' was unchanged . The strongest predictor of cardiotoxicity was ΔGLS ( area under the curve , 0.84 ) ; an 11 % reduction ( 95 % confidence interval , 8.3%-14.6 % ) was the optimal cutoff , with sensitivity of 65 % and specificity of 94 % . In sequential models , the clinical model ( χ(2 ) = 10.2 ) was improved by GLSR-S ( χ(2 ) = 14.7 , P = .03 ) and even more so by GLSR-E ( χ(2 ) = 18.0 , P = .005 ) or GLS ( χ(2 ) = 21.3 , P = .0008 ) . Discrimination improvement by adding GLS was confirmed by an integrated discrimination improvement of 18.6 % ( 95 % confidence interval , 8.6%-28.6 % ; P = .0003 ) . A net 29 % of the patients without events were reclassified into lower risk categories , and a net 48 % of the patients with events were reclassified into higher risk categories , result ing in a total continuous net reclassification improvement ( > 0 ) of 0.77 ( 95 % confidence interval , 0.33 - 1.22 ; P = .036 ) . CONCLUSIONS GLS is an independent early predictor of later reductions in EF , incremental to usual predictors in patients at risk for trastuzum
Output:
| We found that conventional nonstrain diastolic parameters predicted doxorubicin-induced systolic dysfunction . |
MS211994 | ***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 efficacy of self-recording of blood pressure in the management of hypertension was assessed in a r and omized clinical trial involving 140 persons who had been receiving antihypertensive therapy for a year or more , but whose diastolic blood pressure had remained at 95 mm Hg or higher . To control for the increased attention implicit in self-recording , which might affect blood pressure , the patients were assigned at r and om to one of the four groups : self-recording and monthly home visits , self-recording only , monthly home visits only , and neither self-recording nor monthly home visits . This design also permitted assessment of the effect of home visits . During the 6-month experiment no significant differences were apparent between the groups in either compliance or diastolic blood pressure . However , both self-recording and monthly home visits produced a reduction in blood pressure among patients who admitted to difficulty remembering to take their pills ; a reduction was not seen among patients who said they had no such difficulty . This confirmed an earlier observation suggesting that this easily identified group of patients may be the most responsive to intervention programs OBJECTIVES to investigate the effectiveness of a pharmacy discharge plan in elderly hospitalized patients . DESIGN r and omized controlled trial . SUBJECTS AND SETTING S we r and omized patients aged 75 years and older on four or more medicines who had been discharged from three acute general and one long-stay hospital to a pharmacy intervention or usual care . INTERVENTIONS the hospital pharmacist developed discharge plans which gave details of medication and support required by the patient . A copy was given to the patient and to all relevant professionals and carers . This was followed by a domiciliary assessment by a community pharmacist . In the control group , patients were discharged from hospital following st and ard procedures that included a discharge letter to the general practitioner listing current medications . OUTCOMES the primary outcome was re-admission to hospital within 6 months . Secondary outcomes included the number of deaths , attendance at hospital outpatient clinics and general practice and proportion of days in hospital over the follow-up period , together with patients ' general well-being , satisfaction with the service and knowledge of and adherence to prescribed medication . RESULTS we recruited 362 patients , of whom 181 were r and omized to each group . We collected hospital and general practice data on at least 91 and 72 % of patients respectively at each follow-up point and interviewed between 43 and 90 % of the study subjects . There were no significant differences between the groups in the proportion of patients re-admitted to hospital between baseline and 3 months or 3 and 6 months . There were no significant differences in any of the secondary outcomes . CONCLUSIONS we found no evidence to suggest that the co-ordinated hospital and community pharmacy care discharge plans in elderly patients in this study influence outcomes OBJECTIVE To compare patients ' adherence to therapy , expectations , satisfaction with pharmacy services , and health-related quality of life ( HRQOL ) after the provision of pharmaceutical care with those of patients who received traditional pharmacy care . DESIGN R and omized controlled cluster design . SETTING Sixteen community pharmacies in Alberta , Canada . PATIENTS AND OTHER PARTICIPANTS Ambulatory elderly ( > or = 65 years of age ) patients covered under Alberta Health & Wellness 's senior drug benefit plan and who were concurrently using three or more medications according to pharmacy profiles . INTERVENTION Pharmacies were r and omly assigned to either treatment ( intervention ) or control ( traditional pharmacy care ) groups . Patients at treatment pharmacies were recruited into the study , and pharmacists provided comprehensive pharmaceutical care services . Pharmacists at control pharmacies continued to provide traditional pharmacy care . MAIN OUTCOME MEASURES Study participants ' opinions , adherence to therapy , and scores on the Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) . RESULTS Compared with those of patients receiving traditional care , treatment patients ' expectations that their pharmacist would perform activities congruent with pharmaceutical care changed over the study period . Treatment patients ' satisfaction with the constructs " trust , " " evaluation and goal setting , " and " communicates with doctor " were also positively affected . HRQOL and patient adherence were not significantly affected by pharmaceutical care interventions . CONCLUSION Successful implementation of a pharmaceutical care practice model has the potential to increase patients ' satisfaction with their pharmacists ' activities and may increase patients ' expectations that pharmacists will work on their behalf to assist them with their health care needs . If pharmaceutical care affects patients ' HRQOL , instruments more specific than the SF-36 may be needed to detect the differences The effects of metoprolol ( Betaloc tablets ) in a group of 193 hypertensives were compared with the effects of a slow-release formulation ( Betaloc Durules ) in a further group of 196 patients . Patients were selected at r and om for treatment . There were no differences between the groups in terms of age , weight , sex , blood pressure , concurrent illness or concomitant therapy . Blood pressure control and apparent adverse effects were similar for both groups ; the overall withdrawal rate from each group was similar . Compliance , assessed by tablet counts , was significantly improved in the group receiving once-daily therapy . Simplification of the dosage regimen to once-daily therapy appears to improve the patient 's willingness to comply with the physician 's instructions Background : Nearly perfect compliance seems to be indispensable to obtain the maximum benefit from highly active antiretroviral therapy ( HAART ) . Interventions to ensure a high level of adherence during a relatively long‐term period of therapy are necessary . Methods : This is a prospect i ve , r and omized , two‐arm controlled study including patients starting their first‐ or second‐line HAART who were r and omized to receive psychoeducative intervention to implement adherence ( experimental group [ EG ] ) or a usual medical follow‐up ( control group [ CG ] ) . We aim ed to study the efficacy of a psychoeducative intervention to ensure long‐term adherence to HAART , its relation with the virologic efficacy of treatment , and to determine the variables related to long‐term adherence . Visits were made at weeks 0 , 4 , 24 , and 48 for data collection . Self‐reported adherence was registered at each visit and its veracity was tested by r and omized blood analyses performed without previous warning to 40 % of patients . Appropriate adherence was defined as the consumption of ≥95 % of medication prescribed . Statistical analyses were performed both by the as treated ( AT ) and the intention to treat missing = failure ( ITT ) methods . Results : In all , 116 patients were included . At week 48 , 94 % of patients in the EG versus 69 % controls achieved adherence ≥95 % ( p = .008 ) ; 89 % of patients in the EG versus 66 % controls had HIV‐1 RNA levels < 400 copies/ml ( p = .026 ) . Overall , 85 % of patients with adherence ≥95 % but only 45 % of those with adherence < 95 % had viral load ( VL ) < 400 copies/ml ( p = .008 ) . In multivariate analysis , variables significantly related to adherence were having received a psychoeducative intervention ( odds ratio [ OR ] , 6.58 ; p = .04 ) , poor effort to take medication ( OR , 5.38 ; p = .03 ) , and high self‐perceived capacity to follow the regimen ( OR , 13.76 ; p = .04 ) . Self‐reported adherence and drug plasma levels coincided in 93 % of cases . However , differences in adherence did not reach statistical significance in the ITT analysis although a clear tendency toward benefit was observed in EG . Conclusions : Specific and maintained psychoeducative interventions based on excellence on clinical practice are useful to keep high levels of adherence as well as high levels of viral suppression . There is a clear relation between high adherence levels and virologic success . Assessment of certain specific variables related to adherence may be helpful to monitor patient 's compliance in the clinical setting Effective self-management