Datasets:

YBXL

/

MS2_dynamic_1_shot_test

like 0

MS2_dynamic_1_shot500

***TASK*** the task is to summarize an input biomedical literature 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 PURPOSE this paper describes a clinic and community-based diabetes intervention program design ed to improve dietary , physical activity , and self-care behaviors of older African American women with type 2 diabetes . It also describes the study to evaluate this program and baseline characteristics of participants . METHODS The New Leaf ... Choices for Healthy Living With Diabetes program consists of 4 clinic-based health counselor visits , a community intervention with 12 monthly phone calls from peer counselors , and 3 group sessions . A r and omized , controlled trial to evaluate the effectiveness of this intervention is described . RESULTS Seventeen focus groups of African American women were used to assessed the cultural relevance /acceptability of the intervention and measurement instruments . For the r and omized trial , 200 African American women with type 2 diabetes were recruited from 7 practice s in central North Carolina . Mean age was 59 , mean diabetes duration was 10 years , and participants were markedly overweight and physically inactive . CONCLUSIONS Participants found this program to be culturally relevant and acceptable . Its effects on diet , physical activity , and self-care behaviors will be assessed in a r and omized trial PURPOSE Few culturally competent health programs have been design ed for Mexican Americans , a group that bears a disproportionate burden of Type 2 diabetes . In Starr County , a Texas-Mexico border community , investigators design ed and tested a culturally competent intervention aim ed at improving the health of this target population . The purpose of this article is to describe the development process of this diabetes education and support group intervention . METHODS The development stages were ( 1 ) community assessment , ( 2 ) intervention design , ( 3 ) selection or development of outcomes , ( 4 ) pilot testing , and ( 5 ) a r and omized clinical investigation . RESULTS Focus group participants identified knowledge deficits regarding diabetes and self-management strategies , and suggested characteristics of an effective intervention for Mexican Americans . Outcome measures included metabolic control indicators , a newly developed knowledge instrument , and an existing health belief instrument . Preliminary analyses indicated that the intervention was successful in significantly improving metabolic control in the target population . CONCLUSIONS Developing successful diabetes interventions for minority groups requires a number of stages , careful planning , assessment of cultural characteristics of the target population , and a systematic approach to implementation OBJECTIVE To determine whether diabetes care directed by nurses following detailed protocol s and algorithms and supervised by a diabetologist results in meeting the evidence -based American Diabetes Association ( ADA ) process and outcome measures more often than care directed under usual care in a minority population . RESEARCH DESIGN AND METHODS Studies were mainly conducted in two Los Angeles County clinics . In clinic A , nurse-directed diabetes care was provided to 252 patients ( 92 % Hispanic and 2 % African-American ) referred by their primary care providers . These patients were hierarchically matched with 252 diabetic patients in clinic B ( 79 % Hispanic and 19 % African American ) . When nurse-directed care was abruptly discontinued in clinic A for administrative reasons , it was reestablished in clinic B. Those patients were r and omly selected from a teaching clinic , and the outcomes in 114 patients who completed 1 year were compared with outcomes derived the year before receiving nurses ' care . The following process and outcome measures were assessed in the study : 1 ) number of visits , 2 ) diabetes education , 3 ) nutritional counseling , 4 ) HbA(1c ) , 5 ) lipid profiles , 6 ) eye exams , 7 ) foot exams , 8) renal evaluations , and 9 ) ACE inhibitor therapy in appropriate patients . RESULTS For patients under nurse-directed diabetes care in both clinics A and B , almost all process measures were carried out significantly more frequently than for the appropriate control patients . Under the care of nurses in clinic A , HbA(1c ) levels fell 3.5 % from 13.3 to 9.8 % in the 120 patients who were followed OUTPUT: —This systematic review provides evidence for the effectiveness of interventions to improve diabetes care among socially disadvantaged population s and identifies key intervention features that may predict success . 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 OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P < 0.05 ) when compared with education and usual care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P < 0.05 ) . A larger number of website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P < 0.02 ) . Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P < 0.01 ) . HDL cholesterol rose and triglycerides fell in the web-based group ( P < 0.05 ) . CONCLUSIONS Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes OBJECTIVE To evaluate the impact of systematic patient evaluation and patient and provider feedback on the processes and intermediate outcomes of diabetes care in Independent Practice Association model internal medicine practice s. RESEARCH DESIGN AND METHODS Nine practice s providing care to managed care patients were r and omly assigned as intervention or comparison sites . Intervention-site subjects had Annual Diabetes Assessment Program ( ADAP ) assessment s ( HbA(1c ) , blood pressure , lipids , smoking , retinal photos , urine microalbumin , and foot examination ) at years 1 and 2 . Comparison-site subjects had ADAP assessment s at year 2 . At Intervention sites , year 1 ADAP results were review ed with subjects , mailed to providers , and incorporated into electronic medical records with guideline -generated suggestions for treatment and follow-up . Medical records were evaluated for both groups for the year before both the year 1 and year 2 ADAP assessment s. Processes and intermediate outcomes were compared using linear and logistic mixed hierarchical models . RESULTS Of 284 eligible subjects , 103 of 173 ( 60 % ) at the Intervention sites and 71 of 111 ( 64 % ) at the comparison sites participated ; 83 of 103 ( 81 % ) of the intervention-site subjects returned for follow-up at year 2 . Performance of the six recommended assessment s improved in intervention-site subjects at year 2 compared with year 1 ( 5.8 vs. 4.3 , P = 0.0001 ) and compared with comparison-site subjects at year 2 ( 4.2 , P = 0.014 ) . No significant changes were noted in intermediate outcomes . CONCLUSIONS The ADAP significantly improved processes of care but not intermediate outcomes . Additional interventions are needed to improve intermediate outcomes BACKGROUND In the Medicare Modernization Act of 2003 , Congress required the Centers for Medicare and Medicaid Services to test the commercial disease-management model in the Medicare fee-for-service program . METHODS The Medicare Health Support Pilot Program was a large , r and omized study of eight commercial programs for disease management that used nurse-based call centers . We r and omly assigned patients with heart failure , diabetes , or both to the intervention or to usual care ( control ) and compared them with the use of a difference-in-differences method to OUTPUT:

Less frequently reported were quality of life , patient satisfaction , self-care , and healthcare utilization . Most care management modalities were carved out from primary care . Conclusions Most care management programs for patients with type 2 diabetes are ' carved-out ' , accomplish limited effects on metabolic outcomes , and have unknown effects on patient important outcomes .

MS2_dynamic_1_shot501

***TASK*** the task is to summarize an input biomedical literature 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 patients with intermittent claudication , a supervised walking exercise program increases peak exercise performance and community-based functional status . Patients with peripheral arterial disease also have muscle weakness in the affected extremity that may contribute to the walking impairment . However , the potential benefits of training modalities other than walking exercise , such as strength training , have not been critically evaluated in this patient population . The present study tested the hypothesis that a strength training program would be as effective as treadmill walking exercise and that combinations of strengthening and walking exercise would be more effective than either alone in improving exercise performance . METHODS AND RESULTS Twenty-nine patients with disabling claudication were r and omized to 12 weeks of supervised walking exercise on a treadmill ( 3 h/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 h/wk of resistive training of five muscle groups of each leg ) , or a nonexercising control group . Grade d treadmill testing was performed to maximally tolerated claudication pain to define changes in peak exercise performance . After 12 weeks , patients in the treadmill training program had a 74 + /- 58 % increase in peak walking time as well as improvements in peak oxygen consumption ( VO2 ) and the onset of claudication pain . Patients in the strength-trained group had a 36 + /- 48 % increase in peak walking time but no change in peak VO2 or claudication onset time . Control subjects had no changes in any of these measures over the 12-week period . After the first 12 weeks , patients in the initial walking exercise group continued for 12 more weeks of supervised treadmill training . This result ed in an additional 49 + /- 53 % increase in peak walking time ( total of 128 + /- 99 % increase over the 24 weeks ) . After the initial 12 weeks , patients in the strength-trained group began 12 weeks of supervised treadmill training , and patients in the control group participated in a 12-week combined program of strengthening and treadmill walking exercise . The combined strength and treadmill training program and treadmill training after 12 weeks of strength training result ed in increases in peak exercise performance similar to those observed with 12 weeks of treadmill training alone . CONCLUSIONS A supervised treadmill walking exercise program is an effective means to improve exercise performance in patients with intermittent claudication , with continued improvement over 24 weeks of training . In contrast , 12 weeks of strength training was less effective than 12 weeks of supervised treadmill walking exercise . Finally , strength training , whether sequential or concomitant , did not augment the response to a walking exercise program Percutaneous transluminal angioplasty ( PTA ) is a commonly performed procedure for the treatment of intermittent claudication despite the lack of controlled studies . The aim of this study was to compare PTA with supervised exercise therapy for patients with arterial occlusive disease judged suitable for PTA at angiography . Patients were assessed before treatment commenced and at three monthly intervals afterwards . Assessment included measurement of resting ankle brachial pressure indices ( ABPI ) , and claudicating and maximum walking distances on a treadmill up a 10 degrees incline . Twenty patients were r and omised to receive PTA and 16 exercise . The groups were similar in age , sex , smoking habits and arteriographic pattern of disease . In the PTA group two patients had angioplasties that were technically unsuccessful and two other patients subsequently required surgery . One patient in the exercise group subsequently had a PTA . After PTA , mean ABPI were significantly improved at 3 , 6 and 9 months ( P less than 0.01 ) without a corresponding significant increase in mean maximum walking distances . However in the exercise group despite no increase in mean ABPI , mean maximum walking distances increased progressively , with significant increases at 6 , 9 and 12 months ( P less than 0.01 ) PURPOSE Surgical revascularization and angioplasty ( PTA ) are effective therapies for patients with peripheral arterial disease , but there are no data on long-term survival , limb salvage , and hemodynamic status from a r and omized study of such patients . A multicenter , prospect i ve trial compared PTA with bypass surgery ( BP ) in 263 men who had iliac , femoral , or popliteal artery obstruction . PATIENTS AND METHODS Lesions in the iliac versus the femoropopliteal artery and rest pain versus claudication were separately r and omized to the two treatment interventions . One hundred twenty-six patients underwent BP , 129 patients underwent PTA , and eight patients were not treated for lower extremity ischemia . RESULTS Three operative deaths occurred in the BP group and none in the PTA group . For the entire study , average annual mortality was higher in the BP group , but survival was not significantly different on life-table analysis ( P = .08 ) . Primary success favored BP , while limb salvage favored PTA , but differences were not statistically significant ( P = .08 and .35 , respectively ) . Patients with iliac disease or claudication fared better , but there was no statistical difference in response to PTA or BP . CONCLUSION Patients in both treatment groups had prompt and sustained increases in hemodynamics and quality of life . This study of patients r and omly assigned to BP or PTA shows no significant difference in outcomes during a median follow-up of 4 years The success of percutaneous transluminal angioplasty ( PTA ) in the treatment of common and external iliac atherosclerotic lesions has been established for the general population . However , several studies have suggested that the presence of diabetes may reduce the effectiveness of iliac angioplasty , particularly in the setting of limb-threatening ischemia requiring concomitant lower extremity revascularization . This study compared the results of iliac artery PTA performed in conjunction with infrainguinal bypass for limb-threatening ischemia for diabetic ( DM ) and nondiabetic ( non-DM ) patients . OUTPUT: Compared with medical management , each of the three treatments ( surgery , endovascular therapy , and exercise therapy ) was associated with improved walking distance , claudication symptoms , and quality of life ( high- quality evidence ) . Evidence supporting superiority of one of the three approaches was limited . However , blood flow parameters improved faster and better with both forms of revascularization compared with exercise or medical management ( low- to moderate- quality evidence ) . Compared with endovascular therapy , open surgery may be associated with longer length of hospital stay and higher complication rate but result ed in more durable patency ( moderate- quality evidence ) . In patients with claudication , open surgery , endovascular therapy , and exercise therapy were superior to medical management in terms of walking distance and claudication . INPUT: BACKGROUND In patients with intermittent claudication , a supervised walking exercise program increases peak exercise performance and community-based functional status . Patients with peripheral arterial disease also have muscle weakness in the affected extremity that may contribute to the walking impairment . However , the potential benefits of training modalities other than walking exercise , such as strength training , have not been critically evaluated in this patient population . The present study tested the hypothesis that a strength training program would be as effective as treadmill walking exercise and that combinations of strengthening and walking exercise would be more effective than either alone in improving exercise performance . METHODS AND RESULTS Twenty-nine patients with disabling claudication were r and omized to 12 weeks of supervised walking exercise on a treadmill ( 3 h/wk at a work intensity sufficient to produce claudication ) , strength training ( 3 h/wk of resistive training of five muscle groups of each leg ) , or a nonexercising control group . Grade d treadmill testing was performed to maximally tolerated claudication pain to define changes in peak exercise performance . After 12 weeks , patients in the treadmill training program had a 74 + /- 58 % increase in peak walking time as well as improvements in peak oxygen consumption ( VO2 ) and the onset of claudication pain . Patients in the strength-trained group had a 36 + /- 48 % increase in peak walking time but no change in peak VO2 or claudication onset time . Control subjects had no changes in any of these measures over the 12-week period . After the first 12 weeks , patients in the initial walking exercise group continued for 12 more weeks of supervised treadmill training . This result ed in an additional 49 + /- 53 % increase in peak walking time ( total of 128 + /- 99 % increase over the 24 weeks ) . After the initial 12 weeks , patients in the strength-trained group began 12 weeks of supervised treadmill training , and patients in the control group participated in a 12-week combined program of strengthening and treadmill walking exercise . The combined strength and treadmill training program and treadmill training after 12 weeks of strength training result ed in increases in peak exercise performance similar to those observed with 12 weeks of treadmill training alone . CONCLUSIONS A supervised treadmill walking exercise program is an effective means to improve exercise performance in patients with intermittent claudication , with continued improvement over 24 weeks of training . In contrast , 12 weeks of strength training was less effective than 12 weeks of supervised treadmill walking exercise . Finally , strength training , whether sequential or concomitant , did not augment the response to a walking exercise program Patients with atherosclerotic peripheral arterial disease ( PAD ) of the lower extremities have impaired walking ability due to exercise-induced muscle ischemia and the result ant pain of intermittent claudication . To evaluate the benefit of exercise training as a treatment for patients with PAD , as well as possible mechanisms associated with improvement , we r and omly assigned 19 men with disabling claudication to treated and control groups . Treatment consisted of supervised treadmill walking ( 1 hr/day , 3 days/wk , for 12 weeks ) with progressive increases in speed and grade as tolerated . Grade d treadmill testing was performed to maximal toleration of claudication pain on entry and after 12 weeks of training to define changes in peak exercise performance . After 12 weeks , treated subjects had increased their peak walking time 123 % , peak oxygen consumption 30 % , and pain-free walking time 165 % ( all p less than 0.05 ) . Control subjects had no change in peak oxygen consumption , but after 12 weeks , peak walking time increased 20 % ( p less than 0.05 ) . In treated subjects , maximal calf blood flow ( measured by a plethysmograph ) increased 38 + /- 45 % ( p less than 0.05 ) , but the change in flow was not correlated to the increase in peak walking time . Elevated plasma concentrations of acylcarnitines have been associated with the functional impairment of PAD and may reflect the metabolic state of ischemic skeletal muscle . In treated subjects , a 26 % decrease in resting plasma short-chain acylcarnitine concentration was correlated with improvement in peak walking time ( r = -0.78 , p less than 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE Exercise advice is the main treatment for symptom relief in the UK for patients with mild to moderate Intermittent Claudication ( IC ) . Would a weekly exercise and motivation class for 6 months offer adjuvant benefit over written and verbal exercise advice alone ? PATIENTS AND METHODS Fifty-nine patients attending a regional vascular centre for whom IC was the main factor affecting mobility were r and omised to either exercise advice alone ( n=30 ) or exercise advice with a once a week 45 min supervised exercise/motivation class ( n=29 ) . The mean age was 68 years . Baseline and 6-month assessment included a Quality of Life Question naire -- the Short-Form-36 , the Charing Cross Symptom Specific Claudication Question naire ( CCCQ ) and treadmill walking distance ( 3.5 km/h 12 % ) . RESULTS At 6-month follow-up the supervised exercise group had improved their treadmill walking by 129 % compared to 69 % in the advice alone group ( p=0.001 ) . This significant improvement was maintained at the subsequent 9 and 12-month follow-up assessment s. By the 9-month stage the advice only group CCCQ score had improved 16 % from baseline , while the supervised exercise group had a significantly better 43 % improvement in base line score ( p<0.05 ) . Self reported frequency of walks was higher in the exercise class group being significant for improvement in CCCQ score . CONCLUSION A weekly , supervised exercise and motivation class for a 6-month period provides a significant improvement OUTPUT:

CONCLUSION Exercise therapy increases the PWD and AWD in patients with intermittent claudication . Supervised exercise therapy increases the PWD and AWD more than st and ard care .

MS2_dynamic_1_shot502

***TASK*** the task is to summarize an input biomedical literature 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 the Systolic Hypertension in Europe trial ( NCT02088450 ) , we investigated whether systolic blood pressure variability determines prognosis over and beyond level . Methods Using a computerised r and om function and a double-blind design , we r and omly allocated 4695 patients ( ≥60 years ) with isolated systolic hypertension ( 160–219/<95 mm Hg ) to active treatment or matching placebo . Active treatment consisted of nitrendipine ( 10–40 mg/day ) with possible addition of enalapril ( 5–20 mg/day ) and /or hydrochlorothiazide ( 12.5–25.0 mg/day ) . We assessed whether on-treatment systolic blood pressure level ( SBP ) , visit-to-visit variability independent of the mean ( VIM ) or within-visit variability ( WVV ) predicted total ( n = 286 ) or cardiovascular ( n = 150 ) mortality or cardiovascular ( n = 347 ) , cerebrovascular ( n = 133 ) or cardiac ( n = 217 ) endpoints . Findings At 2 years , mean between-group differences were 10.5 mm Hg ( p<0.0001 ) for SBP , 0.29 units ( p = 0.20 ) for VIM , and 0.07 mm Hg ( p = 0.47 ) for WVV . Active treatment reduced ( p≤0.048 ) cardiovascular ( −28 % ) , cerebrovascular ( −40 % ) and cardiac ( −24 % ) endpoints . In analyses dichotomised by the median , patients with low vs. high VIM had similar event rates ( p≥0.14 ) . Low vs. high WVV was not associated with event rates ( p≥0.095 ) , except for total and cardiovascular mortality on active treatment , which were higher with low WVV ( p≤0.0003 ) . In multivariable-adjusted Cox models , SBP predicted all endpoints ( p≤0.0043 ) , whereas VIM did not predict any ( p≥0.058 ) . Except for an inverse association with total mortality ( p = 0.042 ) , WVV was not predictive ( p≥0.15 ) . Sensitivity analyses , from which we excluded blood pressure readings within 6 months after r and omisation , 6 months prior to an event or both were confirmatory . Conclusions The double-blind placebo-controlled Syst-Eur trial demonstrated that blood-pressure lowering treatment reduces cardiovascular complications by decreasing level but not variability of SBP . Higher blood pressure level , but not higher variability , predicted risk . Trial Registration Clinical Trials.gov In previous studies , of which several were underpowered , the relation between cardiovascular outcome and blood pressure ( BP ) variability was inconsistent . We followed health outcomes in 8938 subjects ( mean age : 53.0 years ; 46.8 % women ) r and omly recruited from 11 population s. At baseline , we assessed BP variability from the SD and average real variability in 24-hour ambulatory BP recordings . We computed st and ardized hazard ratios ( HRs ) while stratifying by cohort and adjusting for 24-hour BP and other risk factors . Over 11.3 years ( median ) , 1242 deaths ( 487 cardiovascular ) occurred , and 1049 , 577 , 421 , and 457 participants experienced a fatal or nonfatal cardiovascular , cardiac , or coronary event or a stroke . Higher diastolic average real variability in 24-hour ambulatory BP recordings predicted ( P≤0.03 ) total ( HR : 1.14 ) and cardiovascular ( HR : 1.21 ) mortality and all types of fatal combined with nonfatal end points ( HR : ≥1.07 ) with the exception of cardiac and coronary events ( HR : ≤1.02 ; P≥0.58 ) . Higher systolic average real variability in 24-hour ambulatory BP recordings predicted ( P<0.05 ) total ( HR : 1.11 ) and cardiovascular ( HR : 1.16 ) mortality and all fatal combined with nonfatal end points ( HR : ≥1.07 ) , with the exception of cardiac and coronary events ( HR : ≤1.03 ; P≥0.54 ) . SD predicted only total and cardiovascular mortality . While accounting for the 24-hour BP level , average real variability in 24-hour ambulatory BP recordings added < 1 % to the prediction of a cardiovascular event . Sensitivity analyses considering ethnicity , sex , age , previous cardiovascular disease , antihypertensive treatment , number of BP readings per recording , or the night : day BP ratio were confirmatory . In conclusion , in a large population cohort , which provided sufficient statistical power , BP variability assessed from 24-hour ambulatory recordings did not contribute much to risk stratification over and beyond 24-hour BP BACKGROUND The prognostic significance of long-term visit-to-visit blood pressure variability ( BPV ) has not yet been vali date d in " real world " hypertensive patients . The aim of the current study is to explore the prognostic value of BPV on stroke in hypertensive patients . METHODS This was a dynamic prospect i ve cohort study based on electronic medical records in Shanghai , China . Hypertensive patients ( N=122,636 ) without history of stroke at baseline , were followed up from 2005 to 2011 . The cohort comprised of 4522 stroke patients and 118,1 OUTPUT: Long term variability in blood pressure is associated with cardiovascular and mortality outcomes , over and above the effect of mean blood pressure . Associations are similar in magnitude to those of cholesterol measures with cardiovascular disease . Limited data for mid-term and short term variability showed similar associations . INPUT: Background In the Systolic Hypertension in Europe trial ( NCT02088450 ) , we investigated whether systolic blood pressure variability determines prognosis over and beyond level . Methods Using a computerised r and om function and a double-blind design , we r and omly allocated 4695 patients ( ≥60 years ) with isolated systolic hypertension ( 160–219/<95 mm Hg ) to active treatment or matching placebo . Active treatment consisted of nitrendipine ( 10–40 mg/day ) with possible addition of enalapril ( 5–20 mg/day ) and /or hydrochlorothiazide ( 12.5–25.0 mg/day ) . We assessed whether on-treatment systolic blood pressure level ( SBP ) , visit-to-visit variability independent of the mean ( VIM ) or within-visit variability ( WVV ) predicted total ( n = 286 ) or cardiovascular ( n = 150 ) mortality or cardiovascular ( n = 347 ) , cerebrovascular ( n = 133 ) or cardiac ( n = 217 ) endpoints . Findings At 2 years , mean between-group differences were 10.5 mm Hg ( p<0.0001 ) for SBP , 0.29 units ( p = 0.20 ) for VIM , and 0.07 mm Hg ( p = 0.47 ) for WVV . Active treatment reduced ( p≤0.048 ) cardiovascular ( −28 % ) , cerebrovascular ( −40 % ) and cardiac ( −24 % ) endpoints . In analyses dichotomised by the median , patients with low vs. high VIM had similar event rates ( p≥0.14 ) . Low vs. high WVV was not associated with event rates ( p≥0.095 ) , except for total and cardiovascular mortality on active treatment , which were higher with low WVV ( p≤0.0003 ) . In multivariable-adjusted Cox models , SBP predicted all endpoints ( p≤0.0043 ) , whereas VIM did not predict any ( p≥0.058 ) . Except for an inverse association with total mortality ( p = 0.042 ) , WVV was not predictive ( p≥0.15 ) . Sensitivity analyses , from which we excluded blood pressure readings within 6 months after r and omisation , 6 months prior to an event or both were confirmatory . Conclusions The double-blind placebo-controlled Syst-Eur trial demonstrated that blood-pressure lowering treatment reduces cardiovascular complications by decreasing level but not variability of SBP . Higher blood pressure level , but not higher variability , predicted risk . Trial Registration Clinical Trials.gov No adverse effect upon cognitive function has been detected during the first 9 months of treatment by a thiazide diuretic ( Moduretic ; Merck Sharp & Dohme , Hoddesdon , UK ) or a beta-blocking agent ( atenolol ) of moderately elevated blood pressure in a cohort of 2630 men and women aged between 65 and 74 years . Furthermore , no association was discovered between levels of systolic or diastolic blood pressure at outset and responses to st and ard tests of cognitive function . This study was carried out in general practice s as part of the current Medical Research Council Treatment Trial of Mild Hypertension in the Elderly Nine-hundred- and -twenty-two hypertensive patients were included in a sub study to the Hypertension Optimal Treatment study , which aim ed to investigate the impact on quality of life of lowering the pressure and of intensified therapy . Seven-hundred- and -eighty-one patients completed both baseline and follow-up question naires ( intention-to-treat population ) , while 610 patients were included in a per protocol analysis . Patients were r and omized to three diastolic BP levels ( DBPs ) , i.e. < or = 90 mmHg , < or = 85 mmHg and < or = 80 mmHg . Two self-administered vali date d question naires , the Psychological General Well-Being index and the Subjective Symptoms Assessment Profile ( SSA-P ) were completed at baseline and after 6 months . The lower the DBP achieved , the greater the improvement in well-being ( p < 0.05 ) . The increase in well-being from baseline to 6 months was significant in target groups < or = 80 mmHg ( p < 0.01 ) and < or = 85 mmHg ( p < 0.05 ) . The SSA-P domains , cardiac symptoms and dizziness improved in all groups but the sex life score deteriorated in the < or = 80 and < or = 85 mmHg groups in male patients . In all target groups , headaches were reduced ( p < 0.001 ) , while swollen ankles ( p < 0.001 ) and dry cough in the < or = 80 mmHg group ( p < 0.001 ) increased . Although more intensive antihypertensive therapy is associated with a slight increase in subjective symptoms , it is nonetheless still associated with improvements in patients ' well-being OBJECTIVE To assess the effectiveness of nifedipine treatment in elderly hypertensives . METHODS A single-blind trial was conducted under the direction of the Shanghai Institute of Hypertension in 1632 subjects aged 60 - 79 years alternatively allocated to either nifedipine or placebo after a 4-week placebo run-in period between 1987 and 1990 with mean follow-up of 30 months . Clinical events and risk modification were analysed in collaboration with the University of Montreal . Seventy-four patients with severe hypertension were reallocated to active nifedipine treatment after placebo run-in . R OUTPUT:

Benefits of Treating Higher Versus Lower BP Targets in Older Adults Across all trials , treating high BP in older adults was beneficial . This is probably related to the higher frequency of cardiovascular events seen in these patients . Treatment Effects According to Diastolic BP Evidence was insufficient to determine the benefit of treating diastolic hypertension in the absence of systolic hypertension . A subgroup analysis of SPRINT showed a nonstatistically significant increase in the rate of serious adverse events , hypotension , syncope , electrolyte abnormalities , or acute

MS2_dynamic_1_shot503

***TASK*** the task is to summarize an input biomedical literature 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 Spasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy , a common and distressing experience . We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter . METHODS We conducted a multicentre r and omized , double-blind trial to compare the efficacy of 0.3 % nifedipine and 1.5 % lidocaine ointment versus 1.5 % lidocaine ointment alone in reducing pain after hemorrhoidectomy . A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale ( ACCS ) at baseline ; soon after surgery ; at 2 , 4 , 6 , 8 and 24 hours after surgery ; on day 7 after surgery ; and at a final visit 14 days after surgery . The physician also noted the time to first analgesic administration within 24 hours after surgery . RESULTS In all , 135 patients per group participated ( 270 total ) . Evaluation of the delta ACCS score versus basal value , a covariate for rescue analgesic administration time , revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 ( p < 0.011 and p < 0.054 , respectively ) . We noticed no difference between groups for time of administration of rescue analgesic , blood pressure , heart rate or frequency of headache . CONCLUSION Although there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy , the patients ' assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery . Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended . Further research focusing on these outcomes is warranted Background Atorvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A ( HMG CoA ) reductase inhibitor widely used in treatment of hypercholesterolemia and prevention of coronary heart disease and has various pleiotropic effects . In this study , the efficacy of atorvastatin emulgel ( 2 % ) in reducing postoperative pain at rest , pain during defecation and analgesic requirement after open hemorrhoidectomy was investigated . Methods A total of 66 patients with third- and fourth-degree hemorrhoids undergoing open hemorrhoidectomy were included in this prospect i ve , double-blind , r and omized controlled trial . The patients were r and omly assigned to either atorvastatin emulgel or placebo immediately after surgery and then every 12 h for 14 days . The primary outcomes were intensity of pain at rest and during defecation , measured with a visual analog scale , and the analgesic requirement , measured by amount of pethidine and acetaminophen consumption , and percent of wound healing . Results There was no significant difference in the average postoperative pain scores in the first 48 h ( P12h = 1 , P24h = 0.128 and P48h = 0.079 ) after the surgery between the two groups , but at the week 1 the pain scores during defecation were considerably lower in the atorvastatin group than in placebo group ( P = 0.004 ) , which also was the same at the week 2 ( P = 0.03 ) . There was no significant difference in the average pethidine and acetaminophen ( mg ) administration at 12 h and 24 h between the two groups after surgery . Regarding the data about wound healing , at the week two the healing was much better in the treatment group than it was in control group and the difference was statistically significant ( P = 0.04 ) . Conclusions Compared with placebo , atorvastatin emulgel reduced postoperative pain at rest and on defecation and could improve the healing process after open hemorrhoidectomy . Trial registration numberI RCT 201404013014N8 Objective To determine whether a combination of topical anesthetic ( EMLA ) and local injection with lidocaine is better than lidocaine alone for pain relief after Ferguson hemorrhoidectomy . Methods Sixty patients scheduled for hemorrhoidectomy were r and omized into 2 groups : ( 1 ) control group ( CG , n=30 ) received neomycin ointment ( 5 g ) , and ( 2 ) EMLA group ( EG , n=30 ) received EMLA ( 5 g ) , both agents applied topically after surgery . Before the surgical incision was made , lidocaine ( 10 mL of a 1 % solution ) was locally injected into all 60 patients . After surgery , analgesics were provided when necessary . The visual analog scale score was recorded at 4 time points : ( 1 ) upon arrival in the postanesthesia room , ( 2 ) 2 hours after arriving in the postanesthesia room , ( 3 ) between 9 and 10 PM on the first postoperative evening , and ( 4 ) on the first postoperative morning . The frequency of meperidine requests , 1-time catheterizations for urinary retention , and patient satisfaction with postoperative pain management , were also recorded . Results The median visual analog scale scores and cumulative dosages of meperidine were significantly lower in the EG than the CG ( P<0.05 ) . Patient satisfaction with postoperative pain control was also significantly higher in the EG than the CG ( P<0.01 ) . No systemic complications occurred . Discussion EMLA is considered a breakthrough in cutaneous analgesia , capable of reducing pain in many cutaneous procedures . Because Ferguson hemorrhoidectomy has been performed for years with ongoing concerns over postoperative pain , we felt that using EMLA could lower postoperative pain OUTPUT: There were mixed significant changes in pain for GTN compared with placebo . Conclusion Topical diltiazem , metronidazole and sucralfate appear to significantly reduce pain at various timepoints following excisional haemorrhoidectomy . GTN had mixed evidence . Several single trials identified other promising topical analgesics INPUT: The aim of this study was to compare the efficacy of topical piroxicam and EMLA cream on pain control and subsequent inflammation in neodymium : yttrium – aluminum – garnet ( Nd : YAG ) 1,064 nm laser hair removal in female volunteers . Fifty female volunteers were enrolled in this prospect i ve , r and omized , double-blind , clinical study over a 6-month period . Patients were r and omly assigned to receive topical piroxicam as group Piroxicam or EMLA cream as group EMLA . Topical analgesics were applied to the treatment sites for 60 min . The pain scores [ on a visual analog scale ( VAS ) ] and side effects were recorded before the hair removal , during the hair removal , at the end of the hair removal , and 1 h , 2 h and 24 h after the hair removal . Patients ’ characteristics and the treatment setting s of the Nd : YAG 1,064 nm laser were similar in the two groups . The pain scores ( VAS ) were similar , and satisfaction was high in both groups after the hair removal . The number of blanching and erythema episodes were significantly higher in group E than in group P ( P < 0.001 ) . Inflammatory side effects were less frequent in group P than in group E after the procedure ( P < 0.001 ) . This study showed that topical piroxicam and EMLA provided adequate and similar pain relief after Nd : YAG 1,064 nm laser hair removal in female volunteers . Topical piroxicam was associated with fewer inflammatory side effects than was EMLA cream , because of its anti-inflammatory effect after the procedure Background . The C and ela alex and rite and the Coherent diode laser systems come equipped with built‐in skin cooling systems that are design ed to both protect the epidermis , allowing higher fluences , and to alleviate discomfort . Nevertheless , pain can be a significant problem especially with treatment of larger areas . Scatter of the laser beam is reportedly affected by the spot size . It is cl aim ed that larger spot sizes are more effective at identical fluences . Objective . This study evaluated the effectiveness of a topical 5 % lidocaine cream ( ELA‐Max ) to control pain and compared pain levels at identical fluences between the 8 mm and 12 mm spot size of the alex and rite laser and between the alex and rite and diode laser with its 9 mm spot size . Methods . The study was conducted in the axillae of 12 patients . Each axilla was divided in half for side‐by‐side comparison . Half of the right axilla was treated with the alex and rite 8 mm and the other half with the 12 mm spot size at identical fluences . The left axilla was treated at the maximum tolerated fluences with the alex and rite 12 mm spot size and the diode 9 mm spot size . Results . At identical fluences and other parameters , there was significantly more pain with the alex and rite 12 mm spot size than with the alex and rite 8 mm spot size , both with or without topical anesthesia . The alex and rite laser was significantly less painful than the diode laser both with and without topical anesthetic . The difference was most noticeable between the alex and rite 8 mm spot size and the diode 9 mm spot size . Topical 5 % lidocaine anesthesia was effective in reducing pain , though not completely , for both the alex and rite and the diode lasers . Conclusion . Topical 5 % lidocaine cream is a simple and effective method for reducing patient discomfort during laser hair removal procedures , even when a skin cooling device is being used . A larger spot size causes more pain than a smaller spot size at identical fluences . The 800 nm diode laser causes greater discomfort than the 755 nm alex and rite laser BACKGROUND AND OBJECTIVES Cold air cooling is widely used in dermatological laser therapy . We investigated the influence of cold air cooling at different skin temperatures on therapeutic outcome and side effects of pulsed dye laser treatment of facial telangiectasia . STUDY DESIGN / MATERIAL S AND METHODS From September 2002 to February 2003 , 17 patients with previously untreated facial telangiectasia underwent a single treatment session with flash-lamp pulsed dye laser ( 3.5 J/cm(2 ) , 585 nm , 0.45 milliseconds pulse length , 10 mm beam diameter , Cynosure V ) . The treatment area was divided into three sub- areas : no cooling , cold air cooling to 20 degrees C and to 17 degrees C skin temperature . The skin temperature was monitored by a prototype infrared sensor system which controlled the temperature of the cold air stream ( Cryo5 ) . In a prospect i ve study , we collected data on purpura , pain , clearance , and patient satisfaction on numerical analog scales ( NAS ) from 0 ( meaning " no " ) to 3 ( meaning " high " ) . RESULTS Without cooling , purpura ( 2.53 ) , pain ( 2.41 ) , and clearance ( 2.35 ) were rated medium to high . Cooling to 20 degrees C reduced purpura ( 1.12 ) and pain ( 1.06 ) , whereas the clearance ( 2.12 ) was only slightly affected . Cooling to 17 degrees C reduced purpura ( 0.88 ) and pain ( 0.76 ) even more , the clearance ( 2.06 ) was lowered marginally . Most patients preferred cooling to 20 degrees C skin temperature . CONCLUSION In dermatological laser therapy of facial telangiectasia , the use of cold air cooling can significantly reduce side effects and increase patient satisfaction while only slightly affecting clearance . Cooling to 20 degrees C skin temperature proved to be a well-balanced middle course . For the practical use of cold air cooling , we thus recommend cooling to a level which the patient can tolerate without problems and to try to OUTPUT:

In general , active non-invasive anaesthetic methods seemed to provide favourable results compared to placebo or no anaesthesia , and topical anaesthetic drugs and PSF seemed to result in a better pain reduction than skin cooling . However , the current evidence is insufficient to provide recommendations for daily clinical practice . Future studies should also evaluate sex differences in pain perception , have uniformity with regard to vali date d pain measurement scales and address clinical ly significant differences in pain reduction besides statistically significant differences