and treatment compliance is important in achieving good symptom control in asthma . The aim of this study was to determine whether asthma nurse intervention during hospital admission could increase knowledge and improve self-management and whether this would influence the number of emergency call-out visits by Genera Practitioners ( GPs ) and hospital re-admissions . Patients with acute asthma ( n=80 ) were assessed by the asthma nurse within 24 h of admission using a British Thoracic Society ( BTS ) guideline -based question naire . Main outcome measures were : know edge of inhalers , self-management plans , peak flow monitoring , recognition of worsening symptoms and appropriate emergency action , Following r and omization , half received nurse intervention during hospitalization . All received a follow-up question naire 6 weeks post-discharge and again at 6 months ( response rates 86 % and 81 % respectively ) . GPs were contacted by postal question naire after 4 months . Question naire responses indicated an increase in knowledge in the intervention group , along with an ability to identify appropriate action on worsening symptoms . Emergency GP call-outs were more frequent in the control group in the 4 months post-discharge . Hospital re-admission rates were similar in both groups . Asthma nurse intervention appeared to increase knowledge of asthma management , maintained throughout the study period , but had no significant impact on reducing re-admissions to hospital OBJECTIVE to examine the effects and feasibility of educating and empowering older people with ischaemic heart disease using trained senior lay health mentors . DESIGN r and omised controlled trial with blinded evaluation . SETTING Falkirk and District Royal Infirmary . PARTICIPANTS in patients and out patients aged 60 or over attending secondary care with a diagnosis of angina or acute myocardial infa rct ion . Three-hundred and nineteen entered and 289 completed exit assessment s. The intervention group took part in mentoring groups for 1 year , meeting monthly for 2 hours , each led by two trained lay health mentors in addition to st and ard care . MAIN OUTCOME MEASURES primary outcome measures were changes in coronary risk factors , medication usage and actual use of secondary care health services . Secondary outcomes were total and cardiovascular events ; changes in medication compliance , non-medical support requirement , health status and psychological functioning , and social inclusion . RESULTS there were significant improvements in a reported current exercise score ( mean + 0.33 , + 0.02 to + 0.52 ) , in the average time spent walking per week by 72 minutes ( + 1 to + 137 minutes ) , and in the SF36 Physical Functioning Score ( + 6.1 , + 2.4 to + 9.5 ) . There was a 1.0 % reduction in total fat ( 95 % CI -3.0 % to -0.6 % ) and a 0.6 % reduction in saturated fat ( 95 % CI -1.5 % to -0.03 % ) . The intervention group showed reduced outpatient attendance for coronary heart disease ( -0.25 appointments , -0.61 to -0.08 ) . Attendance rates were high . Socio-economic grouping did not affect participation . CONCLUSIONS Lay Health Mentoring is feasible , practical and inclusive , positively influencing diet , physical activity , and health re source utilisation in older subjects with ischaemic heart disease without causing harm OBJECTIVE This study reports 6- and 12-month follow-up for the families of adolescents with diabetes who participated in a trial of Behavioral-Family Systems Therapy ( BFST ) . RESEARCH DESIGN AND METHODS A total of 119 families of adolescents with type 1 diabetes were r and omized to 3 months of treatment with either BFST , an education and support ( ES ) group , or current therapy ( CT ) . Family relationships , adjustment to diabetes , treatment adherence , and diabetic control were assessed at baseline , after 3 months of treatment , and 6 and 12 months later . This report focuses on the latter two evaluations . RESULTS Compared with CT and ES , BFST yielded lasting improvements in parent-adolescent relationships and diabetes-specific conflict . Delayed effects on treatment adherence emerged at 6- and 12-month follow-ups . There were no immediate or delayed effects on adolescents ' adjustment to diabetes or diabetic control . CONCLUSIONS BFST yielded lasting improvement in parent-adolescent relationships and delayed improvement in treatment adherence , but it had no effect on adjustment to diabetes or diabetic control . A variety of adaptations to BFST could enhance its impact on diabetes outcomes A 24-week open-label clinical trial was conducted in 195 HIV-infected adults commonly underrepresented in research ( 35 % female , 71 % African American , 21 % Hispanic , and 20 % injection drug users [ IDUs ] ) to evaluate the effect of an HIV educational program on efficacy and adherence with a simple , compact , twice-daily triple nucleoside regimen containing a lamivudine ( 150 mg)/zidovudine ( 300 mg ) combination ( COM ) tablet plus abacavir ( ABC ) , 300 mg . At baseline , the patients ' median plasma HIV-1 RNA level was 4.18 log10 copies/mL and the median CD4 + cell count was 379 cells/mm3 . Patients were r and omized 1:1 to 4 modules of the Tools for Health and Empowerment HIV education intervention plus routine counseling ( EI + RC ; n = 96 ) or to routine counseling alone ( RC ; n = 99 ) . No differences between the EI + RC and RC treatment arms were observed with respect to the proportion of patients achieving plasma HIV-1 RNA levels
Output:
| CONCLUSION Several types of interventions are effective in improving medication adherence in chronic medical conditions , but few significantly affected clinical outcomes |
MS211995 | ***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 describe the effect of subfoveal choroidal neovascularization ( CNV ) from age-related macular degeneration ( AMD ) on health-related quality of life ( HRQOL ) of patients at enrollment in two r and omized clinical trials ; to examine the relation of visual acuity to HRQOL ; to compare HRQOL scores between participants with unilateral and bilateral CNV independent of other characteristics . DESIGN R and omized clinical trials . METHODS Two Submacular Surgery Trials ( SST ) recruited patients with AMD and either new subfoveal CNV ( Group N Trial ) or predominantly hemorrhagic CNV ( Group B Trial ) . Health-related quality of life interviews included the National Eye Institute Visual Function Question naire [ NEI-VFQ ] , the SF-36 Health Survey , and the Hospital Anxiety and Depression Scale [ HADS ] . Linear correlation and regression analyses were used to relate baseline HRQOL scores to visual acuity and bilateral disease . RESULTS Interview data were analyzed for 789 AMD patients : 454 patients in the Group N Trial and 335 patients in the Group B Trial . Participants reported poor vision-related functioning in many domains measured by the NEI-VFQ ( mean overall scores of 65 for Group N and 63 for Group B ) . Visual acuity of the better eye was strongly associated with NEI-VFQ scores but not with SF-36 or HADS scores . After adjusting for visual acuity of the better eye and other factors , bilateral cases had NEI-VFQ overall scores six points lower than unilateral cases in Group N Trial and 10 points lower than unilateral cases in the Group B Trial . CONCLUSIONS Subfoveal CNV profoundly affects vision-related quality of life . The effect is more pronounced with bilateral disease , even after controlling for visual acuity PURPOSE To assess patient perceptions concerning discomfort and changes in vision associated with intravitreal triamcinolone injections ( IVTA ) . DESIGN Prospect i ve consecutive case series . METHODS Fifty patients treated with IVTA between June 2003 and February 2005 were interviewed by telephone 10 to 12 weeks after injection . Each question was answered on a 1 to 5 scale . RESULTS There was no significant difference in reported amount of ocular discomfort pre-injection vs post-injection ( 1.0 vs 1.1 , respectively ) . Expected pain level ( 2.9 ) was higher than the actual pain level ( 1.6 ; P < .001 ) . Patients ' self-reported vision improved from 2.7 to 3.7 ( P < .001 ) . Thirty ( 60 % ) patients reported improved vision and 20 ( 40 % ) reported no change . Thirty-three ( 66 % ) patients reported more visual improvement than expected . CONCLUSIONS Patient expectation of discomfort during IVTA was greater than their actual experience ; approximately two-thirds of patients reported improved vision and about one-third reported improved functional status after injection Purpose : To determine factors associated with patients ' comfort during routine in-office intravitreal injection . Methods : Sixty patients receiving intravitreal injections over 15 months for macular edema because of diabetes , age-related macular degeneration , or retinal vein occlusion who were r and omized into 3 groups to receive 1 of 3 commonly used forms of anesthesia — TetraVisc , proparacaine HCl , or tetracaine HCl — before receiving intravitreal injection were studied . Fifteen minutes after injection , patients were asked to rate their pain from 0 ( no pain/no distress ) to 10 ( agonizing pain/unbearable distress ) using a Visual Analog Pain score survey . Self-reported pain scores were stratified by age , gender , diagnosis , injection number , substance injected , needle gauge , and visual acuity improvement . Results : Intravitreal injection was associated with low pain scores . Patients receiving tetracaine reported a statistically significant lower pain score ( 3.05 ± 2.01 ) than patients receiving proparacaine ( 3.17 ± 2.18 ) or TetraVisc ( 3.3 9± 2.26 ; P < 0.01 ) . Other important factors influencing pain score significantly ( P < 0.01 ) included improved vision from previous injection , female sex , and age > 65 years . Pain scores decreased with each consecutive injection . Conclusion : Pain associated with intravitreal injection is generally mild , and may be associated with epidemiologic and environmental factors PURPOSE To determine the quality of life ( QOL ) of patients with bilateral severe age-related macular degeneration ( AMD ) before macular translocation with 360 degrees peripheral retinectomy . DESIGN Prospect i ve , consecutive , noncomparative case series . METHODS An observational study assessed vision-related and general health QOL using the 25-item National Eye Institute Visual Function Question naire ( NEI VFQ-25 ) and the Medical Outcomes Study 12-item short form ( SF-12 ) surveys , respectively . Mean QOL scores were correlated with patient age , duration of vision loss , and visual function . Mean QOL scores in study patients were compared with mean QOL scores in groups of patients with low vision , patients with AMD of varying severity , and reference population s. MAIN OUTCOME MEASURES National Eye Institute VFQ-25 and SF-12 QOL scores . RESULTS Seventy patients with a mean age of 76.4 years were studied . Mean distance visual acuity ( VA ) was 62.4 ( Early Treatment Diabetic Retinopathy Study letters ) , mean near VA was 0.81 ( logarithm of the minimum angle of resolution ) , and mean reading speed was 74.9 words per minute . Important NEI VFQ-25 quality of vision subscales ( general vision , difficulty with distance tasks , difficulty with near tasks ) and vision-specific subscales ( dependency , role difficulties , mental health , social function limitations ) tended to correlate negatively with increasing patient age and duration of vision loss , but correlated positively with better VA and reading speed . The mean QOL scores for these important quality of vision and vision-specific subscales were significantly worse than or similar to mean scores in patients with low vision , and significantly worse than scores in patients with AMD of varying severity and a reference population . The mean SF-12 physical composite score in study patients was similar to that seen in patients with AMD of varying severity , but significantly higher than that in patients with low vision and a reference population . The SF-12 mental composite score in study patients was similar to those of all 3 comparison groups . CONCLUSIONS Patients with bilateral severe AMD have vision-related QOL similar to that of patients with low vision but significantly worse than those of patients with AMD of varying severity and persons without eye disease . This inability to perform vision-related daily tasks is not related to general health problems OBJECTIVE To examine ( 1 ) the prevalence of depressive disorders in community-dwelling adults with advanced age-related macular degeneration ( AMD ) and ( 2 ) the relationship in this population between depression , visual acuity , the number of comorbid medical conditions , disability caused by vision loss as measured by the National Eye Institute-Vision Function Question naire ( NEI-VFQ ) and the vision-specific Sickness Impact Profile ( SIPV ) , and disability caused by overall health status as measured by the Sickness Impact Profile-68 ( SIP ) . DESIGN Analysis of cross-sectional baseline data from a r and omized clinical trial . PARTICIPANTS Participants were 151 adults aged 60 and older ( mean age , 80 years ) with advanced macular degeneration whose vision was 20/60 or worse in their better eye . METHODS Subjects were interviewed using measures of depression , disability , and chronic medical conditions . Visual acuity was obtained . Nonparametric correlation analyses and linear regression analyses were performed . MAIN OUTCOME MEASURES Structured Clinical Interview for DSM-IV ( SCID-IV ) , Geriatric Depression Scale ( GDS ) , NEI-VFQ , SIPV , and SIP . RESULTS Of the participants , 32.5 % ( n = 49 ) met SCID-IV criteria for depressive disorder , twice the rate observed in previous studies of community-dwelling elderly . Over and above depression ( GDS ) , visual acuity aided in prediction of the level of vision-specific disability ( NEI-VFQ and SIPV ) . CONCLUSIONS Depressive disorder is a significant problem for the elderly afflicted with advanced macular degeneration . Further research on psychopharmacologic and psychotherapeutic interventions for depressed AMD patients is warranted to improve depression and enhance functioning . Over and above depression , visual acuity aided in predicting vision-specific disability . Treatment strategies that teach patients to cope with vision loss should be developed and evaluated Aim : To investigate the effects of an informational video on patient expectations and satisfaction with day-stay cataract surgery . Methods : 141 patients undergoing day-stay cataract surgery were r and omised into one of two video groups , explaining either what to expect from the cataract surgery or the anatomy of cataract . Patients were surveyed as to their expectations for visual outcome , anxiety , risk , and discomfort result ing from the surgery . After the operation , patients were again asked to rate their experience of anxiety , discomfort , risk , comprehension , overall satisfaction , and comparison with expectations . Results : 84 % of patients already thought they received enough or too much information . The expectations video group expected more risk and discomfort than the anatomy video group . Yet , after the surgery , the expectations video group was significantly more satisfied , understood better what was happening to them , and felt less anxious . There was no difference in the discomfort or risk actually experienced , or the expected visual outcomes . Patients with previous cataract surgery experience expected less anxiety and discomfort , and found the surgery closer to their expectations . None the less , previous cataract surgery experience did not negate the effects of the video . Conclusions : This study demonstrates that a simple , inexpensive videotape showing patients what to expect from cataract surgery results in significant increases in patient underst and ing of and satisfaction with the cataract surgery , as well as a decrease in anxiety . These effects were independent of patients ’ expected outcomes or previous experience with cataract surgery , and despite the fact that patients generally thought they had already received enough information PURPOSE To compare the anesthetic effectiveness of 3 topical agents used for intravitreal injections . DESIGN R and omized , triple-armed , double-blinded , prospect i ve , single-centered trial in patients receiving intravitreal ranibizumab for neovascular age-related macular degeneration . METHODS Patients were r and omized 1:1:1 to receive 0.5 % tetracaine hydrochloride drops and a 4 % lidocaine pledget ( n = 31 ) , 0.5 % tetracaine hydrochloride drops alone ( n = 31 ) , or 4 % cocaine ( + epinephrine 1/100,000 ) drops alone ( n = 31 ) . Patients were asked to score their pain experience using a visual analogue scale ( VAS ) immediately following and 15 minutes after their injection . The average of these scores was used as the primary outcome . The physician performing the procedure separately scored his perception of the patients ' pain using the Wong-Baker FACES scale . RESULTS Means of the averaged VAS pain score for Groups 1 , 2 , and 3 were : 19 ( 95 % confidence interval [ CI ] 12 - 26 ) , 21 ( 95 % CI 13 - 29 ) , and 21 ( 95 % CI 16 - 27 ) respectively . Mean Wong-Baker pain scores for Groups 1 , 2 , and 3 were 1.9 ( 95 % CI 1.3 - 2.6 ) , 2.1 ( 95 % CI 1.4 - 2.7 ) , and 2.3 ( 95 % CI 1.6 - 3.1 ) respectively . There was no significant difference ( P = .549 ) between groups for average VAS pain score . Similarly , there was no significant difference ( P = .790 ) for the physician-perceived pain score between groups . CONCLUSIONS There was no clinical difference in patient pain experience between the 3 anesthetic options tested . The addition of a 4 % lidocaine pledget offered no clinical advantage in pain relief compared to 0.5 % tetracaine or 4 % cocaine ( + epinephrine 1/100,000 ) drops alone Purpose : To compare the effectiveness of four different anesthetic methods for intravitreal injection . Methods : Twenty-four patients each received four intravitreal injections using each of four types of anesthesia ( proparacaine , tetracaine , lidocaine pledget , and subconjunctival injection of lidocaine ) in a prospect i ve , masked , r and omized block design . Pain was grade d by the patient on a 0 to 10 scale for both the anesthesia and the injection . Results : The average combined pain scores for both the anesthesia and the intravitreal injection were 4.4 for the lidocaine pledget , 3.5 for topical proparacaine , 3.8 for the subconjunctival lidocaine injection , and 4.1 for topical tetracaine . The differences were not significant ( P = 0.65 ) . There were also no statistical differences in the individual anesthesia or injection pain scores . Subconjunctival lidocaine injection had the most side effects . Conclusion : Topical anesthesia is an effective method for limiting pain associated with intravitreal injections
Output:
| These studies have focused primarily on patients ' experiences of the injection procedure with respect to pain and anxiety .
Anticipated discomfort is often greater than actual discomfort experienced during intra-vitreal injection .
However , different stages of the treatment procedure produce varying levels of patient discomfort .
No one method of anaesthesia has consistently been shown to be more effective in reducing discomfort associated with treatment .