MS2_dynamic_1_shot504

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This paper reports the results of two studies of depressed patients , evaluating the efficacy and toleration of the selective serotonin reuptake inhibitor ( SSRI ) sertraline in a general practice setting in the UK . In the first of these studies , 308 patients , with a DSM-III-R diagnosis of major depressive episode , were treated for 6 weeks with either sertraline 50–100 mg/day or the tricyclic antidepressant dothiepin 75–150 mg/day , or placebo . Seventy-six per cent of sertraline-treated patients were maintained on the lower dose ( 50 mg/day ) , whereas 81 % of dothiepin-treated patients required the higher dose ( 150 mg/day ) . Sertraline-treated patients demonstrated a significant improvement in the Montgomery-Asberg Depression Rating Scale ( MADRS ) and the Clinical Global Impression ( CGI ) severity scores compared with placebo-treated patients , while dothiepin-treated patients did not show significant improvement compared with placebo . The active drugs were well tolerated , and there were no significant differences in adverse events between the groups . The second study , “ Sertraline in General Practice , A Multicenter Assessment ” , or SIGMA , was a large , multicentre trial with a cohort of 3396 patients recruited to receive 6 weeks of treatment . Patients started on sertraline 50 mg/day , and for 59 % of patients this was the final dose ; less than 10 % of patients reached final doses of more than 100 mg/day . A 50 % or greater reduction in MADRS scores was seen in 69 % of patients across a wide range of severity of symptoms at baseline , and 87 % of patients demonstrated excellent or good toleration of the drug . A review of the relevant literature and the results of these studies show that sertraline is well suited to treatment of depression in the general practice setting Mild depressive syndromes are highly prevalent among primary -care patients . Evidence -based treatment recommendations need to be derived directly from this diagnostically heterogeneous group . The primary aim was to assess the efficacy of sertraline and cognitive-behavioural group therapy for treatment of depressed primary -care patients , the secondary aim was to evaluate if receiving treatment according to free choice is associated with a better outcome than r and omization to a particular treatment . We conducted a r and omized , placebo-controlled , single-centre , 10-wk trial with five arms : sertraline ( flexible dosages up to 200 mg/d ) ( n = 83 ) ; placebo ( n = 83 ) ; manual-guided cognitive-behavioural group therapy ( one individual session and nine group sessions per 90 min ) ( n = 61 ) ; guided self-help group ( control condition , n = 59 ) ; and treatment with sertraline or cognitive-behavioural group therapy according to patients ' choice ( n = 82 ) . From 1099 consecutively screened adult patients , 368 formed the intent-to-treat population with milder forms of depression . Primary outcome was a global efficacy measure combining z-converted Hamilton Depression Rating Scale and clinician-rated Inventory for Depressive Symptomatology scores . Sertraline was superior to placebo ( p = 0.03 ) . Outcome for guided self-help groups was worse compared to cognitive-behavioural group therapy ( p = 0.002 ) and compared to all other treatment arms including pill placebo ( secondary analyses ) . Outcome in the patients ' choice arm was similar to that in the sertraline and cognitive-behavioural group therapy . Overall , sertraline is efficacious in primary -care patients with milder forms of depression . The superiority of cognitive-behavioural group therapy over guided self-help groups might partly be explained by ' nocebo ' effects of the latter Methods After initial screening and a seven-day washout period , in the case of patients who had received previous antidepressant medication , 47 adult patients who fulfiIled Feighner ’s criteria for the diagnosis of depression ( 1 ) and had a Hamilton Depression Rating Scale ( HAMD ) total score ( 21-item ) of 18 or more were r and omized to treatment with either paroxetine or placebo . The intended duration of double-blind treatment was four weeks . Paroxetine at a single daily dose of 30 mg or matched placebo was administered at night . No concomitant psychotropic medication other than triazolam or flunitrazepam as a hypnotic was permitted . Patients attended for review on days 7,14 , and 28 . The measures of severity of depression were the HAMD scale total score ( 21-item ) , the Beck Depression Inventory ( BDI ) , the Visual Analogue Scale ( VAS ) , and the Clinical Global Impression ( CGI ) of severity of illness . Assessment of tolerability was based on reports of adverse experiences , both spontaneously reported and elicited in response to asideeffect symptom checklist , physical examination , vital signs , and laboratory investigations A controlled double-blind trial of amitriptyline at two dosage levels ( 75 and 150 mg/day ) , amylobarbitone ( 150 mg/day ) , and an inert substance for a period of four weeks was conducted on four matched groups of women attending their general practitioners and suffering from a depressive illness . Improvement at 7 and 28 days was noted on several measures of depression and anxiety in all treatment groups . Of these treatments amitriptyline 150 mg/day was the most consistent in relieving depression and anxiety . Troublesome side effects were equally distributed among the four treatments In summary , the clinical results of this double-blind study clearly show that imipramine , as expected , demonstrated significant antidepressive properties in out patients suffering OUTPUT: AUTHORS ' CONCLUSIONS Both TCAs and SSRIs are effective for depression treated in primary care INPUT: Alprazolam is the first of the triazolobenzodiazepines to be studied in a large population of depressed patients . In a six-week , double-blind multicenter comparison of alprazolam , imipramine hydrochloride , and placebo in the treatment of 723 patients with depression , the two active drugs were statistically more effective than placebo . Alprazolam was at least as effective as imipramine in relieving depressive symptoms , significantly more effective in relieving somatic symptoms , and showed an earlier onset of activity in some measurements . Anticholinergic side effects were reported most often by patients receiving imipramine , while drowsiness was the only side effect reported most often in the alprazolam group . The Feighner Diagnostic Criteria and pre study and post study intercenter conferences with videotaped patient interviews ensured interrater reliability In a four-week double-blind study comparing alprazolam with oxazepam , 62 out patients suffering from anxiety with depressive symptoms were evaluated . The average daily doses of alprazolam and oxazepam were 1.48 mg and 44.4 mg , respectively . According to all rating scales applied , both alprazolam and oxazepam were effective in relieving anxiety associated with mild depression ( p less than 0.01 ) . Alprazolam proved somewhat more effective than oxazepam especially with regard to overall performance ( p less than 0.05 ) . Treatment-emergent adverse effects were few and mild for both compounds tested The purpose of this study was to compare the safety and efficacy of a relatively new antidepressant drug , alprazolam ( a triazolobenzodiazepine ) with imipramine in the treatment of 60 depressed symptomatic volunteers . Eligible patients were r and omly assigned after a 1-week washout to one of the medications and followed for 6 treatment weeks . Contrary to the earlier report of Feighner et al. ( 1983 ) , who found alprazolam superior to imipramine and placebo , but consistent with Rush et al. ( 1985 ) we find imipramine superior in efficacy to alprazolam on a variety of symptoms . Both the present study and Rush 's study employed patients with signs indicative of response to tricyclics . Feighner 's patients may have been the type who tend to be less responsive to tricyclics but may be more responsive to alprazolam . Some of our data also show that alprazolam may have a more advantageous effect in the early weeks of treatment but is overtaken in subsequent treatment weeks by imipramine The therapeutic effect and safety of alprazolam and doxepin were studied in 126 out patients suffering from primary unipolar depression . The 6-week study was double-blind with a r and om allocation of treatment . Patients were treated with a flexible dose of 1.0 - 4.5 mg of alprazolam and 50 - 225 mg of doxepin per day . The mean final doses were 2.7 mg for alprazolam and 137.5 mg for doxepin . The results indicate that alprazolam and doxepin were equally efficacious . The incidence of side-effects was lower in the alprazolam treatment group This paper presents findings from a multisite study of 126 subjects meeting DSM-III-R criteria for Panic Disorder who also met criteria for a concurrent Major Depressive Episode , Dysthymia , or Depressive Disorder NOS . The study 's primary aim was to discern the influence of varying degrees of depression on the comparative efficacy of alprazolam , imipramine and placebo on anxiety outcomes . A placebo-controlled , double-blind , parallel r and om assignment design was utilized over a total of 16 weeks . There was no medication effect on panic outcomes . At endpoint , percent of anticipatory anxiety ( i.e. , time spent worrying about having an anxiety attack ) was significantly lower in the patients taking active medications vs. placebo . Phobic measures were significantly improved by alprazolam , vs. both imipramine and placebo early in the study ; however , by week 8 both active medications were equally superior to placebo in the reduction of phobic symptoms . In addition , both active medications were significantly more effective than placebo in reducing depression . The same efficacy pattern ( i.e. , active medications superior to placebo ) was observed on measures of general functioning . Importantly , there were no significant interactions observed between medication and presence of major depression on the depression measures , indicating that both alprazolam and imipramine were equally efficacious in treating the depression in patients with panic disorder and major depression . Since the patients enrolled in this study suffered from major depressive disorder in the mild to moderate severity range , these results may not be transferrable to patients with panic disorder and severe major depression This study examines clinical predictors of outcome for patients with panic disorder and depression in a 16 week , placebo-controlled trial of alprazolam and imipramine ( n = 126 ) . Baseline global severity of illness and phobic avoidance were differentially predictive of acute response to treatment . Patients in the mild to moderate range of global distress experienced smaller degrees of improvement on alprazolam than on imipramine at week 4 . At endpoint , the relative effectiveness of the active medication versus placebo was diminished in patients with higher levels of phobic avoidance . This relationship was not evident for completers , suggesting that the adverse effects of avoidance on outcome after sustained treatment was reduced The efficacy and safety of alprazolam as compared to imipramine or a placebo added to weekly interpersonal psychotherapy was compared in a 6-week double-blind r and omized clinical trial of 35 ambulatory elderly patients with major depression . The average maximum dosage of alprazolam was 2.2 mg and OUTPUT:

When alprazolam was compared with placebo for reduction in symptoms all estimates indicated a positive effect for alprazolam . The RD of all-cause withdrawals did not differ between alprazolam and placebo . Alprazolam appears to reduce depressive symptoms more effectively than placebo and as effectively as tricyclic antidepressants . Whilst the rate of all-cause withdrawals did not appear to differ between alprazolam and placebo , and withdrawals were less frequent in the alprazolam group than in any of the conventional antidepressants combined group , these findings should be interpreted with caution , given the dependency properties of benzodiazepines

MS2_dynamic_1_shot505

***TASK*** the task is to summarize an input biomedical literature 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 compare 11 preschool vision screening tests administered by licensed eye care professionals ( LEPs ; optometrists and pediatric ophthalmologists ) . DESIGN Multicenter , cross-sectional study . PARTICIPANTS A sample ( N = 2588 ) of 3- to 5-year-old children enrolled in Head Start was selected to over-represent children with vision problems . METHODS Certified LEPs administered 11 commonly used or commercially available screening tests . Results from a st and ardized comprehensive eye examination were used to classify children with respect to 4 targeted conditions : amblyopia , strabismus , significant refractive error , and unexplained reduced visual acuity ( VA ) . MAIN OUTCOME MEASURES Sensitivity for detecting children with > or = 1 targeted conditions at selected levels of specificity was the primary outcome measure . Sensitivity also was calculated for detecting conditions grouped into 3 levels of importance . RESULTS At 90 % specificity , sensitivities of noncycloplegic retinoscopy ( NCR ) ( 64 % ) , the Retinomax Autorefractor ( 63 % ) , SureSight Vision Screener ( 63 % ) , and Lea Symbols test ( 61 % ) were similar . Sensitivities of the Power Refractor II ( 54 % ) and HOTV VA test ( 54 % ) were similar to each other . Sensitivities of the R and om Dot E stereoacuity ( 42 % ) and Stereo Smile II ( 44 % ) tests were similar to each other and lower ( P<0.0001 ) than the sensitivities of NCR , the 2 autorefractors , and the Lea Symbols test . The cover-uncover test had very low sensitivity ( 16 % ) but very high specificity ( 98 % ) . Sensitivity for conditions considered the most important to detect was 80 % to 90 % for the 2 autorefractors and NCR . Central interpretations for the MTI and iScreen photoscreeners each yielded 94 % specificity and 37 % sensitivity . At 94 % specificity , the sensitivities were significantly better for NCR , the 2 autorefractors , and the Lea Symbols VA test than for the 2 photoscreeners for detecting > or = 1 targeted conditions and for detecting the most important conditions . CONCLUSIONS Screening tests administered by LEPs vary widely in performance . With 90 % specificity , the best tests detected only two thirds of children having > or = 1 targeted conditions , but nearly 90 % of children with the most important conditions . The 2 tests that use static photorefractive technology were less accurate than 3 tests that assess refractive error in other ways . These results have important implication s for screening preschool-aged children PURPOSE To assess the accuracy of the Lang II stereotest in screening for strabismus , amblyopia , and anisometropia in 6-year-old children . DESIGN Cross-sectional population -based study . METHODS The Sydney Myopia Study examined 1765 6-year-old children ( 78.9 % of eligible ) who were identified by r and om cluster sampling of 34 schools in Sydney , Australia . Sensitivity and specificity of the Lang II stereotest was determined by best stereoacuity . Cycloplegic autorefraction , assessment of visual acuity , and ocular motility were conducted . RESULTS Test sensitivity ranged from 21.4 % for anisometropia ( > or = 1.0 diopter ) to 31.3 % for amblyopia . The detection rate for new cases of amblyopia ranged from 20 % to 40 % ; the detection rate for new cases of strabismus was 30 % . Specificity was > 98 % in all three conditions . Children with false-negative results included newly diagnosed cases of strabismus ( 14 of 25 children ) or amblyopia ( 5 of 12 children ) . CONCLUSION The Lang II stereotest , when used alone , has very limited value as a screening test of binocular dysfunction BACKGROUND The Enhanced Vision Screening Program is a population -based vision screening program that has , at present , examined 59,782 children . Its main goal is to detect amblyopia , strabismus , and high refractive errors . An average of 11,910 4 1/2- to 5 1/2-year-old children are screened yearly . The current study determines the negative predictive value of the screening program : For a subject having passed the vision screening test , what is the probability of not having amblyopia , strabismus , or high refractive errors ? METHODS Of the 11,734 subjects who passed the vision screening , 200 were r and omly chosen to undergo a strictly defined gold st and ard examination by an orthoptist and an ophthalmologist . RESULTS Of the 200 r and omly chosen subjects , 157 underwent the gold st and ard evaluation . The negative predictive value of the Enhanced Vision Screening Program was 97.6 % for any potentially vision-threatening ocular condition . It was 98.7 % if we considered only the visually significant ocular problems that the test was design ed to detect . CONCLUSION Because the negative predictive value of the Enhanced Vision Screening Program is not 100 % , some children with amblyopia , strabismus , or refractive errors are missed . Occasionally , a rare , potentially vision-threatening condition may go undetected . Parents should be made aware of this when they receive the results of the vision screening Purpose . To compare the agreement between subjective refraction and autorefraction using two commercially available autorefractors . Methods . Prospect i ve data were collected for 190 subjects using either the Nidek ARK-70 OUTPUT: Conclusion Diagnostic test accuracy of preschool vision screening tests can only be sufficiently investigated after establishing age-related values defining amblyopia , refractive errors and binocular disorders . INPUT: Additional unpublished data are presented from a study by Cotton and Evans in 1990 on the use of Irlen ( tinted ) lenses as an intervention for 22 children with a reading disability . These data reinforce rhe earlier conclusion that the r and om facilitatory effects of the lenses are very likely attributional and motivational in nature Background It is possible that cross-over studies included in current systematic review s are being inadequately assessed , because the current risk of bias tools do not consider possible biases specific to cross-over design . We performed this study to evaluate whether this was being done in cross-over studies included in Cochrane Systematic Review s ( CSRs ) . Methods We search ed the Cochrane Library ( up to 2013 issue 5 ) for CSRs that included at least one cross-over trial . Two authors independently undertook the study selection and data extraction . A r and om sample of the CSRs was selected and we evaluated whether the cross-over trials in these CSRs were assessed according to criteria suggested by the Cochrane h and book . In addition we reassessed the risk of bias of these cross-over trials by a checklist developed form the Cochrane h and book . Results We identified 688 CSRs that included one or more cross-over studies . We chose a r and om sample of 60 CSRs and these included 139 cross-over studies . None of these CSRs undertook a risk of bias assessment specific for cross-over studies . In fact items specific for cross-over studies were seldom considered anywhere in quality assessment of these CSRs . When we reassessed the risk of bias , including the 3 items specific to cross-over trials , of these 139 studies , a low risk of bias was judged for appropriate cross-over design in 110(79 % ) , carry-over effects in 48(34 % ) and for reporting data in all stages of the trial in 114(82 % ) . Assessment of biases in cross-over trials could affect the GRADE assessment of a review ’s findings . Conclusion The current Cochrane risk of bias tool is not adequate to assess cross-over studies . Items specific to cross-over trials leading to potential risk of bias are generally neglected in CSRs . A proposed check list for the evaluation of cross-over trials is provided Background We explore whether the number of null results in large National Heart Lung , and Blood Institute ( NHLBI ) funded trials has increased over time . Methods We identified all large NHLBI supported RCTs between 1970 and 2012 evaluating drugs or dietary supplements for the treatment or prevention of cardiovascular disease . Trials were included if direct costs > $ 500,000/year , participants were adult humans , and the primary outcome was cardiovascular risk , disease or death . The 55 trials meeting these criteria were coded for whether they were published prior to or after the year 2000 , whether they registered in clinical trials.gov prior to publication , used active or placebo comparator , and whether or not the trial had industry co-sponsorship . We tabulated whether the study reported a positive , negative , or null result on the primary outcome variable and for total mortality . Results 17 of 30 studies ( 57 % ) published prior to 2000 showed a significant benefit of intervention on the primary outcome in comparison to only 2 among the 25 ( 8 % ) trials published after 2000 ( χ2=12.2,df= 1 , p=0.0005 ) . There has been no change in the proportion of trials that compared treatment to placebo versus active comparator . Industry co-sponsorship was unrelated to the probability of reporting a significant benefit . Pre- registration in clinical trials.gov was strongly associated with the trend toward null findings . Conclusions The number NHLBI trials reporting positive results declined after the year 2000 . Prospect i ve declaration of outcomes in RCTs , and the adoption of transparent reporting st and ards , as required by clinical trials.gov , may have contributed to the trend toward null findings Aim : To test a theory of visual stress by investigating the inter-relationships between ( 1 ) the threshold contrast/saturation at which individuals first report discomfort when viewing colored gratings of progressively increasing contrast and decreasing saturation ; ( 2 ) the choice of a colored overlay for reading ; ( 3 ) any increase in reading speed when the overlay is used . Method : Ninety-five young adults , with normal color vision , reported illusions from square-wave gratings ( Pattern Glare Test ) , chose any colored overlays that improved clarity ( Intuitive Color Overlays ) and read aloud r and omly ordered common words ( Wilkins Rate of Reading Test ) . This was followed by an automated choice of tints for text using various screen colors on a tablet , and a test of discomfort from patterns of progressively increasing contrast and decreasing saturation , using software developed for this study . All participants wore their optimal refractive correction throughout the procedure . Results : Fifty-eight participants chose a colored overlay and reported that it made text easier and more comfortable to read . On average , these individuals had a greater improvement in reading speed with their overlays ( p = 0.003 ) , a lower contrast threshold at which discomfort from achromatic gratings was first reported ( p = 0.015 ) , and a tendency to report more pattern glare ( p = 0.052 ) , compared to the other participants . Participants who chose both a most and least preferred tint for text using the automated procedure reported discomfort from colored gratings at a significantly higher contrast with their most preferred color compared to their least preferred color ( p = 0.003 ) . The choice of a colored tint was moderately consistent across tests . The most and least preferred colors tended to be complementary . Conclusion : Colored tints that improved reading speed reduced pattern glare both in terms of the illusion susceptibility and in terms of discomfort contrast threshold , supporting a theory of visual stress . An automated test that incorporates colored gratings and a choice of most and least preferred color might better identify individuals whose reading speed improves with colored overlays Flaws in the design , conduct , analysis OUTPUT:

While many studies report improvements with coloured lenses , the effect size is generally small and /or similar to the improvement found with a placebo condition . Consistent with previous review s and advice from several professional bodies , we conclude that the use of coloured lenses or overlays to ameliorate reading difficulties can not be endorsed and that any benefits reported by individuals in clinical setting s are likely to be the result of placebo , practice or Hawthorne effects

MS2_dynamic_1_shot506

***TASK*** the task is to summarize an input biomedical literature 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 The present investigation is a preliminary double-blind , controlled placebo , r and omized clinical trial with a six month follow-up period . The study aim ed to assess the efficacy of type A botulinum toxin ( Botox , Allergan , Inc. Irvine , CA ) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers . Twenty patients ( ten males , ten females ; age range 25 - 45 ) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind , controlled placebo , r and omized clinical trial , with a treatment group ( ten subjects treated with botulinum toxin injections- BTX-A ) and a control group ( ten subjects treated with saline placebo injections ) . A number of objective and subjective clinical parameters ( pain at rest and during chewing ; mastication efficiency ; maximum nonassisted and assisted mouth opening , protrusive and laterotrusive movements ; functional limitation during usual jaw movements ; subjective efficacy of the treatment ; tolerance of the treatment ) were assessed at baseline time and at one week , one month , and six months follow-up appointments . Descriptive analysis showed that improvements in both objective ( range of m and ibular movements ) and subjective ( pain at rest ; pain during chewing ) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects . Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects . Differences were not significant in some cases due to the small sample size . Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers , and provided pilot data which need to be confirmed by further research using larger sample Background Bruxism is a disorder of jaw-muscle activity characterised by repetitive clenching or grinding of the teeth which results in discomfort and damage to dentition . The two clinical manifestations of the condition ( sleep and awake bruxism ) are thought to have unrelated aetiologies but are palliated using similar techniques . The lack of a definitive treatment has prompted renewed interest in biofeedback , a behaviour change method that uses electronic detection to provide a stimulus whenever bruxism occurs . This systematic review aims to provide a comprehensive overview of the state of research into biofeedback for bruxism ; to assess the efficacy and acceptability of biofeedback therapy in management of awake bruxism and , separately , sleep bruxism in adults ; and to compare findings between the two variants . Methods A systematic review of published literature examining biofeedback as an intervention directed at controlling primary bruxism in adults . We will search electronic data bases and the grey literature using a predefined search strategy to identify r and omised and non-r and omised studies , technical reports and patents . Search es will not be restricted by language or date and will be exp and ed through contact with authors and experts , and by following up reference lists and citations . Two authors , working independently , will conduct screening of search results , study selection , data extraction and quality assessment and a third will resolve any disagreements . The primary outcomes of acceptability and effectiveness will be assessed using only r and omised studies , segregated by bruxism subtype . A meta- analysis of these data will be conducted only if pre-defined conditions for quality and heterogeneity are met , otherwise the data will be summarized in narrative form . Data from non-r and omised studies will be used to augment a narrative synthesis of the state of technical developments and any safety-related issues . PROSPERO registration number : CRD42013006880 . Discussion Biofeedback is not new , but its place in the clinical management of bruxism remains unclear . New research , and the availability of miniaturized consumer- grade devices , makes a systematic review timely to guide treatment decisions and inform future research The aim of this study was to assess the effects of sleep hygiene measures combined with relaxation techniques in the management of sleep bruxism ( SB ) in a double-blind , parallel , controlled , r and omised clinical trial design . Sixteen participants ( mean ± s.d . age = 39·9 ± 10·8 years ) were r and omly assigned to a control group ( n = 8) or to the experimental treatment group ( n = 8) . Participants belonging to the latter group were instructed to perform sleep hygiene measures and progressive muscle relaxation techniques for a 4-week period . Two polysomnographic recordings , including bilateral masseter electromyographic activity , were made : one prior to the treatment and the other after the treatment period . The number of bruxism episodes per hour , the number of burst per hour and the bruxism time index ( i.e. the percentage of total sleep time spent bruxing ) were established as outcome variables . No significant differences could be observed between the outcome measures obtained before and after the 4-week period , neither for the sleep bruxism variables nor for the sleep variables . Within the limitations of this study , it was concluded that there is no effect of sleep hygiene measures together with progressive relaxation techniques on sleep bruxism or sleep over a 4-week observation period OBJECTIVES Sleep bruxism ( SB ) frequently is associated with other sleep disorders and pain concerns . Our study assesses the efficacy of a m and ibular advancement appliance ( MAA ) for SB management in adolescents reporting snoring and headache ( HA ) . METHODS Sixteen adolescents ( mean age , 14.9±0.5 ) reporting SB , HA ( > 1d/wk ) , or snoring underwent four ambulatory polysomnographies for baseline ( BSL ) and while wearing MAA during sleep . MAA was worn in three positions ( free splints [ FS ] , neutral position [ NP ] , and advanced to 50 % of maximum protrusion [ A50 ] ) for 1 week each in r and om order ( FS-NP-A50 or NP-A50-FS ; titration order , NP-A50 ) . Reports of HA were assessed with pain question naires . RESULTS Overall , sleep variables did not differ across the four nights OUTPUT: Discussion This systematic review aims at identifying and evaluating therapies to treat bruxism . INPUT: OBJECTIVE To evaluate the microtensile bond strengths ( μTBS ) and nanoleakage ( NL ) of three universal or multi-mode adhesives , applied with increasing solvent evaporation times . METHODS One-hundred and forty caries-free extracted third molars were divided into 20 groups for bond strength testing , according to three factors : ( 1 ) Adhesive - All-Bond Universal ( ABU , Bisco , Inc. ) , Prime&Bond Elect ( PBE , Dentsply ) , and Scotchbond Universal Adhesive ( SBU , 3 M ESPE ) ; ( 2 ) Bonding strategy - self-etch ( SE ) or etch- and -rinse ( ER ) ; and ( 3 ) Adhesive solvent evaporation time - 5s , 15s , and 25s . Two extra groups were prepared with ABU because the respective manufacturer recommends a solvent evaporation time of 10s . After restorations were constructed , specimens were stored in water ( 37 ° C/24h ) . Resin-dentin beams ( 0.8mm(2 ) ) were tested at 0.5mm/min ( μTBS ) . For NL , forty extracted molars were r and omly assigned to each of the 20 groups . Dentin disks were restored , immersed in ammoniacal silver nitrate , sectioned and processed for evaluation under a FESEM in backscattered mode . Data from μTBS were analyzed using two-way ANOVA ( adhesive vs. drying time ) for each strategy , and Tukey 's test ( α=0.05 ) . NL data were computed with non-parametric tests ( Kruskal-Wallis and Mann-Whitney tests , α=0.05 ) . RESULTS Increasing solvent evaporation time from 5s to 25s result ed in statistically higher mean μTBS for all adhesives when used in ER mode . Regarding NL , ER result ed in greater NL than SE for each of the evaporation times regardless of the adhesive used . A solvent evaporation time of 25s result ed in the lowest NL for SBU-ER . SIGNIFICANCE Residual water and /or solvent may compromise the performance of universal adhesives , which may be improved with extended evaporation times OBJECTIVE To test the influence of a hydrophobic resin coating ( HC ) on the immediate ( 24h ) and 6-month ( 6 m ) microtensile dentin bond strengths ( μTBS ) and nanoleakage ( NL ) of three universal adhesives applied in self-etch ( SE ) or in etch- and -rinse ( ER ) mode . METHODS Sixty caries-free extracted third molars were assigned to 12 experimental groups result ing from the combination of the factors " adhesive system " ( Scotchbond Universal Adhesive [ SBU ] , 3 M ESPE ; All-Bond Universal [ ABU ] , Bisco Inc. ; and G-Bond Plus [ GBP ] , GC Corporation ) ; " adhesive strategy " ( SE or ER ) ; " hydrophobic resin coating " [ HC ] ( with or without Heliobond , Ivoclar Vivadent ) ; and " storage time " ( 24h or 6 m ) . Specimens were prepared for μTBS testing - ( 24h ) half of the beams were immediately tested under tension ; and ( 6 m ) the other half was stored in distilled water ( 37 ° C ) for 6 m prior to testing . For each tooth , two beams were r and omly selected for NL evaluation for both evaluation times . Data were analyzed for each adhesive system using three-way ANOVA and Tukey 's post-hoc test ( α=0.05 ) . RESULTS μTBS : ( 24h ) : In SE mode , HC result ed in statistically greater mean μTBS for all adhesives . ( 6 m ) : When HC was not used the mean μTBS for SBU/ER , ABU/ER , GBP/ER and SBU/SE decreased significantly . NL : ( 24h ) : SBU/ER , ABU/ER and GBP/SE result ed in a significant reduction in NL when HC was applied . ( 6 m ) : No significant reduction was observed for SBU/ER or for SBU/SE regardless of the use of HC . SIGNIFICANCE The application of a hydrophobic resin coating improved the 24h and the 6 m performances of all three adhesives systems in SE mode BACKGROUND The durability of restorations bonded with one-step self-etching ( OSSE ) adhesive systems is inferior compared with that of restorations bonded with conventional adhesives . The authors conducted an 18-month r and omized clinical study to evaluate the clinical performance of two OSSE systems in noncarious cervical lesions applied as recommended or with an extra layer of hydrophobic adhesive layer after 18 months of clinical service . METHODS Thirty participants , each of whom had at least two pairs of similar-sized noncarious cervical lesions , took part in this study . The authors placed 120 restorations , 30 in each of four groups : Clearfil S3 Bond ( Kuraray , Osaka , Japan ) ( CS ) and iBond Gluma inside ( Heraeus Kulzer , Hanau , Germany ) ( IB ) , and Clearfil S3 Bond ( CSB ) and iBond Gluma inside ( IBB ) with an extra layer of hydrophobic adhesive applied on top of them . They placed the restorations incrementally , using a resin-based composite . The authors evaluated the restorations at baseline and at 18 months following modified U.S. Public Health Service criteria . RESULTS At 18 months , the retention rate for the IB group was statistically lower than those for the CS , IBB and CSB groups . Marginal discoloration occurred in all groups and was statistically worse in the IB group . CONCLUSIONS The conversion of the iBond Gluma inside and Clearfil S3 Bond adhesive systems into two-step OUTPUT:

The meta- analysis demonstrated that the etch- and -rinse technique significantly reduced the nanoleakage of the Peak Universal and G-Bond Plus adhesives , whereas the self-etch mode reduced the nanoleakage of All-Bond Universal . In comparison , the etching technique did not significantly alter the nanoleakage of either Prime&Bond Elect or Scotchbond Universal which was characterized by the smallest nanoleakage . CONCLUSIONS Etching modes significantly , in various ways , influence the nanoleakage of universal adhesives . CLINICAL SIGNIFICANCE Contrary to the drive to simplify bonding technologies , an appreciation of their adhesive components and how these perform according to bonding technique could yield a knowledge-based practical approach that ultimately improves the longevity of direct composite restorations

MS2_dynamic_1_shot507

***TASK*** the task is to summarize an input biomedical literature 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: Heifer mastitis is a well-known problem , with several pathogens being involved . Several generic risk factors associated with the likelihood of intramammary infections ( IMI ) in fresh dairy heifers have been identified before . Yet , a need exists to identify pathogen group-specific factors , as the effect of ( groups of ) pathogens on udder health and milk yield is different . The aim of the present study was to identify pathogen group-specific risk factors for IMI in heifers participating in a prepartum antimicrobial treatment trial , allowing us to test the hypothesis that different factors are of importance between treated and untreated control heifers as well . Data from a clinical trial in which end-term heifers were treated systemically ( over 3 consecutive days ) 2 wk before calving with penethamate hydriodide ( n=76 ) or remained untreated ( n=73 ) , were available . Several potential risk factors at the herd , heifer , and quarter level were recorded in the first 3 d in milk . Quarters from untreated heifers supplemented with ≥4 mg of selenium/d prepartum were significantly less likely to be infected with coagulase-negative staphylococci ( CNS ) , whereas quarters were more likely to be infected with CNS when assistance during calving was needed . Udder edema before calving significantly decreased the odds of IMI with major pathogens . In treated heifers , no factors were detected that were associated with the likelihood of CNS IMI , whereas quarters from heifers were significantly more likely to be infected with major pathogens when they were housed in the calving pen more than 1 d and when they had been in contact with the lactating cows before calving . The risk factors for IMI that were identified in treated heifers were different than those in untreated heifers , independent of the pathogen group that was considered . It looks as if prepartum treatment not only changed the likelihood of infection , but also the factors that were associated with infection . However , except for treated heifers with an IMI with major pathogens , only a small proportion of the variation could be explained in the final models . Therefore , factors other than those that were studied could explain the likelihood of infection OBJECTIVE To determine whether prepartum intramammary treatment of dairy heifers with pirlimycin hydrochloride would reduce the prevalence of intramammary infection ( IMI ) and lower the somatic cell count ( SCC ) during early lactation or improve 305-day mature equivalent milk production . DESIGN Prospect i ve clinical trial . ANIMALS 183 Holstein-Friesian heifers ( 663 quarters ) from 2 dairy farms . PROCEDURE Heifers were assigned to treatment and control groups . Treated heifers received a single 50-mg dose of pirlimycin in each mammary quarter approximately 10 to 14 days prior to parturition . Prepartum mammary gl and secretions and postpartum milk sample s were collected for bacterial culture . Postpartum milk sample s were also collected for determination of SCC or California mastitis testing and were tested for pirlimycin residues . Mature equivalent 305-day milk production data were recorded . RESULTS Treated heifers in herd A had a higher overall cure rate , higher cure rates for IMI caused by coagulase-negative staphylococci ( CNS ) and Staphylococcus aureus , lower SCC , and lower prevalence of chronic IMI , compared with control heifers . Treated heifers in herd B had a higher overall cure rate and cure rate for IMI caused by CNS , compared with control heifers , but postpartum California mastitis test scores and prevalence of chronic IMI did not differ between groups . Mature equivalent 305-day milk production did not differ between herds or treatment groups . No pirlimycin residues were detected in postpartum milk sample s. CONCLUSIONS AND CLINICAL RELEVANCE Results suggest that prepartum treatment of dairy heifers with pirlimycin may reduce the prevalence of early lactation IMI , particularly IMI caused by CNS , without causing pirlimycin residues in milk Abstract AIMS : The main aim was to investigate the effectiveness of a novel internal teat sealant ( ITS ) formulation containing bismuth subnitrate and the antiseptic chlorhexidine , in adult cows ( Trial A ) and nulliparous heifers ( Trial B ) , to reduce the incidence of new intramammary infection ( IMI ) between treatment and calving and reduce the prevalence of IMI within 6 days following calving . METHODS : In Trial A dairy cows ( n=326 ) without history of clinical mastitis and with a maximum composite milk somatic cell count < 200,000 cells/mL during the current lactation were enrolled from three spring-calving mainly pasture-based herds immediately following the final milking . In Trial B all heifers ( n=166 ) were enrolled from two herds approximately 3 weeks before the start of calving . Gl and s were r and omly assigned to controls or treatment with ITS , and mammary secretion sample s were taken from all gl and s prior to treatment , and on two occasions 0–4 and 3–6 days post-calving to determine the incidence of new IMI and the prevalence of IMI immediately post-calving . Additionally , cows in Trial A were monitored for cases of clinical mastitis ( CM ) in the non-lactating period and animals in both trials were monitored for cases of CM within 30 days of calving . RESULTS : The ITS reduced the estimated incidence of new IMI with both major and any pathogens compared to control gl and s in cows ( 6.2 vs. 14.2 % and 14.7 vs. 32.8 % , respectively ) and in heifers ( 3.0 vs. 13.1 % and 13.4 vs. 25.3 % , respectively ) ( p<0.001 ) . The ITS reduced the estimated prevalence of OUTPUT: Although variation was observed in the pathogen-specific effectiveness of treatments at reducing rates of disease , antimicrobials , teat sealants , and combinations of vaccines or teat sealants with antimicrobials were consistently effective , whereas vaccines were only effective for contagious pathogens . INPUT: The main objectives of this prospect i ve cohort study were a ) to describe lameness prevalence at drying off in large high producing New York State herds based on visual locomotion score ( VLS ) and identify potential cow and herd level risk factors , and b ) to develop a model that will predict the probability of a cow developing claw horn disruption lesions ( CHDL ) in the subsequent lactation using cow level variables collected at drying off and /or available from farm management software . Data were collected from 23 large commercial dairy farms located in upstate New York . A total of 7,687 dry cows , that were less than 265 days in gestation , were enrolled in the study . Farms were visited between May 2012 and March 2013 , and cows were assessed for body condition score ( BCS ) and VLS . Data on the CHDL events recorded by the farm employees were extracted from the Dairy-Comp 305 data base , as well as information regarding the studied cows ’ health events , milk production , and reproductive records throughout the previous and subsequent lactation period . Univariable analyses and mixed multivariable logistic regression models were used to analyse the data at the cow level . The overall average prevalence of lameness ( VLS > 2 ) at drying off was 14 % . Lactation group , previous CHDL , mature equivalent 305-d milk yield ( ME305 ) , season , BCS at drying off and sire PTA for strength were all significantly associated with lameness at the drying off ( cow-level ) . Lameness at drying off was associated with CHDL incidence in the subsequent lactation , as well as lactation group , previous CHDL and ME305 . These risk factors for CHDL in the subsequent lactation were included in our predictive model and adjusted predicted probabilities for CHDL were calculated for all studied cows . ROC analysis identified an optimum cut-off point for these probabilities and using this cut-off point we could predict CHDL incidence in the subsequent lactation with an overall specificity of 75 % and sensitivity of 59 % . Using this approach , we would have detected 33 % of the studied population as being at risk , eventually identifying 59 % of future CHDL cases . Our predictive model could help dairy producers focusing their efforts on CHDL reduction by implementing aggressive preventive measures for high risk cows This paper describes the development and testing of a lameness control programme ( LCP ) for heifers on dairy farms . The LCP , which is based on the analysis of hazards and critical control points ( HACCP ) , was tested via a r and omised intervention study on 60 farms . Tangible hazards for each farm were identified , allotted to 11 categories of proximate hazard and scored on each farm to quantify the risks presented by each hazard . Feet were inspected for signs of claw horn disease and infection , such as digital dermatitis . Intervention was generally ineffective , primarily through failure to implement the LCP . However , retrospective analysis was able to demonstrate highly significant associations between risks attached to proximate hazards and probabilities of lameness and foot lesions , allowing the severity of these hazards to be ranked . The most significant proximate hazards of environmental origin were prolonged st and ing on concrete , st and ing in wet slurry and factors that cause claw trauma . The most severe proximate hazards however were those associated with failures of management , especially poor claw condition and inadequate foot care . Overall farm risks ( OFR ) were estimated by summing the products of the generic severity for proximate hazards with on-farm risks . Changes in OFR were significantly related to changes in outcome ( lameness and lesions ) 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 A 2-year experiment on the effect of claw trimming on hoof health was performed in 77 Swedish dairy herds ( 3444 dairy cattle ) selected on herd size , breed composition and membership in the official milk-recording scheme . In the autumn , cows within each herd were blocked according to breed , parity and stage of lactation and allocated to two treatments : autumn trimming ( AT ) or no autumn trimming ( NAT ) . Outcome variables were claw measurements and prevalence of hoof lesions and lameness ( measured at spring trimming ) and the need for hoof treatments between scheduled trimmings . At spring trimming , NAT cows had longer and shallower claws than AT cows . The average net growth of the toe wall was greater for AT than for NAT cattle , with a marked variation between housing systems . Most hoof lesions present at AT had disappeared at the subsequent spring trimming . Controlled for clustering by herd-within-year and for the effects of individual- and herd-level covariates , AT cattle at spring trimmings had significantly lower odds of lameness ( OR=0.66 ) and of haemorrhages of the sole or white-line ( OR=0.86 ) , sole ulcer ( OR=0.59 ) and white-line fissure or double sole (OR=0.71)-but not of moderate-to-severe heel-horn erosion or dermatitis ( OR=0.96 ) . Acute hoof treatments between claw trimmings were more common in the NAT group ( OR=2.02 ) 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 This study was carried out to detect differences in locom OUTPUT:

A higher risk of being lame was found for the presence of claw overgrowth , the first 120 days in milk , larger herd sizes , and increasing parity .