Common reasons underlying patient apprehension surrounding treatment include the thought of having an injection , fear of losing eyesight and fear of the unknown . |
MS211996 | ***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: Antral biopsy specimens from 89 consecutive patients with nonulcer dyspepsia and erosive prepyloric changes included in a prospect i ve , r and omized , double-blind 4-wk study of the effect of an aluminum-magnesium antacid ( 120 mmol/day ) or pirenzepine ( 50 mg b.i.d . ) vs. placebo were examined histologically . Campylobacter pylori ( CP ) was found by light microscopy of silver-stained sections in 25 patients ( 28 % ) . Campylobacter pylori-positive patients were on average older than CP-negative patients ( p = 0.02 ) . There was a strong association between CP colonization and acute inflammation ( p less than 0.001 ) , both being rare in the absence of chronic inflammation . During treatment with antacids , the density of CP decreased ( p less than 0.001 ) without any improvement of the inflammatory reaction . On the contrary , the number of patients with gastritis tended to increase after antacids as compared with placebo ( p less than 0.10 ) . A separate analysis showed no symptomatic effect of the drugs . Thus , neither nonulcer dyspepsia nor erosive prepyloric changes are strongly associated with antral CP colonization or acute inflammation . Aluminum-magnesium antacids may suppress antral CP infection without healing the gastritis or relieving symptoms The aim of this study was to determine the effect of colloidal bismuth subcitrate ( De Nol ) on symptoms and gastric histology in patients with non-ulcer dyspepsia . In a single centre trial , patients with food related upper abdominal pain not caused by ulcer disease were r and omised to receive one tablet of colloidal bismuth subcitrate or matching placebo four times daily for eight weeks . Seventy three patients were entered and 51 completed the trial : 28 patients in the colloidal bismuth subcitrate group and 23 in the placebo group . Overall there was no difference between the two groups in terms of symptom relief . Among patients with histological gastritis ( n = 23 ) , however , those who took colloidal bismuth subcitrate used fewer antacid tablets ( for three of four fortnightly periods ) and were more likely to become asymptomatic ( eight of 11 v three of 12 , p less than 0.05 ) ; their gastritis was more likely to resolve ( five of 10 v 0 of 12 , p less than 0.025 ) and their gastric biopsies more likely to become negative for Helicobacter like organisms ( eight of nine v 0 of 12 , p less than 0.001 ) when compared with patients taking placebo . In contrast , patients who did not have gastritis in their index biopsies ( n = 28 ) fared similarly whether they received colloidal bismuth subcitrate or placebo . Our results indicate that the administration of colloidal bismuth subcitrate benefited non-ulcer dyspepsia patients with gastritis but had no effect on those without Duodenal biopsy specimens from 471 adults and 47 children were examined to determine the prevalence and distribution of gastric epithelium in the duodenal bulb in relation to age , gender , gastroduodenal inflammation , smoking , alcohol and consumption of nonsteroidal anti-inflammatory drugs ( NSAID ) . Gastric metaplasia was present in the anterior wall duodenal biopsy specimen in 31 % , was significantly less common in patients under 17 than in adults , and was more common in males than females . In sixty two adults who underwent multiple radial duodenal biopsy gastric metaplasia was r and omly distributed around the duodenal circumference ; sixty three per cent of the patients with gastric metaplasia found on multiple biopsy were detected by just the anterior biopsy . Gastric metaplasia was not obviously associated with alcohol , cigarette , or NSAID consumption . While the presence of gastric metaplasia was associated with adulthood , male sex , and low fasting gastric juice pH , its extent was associated with active duodenitis and Helicobacter-associated gastritis . On logistic regression , gastric metaplasia in the duodenum and gastric Helicobacter pylori were independent predictors of active duodenitis , but were not significantly associated with inactive duodenal inflammation . H pylori was observed in duodenal biopsy specimens from 32 patients , all with active duodenitis ; bacteria were present only on foci of gastric metaplasia , and were more likely to be seen when the metaplasia was extensive . It is proposed that inflammatory injury to the duodenal mucosa by H pylori may stimulate the development of further gastric metaplasia , and that the area of duodenum susceptible to colonisation with H pylori may therefore increase progressively until mucosal integrity is compromised and ulceration supervenes BACKGROUND The efficacy of anti-Helicobacter pylori treatment and cytoprotective drugs in H. pylori-positive and -negative non-ulcer dyspepsia ( NUD ) , respectively , is debatable . METHODS In a r and omized study , the efficacy of anti-H. pylori treatment versus sucralphate was tested in patients with NUD . One hundred and twelve patients with NUD , 62 positive and 50 negative for H. pylori were studied . Of 62 patients positive for H. pylori , 32 were treated with triple therapy ( colloidal bismuth subcitrate , tetracycline and metronidazole ) for 2 weeks and the remaining 30 were treated with sucralphate ( 1 g , q.i.d . ) for 4 weeks . Of 50 patients negative for H. pylori , 25 each were treated with either sucralphate ( 1 g , q.i.d . ) or ranitidine ( 150 mg , b.d . ) for 4 weeks . RESULTS In patients with NUD and H. pylori infection , triple therapy eradicated H. pylori in 88 % and was superior to sucralphate in producing symptom relief ( 81 vs 33 % , P = 0.0003 ) and histological improvement in gastritis ( 73 vs 30 % , P = 0.003 ) . In the H. pylori-negative group , sucralphate was superior to ranitidine with regard to symptom relief ( 68 vs 36 % , P = 0.04 ) and improvement in gastritis ( 44 vs 12 % , P = 0.09 ) . The symptomatic improvement persisted until 12 weeks after the start of treatment in triple therapy group only . CONCLUSIONS In patients with NUD associated with H. pylori , triple therapy was better than sucralphate in terms of symptomatic and histological improvement . However , sucralphate was superior to ranitidine in providing symptom relief in patients with H. pylori-negative NUD This r and omised double blind placebo controlled study evaluated the effectiveness of colloidal bismuth subcitrate ( CBS ) , ampicillin and their combination in the treatment of Helicobacter Pylori in non-ulcer dyspepsia ( NUD ) and assessed if elimination of this organism is associated with improvement of gastritis and the symptoms . Forty-eight NUD patients with H. pylori and histologic gastritis were r and omly allocated to one of the three regimens for 28 days . Symptoms were assessed before and after treatment . Forty-three patients completed the trial . Repeat endoscopy within 48 hours of completing treatment showed suppression of H. pylori in 6 of 7 patients ( 85.7 % ) on combined therapy and one of 8 patients ( 12.5 % ) on CBS therapy ( p = 0.0205 ) . There was no suppression of the bacteria in patients treated with ampicillin . Repeat endoscopy performed 2 weeks after completing treatment showed suppression of H. pylori in 3 of 7 patients ( 42.9 % ) on combined therapy and none in the other two groups . Patients on combined therapy who had suppression of H. pylori , 48 hours or 2 weeks after completing treatment were noted to have historical improvement of their gastritis ( p = 0.0001 and p = 0.05 respectively ) . This was also associated with improvement of symptoms in these patients This study investigated the effect of colloidal bismuth subcitrate and cimetidine on Campylobacter pylori in peptic disease . In 74 % of 135 patients with peptic disease diagnosed at endoscopy C pylori was detected before treatment . Compared with cimetidine , colloidal bismuth subcitrate significantly decreased the incidence of C pylori after six weeks of treatment ( p less than 0.001 ) . In the colloidal bismuth subcitrate group , subsequent healing of the lesion was correlated with the clearance of C pylori , unlike in the cimetidine group . C pylori was strongly associated with the presence of histological gastritis , which was decreased by colloidal bismuth subcitrate ( p less than 0.001 ) Gastritis caused byHelicobacter pylori ( HP ) is common in patients with nonulcer dyspepsia ( NUD ) , but an etiologic relationship between the histologic lesion and clinical symptoms is unproven . HP is inhibited by bismuth subsalicylate ( BSS ) , a traditional remedy for dyspeptic complaints . The aim of this study was to assess the short- and long-term effects of BSS on HP , gastritis , and symptoms in patients with NUD . One hundred twenty-six patients with NUD who were shown to be infected withH. pylori ( HP+ ) were enrolled . There was a two-week placebo run-in period to eliminate placebo responders . Fifty patients remained symptomatic and were r and omly assigned to therapy with either BSS liquid or a matching placebo . EGD , biopsy , and clinical evaluations were performed at entry , at week 5 ( end of therapy ) , at week 9 ( four weeks after therapy ) , or at time of symptomatic relapse . Twenty-seven patients received placebo and 23 patients received BSS . BSS suppressedH. pylori in 15/23 patients ( 65 % ) and eradicated it in one patient , whereas the placebo had no effect onH. pylori . Gastritis improved during therapy with BSS but relapsed by week 9 . There was no significant change in level of dyspeptic symptoms during or after treatment , although one month after the end of treatment , the patients in the BSS group consistently had lower symptom scores and fewer symptomatic days for all symptoms measured . The study confirms that BSS given for three weeks suppresses but does not usually eradicateH. pylori . Such short-term suppression ofH. pylori heals gastritis but does not result in clinical improvement We conducted a 12-week , double-blind , r and omized , placebo-controlled trial to determine whether cimetidine ( 300 mg with meals and at bedtime ) or a convenient , liquid aluminum-magnesium antacid regimen ( 15 ml one hour after meals and at bedtime ) would expedite healing or relief of symptoms in patients with benign gastric ulcer . Of the 101 patients who completed the trial according to protocol , 32 received the antacid , 36 cimetidine , and 33 placebo . At 4 , 8 , and 12 weeks after entry , ulcers had healed in a larger percentage of patients treated with cimetidine than of those treated with placebo : 53 , 86 , and 89 per cent of the cimetidine group versus 26 , 58 , and 70 per cent of the placebo group ( P = 0.02 , 0.01 , 0.05 ) , respectively . Healing at the three intervals had occurred in 38 , 70 , and 84 per cent , respectively , of the antacid-treated patients . Neither cimetidine nor antacid was more effective than placebo in relieving symptoms . The presence or absence of symptoms during the fourth and eighth treatment weeks was a poor predictor of the presence of absence of an ulcer crater . We conclude that cimetidine significantly hastens the healing of benign gastric ulcer Non-ulcer dyspepsia ( NUD ) is a common complaint in which no systematic illness or organic proximal alimentary tract disease can be identified . The pathophysiology of NUD is probably heterogeneous . Eighty-two subjects with NUD were studied in a prospect i ve r and omized placebo-controlled study to assess the efficacy of colloidal bismuth subcitrate ( CBS ) chewable tablets at a dose of four tablets daily for 1 month . The role of Campylobacter pylori and associated histological gastritis was evaluated . Sixty-one percent of NUD patients had C. pylori in the gastric antrum compared with 25 % of age-matched controls . C. pylori was associated with acute and chronic inflammation ( P less than 0.001 ) in the antrum . C. pylori was cleared in 59 % of CBS-treated subjects compared with only 4 % placebo ( P less than 0.05 ) . Both acute and chronic inflammation improved in subjects cleared of bacteria . Clearance of C. pylori and histological improvement was associated with a significant decrease in symptoms . In C. pylori negative subjects improvement in symptoms occurred in both the placebo and active treatment groups . This study would suggest that C. pylori and associated histological gastritis may play a role in non-ulcer dyspepsia OBJECTIVES : The aim of this study was to assess the still controversial role of treatment of Helicobacter pylori ( H. p
Output:
| These trials were smaller and had a shorter follow-up but suggested H pylori eradication was more effective than either H2 receptor antagonists or sucralfate in treating non-ulcer dyspepsia .