MS2_dynamic_1_shot508

***TASK*** the task is to summarize an input biomedical literature 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 Objective : Gastric acidity is a major nonimmune defense mechanism against infections . The objective of this study was to investigate whether ranitidine treatment in very low birth weight ( VLBW ) infants is associated with an increased risk of infections , necrotizing enterocolitis ( NEC ) , and fatal outcome . Methods : Newborns with birth weight between 401 and 1500 g or gestational age between 24 and 32 weeks , consecutively observed in neonatal intensive care units , were enrolled in a multicenter prospect i ve observational study . The rates of infectious diseases , NEC , and death in enrolled subjects exposed or not to ranitidine were recorded . Results : We evaluated 274 VLBW infants : 91 had taken ranitidine and 183 had not . The main clinical and demographic characteristics did not differ between the 2 groups . Thirty-four ( 37.4 % ) of the 91 children exposed to ranitidine and 18 ( 9.8 % ) of the 183 not exposed to ranitidine had contracted infections ( odds ratio 5.5 , 95 % confidence interval 2.9–10.4 , P < .001 ) . The risk of NEC was 6.6-fold higher in ranitidine-treated VLBW infants ( 95 % confidence interval 1.7–25.0 , P = .003 ) than in control subjects . Mortality rate was significantly higher in newborns receiving ranitidine ( 9.9 % vs 1.6 % , P = .003 ) . Conclusions : Ranitidine therapy is associated with an increased risk of infections , NEC , and fatal outcome in VLBW infants . Caution is advocated in the use of this drug in neonatal age Objectives : Gastroesophageal reflux ( GER ) is a frequently occurring condition in infants capable of causing distressing symptoms . The aim of our study is to evaluate the efficacy of Mg alginate plus simethicone ( Gastrotuss Baby , DMG Italia SRL , Pomezia , Italy ) , compared with rice-starch – thickened formula or with reassurance alone , in the treatment of GER in infants . Methods : The present r and omized controlled trial was conducted in full-term infants affected by symptoms suggestive of GER , evaluated through a vali date d question naire ( Infant Gastroesophageal Reflux Question naire Revised ) . The patients were r and omized into 3 groups according to treatment ( group A : Mg alginate plus simethicone ; group B : thickened formula ; group C : reassurance with lifestyle changes ) . Evaluation of symptom scores was performed after 1 month ( T1 ) and 2 months ( T2 ) . Results : A total of 64 ( 85.3 % ) of 75 enrolled infants ( median age 5 months ; range 1–10 ) concluded the study . After 1 month of treatment ( T1 ) , infants treated with Mg alginate plus simethicone showed a statistically significant improvement in symptoms compared with the thickened formula and reassurance ( P < 0.03 , < 0.0001 , respectively ) . At the end of the study , all 3 groups of patients showed a significant reduction in symptom scores ( P < 0.002 , < 0.038 , < 0.03 , respectively ) . Median symptom score values were more significantly reduced in group A than in group B and in group C ( group A vs group B P < 0.002 ; group A vs group C P < 0.0001 ; group B vs group C P < 0.001 ) . Conclusions : Mg alginate plus simethicone seems to be more efficacious on GER symptom scores than thickened formula and reassurance with lifestyle changes alone OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review OBJECTIVE . Our aim was to compare 2 laxatives , namely , polyethylene glycol 3350 without electrolytes and milk of magnesia , evaluating the OUTPUT: Results We found no evidence -based guidelines or systematic review s about the utility of pharmacological therapy in functional regurgitation , infant colic and functional diarrhea . In case of regurgitation associated with marked distress , some evidence s support a short trial with alginate when other non pharmacological approach failed ( stepped-care approach ) . In constipated infants younger than 6 months of age Lactulose is recommended , whilst in older ages Polyethylene glycol ( PEG ) represents the first-line therapy both for fecal disimpaction and maintenance therapy of constipation . Conversely , no evidence supports the use of laxatives for dyschezia . Furthermore , we found no RCTs regarding the pharmacological treatment of cyclic vomiting syndrome , but retrospective studies showed a high percentage of clinical response using cyproheptadine , propanolol and pizotifen . Conclusion There is some evidence that a pharmacological intervention is necessary for rectal disimpaction in childhood constipation and that PEG is the first line therapy . In contrast , for the other early FGIDs there is a lack of well- design ed high- quality RCTs and no evidence on the use of pharmacological therapy was found INPUT: Background And Objective : Gastric acidity is a major nonimmune defense mechanism against infections . The objective of this study was to investigate whether ranitidine treatment in very low birth weight ( VLBW ) infants is associated with an increased risk of infections , necrotizing enterocolitis ( NEC ) , and fatal outcome . Methods : Newborns with birth weight between 401 and 1500 g or gestational age between 24 and 32 weeks , consecutively observed in neonatal intensive care units , were enrolled in a multicenter prospect i ve observational study . The rates of infectious diseases , NEC , and death in enrolled subjects exposed or not to ranitidine were recorded . Results : We evaluated 274 VLBW infants : 91 had taken ranitidine and 183 had not . The main clinical and demographic characteristics did not differ between the 2 groups . Thirty-four ( 37.4 % ) of the 91 children exposed to ranitidine and 18 ( 9.8 % ) of the 183 not exposed to ranitidine had contracted infections ( odds ratio 5.5 , 95 % confidence interval 2.9–10.4 , P < .001 ) . The risk of NEC was 6.6-fold higher in ranitidine-treated VLBW infants ( 95 % confidence interval 1.7–25.0 , P = .003 ) than in control subjects . Mortality rate was significantly higher in newborns receiving ranitidine ( 9.9 % vs 1.6 % , P = .003 ) . Conclusions : Ranitidine therapy is associated with an increased risk of infections , NEC , and fatal outcome in VLBW infants . Caution is advocated in the use of this drug in neonatal age Background —The effect of histamine H2receptor antagonists on gastric emptying is controversial . Aims —To determine the effects of ranitidine , famotidine , and omeprazole on gastric motility and emptying . Patients and methods —Fifteen normal subjects underwent simultaneous antroduodenal manometry , electrogastrography ( EGG ) , and gastric emptying with dynamic antral scintigraphy ( DAS ) . After 30 minutes of fasting manometry and EGG recording , subjects received either intravenous saline , ranitidine , or famotidine , followed by another 30 minutes recording and then three hours of postpr and ial recording after ingestion of a radiolabelled meal . Images were obtained every 10–15 minutes for three hours to measure gastric emptying and assess antral contractility . Similar testing was performed after omeprazole 20 mg daily for one week . Results —Fasting antral phase III migrating motor complexes ( MMCs ) were more common after ranitidine ( 9/15 subjects , 60 % ) , famotidine ( 12/15 , 80 % ) , and omeprazole ( 8/12 , 67 % ) compared with placebo ( 4/14 , 29 % ; p<0.05 ) . Postpr and ially , ranitidine , famotidine , and omeprazole slowed gastric emptying , increased the amplitude of DAS contractions , increased the EGG power , and increased the antral manometric motility index . Conclusions —Suppression of gastric acid secretion with therapeutic doses of gastric acid suppressants is associated with delayed gastric emptying but increased antral motility Objective : To evaluate whether infants treated in neonatal intensive care units have stress-induced bleeding from gastrointestinal tract or gastric lesions and to define risk factors for these findings . Design : Part one : retrospective ; part two : prospect i ve . Setting : Tampere University Hospital , neonatal intensive care unit . Patients and interventions : In part one , 100 consecutive newborn infants treated in intensive care were retrospectively evaluated for gastrointestinal tract bleeding and risk factors , and in part two 89 gastroscopied and mechanically ventilated infants were prospect ively evaluated for further risk factors for gastric mucosal lesions . The statistical evaluation of risk factors was made by multivariate analysis using logistic regression modeling . Main results : Of infants treated in the neonatal intensive care unit 20 % had signs of gastrointestinal bleeding . Mechanical ventilation was the only risk factor ( OR = 4.06 , 95 % confidence interval 1.21–12.3 ) . In part two , when mechanically ventilated infants were prospect ively evaluated , 53 % had remarkable gastric mucosal lesions . The analysis showed three other risk factors : abnormal and delayed delivery and hypotension after birth . Conclusions : Newborn infants treated in the intensive care unit had a high frequency of stress-induced gastric hemorrhage with gastric lesions similar to adults and children treated in intensive care . Mechanical ventilation is the main risk factor . Also mode of delivery and hypotension after birth increase the risk of stress-induced gastric lesions . These infants should be the target for prophylactic gastroprotective treatment BACKGROUND Stress ulcer prophylaxis ( SUP ) using ranitidine , a histamine H2 receptor antagonist , has been associated with an increased risk of ventilator-associated pneumonia . The proton pump inhibitor ( PPI ) pantoprazole is also commonly used for SUP . PPI use has been linked to an increased risk of community-acquired pneumonia . The objective of this study was to determine whether SUP with pantoprazole increases pneumonia risk compared with ranitidine in critically ill patients . METHODS The cardiothoracic surgery data base at our institution was used to identify retrospectively all patients who had received SUP with pantoprazole or ranitidine , without crossover between agents . From January 1 , 2004 , to March 3 OUTPUT:

Exposure to H2 receptor antagonists may be associated with increased risk of NEC and infections in preterm infants

MS2_dynamic_1_shot509

***TASK*** the task is to summarize an input biomedical literature 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 ; This was a 6‐week , double‐blind , r and omized trial of the efficacy and tolerability of venlafaxine and fluoxetine in 109 patients with major depression and melancholia . Hospitalized and day care patients with DSM‐IV major depression and melancholia and a baseline Montgomery‐Asberg Depression Rating Scale ( MADRS ) score of ≥ 25 were eligible . The doses were venlafaxine 75 mg/day or fluoxetine 20 mg/day from days 1‐4 , venlafaxine 150 mg/day or fluoxetine 40 mg/day from days 5‐10 , and venlafaxine 225 mg/day or fluoxetine 60 mg/day from days 11‐42 . The intention‐to‐treat analyses included 55 patients on venlafaxine and 54 on fluoxetine . At the final evaluation , 70 % of patients with venlafaxine and 66 % with fluoxetine had ≥ 50 % reduction in the MADRS score , and 70 % with venlafaxine and 62 % with fluoxetine had a Clinical Global Impression ( CGI ) score of 1 or 2.A CGI improvement score of 1 was observed in 51 % of patients with venlafaxine and 32 % with fluoxetine ( P = 0.018 ) . A final Hamilton Depression Rating Scale ( HAM‐D ) score < 7 was attained in 41 % of venlafaxine‐treated and 36 % of fluoxetine‐treated patients . Overall , 22 % of patients in each group discontinued therapy , but only 5 % on venlafaxine and 9 % on fluoxetine discontinued for adverse events . Nausea was reported in 5.5 % of venlafaxinetreated patients and 14.8 % of fluoxetine‐treated patients . Venlafaxine was effective and well tolerated for treating in patients with major depression and melancholia . Based on remission criteria ( HAM‐D < 7 or CGI of 1 ) , venlafaxine was superior to fluoxetine Mild depressive syndromes are highly prevalent among primary -care patients . Evidence -based treatment recommendations need to be derived directly from this diagnostically heterogeneous group . The primary aim was to assess the efficacy of sertraline and cognitive-behavioural group therapy for treatment of depressed primary -care patients , the secondary aim was to evaluate if receiving treatment according to free choice is associated with a better outcome than r and omization to a particular treatment . We conducted a r and omized , placebo-controlled , single-centre , 10-wk trial with five arms : sertraline ( flexible dosages up to 200 mg/d ) ( n = 83 ) ; placebo ( n = 83 ) ; manual-guided cognitive-behavioural group therapy ( one individual session and nine group sessions per 90 min ) ( n = 61 ) ; guided self-help group ( control condition , n = 59 ) ; and treatment with sertraline or cognitive-behavioural group therapy according to patients ' choice ( n = 82 ) . From 1099 consecutively screened adult patients , 368 formed the intent-to-treat population with milder forms of depression . Primary outcome was a global efficacy measure combining z-converted Hamilton Depression Rating Scale and clinician-rated Inventory for Depressive Symptomatology scores . Sertraline was superior to placebo ( p = 0.03 ) . Outcome for guided self-help groups was worse compared to cognitive-behavioural group therapy ( p = 0.002 ) and compared to all other treatment arms including pill placebo ( secondary analyses ) . Outcome in the patients ' choice arm was similar to that in the sertraline and cognitive-behavioural group therapy . Overall , sertraline is efficacious in primary -care patients with milder forms of depression . The superiority of cognitive-behavioural group therapy over guided self-help groups might partly be explained by ' nocebo ' effects of the latter & NA ; Primary care patients with a major depressive disorder and 17‐item Hamilton Rating Scale for Depression ( 17‐HAM‐D ) score > 18 were r and omized to 24 weeks of treatment with mirtazapine 30‐45 mg/day ( n= 99 ) or paroxetine 20‐30 mg/day ( n=98 ) . Both treatments were efficacious in improving depressive symptomatology , as assessed by group mean 17‐HAM‐D scores , percentages of HAM‐D responders and remitters and Clinical Global Improvement responders . The mirtazapine group showed statistically significantly larger decreases from baseline in group mean 17‐HAM‐D scores at weeks 1 , 2 and 4 , and the difference with the paroxetine group reached the level of clinical relevance at weeks 2 and 4 . Antidepressant efficacy was maintained throughout both the acute and continuation phase of treatment . Both treatments were well tolerated . The only adverse event with a statistically significantly higher incidence in the mirtazapine group was fatigue . Statistically significantly more paroxetine‐treated patients complained of increased sweating , headache and nausea . The results demonstrate that both mirtazapine and paroxetine were efficacious and well tolerated when used for 24 weeks in depressed patients treated in primary care . An observed difference in efficacy favouring mirtazapine between weeks 1 and 4 indicates that mirtazapine patients had improved earlier compared to those on paroxetine , and corroborates similar findings in other comparisons of mirtazapine versus selective serotonin reuptake inhibitors ABSTRACT Objective : This trial was conducted to compare the efficacy and tolerability of a fixed dose OUTPUT: Overall , our analyses indicate that IR and extended-release formulations do not differ substantially with respect to efficacy and risk of harms . The evidence is mixed with respect to differences in adherence , indicating lower adherence for IR formulations . Conclusion Available evidence currently shows no clear differences between the two formulations and therefore we can not recommend a first choice . INPUT: Antidepressant effects and unintended effects of paroxetine ( 30 mg/day ) and clomipramine ( 150 mg/day ) were compared in a double-blind , r and omized , inpatient , fixed-dose , plasma-level-controlled study . Patients with a DSM-III diagnosis of major depressive disorder participated . After 1 week of single-blind placebo treatment 120 patients fulfilled the criterion of a Hamilton ( 17-item ) score of greater than or equal to 18 and were started on active treatment for 6 weeks . Drop-outs on paroxetine ( n = 12 ) were largely due to lack of effect , and on clomipramine ( n = 19 ) due to lack of effect ( n = 7 ) , adverse reactions or severe side effects ( n = 10 ) and development of mania ( n = 2 ) . According to the protocol , non-responders ( Hamilton total greater than or equal to 16 ) after 4 weeks active treatment were terminated , and this occurred to 23 patients on paroxetine and four patients on clomipramine . Categorical response measures and group averages of rating scores showed a significantly better therapeutic effect of clomipramine from the second week of treatment on . These results are very similar to our earlier results with another selective serotonin reuptake inhibitor ( citalopram ) , but generally at variance with the literature on this class of antidepressants , which , however , mostly deals with outpatient studies This 8-week , r and omised , double-blind study compared the efficacy and tolerability of escitalopram to that of venlafaxine XR in primary care patients with major depressive disorder . The efficacy of escitalopram ( 10– 20 mg ; n = 148 ) was similar to venlafaxine XR ( 75– 150 mg ; n = 145 ) , based on mean change from baseline to week 8 in Montgomery and Åsberg Depression Rating Scale total score . In ad hoc analyses , escitalopram-treated patients achieved sustained remission significantly faster than did venlafaxine-treated patients . More venlafaxine-treated patients had nausea , constipation , and increased sweating ( p < 0.05 ) . When treatment was completed after 8 weeks , significantly more venlafaxine-treated patients had discontinuation symptoms ( p < 0.01 ) . Thus escitalopram treatment was similar to venlafaxine treatment with respect to efficacy and was better tolerated by patients in primary care ABSTRACT Objective : This study evaluated the efficacy and tolerability of escitalopram and duloxetine in the treatment of major depressive disorder ( MDD ) . Research design and methods : Patients were r and omised to 24 weeks of double-blind treatment with fixed doses of escitalopram ( 20 mg ) ( n = 143 ) or duloxetine ( 60 mg ) ( n = 151 ) . The primary analysis of efficacy was an analysis of covariance ( ANCOVA ) of change from baseline to endpoint ( week 24 ) in MADRS total score ( last observation carried forward ) . Main outcome measures ; Results : At week 8 , the mean change from baseline in total MADRS score was –19.5 for patients treated with escitalopram ( n = 141 ) and –17.4 for patients treated with duloxetine ( n = 146 ) , a difference of 2.1 points ( p < 0.05 ) . At week 8 , the proportion of responders ( ≥ 50 % decrease in MADRS ) was 69 % ( escitalopram ) and 58 % ( duloxetine ) ( p < 0.05 ) and remission ( MADRS ≤ 12 ) rates were 56 % ( escitalopram ) and 48 % ( duloxetine ) ( NS ) . For the primary endpoint , the mean change from baseline in total MADRS score at week 24 was –23.4 for patients treated with escitalopram and –21.7 for patients treated with duloxetine , a difference of 1.7 points ( p = 0.055 , one-sided ) . The difference in mean change from baseline in MADRS total score favoured escitalopram at weeks 1 , 2 , 4 , 8 , 12 and 16 ( p < 0.05 ) . The overall withdrawal rates were 22 % ( escitalopram ) and 25 % ( duloxetine ) ( NS ) . The withdrawal rate due to adverse events was lower for escitalopram ( 9 % ) compared to duloxetine ( 17 % ) ( p < 0.05 ) and significantly more patients treated with duloxetine reported insomnia ( 12.6 % vs. 4.9 % ) and constipation ( 8.6 % vs. 2.8 % ) . Conclusion : Escitalopram was superior to duloxetine in acute treatment and at least as efficacious and better tolerated in long-term treatment of MDD Objective : To test the hypothesis that in patients with major depressive disorder ( MDD ) , the response for specific Hamilton Depression Rating Scale items will differ for duloxetine compared with selective serotonin reuptake inhibitors ( SSRIs ) and that patterns of response will differ based on symptom severity at baseline . Method : Data were pooled from all Lilly-sponsored clinical trials where duloxetine was compared with placebo and an SSRI in patients with MDD : 7 r and omized , double-blind , fixed-dose , 8-week studies of duloxetine ( n = 1,133 ) versus SSRI ( n = 689 ) versus placebo ( n = 641 ) . Duloxetine doses were 40 , 60 , 80 and 120 mg/day . SSRI doses were 10 mg/day OUTPUT:

Evidence from meta- analysis of r and omised controlled trials ( RCTs ) and r and omised pragmatic trials was found in support of greater efficacy of the serotonin noradrenaline reuptake inhibitors ( SNRIs ) , venlafaxine and duloxetine , in moderate to severe depression compared to SSRIs but no evidence was found for superiority of milnacipran . There is sufficient current evidence that demonstrates an increase in efficacy , when noradrenaline reuptake is added to serotonin ( 5-HT ) reuptake , to suggest that patients with severe depression or those who have failed to reach remission with a SSRI may benefit from treatment with a SNRI .

MS2_dynamic_1_shot510

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract Background : Falls and fall-related injuries are symptomatic of an aging population . This study aim ed to design , develop , and deliver a novel method of balance training , using an interactive game-based system to promote engagement , with the inclusion of older adults at both high and low risk of experiencing a fall . Study Design : Eighty-two older adults ( 65 years of age and older ) were recruited from sheltered accommodation and local activity groups . Forty volunteers were r and omly selected and received 5 weeks of balance game training ( 5 males , 35 females ; mean , 77.18 ± 6.59 years ) , whereas the remaining control participants recorded levels of physical activity ( 20 males , 22 females ; mean , 76.62 ± 7.28 years ) . The effect of balance game training was measured on levels of functional balance and balance confidence in individuals with and without quantifiable balance impairments . Results : Balance game training had a significant effect on levels of functional balance and balance confidence ( P < 0.05 ) . This was further demonstrated in participants who were deemed at high risk of falls . The overall pattern of results suggests the training program is effective and suitable for individuals at all levels of ability and may therefore play a role in reducing the risk of falls . Conclusions : Commercial hardware can be modified to deliver engaging methods of effective balance assessment and training for the older population BACKGROUND the study compares the effects of a Nintendo Wii exercise programme and a st and ard Gym-based exercise intervention on fear of falling , knee strength , physical function and falls rate in older adults . METHODS eighty community-dwelling adults aged 60 years and above with short physical performance battery score of 5 - 9 points and modified falls efficacy scale ( MFES ) score of ≤9 points participated in the parallel-group r and omised trial . Each intervention arm involved an hour of intervention per week , totalling 12 sessions over 12 weeks . Besides 1-year fall incidence , the participants were evaluated on MFES , knee extensor strength ( KES ) , timed-up- and -go test , gait speed , 6-minute walk test and narrow corridor walk test at weeks 13 and 24 . RESULTS at week 13 , between interventions , the effect of MFES changes did not reach statistical significance ( difference = -0.07 point , 95 % CI -0.56 to 0.42 , P = 0.78 ) ; at week 24 , the Wii group showed statistically significant effects over the Gym group ( difference = 0.8 point , 95 % CI 0.27 to 1.29 , P < 0.01 ) . For KES , the two groups did not differ statistically at week 13 ( difference = -2.0 % , 95 % CI -5.6 to -1.7 , P = 0.29 ) ; at week 24 , the Gym group had greater strength gains than the Wii group ( difference = -5.1 % , 95 % CI -8.7 to -1.5 , P < 0.01 ) . No between-group differences were observed for other outcome measures . CONCLUSION on completion of a 12-week Nintendo Wii exercise programme , there was no significant benefit seen on fear of falling when compared to a st and ard Gym-based exercise intervention ; however , post-intervention there was an apparent reduction in fear of falling in the group allocated to Wii training , despite knee strength apparently improving more in those allocated to the Gym . It is possible that long-term gains after using the Wii might be due to a carry-over effect . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry , ACTRN12610000576022 BACKGROUND Many issues prevent elderly individuals from exercising in daily life . There is a need for a system that allows elderly individuals to engage in exercise regularly at a low cost . We developed an exergame that uses a Kinect ( ® ) sensor ( Microsoft Corp. , Redmond , WA ) and conducted a r and omized controlled trial of the effects of using this exergame on muscle strength and balance in healthy elderly individuals . SUBJECTS AND METHODS We enrolled 57 healthy elderly individuals and r and omly divided them into an intervention group ( n=29 ) and a control group ( n=28 ) using a table of r and om numbers . All participants underwent gait analyses and were examined using the Berg Balance Scale ( BBS ) , Functional Reach Test ( FRT ) , and the 30-second chair-st and ( CS-30 ) test before the intervention . Participants in the intervention group played the exergame once or twice a week , up to a total of 24 times . The tests were repeated after intervention , and the scores were compared with those obtained before intervention . RESULTS Our results indicated that walking , muscle strength , and motor function improved in participants in the intervention group . Decreased double st and ing time ( P=0.03 ) , minimum foot clearance ( P=0.04 ) , BBS scores ( P<0.01 ) , CS-30 scores ( P<0.01 ) , and FRT scores ( P<0.01 ) significantly improved in the intervention group compared with values in the control group . CONCLUSIONS The Kinect-based exergame developed in this study was found to be effective in improving walking , muscular strength , and balance in elderly people Background Falls are a leading cause of injury and death for old adults , with one risk factor for falls being balance deficits . The low cost ( < 400 USD ) , wide availability , and ability to incorporate multiple training paradigms make gaming systems appealing as possible balance intervention tools . Aims To investigate the feasibility of using the Xbox Kinect for training to improve clinical measures of balance in old adults and retain improvements after a period of time . Methods Thirteen healthy old adults ( aged 70 + years ) were r and omly divided into two groups . The experimental group completed Kinect training three times a week for 3 weeks while the control group continued with normal activities . Four clinical measures of balance were assessed before training OUTPUT: Exergaming does encourage individuals to st and up ( 3 ) , lean while st and ing ( 4 ) , move upper limbs and turn heads ( 6 ) and dual-task while st and ing ( 9 ) , to some extent move the body forwards , backwards and sideways ( 1 ) , and coordinate movements ( 2 ) but hardly at all to kick , hop , jump or walk ( 7 ) , or to force a postural reaction from a physical force to the individual ( 5 ) and it does not mimic actual changes in sensory context ( 8) . Some elements of PC are too unsafe to be trained using exergames , such as restricting sensory inputs or applying physical perturbations to an individual to elicit postural responses INPUT: Background : The knowledge concerning balance training actually lowering fall rates among frail older persons is limited . Objective : The aim of this study was to examine the effects of a 4-week individualized visual feedback-based balance training on the fall incidence during 1-year follow-up among frail older women living in residential care . Methods : Twenty-seven older women from 2 residential care homes were r and omized into exercise ( n = 20 ) and control ( n = 7 ) groups . Balance measurements were carried out before and after a 4-week training period and falls were monitored by monthly diaries for 1 year . An interview about fear of falling and physical activity was completed before and after the intervention and after the 1-year follow-up . Results : A positive effect of balance training on fall incidence was found . A dynamic Poisson regression model showed that during the follow-up the monthly risk of falling was decreased in the exercise group compared to controls ( risk ratio 0.398 , 95 % CI 0.174–0.911 , p = 0.029 ) . In addition , the exercise group reported a reduced fear of falling and increased physical activity after a training period but these changes declined during the follow-up period . Conclusion : Individualized visual feedback-based balance training was shown to be a promising method for fall prevention among frail older women . High compliance ( 97.5 % ) with the training program showed that carefully targeted training programs can be carried out among older people with health limitations Background : Controversial findings exist in the literature with respect to the efficacy of visually guided weight-shifting ( WS ) training as a means of improving balance in healthy older adults . Objective : The purpose of this study was to investigate the impact of two direction-specific , visually guided WS training protocol s on st and ing balance of healthy elderly women . Methods : Forty-eight community-dwelling elderly women , all free of any neurological or musculoskeletal impairment , were r and omly assigned into : a group that practice d WS in the anterior/posterior direction ( A/P group , n = 19 ) , a group that practice d WS in the medio/lateral direction ( M/L group , n = 15 ) and a control group ( n = 14 ) . Participants performed 12 training sessions of visually guided WS ( 3 sessions a week for 25 minutes per session ) . Static balance was measured before and after training in normal ( bipedal ) quiet stance ( NQS ) and sharpened-Romberg stance ( SRS ) by recording center of pressure ( CoP ) variations and angular segment kinematics . Results : In NQS , neither of the two training protocol s had a significant impact on postural sway measures , although a significant decrease in interlimb asymmetry of CoP displacement was noted for the A/P group . In SRS , A/P training induced a significant reduction of CoP displacement , lower limb pitch and upper trunk roll rotation . Conclusion : The results of the study stress the importance of using direction-specific WS tasks in balance training , particularly in the A/P direction , in order to improve control of static balance in elderly women Background Motor learning research has had little impact on clinical applications and rarely extended to research about how older adults learn motor skills . There is consistent evidence that motor skill performance and learning can be enhanced by giving learners instructions that direct their attention . The aim of this study was to test whether elderly individuals that receive an external focus instruction during training of dynamic balance skills would learn in a different manner compared to individuals that received an internal focus instruction . Methods This r and omised trial included 26 older persons ( 81 ± 6 years ) that were training functional balance twice a week for the duration of 5 weeks . Learning outcomes were recorded after every training session . Weight shifting score and dynamic balance parameters ( Biodex Balance System ) , components of the Extended Timed-Get-Up- and -Go test , five chair rises , and falls efficacy ( FES-I ) was assessed at baseline and post-intervention . Results Participation for training sessions was 94 % . No differences between groups were found following 5 weeks of training for weight shifting score , dynamic balance index and dynamic balance time ( p < 0.95 , p = 0.16 , p < 0.50 ) , implying no learning differences between training groups . Extended Timed-Get-Up- and -Go components Sit-to-st and , p = .036 ; Gait initiation , p = .039 ; Slow down , stop , turnaround , and sit down , p = 0.011 and the Fes-I ( p = 0.014 ) showed improvements for the total group , indicating that function improved compared to baseline . Conclusion A 5-week balance training improved weight shifting scores and dynamic balance parameters as well as functional abilities . The observed improvements were independent from the type of attentional focus instructions . The findings provide support for the proposition of different motor learning principles in older adults compared to younger adults . Trial Registration IS RCT Objective : To assess the balance function of hemiplegic stroke patients and to investigate whether visual feedback rhythmic weight-shift training following acute stroke can decrease falls among patients with hemiplegic stroke . Design : A prospect i ve study , using a Balance Master . Setting : Hospital-based rehabilitation units . Subjects : Fifty-two hemiplegic stroke patients ( 28 in the training group and 24 in the control group ) . Interventions : Conventional stroke rehabilitation programme plus visual feedback rhythmic weight-shift training . Training effect was evaluated by assessing the static and dynamic balance performance as well as comparing the occurrence of falls in the training and control groups at six-month follow-up . Main measures : Occurrence of falls ; static balance in different sensory conditions ; and dynamic balance performance , including on-axis velocity and directional control during rhythmic weight-shift . Results : Significant improvement in dynamic balance performance was found in hemiplegic patients in the training group . The improvement was sustained for six months . With regarding to static balance function , no significant improvement was found . At six-month follow-up , 5 of 28 patients ( 17.8 % ) in the training group had fallen , compared with 10 of 24 patients ( 41. OUTPUT:

Results and Conclusions Although most available studies did not systematic ally evaluate feasibility aspects , reports of high participation rates , low drop-out rates , absence of adverse events and positive training experiences suggest that biofeedback methods can be applied in older adults . An indication for effectiveness of visual feedback-based training of balance in ( frail ) older adults was identified for postural sway , weight-shifting and reaction time in st and ing , and for the Berg Balance Scale . Indications for added effectiveness of applying biofeedback during training of balance , gait , or sit-to-st and transfers in older patients post-stroke were identified for training-specific aspects . The same applies for auditory feedback-based training of gait in older patients with lower-limb surgery . Implication sFurther appropriate studies are needed in different population s of older adults to be able to make definitive statements regarding the ( long-term ) added effectiveness , particularly on measures of functioning

MS2_dynamic_1_shot511

***TASK*** the task is to summarize an input biomedical literature 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: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest OUTPUT: A number of patient characteristics , hospital characteristics , physician characteristics , care processes and " other " factors were associated with door to balloon time . Prognostic factors for longer times include : pre-hospital delay in presentation , cerebrovascular disease , absence of chest pain , lower PCI volume and specialization hospital , lower sum ST elevation , absence of Q waves and left bundle branch block . Underst and ing prognostic factors for door to balloon time can likely lead to improved quality of care for STEMI INPUT: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest OUTPUT:

The most important predictive factors for upper limb recovery following stroke appears to the initial severity of motor impairment or function

MS2_dynamic_1_shot512

***TASK*** the task is to summarize an input biomedical literature 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 ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies CONTEXT Low back pain is a frequent and costly health problem . Prevention of low back pain is important both for the individual patient and from an economic perspective . OBJECTIVE To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry . DESIGN A r and omized controlled trial with a factorial design . SETTING The cargo department of an airline company in the Netherl and s. PARTICIPANTS A total of 312 workers were r and omized , of whom 282 were available for the 6-month follow-up . INTERVENTIONS Subjects were r and omly assigned to 4 groups : ( 1 ) education ( lifting instructions ) and lumbar support , ( 2 ) education , ( 3 ) lumbar support , and ( 4 ) no intervention . Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours . Lumbar supports were recommended to be used during working hours for 6 months . MAIN OUTCOME MEASURES Low back pain incidence and sick leave because of back pain during the 6-month intervention period . RESULTS Compliance with wearing the lumbar support at least half the time was 43 % . In the 282 subjects for whom data were available , no statistically significant differences in back pain incidence ( 48 [ 36 % ] of 134 with lumbar support vs 51 [ 34 % ] of 148 without , P=.81 ) or in sick leave because of low back pain ( mean , 0.4 days per month with lumbar support vs 0.4 days without , P=.52 ) were found among the intervention groups . In a subgroup of subjects with low back pain at baseline , lumbar supports reduced the number of days with low back pain per month ( median , 1.2 vs 6.5 days per month ; P=.03 ) . CONCLUSIONS Overall , lumbar supports or education did not lead to a reduction in low back pain incidence or sick leave . The results of the subgroup analysis need to be confirmed by future research . Based on our results , the use of education or lumbar supports can not be recommended in the prevention of low back pain in industry The aims of this study were to assess the compliance of home care workers with low back pain ( LBP ) in using a lumbar support , to establish the benefit experienced from the support , and to determine the predictive factors for that compliance and benefit . Only home care workers who had LBP at the start of the study or who had experienced at least two episodes of LBP in the 12 months prior to the study could apply for participation . The study consisted of two phases . In phase I ( the first week of the study ) , workers used the lumbar support each working day . In phase II ( the following 6 months ) , subjects were instructed to use the lumbar support only on those working days when they experienced LBP . Weekly question naires were used to measure compliance ; monthly question naires were used to measure the benefit experienced . Fifty-nine workers participated in the study . Overall , they scored their perceived benefit from the lumbar support as 7 on a scale of 0 - 10 , and 61 - 81 % of the workers were compliant . Multiple linear regression analysis showed that the best predictor for experienced benefit is the degree of confidence in expected pain reduction due to the lumbar support , measured after phase I ( R(2 ) = 0.70 ) . Multiple logistic analysis showed that the best predictor for compliance is the extent to which subjects consider they can influence their own health status ( R(2 ) = 0.49 ) . Because both the benefit experienced and the compliance rate were substantial , the use of lumbar supports by home care workers with LBP seems feasible . However , we can not recommend extensive use of lumbar supports in home care workers with LBP based solely on the results of the present study . First , there is a clear need for a r and omized clinical trial on this topic Abstract . When measuring treatment effect in chronic low back pain with multi-item outcome instruments , it is necessary , both for clinical decision-making and research purpose s , to underst and the clinical importance of the outcome scores . The aims of the present study were three-fold . Firstly , it aim ed to estimate the OUTPUT: Implication Adding lumbar supports to instruction on healthy work habits may decrease low back pain recurrence , but not absenteeism , among workers with previous low back pain . Recent systematic review s of the sparse evidence on lumbar supports ( 6 , 7 ) concluded that no evidence exists for the effectiveness of lumbar supports in the primary prevention of low back pain in the workplace , but 2 of the 4 included r and omized , controlled trials ( 8 , 9 ) reported that lumbar supports might be effective in workers with a history of low back pain ( secondary prevention ) . In cohort studies , a history of low back pain proved to be a strong predictor for the incidence of new episodes of low back pain ( 1012 ) . Home care workers with a history of low back pain may therefore be well suited to secondary preventive measures . INPUT: Abstract The assessment of clinical ly meaningful changes in patient‐reported pain has become increasingly important when interpreting results of clinical studies . However , proposed response criteria , such as the minimal clinical ly important difference , do not correspond with the growing need for information on truly meaningful , individual improvements . The aim of the present study was to investigate satisfactory improvements in pain from the patient ’s perspective . Data were collected in a 2‐week prospect i ve study of 181 arthritis patients treated with a local corticosteroid injection . Baseline and follow‐up pain were assessed on 100 mm visual analogue scales for pain intensity ( VAS‐PI ) . At baseline , patients also marked a hypothetical level on a VAS‐PI representing a satisfactory improvement in pain . Patient‐perceived satisfactory improvement ( PPSI ) was constructed using a 5‐point categorical rating of change scale at follow‐up as the anchor . PPSI was associated with a minimal reduction of 30 mm or 55 % on the VAS‐PI . Since absolute change in pain associated with satisfactory improvement proved highly dependent on baseline pain , percent change scores performed better in classifying improved patients . The 55 % threshold for satisfactory improvement was consistent over the course of treatment and reasonably consistent across groups of patients . Our data suggest that PPSI is a clinical ly relevant and stable concept for interpreting truly meaningful improvements in pain from the individual perspective Objective To investigate the degree of pain reduction in patients with complex regional pain syndrome type 1 ( CRPS 1 ) that can be defined as “ successful . ” Design All patients rated their pain on a visual analog scale ( VAS ; 0–10 ) before treatment and on three occasions after treatment , at 6 months , 1 year , and 2 years . Patients also rated a Global Perceived Effect ( GPE ) for their pain relief at the same time periods . The GPE items were classified as “ successful ” or “ unsuccessful . ” The mean absolute and relative pain reduction ( using the VAS ) was calculated for both “ successful ” and “ unsuccessful ” GPE classifications for each time period . Sensitivity and specificity analyses were performed . Patients Sixty-one patients with CRPS 1 . Results The patients defined a relative pain reduction of 58 % ( SD , 23.4 ) or more as “ successful , ” whereas in “ successful ” and “ unsuccessful ” patient groups the pain was reduced significantly on the VAS . Furthermore , sensitivity and specificity analyses showed that a cut-off point of 50 % relative pain reduction and a 3-cm absolute pain reduction on the VAS have the highest likelihood that patients will report their treatment “ successful ” on the GPE . Conclusions Relative pain reduction of 50 % or more and an absolute pain reduction of at least 3 cm on the VAS are accurate in predicting a successful pain reduction after a given treatment Abstract Purpose : The purpose of this trial was to investigate changes in pain , the range of motion ( ROM ) and spasticity in people with painful hemiplegic shoulder ( PHS ) after the application of an upper limb neuromuscular taping ( NMT ) . Methods : We conducted a r and omised clinical trial . The study included 32 people , 31 % female ( mean ± SD age : 66 ± 9 years ) , with PHS after stroke with pain at rest and during functional movements . The experimental group received the application of NMT and a st and ard physical therapy programme ( SPTP ) , whereas the control group received SPTP . The groups received four 45-minute long sessions over four weeks . The VAS , ROM and spasticity were assessed before and after the intervention with follow-up at four weeks . Results : The experimental group had a greater reduction in pain compared to the control group at the end of the intervention , as well as at one month after the intervention ( p < 0.001 ; all the group differences were greater than 4.5 cm , which is greater than the minimal clinical ly important difference of 2.0 cm ) . The experimental group had a significantly higher ( i.e. better ) ROM , by 30.0 ° , than the control group in shoulder flexion ( 95 % CI : 37.3–22.7 ) at 4 weeks and by 24.8 ° ( 95 % CI : 32.1–17.6 ) at 8 weeks as well as in abduction by 30.6 ° ( 95 % CI : 37.5–23.7 ) at 4 weeks and 25.1 ° ( 95 % CI : 33.8–16.3 ) at 8 weeks . Conclusion : Our study demonstrates that NMT decreases pain and increases the ROM in subjects with shoulder pain after a stroke . Implication s for Rehabilitation Painful hemiplegic shoulder is a frequent complication after stroke with negative impacts on functional activities and on quality of life of people , moreover restricts rehabilitation intervention . Neuromuscular taping is a technique introduced by David Blow for the treatment of neuromuscoloskeletal problems . This study shows the reduction of pain and the improvement of range of motion after the application of an upper limb neuromuscular taping . Rehabilitation professionals who are involved in the management of painful hemiplegic shoulder may like to consider the benefits that neuromuscular taping can produce on upper limb Study Design . Prospect i ve study of two sample s of patients with acute and chronic low back pain , respectively . Objectives . To compare the responsiveness of four functional status question naires , Rol and Morris Disability Question naire ( RMDQ ) , Oswestry Disability Index ( ODI ) , Disability Rating Index ( DRI ) , and Physical Functioning scale of the SF-36 ( PFSF-36 ) , and two pain scales , a Numerical Pain Rating Scale ( NRS ) and Visual Analogue Scale ( VAS ) . Summary of Background Data . Concurrent comparisons of different outcome measurements in back patients have been requested . Methods . Norwegian versions of the scales and question naires were completed by 54 patients with acute ( < 3weeks ) and 50 patients with chronic low back pain ( > 3 months ) . Clinical change was estimated on a global change index . An alternative external criterion was the expected clinical course in OUTPUT:

Absolute MCID was strongly associated with baseline pain , explaining approximately two-thirds of the variation , and to a lesser degree with the operational definition of minimum pain relief and clinical condition . MCID for chronic pain relief vary considerably . Baseline pain is strongly associated with absolute , but not relative , measures . To a much lesser degree , MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition .

MS2_dynamic_1_shot513

***TASK*** the task is to summarize an input biomedical literature 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 height growth over 10 years in children treated for obesity . DESIGN Longitudinal , prospect i ve follow-up of a series of r and omized , controlled weight control trials . SETTING Specialized pediatric weight control clinic . PARTICIPANTS One hundred fifty-eight 6- to 12-year-old obese children who were followed up for 10 years after treatment . INTERVENTIONS Family-based behavioral weight control . MEASUREMENTS /MAIN RESULTS At entry the height percentiles of the obese children were significantly higher ( 71.6 percentile ) than same-sex parent ( 52.0 percentile ) or midparent ( 51.5 percentile ) height ( an estimate of parental contribution to height ) . After an average growth of 22.7 cm , children were 2.2 cm taller than their same-sex parent and decreased to an average height percentile of 57.8 . Multiple regression analysis showed that child sex , age , baseline height and percent overweight , midparent height , and height change of the child from baseline to 5 years accounted for 94 % of the variance in growth . Child percent overweight change made no contribution to predicting height change . Comparison between children obese and nonobese at 10 years showed no differences in growth . CONCLUSIONS Moderate energy restriction with dietary guidance by overweight children did not negatively influence long-term growth CONTEXT The prevalence of overweight and obesity in children and adolescents is increasing rapidly . In this population , behavioral therapy alone has had limited success in providing meaningful , sustained weight reduction , and pharmacological treatment has not been extensively studied . OBJECTIVE To determine the efficacy and safety of orlistat in weight management of adolescents . DESIGN , SETTING , AND PATIENTS Multicenter , 54-week ( August 2000-October 2002 ) , r and omized , double-blind study of 539 obese adolescents ( aged 12 - 16 years ; body mass index [ BMI ] > or=2 units above the 95th percentile ) at 32 centers in the United States and Canada . INTERVENTIONS A 120-mg dose of orlistat ( n = 357 ) or placebo ( n = 182 ) 3 times daily for 1 year , plus a mildly hypocaloric diet ( 30 % fat calories ) , exercise , and behavioral therapy . MAIN OUTCOME MEASURES Change in BMI ; secondary measures included changes in waist and hip circumference , weight loss , lipid measurements , and glucose and insulin responses to oral glucose challenge . RESULTS There was a decrease in BMI in both treatment groups up to week 12 , thereafter stabilizing with orlistat but increasing beyond baseline with placebo . At the end of the study , BMI had decreased by 0.55 with orlistat but increased by 0.31 with placebo ( P = .001 ) . Compared with 15.7 % of the placebo group , 26.5 % of participants taking orlistat had a 5 % or higher decrease in BMI ( P = .005 ) ; 4.5 % and 13.3 % , respectively , had a 10 % or higher decrease in BMI ( P = .002 ) . At study end , weight had increased 0.53 kg with orlistat and 3.14 kg with placebo ( P<.001 ) . Dual-energy x-ray absorptiometry showed that this difference was explained by changes in fat mass . Waist circumference decreased in the orlistat group but increased in the placebo group ( -1.33 cm vs + 0.12 cm ; P<.05 ) . Generally mild to moderate gastrointestinal tract adverse events occurred in 9 % to 50 % of the orlistat group and in 1 % to 13 % of the placebo group . CONCLUSIONS In combination with diet , exercise , and behavioral modification , orlistat statistically significantly improved weight management in obese adolescents compared with placebo . The use of orlistat for 1 year in this adolescent population did not raise major safety issues although gastrointestinal adverse events were more common in the orlistat group BACKGROUND The prevalence of overweight and obesity in children and adolescents is increasing in both the United States and Mexico . OBJECTIVE The goal of this article was to assess the efficacy and safety of sibutramine in obese Mexican adolescents . METHODS This was a 6-month , r and omized , double-blind , placebo-controlled , prospect i ve clinical trial of sibutramine QD . Male and female patients aged 14 to 18 years with sex-specific body mass index ( BMI ) for age and sex > 85th percentile were eligible . The primary end points for the trial were the baseline versus end point absolute values for body weight , BMI , and percentage of the initial BMI ( % BMI ) ; secondary end points were waist circumference and percentage of the initial waist circumference ( % waist ) . These were measured at days -15 , 0 , 30 , 60 , 90 , 120 , 150 , and 180 of the study . Quality of life was assessed at the study start and end using the 36-Item Short-Form Health Survey ( SF-36 ) question naire . Blood pressure and heart rate were assessed , and adverse events ( AEs ) were recorded . Both groups received individually tailored diet and exercise programs . RESULTS Forty-six patients ( age range , 14 - 18 years ) with a BMI > 95th percentile for age were included ( sibutramine group , n = 23 [ 14 females , 9 males ] ; placebo group , n = 23 [ 12 females , 11 males ] ) . Twenty-one patients in the sibutramine group and 19 patients in the placebo group completed the 6-month trial . Using the intent-to-treat data , weight ( mean [ SD ] ) OUTPUT: More limited evidence suggests that these improvements can be maintained over the 12 months after the end of treatments and that there are few harms with behavioral interventions . Potential adverse effects were greater than for behavioral interventions alone and varied in severity . Despite important gaps , available research supports at least short-term benefits of comprehensive medium- to high-intensity behavioral interventions in obese children and adolescents INPUT: BACKGROUND Infants with Prader-Willi syndrome ( PWS ) show abnormalities of body composition . Children with PWS treated with growth hormone ( GH ) demonstrate improved body composition and motor skills . OBJECTIVE To assess body composition and motor changes in infants with PWS following 6 months GH therapy . METHODS Twenty-five infants with PWS ( mean age 15.5 mo ) underwent dual energy X-ray absorptiometry ( DEXA ) assessment of body composition , and motor assessment with the Toddler Infant Motor Evaluation ( TIME ) . Patients were then r and omized to treatment ( Genotropin , 1 mg/m2/day ) or control , with re assessment at 6 months . RESULTS GH treatment significantly increased lean body mass ( 6.4 + /- 2.4 kg to 8.9 + /- 2.7 kg ) and decreased body fat ( 27.6 + /- 9.9 % to 22.4 + /- 10.3 % ) . Age equivalent motor scores improved 4 months in the treated group vs 2 months in controls ( p < 0.01 ) . CONCLUSIONS Infants with PWS show significant body composition and motor development improvement following 6 months GH therapy . We are investigating whether this improvement leads to long-term reductions in obesity A total of 130 short children were included in a French multicentre study and r and omized between a control group ( group A ) and two groups treated with daily subcutaneous injections of GH at doses of 0.7 IU/kg/week ( group B ) and 1.4 IU/kg/week ( group C ) for 2 years . Height velocity was significantly increased ( p<0.0005 ) in groups B and C , with a greater increase in group C than in group B ( p < 0.001 ) . The benefit after 2 years compared with controls was 4.3 cm in group B and 5.9 cm in group C. The rate of bone maturation was not affected by GH therapy . These results led to the conclusion that 2 years of treatment with GH improves final height prognosis in children with short stature secondary to IUGR , and that this effect is dose dependent . The effect on final height has still to be demonstrated Background : In boys with Prader-Labhart-Willi syndrome ( PWS ) , hypogonadism causes pubertal arrest and reduces pubertal muscle growth . Formerly , it was assumed that therapy with gonadal hormones accentuates behaviour abnormalities in PWS . Our aim was to assess the clinical effects of human chorionic gonadotropin ( hCG ) therapy on pubertal development , muscle mass and behaviour in adolescents with PWS . Methods : 6 peripubertal boys with PWS undergoing long-term treatment with growth hormone were examined 6-monthly for at least 2 years before and after pubertal arrest ( 13.5 ± 0.3 years , mean ± SEM ) and the beginning of hCG therapy ( 500–1,500 IU twice weekly , intramuscularly ) . Height , weight , pubertal stage , bone age , body composition ( by dual-energy X-ray absorptiometry ) , testosterone levels and behaviour abnormalities ( obtained from parents ) were assessed . Results : Testicular volume and lean mass were reduced in pubertal boys with PWS . During hCG therapy , testosterone levels and lean mass significantly increased ( at the beginning and after 2 years of hCG therapy : 2.3 ± 0.9 and 10.7 ± 1.3 nmol/l , –3.1 ± 0.3 and –1.4 ± 0.6 SD , respectively ) , and fat mass stabilized at 38 % . The characteristically observed PWS-associated problems , mood instability , aggressiveness and difficulties in social interaction , did not deteriorate during therapy . Conclusion : In the present study , timely application of hCG to treat hypogonadism in boys with PWS promoted virilization and normalized muscle mass without detrimental effects on behaviour . Larger studies comparing hCG therapy with testosterone replacement would be useful Aims : To determine the effectiveness of different doses of r-hGH therapy during puberty in children with growth hormone deficiency ( GHD ) . Methods : R and omized controlled trial of different doses of r-hGH therapy administered during puberty in 49 children with GHD . The patients were allocated r and omly using a r and om number table to one of two groups : group 1 ( 15 IU/m2/week ) or group 2 ( 30 IU/m2/week ) . Patients were included if they had received r-hGH daily at a dose of 15 IU/m2/week ( 0.7 mg/m2/day ) for at least 1 year before r and omization . Results : Height increase st and ard deviation scores ( SDS ) were similar between the two groups ( group 1 : 1.1 ; group 2 : 1.2 ; p = 0.81 ) . Conclusion : A higher dose of r-hGH administered during puberty does not appear to have a significant effect on final height of children with GH deficiency . Altering pubertal tempo or intensifying prepubertal r-hGH therapy may be a more promising approach to improving final height in children with GH deficiency Background / Aim : Since hyper and rogenism in simple obesity is assumed to arise from hyperinsulinism and /or increased insulin-like growth factor I ( IGF-I ) or leptin levels , we examined how in patients with Prader-Willi syndrome ( PWS ) , the most frequent form of syndromal obesity , the accelerated adrenarche can be explained despite hypothalamic-pituitary insufficiency with low levels of insulin and IGF-I. Methods : In 23 children with PWS and a mean age of 5.6 years , height , weight , fat mass , fasting insulin concentration , insulin resistance ( by HO OUTPUT:

This SR highlights the lack of long-term RCTs reporting final height data and other important qualitative outcomes , such as quality of life .