H pylori eradication therapy has a small but statistically significant effect in H pylori positive non-ulcer dyspepsia . |
MS211997 | ***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 We evaluated the effects of exercise on neurobehavioral function in healthy older people more than 75 years of age . DESIGN A r and omized controlled trial with 6-month follow-up was conducted . SETTING The study was performed in the rural town of Kahoku , Japan , the population of which is considered representative of the older population of Japan . PARTICIPANTS We studied 42 healthy volunteers ( 18 men and 24 women ; mean age , 79 years ( range 75 to 87 years ) ) who were r and omly assigned to one of two groups , exercise or control . INTERVENTION Subjects assigned to the exercise group were instructed to exercise for 60 minutes twice a week for 6 months . Subjects in the control group were not instructed to engage in an specific exercise regimen . MEASUREMENTS The following measurements were recorded for both groups at baseline and at 6-month follow-up : ( 1 ) Neurobehavioral function as determined by the following tests : Mini-Mental State Exam ( MMSE ) , Hasegawa Dementia Scale Revised ( HDSR ) , Visuospatial Cognitive Performance Test ( VCP-test ) , Button score , Up & Go test , and Functional Reach ; and ( 2 ) Body mass index and blood pressure . RESULTS The effects of exercise were shown in the Up & Go test , and Functional Reach ( ANOVA with repeated measures ) . CONCLUSION This study demonstrates the acceptability and effectiveness of exercise on neurobehavioral function , even in older people more than 75 years of age The goal was to determine the existence of differential effects of long-term moderate- or low-intensity exercise on selected bio-behavioral variables in 72 community-dwelling persons over 60 years of age . After screening , subjects were r and omly assigned to a moderate ( n = 39 , 60 - 70 % heart rate reserve [ HRR ] ) or low ( n = 33 , 30 - 40 % HRR ) intensity exercise protocol . Both groups exercised three times per week for 9 months and dependent measures were taken at baseline , 4.5 months and after 9 months . Repeated measures ANOVA with Tukey post hoc comparisons constituted the analysis approach . Moderate exercise showed no superiority over low-intensity exercise ; both groups improved about equally . Variables that significantly improved included : self-reported sleep ( sleep quantity and dream recall ) , mental status ( attention/concentration , short-term memory and higher cognitive functioning ) , health perceptions ( health outlook , health worry , rejection of the sick role ) , and cardiovascular fitness indicators ( submaximum stress test heart rate , maximum oxygen consumption ( VO2max ) , maximum work capacity and maximum exercise time ) . Similarity of outcomes in both groups may mean that the moderate exercise protocol was too conservative . Conversely , the findings may indicate that lower levels of exercise , which may be safer and more feasible over time , do improve fitness levels , prolong independent functioning , and promote positive perceptions of well-being in older adults BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Abstract A r and omised controlled trial was undertaken to measure effects of exercise on : 1 . Progression of cognitive symptoms related to dementia using the Clock-Drawing Test ( Shulman et al. 1993 ) ; and 2 . Disability using the Revised Elderly Persons Disabilities Scale ( REPDS ; Fleming and Bowles 1993 ) . Data was analysed from 75 nursing home residents with dementia who were r and omly assigned to one experimental group and two control groups . Group 1 ( control ) received no intervention . Group 2 ( control ) received a social visit equivalent in duration and frequency as those undertaking the exercise program in the experimental group , Group 3 . A specifically design ed , frail aged appropriate , twelve-week exercise program was undertaken by the those in the experimental group three times per week . Each session lasted for 30 minutes . Findings from the : 1 . Clock-drawing test showed that exercise may slow the rate of progression of the cognitive symptoms related to dementia ; and 2 . REPDS showed that exercise slowed and reversed disability in some of the activities of daily living BACKGROUND The present study examined whether aerobic fitness training of older humans can increase brain volume in regions associated with age-related decline in both brain structure and cognition . METHODS Fifty-nine healthy but sedentary community-dwelling volunteers , aged 60 - 79 years , participated in the 6-month r and omized clinical trial . Half of the older adults served in the aerobic training group , the other half of the older adults participated in the toning and stretching control group . Twenty young adults served as controls for the magnetic resonance imaging ( MRI ) , and did not participate in the exercise intervention . High spatial resolution estimates of gray and white matter volume , derived from 3D spoiled gradient recalled acquisition MRI images , were collected before and after the 6-month fitness intervention . Estimates of maximal oxygen uptake ( VO2 ) were also obtained . RESULTS Significant increases in brain volume , in both gray and white matter regions , were found as a function of fitness training for the older adults who participated in the aerobic fitness training but not for the older adults who participated in the stretching and toning ( nonaerobic ) control group . As predicted , no significant changes in either gray or white matter volume were detected for our younger participants . CONCLUSIONS These results suggest that cardiovascular fitness is associated with the sparing of brain tissue in aging humans . Furthermore , these results suggest a strong biological basis for the role of aerobic fitness in maintaining and enhancing central nervous system health and cognitive functioning in older adults Objective : To examine the effects of aerobic exercise or vitamin B supplementation on cognitive function in older adults with mild cognitive impairment ( MCI ) . Design : R and omised placebo-controlled trial . Setting : General community . Participants : Community-dwelling adults aged 70–80 with MCI . Interventions : The 152 participants were r and omly assigned to two interventions : ( 1 ) a twice-weekly , group-based , moderate-intensity walking programme ( WP , n = 77 ) or a low-intensity placebo activity programme ( n = 75 ) for one year ; and ( 2 ) daily vitamin pill containing 5 mg folic acid , 0.4 mg vitamin B-12 , 50 mg vitamin B-6 ( FA/B12/B6 , n = 78 ) or placebo pill ( n = 74 ) for one year . Outcome measures : Cognitive function , measured with neuropsychological tests at baseline and after six and 12 months . Results : Median session attendance at the exercise programmes ( 25th–75th percentile ) was 63 % ( 2%–81 % ) and median compliance with taking pills ( 25th–75th percentile ) was 100 % ( 99%–100 % ) . Gender was an effect modifier . Intention-to-treat analysis revealed no main intervention effect for either intervention . In women in the WP , attention ( Stroop combination task ) improved by 0.3 seconds ( p = 0.04 ) and memory ( auditory verbal learning test ) by 0.04 words ( p = 0.06 ) with each percentage increase in session attendance . In men attending at least 75 % of the sessions , the WP improved memory ( β 1.5 ( 95 % CI : 0.1 to 3.0 ) words ) . Conclusion : The walking programme and /or FA/B12/B6 supplementation were not effective in improving cognition within one year . The walking programme , however , was efficacious in improving memory in men and memory and attention in women with better adherence . Trial registration : International St and ard R and omised Controlled Trial Number Register , 19227688 , http://www.controlled-trials.com/is rct Abstract : A r and omised controlled trial was conducted to determine whether a 12–month program of group exercise had beneficial effects on physiological and cognitive functioning and mood in 187 older community – dwelling women . The exercisers ( n= 94 ) and controls ( n= 93 ) were well matched in terms of the test measures and a number of health and life – style assessment s. The mean number of classes attended by the 71 exercise subjects who completed the program was 59.0 ( range 26 to 82 ) . At the end of the trial , the exercisers showed significant improvements in reaction time , strength , memory span and measures of wellbeing when compared with the controls . There was also an indication that anxiety had been reduced in the exercisers . Within the exercise group , improvements in memory span were associated with concomitant improvements in both reaction time and muscle strength . Also , within this group , initial mood measures were significantly inversely associated with improvements at retest , which suggests that the program may have normalised mood states in subjects who had high initial depression , anxiety and stress levels , rather than inducing improvements in all subjects . These findings suggest that group exercise has beneficial effects on physiological and cognitive functioning and wellbeing in older people PURPOSE The purpose of this study was to assess the impact of 24 wk of resistance training at two different intensities on cognitive functions in the elderly . METHODS Sixty-two elderly individuals were r and omly assigned to three groups : CONTROL ( N = 23 ) , experimental moderate ( EMODERATE ; N = 19 ) , and experimental high ( EHIGH ; N = 20 ) . The volunteers were assessed on physical , hemodynamic , cognitive , and mood parameters before and after the program . RESULTS On the 1 RM test ( P < 0.001 ) , the two experimental groups performed better than the CONTROL group , but they did not show differences between themselves . The EHIGH group gained more lean mass ( P = 0.05 ) than the CONTROL group and performed better on the following tests : digit span forward ( P < 0.001 ) , Corsi 's block-tapping task backward ( P = 0.001 ) , similarities ( P = 0.03 ) , Rey-Osterrieth complex figure immediate recall ( P = 0.02 ) , Toulouse-Pieron concentration test errors ( P = 0.01 ) , SF-36 ( general health ) ( P = 0.04 ) , POMS ( tension-anxiety , P = 0.04 ; depression-dejection , P = 0.03 ; and total mood disorder , P = 0.03 ) . The EMODERATE group scored higher means than the CONTROL group on digit span forward ( P < 0.001 ) , Corsi 's block-tapping task backward ( P = 0.01 ) , similarities ( P = 0.02 ) , Rey-Osterrieth complex figure immediate recall ( P = 0.02 ) , SF-36 ( general health , P = 0.005 ; vitality , P = 0.006 ) , POMS ( tension-anxiety , P = 0.001 ; depression-dejection , P = 0.006 ; anger-hostility , P = 0.006 ; fatigue-inertia , P = 0.02 ; confusion-bewilderment , P = 0.02 ; and total mood disorder , P = 0.001 ) . We also found that IGF-1 serum levels were higher in the experimental groups ( EMODERATE , P = 0.02 ; EHIGH , P < 0.001 ) . CONCLUSIONS Moderate- and high-intensity resistance exercise programs had equally beneficial effects on cognitive functioning Objective : To evaluate the effect of a musical exercise programme on mood state and cognitive function in women with dementia . Design : R and omized controlled trial . Setting : Public Psychiatric Hospital Rekem , Belgium . Patients : Twenty-five patients with dementia . Interventions : Fifteen patients attended exercise training for three months , which consisted of daily physical exercises supported by music for 30 min/session
Output:
| Beneficial effects of various exercise programs on aspects of cognition have been observed in studies among subjects with and without cognitive decline .
The majority of the studies , however , did not find any effect . |
MS211998 | ***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: We carried out a prospect i ve , r and omised controlled trial on two groups of 40 patients with painful calcific tendonitis and a mean age of 48.4 years ( 32.5 to 67.3 ) . All were to undergo arthroscopic removal of the calcific deposit within six months after r and omisation . The 40 patients in group I received ultrasound-guided needling followed by high-energy shock-wave therapy and the 40 in group II had shock-wave therapy alone . In both groups one treatment consisting of 2500 impulses of shock waves with an energy flux density of 0.36 mJ/mm(2 ) was applied . The clinical and radiological outcome was assessed using the 100-point Constant shoulder scoring system and st and ardised radiographs . The mean follow-up was 4.1 months and no patient was lost to follow-up . Both groups had significant improvement in their Constant shoulder score . Radiographs showed disappearance of the calcific deposit in 60.0 % of the shoulders in group I and in 32.5 % of group II ( p < 0.05 ) . Significantly better clinical and radiological results were obtained in group I than in group II . Arthroscopic removal of the deposit was avoided in 32 patients of group I and in 22 of group II . No severe side-effects were recorded . Ultrasound-guided needling in combination with high-energy shock-wave therapy is more effective than shock-wave therapy alone in patients with symptomatic calcific tendonitis , giving significantly higher rates of elimination of the calcium deposits , better clinical results and reduction in the need for surgery PURPOSE To evaluate clinical response to treatment of calcified tendinitis of the shoulder by using a modified percutaneous ultrasonography (US)-guided fine-needle technique . MATERIAL S AND METHODS Thirty shoulders of 30 consecutive patients ( 23 women , seven men ; mean age , 47.4 years ) with chronic shoulder pain ( average duration , 43.1 months ) refractory to medical treatment were treated percutaneously by using a fine needle and US guidance . Patients were prospect ively evaluated by using a shoulder pain and disability index consisting of 13 items and divided into two subcategories : pain and disability . The patient completed the question naire before the procedure and during the follow-up visit approximately 1 month later . A diagnostic US examination was also performed at that time . RESULTS There was a statistically significant improvement in the shoulder pain and disability index total score ( 27.0 % ) and the pain ( 30.5 % ) and disability ( 23.9 % ) scores . According to the index , these results indicate a significant clinical response . CONCLUSION This modified US-guided fine-needle technique for calcified tendinitis of the shoulder appears to be an effective therapy and was less aggressive than previously described percutaneous techniques PURPOSE To compare short- and long-term outcomes of patients with rotator cuff calcific tendonitis who did and did not undergo ultrasonographically (US)-guided percutaneous treatment . MATERIAL S AND METHODS Institutional review board approval and informed patient consent were obtained . Of patients referred for US-guided treatment of rotator cuff calcific tendonitis , 219 ( 86 men , 133 women ; mean age , 40.3 years + /- 10.9 [ st and ard deviation ] ) were treated ; 68 ( 31 men , 37 women ; mean age , 40.2 years + /- 11.3 ) patients refused treatment and served as control subjects . After local anesthesia was induced , two 16-gauge needles were inserted into the calcific deposit . Saline solution was injected through one needle , and the dissolved calcium was extracted through the other needle . Shoulder joint function was assessed by using Constant scores , and pain was assessed by using visual analogue scale ( VAS ) scores . Mann-Whitney U and chi(2 ) tests were performed . RESULTS At baseline , no significant difference in age or sex distribution , Constant score , or VAS score was detected between treated and nontreated ( control ) patients . Compared with control subjects , treated patients reported a significant decrease in symptoms at 1 month ( mean Constant score , 73.2 + /- 6.2 vs 57.5 + /- 3.9 ; mean VAS score , 4.8 + /- 0.6 vs 9.1 + /- 0.5 ) , 3 months ( mean Constant score , 90.2 + /- 2.6 vs 62.6 + /- 7.2 ; mean VAS score , 3.3 + /- 0.4 vs 7.3 + /- 1.8 ) , and 1 year ( mean Constant score , 91.7 + /- 3.1 vs 78.4 + /- 9.5 ; mean VAS score , 2.7 + /- 0.5 vs 4.5 + /- 0.9 ) ( P < .001 ) . Symptom scores were not significantly different between the groups at 5 years ( mean Constant score , 90.9 + /- 3.6 vs 90.5 + /- 4.8 ; mean VAS score , 2.6 + /- 0.5 vs 2.8 + /- 0.7 ) ( P > or= .795 ) and 10 years ( mean Constant score , 91.8 + /- 5.0 vs 91.3 + /- 9.6 ; mean VAS score , 2.5 + /- 0.6 vs 2.7 + /- 0.6 ) ( P > or= .413 ) . CONCLUSION US-guided percutaneous treatment facilitated prompt shoulder function recovery and pain relief . Treated patients had better outcomes than did nontreated patients at 1 year . However , 5 and 10 years after the procedure , the nontreated group reported outcomes similar to those of the treated group OBJECTIVE The purpose of our study was to evaluate the short- and long-term effectiveness of sonographically guided percutaneous needle aspiration and lavage in calcific tendinitis of the shoulder and to study the progress of calcifications and symptoms in the first year after treatment . MATERIAL S AND METHODS Symptoms and radiologic findings after percutaneous aspiration of calcific tendinitis were prospect ively evaluated in the short and the long term using a shoulder pain and disability index , evaluation of shoulder motion , and a survey of the self-perception by the patients regarding the progress of their disease . RESULTS Sixty-seven consecutive shoulders were treated . A significant improvement was seen in shoulder motion , pain , and disability in the short term and in the long term ( p < 0.0001 ) . One year after treatment , 91 % of shoulders had substantially or completely improved , 64 % had perfect motion , and calcifications on radiography had resolved completely or nearly completely in 89 % . A transitory recurrence was observed approximately 15 weeks after treatment in 44.3 % of shoulders that improved . CONCLUSION Percutaneous needle aspiration and lavage is effective in the short term and in the long term in calcific tendinitis of the shoulder , with results similar to or better than those published for other techniques , and it is only slightly invasive and painful . Progress after treatment may include a transitory period of recurrence of the pain OBJECTIVE To define prognostic factors in chronically symptomatic patients with calcific tendinitis of the shoulder . METHODS We evaluated 420 patients ( 488 shoulders ) in the context of a prospect i ve cohort study . Epidemiologic data were assessed . The radiographic and sonographic appearance of the calcific deposits was classified . The mean period of nonoperative therapy was 4.4 years ( range 0.5 - 13.7 years ) . After referral to our institution , st and ardized nonoperative therapy was continued for a minimum of 3 months . Failure of nonoperative