MS2_dynamic_1_shot514

***TASK*** the task is to summarize an input biomedical literature 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 Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer . The Exercise and Nutrition to Enhance Recovery and Good Health for You ( ENERGY ) study is the largest weight loss intervention trial among survivors of breast cancer to date . METHODS In this multicenter trial , 692 overweight/obese women who were , on average , 2 years since primary treatment for early-stage breast cancer were r and omly assigned to either a group-based behavioral intervention , supplemented with telephone counseling and tailored newsletters , to support weight loss or a less intensive control intervention and observed for 2 years . Weight and blood pressure were measured at 6 , 12 , 18 , and 24 months . Longitudinal mixed models were used to analyze change over time . RESULTS At 12 months , mean weight loss was 6.0 % of initial weight in the intervention group and 1.5 % in the control group ( P<.001 ) . At 24 months , mean weight loss in the intervention and control groups was 3.7 % and 1.3 % , respectively ( P<.001 ) . Favorable effects of the intervention on physical activity and blood pressure were observed . The weight loss intervention was more effective among women older than 55 years than among younger women . CONCLUSION A behavioral weight loss intervention can lead to clinical ly meaningful weight loss in overweight/obese survivors of breast cancer . These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival IMPORTANCE Leisure-time physical activity has been associated with lower risk of heart-disease and all-cause mortality , but its association with risk of cancer is not well understood . OBJECTIVE To determine the association of leisure-time physical activity with incidence of common types of cancer and whether associations vary by body size and /or smoking . DESIGN , SETTING , AND PARTICIPANTS We pooled data from 12 prospect i ve US and European cohorts with self-reported physical activity ( baseline , 1987 - 2004 ) . We used multivariable Cox regression to estimate hazard ratios ( HRs ) and 95 % confidence intervals for associations of leisure-time physical activity with incidence of 26 types of cancer . Leisure-time physical activity levels were modeled as cohort-specific percentiles on a continuous basis and cohort-specific results were synthesized by r and om-effects meta- analysis . Hazard ratios for high vs low levels of activity are based on a comparison of risk at the 90th vs 10th percentiles of activity . The data analysis was performed from January 1 , 2014 , to June 1 , 2015 . EXPOSURES Leisure-time physical activity of a moderate to vigorous intensity . MAIN OUTCOMES AND MEASURES Incident cancer during follow-up . RESULTS A total of 1.44 million participants ( median [ range ] age , 59 [ 19 - 98 ] years ; 57 % female ) and 186 932 cancers were included . High vs low levels of leisure-time physical activity were associated with lower risks of 13 cancers : esophageal adenocarcinoma ( HR , 0.58 ; 95 % CI , 0.37 - 0.89 ) , liver ( HR , 0.73 ; 95 % CI , 0.55 - 0.98 ) , lung ( HR , 0.74 ; 95 % CI , 0.71 - 0.77 ) , kidney ( HR , 0.77 ; 95 % CI , 0.70 - 0.85 ) , gastric cardia ( HR , 0.78 ; 95 % CI , 0.64 - 0.95 ) , endometrial ( HR , 0.79 ; 95 % CI , 0.68 - 0.92 ) , myeloid leukemia ( HR , 0.80 ; 95 % CI , 0.70 - 0.92 ) , myeloma ( HR , 0.83 ; 95 % CI , 0.72 - 0.95 ) , colon ( HR , 0.84 ; 95 % CI , 0.77 - 0.91 ) , head and neck ( HR , 0.85 ; 95 % CI , 0.78 - 0.93 ) , rectal ( HR , 0.87 ; 95 % CI , 0.80 - 0.95 ) , bladder ( HR , 0.87 ; 95 % CI , 0.82 - 0.92 ) , and breast ( HR , 0.90 ; 95 % CI , 0.87 - 0.93 ) . Body mass index adjustment modestly attenuated associations for several cancers , but 10 of 13 inverse associations remained statistically significant after this adjustment . Leisure-time physical activity was associated with higher risks of malignant melanoma ( HR , 1.27 ; 95 % CI , 1.16 - 1.40 ) and prostate cancer ( HR , 1.05 ; 95 % CI , 1.03 - 1.08 ) . Associations were generally similar between overweight/obese and normal-weight individuals . Smoking status modified the association for lung cancer but not other smoking-related cancers . CONCLUSIONS AND RELEVANCE Leisure-time physical activity was associated with lower risks of many cancer types . Health care professionals counseling inactive adults should emphasize that most of these associations were evident regardless of body size or smoking history , supporting broad generalizability of findings Exercise improves health in lymphoma patients but the determinants of adherence in this population are unknown . The purpose of this study OUTPUT: The most prominent predictors of adherence to exercise interventions were location of the rehabilitation center , extensive exercise history , high motivation for exercise , and fewer exercise limitations . INPUT: Objective Research suggests that physical activity is associated with improved breast cancer survival , yet no studies have examined the association between post-diagnosis changes in physical activity and breast cancer outcomes . The aim of this study was to determine whether baseline activity and 1-year change in activity are associated with breast cancer events or mortality . Methods A total of 2,361 post-treatment breast cancer survivors ( Stage I – III ) enrolled in a r and omized controlled trial of dietary change completed physical activity measures at baseline and one year . Physical activity variables ( total , moderate – vigorous , and adherence to guidelines ) were calculated for each time point . Median follow-up was 7.1 years . Outcomes were invasive breast cancer events and all-cause mortality . Results Those who were most active at baseline had a 53 % lower mortality risk compared to the least active women ( HR = 0.47 ; 95 % CI : 0.26 , 0.84 ; p = .01 ) . Adherence to activity guidelines was associated with a 35 % lower mortality risk ( HR = 0.65 , 95 % CI : 0.47 , 0.91 ; p < .01 ) . Neither baseline nor 1-year change in activity was associated with additional breast cancer events . Conclusions Higher baseline ( post-treatment ) physical activity was associated with improved survival . However , change in activity over the following year was not associated with outcomes . These data suggest that long-term physical activity levels are important for breast cancer prognosis Background : This r and omized controlled trial assessed the safety and effects of twice-weekly weight training among recent breast cancer survivors . Outcomes included body size and biomarkers hypothesized to link exercise and breast cancer risk . Methods : A convenience sample of 85 recent survivors was r and omized into immediate and delayed treatment groups . The immediate group trained from months 0 to 12 ; the delayed treatment group served as a no exercise parallel comparison group from months 0 to 6 and trained from months 7 to 12 . Measures at baseline , 6 and 12 months included body weight , height , body fat , lean mass , body fat % , and waist circumference , as well as fasting glucose , insulin , insulin resistance , insulin-like growth factor-I ( IGF-I ) , IGF-II , and IGF-binding protein-1 , IGFBP-2 , and IGFBP-3 . Injury reporting was st and ardized . Results : The intervention result ed in significant increases in lean mass ( 0.88 versus 0.02 kg , P < 0.01 ) , as well as significant decreases in body fat % ( −1.15 % versus 0.23 % , P = 0.03 ) and IGF-II ( −6.23 versus 28.28 ng/mL , P = 0.02 ) comparing immediate with delayed treatment from baseline to 6 months . Within-person changes experienced by delayed treatment group participants during training versus no training were similar . Only one participant experienced a study related injury that prevented continued participation . Conclusion : Twice-weekly weight training is a safe exercise program for recent breast cancer survivors that may result in increased muscle mass , as well as decreased body fat % and IGF-II . The implication s of these results on cancer recurrence or survival may become more evident with longer exercise intervention trials among breast cancer survivors A continuing challenge in weight loss treatment is attaining maintenance of weight loss . The goal of this study was to develop a counseling method that would assist African American breast cancer survivors with weight loss maintenance . In this pilot study , 31 obese breast cancer survivors were recruited . Individualized , dietitian-led counseling by telephone and free Weight Watchers coupons were provided to all participants for 18 months . At the 6-month time point , women were r and omized to receive spirituality counseling or not in addition to the st and ard program . The spirituality counseling was delivered via telephone using an 8-step framework . Subjects were asked to utilize daily meditation or prayer , daily readings , and the recording of thoughts in a journal . Mean weight loss from baseline to 6 months was a modest 2.0 % of baseline weight . From 6 to 18 months , there was no further weight change in the spirituality arm and a gain of 0.7 % in the dietitian-only arm . Despite little effect on weight loss , it did appear that spirituality counseling positively affected spiritual well-being ( FACIT-Sp ) scores and dietary quality . The spirituality counseling framework therefore may be further refined and useful for other health promotion studies with African American population PURPOSE Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer . The Exercise and Nutrition to Enhance Recovery and Good Health for You ( ENERGY ) study is the largest weight loss intervention trial among survivors of breast cancer to date . METHODS In this multicenter trial , 692 overweight/obese women who were , on average , 2 years since primary treatment for early-stage breast cancer were r and omly assigned to either a group-based behavioral intervention , supplemented with telephone counseling and tailored newsletters , to support weight loss or a less intensive control intervention and observed for 2 years . Weight and blood pressure were measured at 6 , 12 , 18 , and 24 months . Longitudinal mixed models were used to analyze change over time . RESULTS At 12 months , mean weight loss was 6.0 % of initial weight in the intervention group and 1.5 % in the control group ( P<.001 ) . At 24 months , mean weight loss in the intervention and control groups was 3.7 % and 1.3 % , respectively ( P<.001 ) . Favorable effects of the intervention on physical activity and blood pressure were observed . The weight loss intervention was more effective among women older than 55 years than among younger women . CONCLUSION A behavioral weight loss intervention can lead to clinical OUTPUT:

Conclusions : The available literature suggests that African American breast cancer survivors adhere to interventions of various modalities and are capable of making modest to significant changes .

MS2_dynamic_1_shot515

***TASK*** the task is to summarize an input biomedical literature 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: There is limited information on the effects of vitamin D on serum 25 hydroxyvitamin D ( 25OHD ) in young people and none on African Americans . The main objective of this trial was to measure the effect of different doses of vitamin D3 on serum 25OHD and serum parathyroid hormone ( PTH ) in young women with vitamin D insufficiency ( serum 25OHD ≤ 20 ng/mL ( 50 nmol/L ) . A r and omized double-blind placebo-controlled trial of vitamin D3 was conducted in young white and African American women , age 25 to 45 years . A total of 198 healthy white ( 60 % ) and African American ( 40 % ) women were r and omly assigned to placebo , or to 400 , 800 , 1600 , or 2400 IU of vitamin D3 daily . Calcium supplements were added to maintain a total calcium intake of 1000 to 1200 mg daily . The primary outcomes of the study were the final serum 25OHD and PTH levels at 12 months . The absolute increase in serum 25OHD with 400 , 800 , 1600 , and 2400 IU of vitamin D daily was slightly greater in African American women than in white women . On the highest dose of 2400 IU/d , the mixed model predicted that mean 25OHD increased from baseline 12.4 ng/mL ( 95 % confidence interval [ CI ] , 9.2 - 15.7 ) to 43.2 ng/mL ( 95 % CI , 38.2 - 48.1 ) in African American women and from 15.0 ng/mL ( 95 % CI , 12.3 - 17.6 ) to 39.1 ng/mL ( 95 % CI , 36.2 - 42.0 ) in white women . There was no significant effect of vitamin D dose on serum PTH in either race but there was a significant inverse relationship between final serum PTH and serum 25OHD . Serum 25OHD exceeded 20 ng/mL in 97.5 % of whites on the 400 IU/d dose and between 800 and 1600 IU/d for African Americans . The recommended dietary allowance ( RDA ) suggested by the Institute of Medicine for young people is 600 IU daily . The increase in serum 25OHD after vitamin D supplementation was similar in young and old , and in white and African American women OBJECTIVE In observational studies , low serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease . RESEARCH DESIGN AND METHODS We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose ( IFG ) and /or impaired glucose tolerance ( IGT ) r and omly assigned to 20,000 IU/week vitamin D3 or placebo . An oral glucose tolerance test was performed at baseline and after 1 year . RESULTS Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups , respectively , and increased by 45.8 nmol/L and 3.4 nmol/L , respectively . With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after 1 year . There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly . Only analyzing subjects with 25(OH)D < 50 nmol/L did not change the results . CONCLUSIONS This study shows that vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and /or IGT CONTEXT Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality . Data from r and omized controlled trials are limited . OBJECTIVE The aim of this study was to test whether daily doses of vitamin D(3 ) at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease ( CVD ) risk . DESIGN We conducted a parallel-group , double-blind , placebo-controlled r and omized controlled trial . R and omization was computer generated . Participants and study investigators were blinded to intervention groupings throughout the trial . SETTING The study was conducted at the Clinical Research Facility , University of Aberdeen , United Kingdom . PARTICIPANTS A total of 305 healthy postmenopausal women aged 60 - 70 yr were recruited for the study . INTERVENTION Each woman received a daily capsule of 400 or 1000 IU vitamin D(3 ) or placebo r and omly allocated . MAIN OUTCOME MEASURES Primary outcomes were serum lipid profile [ total , high-density lipoprotein , and low-density lipoprotein cholesterol ; triglycerides ; and apolipoproteins A-1 and B100 ] , insulin resistance ( homeostatic model assessment ) , inflammatory biomarkers ( high-sensitivity C-reactive protein , IL-6 , soluble intracellular adhesion molecule-1 ) , and blood pressure . RESULTS A total of 265 ( 87 % ) participants completed all study visits . Small differences between groups for serum apol OUTPUT: In subgroup analyses , it was shown that the effect of vitamin D supplementation on risk of hypercalcemia , hypercalciuria , or kidney stones was not modified by baseline 25-hydroxyvitamin D , vitamin D dose and duration , or calcium co-supplementation . CONCLUSIONS Long-term vitamin D supplementation result ed in increased risks of hypercalcemia and hypercalciuria , which were not dose related . However , vitamin D supplementation did not increase risk of kidney stones . INPUT: Summary This trial compared the effects of daily treatment with vitamin D or placebo for 1 year on blood tests of vitamin D status . The results demonstrated that daily 4000 IU vitamin D3 is required to achieve blood levels associated with lowest disease risks , and this dose should be tested in future trials for fracture prevention . Introduction The aim of this trial was to assess the effects of daily supplementation with vitamin D3 4000 IU ( 100 μg ) , 2000 IU ( 50 μg ) or placebo for 1 year on biochemical markers of vitamin D status in preparation for a large trial for prevention of fractures and other outcomes . Methods This is a r and omized placebo-controlled trial in 305 community-dwelling people aged 65 years or older in Oxfordshire , UK . Outcomes included biochemical markers of vitamin D status ( plasma 25-hydroxy-vitamin D [ 25[OH]D ] , parathyroid hormone [ PTH ] , calcium and alkaline phosphatase ) , cardiovascular risk factors and tests of physical function . Results Mean ( SD ) plasma 25(OH)D levels were 50 ( 18 ) nmol/L at baseline and increased to 137 ( 39 ) , 102 ( 25 ) and 53 ( 16 ) nmol/L after 12 months in those allocated 4000 IU , 2000 IU or placebo , respectively ( with 88 % , 70 % and 1 % of these groups achieving the pre-specified level of > 90 nmol/L ) . Neither dose of vitamin D3 was associated with significant deviation outside the normal range of PTH or albumin-corrected calcium . The additional effect on 25(OH)D levels of 4000 versus 2000 IU was similar in all subgroups except for body mass index , for which the further increase was smaller in overweight and obese participants compared with normal-weight participants . Supplementation with vitamin D had no significant effects on cardiovascular risk factors or on measures of physical function . Conclusions After accounting for average 70 % compliance in long-term trials , doses of 4000 IU vitamin D3 daily may be required to achieve plasma 25(OH)D levels associated with lowest disease risk in observational studies UNLABELLED This study of 9605 community-dwelling residents supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in elderly in a northern European region known to be deficient in vitamin D , especially during winter periods . INTRODUCTION We evaluated the effect of two programs for the prevention of osteoporotic fractures leading to acute hospital admission in a population of elderly community-dwelling residents . MATERIAL S AND METHODS This was a factorial , cluster-r and omized , pragmatic , intervention study . We included 9605 community-dwelling residents aged 66 + years . We offered a prevention program of a daily supplement of 1000 mg of elemental calcium as calcium carbonate and 400 IU ( 10 microg ) of vitamin D3 to a total of 4957 participants . Another program with evaluation and suggestions for the improvement of the domestic environment was offered to a total of 5063 participants . Both programs included revision of the resident 's current pharmaceutical treatment . We achieved information on osteoporotic fractures in the study population from the Danish Hospital Registration Data base . We defined osteoporotic fractures as low energy fractures of the proximal humerus , distal forearm , vertebral column , pelvis , cervical femur , and intertrochanteric femur . RESULTS Active participation was 50.3 % in the Calcium and Vitamin D Program and 46.4 % in the Environmental and Health Program . We observed a 16 % reduction in fracture incidence rate ( relative risk [ RR ] , 0.84 ; CI , 0.72 - 0.98 ; p < 0.025 ) among male and female residents offered the Calcium and Vitamin D Program ( intention-to-prevent analysis ) . CONCLUSIONS This study supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in community-dwelling elderly people in a northern European region known to be deficient in vitamin D , especially during winter periods Conflicting data regarding cardiovascular effects of thiazolidinediones ( TZDs ) and extra-skeletal effects of vitamin D supported the need for a definitive trial . The Thiazolidinedione Intervention with vitamin D Evaluation ( TIDE ) trial aim ed to assess the effects of TZDs ( rosiglitazone and pioglitazone ) on cardiovascular outcomes and the effects of vitamin D ( cholecalciferol ) on cancers and mortality . A large multicentre 3 × 2 factorial double-blind placebo-controlled r and omised trial recruited from outpatient primary care and specialty clinics in 33 countries . From June 2009 to July 2010 , 1,332 people with type 2 diabetes and other cardiovascular risk factors aged ≥50 years whose HbA1c was 6.5–9.5 % ( 48–80 mmol/mol ) when using two or fewer glucose-lowering drugs were r and omised by a central computer system to placebo ( n = 541 ) , rosiglitazone 4–8 mg/day ( n = 399 ) or pioglitazone 30–45 mg/day ( n = 392 ) ; 1,221 participants were r and omised to placebo ( n = 614 ) or vitamin D 1,000 IU/day ( n = 607 ) . Participants and all study personnel were blind to treatment allocation . The primary outcome for the TZD arm was the composite of myocardial infa OUTPUT:

Subgroup analyses showed that these results were generally consistent regardless of the calcium or vitamin D dose , sex , fracture history , dietary calcium intake , and baseline serum 25-hydroxyvitamin D concentration . Conclusions and Relevance In this meta- analysis of r and omized clinical trials , the use of supplements that included calcium , vitamin D , or both compared with placebo or no treatment was not associated with a lower risk of fractures among community-dwelling older adults .

MS2_dynamic_1_shot516

***TASK*** the task is to summarize an input biomedical literature 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 Telehealth ( TH ) and telecare ( TC ) interventions are increasingly valued for supporting self-care in ageing population s ; however , evaluation studies often report high rates of non-participation that are not well understood . This paper reports from a qualitative study nested within a large r and omised controlled trial in the UK : the Whole System Demonstrator ( WSD ) project . It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial . Methods Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention ( n = 19 ) , or who withdrew from the intervention arm ( n = 3 ) . Participants were recruited from the four trial groups ( with diabetes , chronic obstructive pulmonary disease , heart failure , or social care needs ) ; and all came from the three trial areas ( Cornwall , Kent , east London ) . Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home . Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes . Results Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes : requirements for technical competence and operation of equipment ; threats to identity , independence and self-care ; expectations and experiences of disruption to services . Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderst and ings . Respondents ’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance , and views that interventions could undermine self-care and coping . Finally , participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued . Conclusions These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake . These insights have implication s for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction . It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation An ethnographic ( participant observation ) study was undertaken of the socio-technical processes involved in the implementation , within a r and omized controlled trial , of a home telehealth nursing service for patients with chronic obstructive pulmonary disease ( COPD ) . Ethnographic field notes were taken about technology-related tasks and the interplay between the research team and the 12 nurses who were to use the telehealth equipment . Views of the technology were linked to views of professional self-image and status . The technology was sometimes seen as unhelpful in establishing effective relationships with patients . Considerable work by all participants , over a period of months , was required to develop the technology in ways that minimized the risk to the stability of the specialist service and existing nurse – patient relationships . Our work highlights the complex problems that health professionals encounter when they try to integrate new technologies into routine service delivery . The concerns arising from the interplay of new technology with existing professional practice s and relationships go beyond simple issues of training We conducted a systematic review of the evidence on the costs and cost-effectiveness of telehealth for patients with chronic obstructive pulmonary disease ( COPD ) . A literature search identified six relevant economic evaluations that were assessed according to the Consensus Health Economic Criteria list ( CHEC list ) . Three studies were from North America and three studies were from Europe . All studies reported the use of home monitoring devices that measured and transmitted different physical indicators to nurses who provided personalised feedback to patients during weekdays . The six studies involved a total of 559 COPD patients of whom 281 were r and omised to telehealth . The review demonstrated a potential for cost savings . All six studies reported a lower average cost per patient with telehealth plus usual care compared with usual care alone . However , the quality of the economic evidence was poor . Five studies were evaluated as low quality and one study was evaluated as moderate quality , with CHEC list scores of 21–68 % . Caution is advised for healthcare decision-makers seeking large-scale implementation of telehealth in routine clinical practice . The clinical effectiveness of such implementations with follow-up exceeding 12 months has not yet been demonstrated ABSTRACT In the last five years , home health agencies have become increasingly interested in telemedicine as a potential means to meet the future healthcare needs of their aged and chronically ill clientele . This case study examines the organizational and environmental conditions that affected the implementation of a telemedicine program in one rural home healthcare organization . Several factors restricted the utilization of telemedicine , including Medicare 's Prospect i ve Payment System and corresponding documentation ( Outcome Assessment and Information Set ) , the organization controlling grant funding for the program , and several environmental factors . Findings suggest that in rural communities , older homecare patients may have less opportunity to benefit from telemedicine . The study demonstrates the importance of environmental and organizational factors when implementing a telemedicine program . Recommendations are offered for home healthcare organizations considering development of telemedicine programs BACKGROUND Continuity of care is widely regarded as an important marker of quality in the management of patients with long-term conditions . New services that integrate telemonitoring into care pathways have potential to change aspects of continuity in both positive and negative ways . AIMS A telemonitoring service for patients with chronic obstructive pulmonary disease ( COPD ) was introduced in Lothian , Scotl and , in 2009 . A qualitative study , nested within the TELESCOT COPD r and omised control trial , was undertaken to explore the views of patients and professionals on telemonitoring . The perceived impact of telemonitoring on continuity of care was investigated as part of the research . METHODS Semi-structured interviews were undertaken with 38 patients ( 47 % male , mean age 67.5 years ) . A maximum variation sample in relation to age , sex , socio-economic background , disease severity , and compliance with telemonitor OUTPUT: The findings of this systematic review provide implication s for sustained usage of tele-homecare programs by home health nursing agencies and can help such programs realize their potential for chronic disease management INPUT: Background Telehealth ( TH ) and telecare ( TC ) interventions are increasingly valued for supporting self-care in ageing population s ; however , evaluation studies often report high rates of non-participation that are not well understood . This paper reports from a qualitative study nested within a large r and omised controlled trial in the UK : the Whole System Demonstrator ( WSD ) project . It explores barriers to participation and adoption of TH and TC from the perspective of people who declined to participate or withdrew from the trial . Methods Qualitative semi-structured interviews were conducted with 22 people who declined to participate in the trial following explanations of the intervention ( n = 19 ) , or who withdrew from the intervention arm ( n = 3 ) . Participants were recruited from the four trial groups ( with diabetes , chronic obstructive pulmonary disease , heart failure , or social care needs ) ; and all came from the three trial areas ( Cornwall , Kent , east London ) . Observations of home visits where the trial and interventions were first explained were also conducted by shadowing 8 members of health and social care staff visiting 23 people at home . Field notes were made of observational visits and explored alongside interview transcripts to elicit key themes . Results Barriers to adoption of TH and TC associated with non-participation and withdrawal from the trial were identified within the following themes : requirements for technical competence and operation of equipment ; threats to identity , independence and self-care ; expectations and experiences of disruption to services . Respondents held concerns that special skills were needed to operate equipment but these were often based on misunderst and ings . Respondents ’ views were often explained in terms of potential threats to identity associated with positive ageing and self-reliance , and views that interventions could undermine self-care and coping . Finally , participants were reluctant to risk potentially disruptive changes to existing services that were often highly valued . Conclusions These findings regarding perceptions of potential disruption of interventions to identity and services go beyond more common expectations that concerns about privacy and dislike of technology deter uptake . These insights have implication s for health and social care staff indicating that more detailed information and time for discussion could be valuable especially on introduction . It seems especially important for potential recipients to have the opportunity to discuss their expectations and such views might usefully feed back into design and implementation Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care . Design Research er blind , multicentre , r and omised controlled trial . Setting UK primary care ( Lothian , Scotl and ) . Participants Adults with at least one admission for chronic obstructive pulmonary disease ( COPD ) in the year before r and omisation . We excluded people who had other significant lung disease , who were unable to provide informed consent or complete the study , or who had other significant social or clinical problems . Interventions Participants were recruited between 21 May 2009 and 28 March 2011 , and central ly r and omised to receive telemonitoring or conventional self monitoring . Using a touch screen , telemonitoring participants recorded a daily question naire about symptoms and treatment use , and monitored oxygen saturation using linked instruments . Algorithms , based on the symptom score , generated alerts if readings were omitted or breached thresholds . Both groups received similar care from existing clinical services . Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after r and omisation . Other outcomes included number and duration of admissions , and vali date d question naire assessment s of health related quality of life ( using St George ’s respiratory question naire ( SGRQ ) ) , anxiety or depression ( or both ) , self efficacy , knowledge , and adherence to treatment . Analysis was intention to treat . Results Of 256 patients completing the study , 128 patients were r and omised to telemonitoring and 128 to usual care ; baseline characteristics of each group were similar . The number of days to admission did not differ significantly between groups ( adjusted hazard ratio 0.98 , 95 % confidence interval 0.66 to 1.44 ) . Over one year , the mean number of COPD admissions was similar in both groups ( telemonitoring 1.2 admissions per person ( st and ard deviation 1.9 ) v control 1.1 ( 1.6 ) ; P=0.59 ) . Mean duration of COPD admissions over one year was also similar between groups ( 9.5 days per person ( st and ard deviation 19.1 ) v 8.8 days ( 15.9 ) ; P=0.88 ) . The intervention had no significant effect on SGRQ scores between groups ( 68.2 ( st and ard deviation 16.3 ) v 67.3 ( 17.3 ) ; adjusted mean difference 1.39 ( 95 % confidence interval −1.57 to 4.35 ) ) , or on other question naire outcomes . Conclusions In participants with a history of admission for exacerbations of COPD , telemonitoring was not effective in postponing admissions and did not improve quality of life . The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication . Trial registration IS RCT N96634935 . Funding : The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government ( ARPG/07/03 ) . The funder had no role in study design and the collection , analysis , and interpretation of data and the writing of the article and the decision to su bmi t it for publication . NHS Lothian supported the telemonitoring service and the clinical services Background Early treatment of COPD exacerbations has shown to be important . Despite a non-negligible negative impact on health related quality of life , a large proportion of these episodes is not reported ( no change in treatment ) . Little is known whether ( low burden ) strategies are able to capture these unreported exacerbations . Methods The OUTPUT:

Only then will telemonitoring achieve the aim of preventing hospital admissions , contributing to the reduction of health re source utilization and improving the quality of life of patients

MS2_dynamic_1_shot517

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: In this multicentre , prospect i ve , r and omized , open-label , blinded-endpoint ( PROBE ) study , the efficacy of 12 weeks ' treatment with once-daily telmisartan 40–80 mg and enalapril 10–20 mg was evaluated using ambulatory blood pressure monitoring ( ABPM ) in 522 patients with mild-to-moderate essential hypertension . Patients were titrated to the higher dose of study drug at week 6 if mean seated diastolic blood pressure ( DBP ) was ≥ 90 mmHg . The primary endpoint was the change from baseline in ambulatory DBP in the last 6 h of the 24-h dosing interval after 12 weeks ' treatment . Telmisartan and enalapril produced similar reductions from baseline in DBP and systolic blood pressure ( SBP ) over all ABPM periods evaluated ( last 6 h , 24-h , daytime and night-time ) . Telmisartan produced a significantly greater reduction in mean seated trough DBP , measured unblinded with an automated ABPM device in the clinic , amounting to a difference of −2.02 mmHg ( P < 0.01 ) . A significantly greater proportion of patients achieved a seated diastolic response with telmisartan than enalapril ( 59 % versus 50 % ; P < 0.05 ) , also measured with the same ABPM device . Both treatments were well tolerated . Compared with telmisartan , enalapril was associated with a higher incidence of cough ( 8.9 % versus 0.8 % ) and hypotension ( 3.9 % versus 1.1 % ) . Therefore , telmisartan may provide better long-term compliance and , consequently , better blood pressure control than enalapril BACKGROUND Blood pressure ( BP ) has a circadian pattern with a morning surge that is associated with an increased risk of acute coronary and cerebrovascular events . In a prospect i ve , r and omized , open-label , blinded-endpoint , parallel-group , multicenter , forced-titration study of telmisartan and ramipril , the efficacy of both drugs on mean ambulatory diastolic BP ( DBP ) and systolic BP ( SBP ) during the last 6 h of a 24-h dosing interval was evaluated . METHODS After screening and a single-blind run-in phase , 812 adults with mild-to-moderate hypertension ( defined as a mean seated DBP > or = 95 mm Hg and < or = 109 mm Hg and a 24-h ABPM mean DBP 7 > or = 85 mm Hg ) were r and omized to the open-label , 14-week , forced-titration , active-treatment phase as follows : telmisartan 40 mg/80 mg/80 mg ( n = 405 ) or ramipril 2.5 mg/5 mg/10 mg ( n = 407 ) , once daily in the morning . The primary efficacy variable was change from baseline in the last 6-h mean DBP and SBP at 8 and 14 weeks as assessed by ambulatory BP monitoring ( ABPM ) . Secondary efficacy variables were changes from baseline in BP control during each of the 24-h periods and in-clinic trough cuff BP . RESULTS Telmisartan 80 mg was superior to ramipril 5 mg and 10 mg in change from baseline in the last 6-h ABPM mean DBP and SBP at both 8 and 14 weeks ( both P < .0001 ) , respectively . At 14 weeks , the adjusted mean change from baseline in DBP for telmisartan 80 mg was -8.8 mm Hg compared with that for ramipril 10 mg of -5.4 mm Hg ( P < .0001 ) . For SBP , the adjusted mean change from baseline for telmisartan 80 mg was -12.7 mm Hg compared with that for ramipril 10 mg of -7.9 mm Hg ( P < .0001 ) . At 14 weeks , telmisartan 80 mg also yielded superior reductions from baseline in trough cuff BP compared with ramipril 10 mg ( DBP : -11.0 mm Hg v -7.8 mm Hg , respectively ; SBP : -14.3 mm Hg v -9.1 mm Hg , respectively ; both P < .0001 ) . Measures of 24-h BP control favored telmisartan 80 mg versus ramipril 10 mg ( P < .0001 ) , as did other secondary ABPM endpoints during the daytime , night-time , and morning periods . Treatment-related adverse events were uncommon ; patients treated with ramipril had a higher incidence of cough than those treated with telmisartan ( 10.1 % v 1.5 % , respectively ) . CONCLUSIONS Telmisartan 80 mg was consistently more effective than ramipril 10 mg in reducing both DBP and SBP during the last 6 h of the dosing interval , a measure of the early morning period when patients are at greatest risk of life-threatening cardiovascular and cerebrovascular events . Telmisartan 80 mg was also more effective than ramipril 10 mg in reducing BP throughout the entire 24-h dosing interval . Both drugs were well tolerated BACKGROUND This study compared the effects of losartan and perindopril on plasma plasminogen activator inhibitor-1 ( PAI-1 ) and fibrinogen in hypertensive type 2 diabetic patients . METHODS We studied 85 nonsmoking out patients , aged 46 to 64 years , with mild to moderate essential hypertension ( diastolic blood pressure [ OUTPUT: Contribution This systematic review of trials that directly compared ACE inhibitors and ARBs in adults with essential hypertension found good evidence that the agents had similar long-term effects on blood pressure . There were no consistent differential effects for mortality , cardiovascular events , progression to diabetes , left ventricular function , or kidney disease . Cough was more frequent with ACE inhibitors than ARBs . Implication Both ACE inhibitors and ARBs have similar effects on blood pressure and may not have differential effects on other clinical outcomes , although ACE inhibitors do cause cough more often than ARBs . For example , ACE inhibitors do not entirely block production of angiotensin II because of other , unaffected converting enzymes . INPUT: The objectives of our study were to assess the reproducibility of the trough-to-peak ratio ( T/P ) and to see whether a high T/P is accompanied by more organ protection or vice versa . The study included 175 ( mean+/-SD age , 51+/-9 years ) subjects with mild-moderate essential hypertension who had echocardiographic evidence of left ventricular ( LV ) hypertrophy taken from the SAMPLE study ( Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation ) , an open-label multicenter study . The study included a 3-week washout pretreatment period , a 12-month treatment period with lisinopril ( n=84 ) or lisinopril plus hydrochlorothiazide ( n=91 ) once daily , and a 4-week placebo follow-up period . Results of 24-hour ambulatory blood pressure monitoring and echocardiographic determination of left ventricular mass index ( LVMI ) were obtained before and after 3 and 12 months of treatment . T/Ps were computed in each patient by dividing the systolic and diastolic blood pressure changes at trough ( changes in the last 2 hours of the monitoring period ) by those at peak ( average of the 2 adjacent hours with the maximal blood pressure reduction between the 2nd and 8th hour from drug intake ) after 3 and 12 months of treatment . Average 24-hour blood pressure was similarly reduced at 3 and 12 months . Trough blood pressure changes at 3 and 12 months were closely correlated , as were the corresponding peak blood pressure changes . However , the 3- and 12-month T/Ps correlated to a lesser degree ( r<0.42 ) . Furthermore , the reduction of LVMI induced by treatment was similarly correlated with the treatment-induced reduction in 24-hour average , trough , and peak blood pressures but not with the T/Ps . This was also evident when the contribution to LV hypertrophy regression by 24-hour blood pressure changes and T/Ps was assessed in a multivariate regression analysis . In patients with a T/P > /=0.5 or < 0.5 , the regression of LVMI was similar . In conclusion , peak and trough blood pressure changes are reproducible and predict the regression of LVMI induced by treatment as well as average 24-hour blood pressure . T/Ps are less reproducible , and their value does not predict regression of organ damage by antihypertensive treatment An 8-week , multicenter , double-blind , r and omized , parallel-group , forced-titration study was conducted to evaluate the antihypertensive efficacy of c and esartan vs. losartan in 654 hypertensive patients with a diastolic blood pressure between 95 and 114 mm Hg from 72 sites throughout the U.S. Eligible patients were r and omized to c and esartan cilexetil 16 mg once daily , or losartan 50 mg once daily . Two weeks following r and omization , patients doubled the respective doses of their angiotensin receptor blockers for an additional 6 weeks . At week 8 , c and esartan cilexetil lowered trough systolic/diastolic blood pressure by a significantly greater amount than did losartan ( 13.3/10.9 mm Hg with c and esartan cilexetil vs. 9.8/8.7 mm Hg with losartan ; p less than 0.001 ) . At the same period , c and esartan cilexetil also lowered peak blood pressure by a significantly greater amount than did losartan ( 15.2 to 11.6 mm Hg with c and esartan cilexetil vs. 12.6 to 10.1 mm Hg with losartan ; p less than 0.05 ) . There were statistically significantly ( p less than 0.05 ) higher proportions of responders and controlled patients in the c and esartan cilexetil group ( 62.4 % and 56.0 % , respectively ) than in the losartan group ( 54.0 % and 46.9 % , respectively ) . Both treatment regimens were well tolerated ; 1.8 % in the c and esartan cilexetil group and 1.6 % in the losartan group withdrew because of adverse events . In conclusion , this forced-titration study confirms that c and esartan cilexetil is more effective than losartan in lowering blood pressure when both are administered once daily at maximum doses . Both drugs were well tolerated . (c)2001 by Le Jacq An 8-week , multicentre ( 72 sites in the US ) , double-blind , r and omised , parallel group , forced titration study compared the antihypertensive efficacy of c and esartan cilexetil and losartan . A total of 611 patients with essential hypertension ( diastolic blood pressure 95 to 114 mm Hg ) were r and omised initially to c and esartan cilexetil 16 mg once daily or losartan 50 mg once daily . After 2 weeks of r and omised treatment , the doses of c and esartan cilexetil and losartan were doubled to 32 mg and 100 mg once daily and continued respectively for 6 weeks . At week 8 , c and esartan cilexetil lowered the blood pressure ( BP ) at 24 h ( trough ) , 6 h ( peak ) and 48 h post dose to a significantly greater extent ( P < 0.05 ) than losartan : c and esartan cilexetil lowered trough BP by 13.4/10.5 mm Hg , peak BP by 15.5/12.9 mm Hg and 48-h BP by 10.5/9.9 mm Hg compared to a reduction of trough BP by 10.1/9.1 mm Hg OUTPUT:

Conclusions : C and esartan is superior to losartan in reducing blood pressure . C and esartan also causes fewer serious adverse events than losartan