therapy was defined as the persistence of symptomatic calcific tendinitis of the shoulder after a minimum of 6 months . Prognostic factors ( determined at P < 0.05 by chi-square test ) were analyzed by logistic regression . RESULTS Of the 420 patients , 269 ( 64 % ) were women , 151 ( 36 % ) were men . The mean age of the patients was 51.3 years ( range 28 - 84 years ) . Occurrence of calcific tendinitis of the shoulder was unilateral in 84 % and bilateral in 16 % . Gärtner type I calcific deposits were found in 37 % , type II in 32 % , and type III in 31 % . Failure of nonoperative therapy was observed in 114 patients ( 27 % ) . Negative prognostic factors were bilateral occurrence of calcific tendinitis of the shoulder , localization to the anterior portion of the acromion , medial ( subacromial ) extension , and high volume of the calcific deposit . Positive prognostic factors were a Gärtner type III deposit and a lack of sonographic sound extinction of the calcific deposit . CONCLUSION Our findings demonstrate the existence of prognostic factors in the nonoperative treatment of chronic symptomatic calcific tendinitis of the shoulder . Guidelines for optimal treatment can be implemented according to these factors to avoid a long-term symptomatic disease course PURPOSE To determine whether saline temperature influences procedure performance and outcome in patients undergoing ultrasonography (US)-guided lavage for the treatment of rotator cuff calcific tendinitis ( RCCT ) . MATERIAL S AND METHODS This study was approved by the institutional review board , and informed consent was obtained from all patients . From December 2009 to May 2011 , 462 patients ( 191 men and 271 women ; mean age , 39.7 years ) with painful RCCT diagnosed at US were prospect ively enrolled and r and omized into two groups . Operators subjectively classified calcifications as hard , soft , or fluid according to their appearance at US . US-guided percutaneous treatment of RCCT ( local anesthesia , double-needle lavage , intrabursal steroid injection ) was performed with warm saline ( 42 ° C , 107 ° F ) in 229 patients and with room-temperature saline in 233 . Operators and patients were not blinded to saline temperature . The ease of calcium dissolution was subjectively scored ( easy=1 , intermediate=2 , difficult=3 ) . Procedure duration was recorded . Patient discomfort was assessed by using a visual analog scale ( VAS ) . The occurrence of postprocedure bursitis was recorded . Statistical analyses were performed with Mann-Whitney U , χ2 , and analysis of variance tests . RESULTS Procedure duration was significantly shorter ( P<.001 ) in patients treated with warm saline ( mean , 576 seconds±121 ) than in those treated with room-temperature saline ( mean , 777 seconds±151 ) . Calcium dissolution was significantly easier in patients treated with warm saline ( median score , 1 ) than in those treated with room-temperature saline ( median score , 2 ) . Subgroup analysis according to calcification appearance at US showed a significant difference between groups for both soft ( P=.003 ) and hard ( P<.001 ) calcifications . No overall significant differences were found for VAS score ( warm saline group : baseline=8.9±0.6 , 1 month=4.7±0.6 , 2 months=4.0±0.7 , 3 months=3.4±0.4 , 1 year=3.0±0.7 ; room-temperature saline group : baseline=9.2±0.4 , 1 month=4.5±0.7 , 2 months=4.1±0.9 , 3 months=3.1±0.7 , 1 year=3.2±0.8 ; P=.491 ) . Postprocedural bursitis was observed in eight patients in the warm saline group and 20 in the room-temperature saline group ( P<.022 ) . CONCLUSION In the treatment of RCCT , warm saline appears to reduce procedure duration and improve calcification dissolution while reducing the frequency of postprocedural bursitis HYPOTHESIS Needle lavage is frequently performed before consideration of surgical removal in shoulders with calcific tendinitis because this may avoid surgery . However , its role in nonoperative treatment has not been fully investigated in terms of clinical and radiographic response . We hypothesized that needle decompression and subacromial steroid injection would show good clinical results in chronic calcific tendinitis patients . MATERIAL S AND METHODS Thirty-five shoulders in 30 consecutive patients with painful calcific tendinitis were treated by ultrasound-guided needle decompression and subacromial corticosteroid injection . Patients were prospect ively evaluated using American Shoulder and Elbow Surgeons ( ASES ) and Constant scores at 1 , 3 , and 6 months after the intervention . Size and morphology of the calcific deposits were compared with those in baseline radiographs at each visit . RESULTS At 6 months after the index procedure , 25 shoulders ( 71.4 % ) showed ASES and Constant score improvements from 48.0 and 53.7 to 84.6 and 87.9 , respectively ( P < .01 ) . Ten shoulders ( 28.6 % ) showed no symptom relief at the last follow-up . In shoulders with pain improvement , the mean size of calcific deposits reduced from 13.6 to 5.6 mm ( P < .01 ) , and in shoulders with no pain improvement or that underwent operation , mean size was 13.1 mm at initial visits and 12.7 mm at final visits ( P = .75 ) . DISCUSSION Shoulders showing little evidence of deposit size reduction at 6 months after needle decompression are less likely to achieve symptomatic improvement and may be considered as c and i date s for surgical removal . CONCLUSION Needle decompression with subacromial steroid injection is effective in 71.4 % of calcific tendinitis within 6 months . The size of calcific deposits in patients that achieved symptom relief was reduced
Output:
| Additional high- quality evidence is required to determine the relative efficacy of ultrasound-guided needle lavage in the management of calcific tendinitis of the rotator cuff |
MS211999 | ***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 Diabetes negatively impacts the health-related quality of life ( HRQOL ) of patients with type 2 diabetes . An earlier analysis showed HRQOL to be associated with mortality , which suggests that measuring HRQOL could have clinical implication s. We studied the association between HRQOL and total and cardiovascular mortality in patients with type 2 diabetes during long-term follow-up and specifically focused on old age and sex differences . RESEARCH DESIGN AND METHODS HRQOL was measured in a prospect ively followed cohort of 1,353 patients with type 2 diabetes using the R AND -36 . Cox proportional hazard models were used to measure the independent effect of baseline HRQOL on mortality . RESULTS During a mean follow-up of 9.6 years , 570 ( 42 % ) patients died , 280 of whom died of cardiovascular disease ( 49 % ) . The Physical Component Score ( PCS ) and the Mental Component Score ( MCS ) were inversely associated with total mortality , with hazard ratios of 0.988 ( 95 % CI 0.983–0.993 ) and 0.990 ( 95 % CI 0.985–0.995 ) , respectively . A 10-point-higher score on the PCS and MCS decreased the risk for total mortality by 11 and 10 % , respectively . An inverse relationship with mortality was also seen for men , women , and for patients aged > 75 years . Mental health was significantly related to mortality in men but not in women . CONCLUSIONS Lower physical and mental HRQOL was associated with a higher total mortality and cardiovascular mortality in patients with type 2 diabetes ; this is also the case when study ing men and women and the elderly separately . The dimension mental health , related to depression and anxiety , was only associated with mortality in men , not in women PURPOSE Recent evidence suggests that depression is linked to increased mortality among patients with diabetes . This study examines the association of depression with all-cause and cause-specific mortality in diabetes . METHODS We conducted a prospect i ve cohort study of primary care patients with type 2 diabetes at Group Health Cooperative in Washington state . We used the Patient Health Question naire ( PHQ-9 ) to assess depression at baseline and review ed medical records supplemented by the Washington state mortality registry to ascertain the causes of death . RESULTS Among a cohort of 4,184 patients , 581 patients died during the follow-up period . Deaths occurred among 428 ( 12.9 % ) patients with no depression , among 88 ( 17.8 % ) patients with major depression , and among 65 ( 18.2 % ) patients with minor depression . Causes of death were grouped as cardiovascular disease , 42.7 % ; cancer , 26.9 % ; and deaths that were not due to cardiovascular disease or cancer , 30.5 % . Infections , dementia , renal failure , and chronic obstructive pulmonary disease were the most frequent causes in the latter group . Adjusting for demographic characteristics , baseline major depression ( relative to no depression ) was significantly associated with all-cause mortality ( hazard ratio [HR]=2.26 , 95 % confidence interval [ CI ] , 1.79–2.85 ) , with cardiovascular mortality ( HR = 2.00 ; 95 % CI , 1.37–2.94 ) , and with noncardiovascular , noncancer mortality ( HR = 3.35 ; 95 % CI , 2.30–4.89 ) . After additional adjustment for baseline clinical characteristics and health habits , major depression was significantly associated only with all-cause mortality ( HR = 1.52 ; 95 % CI , 1.19–1.95 ) and with death not caused by cancer or atherosclerotic cardiovascular disease ( HR = 2.15 ; 95 % CI , 1.43–3.24 ) . Minor depression showed similar but nonsignificant associations . CONCLUSIONS Patients with diabetes and coexisting depression face substantially elevated mortality risks beyond cardiovascular deaths CONTEXT Depression and diabetes mellitus have been associated with an increased risk of all-cause and cardiovascular disease ( CVD ) mortality . However , data evaluating the joint effects of these 2 conditions on mortality are sparse . OBJECTIVES To evaluate the individual and joint effects of depression and diabetes on all-cause and CVD mortality rate . DESIGN Prospect i ve cohort study . SETTING The 11 states of the Nurses ' Health Study . PARTICIPANTS A total of 78 282 women who participated in the Nurses ' Health Study aged 54 to 79 years at baseline in 2000 were followed up until 2006 . Depression was defined as having self-reported diagnosed depression , treatment with antidepressant medications , or a score indicating severe depressive symptoms ( ie , a 5-item Mental Health Index score ≤52 ) . Self-reported type 2 diabetes was confirmed using a supplementary question naire . MAIN OUTCOME MEASURES All-cause and CVD-specific mortality rate . RESULTS During 6 years of follow-up ( 433 066 person-years ) , 4654 deaths were documented , including 979 deaths from CVD . Compared with participants without either condition , the age-adjusted relative risks ( RRs ) ( 95 % confidence interval ) for all-cause mortality were 1.76 ( 1.64 - 1.89 ) for women with depression only , 1.71 ( 1.54 - 1.89 ) for individuals with diabetes only , and 3.11 ( 2.70 - 3.58 ) for women with both conditions . The corresponding age-adjusted RRs of CVD mortality were 1.81 ( 1.54 - 2.13 ) , 2.67 ( 2.20 - 3.23 ) , and 5.38 ( 4.19 - 6.91 ) , respectively . These associations were attenuated after multivariate adjustment for other demographic variables , body mass index , smoking status , alcohol intake , physical activity , and major comorbidities ( including hypertension , hypercholesterolemia , heart diseases , stroke , and cancer ) but remained significant , with the highest RRs for all-cause and CVD mortality found in those with both conditions ( 2.07 [ 1.79 - 2.40 ] and 2.72 [ 2.09 - 3.54 ] , respectively ) . Furthermore , the combination of depression with a long duration of diabetes mellitus ( ie , > 10 years ) or insulin therapy was associated with a particularly higher risk of CVD mortality after multivariate adjustment ( RRs , 3.22 and 4.90 , respectively ) . CONCLUSIONS Depression and diabetes are associated with a significantly increased risk of all-cause and CVD mortality rate . The coexistence of these conditions identifies women at particularly high risk Context Many patients have both diabetes and depression . Some hypothesize that treating depression might improve diabetes outcomes . Contribution In this r and omized trial , 12 months of depression care management for depressed patients with diabetes improved depression-related outcomes and increased the frequency of exercise . However , care management did not affect diet , diabetes medication adherence , glucose testing , or glycemic control . Caution s The study sample had reasonably good diabetes control at baseline . Whether patients with poorly controlled diabetes would benefit from depression care is not known . The Editors Major depression and dysthymic disorder affect 5 % to 10 % of older adults seen in primary care setting s ( 1 - 3 ) . Late-life depression is often chronic or recurrent ( 4 - 6 ) and is associated with substantial suffering , functional impairment , and diminished health-related quality of life ( 7 ) . Diabetes mellitus affects 7.8 % of all adults and almost 1 in 5 of those age 60 years and older ( 8) . Individuals with diabetes mellitus have a 2-fold higher rate of major depression than those without diabetes ( 9 , 10 ) . Depression adversely affects the course of coexisting medical illness , contributing to increased symptom burden , functional impairment , and mortality ( 11 , 12 ) . For patients with diabetes mellitus , depression is associated with decreased glycemic control and increased number of micro- and macrovascular complications ( 13 , 14 ) . The mechanism of effect is not understood but may be related to depression-induced abnormalities in neuroendocrine and neurotransmitter function or decreased self-care behaviors ( 15 - 20 ) . Integrating evidence -based depression care for persons with diabetes may improve both depression and diabetes outcomes . Three small r and omized , controlled trials have studied the effect of treatment for depression on affective and glycemic outcomes in patients with depression and diabetes mellitus ( 21 - 23 ) . These studies have consistently shown improvements in affective outcomes , but effects on glycemic control have been mixed . Primary care physicians are well positioned to provide integrated care for depression and diabetes mellitus but face many barriers . Controlled trials report that treatment for depression is efficacious in approximately 70 % of persons who complete treatment compared with 30 % of those who receive placebo ( 24 ) . However , these results are difficult to replicate in routine primary care practice . Barriers to high- quality care include suboptimal recognition ; inconsistent treatment with lack of close follow-up and monitoring ; and organizational barriers , such as brief visits , poor integration with specialty mental health care , competing clinical priorities , and lack of decision support systems ( 25 - 27 ) . Simple interventions , such as depression screening and physician education , have little impact on these barriers and patient outcomes ( 28 - 30 ) . Treatment models that use a depression specialist working collaboratively with primary care physicians have shown clinical ly important improvement in patient outcomes ( 31 - 37 ) . We recently reported robust effects of such a model for older adults with major depression or dysthymia ( 37 ) . In this preplanned analysis , we evaluate the effects on affective and diabetes-specific outcomes . If effective care for depression also benefits adherence to self-care regimens , functional status , and other medical illness outcomes , it would add powerful quality -of-care and economic incentives for the dissemination and maintenance of these models . In addition , if effective care for depression improves self-care behaviors , it may also positively affect other chronic medical illnesses with important self-care components . For this prespecified subgroup analysis , we focused on older adults with clinical depression and coexisting diabetes mellitus . We hypothesized that the collaborative care intervention would improve affective symptoms , functional status , self-care behaviors , and glycemic control . In addition , we hypothesized that effects on glycemic control would be greatest for patients with baseline hemoglobin A1c values of 8.0 % or greater . Methods The Improving MoodPromoting Access to Collaborative Treatment ( IMPACT ) study is a multisite r and omized , controlled trial of a collaborative care intervention program for late-life depression in primary care ( 37 , 38 ) . Institutional review boards at participating sites approved study protocol s , and all participants gave written informed consent . Patients Seven study sites representing 8 diverse health care organizations with a total of 18 primary care clinics in 5 states participated in the study . From July 1999 to August 2001 , depressed older adults were recruited through referrals from primary care practitioners and other clinic staff or through systematic depression screening with a 2-item depression screener adapted from the Primary Care Evaluation of Mental Disorders ( 39 ) . Of the 2190 patients referred to the study , 308 ( 14 % ) declined the initial eligibility screening or additional interviews , 54 ( 3 % ) had incomplete initial screenings , and 202 ( 9 % ) were ineligible because they were younger than 60 years of age or they did not plan to use the participating clinic over the coming 12 months . Of the 32908 patients approached for screening , 5246 ( 16 % ) declined the initial screening or follow-up interviews . A total of 1791 ( 5 % ) of the initial screenings were incomplete and 23233 ( 71 % ) of those screened were not eligible because they did not have one of the core depression symptoms ( 95 % ) or because of logistic reasons such as lack of transportation or access to a telephone ( 5 % ) . The remaining 1626 ( 74 % ) of those referred and 2638 ( 8 % ) of those screened completed a computer-assisted structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders , fourth edition ( DSM-IV ) , to assess whether patients met research diagnostic criteria for major depression or dysthymia ( 40 ) . Inclusion criteria were age 60 years or older , plans to use one of the participating clinics as the main source of general medical care in the coming year , and a diagnosis of current major depression or dysthymic disorder according to the structured clinical interview for DSM-IV . Otherwise eligible persons were excluded because of a current drinking problem ( a score of 2 on the CAGE question naire ) ( 41 ) , a history of bipolar disorder or psychosis ( 38 ) , ongoing treatment with a psychiatrist , or
Output:
| Depression significantly increases the risk of mortality among individuals with diabetes .
Early detection and treatment of depression may improve health outcomes in this population |
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