MS2_dynamic_1_shot518

***TASK*** the task is to summarize an input biomedical literature 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 patients with atrial fibrillation ( AF ) undergoing radiofrequency ( RF ) electrical disconnection of multiple pulmonary veins ( PVs ) , the incidence of late conduction recurrences has not been systematic ally determined . Methods and Results —Using a prospect ively design ed , multistep approach , we aim ed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients ( 52.3±8.2 years ) with AF . Forty-one left superior ( LS ) , 42 right superior ( RS ) , 25 left inferior ( LI ) , and 9 right inferior ( RI ) PVs were targeted during 108 EP procedures ( 2.6±0.5 per patient ) . Seventeen patients underwent 2 procedures , 23 patients underwent 3 procedures , and 3 patients underwent 4 procedures . During the first attempt , electrical disconnection was achieved in 112 PVs ( 95.7 % ) . During a next procedure ( time interval , 4.6±1.9 months ) , conduction recurrence was observed in 32 of 39 LSPVs ( 82.1 % ) , 29 of 40 RSPVs ( 72.5 % ) , 20 of 24 LIPVs ( 83.3 % ) , and 7 of 9 RIPV ( 77.8 % ) . After reablation at gap sites , a later procedure ( time interval , 5.1±2.4 months ) revealed a second recurrence in 13 of 22 LSPVs ( 59.1 % ) and 14 of 19 RSPVs ( 73.7 % ) . Conclusions —Conduction recurrence across disconnecting RF lesions can be observed in ≈80 % of cases 4 months after ablation . After reablation , similar recurrence rates are observed 5 months later . This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aim ing at disconnection of multiple PVs BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range OUTPUT: Conclusion : CF‐guided RF catheter ablation was associated with a significant AF/atrial tachycardia‐free survival benefit compared with non‐CF‐guided ablation in patients with paroxysmal AF rather than persistent AF . In addition , CF‐guided ablation strategy also reduced the procedure time , fluoroscopy time , as well as RF time despite no distinct effect on the alleviation of procedure‐related complications INPUT: Background —Circumferential radiofrequency ablation around pulmonary vein ( PV ) ostia has recently been described as a new anatomic approach for atrial fibrillation ( AF ) . Methods and Results —We treated 251 consecutive patients with paroxysmal ( n=179 ) or permanent ( n=72 ) AF . Circular PV lesions were deployed transseptally during sinus rhythm ( n=124 ) or AF ( n=127 ) using 3D electroanatomic guidance . Procedures lasted 148±26 minutes . Among 980 lesions surrounding individual PVs ( n=956 ) or 2 ipsilateral veins with close openings or common ostium ( n=24 ) , 75 % were defined as complete by a bipolar electrogram amplitude < 0.1 mV inside the lesion and a delay > 30 ms across the line . The amount of low-voltage encircled area was 3594±449 mm2 , which accounted for 23±9 % of the total left atrial ( LA ) map surface . Major complications ( cardiac tamponade ) occurred in 2 patients ( 0.8 % ) . No PV stenoses were detected by transesophageal echocardiography . After 10.4±4.5 months , 152 patients with paroxysmal AF ( 85 % ) and 49 with permanent AF ( 68 % ) were AF-free . Patients with and without AF recurrence did not differ in age , AF duration , prevalence of heart disease , or ejection fraction , but the LA diameter was significantly higher ( P < 0.001 ) in permanent AF patients with recurrence . The proportion of PVs with complete lesions was similar between patients with and without recurrence , but the latter had larger low-voltage encircled areas after radiofrequency ( expressed as percent of LA surface area;P < 0.001 ) . Conclusions —Circumferential PV ablation is a safe and effective treatment for AF . Its success is likely due to both PV trigger isolation and electroanatomic remodeling of the area encompassing the PV ostia AIMS This study examined the difference in autonomic modification ( AM ) and its effect on paroxysmal atrial fibrillation ( PAF ) recurrence between segmental pulmonary vein isolation ( S-PVI ) and circumferential PVI ( C-PVI ) . METHODS AND RESULTS Successful S-PVI or C-PVI with a basket catheter was achieved in 120 consecutive PAF patients . Serial 24 Holter-recordings were obtained before , immediately , and 1 , 3 , 6 , 12 months after the PVI to analyse the heart rate variability ( HRV ) . Nineteen patients were excluded from analysis because of additional ablation for recurrent PAF after successful PVI . Among the residual 101 patients , 33 had PAF recurrences ( S-PVI = 44.0 % , C-PVI = 21.6 % ) at 1 year of follow-up . The root mean square of successive differences and high-frequency power reflecting parasympathetic nervous activity were significantly lower in patients with and without PAF recurrences after C-PVI and patients without PAF recurrences after S-PVI than patients with PAF recurrences after S-PVI ( P < 0.005 - 0.0001 ) . However , there were no significant differences in any HRV parameters in the immediate aftermath of PVI among the patients without PAF recurrences after S-PVI and those with and without PAF recurrences after C-PVI . CONCLUSION Although additional radiofrequency ablation for AM may be recommended after S-PVI to reduce PAF recurrences , it should be carefully determined after C-PVI Background — Pulmonary vein ( PV ) isolation is a promising new treatment for atrial fibrillation ( AF ) . We hypothesized that isolation of large areas around both ipsilateral PVs with verification of conduction block is more effective than the isolation of each individual PV . Methods and Results — A total of 110 patients , 67 with paroxysmal AF and 43 with persistent AF , were r and omly assigned to undergo either isolation of each individual PV or isolation of large areas around both ipsilateral PVs . The isolation of each individual PV was an electrophysiologically guided , ostial segmental ablation with a 64-pole basket catheter or a 20-pole circular mapping catheter ( group I ) . Isolation of large areas was performed around the 2 ipsilateral veins with a nonfluoroscopic navigation system and a circular 20-pole mapping catheter for verification of conduction block ( group II ) . In both groups , an irrigated-tip ablation catheter ( 25 to 35 W ) was used to achieve complete isolation . Procedure and ablation times were longer in group II , whereas fluoroscopic time was significantly shorter ( P≤0.001 ) . After a follow-up period of 15±4 months , 27 patients in group I ( 49 % ) and 37 patients in group II ( 67 % ) remained free of symptoms of AF and had no AF or atrial flutter during repetitive Holter monitoring without antiarrhythmic drug treatment after a single procedure ( P≤0.05 ) . Conclusions — The rate of success was significantly higher and fluoroscopy times were significantly lower in the group with large isolation areas around both ipsilateral PVs than in those who underwent individual PV isolation Background —The pulmonary veins ( PVs ) and surrounding ostial areas frequently house focal triggers or reentrant circuits critical to the genesis of atrial fibrillation ( AF ) . We developed an anatomic approach aim ed at isolating each PV from the left atrium ( LA ) by circumferential radiofrequency ( RF ) lesions around their ostia . Methods and Results —We selected 26 patients with resistant AF , either paroxysmal ( n=14 ) or permanent ( n=12 ) . A nonfluoros OUTPUT:

Our primary finding is that PVI performed with a wide antral approach is more effective than ostial PVI in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up

MS2_dynamic_1_shot519

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This study was design ed to evaluate the performance of movement detectors ( pedometers ) in measuring daily activity of patients with chronic lung disease . Three groups of subjects were studied : group 1 : 25 patients with stable nonhypercapnic chronic obstructive pulmonary disease ( COPD ) ( forced expiratory volume in one second ( FEV1 ) = 47+/-9 % predicted ) studied twice , one month apart ; group 2 : 25 patients with chronic respiratory failure studied before and three months after nasal nocturnal mechanical ventilation ; and group 3 : 25 normal healthy subjects studied once . The median level of activity in the healthy subjects ( group 3 ) was three times greater than in either group of patients ( groups 1 and 2 ) . Activity levels were not correlated with age , sex or employment status . The repeatability of the activity counts in the nonhypercapnic COPD patients was high ( intraclass correlation coefficient=0.94 ) and in these patients activity correlated significantly with FEV1 ( r=0.54 , p=0.006 ) . In the respiratory failure patients , daytime arterial carbon dioxide pressure ( Pa , CO2 ) improved following nasal nocturnal mechanical ventilation ( NMV ) ( pre NMV : 8.5+/-1.2 kPa ; post NMV : 6.2+/-0.5 kPa ) , health status improved ( p<0.004 ) and daily movement count doubled ( p<0.0001 ) . This increase correlated with change in Pa , CO2 ( r-0.53 , p=0.006 ) , but not with improved health status . We conclude that motion detectors may provide repeatable measures of daily activity that are related to physiological impairment and improvement following treatment . Activity counts appear to be complementary to estimates of exercise limitation obtained using health question naires Study objectives The aims of this study were to establish whether pulmonary rehabilitation ( PR ) improves domestic function and daily activity levels in COPD and whether individually targeted exercise is more effective than general exercise . Design Prospect i ve r and omized , controlled trial . Setting Outpatient PR program in secondary care . Participants One-hundred eighty patients ( mean [ ±SD ] age , 68.3 ± 8.6 years ; FEV 1 , 0.95 ± 0.4 L ; FEV 1 /FVC ratio , 0.51 ± 0.15 ; 111 male patients ; 69 female patients ) with stable COPD . One hundred twenty-one patients completed the study . Interventions Patients were r and omized to a conventional 7-week general exercise program ( [ GEP ] n=90 ) or an individually targeted exercise program ( [ ITEP ] n=90 ) . Measurement and results Daily activity was measured using ambulatory activity monitors ( Z80 –32k V1 Int ; Gaehwiler Electronics ; Hombrechtikon , Switzerl and ) . These were lightweight devices , which contained a uniaxial accelerometer . Domestic function was assessed by the Canadian Occupational Performance Measure ( COPM ) . Exercise performance was assessed by the incremental shuttle walk test ( ISWT ) and the endurance shuttle walk test and health status by the chronic respiratory question naire – self-reported . Activity monitor counts increased by 29.18 % ( 95 % confidence interval [ CI ] , 3.19 to 55.17 ; p=0.03 ) for the GEP and 40.63 % ( 95 % CI , 7.42 to 73.83 ; p=0.02 ) for the ITEP . Mean COPM performance scores increased by 1.71 ( 95 % CI , 1.37 to 2.05 ; p=0.0001 ) for the GEP and 1.46 ( 95 % CI , 1.05 to 1.87 ; p=0.0001 ) for the ITEP . Mean COPM satisfaction scores increased by 2.27 ( 95 % CI , 1.74 to 2.81 ; p=0.0001 ) for the GEP and 2.04 ( 95 % CI , 1.56 to 2.52 ; p=0.0001 ) for the ITEP . ISWT scores increased by 81.72 m ( range , 63.83 to 99.62 ) for the GEP and by 85.52 m ( range , 67.62 to 103.42 ) for the ITEP . No statistically significant difference was found between the general exercise group and the individually targeted exercise group for any outcome measure . Conclusions Pulmonary rehabilitation improves domestic function and physical activity . This study also demonstrates that general exercise training is as effective as individually targeted training Chronic obstructive pulmonary disease ( COPD ) is a highly prevalent disease . Currently , severity Global initiative for chronic Obstructive Lung Disease ( GOLD ) criteria are used to diagnose the severity of COPD , but a new grading system , the body mass index , bronchial obstruction , dyspnea , exercise ( BODE ) index , was recently proposed to provide useful prognostic information . The objective of this study is to evaluate the association between health-related quality of life ( HRQOL ) and COPD severity assessed by two criteria : the GOLD classification and the BODE index . Sixty-four patients with COPD were examined with lung function tests and specific and generic HRQOL question naires ( St. George 's Respiratory Question naire [ SGRQ ] , Nottingham Health Profile [ NHP ] ) . Participants were divided into four severity groups using the GOLD guidelines and the BODE index quartiles . The association between NHP and SGRQ subscales , and the BODE index was significant ( P < 0.01 ) . However , the GOLD classification shows a correlation only with SGRQ total score ( P < 0.05 ) but not with NHP or SGRQ subscales . There was an association of the SGRQ total score between the severity OUTPUT: Reduced daily physical activity is associated with higher levels of airway obstruction , higher levels of systemic inflammation , and lower levels of physical fitness . In conclusion , this is the first review that examined the level , type and determinants of daily physical activity in COPD . It demonstrates that reduced daily physical activity frequently occurs in COPD patients , yet with a large variation . INPUT: Rationale : Increasing physical activity is a key therapeutic aim in chronic obstructive pulmonary disease ( COPD ) . Pulmonary rehabilitation ( PR ) improves exercise capacity , but there is conflicting evidence regarding its ability to improve physical activity levels . Objectives : To determine whether using pedometers as an adjunct to PR can enhance time spent in at least moderate‐intensity physical activity ( time expending ≥3 metabolic equivalents [ METs ] ) by people with COPD . Methods : In this single‐blind r and omized controlled trial , participants were assigned 1:1 to receive a control intervention ( PR comprising 8 wk , two supervised sessions per week ) or the trial intervention ( PR plus pedometer‐directed step targets , review ed weekly for 8 wk ) . In the r and omization process , we used minimization to balance groups for age , sex , FEV1 percent predicted , and baseline exercise capacity and physical activity levels . Outcome assessors and PR therapists were blinded to group allocation . The primary analysis was based on the intention‐to‐treat principle . Measurements and Main Results : The primary outcome was change from baseline to 8 weeks in accelerometer‐measured daily time expending at least 3 METs . A total of 152 participants ( 72 % male ; mean [ SD ] FEV1 percent predicted , 50.5 % [ 21.2 ] ; median [ first quartile , third quartile ] time expending ≥3 METs , 46 [ 21 , 92 ] min ) were enrolled and assigned to the intervention ( n = 76 ) or control ( n = 76 ) arm . There was no significant difference in change in time expending at least 3 METs between the intervention and control groups at 8 weeks ( median [ first quartile , third quartile ] difference , 0.5 [ −1.0 , 31.0 ] min ; P = 0.87 ) or at the 6‐month follow‐up ( 7.0 [ −9 , 27 ] min ; P = 0.16 ) . Conclusions : Pedometer‐directed step‐count targets during an outpatient PR program did not enhance moderate‐intensity physical activity levels in people with COPD . Clinical trial registered with www . clinical trials.gov ( NCT01719822 ) Background In some patients with COPD , the disease is characterized by exacerbations . Severe exacerbations warrant a hospitalization , with prolonged detrimental effects on physical activity . Interventions after an exacerbation may improve physical activity , with longst and ing health benefits . Physical activity counseling and real-time feedback were effective in stable COPD . No evidence is available on the use of this therapeutic modality in patients after a COPD exacerbation . Methods Thirty patients were r and omly assigned to usual care or physical activity counseling , by telephone contacts at a frequency of 3 times a week and real-time feedback . Lung function , peripheral muscle strength , functional exercise capacity , symptom experience and COPD -related health status were assessed during hospital stay and 1 month later . Results Both groups significantly recovered in physical activity ( PAsteps : control group : 1013 ± 1275 steps vs intervention group : 984 ± 1208 steps ( p = 0.0005 ) ; PAwalk : control group : 13 ± 14 min vs intervention group : 13 ± 16 min ( p = 0.0002 ) ) , functional exercise capacity ( control group : 64 ± 59 m ( p = 0.002 ) vs intervention group : 67 ± 84 m ( p = 0.02 ) ) and COPD -related health status ( CAT : control group : −5 [ −7 to 1 ] ( p = 0.02 ) vs intervention group : −3 [ −10 to 1 ] points ( p = 0.03 ) ) . No differences between groups were observed . Conclusion From our pilot study , we concluded that telephone based physical activity counseling with pedometer feedback after an exacerbation did not result in better improvements in physical activity and clinical outcomes compared to usual care . Because of the difficult recruitment and the negative intermediate analyses , this study was not continued . Trial registration Clinical trials.gov NCT02223962 . Registered 4 September 2013 Reduced physical activity is an important feature of Chronic Obstructive Pulmonary Disease ( COPD ) . Various activity monitors are available but their validity is poorly established . The aim was to evaluate the validity of six monitors in patients with COPD . We hypothesized triaxial monitors to be more valid compared to uniaxial monitors . Thirty-nine patients ( age 68±7years , FEV1 54±18%predicted ) performed a one-hour st and ardized activity protocol . Patients wore 6 monitors ( Kenz Lifecorder ( Kenz ) , Actiwatch , RT3 , Actigraph GT3X ( Actigraph ) , Dynaport MiniMod ( MiniMod ) , and SenseWear Armb and ( SenseWear ) ) as well as a portable metabolic system ( Oxycon Mobile ) . Validity was evaluated by correlation analysis between indirect calorimetry ( VO2 ) and the monitor outputs : Metabolic Equivalent of Task [ METs ] ( SenseWear , MiniMod ) , activity counts ( Actiwatch ) , vector magnitude units ( Actigraph , RT3 ) and arbitrary units ( Kenz ) over the whole protocol and slow versus fast walking . Minute-by-minute correlations were highest for the MiniMod ( r = 0.82 ) , Actigraph ( r = 0.79 ) , SenseWear ( r = 0.73 ) and RT3 ( r = 0.73 ) . Over the whole protocol , the mean correlations were best for the SenseWear ( r = 0.76 ) , Kenz ( r = 0.52 ) , Actigraph ( r = 0.49 ) and MiniMod OUTPUT:

A subgroup analysis reported significant differences in the promotion of physical activity based on baseline physical activity levels and the type of instrument used to assess levels of physical activity .

MS2_dynamic_1_shot520

***TASK*** the task is to summarize an input biomedical literature 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: Prognostic markers help to stratify patients for treatment by identifying patients with different risks of outcome ( e.g. recurrence of disease ) , and are important tools in the management of cancer and many other diseases . Systematic review and meta-analytical approaches to identifying the most valuable prognostic markers are needed because ( sometimes conflicting ) evidence relating to markers is often published across a number of studies . To investigate the practicality of this approach , an empirical investigation of a systematic review of tumour markers for neuroblastoma was performed ; 260 studies of prognostic markers were identified , which considered 130 different markers . The reporting of these studies was often inadequate , in terms of both statistical analysis and presentation , and there was considerable heterogeneity for many important clinical /statistical factors . These problems restricted both the extraction of data and the meta- analysis of results from the primary studies , limiting feasibility of the evidence -based approach . Guidelines for reporting the results of primary prognostic marker studies in cancer , and other diseases , are given in order to facilitate both the interpretation of individual studies and the undertaking of systematic review s , meta- analysis and , ultimately , evidence -based practice . General availability of full individual patient data is a necessary step forward and would overcome the majority of problems encountered , including poorly reported summary statistics and variability in cutoff level , outcome assessed and adjustment factors used . It would also limit the problem of reporting bias , although publication bias will remain a concern until studies are prospect ively registered . Such changes in practice would help important evidence -based review s to be conducted in order to establish the most appropriate prognostic markers for clinical use , which should ultimately improve patient care PURPOSE Pediatric intracranial ependymomas are a heterogeneous group of neoplasms with unpredictable clinical and biologic behavior . As part of ongoing studies to identify potential biologic and therapeutic markers , we analyzed the role of human telomere reverse transcriptase ( hTERT ; the catalytic subunit of telomerase ) expression as a prognostic marker for this disease . PATIENTS AND METHODS Primary intracranial ependymomas that were resected at our institution between 1986 and 2004 were identified through the pathology and oncology data bases . A tissue array was constructed from the patient sample s and hTERT expression was evaluated by immunohistochemistry . Twenty-one sample s were also analyzed for telomerase activity ( telomerase repeat amplification protocol assay ) . RESULTS Eighty-seven tumors from 65 patients were analyzed . Five-year progression-free survival was 57 % ( SEM , 12 % ) and 21 % ( SEM , 8 % ) for hTERT-negative and hTERT-positive tumors , respectively ( P = .002 ) . Five-year overall survival was 84 % ( SEM , 7 % ) and 41 % ( SEM , 7 % ) for hTERT-negative and hTERT-positive tumors , respectively ( P = .001 ) . There was good correlation between telomerase activity and hTERT expression ( kappa = 0.637 ) . Multivariate analysis revealed hTERT expression to be the single most important predictor of survival of all known pathologic , clinical , and treatment factors ( hazard ratio , 60.4 ; 95 % CI , 6.4 to 561 ) . All four patients with hTERT-negative tumors at relapse are still alive , with median follow-up of 11.2 years . CONCLUSION In this study , hTERT expression was the strongest predictor of outcome and was independent of other clinical and pathologic prognostic markers . It represents a simple and reliable biologic prognostic factor for intracranial ependymomas . These results should be confirmed in larger prospect i ve trials OBJECT Ependymomas in children continue to generate controversy regarding their histological diagnosis and grading . optimal management , and possible prognostic factors . To increase our knowledge of these tumors the authors addressed these issues in a cohort of children with prospect ively staged ependymomas treated with radiotherapy and chemotherapy . METHODS Children between the ages of 2 and 17.3 years harboring an intracranial ependymoma confirmed by a central review of the tumor 's pathological characteristics were treated according to Children 's Cancer Group Protocol 921 from 1986 to 1992 . Treatment following surgery and postoperative tumor staging ( including brain computerized tomography or magnetic resonance [ MR ] imaging , spinal MR imaging or myelography , and cerebrospinal fluid cytological investigation ) included craniospinal irradiation with a local boost to the primary tumor and patient r and omization to receive adjuvant chemotherapy with either 1 ) CCNU , vincristine , and prednisone , or 2 ) the eight-drugs-in-1-day regimen . Central ized review of the tumor pathological characteristics revealed 20 ependymomas and 12 anaplastic ependymomas in the 32 children included in the study . Diagnoses made at the individual institutions included anaplastic ( malignant ) ependymoma ( 15 patients ) , ependymoma ( four patients ) , ependymoblastoma ( nine patients ) , ependymoastrocytoma ( one patient ) , and primitive neuroectodermal tumor ( three patients ) , which were discordant with the central ized review diagnosis in 22 of 32 cases . Only three of the 32 patients had metastatic disease ( two with M and one with M3 stages ) . At surgery , 47 % of tumors were estimated to be totally resected . Among the 14 of 17 patients who suffered a relapse and were evaluated for site of relapse , 10 ( 71 % ) had an isolated local relapse , three ( 21 % ) had concurrent local and metastatic relapse , and only one ( 7 % ) had an isolated metastatic relapse . Kaplan-Meier estimates of 5-year progression-free survival ( PFS ) and overall survival rates were 50 + /- 10 % and OUTPUT: Although the prognostic impact of MIB-1 immunoexpression in IE could be confirmed , there remains lack of further reliable IPM that could be used in routine diagnosis . INPUT: Objective This study aim ed to demonstrate that maximal strength training improves muscle strength and to assess the effect of training on function , aerobic status , and quality -of-life among chronic stroke survivors . Design Ten patients acted as their own controls for 4 wks , before an 8-week training intervention . Patients trained 3 days/wk , with four sets of four repetitions at 85%–95 % one repetition maximum in unilateral leg press and plantarflexion with an emphasis on maximal mobilization of force in the concentric phase . Results After training , leg press strength improved by 30.6 kg ( 75 % ) and 17.8 kg ( 86 % ) ; plantarflexion strength improved by 35.5 kg ( 89 % ) and 28.5 kg ( 223 % ) for the unaffected and affected limbs , respectively , significantly different from the control period ( all P < 0.01 ) . The 6-min walk test improved by 13.9 m ( within training period ; P = 0.01 ) , and the Timed Up and Go test time improved by 0.6 secs ( within training period ; P < 0.05 ) . There were no significant changes in walking economy , peak aerobic capacity , Four-Square Step Test , or health-related quality -of-life after training . Conclusions Maximal strength training improved muscle strength in the most affected as well as in the nonaffected leg and improved Timed-Up- And -Go time and 6-min walk distance but did not alter Four-Step Square Test time , aerobic status , or quality -of-life among chronic stroke survivors Background Many bibliographic data bases index research studies evaluating the effects of health care interventions . One study has concluded that the Physiotherapy Evidence Data base ( PEDro ) has the most complete indexing of reports of r and omized controlled trials of physical therapy interventions , but the design of that study may have exaggerated estimates of the completeness of indexing by PEDro . Objective The purpose of this study was to compare the completeness of indexing of reports of r and omized controlled trials of physical therapy interventions by 8 bibliographic data bases . Design This study was an audit of bibliographic data bases . Methods Prespecified criteria were used to identify 400 reports of r and omized controlled trials from the reference lists of systematic review s published in 2008 that evaluated physical therapy interventions . Eight data bases ( AMED , CENTRAL , CINAHL , EMBASE , Hooked on Evidence , PEDro , PsycINFO , and PubMed ) were search ed for each trial report . The proportion of the 400 trial reports indexed by each data base was calculated . Results The proportions of the 400 trial reports indexed by the data bases were as follows : CENTRAL , 95 % ; PEDro , 92 % ; PubMed , 89 % ; EMBASE , 88 % ; CINAHL , 53 % ; AMED , 50 % ; Hooked on Evidence , 45 % ; and PsycINFO , 6 % . Almost all of the trial reports ( 99 % ) were found in at least 1 data base , and 88 % were indexed by 4 or more data bases . Four trial reports were uniquely indexed by a single data base only ( 2 in CENTRAL and 1 each in PEDro and PubMed ) . Limitations The results are only applicable to search ing for English- language published reports of r and omized controlled trials evaluating physical therapy interventions . Conclusions The 4 most comprehensive data bases of trial reports evaluating physical therapy interventions were CENTRAL , PEDro , PubMed , and EMBASE . Clinicians seeking quick answers to clinical questions could search any of these data bases knowing that all are reasonably comprehensive . PEDro , unlike the other 3 most complete data bases , is specific to physical therapy , so studies not relevant to physical therapy are less likely to be retrieved . Research ers could use CENTRAL , PEDro , PubMed , and EMBASE in combination to conduct exhaustive search es for r and omized trials in physical therapy OUTPUT:

DISCUSSION This systematic review will provide information on which interventions are effective for increasing physical activity levels of stroke survivors .

MS2_dynamic_1_shot521

***TASK*** the task is to summarize an input biomedical literature 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 describe the beneficial long-term effects of an average of 6.5 years of intensive diabetes therapy ( INT ) in type 1 diabetes on measures of atherosclerosis , cardiac structure and function , and clinical cardiovascular events observed in the Diabetes Control and Complications Trial ( DCCT ) and the Epidemiology of Diabetes Interventions and Complications ( EDIC ) study . RESEARCH DESIGN AND METHODS The DCCT was a r and omized clinical trial of 1,441 participants assigned to receive INT or conventional therapy ( CON ) . It was conducted between 1983–1993 with an average follow-up of 6.5 years . EDIC ( 1994–present ) is an observational follow-up of the DCCT cohort . Cardiovascular events have been recorded throughout . During EDIC common carotid intima-media thickness ( IMT ) was measured with ultrasound , coronary artery calcification with computed tomography , and cardiac structure and function with cardiac magnetic resonance imaging . RESULTS DCCT INT and lower levels of HbA1c during DCCT/EDIC were associated with thinner carotid IMT , less coronary calcification , and a lower incidence of clinical cardiovascular events including myocardial infa rct ion , stroke , and cardiac death . While there were no significant differences in cardiac structure and function between the former INT and CON groups , they were significantly associated with higher HbA1c during DCCT/EDIC . CONCLUSIONS DCCT INT and the attendant 6.5 years of lower HbA1c had long-term salutary effects on the development and progression of atherosclerosis and cardiovascular disease during the subsequent follow-up during EDIC Type 2 diabetes is a chronic illness that is increasing in epidemic proportions worldwide . Major factors contributing to the development of type 2 diabetes include obesity and poor lifestyle habits ( e.g. , excess dietary intake and limited physical activity ) . Despite the proven efficacy of lifestyle interventions and the use of multiple pharmacological agents , the economic and public health burden of type 2 diabetes remains substantial . Obstructive sleep apnea ( OSA ) is a treatable sleep disorder that is pervasive among overweight and obese adults , who represent about two thirds of the U.S. population today . An ever-growing number of studies have shown that OSA is associated with insulin resistance , glucose intolerance and type 2 diabetes , independent of obesity . Evidence from animal and human models that mimic OSA provides potential mechanisms for how OSA may alter glucose metabolism . Up to 83 % of patients with type 2 diabetes suffer from unrecognized OSA and increasing severity of OSA is associated with worsening glucose control . However , it is still unclear whether OSA may lead to the development of diabetes over time . More data from large-scale longitudinal studies with rigorous assessment s of diabetes and OSA are needed . In addition , there is still controversy whether continuous positive airway pressure ( CPAP ) treatment of OSA improves glucose metabolism . Large-scale r and omized-controlled trials of CPAP treatment of OSA with well-vali date d assessment s of insulin sensitivity and glucose tolerance are needed . These studies may reveal that OSA represents a novel , modifiable risk factor for the development of prediabetes and type 2 diabetes IMPORTANCE Whether mortality in type 1 diabetes mellitus is affected following intensive glycemic therapy has not been established . OBJECTIVE To determine whether mortality differed between the original intensive and conventional treatment groups in the long-term follow-up of the Diabetes Control and Complications Trial ( DCCT ) cohort . DESIGN , SETTING , AND PARTICIPANTS After the DCCT ( 1983 - 1993 ) ended , participants were followed up in a multisite ( 27 US and Canadian academic clinical centers ) observational study ( Epidemiology of Diabetes Control and Complications [ EDIC ] ) until December 31 , 2012 . Participants were 1441 healthy volunteers with diabetes mellitus who , at baseline , were 13 to 39 years of age with 1 to 15 years of diabetes duration and no or early microvascular complications , and without hypertension , preexisting cardiovascular disease , or other potentially life-threatening disease . INTERVENTIONS AND EXPOSURES During the clinical trial , participants were r and omly assigned to receive intensive therapy ( n = 711 ) aim ed at achieving glycemia as close to the nondiabetic range as safely possible , or conventional therapy ( n = 730 ) with the goal of avoiding symptomatic hypoglycemia and hyperglycemia . At the end of the DCCT , after a mean of 6.5 years , intensive therapy was taught and recommended to all participants and diabetes care was returned to personal physicians . MAIN OUTCOMES AND MEASURES Total and cause-specific mortality was assessed through annual contact with family and friends and through records over 27 years ' mean follow-up . RESULTS Vital status was ascertained for 1429 ( 99.2 % ) participants . There were 107 deaths , 64 in the conventional and 43 in the intensive group . The absolute risk difference was -109 per 100,000 patient-years ( 95 % CI , -218 to -1 ) , with lower all-cause mortality risk in the intensive therapy group ( hazard ratio [ HR ] = 0.67 [ 95 % CI , 0.46 - 0.99 ] ; P = .045 ) . Primary causes of death were cardiovascular disease ( 24 deaths ; 22.4 % ) , cancer ( 21 deaths ; 19.6 % ) , acute diabetes complications ( 19 deaths ; 1 OUTPUT: T1D was associated with poorer sleep and high prevalence of OSA . Poor sleep quality , shorter sleep duration , and OSA were associated with suboptimal glycemic control in T1D patients INPUT: CONTEXT Guidelines recommend that exercise training be considered for medically stable out patients with heart failure . Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes . OBJECTIVE To test the efficacy and safety of exercise training among patients with heart failure . DESIGN , SETTING , AND PATIENTS Multicenter , r and omized controlled trial of 2331 medically stable out patients with heart failure and reduced ejection fraction . Participants in Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) were r and omized from April 2003 through February 2007 at 82 centers within the United States , Canada , and France ; median follow-up was 30 months . INTERVENTIONS Usual care plus aerobic exercise training , consisting of 36 supervised sessions followed by home-based training , or usual care alone . MAIN OUTCOME MEASURES Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality , cardiovascular mortality or cardiovascular hospitalization , and cardiovascular mortality or heart failure hospitalization . RESULTS The median age was 59 years , 28 % were women , and 37 % had New York Heart Association class III or IV symptoms . Heart failure etiology was ischemic in 51 % , and median left ventricular ejection fraction was 25 % . Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12 . A total of 759 patients ( 65 % ) in the exercise training group died or were hospitalized compared with 796 patients ( 68 % ) in the usual care group ( hazard ratio [ HR ] , 0.93 [ 95 % confidence interval { CI } , 0.84 - 1.02 ] ; P = .13 ) . There were nonsignificant reductions in the exercise training group for mortality ( 189 patients [ 16 % ] in the exercise training group vs 198 patients [ 17 % ] in the usual care group ; HR , 0.96 [ 95 % CI , 0.79 - 1.17 ] ; P = .70 ) , cardiovascular mortality or cardiovascular hospitalization ( 632 [ 55 % ] in the exercise training group vs 677 [ 58 % ] in the usual care group ; HR , 0.92 [ 95 % CI , 0.83 - 1.03 ] ; P = .14 ) , and cardiovascular mortality or heart failure hospitalization ( 344 [ 30 % ] in the exercise training group vs 393 [ 34 % ] in the usual care group ; HR , 0.87 [ 95 % CI , 0.75 - 1.00 ] ; P = .06 ) . In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics , the HRs were 0.89 ( 95 % CI , 0.81 - 0.99 ; P = .03 ) for all-cause mortality or hospitalization , 0.91 ( 95 % CI , 0.82 - 1.01 ; P = .09 ) for cardiovascular mortality or cardiovascular hospitalization , and 0.85 ( 95 % CI , 0.74 - 0.99 ; P = .03 ) for cardiovascular mortality or heart failure hospitalization . Other adverse events were similar between the groups . CONCLUSIONS In the protocol -specified primary analysis , exercise training result ed in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points . After adjustment for highly prognostic predictors of the primary end point , exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047437 OBJECTIVE The purpose of this study is to determine the impact of a home communication intervention ( HCI ) for ischemic heart failure Coronary Artery Bypass Graft ( CABG ) patients > /= 65 years of age on self-efficacy , coronary artery disease risk factor modification and functioning posthospitalization . DESIGN A r and omized clinical trial with repeated measures was used . SAMPLE A sub sample of ischemic heart failure CABG surgery patients ( n = 35 ) was drawn from the parent study of 180 CABG patients . RESULTS HCI participants ( n = 18 ) had significantly higher adjusted mean self-efficacy scores [ F(1 , 29 ) = 6.40 , P < .05 ] and adjusted mean levels of functioning ( physical , general health , mental , and vitality functioning ) compared with the routine care group ( n = 17 ) , using repeated measures analysis of covariance with baseline scores as covariates . There were also significant effects of time on bodily pain and role emotional functioning . Significantly higher exercise adherence ( t = 3.09 , P < .01 ) and lower reported stress ( t = 3.77 , P < .01 ) at 3 months after surgery was reported by HCI subjects . CONCLUSIONS Data from this pilot study can be used to strengthen the HCI intervention with more tailored strategies for vulnerable subgroups of CABG patients OUTPUT:

How individuals responded to their diagnosis and their altered physical status related to their activity levels , as did the degree of encouragement to exercise coming from family , friends , and professionals . These findings can be connected to the theory of behavioral change developed by B and ura , known as social cognitive theory ( SCT ) . SCT may be a useful framework for developing interventions to support patients with HF in undertaking and maintaining regular exercise patterns . These were issues referred to in papers for the systematic review that appear to be particularly related to exercise adherence

MS2_dynamic_1_shot522

***TASK*** the task is to summarize an input biomedical literature 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 effectiveness of structured blood glucose testing in poorly controlled , noninsulin-treated type 2 diabetes . RESEARCH DESIGN AND METHODS This 12-month , prospect i ve , cluster-r and omized , multicenter study recruited 483 poorly controlled ( A1C ≥7.5 % ) , insulin-naïve type 2 diabetic subjects from 34 primary care practice s in the U.S. Practice s were r and omized to an active control group ( ACG ) with enhanced usual care or a structured testing group ( STG ) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose ( SMBG ) . STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days . The primary end point was A1C level measured at 12 months . RESULTS The 12-month intent-to-treat analysis ( ACG , n = 227 ; STG , n = 256 ) showed significantly greater reductions in mean ( SE ) A1C in the STG compared with the ACG : −1.2 % ( 0.09 ) vs. −0.9 % ( 0.10 ) ; Δ = −0.3 % ; P = 0.04 . Per protocol analysis ( ACG , n = 161 ; STG , n = 130 ) showed even greater mean ( SE ) A1C reductions in the STG compared with the ACG : −1.3 % ( 0.11 ) vs. −0.8 % ( 0.11 ) ; Δ = −0.5 % ; P < 0.003 . Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients , regardless of the patient ’s initial baseline A1C level : 179 ( 75.5 % ) vs. 61 ( 28.0 % ) ; < 0.0001 . Both STG and ACG patients displayed significant ( P < 0.0001 ) improvements in general well-being ( GWB ) . CONCLUSIONS Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB Objectives To assess the effect of self monitoring of blood glucose concentrations on glycaemic control and psychological indices in patients with newly diagnosed type 2 diabetes mellitus . Design Prospect i ve r and omised controlled trial of self monitoring versus no monitoring ( control ) . Setting Hospital diabetes clinics . Participants 184 ( 111 men ) people aged < 70 with newly diagnosed type 2 diabetes referred to the participating diabetes clinics . Major exclusion criteria were secondary diabetes , insulin treatment , previous self monitoring of blood glucose . Interventions Participants were r and omised to self monitoring or no monitoring ( control ) groups for one year with follow-up at three monthly intervals . Both groups underwent an identical structured core education programme . The self monitoring group received additional education on monitoring . Main outcome measures Between group differences in HbA1c , psychological indices , use of oral hypoglycaemic drugs , body mass index ( BMI ) , and reported hypoglycaemia rates . Results 96 patients ( 55 men ) were r and omised to monitoring and 88 ( 56 men ) to control . There were no baseline differences in mean ( SD ) age ( 57.7 ( 11.0 ) in monitoring group v 60.9 ( 11.5 ) in control group ) or HbA1c ( 8.8 (2.1)% v 8.6 (2.3)% , respectively ) . Those in the monitoring group had a higher baseline BMI ( 34 ( 7 ) v 32 ( 6.2 ) ) . There were no significant differences between groups at any time point ( 12 months values given ) in HbA1c ( 6.9 (0.8)% v 6.9 (1.2)% , P=0.69 ; 95 % confidence interval for difference −0.25 % to 0.38 % ) , BMI ( 33.1 ( 6.4 ) v 31.8 ( 6.0 ) ; adjusted for baseline BMI , P=0.32 ) , use of oral hypoglycaemic drugs , or reported incidence of hypoglycaemia . Monitoring was associated with a 6 % higher score on the depression subscale of the well-being question naire ( P=0.01 ) . Conclusions In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycaemic control but is associated with higher scores on a depression subscale . Trial registration IS RCT N 49814766 OBJECTIVE To investigate the effect of meal-related self-monitoring of blood glucose on glycemic control and well-being in non-insulin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS This 6-month study , which included 6 months of follow-up , adopted a prospect i ve , multicenter , r and omized controlled design . Subjects were r and omized to two groups : one group used a blood glucose-monitoring device , kept a blood glucose/eating diary , and received st and ardized counseling ; the control group received nonst and ardized counseling on diet and lifestyle . The primary efficacy parameter was the change in HbA(1c ) . Secondary efficacy variables included changes in body weight , lipids , and microalbumin and changes in treatment satisfaction and well-being . RESULTS In the per- protocol analysis , the use of a self-monitoring blood glucose device significantly reduced HbA(1c ) levels by 1.0 + /- 1.08 % compared with 0.54 + /- 1.41 % OUTPUT: Recent evidence demonstrates that when SMBG is ' structured ' , incorporated as part of a complex intervention , and embedded within education and collaborative care , improvements in average blood glucose levels result . In contrast , studies that do not apply SMBG systematic ally , or that assess a low frequency SMBG regimen that precludes identification and interpretation of SMBG patterns , are not clinical ly effective . CONCLUSIONS It is the quality , not quantity , of SMBG that makes a difference to outcomes for people with non-insulin-treated T2DM . INPUT: OBJECTIVE To assess the effectiveness of structured blood glucose testing in poorly controlled , noninsulin-treated type 2 diabetes . RESEARCH DESIGN AND METHODS This 12-month , prospect i ve , cluster-r and omized , multicenter study recruited 483 poorly controlled ( A1C ≥7.5 % ) , insulin-naïve type 2 diabetic subjects from 34 primary care practice s in the U.S. Practice s were r and omized to an active control group ( ACG ) with enhanced usual care or a structured testing group ( STG ) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose ( SMBG ) . STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days . The primary end point was A1C level measured at 12 months . RESULTS The 12-month intent-to-treat analysis ( ACG , n = 227 ; STG , n = 256 ) showed significantly greater reductions in mean ( SE ) A1C in the STG compared with the ACG : −1.2 % ( 0.09 ) vs. −0.9 % ( 0.10 ) ; Δ = −0.3 % ; P = 0.04 . Per protocol analysis ( ACG , n = 161 ; STG , n = 130 ) showed even greater mean ( SE ) A1C reductions in the STG compared with the ACG : −1.3 % ( 0.11 ) vs. −0.8 % ( 0.11 ) ; Δ = −0.5 % ; P < 0.003 . Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients , regardless of the patient ’s initial baseline A1C level : 179 ( 75.5 % ) vs. 61 ( 28.0 % ) ; < 0.0001 . Both STG and ACG patients displayed significant ( P < 0.0001 ) improvements in general well-being ( GWB ) . CONCLUSIONS Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB OBJECTIVE This study was design ed to evaluate the impact of a teleassistance system on the metabolic control of type 2 diabetes patients . RESEARCH DESIGN AND METHODS We conducted a 1-year controlled parallel-group trial comparing patients r and omized ( 1 ) to an intervention group , assigned to a teleassistance system using real-time transmission of blood glucose results , with immediate reply when necessary , and telephone consultations , or ( 2 ) to a control group , being regularly followed-up at their healthcare center . Study subjects were type 2 diabetes patients > 30 years of age followed in the primary care setting . RESULTS A total of 328 type 2 diabetes patients were recruited from 35 family practice s in the province of Málaga , Spain . There was a reduction in hemoglobin A1c after 12 months from 7.62 + /- 1.60 % to 7.40 + /- 1.43 % ( P = 0.027 ) in the intervention group and from 7.44 + /- 1.31 % to 7.35 + /- 1.38 % ( P = 0.303 ) in the control group . The difference in the change between groups was not statistically significant . There was also a significant decrease in systolic and diastolic blood pressure , total cholesterol , low-density lipoprotein cholesterol , and body mass index in the intervention group . In the control group , the only significant decline was in low-density lipoprotein cholesterol . CONCLUSIONS A teleassistance system using real-time transmission of blood glucose results with an option to make telephone consultations is feasible in the primary care setting as a support tool for family physicians in their follow-up of type 2 diabetes patients BACKGROUND Telehome care has been proposed as a solution to the challenges of providing effective and affordable care for patients with diabetes . METHODS A total of 100 adult patients with type 2 diabetes-divided between insulin and noninsulin requiring-was enrolled in a r and omized , controlled trial aim ed at investigating the effects of telehome monitoring . The experimental group ( n = 50 ) received an in-home wireless glucose monitor and transmitter , whereas the control group ( n = 50 ) was instructed to follow the conventional arrangement . RESULTS There was an overall reduction in HbA1c values in both experimental and control groups after 6 months . A significant difference in HbA1c values between the groups was observed only among the noninsulin-requiring patients ( decline from 6.95 % ± 0.82 % to 6.66 % ± 0.86 % in IB vs. 7.21 % ± 2.02 % to 7.2 % ± 1.86 % in IIB ; p = 0.02 ) . The experimental group reported considerably less hyperglycemic and hypoglycemic events . The profile of the patient who benefited the most from telemonitoring consisted of older , more educated patient who had acquired the disease relatively recently , and who spends most of the time at home . The experimental group had higher overall scores on quality of life measures and sense of control over diabetes . There was a positive association between educational attainment and ability to use the telemonitoring system without help ( p = 0.045 ) . CONCLUSIONS Although not conclusive because of the small sample and short observation period , the study suggests that telehome monitoring is an effective tool in controlling type 2 diabetes in a primary care setting Background Type 2 diabetes mellitus is a worldwide challenge . Practice guidelines promote structured self-monitoring of blood glucose ( SMB OUTPUT:

Conclusions Telemonitoring interventions may be a better option than usual care in improving glycated haemoglobin control of patients with type 2 diabetes .

MS2_dynamic_1_shot523

***TASK*** the task is to summarize an input biomedical literature 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 heart failure have reduced peripheral blood flow at rest , during exercise , and in response to endothelium-dependent vasodilators . Nitric oxide formed from L-arginine metabolism in endothelial cells contributes to regulation of blood flow under these conditions . A r and omized , double-blind crossover study design was used to determine whether supplemental oral L-arginine can augment peripheral blood flow and improve functional status in patients with moderate to severe heart failure . METHODS AND RESULTS Fifteen subjects were given 6 weeks of oral L-arginine hydrochloride ( 5.6 to 12.6 g/d ) and 6 weeks of matched placebo capsules in r and om sequence . Compared with placebo , supplemental oral L-arginine significantly increased forearm blood flow during forearm exercise , on average from 5.1 + /- 2.8 to 6.6 + /- 3.4 mL. min-1 . dL-1 ( P < .05 ) . Furthermore , functional status was significantly better on L-arginine compared with placebo , as indicated by increased distances during a 6-minute walk test ( 390 + /- 91 versus 422 + /- 86 m , P < .05 ) and lower scores on the Living With Heart Failure question naire ( 55 + /- 28 versus 42 + /- 26 , P < .05 ) . Oral L-arginine also improved arterial compliance from 1.99 + /- 0.38 to 2.36 + /- 0.30 mL/mm Hg ( P < .001 ) and reduced circulating levels of endothelin from 1.9 + /- 1.1 to 1.5 + /- 1.1 pmol/L ( P < .05 ) . CONCLUSIONS Supplemental oral L-arginine had beneficial effects in patients with heart failure . Further studies are needed to confirm the therapeutic potential of supplemental oral L-arginine and to identify mechanisms of action in patients with heart failure UNLABELLED The aim of this study was to evaluate whether long-term administration of arginine acting through a normalization of NO/cyclic-guanosine-3 ' 5'-cyclic monophosphate ( cGMP ) pathway was able to ameliorate peripheral and hepatic insulin sensitivity in 12 lean type 2 diabetic patients . RESEARCH DESIGN AND METHODS A double-blind study was performed for 3 months . In the first month , patients were treated with their usual diet . Then they were r and omly allocated into to groups . In group 1 , patients were treated with diet plus placebo ( orally three times per day ) for 2 months . In group 2 patients were treated for 1 month with diet plus placebo orally , three times per day ) and then for 1 month with diet plus L-arginine ( 3 g three times per day ) . At the end of the first and the second month of therapy , patients underwent a euglycemic-hyperinsulinemic clamp combined with [ 6,6 - 2H2 ] glucose infusion . A total of 10 normal subjects underwent the same test as control subjects . RESULTS In group 1 , no changes in basal cGMP levels , systolic blood pressure , forearm blood flow , glucose disposal , and endogenous glucose production were observed throughout . In group 2 , L-arginine normalized basal cGMP levels and significantly increased forearm blood flow by 36 % and glucose disposal during the clamp by 34 % whereas it decreased systolic blood pressure and endogenous glucose production by 14 and 29 % , respectively . However , compared with normal subjects , L-arginine treatment was not able to completely overcome the defect in glucose disposal . CONCLUSIONS L-Arginine treatment significantly improves but does not completely normalizc peripheral and hepatic insulin sensitivity in type 2 diabetic patients Background : Recently , the potential of L-arginine supplementation as a novel and effective strategy for weight loss and improving biochemical parameters in obese patients has been under consideration . Objectives : To evaluate the influence of 8-week oral L-arginine supplementation on body mass index ( BMI ) , waist circumference ( WC ) , triceps skinfold ( TS ) , subscapular skinfold ( SS ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , plasma fasting blood sugar ( FBS ) , glycated hemoglobin ( HbA1c ) , triglyceride ( TG ) , total cholesterol ( TC ) , low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) , and malondialdehyde ( MDA ) in patients with BMI values > 29.9 or visceral obesity ( WC > 102 cm in men or > 88 cm in women ) . Patients and Methods : Ninety obese patients were included in a single-blind r and omized controlled trial . Patients were r and omized to receive either L-arginine ( 3 or 6 g thrice daily ) or placebo for 8 weeks . Anthropometric and biochemical indices , dietary intake , and blood pressure values were measured at the baseline and after the 8-week intervention . Results : Significant decreases in anthropometric parameters , blood pressure ( SBP , DBP ) , FBS , HbA1c , LDL , MDA ( P < 0.001 ) , TG ( P = 0.02 ) , and TC ( P = 0.002 ) and a significant increase in HDL ( P < 0.001 ) were observed in the intervention group , compared to the control group . In the control group , no significant differences were found between the baseline and end-of-intervention measurements . Conclusions : In conclusion , oral L-Arginine supplementation appears to improve anthropometric parameters , blood pressure values , and some blood biochemical OUTPUT: No difference was found in meta-analytical estimates of NOx and ADMA responses between arginine or placebo treatments . INPUT: Background : Recently , the potential of L-arginine supplementation as a novel and effective strategy for weight loss and improving biochemical parameters in obese patients has been under consideration . Objectives : To evaluate the influence of 8-week oral L-arginine supplementation on body mass index ( BMI ) , waist circumference ( WC ) , triceps skinfold ( TS ) , subscapular skinfold ( SS ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , plasma fasting blood sugar ( FBS ) , glycated hemoglobin ( HbA1c ) , triglyceride ( TG ) , total cholesterol ( TC ) , low-density lipoprotein ( LDL ) , high-density lipoprotein ( HDL ) , and malondialdehyde ( MDA ) in patients with BMI values > 29.9 or visceral obesity ( WC > 102 cm in men or > 88 cm in women ) . Patients and Methods : Ninety obese patients were included in a single-blind r and omized controlled trial . Patients were r and omized to receive either L-arginine ( 3 or 6 g thrice daily ) or placebo for 8 weeks . Anthropometric and biochemical indices , dietary intake , and blood pressure values were measured at the baseline and after the 8-week intervention . Results : Significant decreases in anthropometric parameters , blood pressure ( SBP , DBP ) , FBS , HbA1c , LDL , MDA ( P < 0.001 ) , TG ( P = 0.02 ) , and TC ( P = 0.002 ) and a significant increase in HDL ( P < 0.001 ) were observed in the intervention group , compared to the control group . In the control group , no significant differences were found between the baseline and end-of-intervention measurements . Conclusions : In conclusion , oral L-Arginine supplementation appears to improve anthropometric parameters , blood pressure values , and some blood biochemical indices associated with cardiovascular disease prevention Background In the present study , the effect of arginine and leucine supplementation , and dietary protein level , were investigated in commercial crossbred pigs to clarify their individual or combined impact on plasma metabolites , hepatic fatty acid composition and mRNA levels of lipid sensitive factors . The experiment was conducted on fifty-four entire male pigs ( Duroc × Pietrain × Large White × L and race crossbred ) from 59 to 92 kg of live weight . Each pig was r and omly assigned to one of six experimental treatments ( n = 9 ) . The treatments followed a 2 × 3 factorial arrangement , providing two levels of arginine supplementation ( 0 vs. 1 % ) and three levels of basal diet ( normal protein diet , NPD ; reduced protein diet , RPD ; reduced protein diet with 2 % of leucine , RPDL ) . Results Significant interactions between arginine supplementation and protein level were observed across plasma lipids . While dietary arginine increased total lipids , total cholesterol , HDL-cholesterol , LDL-cholesterol , VLDL-cholesterol and triacylglycerols in NPD , the inverse effect was observed in RPD . Overall , dietary treatments had a minor impact on hepatic fatty acid composition . RPD increased 18:1c9 fatty acid while the combination of leucine and RPD reduced 18:0 fatty acid . Arginine supplementation increased the gene expression of FABP1 , which contributes for triacylglycerols synthesis without affecting hepatic fatty acids content . RPD , with or without leucine addition , upregulated the lipogenic gene CEBPA but downregulated the fat oxidation gene LPIN1 . Conclusions Arginine supplementation was responsible for a modulated effect on plasma lipids , which is dependent on dietary protein level . It consistently increased lipaemia in NPD , while reducing the correspondent metabolites in RPD . In contrast , arginine had no major impact , neither on hepatic fatty acids content nor on fatty acid composition . Likewise , leucine supplementation of RPD , regardless the presence of arginine , promoted no changes on total fatty acids in the liver . Ultimately , arginine , leucine and dietary protein reduction seem to be unrelated with fatty liver development Our study aims at investigating a possible role for L-arginine and D-arginine in insulin-mediated glucose uptake . Twelve lean healthy subjects volunteered for the study and were su bmi tted to three euglycemic-hyperinsulinemic glucose clamps to investigate the effect of L-arginine ( 0.5 g/min in the last 60 minutes of the clamp ) , D-arginine ( 0.5 g/min in the last 60 minutes of the clamp ) , and saline 0.9 % NaCl on insulin-mediated glucose uptake . All tests were made in r and om order . In study 1 , L-arginine versus saline infusion was associated with a significant increase in blood flow ( 131 % + /- 7 % v 87 % + /- 5 % , P < .001 ) and whole-body glucose disposal ( [ WBGD ] 61.4 + /- 4.4 v 41.3 + /- 3.5 mumol/kg fat-free mss [FFM].min , P < .001 ) . Analysis of substrate oxidation demonstrated that both oxidative and nonoxidative glucose metabolism was improved by L-arginine delivery . After adjustment for the change in blood flow , WBGD was still greater after L-arginine than after saline infusion . Along with L-arginine infusion and independently of the change in blood flow , the percent change in WBGD correlated with the percent change in plasma cGMP ( r = .55 , P < .05 ) . D-Arginine infusion OUTPUT:

This meta- analysis concludes that l-arginine supplementation can significantly reduce blood TAG levels ; however , there is insufficient evidence to support its hypocholesterolaemic effects .

MS2_dynamic_1_shot524

***TASK*** the task is to summarize an input biomedical literature 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: Balanced glucose metabolism ensures optimal fetal growth with long-term health implication s conferred on both mother and child . We examined whether supplementation of probiotics with dietary counselling affects glucose metabolism in normoglycaemic pregnant women . At the first trimester of pregnancy 256 women were r and omised to receive nutrition counselling to modify dietary intake according to current recommendations or as controls ; the dietary intervention group was further r and omised to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) in a double-blind manner , whilst the control group received placebo ( control/placebo ) . Blood glucose concentrations were lowest in the diet/probiotics group during pregnancy ( baseline-adjusted means 4.45 , 4.60 and 4.56 mmol/l in diet/probiotics , diet/placebo and control/placebo , respectively ; P = 0.025 ) and over the 12 months ' postpartum period ( baseline-adjusted means 4.87 , 5.01 and 5.02 mmol/l ; P = 0.025 ) . Better glucose tolerance in the diet/probiotics group was confirmed by a reduced risk of elevated glucose concentration compared with the control/placebo group ( OR 0.31 ( 95 % CI 0.12 , 0.78 ) ; P = 0.013 ) as well as by the lowest insulin concentration ( adjusted means 7.55 , 9.32 and 9.27 mU/l ; P = 0.032 ) and homeostasis model assessment ( adjusted means 1.49 , 1.90 and 1.88 ; P = 0.028 ) and the highest quantitative insulin sensitivity check index ( adjusted means 0.37 , 0.35 and 0.35 ; P = 0.028 ) during the last trimester of pregnancy . The effects observed extended over the 12-month postpartum period . The present study demonstrated that improved blood glucose control can be achieved by dietary counselling with probiotics even in a normoglycaemic population and thus may provide potential novel means for the prophylactic and therapeutic management of glucose disorders BACKGROUND Galactooligosaccharides ( GOS ) and long-chain fructooligosaccharides ( lcFOS ) proliferate bifidobacteria in infant gut microbiota . However , it is not known how GOS and FOS influence the microbiota of pregnant women and whether a potential prebiotic effect is transferred to the offspring . OBJECTIVES We aim ed to test how supplementation with GOS and lcFOS ( GOS/lcFOS ) in the last trimester of pregnancy affects maternal and neonatal gut microbiota . Variables of fetal immunity were assessed as a secondary outcome . DESIGN In a r and omized , double-blind , placebo-controlled pilot study , 48 pregnant women were supplemented 3 times/d with 3 g GOS/lcFOS ( at a ratio of 9:1 ) or maltodextrin ( placebo ) from week 25 of gestation until delivery . Percentages of bifidobacteria and lactobacilli within total bacterial counts were detected by fluorescent in situ hybridization and quantitative polymerase chain reaction in maternal and neonatal ( days 5 , 20 , and approximately 182 ) stool sample s. Variables of fetal immunity were assessed in cord blood by using flow cytometry and cytokine multiplex-array analysis . RESULTS The proportions of bifidobacteria in the maternal gut were significantly higher in the supplemented group than in the placebo group ( 21.0 % and 12.4 % , respectively ; P = 0.026 ) ; the proportion of lactobacilli did not differ between the groups . In neonates , bifidobacteria and lactobacilli percentages , diversity and similarity indexes , and fetal immune parameters did not differ significantly between the 2 groups . Mother-neonate similarity indexes of bifidobacteria decreased over time . CONCLUSIONS GOS/lcFOS supplementation has a bifidogenic effect on maternal gut microbiota that is not transferred to neonates . The increased maternal bifidobacteria did not affect fetal immunity as measured by a comprehensive examination of cord blood immunity variables Abstract Objective To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women . Design Multicentre , prospect i ve , r and omised controlled trial . Setting Non-hospital based antenatal clinics . Participants 4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection . In the intervention group , the women 's obstetricians received the test results and women received st and ard treatment and follow up for any detected infection . In the control group , the results of the vaginal smears were not revealed to the caregivers . Main outcome measures The primary outcome variable was preterm delivery at less than 37 weeks . Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage . Results Outcome data were available for 2058 women in the intervention group and 2097 women in the control group . In the intervention group , the number of preterm births was significantly lower than in the control group ( 3.0 % v 5.3 % , 95 % confidence interval 1.2 to 3.6 ; P = 0.0001 ) . Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and ≤ OUTPUT: Although the use of probiotics appears to treat vaginal infections in pregnancy , there are currently insufficient data from trials to assess impact on preterm birth and its complications INPUT: Balanced glucose metabolism ensures optimal fetal growth with long-term health implication s conferred on both mother and child . We examined whether supplementation of probiotics with dietary counselling affects glucose metabolism in normoglycaemic pregnant women . At the first trimester of pregnancy 256 women were r and omised to receive nutrition counselling to modify dietary intake according to current recommendations or as controls ; the dietary intervention group was further r and omised to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) in a double-blind manner , whilst the control group received placebo ( control/placebo ) . Blood glucose concentrations were lowest in the diet/probiotics group during pregnancy ( baseline-adjusted means 4.45 , 4.60 and 4.56 mmol/l in diet/probiotics , diet/placebo and control/placebo , respectively ; P = 0.025 ) and over the 12 months ' postpartum period ( baseline-adjusted means 4.87 , 5.01 and 5.02 mmol/l ; P = 0.025 ) . Better glucose tolerance in the diet/probiotics group was confirmed by a reduced risk of elevated glucose concentration compared with the control/placebo group ( OR 0.31 ( 95 % CI 0.12 , 0.78 ) ; P = 0.013 ) as well as by the lowest insulin concentration ( adjusted means 7.55 , 9.32 and 9.27 mU/l ; P = 0.032 ) and homeostasis model assessment ( adjusted means 1.49 , 1.90 and 1.88 ; P = 0.028 ) and the highest quantitative insulin sensitivity check index ( adjusted means 0.37 , 0.35 and 0.35 ; P = 0.028 ) during the last trimester of pregnancy . The effects observed extended over the 12-month postpartum period . The present study demonstrated that improved blood glucose control can be achieved by dietary counselling with probiotics even in a normoglycaemic population and thus may provide potential novel means for the prophylactic and therapeutic management of glucose disorders Background Although several studies have found probiotics encouraging in prevention of gestational diabetes mellitus ( GDM ) , the evidence for the use of probiotics in diagnosed GDM is largely limited . The aim of this study was to assess the effect of a probiotic supplement capsule containing four bacterial strains on glucose metabolism indices and weight changes in women with newly diagnosed GDM . Methods Sixty-four pregnant women with GDM were enrolled into a double-blind placebo-controlled r and omized clinical trial . They were r and omly assigned to receive either a probiotic or placebo capsule along with dietary advice for eight consecutive weeks . The trend of weight gain along with glucose metabolism indices was assayed . Results During the first 6 weeks of the study , the weight gain trend was similar between the groups . However , in the last 2 weeks of the study , the weight gain in the probiotic group was significantly lower than in the placebo group ( p < 0.05 ) . Fasting blood sugar ( FBS ) decreased in both intervention ( from 103.7 to 88.4 mg/dl ) and control ( from 100.9 to 93.6 mg/dl ) groups significantly , and the decrease in the probiotic group was significantly higher than in the placebo group ( p < 0.05 ) . Insulin resistance index in the probiotic group had 6.74 % reduction over the study period ( p < 0.05 ) . In the placebo group , however , there was an increase in insulin resistance index ( 6.45 % ) , but the observed change in insulin resistance was not statistically significant . Insulin sensitivity index was increased in both groups . The post-intervention insulin sensitivity index in the probiotic group was not significantly different from placebo when adjusted for the baseline levels . Conclusions The probiotic supplement appeared to affect glucose metabolism and weight gain among pregnant women with GDM . This needs to be confirmed in other setting s before a therapeutic value could be approved Abstract Synbiotics are known to exert multiple beneficial effects , including anti-inflammatory and antioxidative actions . This study was design ed to evaluate the effects of synbiotic administration on biomarkers of inflammation , oxidative stress , and pregnancy outcomes among gestational diabetic ( GDM ) women . This r and omized , double-blind , placebo-controlled clinical trial was carried out among 60 subjects with GDM who were not on oral hypoglycemic agents . Patients were r and omly assigned to consume either one synbiotic capsule containing Lactobacillus acidophilus strain T16 ( IBRC-M10785 ) , L. casei strain T2 ( IBRC-M10783 ) , and Bifidobacterium bifidum strain T1 ( IBRC-M10771 ) ( 2 × 109 CFU/g each ) plus 800 mg inulin ( HPX ) ( n = 30 ) or placebo ( n = 30 ) for 6 weeks . Compared with the placebo , synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein ( hs-CRP ) ( − 1.9 ± 4.2 vs. + 1.1 ± 3.5 mg/L , P = 0.004 ) , plasma malondialdehyde ( MDA ) ( − 0.1 ± 0.6 vs. + 0.3 ± 0.7 μmol/ OUTPUT:

Among secondary endpoints , a significant reduction of maternal insulin ( both in women with or without diabetes ) was observed in the probiotics group . INTERPRETATION Probiotics during pregnancy do not reduce the incidence of GDM , with a very little ( statistically but not clinical ly significant ) reduction of fasting plasma glucose

MS2_dynamic_1_shot525

***TASK*** the task is to summarize an input biomedical literature 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 Wong-Baker FACES Pain Rating Scale ( WBS ) , used in children to rate pain severity , has been vali date d outside the emergency department ( ED ) , mostly for chronic pain . The authors vali date d the WBS in children presenting to the ED with pain by identifying a corresponding mean value of the visual analog scale ( VAS ) for each face of the WBS and determined the relationship between the WBS and VAS . The hypothesis was that the pain severity ratings on the WBS would be highly correlated ( Spearman 's rho > 0.80 ) with those on a VAS . METHODS This was a prospect i ve , observational study of children ages 8 - 17 years with pain presenting to a suburban , academic pediatric ED . Children rated their pain severity on a six-item ordinal faces scale ( WBS ) from none to worst and a 100-mm VAS from least to most . Analysis of variance ( ANOVA ) was used to compare mean VAS scores across the six ordinal categories . Spearman 's correlation ( rho ) was used to measure agreement between the continuous and ordinal scales . RESULTS A total of 120 patients were assessed : the median age was 13 years ( interquartile range [ IQR ] = 10 - 15 years ) , 50 % were female , 78 % were white , and six patients ( 5 % ) used a language other than English at home . The most commonly specified locations of pain were extremity ( 37 % ) , abdomen ( 19 % ) , and back/neck ( 11 % ) . The mean VAS increased uniformly across WBS categories in increments of about 17 mm . ANOVA demonstrated significant differences in mean VAS across face groups . Post hoc testing demonstrated that each mean VAS was significantly different from every other mean VAS . Agreement between the WBS and VAS was excellent ( rho = 0.90 ; 95 % confidence interval [ CI ] = 0.86 to 0.93 ) . There was no association between age , sex , or pain location with either pain score . CONCLUSIONS The VAS was found to have an excellent correlation in older children with acute pain in the ED and had a uniformly increasing relationship with WBS . This finding has implication s for research on pain management using the WBS as an assessment tool 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 a r and omized double-blind study of 57 children ( aged 6 months-6 yr ) , pain following lateral thoracotomy was relieved with repeated i.v . doses of morphine 100 or 50 micrograms kg-1 , or buprenorphine 3.0 or 1.5 micrograms kg-1 . The same drug and dosage were continued and cardioventilatory indices , pain intensity and sedation measured for an observation period of 24 h. The sums of the pain intensity differences were equal in all groups . The mean doses for the complete initial analgesia were 230 and 180 micrograms kg-1 with the larger and the smaller bolus doses of morphine and 5.8 and 3.7 micrograms kg-1 with buprenorphine , respectively . The mean duration of action of buprenorphine was slightly but not significantly longer than that of morphine . The total consumption of both morphine and buprenorphine was less when the smaller bolus doses were used . Two patients developed a degree of ventilatory depression following repeated doses of buprenorphine . Buprenorphine was equal to morphine as a postoperative analgesic This study was a prospect i ve , r and omized comparison of the ventilatory effects of equianalgesic single‐doses of morphine , 100 μg/kg , and buprenorphine , 3.0 μg/kg , administered intravenously to 20 children ( 5–8 years of age ) after elective ophthalmic surgery . The decrease in ventilatory rate and acute change in the arteriolar oxygen saturation and the increase in end‐tidal CO2 levels were statistically significantly greater in magnitude and duration after buprenorphine than after morphine . For both drugs , the time , duration and magnitude of ventilatory changes varied appreciably between individuals . No child had apnea or hypoventilation requiring assistance . The authors conclude that acutely administered buprenorphine depresses ventilation to a greater degree than morphine . The maximal ventilatory effect of buprenorphine occurs later than with morphine , and ventilatory depression after buprenorphine may develop late . For safety , all children given opioids intravenously should be observed until they are fully responsive and ventilatory control has stabilized The safety and efficacy of buprenorphine and morphine as postoperative analgesicsfor children were compared in 60 boys and girls 4 to 14 years old having elective orthopedic operations on upper or lower extremities . The drugs were given in a double-blind manner initially intravenously and thereafter by sublingual buprenorphine or intramuscular morphine administered as required to relieve pain until the third postoperative morning . The IV dose needed to achieve complete initial analgesia was 5.2 ± 2.8 μg/kg buprenorphine and 166 ± 100 μg/kg morphine . The duration of effect was significantly longer with buprenorphine than with morphine , 248 ± 314 and 114 ± 109 minutes , respectively ( P = 0.03 ) . The most common side effects were nausea and vomiting ( 28 and 16 % ) and urinary retention ( 21 and 19 % ) in the buprenorphine and morphine groups , respectively . Analgesia with sublingual buprenorphine was as effective and reliable as with intramuscular morphine but a longer duration of action could not be demonstrated The study describes long term ventil OUTPUT: There was no significant difference in the rates of adverse effects . Conclusions Buprenorphine provided a longer duration of analgesia than morphine . This in combination with its unique sublingual preparation could prove particularly advantageous in the paediatric population . INPUT: BACKGROUND The durability of restorations bonded with one-step self-etching ( OSSE ) adhesive systems is inferior compared with that of restorations bonded with conventional adhesives . The authors conducted an 18-month r and omized clinical study to evaluate the clinical performance of two OSSE systems in noncarious cervical lesions applied as recommended or with an extra layer of hydrophobic adhesive layer after 18 months of clinical service . METHODS Thirty participants , each of whom had at least two pairs of similar-sized noncarious cervical lesions , took part in this study . The authors placed 120 restorations , 30 in each of four groups : Clearfil S3 Bond ( Kuraray , Osaka , Japan ) ( CS ) and iBond Gluma inside ( Heraeus Kulzer , Hanau , Germany ) ( IB ) , and Clearfil S3 Bond ( CSB ) and iBond Gluma inside ( IBB ) with an extra layer of hydrophobic adhesive applied on top of them . They placed the restorations incrementally , using a resin-based composite . The authors evaluated the restorations at baseline and at 18 months following modified U.S. Public Health Service criteria . RESULTS At 18 months , the retention rate for the IB group was statistically lower than those for the CS , IBB and CSB groups . Marginal discoloration occurred in all groups and was statistically worse in the IB group . CONCLUSIONS The conversion of the iBond Gluma inside and Clearfil S3 Bond adhesive systems into two-step systems by means of applying an extra hydrophobic adhesive layer improved the clinical performance of these material s after 18 months of clinical service . CLINICAL IMPLICATION S The application of an extra hydrophobic adhesive layer over OSSE adhesive systems , layers improved the OSSE systems clinical performance , mainly in terms of retention rate Self-assembled nanolayering structures have been reported in resin-dentin interfaces created by adhesives that contain 10-methacryloyloxydecyl dihydrogen phosphate ( 10-MDP ) . These structures have been hypothesized to contribute to bond durability . The objective of the present study was to determine the extent of nanolayering in resin-dentin interfaces after application of commercialized 10-MDP-containing self-etch and universal adhesives to human dentin . Seven commercialized adhesives were examined : Adhese Universal ( Ivoclar-Vivadent ) , All-Bond Universal ( Bisco , Inc. ) , Clearfil SE Bond 2 , Clearfil S3 Bond Plus , Clearfil Universal Bond ( all from Kuraray Noritake Dental Inc. ) , G-Premio Bond ( GC Corp. ) , and Scotchbond Universal ( 3 M ESPE ) . Each adhesive was applied in the self-etch mode on midcoronal dentin according to the respective manufacturer ’s instructions . Bonded specimens ( n = 6 ) were covered with flowable resin composite , processed for transmission electron microscopy , and examined at 30 r and om sites without staining . Thin-film glancing angle X-ray diffraction ( XRD ) was used to detect the characteristic peaks exhibited by nanolayering ( n = 4 ) . The control consisted of 15%wt , 10%wt , and 5%wt 10-MDP ( DM Healthcare Products , Inc. ) dissolved in a mixed solvent ( ethanol and water weight ratio 9:8 , with photoinitiators ) . Experimental primers were applied to dentin for 20 s , covered with hydrophobic resin layer , and examined in the same manner . Profuse nanolayering with highly ordered periodicity ( ~3.7 nm wide ) was observed adjacent to partially dissolved apatite crystallites in dentin treated with the 15 % 10-MDP primer . Three peaks in the 2θ range of 2.40 ° ( 3.68 nm ) , 4.78 ° ( 1.85 nm ) , and 7.18 ° ( 1.23 nm ) were identified from thin-film XRD . Reduction in the extent of nanolayering was observed in the 10 % and 5 % 10-MDP experimental primer-dentin interface along with lower intensity XRD peaks . Nanolayering and characteristic XRD peaks were rarely observed in specimens prepared from the commercialized adhesives . The sparsity of nanolayering in resin-dentin interfaces created by commercialized adhesives challenges its clinical effectiveness as a mechanism for improving bond longevity in dentin bonding OUTPUT:

The 10-MDP monomer has the capacity to produce an acid-base resistant zone on the adhesive interface , which increases the response to acid-base challenges . The adhesion established by these systems is stable over time .

MS2_dynamic_1_shot526

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND The aim of this study was to investigate the reoperation rates after open indirect inguinal hernia repair with and without mesh in young males and other age groups . Younger males have higher risk of developing chronic pain after open inguinal hernia repair with mesh compared with older patients . Avoiding mesh among younger patients could be justified , if they have an acceptable low risk of recurrence compared with other groups and compared with Lichtenstein repair . METHODS Data were extracted from the nationwide Danish Hernia Data base which is recording prospect ively . Included were males with primary indirect inguinal hernia , repaired with Lichtenstein or annulorrhaphy from the period January 1 , 1998 to December 31 , 2015 . Reoperation rate for recurrence was used as outcome . RESULTS In total 52,281 primary repairs of open indirect inguinal hernia were included of which 49,951 were Lichtenstein repairs and 2330 were annulorrhaphies . The overall reoperation rates increased year after year in both groups but the 18 - 29 year old males had a significant lower risk of reoperation after annulorrhaphy compared with all other age groups ( cumulative reoperation rate 8.1 % versus 12.5 % , log rank p = 0.001 ) . CONCLUSIONS The cumulative reoperation rate after annulorrhaphy for 18 - 29 year old males was significantly lower compared with all other age groups . When taken into consideration , that young males at the same time have the highest risk of developing chronic pain after mesh repair the results indicate , that annulorrhaphy could be a valid option for young men with indirect inguinal hernias . Thus , we propose a tailored approach for this patient group Background In recent years long-term discomfort after inguinal hernia surgery has become an issue of great concern to hernia surgeons . Long-term results on discomfort from large r and omised studies are sparse . Methods One-thous and one-hundred and eighty-three patients were r and omised in a multicentre trial with the primary aim of comparing recurrence rates after laparoscopic TAPP and Shouldice repair . Evaluating late discomfort and its possible risk factors were secondary objectives , and are reported here . The patients were clinical ly examined after 1 and 5 years , and answered question naires 2 and 3 years postoperation . Results Of 1,068 operated patients , 867 were eligible for analysis after 5 years ( 81.2 % ) . The percentage of patients experiencing discomfort of any kind were 8.5 % in the TAPP group and 11.4 % ( p = 0.156 ) in the Shouldice group . Although discomfort was usually mild it was severe for 0.2 and 0.7 % , respectively . Severe pain the first postoperative week was a risk factor for late discomfort in the Shouldice group ( OR 2.25 , P = 0.022 ) but not in the TAPP group . No other risk factor for late discomfort was found . Conclusion There was no difference between late discomfort at five-year follow-up after laparoscopic TAPP and Shouldice repair . Discomfort was mostly mild and pain during the first postoperative week was a prognostic variable for late discomfort in Shouldice patients BACKGROUND The Cooperative Hernia Study assessed postoperative pain in a prospect i ve trial as part of a larger study looking at the recurrence rate and other morbidity of the Bassini , McVay , and Shouldice repairs . METHODS Patients were r and omized to one of three surgical hernia repairs . Patients were seen in follow-up at 6 , 12 , and 24 months and were assessed for the presence of pain , numbness , paresthesia , and recurrence . RESULTS Three hundred fifteen patients were seen in follow-up , with 276 seen at the 2-year mark . At 1 year , 62.9 % of patients had groin or inguinal pain and 11.9 % of patients had moderate to severe pain ; 53.6 % had pain and 10.6 % of patients continued to report moderate to severe pain 2 years postoperatively . The predictors for long-term postoperative pain were as follows : absence of a visible bulge before the operation ( p < 0.001 ) ; presence of numbness in the surgical area postoperatively ( p < 0.05 ) ; and patient requirement of more than 4 weeks out of work postoperatively ( p < 0.004 ) . Three distinct chronic pains were identified . The most common and most severe pain was somatic , localized to the common ligamentous insertion to the public tubercle . The second was neuropathic and was referable to the ilioinguinal or genitofemoral nerve distribution . This was likely because of injury to the genitofemoral nerves , either at surgery or subsequently by encroachment of scar . The third pain was visceral , ejaculatory pain . Twenty-four percent of patients had postoperative numbness at 2 years , independent of the type of repair . Numbness was most common in the distribution of cutaneous branches of the ilioinguinal and iliohypogastric nerves . CONCLUSION Pain or numbness are common late sequelae of traditional external surgical hernia repairs . Strategies need to be developed to reduce the risk of these complications BACKGROUND The ideal operation to treat inguinal hernia is still far to define . We analyzed the outcomes of the Desarda tissue-based repair in comparison with the st and ard Lichtenstein procedure in treatment of primary inguinal hernia . METHODS A total of 168 patients were r and omly allocated into two groups to undergo one of two repairs : Desarda ( group I ) or Lichtenstein ( group II ) ( 85 vs. 83 , respectively ) . The primary outcome measures were recurrence of inguinal hernia and chronic groin pain . Secondary outcome measures included operating time , postoperative pain scores , time to return to normal gait and to work , foreign body sensation in the OUTPUT: Both the meta‐analyses and the network meta‐ analysis indicated no difference in chronic pain rates when comparing nonmesh repairs with open‐ and laparoscopic mesh repairs . Conclusion : Mesh may be used without fear of causing a greater rate of chronic pain INPUT: Inguinal hernias in women are relatively rare , and an outcome in this specific subgroup of hernias has not been documented in the literature . An analysis was performed using data from the prospect i ve recording of 3,696 female inguinal hernia repairs in the national Danish hernia data base , in the 5.5 year period from January 1 , 1998 to June 30 , 2003 , where observation time specific reoperation rates were used as a proxy for recurrence . In the 3,696 female inguinal herniorrhaphies recorded , the overall reoperation rate was 4.3 % , which is slightly higher compared to male inguinal herniorrhaphies ( 3.1 % ) ( P=0.001 ) . The reoperation rate was independent of the type of surgical repair . In 41.5 % of the reoperations a femoral hernia was found , compared to 5.4 % in males . Female inguinal herniorrhaphy is followed by a higher reoperation rate than in males , and is unrelated to the type of repair . The frequent finding of a femoral hernia at reoperation suggests the need for the exploration of the femoral canal at the primary operation The European Hernia Society ( EHS ) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients . The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare . They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS . They are evidence -based and , when necessary , a consensus was reached among all members . The Guidelines have been review ed by a Steering Committee . Before finalisation , feedback from different national hernia societies was obtained . The Appraisal of Guidelines for REsearch and Evaluation ( AGREE ) instrument was used by the Cochrane Association to vali date the Guidelines . The Guidelines can be used to adjust local protocol s , for training purpose s and quality control . They will be revised in 2012 in order to keep them up date d. In between revisions , it is the intention of the Working Group to provide every year , during the EHS annual congress , a short up date of new high-level evidence ( r and omised controlled trials [ RCTs ] and meta-analyses ) . Developing guidelines leads to questions that remain to be answered by specific research . Therefore , we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment . In addition , a short summary , specifically for the general practitioner , is given . In order to increase the practical use of the Guidelines by consultants and residents , more details on the most important surgical techniques , local infiltration anaesthesia and a patient information sheet is provided . The most important challenge now will be the implementation of the Guidelines in daily surgical practice . This remains an important task for the EHS . The establishment of an EHS school for teaching inguinal hernia repair surgical techniques , including tips and tricks from experts to overcome the learning curve ( especially in endoscopic repair ) , will be the next step . Working together on this project was a great learning experience , and it was worthwhile and fun . Cultural differences between members were easily overcome by educating each other , respecting different views and always coming back to the principles of evidence -based medicine . The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project BACKGROUND An association between smoking and impaired wound healing has been reported in retrospective studies . The smoking status of a surgical patient may be confounded by social and medical parameters . We have evaluated the effect of smoking in a test wound in volunteers , with special reference to a reliable scientific match between smokers and nonsmokers . METHODS In a prospect i ve open study with blinded assessment , 19 smoking ( 20 cigarettes/day ) and 18 nonsmoking healthy volunteers were matched with respect to baseline characteristics . The deposition of total protein and mature collagen ( expressed as hydroxyproline ) was assessed in an exp and ed polytetrafluoroethylene wound healing model implanted subcutaneously for 10 days . RESULTS The nonsmokers had a 1.8 times higher median amount of hydroxyproline than the smokers ( p < 0.01 ) . The deposition of hydroxyproline was negatively correlated with the consumption of tobacco both before ( r = -0.44 ; p < 0.01 ) and during the study ( r = -0.48 ; p < 0.005 ) . The impairment was specific for the production of collagenous proteins and not other proteins . CONCLUSIONS The synthesis of subcutaneous collagen in smokers is specifically impeded , indicating an impaired wound-healing process . Because mature collagen is the main determinator of strength of an operative wound , the results support the view that patients should be advised to stop smoking before an operation Background Large-scale data for the optimal inguinal hernia repair in younger men with an indirect hernia is not available . We analysed nationwide data for risk of reoperation in younger men after a primary repair using a Lichtenstein operation or a conventional non-mesh hernia repair . Methods Prospect i ve recording of all inguinal hernia repairs from 1 January 1998 to 31 December 2005 in the national Danish Hernia Data base , using reoperation rate as a proxy for recurrence . We included only men between the age of 18 and 30 years with a primary repair of a primary indirect inguinal hernia . Results A primary sutured repair was performed in 1,120 men ( median age 23 years , range 18–30 ) and a Lichtenstein mesh repair in 2,061 young men ( 24 years , range 18–30 ) ( total 3,181 patients ) . The observation time after conventional hernia repair was median 62 months ( range 0–96 ) and 41 months ( range OUTPUT:

We found that female sex , direct inguinal hernias at the primary procedure , operation for a recurrent inguinal hernia , and smoking were significant risk factors for recurrence after inguinal hernia surgery .

MS2_dynamic_1_shot527

***TASK*** the task is to summarize an input biomedical literature 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 adapt a recent model from the Framingham study ( Circulation 1991 ; 83 : 356 - 362 ) to predict CHD in France for both sexes over a large age range . Calculations were based on data from the French PCV-METRA study . In France , the Paris Prospect i ve Study model could predict CHD but only for men aged 43 - 53 years . Applied to men 43 - 53 years from the PCV-METRA , the Framingham model estimated a 5-year CHD risk ( 4 % ) lower than the risk reported in the Framingham sample , but significantly higher than the risk estimated by the French model ( 2 % ) . Differences in estimated CHD risk between the Framingham and the PCV-METRA sample s were explained for only 30 % by adjustment on major CHD risk factors ( mainly HDL-cholesterol and tobacco ) . Modifying the intercept in the Framingham model , agreement with estimated risk by the French model was improved from 29 to 80 % . By an appropriate change of the intercept , the Framingham model might be used to estimate CHD risk in other population To develop a simple , patient self-report-based coronary heart disease ( CHD ) risk score for adults without previously diagnosed CHD ( Personal Heart Early Assessment Risk Tool [ HEART ] score ) , the Atherosclerosis Risk In Communities ( ARIC ) Study , a prospect i ve cohort of subjects aged 45 to 64 years at baseline , was used to develop a measure for 10-year risk of CHD ( n = 14,343 ) . Variables evaluated for inclusion were age , history of diabetes mellitus , history of hypercholesterolemia , history of hypertension , family history of CHD , smoking , physical activity , and body mass index . The 10-year risk of CHD events was defined as myocardial infa rct ion , fatal CHD , or cardiac procedure . The new measure was compared with the Framingham Risk Score ( FRS ) and European Systematic Coronary Risk Evaluation ( SCORE ) . The Personal HEART score for men included age , diabetes , hypertension , hypercholesterolemia , smoking , physical activity , and family history . In men , the area under the receiver-operator characteristic curve for predicting 10-year CHD for the Personal HEART score ( 0.65 ) was significantly different from that for the FRS ( 0.69 , p = 0.03 ) , but not for the European SCORE ( 0.62 , p = 0.12 ) . The Personal HEART score for women included age , diabetes , hypertension , hypercholesterolemia , smoking , and body mass index . The area under the curve for the Personal HEART score ( 0.79 ) for women was not significantly different from that for the FRS ( 0.81 , p = 0.42 ) and performed better than the European SCORE ( 0.69 , p = 0.01 ) . In conclusion , the Personal HEART score identifies 10-year risk for CHD based on self-report data , is similar in predictive ability to the FRS and European SCORE , and has the potential for easy self- assessment Objectives To investigate the performance of classic risk factors , and of some new biomarkers , in predicting cardiovascular mortality in very old people from the general population with no history of cardiovascular disease . Design The Leiden 85-plus Study ( 1997 - 2004 ) is an observational prospect i ve cohort study with 5 years of follow-up . Setting General population of the city of Leiden , the Netherl and s. Participants Population based sample of participants aged 85 years ( 215 women and 87 men ) with no history of cardiovascular disease ; no other exclusion criteria . Main measurements Cause specific mortality was registered during follow-up . All classic risk factors included in the Framingham risk score ( sex , systolic blood pressure , total and high density lipoprotein cholesterol , diabetes mellitus , smoking and electrocardiogram based left ventricular hypertrophy ) , as well as plasma concentrations of the new biomarkers homocysteine , folic acid , C reactive protein , and interleukin 6 , were assessed at baseline . Results During follow-up , 108 of the 302 participants died ; 32 % ( 35/108 ) of deaths were from cardiovascular causes . Classic risk factors did not predict cardiovascular mortality when used in the Framingham risk score ( area under receiver operating characteristic curve 0.53 , 95 % confidence interval 0.42 to 0.63 ) or in a newly calibrated model ( 0.53 , 0.43 to 0.64 ) . Of the new biomarkers studied , homocysteine had most predictive power ( 0.65 , 0.55 to 0.75 ) . Entering any additional risk factor or combination of factors into the homocysteine prediction model did not increase its discriminative power . Conclusions In very old people from the general population with no history of cardiovascular disease , concentrations of homocysteine alone can accurately identify those at high risk of cardiovascular mortality , whereas classic risk factors included in the Framingham risk score do not . These preliminary findings warrant validation in a separate cohort Background — Present cardiovascular disease ( CVD ) risk prediction algorithms were developed for a ≤10-year follow up period . Clustering of risk factors at younger ages and increasing life expectancy suggest the need for longer-term risk prediction tools . Methods and Results — We prospect ively followed 4506 participants ( 2333 women ) of the Framingham Offspring cohort aged 20 to 59 years and free of CVD and cancer at baseline examination in 1971–1974 for the development of “ hard ” CVD events ( coronary death , myocardial infa rct ion , stroke ) . We used a modified Cox model that allows adjustment for compet OUTPUT: There is an excess of models predicting incident CVD in the general population . INPUT: Risk prediction for electrocardiographic ( ECG ) left ventricular hypertrophy related criteria , used in clinical trials , and epidemiologic studies of clinical ly healthy people , has depended in the past on dichotomous classification of ECG LVH criteria . Recent analyses have shown that more sensitive methods of LVH ECG classification without loss of specificity are needed to improve on dichotomous classification . This was done by relating six year incident significant change in continuous score criteria of ECG LVH to the 16 year ( 10 year post trial ) coronary heart disease ( CHD ) and cardiovascular disease ( CVD ) mortality among 12,866 men , free of clinical disease , aged 35 to 57 years at baseline in the Multiple Risk Factor Intervention Trial . It was found that significant change in continuous ECG LVH criteria was a stronger independent predictor of future CHD and CVD mortality than was use of dichotomous classification of the same criteria . It was also demonstrated that increase in continuous ECG LVH indexes , below previous dichotomous thresholds independently ( of st and ard CVD risk factors , including increase in obesity-indicated by an increase in adult BMI ) predicted excess CHD and CVD mortality and that combinations of continuous indices increases the specificity and relative risk in clinical ly disease-free middle-aged men 1 . Frei B , Engl and L , Ames BN . Ascorbate is an outst and ing antioxidant in human blood plasma . Proc Natl Acad Sci U S A 1989;86:6377–6381 . 2 . Ting HH , Timimi FK , Boles KS , Creager SJ , Ganz P , Creager MA . Vitamin C improves endothelium-dependent vasodilation in patients with non-insulindependent diabetes mellitus . J Clin Invest 1996;97:22–28 . 3 . Heitzer T , Just H , Munzel T. Antioxidant vitamin C improves endothelial dysfunction in chronic smokers . Circulation 1996;94:6–9 . 4 . Slakey D , Roza A , Pieper G , Johnson C , Adams M. Delayed cardiac allograft rejection due to combined cyclosporine and antioxidant therapy . Transplantation 1993;56:1305–1309 . 5 . Fish RD , Nabel EG , Selwyn AP , Ludmer PL , Mudge GH , Kirshenbaum JM , Schoen FJ , Alex and er RW , Ganz P. Responses of coronary arteries of cardiac transplant patients to acetylcholine . J Clin Invest 1988;81:21–31 . 6 . Davis SF , Yeung AC , Meredith IT , Charbonneau F , Ganz P , Selwyn AP , And erson TJ . Early endothelial dysfunction predicts the development of transplant coronary artery disease at 1 year posttransplant . Circulation 1996;93:457– 462 . 7 . Morrow JD , Roberts LJ II . Mass spectrometric quantification of F2-isoprostanes in biological fluids and tissues as measure of oxidant stress . Methods Enzymol 1999;300:3–12 . 8 . Watanabe H , Kakihana M , Ohtsuka S , Sugishita Y. R and omized , double-blind , placebo-controlled study of ascorbate on the preventive effect of nitrate tolerance in patients with congestive heart failure . Circulation 1998;97:886–891 Key Summary Points Risk prediction models are statistical models used to predict the probability of an outcome on the basis of the values of 1 or more risk factors ( markers ) . The accuracy of the model 's predictions is typically summarized with statistics that describe the model 's discrimination and calibration . Risk stratification tables are a more informative way to assess and compare the models . The tables illustrate the distribution of predictions across risk categories . That illustration allows users to assess 3 key measures of the models ' value for guiding medical decisions : the models ' calibration , ability to stratify people into clinical ly relevant risk categories , and accuracy at classifying patients into higher- and lower-risk categories . This information is contained in the margins of the risk stratification table rather than in its cells . The tables should only be used to compare risk prediction models when one of the models contains all of the markers that are contained in the other ( nested models ) ; they should not be used to compare models with different sets of markers ( nonnested models ) . The table predictions require corrections when casecontrol data are used . The recent epidemiologic and clinical literature is filled with studies evaluating statistical models that predict risk for disease or some other adverse event ( 15 ) . Because risk prediction models are intended to help patients and clinicians make decisions , evaluation of these models requires methods that differ from those used to assess models describing disease etiology . This is because the characteristics of the models are less important than their value for guiding decisions . Cook and colleagues ( 1 , 6 ) recently proposed a new approach to evaluate risk prediction models : a risk stratification table . This methodology appropriately focuses on the key purpose of a risk prediction model , which is to classify individuals into clinical ly relevant risk categories , and it has therefore been widely adopted in the literature ( 24 ) . We examine the risk stratification approach in detail in this article , identifying the relevant information that can be abstract ed from a risk stratification table and caution ing against misuses of the method that frequently occur in practice . We use a recently published study of a breast cancer risk prediction model by Tice and colleagues ( 2 ) to illustrate the concepts . Background A risk prediction marker is any measure that is used to predict a person 's risk for an event . It may be a quantitative measure , such as high-density lipoprotein cholesterol level , or a qualitative measure , such as family history of disease . Risk predictors are also risk factors , in the sense that they will necessarily be strongly associated with the risk for disease . But a large , significant association does OUTPUT:

Evidence on harms was limited , but direct harms seemed minimal ( for resting ECG ) or small ( for exercise ECG ) .

MS2_dynamic_1_shot528

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Aims /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 Meat contains numerous carcinogens , such as heterocyclic amines , polycyclic aromatic hydrocarbons , and N‐nitroso compounds , which can be derived either from natural food or during the process of food preparation . These carcinogens may increase pancreatic cancer risk . Furthermore , studies in animals showed that polyunsaturated fatty acids , especially linoleic acid , increase pancreatic cancer risk . We examined prospect ively the relation between pancreatic cancer risk and intake of fresh meat , processed meat , fish , eggs , total fat , and different types of fat . The Netherl and s Cohort Study consisted of 120,852 men and women who completed a baseline question naire in 1986 . After 13.3 years of follow‐up , 350 pancreatic cancer cases ( 66 % microscopically confirmed ) were available for analysis . A vali date d 150‐item food‐frequency question naire was used to calculate intake of fresh meat , processed meat , fish , eggs , fat and different types of fat . No association was found when examining the association between intake of fresh meat , other types of meat , fish , eggs , dietary intake of total fat and different types of fat and risk of pancreatic cancer . It is important for future studies to investigate the relation between different meat‐cooking methods and pancreatic cancer . © 2009 Case-control studies suggest that meat and cholesterol intakes may be related to elevated risks of pancreatic cancer . Few prospect i ve studies have examined associations between diet and pancreatic cancer , although in one recent study saturated fat consumption was related to higher risk . In a cohort of US women , the authors confirmed 178 pancreatic cancer cases over 18 years of follow-up . A mailed 61-item food frequency question naire was self-administered at baseline , and health and lifestyle variables were up date d biennially . Analyses were performed using Cox proportional hazards models to adjust for potential confounders . Intakes of total fat , different types of fats , and cholesterol were not associated with pancreatic cancer risk . Similarly , total meat , red meat , and dairy products were not related to risk . Individual food items contributing to intakes of total meat and dairy products , as well as fish and eggs , did not reveal any specific association . Updating dietary exposures by using question naires from 1980 , 1984 , 1986 , and 1990 produced similar findings . The authors ' data do not support previous findings that meat or saturated fat intakes are related to pancreatic cancer risk . Future prospect i ve studies should examine the influence of cooking practice s as well as other dietary habits on the risk of pancreatic cancer BACKGROUND Previous research relating dietary fat , a modifiable risk factor , to pancreatic cancer has been inconclusive . METHODS We prospect ively analyzed the association between intakes of fat , fat subtypes , and fat food sources and exocrine pancreatic cancer in the National Institutes of Health-AARP Diet and Health Study , a US cohort of 308 736 men and 216 737 women who completed a 124-item food frequency question naire in 1995 - 1996 . Hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) were calculated using Cox proportional hazards regression models , with adjustment for energy intake , smoking history , body mass index , and diabetes . Statistical tests were two-sided . RESULTS Over an OUTPUT: There was no evidence of publication bias or significant heterogeneity between subgroups on meta-regression analyses . The results of this meta- analysis do not support an independent association between diets high in total fat and pancreatic cancer risk INPUT: OBJECTIVE High intake of trans fatty acids and saturated fatty acids ( SFAs ) is known to increase the risk of coronary heart disease . We studied the effects of diets enriched in various fatty acids on postpr and ial insulinemia and fasting serum levels of lipids and lipoproteins in obese patients with NIDDM . RESEARCH DESIGN AND METHODS Sixteen obese NIDDM patients were studied in a free-living outpatient regimen . After a run-in period , the patients received three different isocaloric diets for 6 weeks using a r and omized crossover design . The patients were instructed to keep the energy intake from carbohydrate and protein constant at 50 and 20 E% ( percent of energy intake ) , respectively , on all three diets . The fat composition of the diets differed : saturated fat ( SAT ) diet ( 20 E% SFAs , 5 E% polyunsaturated fatty acids [ PUFAs ] , and 5 E% monounsaturated fatty acids [ MUFAs ] ) versus cis monounsaturated fatty acid ( CMUFA ) diet ( 20 E% cis-MUFAs , 5 E% PUFAs , and 5 E% SFAs ) versus trans monounsaturated fatty acid ( TMUFA ) diet ( 20 E% trans-MUFAs , 5 E% PUFAs , and 5 E% SFAs ) . Fasting serum levels of lipids and lipoproteins were measured at baseline and in the fasting state before meal tolerance tests at the end of each study period . Insulin secretion was assessed from incremental serum insulin and C-peptide responses during the meal tests . RESULTS BMI , waist-to-hip ratio , and glycemic control remained stable throughout the study . After meal stimulation , postpr and ial glycemic responses were similar on all diets ; however , serum insulin and C-peptide responses were greater following the TMUFA and SAT diets than following the baseline or CMUFA diets ( P < 0.05 ) . No statistical difference was found in fasting levels of serum lipids ( total cholesterol , triglyceride , phospholipid , and nonesterified fatty acids ) or lipoproteins of HDL cholesterol , VLDL cholesterol , LDL cholesterol , and apolipoprotein B between diets . CONCLUSIONS In the presence of unchanged glycemia , both dietary trans fatty acids and SFAs induce an increase in postpr and ial insulinemia in obese patients with NIDDM BACKGROUND Dietary trans fatty acids ( FAs ) , which are formed during the process of hydrogenating vegetable oil , are known to increase plasma LDL-cholesterol concentrations . However , their effect on LDL particle size has yet to be investigated . OBJECTIVE We investigated the effect of trans FA consumption on the electrophoretic characteristics of LDL particles . DESIGN Eighteen women and 18 men each consumed 5 experimental diets in r and om order for 35-d periods . Fat represented 30 % of total energy intake in each diet , with two-thirds of the fat in the form of semiliquid margarine ( 0.6 g trans FAs/100 g fat ) , soft margarine ( 9.4 g trans FAs/100 g fat ) , shortening ( 13.6 g trans FAs/100 g fat ) , stick margarine ( 26.1 g trans FAs/100 g fat ) , or butter , which was low in trans FAs ( 2.6 g trans FAs/100 g fat ) but rich in saturated fat . LDL particle size and distribution were characterized by nondenaturing , 2 - 16 % polyacrylamide gradient gel electrophoresis . RESULTS Relative to the LDL particle size observed after consumption of the butter-enriched diet , LDL particle size decreased significantly and in a dose-dependent fashion with increasing amounts of dietary trans FAs ( P < 0.001 ) . Cholesterol concentrations in large ( > 260 A ) and medium-sized ( 255 - 260 A ) LDL particles also increased proportionately to the amount of trans FAs in the diet . CONCLUSION Consumption of dietary trans FAs is associated with a deleterious increase in small , dense LDL , which further reinforces the importance of promoting diets low in trans FAs to favorably affect the lipoprotein profile BACKGROUND The effect of individual dietary fatty acids on emerging risk factors for cardiovascular disease that are associated with sub clinical inflammation is unknown . OBJECTIVE The goal was to evaluate the role of dietary fat and specific fatty acids , especially trans fatty acids , in altering concentrations of markers of inflammation in humans fed controlled diets . DESIGN In a r and omized crossover design , 50 men consumed controlled diets for 5 wk that provided 15 % of energy from protein , 39 % of energy from fat , and 46 % of energy from carbohydrate . Eight percent of fat or fatty acids was replaced across diets with the following : cholesterol , oleic acid , trans fatty acids ( TFAs ) , stearic acid ( STE ) , TFA+STE ( 4 % of energy each ) , and 12:0 - 16:0 saturated fatty acids ( LMP ) . RESULTS Fibrinogen concentrations were higher after consumption of the diet enriched in stearic acid than after consumption of the carbohydrate diet . C-reactive protein concentrations were higher after consumption of the TFA diet than after consumption of the carbohydrate diet , but were not significantly different after consumption of the TFA and TFA+STE diets than after consumption of the LMP diet . Interleukin 6 concentrations were lower after consumption of the OUTPUT:

RESULTS Increased TFA intake did not result in significant changes in glucose or insulin concentrations . Our analysis also showed the absence of publication bias and any dose-response relations between the ES and TFA intake . Increased TFA intake does not result in changes in glucose , insulin , or triglyceride concentrations but leads to an increase in total and LDL-cholesterol and a decrease in HDL-cholesterol concentrations . There is no evidence to support a potential benefit of the reduction of dietary TFA intake on glucose homeostasis

MS2_dynamic_1_shot529

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract Objective : To evaluate the effect of simultaneous zinc and vitamin A supplementation on diarrhoea and acute lower respiratory infections in children . Study design : R and omised double blind placebo controlled trial . Setting : Urban slums of Dhaka , Bangladesh . Participants and methods : 800 children aged 12 - 35 months were r and omly assigned to one of four intervention groups : 20 mg zinc once daily for 14 days ; 200 000 IU vitamin A , single dose on day 14 ; both zinc and vitamin A ; placebo . The children were followed up once a week for six months , and morbidity information was collected . Results : The incidence and prevalence of diarrhoea were lower in the zinc and vitamin A groups than in the placebo group . Zinc and vitamin A interaction had a rate ratio ( 95 % confidence interval ) of 0.79 ( 0.66 to 0.94 ) for the prevalence of persistent diarrhoea and 0.80 ( 0.67 to 0.95 ) for dysentery . Incidence ( 1.62 ; 1.16 to 2.25 ) and prevalence ( 2.07 ; 1.76 to 2.44 ) of acute lower respiratory infection were significantly higher in the zinc group than in the placebo group . The interaction term had rate ratios of 0.75 ( 0.46 to 1.20 ) for incidence and 0.58 ( 0.46 to 0.73 ) for prevalence of acute lower respiratory infection . Conclusions : Combined zinc and vitamin A synergistically reduced the prevalence of persistent diarrhoea and dysentery . Zinc was associated with a significant increase in acute lower respiratory infection , but this adverse effect was reduced by the interaction between zinc and vitamin A. What is already known on this topic Trials of vitamin A supplementation have failed to show a beneficial effect on morbidity in children Experimental studies have shown that , in the presence of zinc deficiency , vitamin A supplementation fails to reverse vitamin A deficiency Coexistence of deficiencies of zinc and vitamin A could be a reason for the failure of vitamin A supplementation , but data in humans are limited What this paper adds Combined zinc and vitamin A supplementation is more effective in reducing persistent diarrhoea and dysentery than either vitamin A or zinc alone Zinc alone increased respiratory illnesses , but interaction between zinc and vitamin A reduced this adverse OBJECTIVE . The purpose of this work was to evaluate whether education about zinc supplements and provision of zinc supplements to caregivers is effective in the treatment of acute diarrhea and whether this strategy adversely affects the use of oral rehydration salts . PATIENTS AND METHODS . Six clusters of 30 000 people each in Haryana , India , were r and omly assigned to intervention and control sites . Government and private providers and village health workers were trained to prescribe zinc and oral rehydration salts for use in diarrheal episodes in 1-month-old to 5-year-old children in intervention communities ; in the control sites , oral rehydration salts alone was promoted . In 2 cross-sectional surveys commencing 3 months ( survey 2 ) and 6 months ( survey 3 ) after the start of the intervention , care-seeking behavior , drug therapy , and oral rehydration salts use during diarrhea , diarrheal and respiratory morbidity , and hospitalization rates were measured . RESULTS . In the 2 surveys , zinc was used in 36.5 % ( n = 1571 ) and 59.8 % ( n = 1649 ) and oral rehydration salts in 34.8 % ( n = 1571 ) and 59.2 % ( n = 1649 ) of diarrheal episodes occurring in the 4 weeks preceding interviews in the intervention areas . In control areas , oral rehydration salts were used in 7.8 % ( n = 2209 ) and 9.8 % ( n = 2609 ) of episodes . In the intervention communities , care seeking for diarrhea reduced by 34 % ( survey 3 ) , as did the prescription of drugs of unknown identity ( survey 3 ) and antibiotics ( survey 3 ) for diarrhea . The 24-hour prevalences of diarrhea and acute lower respiratory infections were lower in the intervention communities ( survey 3 ) . All-cause , diarrhea , and pneumonia hospitalizations in the preceding 3 months were reduced in the intervention compared with control areas ( survey 3 ) . CONCLUSIONS . Diarrhea is more effectively treated when caregivers receive education on zinc supplementation and have ready access to supplies of oral rehydration salts and zinc , and this approach does not adversely affect the use of oral rehydration salts ; in fact , it greatly increases use of the same Objective Oral rehydration solution remains the mainstay of acute gastroenteritis therapy . The aim of this study was to investigate the acceptability of a new zinc-containing hypotonic super-oral rehydration solution ( ORS ) in a gel formulation and its efficacy in reducing the duration and severity of diarrhea in children . Methods This was a r and omized-controlled trial of children ( 5–36 months of age ) observed for diarrhea lasting less than 24 h. Children were r and omized to receive st and ard hypotonic ORS ( group 1 ) or a gel hypotonic super-ORS containing zinc ( group 2 ) . The main study outcome was ORS intake in the first 24 h. ORS intake at 4 h , rate of diarrhea resolution at 72 h of treatment , total duration and severity of diarr OUTPUT: Authors ' conclusions In areas where the prevalence of zinc deficiency or the prevalence of malnutrition is high , zinc may be of benefit in children aged six months or more . The current evidence does not support the use of zinc supplementation in children less six months of age , in well‐nourished children , and in setting s where children are at low risk of zinc deficiency . INPUT: Objective To investigate the impact of zinc supplementation in children with cholera . Design Double blind , r and omised , placebo controlled trial . Setting Dhaka Hospital , Bangladesh . Participants 179 children aged 3 - 14 years with watery diarrhoea and stool dark field examination positive for Vibrio cholerae and confirmed by stool culture . Intervention Children were r and omised to receive 30 mg elemental zinc per day ( n=90 ) or placebo ( n=89 ) until recovery . All children received erythromycin suspension orally in a dose of 12.5 mg/kg every six hours for three days . Main outcome measures Duration of diarrhoea and stool output . Results 82 children in each group completed the study . More patients in the zinc group than in the control group recovered by two days ( 49 % v 32 % , P=0.032 ) and by three days ( 81 % v 68 % , P=0.03 ) . Zinc supplemented patients had 12 % shorter duration of diarrhoea than control patients ( 64.1 v 72.8 h , P=0.028 ) and 11 % less stool output ( 1.6 v 1.8 kg/day , P=0.039 ) . Conclusion Zinc supplementation significantly reduced the duration of diarrhoea and stool output in children with cholera . Children with cholera should be supplemented with zinc to reduce its duration and severity . Trial registration Clinical trials NCT00226616 OBJECTIVE To evaluate the efficacy and safety of zinc in the treatment of acute gastroenteritis ( AGE ) in children in Pol and . STUDY DESIGN Children aged 3 to 48 months with AGE were enrolled in a r and omized , double-blind , placebo-controlled trial in which they received zinc sulfate ( 10 or 20 mg/day depending on age ) or placebo for 10 days . A total of 141 of 160 children recruited were available for intention-to-treat analysis . The primary outcome was the duration of diarrhea . RESULTS In the experimental group ( n = 69 ) compared with the control group ( n = 72 ) , there was no significant difference in the duration of diarrhea ( P > .05 ) . Similarly , there was no significant difference in the groups in secondary outcome measures such as stool frequency on days 1 , 2 , and 3 , vomiting frequency , intravenous fluid intake , and the number of children with diarrhea lasting > 7 days . CONCLUSION Children living in a country where zinc deficiency is rare do not appear to benefit from the use of zinc in the treatment of AGE OBJECTIVE To compare the clinical efficacy of supplementation of zinc , zinc plus vitamin A , and zinc plus combination of micronutrients and vitamins ( iron , copper , selenium , vitamin B(12 ) , folate , and vitamin A ) on acute diarrhea in children . STUDY DESIGN This was a double-blind , r and omized , placebo-controlled trial . Children aged 6 to 24 months with diarrhea and moderate dehydration were r and omized to receive zinc plus placebo vitamin A ( group 1 ) , zinc plus other micronutrients plus vitamin A ( group 2 ) , zinc plus vitamin A ( group 3 ) , or placebo ( group 4 ) as an adjunct to oral rehydration solution . Duration , volume of diarrhea , and consumption of oral rehydration solution were compared as outcome variables within the supplemented groups and with the placebo group . RESULTS The 167 study subjects included 41 in group 1 , 39 in group 2 , 44 in group 3 , and 43 in group 4 . All 3 supplemented groups demonstrated a significant reduction in outcome variables ( P < .0001 ) compared with the placebo group . Group 3 had the lowest reduction of outcome variables and group 2 had a speedy recovery , but differences among the supplemented groups were not statistically significant . CONCLUSIONS Supplementation with a combination of micronutrients and vitamins was not superior to zinc alone , confirming the clinical benefit of zinc in children with diarrhea Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year , 35 % of which are due to acute diarrhea . Zinc and copper stores in the body are known to be depleted during acute diarrhea . Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with st and ard treatment to children with acute watery or bloody diarrhea . Methods We conducted a double-blind r and omized controlled clinical trial in the Department of Pediatrics at Indira G and hi Government Medical College Nagpur , India . Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually r and omized to placebo ( Pl ) , zinc ( Zn ) only , and zinc and copper ( Zn+Cu ) together with st and ard treatment for acute diarrhea . Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams , respectively , and there were no significant differences in the adjusted means across treatment groups . Similarly , the adjusted means of the amount of oral rehydration solution or intravenous fluids used , the proportion of participants with diarrhea more than 7 days from onset , and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment , did not differ across the three groups . Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed . Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children . Trial registration The study was registered as OUTPUT:

Diarrhea prevalence on days 3 , 5 , and 7 was lower in the zinc group . The incidence of vomiting was significantly greater in the group that received zinc than in the control group . CONCLUSIONS Oral zinc supplementation significantly decreases diarrhea duration and has a greater effect on malnourished children .

MS2_dynamic_1_shot530

***TASK*** the task is to summarize an input biomedical literature 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 determine the incidence of major bleeding in out patients treated with warfarin and to identify predictive factors known at the start of therapy . PATIENTS AND METHODS The records of 565 patients starting outpatient therapy with warfarin upon discharge from a university hospital were review ed . Follow-up information was obtained for 562 patients ( 99.5 % ) . Bleeding was classified as major or minor using explicit criteria . The cumulative incidence of bleeding was estimated by means of survival analysis . Independent risk factors for major bleeding were identified using Cox regression analysis in 375 r and omly chosen patients ; they were tested in the remaining 187 patients . RESULTS Major bleeding occurred in 65 patients ( 12 % ) and was fatal in 10 patients ( 2 % ) . The cumulative incidences of major bleeding at one , 12 , and 48 months were 3 % , 11 % , and 22 % , respectively . The monthly risk of major bleeding decreased over time , from 3 % during the first month of outpatient therapy to 0.3 % per month after the first year of therapy . Five independent risk factors for major bleeding -- age 65 years or greater , history of stroke , history of gastrointestinal bleeding , a serious comorbid condition ( recent myocardial infa rct ion , renal insufficiency , or severe anemia ) , atrial fibrillation -- predicted major bleeding in the testing group ; the cumulative incidence of major bleeding at 48 months was 2 % in 57 low-risk patients , 17 % in 110 middle-risk patients , and 63 % in 20 high-risk patients . CONCLUSION These findings provide a quantitative basis for evaluating the risk of major bleeding in individual patients at the start of outpatient therapy with warfarin . Whether the risk of bleeding can be reduced in high-risk patients without reducing the benefit of therapy remains to be determined BACKGROUND The Outpatient Bleeding Risk Index ( BRI ) prospect ively classified patients who were at high , intermediate , or low risk for warfarin-related major bleeding . However , there are only 2 published validation studies of the index and neither included veterans . OBJECTIVE To determine the accuracy of the BRI in patients attending a Veterans Affairs ( VA ) anticoagulation clinic and to specifically evaluate the accuracy of the BRI in patients with atrial fibrillation . DESIGN Retrospective cohort study . PATIENTS AND MEASUREMENTS Using the BRI , all patients managed by the Anticoagulation Clinic between January 1 , 2001 and December 31 , 2002 were classified as high , intermediate , or low risk for major bleeding . Bleeds were identified via quality -assurance reports . Poisson regression was used to determine whether there was an association between the index and the development of bleeding . RESULTS The rate of major bleeding was 10.6 % , 2.5 % , and 0.8 % per patient-year of warfarin in the high- , intermediate- , and low-risk groups , respectively . Patients in the high-risk category had 14 times the rate of major bleeding of those in the low-risk group ( incidence rate ratio ( IRR ) 14 ; 95 % confidence interval ( CI ) , 1.9 to 104.7 ) . The rate of major bleeding was significantly different between the high- and intermediate-risk categories ( P<.001 ) . Among those with atrial fibrillation , patients in the high-risk category had 6 times the major bleeding rate of those in the intermediate- and low-risk groups combined ( IRR=6 ; 95 % CI , 2.4 to 15.3 ) . CONCLUSIONS The BRI discriminates between high- and intermediate-risk patients in a VA anticoagulation clinic , including those with atrial fibrillation PURPOSE To evaluate the accuracy and clinical utility of the Outpatient Bleeding Risk Index for estimating the probability of major bleeding in out patients treated with warfarin . The index was previously derived in a retrospective cohort of 556 patients from a different hospital ( derivation cohort ) . SUBJECTS AND METHODS We enrolled 264 out patients starting warfarin ( validation cohort ) to vali date the index prospect ively . All patients were identified upon hospital discharge , and physician estimates of the probability of major bleeding were obtained before discharge in the validation cohort . RESULTS Major bleeding occurred in 87 of 820 out patients ( 6.5%/yr ) . The index included four independent risk factors for major bleeding : age 65 years or greater ; history of gastrointestinal bleeding ; history of stroke ; and one or more of four specific comorbid conditions . In the validation cohort , the index predicted major bleeding : the cumulative incidence at 48 months was 3 % in 80 low-risk patients , 12 % in 166 intermediate-risk patients , and 53 % in 18 high-risk patients ( c index , 0.78 ) . The index performed better than physicians , who estimated the probability of major bleeding no better than expected by chance . Of the 18 episodes of major bleeding that occurred in high-risk patients , 17 were potentially preventable . CONCLUSIONS The Outpatient Bleeding Risk Index prospect ively classified patients according to risk of major bleeding and performed better than physicians . Major bleeding may be preventable in many high-risk patients by avoidance of over-anticoagulation and nonsteroidal anti-inflammatory agents This article concerning the pharmacokinetics and pharmacodynamics of vitamin K antagonists ( VKAs ) is part of the American College of Chest Physicians Evidence -Based Clinical Practice Guidelines ( 8th Edition ) . It describes the antithrombotic effect of the VKAs , the monitoring of anticoagulation intensity , and the clinical applications of VKA therapy and provides specific management recommendations . Grade 1 recommendations are strong and indicate that the benefits do or do not outweigh the ris OUTPUT: A RIETE score of 0 point was moderately predictive of the absence of major bleeding . None of the CPRs exhibited sufficient predictive accuracy or had sufficient validation to be recommended for routine use in practice . None of the available CPRs exhibit sufficient predictive accuracy or have trials evaluating the impact of their use on patient outcomes . INPUT: PURPOSE To determine the incidence of major bleeding in out patients treated with warfarin and to identify predictive factors known at the start of therapy . PATIENTS AND METHODS The records of 565 patients starting outpatient therapy with warfarin upon discharge from a university hospital were review ed . Follow-up information was obtained for 562 patients ( 99.5 % ) . Bleeding was classified as major or minor using explicit criteria . The cumulative incidence of bleeding was estimated by means of survival analysis . Independent risk factors for major bleeding were identified using Cox regression analysis in 375 r and omly chosen patients ; they were tested in the remaining 187 patients . RESULTS Major bleeding occurred in 65 patients ( 12 % ) and was fatal in 10 patients ( 2 % ) . The cumulative incidences of major bleeding at one , 12 , and 48 months were 3 % , 11 % , and 22 % , respectively . The monthly risk of major bleeding decreased over time , from 3 % during the first month of outpatient therapy to 0.3 % per month after the first year of therapy . Five independent risk factors for major bleeding -- age 65 years or greater , history of stroke , history of gastrointestinal bleeding , a serious comorbid condition ( recent myocardial infa rct ion , renal insufficiency , or severe anemia ) , atrial fibrillation -- predicted major bleeding in the testing group ; the cumulative incidence of major bleeding at 48 months was 2 % in 57 low-risk patients , 17 % in 110 middle-risk patients , and 63 % in 20 high-risk patients . CONCLUSION These findings provide a quantitative basis for evaluating the risk of major bleeding in individual patients at the start of outpatient therapy with warfarin . Whether the risk of bleeding can be reduced in high-risk patients without reducing the benefit of therapy remains to be determined OBJECTIVES We sought to evaluate the relation between warfarin anticoagulation and survival and morbidity from cardiac disease in patients with left ventricular ( LV ) dysfunction . BACKGROUND Warfarin anticoagulation plays a major role in the management of patients who have had a large myocardial infa rct ion and in those with atrial fibrillation . However , its use in patients with LV systolic dysfunction has been controversial . METHODS We review ed data on warfarin use in 6,797 patients enrolled in the Studies of Left Ventricular Dysfunction ( SOLVD ) trial and analyzed the relation between warfarin use and all-cause mortality , as well as the combined end point of death or hospital admission for heart failure . We used Cox regression to adjust for differences in baseline characteristics and to test for the interaction between warfarin use and selected patient variables in relation to outcome . RESULTS On multivariate analysis , use of warfarin was associated with a significant reduction in all-cause mortality ( adjusted hazard ratio [ HR ] 0.76 , 95 % confidence interval [ CI ] 0.65 to 0.89 , p = 0.0006 ) and in the risk of death or hospital admission for heart failure ( HR 0.82 , 95 % CI 0.72 to 0.93 , p = 0.0002 ) . Risk reduction was observed when each trial or r and omization arm was analyzed separately , as well as in both genders . It was not significantly influenced by the presence of atrial fibrillation , age , ejection fraction , New York Heart Association functional class or etiology . CONCLUSIONS In patients with LV systolic dysfunction , warfarin use is associated with improved survival and reduced morbidity . This association is primarily due to a reduction in cardiac events and does not appear to be limited to any particular subgroup BACKGROUND In patients who have had a myocardial infa rct ion , the long-term risk of stroke and its relation to the extent of left ventricular dysfunction have not been determined . We studied whether a reduced left ventricular ejection fraction is associated with an increased risk of stroke after myocardial infa rct ion and whether other factors such as older age and therapy with anticoagulants , thrombolytic agents , or captopril affect long-term rates of stroke . METHODS We performed an observational analysis of prospect ively collected data on 2231 patients who had left ventricular dysfunction after acute myocardial infa rct ion who were enrolled in the Survival and Ventricular Enlargement trial . The mean follow-up was 42 months . Risk factors for stroke were assessed by both univariate and multivariate Cox proportional-hazards analysis . RESULTS Among these patients , 103 ( 4.6 percent ) had fatal or nonfatal strokes during the study ( rate of stroke per year of follow-up , 1.5 percent ) . The estimated five-year rate of stroke in all the patients was 8.1 percent . As compared with patients without stroke , patients with stroke were older ( mean [ + /-SD ] age , 63+/-9 years vs. 59+/-11 years ; P<0.001 ) and had lower ejection fractions ( 29+/-7 percent vs. 31+/-7 percent , P=0.01 ) . Independent risk factors for stroke included a lower ejection fraction ( for every decrease of 5 percentage points in the ejection fraction there was an 18 percent increase in the risk of stroke ) , older age , and the absence of aspirin or anticoagulant therapy . Patients with ejection fractions of < or = 28 percent after myocardial infa rct ion had a relative risk of stroke of 1.86 , as compared with patients with ejection fractions of more than 35 percent ( P=0.01 ) . The use of thrombolytic agents and captopril had no significant effect on the risk of stroke . CONCLUSIONS During the five years after myocardial infa rct ion , patients have a substantial risk of stroke . A decreased ejection fraction and older age are both independent predict OUTPUT:

Limited evidence from r and omized trials and observational studies found a reduction in mortality and cardiovascular events with anticoagulants compared to controls . Although oral anticoagulation is indicated in certain groups of patients with heart failure ( e.g. atrial fibrillation ) , the available data do not support its routine use in heart failure patients who remain in sinus rhythm

MS2_dynamic_1_shot531

***TASK*** the task is to summarize an input biomedical literature 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 Delays and deficits in joint attention and symbolic play constitute two important developmental problems in young children with autism . These areas of deficit have been well studied in autism but have rarely been the focus of treatment efforts ( see Kasari , Freeman , & Paparella , 2001 ) . In this study , we examine the efficacy of targeted interventions of joint attention and symbolic play . METHODS Participants were 58 children with autism aged 3 and 4 years ( 46 boys ) . Children were r and omized to a joint attention intervention , a symbolic play intervention , or control group . Interventions were conducted 30 minutes daily for 5 - 6 weeks . Both structured assessment s of joint attention and play skills and mother-child interactions were collected pre and post intervention by independent assessors . RESULTS Results indicate that both intervention groups improved significantly over the control group on certain behaviors . Children in the joint attention intervention initiated significantly more showing and responsiveness to joint attention on the structured joint attention assessment and more child-initiated joint attention in the mother-child interaction . The children in the play group showed more diverse types of symbolic play in interaction with their mothers and higher play levels on both the play assessment and in interaction with their mothers . CONCLUSIONS This r and omized controlled trial provides promising data on the specificity and generalizability of joint attention and play interventions for young children with autism . Future studies need to examine the long-term effects of these early interventions on children 's development Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results This study follows 40 children who were participants in a r and omized controlled early intervention trial ( Kasari et al. ) from early childhood ( 2–5 years of age ) to elementary school age ( 8–10 years ) . To fully utilize the available longitudinal data , the general linear mixed model was the primary analytical approach . The growth trajectories of joint attention skills ( pointing , coordinated joint looking , and showing ) and expressive language outcomes in these children were estimated based on five time points during the measurement period . The children were grouped by diagnosis at the last follow‐up ( autism , autism spectrum disorder ( ASD ) , no diagnosis ) and by their original treatment group assignment ( joint attention , symbolic play , control ) , and differences between these groups were evaluated . Results showed that joint attention skills of coordinated joint looking and showing increased over time , and pointing to share interest increased over the first year measured and decreased thereafter . These trajectories were influenced by both original treatment assignment and diagnostic status at follow‐up . In addition , a cross‐lagged panel analysis revealed a causal relationship between early pointing and later language development . This study highlights the longitudinal and developmental importance of measures of early core deficits in autism , and suggests that both treatment and ASD symptomatology may influence growth in these skills over time . Autism Res 2014 , 7 : 207–215 . © 2014 International Society for Autism Research , Wiley Periodicals , We evaluated a more-to-less , child-directed continuum of interventions to increase toy play among toddlers with multiple disabilities in an inclusive classroom . In keeping with recommended practice s in early intervention , all procedures were conducted within the toddlers ' classroom . Following initial observations of three toddlers ( under 3 years of age ) that indicated toy play was less frequent than that of their typically developing peers , preference assessment s were conducted of selected toys . The toddlers were then provided with repeated choices of preferred toys in a child-directed manner . Two of the toddlers subsequently received staff prompts and praise for toy play , representing a less child-directed ( i.e. , more staff-directed ) intervention component , in addition to choices of preferred toys . Overall , toy play as well as nonprompted toy play increased for one toddler during the former condition and for two toddlers during the latter condition . For two of the toddlers , toy play increased to a level commensurate with that of their classmates who did not have disabilities . Small increases also occurred in the number of toys played with by each toddler . Results are discussed in terms of how intervention procedures can be applied along a more- to less- OUTPUT: Overall , the identified studies demonstrated positive outcomes , although quality and rigor limited interpretations of the outcomes . Our results should be interpreted with caution given previous review s of play intervention studies identified strong outcomes and quality from group- design studies . INPUT: BACKGROUND Delays and deficits in joint attention and symbolic play constitute two important developmental problems in young children with autism . These areas of deficit have been well studied in autism but have rarely been the focus of treatment efforts ( see Kasari , Freeman , & Paparella , 2001 ) . In this study , we examine the efficacy of targeted interventions of joint attention and symbolic play . METHODS Participants were 58 children with autism aged 3 and 4 years ( 46 boys ) . Children were r and omized to a joint attention intervention , a symbolic play intervention , or control group . Interventions were conducted 30 minutes daily for 5 - 6 weeks . Both structured assessment s of joint attention and play skills and mother-child interactions were collected pre and post intervention by independent assessors . RESULTS Results indicate that both intervention groups improved significantly over the control group on certain behaviors . Children in the joint attention intervention initiated significantly more showing and responsiveness to joint attention on the structured joint attention assessment and more child-initiated joint attention in the mother-child interaction . The children in the play group showed more diverse types of symbolic play in interaction with their mothers and higher play levels on both the play assessment and in interaction with their mothers . CONCLUSIONS This r and omized controlled trial provides promising data on the specificity and generalizability of joint attention and play interventions for young children with autism . Future studies need to examine the long-term effects of these early interventions on children 's development Abstract The study of mediation of treatment effects , or how treatments work , is important to underst and ing and improving psychological and behavioral treatments , but applications often focus on mediators and outcomes measured at a single time point . Such cross-sectional analyses do not respect the implied temporal ordering that mediation suggests . Clinical trials of treatments often provide repeated measures of outcomes and , increasingly , of mediators as well . Repeated measurements allow the application of various types of longitudinal structural equation mediation models . These provide flexibility in modeling , including the ability to incorporate some types of measurement error and unmeasured confounding that can strengthen the robustness of findings . The usual approach is to identify the most theoretically plausible model and apply that model . In the absence of clear theory , we put forward the option of fitting a few theoretically plausible models , providing a type of sensitivity analysis for the mediation hypothesis . In this tutorial , we outline how to fit several longitudinal mediation models , including simplex , latent growth and latent change models . This will allow readers to learn about one type of model that is of interest , or about several alternative models , so that they can take this sensitivity approach . We use the Pacing , Grade d Activity , and Cognitive Behavioral Therapy : A R and omized Evaluation ( PACE ) trial of rehabilitative treatments for chronic fatigue syndrome ( IS RCT N 54285094 ) as a motivating example and describe how to fit and interpret various longitudinal mediation models using simulated data similar to those in the PACE trial . The simulated data set and Mplus code and output are provided This study aim ed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism . The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later . Compared to caregivers and toddlers r and omized to the waitlist control group the immediate treatment ( IT ) group made significant improvements in targeted areas of joint engagement . The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention . These are among the first r and omized controlled data to suggest that short-term parent-mediated interventions can have important effects on core impairments in toddlers with autism . Clinical Trials # : NCT00065910 In 2002 , the National Institutes of Health sponsored a meeting concerning method ological challenges of research in psychosocial interventions in Autism Spectrum Disorders . This paper provides a summary of the presentations and the discussion s that occurred during this meeting . Recommendations to federal and private agencies included the need for r and omized clinical trials of comprehensive interventions for autism as the highest , but not the sole priority . Ongoing working groups were proposed to address psychosocial interventions with a focus on relevant statistics , st and ardized documentation and methods of diagnosis , development of outcome measures , establishment of st and ards in research ; and the need for innovative treatment design s , including application of design s from other research areas to the study of interventions in ASD Objective : To evaluate the effectiveness of the Play and Language for Autistic Youngsters ( PLAY ) Project Home Consultation model , in combination with usual community services ( CS ) , to improve parent-child interaction , child development , and autism symptomatology in young children with autism spectrum disorders ( ASDs ) compared with CS only . Methods : Children ( N = 128 ) with autism or PDD-NOS ( DSM-4 criteria ) aged 2 years 8 months to 5 years 11 months and recruited from 5 disability agencies in 4 US states were r and omized in two 1-year cohorts . Using videotape and written feedback within a developmental framework , PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction . CS included speech/ language and occupational therapy and public education services . Primary outcomes included change in parent-child interactions , language and development , and autism-related diagnostic category/symptoms . Secondary outcomes included parent stress and depression and home consultant fidelity . Data were collected pre- and post-intervention . Results : Using intent-to-treat analysis ( ITT ) , large treatment effects were evident for parent and child interactional behaviors on the Maternal and Child Behavior Rating Scales . Child language and developmental quotient did not differ over time by group , although functional development improved significantly . PLAY children improved in diagnostic categories on the Autism Diagnostic Observation Schedule ( ADOS ) . PLAY caregivers ' stress did not increase , and depressive symptomatology decreased . Home consultants OUTPUT:

The findings did not support the widely reported generalisation ' difficulties ' associated with autism .

MS2_dynamic_1_shot532

***TASK*** the task is to summarize an input biomedical literature 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 study was to evaluate the efficacy of endosurgery for generalized appendiceal peritonitis in children . Laparoscopic appendectomy ( LA ) was used as a procedure of choice in all forms of peritonitis and its complications . Original three-trocar approach and modified Gotz technique were applied . From 1991 to 2002 LA was performed in 4024 children aged from 7 days to 16 years , in 298 ( 5.8 % ) patients generalized peritonitis was diagnosed current . Prospect i ve comparative r and omized study includes 200 patients with generalized appendicular peritonitis . Contraindications were in 7 % cases , rate of conversion to open surgery--2.1 % . Duration of surgery was 61.7 + /- 24 min in laparoscopic group ( LG ) vs 73.2 + /- 31 min in open surgery group ( OG ) . Patients of LG demonstrated earlier repair of many functions . There were no lethal outcomes . Rate of minor surgical complications was 10 % in LG and 21 % in OG ( p < 0.05 ) , major complications--13 and 16 % ( p = 0.55 ) , respectively . There was no difference in rate of abscess formation ( 4 % ) . Rate of pneumonia was 1 % in LG and 3 % in OG ( p < 0.05 ) , rate of critical conditions--2 and 4 % ( p = 0.067 ) . Hospital stay was 15.7 + /- 3.1 days in LG and 21.2 + /- 3.8 days in OG . It is concluded that laparoscopic approach could be successfully used in more than 90 % cases of generalized appendicular peritonitis . Endosurgery has many advantages over open surgery . LA demonstrates the best benefits in generalized peritonitis OBJECTIVE . The role of laparoscopic surgery in pediatric inguinal hernia repair is unclear . We aim ed to compare day-case laparoscopic hernia repair with open repair . METHODS . A prospect i ve , single-blinded r and omized study in children aged 4 months to 16 years with unilateral inguinal hernia was performed . The primary outcome measure was the time to normal daily activities after surgery . Secondary outcome measures included postoperative pain , time in the operation room , results , and complications . RESULTS . Eighty-nine patients were enrolled ( laparoscopic hernia repair : 47 , open repair : 42 ) . The mean number of days to normal activity after laparoscopic hernia repair and open repair was 2.4 and 2.5 , respectively . Thirty-seven ( 79 % ) patients with laparoscopic hernia repair and 20 ( 42 % ) with open repair required rescue analgesia postoperatively . The median pain score in the second postoperative morning was significantly higher after laparoscopic hernia repair . The median times in the operation room for laparoscopic hernia repair and open repair were 63 and 38 minutes , respectively . Surgical and cosmetic results were similar at up to 2 years ' follow-up . CONCLUSIONS . Recovery and outcome were similar after open repair and laparoscopic hernia repair in children . Laparoscopic hernia repair was associated with increased theater time and postoperative pain Although laparoscopic procedures are currently in vogue in general surgery , the role of this approach in children has not been prospect ively evaluated in the United States using the new instrumentation now available to us . To assess the value of laparoscopic appendectomy ( LA ) in childhood , we prospect ively compared 14 LAs with 50 open appendectomies ( OA ) over 6 months in a single children 's hospital . Antibiotic usage was at the discretion of the surgeon regardless of the procedure performed and was not different between groups . LA was performed under the direction of a single laparoscopy-trained surgeon and patient selection was based on parental consent . A three-puncture LA technique was used ; children from this group were allowed to return to full activities as soon as they were comfortable . There were no significant differences between groups for severity of disease , age , weight , hospital cost , or complications . The types of complications that developed were comparable in both groups . The percent of complicated appendicitis ( gangrene or perforation ) was 32 % in the OA group and 36 % in the LA group . Patients in the LA group spent significantly fewer days in the hospital and returned to unrestricted activities ( school , athletics , etc ) faster than patients in the OA group . LA is approximately $ 1,000 more expensive than OA , the differences being easily explainable by the cost of the disposable supplies necessary for the procedure ( laser fibers , trocars , etc ) , but because of the shorter hospital stay in the LA group the mean total cost for each group was comparable . These data suggest that although there appears to be no cost advantage , LA shortens the hospital stay and allows children to return to unrestricted activity sooner than OA . ( ABSTRACT TRUNCATED AT 250 WORDS Background : The aim of this study was to evaluate prospect ively whether laparoscopic ( LA ) and open appendectomy ( OA ) are equally safe and feasible in the treatment of pediatric appendicitis . Methods : A total of 517 children with acute appendicitis were r and omly assigned to undergo LA or OA appendectomy , based on the schedule of the attending surgeon on call . Patient age , sex , postoperative diagnosis , operating time , level of training of surgical resident , length of postoperative hospitalization , and minor and major postoperative complications were recorded . Chi-square analysis and the Student t-test were used for statistical analysis . Results : In all , 376 OA and 141 LA were performed . The two groups were comparable in terms of patient demographics and the incidence of perforated appendicitis . The operative time was also similar ( 47.3 ± 19. OUTPUT: Total hospital costs of the laparoscopic approaches were found to be insignificantly increased compared to the open techniques . This review further supports the use of minimally invasive surgery ( MIS ) in pediatric population s , demonstrating that the three types laparoscopic procedures review ed result ed in better patient outcomes compared to open procedures , in the form of reduced LOS and overall complication rates . Increased utilization of this approach may prove beneficial to pediatric patients INPUT: A total of 231 children with acute appendicitis were treated at our hospitals during the 10 years between 1984 and 1993 , 53 of whom had a perforated appendix . These 53 patients were r and omly assigned to two groups at the time of surgery according to the different procedures performed . Thus , 29 children were managed by appendectomy followed by peritoneal lavage using a large amount of saline , and intravenous antibiotic therapy consisting of aminoglycoside and cephem ( lavage group ) , while the other 24 children were treated by appendectomy with silicon tube drainage and the same systemic antibiotic therapy ( drainage group ) . The mean length of hospitalization , and the mean duration s of fever and the need for fasting after laparotomy in the lavage group were significantly less than those in the drainage group : 10.1 versus 18.8 days , 2.8 versus 7.7 days , and 1.8 versus 3.5 days , respectively . The operation wounds healed well in the lavage group due to the fact that there was no drain . Wound infections occurred in two children from the lavage group and six from the drainage group . Intra-abdominal abscesses occurred in two children from the drainage group . Accordingly , peritoneal lavage appears to be superior to intraperitoneal tube drainage for the management of perforated appendicitis in children PURPOSE / BACKGROUND In this study , we aim ed to evaluate the effect of peritoneal drainage ( PD ) on postoperative infective complications in cases with perforated appendicitis . METHOD One hundred nine patients ( with PD ) were evaluated retrospectively and 117 cases ( with no drainage [ ND ] ) were evaluated prospect ively regarding complications like wound infection ( WI ) , intraabdominal abscess ( IAA ) , and small bowel obstruction caused by adhesions ( SBO ) in perforated appendicitis cases . The abdomen was irrigated with isotonic NaCl solution and the wounds were closed primarily in all patients . RESULTS The total number of patients was 226 ( male , 66.4 % ; female , 33.6 % ) , with a mean age of 8.6 + /- 3.4 years ( range , 1 - 15 years ) . The WI rates in PD and ND groups were 28.4 % to 16.2 % , respectively . The ratio of IAA in the PD group was 12.8 % which decreased to 3.4 % in the ND group . The difference was statistically significant ( P < .05 ) . The postoperative hospitalization period in the PD and ND groups were 10.2 + /- 6.5 and 8.3 + /- 3.3 days , duration s of antibiotic use were 9.5 + /- 5.5 and 7.7 + /- 2.7 days , duration s of NG tube usage were 3.2 + /- 1.5 and 2.2 + /- 1.2 days , time to oral feeding was 3.7 + /- 1.7 and 2.5 + /- 1.4 days , and time to normalization of the body temperatures was 3.7 + /- 2.3 vs 2.3 + /- 1.7 days . All differences were statistically significant ( P < .05 ) . The ratio of SBO increased from 2.8 % to 3.4 % in the ND group , but this result was not statistically significant . CONCLUSIONS As a result of this study , we recommend that peritoneal drainage should be ab and oned in childhood appendicitis Consecutive patients undergoing emergency appendectomy ( 283 ) or urgent cholecystectomy ( 51 ) were prospect ively studied for the development of postoperative incisional or peritoneal sepsis . Severity of the original peritoneal infection was carefully recorded , while use of a Penrose dam to drain the peritoneum was r and omized according to pre-assigned hospital number . Both aerobic and anaerobic cultures were taken from the abdomen at the time of operation as well as from all postoperative infectious foci . Results demonstrated no essential differences in incidence of wound and peritoneal infection following appendectomy for simple or suppurative appendicitis ( 187 ) or following cholecystectomy for acute cholecystitis ( 51 ) . However , with gangrenous or perforative appendicitis ( 94 ) , incisional and intra-abdominal infection rates were 43 % and 45 % , respectively , when a drain was used ; yet only 29 and 13 % , respectively , without a drain . These latter differences were significant ( p < 0.001 ) . In addition , intra-abdominal abscesses were three times as likely to drain through the incision than along any tract provided by the rubber conduit . Cultures revealed that hospital pathogens accounted for a greater proportion of wound and peritoneal sepsis after cholecystectomy and appendectomy for simple or suppurative appendicitis if a drain had been inserted than if managed otherwise . By contrast , a mixed bacterial flora was responsible for most infections following appendectomy for gangrenous or perforated appendicitis , irrespective as to use of a drain Abstract A prospect i ve , r and omised clinical trial has been carried out to determine the effects of peritoneal drainage or prophylactic systemic antibiotics on infection after emergency appendicectomy . 329 patients were included . Drainage increased the number of days of postoperative fever significantly ( 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 OUTPUT:

There were no significant differences between the two groups in the rates of intra-peritoneal abscess or wound infection . It is not clear whether routine abdominal drainage has any effect on the prevention of intra-peritoneal abscess after open appendectomy for complicated appendicitis . Abdominal drainage after an emergency open appendectomy may be associated with delayed hospital discharge for patients with complicated appendicitis

MS2_dynamic_1_shot533

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p < 0.001 within groups . At 24 months , patients on the LFD had lost −2.97 ± 4.9 kg and those on LCD −2.34 ± 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping 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 BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study OUTPUT: The proportion of daily energy provided by carbohydrate intake is not an important determinant of response to dietary management , especially when considering longer term trials . INPUT: OBJECTIVE To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake . RESEARCH DESIGN AND METHODS This r and omized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) . RESULTS Relative weight loss was 7.4 % ( 95 % CI 5.7–9.2 % ) , 9.0 % ( 7.1–10.9 % ) , and 2.5 % ( 1.3–3.8 % ) for the lower fat , lower carbohydrate , and UC groups ( P < 0.001 intervention effect ) . Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133–149 ] vs. 159 [ 144–174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6–7.1 % ] vs. 7.5 % [ 7.1–7.9 % ] or 52 [ 49–54 ] vs. 58 [ 54–63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134–163 ] vs. 204 [ 173–234 ] mg/dL , P < 0.001 ) . The lower versus higher carbohydrate groups maintained lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3–6.8 % ] vs. 7.2 % [ 6.8–7.5 % ] or 49 [ 45–51 ] vs. 55 [ 51–58 ] mmol/mol ) at 1 year ( P = 0.008 ) . CONCLUSIONS The weight loss program result ed in greater weight loss and improved glycemic control in type 2 diabetes Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p < 0.001 within groups . At 24 months , patients on the LFD had lost −2.97 ± 4.9 kg and those on LCD −2.34 ± 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping AIMS To compare the effects of lifestyle modification programs that prescribe low-glycemic load ( GL ) vs. low-fat diets in a r and omized trial . METHODS Seventy-nine obese adults with type 2 diabetes received low-fat or low-GL dietary instruction , delivered in 40-week lifestyle modification programs with identical goals for calorie OUTPUT:

According to the network meta- analysis the Mediterranean diet is the most effective and efficacious dietary approach to improve glycaemic control in type 2 diabetes patients

MS2_dynamic_1_shot534

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Purpose The purpose of this study is to test the efficacy of the Survivor Health and Resilience Education Program intervention — a manualized , behavioral intervention focusing on bone health behaviors among adolescent survivors of childhood cancer . Methods Participants were 75 teens aged 11–21 years , one or more years post-treatment , and currently cancer-free . Teens were r and omized to a group-based intervention focusing on bone health or a wait-list control . Bone health behaviors were assessed at baseline and 1-month post-intervention . Results Controlling for baseline outcome measures and theoretical predictors , milk consumption frequency ( p = 0.03 ) , past month calcium supplementation ( p < 0.001 ) , days in the past month with calcium supplementation ( p < 0.001 ) , and dietary calcium intake ( p = 0.04 ) were significantly greater at 1-month follow-up among intervention participants compared with control participants . Conclusions The intervention had a significant short-term impact on self-reported bone health behaviors among adolescent survivors of childhood cancer . Research examining long-term intervention effectiveness is warranted Background While research on exercise interventions during anticancer treatment is well-established in adults , only very few studies exist in children . However , pediatric patients experience great limitations to being physically active , and appropriate interventions are desired . ProcedureThe present study aim ed at investigating the effects of individualized exercise interventions during inpatient stays on pediatric patients with a malignant bone tumor . The parameter of interest was physical activity ( PA ) . Patients ’ PA during home stays was assessed 6 weeks as well as 3 , 6 , 12 , and 18 months post-surgery . Patients were distinguished into an intervention group and a control group . All patients received endoprosthetic replacement of the affected bone in the same institution . Results A constant increase in all PA parameters was observed during follow-up . Exercise interventions were possible and appeared worthwhile . The intervention group showed better PA results at all measurements ; however , no significant differences between groups were found . Furthermore , differences decreased especially after the cessation of the intervention . General problems in reaching appropriate power and compliance were observed . Conclusions Individualized exercise interventions in pediatric bone tumor patients are possible and appear to be beneficial . Such interventions should be implemented in adjuvant care ; however , future research is needed to underst and more about the effects of different interventions Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND The risk for cardiovascular disease ( CVD ) is increased in long-term survivors of childhood acute lymphoblastic leukemia ( ALL ) . Chemotherapy may have direct toxic effects on vascular endothelium , potentially increasing the significance of endothelial dysfunction in the development of CVD in ALL survivors . Endothelial structure and function can be measured with carotid intima media thickness ( IMT ) and brachial flow mediated dilation ( FMD ) . IMT and FMD are intermediate markers of CVD . We studied endothelial function and the effects of an exercise program on vascular endothelium in long-term survivors of childhood ALL . PROCEDURE Twenty-one 16 - 30 year old long-term survivors of ALL ( age at diagnosis ≤16 years ) and 21 healthy controls were studied at baseline , and 17 of the ALL survivors participated in a 16 week home-based exercise program . IMT and FMD were studied before and after the exercise program . RESULTS At baseline , the ALL survivors had impaired overall FMD response ( FMDauc , P = 0.02 ) . FMDmax(% ) was 22 % lower ( P = 0.06 ) and FMD at 40 seconds 44 % lower ( P = 0.01 ) compared to healthy controls . After the exercise program , FMD at 40 seconds ( P < 0.01 ) and IMT ( P = 0.02 ) improved . The mean overall FMD response increased by 25 % after the exercise program , but this change was not statistically significant ( P = 0.27 ) . CONCLUSIONS Our results show that the excess burden of CVD morbidity in this population may possibly be alleviated by simple means . The importance of physical activity on the health of childhood ALL survivors should be emphasized . Longer , controlled studies are needed to confirm our findings The aim was to evaluate the effects of additional exercises during inpatient stays on bone mass in pediatric bone tumor patients . 21 patients were non-r and omly allocated either to the exercise group ( n = 10 ) or the control group ( n = 11 ) . DXA of the lumbar spine , the non-affected femur and both calcanei was performed after completion of neoadjuvant chemotherapy ( baseline ) , as well as 6 and 12 months after baseline . Bone mineral content ( BMC ) , bone mineral density ( BMD ) and height-corrected lumbar spine Z-scores were determined . Group changes after 6 and 12 months were compared by covariance analyses . Additionally , daily physical activities ( PA ) were assessed by means of accelerometry . After adjusting for initial age , height and weight , mean reductions in lumbar spine and femoral BMC were lower in the exercise group ( not significant ) . Effect sizes during the observational period for lumbar spine and femur BMC were generally small ( partial η² = 0.03 ) . The exercise group demonstrated substantially higher PA levels in terms of gait cycles per day , per hour and moderate PA ( activities above 40 gait cycles per minute ) . Additional exercises for bone tumor patients are feasible during hospitalization . Though the intervention did not influence BMC , it appeared beneficial regarding PA promotion with respect to volume and intensity OUTPUT: The studies that included direct parental involvement showed positive outcomes on a variety of measures suggesting that increasing parental involvement in interventions for CCS may be one way to promote long-term lifestyle changes for pediatric cancer patients . INPUT: Purpose The purpose of this study is to test the efficacy of the Survivor Health and Resilience Education Program intervention — a manualized , behavioral intervention focusing on bone health behaviors among adolescent survivors of childhood cancer . Methods Participants were 75 teens aged 11–21 years , one or more years post-treatment , and currently cancer-free . Teens were r and omized to a group-based intervention focusing on bone health or a wait-list control . Bone health behaviors were assessed at baseline and 1-month post-intervention . Results Controlling for baseline outcome measures and theoretical predictors , milk consumption frequency ( p = 0.03 ) , past month calcium supplementation ( p < 0.001 ) , days in the past month with calcium supplementation ( p < 0.001 ) , and dietary calcium intake ( p = 0.04 ) were significantly greater at 1-month follow-up among intervention participants compared with control participants . Conclusions The intervention had a significant short-term impact on self-reported bone health behaviors among adolescent survivors of childhood cancer . Research examining long-term intervention effectiveness is warranted BACKGROUND We sought to improve lumbar spine bone mineral density ( LS-BMD ) in long-term survivors of childhood acute lymphoblastic leukemia ( ALL ) using calcium and cholecalciferol supplementation . PROCEDURE This double-blind , placebo-controlled trial r and omized 275 participants ( median age , 17 [ 9 - 36.1 ] years ) with age- and gender-specific LS-BMD Z-scores < 0 to receive nutritional counseling with supplementation of 1,000 mg/day calcium and 800 International Unit cholecalciferol or placebo for 2 years . The primary outcome was change in LS-BMD assessed by quantitative computerized tomography ( QCT ) at 24 months . Linear regression models were employed to identify the baseline risk factors for low LS-BMD and to compare LS-BMD outcomes . RESULTS Pre-r and omization LS-BMD below the mean was associated with male gender ( P = 0.0024 ) , White race ( P = 0.0003 ) , lower body mass index ( P < 0.0001 ) , and cumulative glucocorticoid doses of ≥ 5,000 mg ( P = 0.0012 ) . One hundred eighty-eight ( 68 % ) participants completed the study ; 77 % adhered to the intervention . Mean LS-BMD change did not differ between survivors r and omized to supplements ( 0.33 ± 0.57 ) or placebo ( 0.28 ± 0.56 ) . Participants aged 9 - 13 years and those 22 - 35 years had the greatest mean increases in LS-BMD ( 0.50 ± 0.66 and 0.37 ± 0.23 , respectively ) . Vitamin D insufficiency ( serum 25[OH]D < 30 ng/ml ) found in 296 ( 75 % ) , was not associated with LS-BMD outcomes ( P = 0.78 ) . CONCLUSION Cholecalciferol and calcium supplementation provides no added benefit to nutritional counseling for improving LS-BMD among adolescent and young adult survivors of ALL ( 93 % of whom had LS-BMD Z-scores above the mean at study entry ) Survivors of childhood cancer are a growing and vulnerable population . Cure rates for pediatric cancers now exceed 60 % and , by the year 2000 , an estimated 1 of every 1,000 young adults will be a cancer survivor . Because this population is at increased risk for late medical and neoplastic complications that impact adversely on health‐related quality of life , it is important to investigate methods to promote risk reduction by motivating survivors to practice health‐promoting behaviors . With this background , we initiated a prospect i ve , r and omized , controlled feasibility study in which survivors attending a long‐term follow‐up clinic were r and omized to receive st and ard care or st and ard care plus an educational intervention . Our objectives were to determine if the intervention would improve the survivors ' knowledge about their cancer treatment and risks of late effects and increase their practice of health‐protective behaviors . Since July 1995 , 272 of 318 families ( 86 % ) approached about the study agreed to participate . Of these , 266 are evaluable for assessment of baseline knowledge and health behaviors . Demographic features , baseline knowledge , health perceptions and health behaviors did not differ among r and omized groups . Assessment of the intervention 's efficacy at changing health behaviors of survivors r and omized to the intervention group will be available when the 1‐year follow‐up evaluations are completed for the study cohort . Our preliminary experience with this pilot study supports the feasibility of educational intervention research in a specialty clinic dedicated to monitoring long‐term childhood cancer survivors . Int . J. Cancer Suppl . 12:138–142 , 1999 . © 1999 Wiley‐Liss , The BONEII study is a large two-phase study . The baseline study ( Study 1 ) aims to estimate the prevalence of diminished bone mineral density ( BMD ) in patients treated for childhood acute lymphoblastic leukemia ( ALL ) and identify risk factors for BMD deficits . The interventional phase ( Study 2 ) of BONEII has a placebo-controlled double-blind r and omized longitudinal design to evaluate the effects of nutritional counseling and calcium and vitamin D supplementation on changes in BMD and serum and urine markers of bone metabolism . The extensive information being collected through this large study will serve as a repository of OUTPUT:

Due to a paucity of studies , and the heterogeneity of the studies included in this review , we are unable to draw conclusions regarding the effectiveness of nutritional interventions for use with childhood cancer survivors . Although there is low quality evidence for the improvement in health behaviours using health behaviour change interventions , there remains no evidence as to whether this translates into an improvement in dietary intake . There was also no evidence that the studies reduced the risk of cardiovascular and metabolic disorders in childhood cancer survivors , although no evidence of effect is not the same as evidence of no effect .

MS2_dynamic_1_shot535

***TASK*** the task is to summarize an input biomedical literature 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 Peripheral arterial disease ( PAD ) of the lower limbs is a cardiovascular disease highly prevalent particularly in the asymptomatic form . Its prevalence starts to be a concern in low coronary risk countries like Spain . Few studies have analyzed the relationship between ankle-brachial index ( ABI ) and cardiovascular morbi-mortality in low cardiovascular risk countries like Spain where we observe significant low incidence of ischemic heart diseases together with high prevalence of cardiovascular risk factors . The objective of this study is to determine the relationship between pathological ABI and incidence of cardiovascular events ( coronary disease , cerebrovascular disease , symptomatic aneurism of abdominal aorta , vascular surgery ) and death in the > 49 year population -based cohort in Spain ( ARTPER ) . Methods Baseline ABI was measured in 3,786 r and omly selected patients from 28 Primary Health Centers in Barcelona , distributed as : ABI<0.9 peripheral arterial disease ( PAD ) , ABI ≥1.4 arterial calcification ( AC ) , ABI 0.9 - 1.4 healthy ; and followed during 4 years . Results 3,307 subjects were included after excluding those with previous vascular events . Subjects with abnormal ABI were older with higher proportion of men , smokers and diabetics . 260 people presented cardiovascular events ( incidence 2,117/100,000 person-years ) and 124 died from any cause ( incidence 978/100,000 person-years ) . PAD had two-fold greater risk of coronary disease ( adjusted hazard ratio ( HR ) = 2.0 , 95 % confidence interval ( CI ) 1.3 - 3.2 ) and increased risk of vascular surgery ( HR = 5.6 , 95%CI 2.8 - 11.5 ) and mortality ( HR = 1.8 , 95%CI 1.4 - 2.5 ) . AC increased twice risk of cerebrovascular events ( HR = 1.9 , 95%CI 1.0 - 3.5 ) with no relationship with ischemic heart disease . Conclusions PAD increases coronary disease risk and AC cerebrovascular disease risk in low cardiovascular risk Mediterranean population . ABI could be a useful tool to detect patients at risk in Primary Health Care INTRODUCTION AND OBJECTIVES To estimate the prevalence of peripheral arterial disease as measured on ankle-brachial index and evaluate the associated risk , clinical , and diagnostic factors . METHODS Cross-sectional study conducted in a r and om population -based sample of 2833 individuals aged 25 to 79 years from Don Benito health area ( Badajoz ) . Peripheral arterial disease was considered for ankle-brachial index<0.90 . To identify symptomatic disease we used the Edinburgh question naire . The current screening recommendations , changes to other categories of estimated coronary risk associated with index measurements , and the association with risk factors were assessed . RESULTS The prevalence of peripheral arterial disease was 3.7 % ( 95 % confidence interval , 3.0%-4.5 % ) , 5.0 % ( 3.9%-6.3 % ) in men and 2.6 % ( 1.8%-3.5 % ) in women ( P=.001 ) . The cumulative prevalence in those aged 50 , 60 and 70 years were 6.2 % , 9.1 % , and 13.1 % respectively . The disease was symptomatic in 13.3 % ( 6.8%-19.8 % ) of cases and 29.6 % of asymptomatic patients were not detected as recommended for high-risk groups . The use of ankle-brachial index increased the number of individuals with high coronary risk by 32.7 % . Peripheral arterial disease was positively associated with age , smoking , hypercholesterolemia , sedentary lifestyle , microalbuminuria and history of cardiovascular disease , and negatively with alcohol consumption . CONCLUSIONS The use of ankle-brachial index for peripheral arterial disease diagnosis is advisable because of the low prevalence of symptomatic cases and the associated change in estimated coronary risk . Screening groups should be adapted to the Spanish population . Smoking and hypercholesterolemia are major associated risk factors OBJECTIVE A population -based point-prevalence study was conducted to determine the prevalence of peripheral arterial disease ( PAD ) in Sweden , with special attention to critical limb ischemia and sex differences . METHODS An age-st and ardized r and omly selected population sample of 8000 women and men , aged 60 to 90 years , from four different regions in Sweden was invited to participate . The sample had the same age and gender distribution as the Swedish population in this age group . Participating subjects completed question naires on medical history , present medication , and symptoms , and their ankle-brachial index ( ABI ) was measured . Subjects were analyzed for presence of PAD according to reported symptoms and an ABI<0.9 . RESULTS A total of 5080 subjects were included , giving a participation rate of 64 % . The prevalence of any PAD , asymptomatic PAD , intermittent claudication , and severe limb ischemia was , respectively , 18 % ( 95 % confidence interval [ CI ] , 16 % to 20 % ) 11 % ( 9 % to 13 % ) , 7 % ( 6.5 to 7 % ) and 1.2 % ( 1 % to 1.5 % ) . Women had a higher prevalence than men when PAD was diagnosed with ABI only ; that is , asymptomatic PAD ( 12.6 % vs 9.4 % , P=.03 ) and severe limb ischem OUTPUT: Blacks are vulnerable to PAD , in contrast to Asians who have lower prevalence of PAD when compared to whites . INPUT: Peripheral arterial disease ( PAD ) is associated with major cardiovascular morbidity and mortality . Abnormalities in nitric oxide metabolism due to excess of the NO synthase inhibitor asymmetric dimethylarginine ( ADMA ) may be pathogenic in PAD . We explored the association between ADMA levels and markers of atherosclerosis , function , and prognosis . A total of 133 patients with symptomatic PAD were enrolled . Ankle — brachial index ( ABI ) , walking time , vascular function measures ( arterial compliance and flow-mediated vasodilatation ) and plasma ADMA level were assessed for each patient at baseline . ADMA correlated inversely with ABI ( r = —0.238 , p = 0.003 ) and walking time ( r = —0.255 , p = 0.001 ) , independent of other vascular risk factors . We followed up 125 ( 94 % ) of our 133 initial subjects with baseline measurements ( mean 35 months ) . Subjects with ADMA levels in the highest quartile ( > 0.84 μmol/l ) showed a significantly greater occurrence of a major adverse cardiovascular event ( MACE ) compared to those with ADMA levels in the lower three quartiles ( p = 0.001 ) . Cox proportional-hazards regression analysis revealed that ADMA was a significant predictor of MACE , independent of other risk factors including age , sex , blood pressure , smoking history , diabetes and ABI ( hazard ratio = 5.1 , p < 0.001 ) . Measures of vascular function , such as compliance , flow-mediated vasodilatation ( FMVD ) and blood pressure , as well as markers of PAD severity , including ABI and walking time , were not predictive . In conclusion , circulating levels of ADMA correlate independently with measures of disease severity and major adverse cardiovascular events . Agents that target this pathway may be useful for this patient population . Clinical Trial Registration — URL : http:// www . clinical trials.gov . Unique identifier : Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND The objective of this study was to assess the role of a symptom-limited stair climbing test in predicting postoperative cardiopulmonary complications in elderly c and i date s for lung resection . METHODS A consecutive series of 109 patients more than 70 years of age who underwent pulmonary lobectomy for lung carcinoma from January 2000 through May 2003 formed the prospect i ve data base of this study . All patients in the analysis performed a preoperative symptom-limited stair climbing test . Univariate and multivariate analyses were performed to identify predictors of postoperative cardiopulmonary complications . RESULTS At univariate analysis , the patients with complications had a lower forced expiratory capacity percentage of predicted ( p = 0.048 ) , predicted postoperative forced expiratory volume in 1 second percentage of predicted ( p = 0.049 ) , climbed a lower height at preoperative stair climbing test ( p = 0.0004 ) , and presented a greater proportion of cardiac comorbiditiy with respect to the patients without complications ( p = 0.02 ) . After logistic regression analysis , significant predictors of postoperative complications result ed in the presence of a concomitant cardiac disease ( p = 0.04 ) and a low height climbed preoperatively ( p = 0.0015 ) . CONCLUSIONS A symptom-limited stair climbing test was a safe and simple instrument capable of predicting cardiopulmonary complications in the elderly after lung resection OBJECTIVE To establish associations between leg strength and mortality in men and women with lower extremity peripheral arterial disease ( PAD ) . METHODS This was an observational , prospect i ve study of 410 men and women with PAD aged 55 and older recruited from Chicago-area medical centers and followed for a mean of 60 months . The participants were followed for a mean of 60.0 months . Isometric knee extension , knee flexion , hip extension , and hip flexion were measured at baseline . Primary outcomes were all-cause and cardiovascular disease mortality . Cox proportional hazards models were used to assess relations between leg strength and all-cause and cardiovascular disease mortality among men and women , adjusting for age , race , comorbidities , physical activity , smoking , body mass index , and the ankle brachial index . RESULTS Among the 246 male participants , poorer baseline strength for knee flexion ( P trend = .029 ) , knee extension ( P trend = .010 ) , and hip extension ( P trend = .013 ) were each associated independently with higher all-cause mortality . Poorer strength for knee flexion ( P trend = .042 ) and hip extension ( P trend = .029 ) were associated with higher cardiovascular mortality . Compared with those in the fourth ( best ) baseline knee flexion quartile , hazard ratios for all-cause and cardiovascular disease mortality among men in the first ( poorest ) knee flexion quartile were 2.23 ( 95 % confidence interval [ CI ] , 1.02 - 4.87 ; P = .045 ) and 4.20 ( 95 % CI , 1.12 - 15.79 ; P = .044 ) , respectively . No significant associations of leg strength and all-cause mortality were identified among women . CONCLUSIONS Poorer leg strength is associated with increased mortality in men , but not women , with PAD . Future study is needed to determine whether interventions that increase leg strength improve survival in men with PAD OBJECTIVES OUTPUT:

No significant associations were found for hip flexion strength , WIQ distance score , or WIQ speed score with mortality . CONCLUSIONS A number of lower extremity performance measures are prognostic markers for mortality in PAD and may be useful clinical tools for identifying patients at higher risk of death .

MS2_dynamic_1_shot536

***TASK*** the task is to summarize an input biomedical literature 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: Surgical therapy for stage III non-small cell lung cancer ( NSCLC ) has not result ed in substantial long-term survival . Neoadjuvant treatment programs that could down-stage the tumor and achieve increased long-term survival would be of obvious benefit . We have used preoperative simultaneous chemotherapy and irradiation in 85 patients with clinical stage III non-small cell lung cancer considered c and i date s for surgical resection . One group of 56 patients was treated with cisplatin , 5-fluorouracil , and simultaneous irradiation for five days every other week for a total of four cycles . After treatment , 39 patients underwent resection , and the operative mortality was 2 ( 5 % ) of 39 . A second trial was undertaken in which etoposide ( VP-16 ) was added because of its synergism with cisplatin . In this group , 29 patients were considered to have potentially resectable disease , and 23 underwent thoracotomy with 1 operative death ( 4 % ) . Of the total of 62 patients having thoracotomy , 60 underwent resection ( 97 % ) . Complications were major , and there were four bronchopleural fistulas . For the 85 patients eligible for surgical intervention in these two groups of patients , the Kaplan-Meier median survival estimate is 40 % at 3 years . The median survival of the 62 patients having thoracotomy is 36.6 months . Combination preoperative chemotherapy and irradiation is feasible with acceptable toxicity and operative mortality in patients with clinical stage III non-small cell lung cancer . Prospect i ve r and omized studies are suggested for further evaluation of this treatment program OBJECTIVES Surgical resection after preoperative chemotherapy in patients with non-small cell lung cancer might only be best for patients who are responders . We compared positron emission tomographic scanning with 2-fluoro-2-deoxy-d-glucose ( FDP-PET scanning ) with computed tomographic scanning to evaluate their ability to predict this response for the primary tumor , N1 and N2 lymph nodes . METHODS All patients with non-small cell lung cancer who had an initial FDP-PET scan staging with tissue biopsy , neoadjuvant chemotherapy , repeat FDP-PET scanning , and repeat biopsies were prospect ively studied . RESULTS There were 34 patients ( 24 men ; median age , 64 years ) . Eleven patients had N2 disease , and 7 had N1 disease . Twenty-seven patients received chemotherapy , and 7 patients received chemotherapy and radiation . All but 9 patients underwent resection . Statistical analysis showed FDP-PET scanning to be more specific ( P < .0001 ) , to have a higher positive predictive value ( P = .0018 ) , and to have a higher negative predictive value ( P < .0001 ) than computed tomographic scanning for predicting residual tumor at the primary site . FDP-PET scanning was more sensitive ( P < .0001 ) and more accurate ( P < .0001 ) , had a higher positive predictive value ( P < .0001 ) , and had a higher negative predictive value ( P = .0002 ) than computed tomographic scanning for paratracheal nodes ( number 2 and 4 lymph nodes ) . FDP-PET scanning had a higher positive predictive value ( P < .0001 ) than computed tomographic scanning for the other N2 ( numbers 5 , 6 , 7 , 8 , and 9 ) lymph nodes . CONCLUSIONS Repeat FDP-PET scanning is more specific and has a higher positive predictive value and negative predictive value than computed tomographic scanning for detecting residual tumor in the lung in patients with non-small cell lung cancer who have received preoperative chemotherapy . It is more sensitive and accurate for paratracheal N2 nodes as well . However , there is no significant difference in its detection of N1 lymph nodes PURPOSE A number of studies have demonstrated that 18F-fluorodeoxyglucose positron emission tomography ( FDG-PET ) is effective for staging of lung cancer . However , the efficacy of FDG-PET for staging lung cancer after neoadjuvant treatment is still controversial . This study compared FDG-PET and computed tomography ( CT ) for lung cancer staging , and evaluated the ability of the two methods to predict the pathologic response of the primary tumor to neoadjuvant treatment . PATIENTS AND METHODS Twenty-two patients who underwent neoadjuvant treatment followed by surgery were investigated . Eighteen patients received chemoradiotherapy and four patients received chemotherapy only . One hundred and three lymph node stations in the 22 patients were evaluated by FDG-PET and CT . The pathologic responses of the tumors were compared by FDG-uptake and tumor size on CT for the 15 patients who underwent FDG-PET and CT both before and after neoadjuvant treatment . RESULTS There was no significant difference in the ability of FDG-PET or CT to predict residual viable tumor . Although positive predictive value by FDG-PET ( 0.29 ) was lower than that by CT ( 0.64 ) ( p=0.04 ) in the mediastinal lymph nodes , there were no statistically significant differences in the other results of lymph nodes by FDG-PET and CT . Both decrease in FDG-uptake and decrease in tumor size by CT after neoadjuvant treatment correlated significantly with pathologic response in the 15 patients ( p=0.003 and 0.009 , respectively ) . CONCLUSION FDG-PET did not appear to offer any advantages over CT for lymph node staging or for predicting the pathologic response after neoadjuvant treatment of non-small cell lung cancer PURPOSE This phase II trial was design ed to evaluate the feasibility , toxicity , response rates , and survival for neoadjuvant OUTPUT: These results are not significantly affected by the type of induction therapy or the timing of restaging . The ability to identify patients who have achieved mediastinal downstaging other than by a careful primary mediastinoscopy is poor INPUT: PURPOSE Adjuvant cisplatin-based chemotherapy ( ACT ) is now an accepted st and ard for completely resected stage II and III A non-small-cell lung cancer ( NSCLC ) . Long-term follow-up is important to document persistent benefit and late toxicity . We report here up date d overall survival ( OS ) and disease-specific survival ( DSS ) data . PATIENTS AND METHODS Patients with completely resected stage IB ( T2N0 , n = 219 ) or II ( T1 - 2N1 , n = 263 ) NSCLC were r and omly assigned to receive 4 cycles of vinorelbine/cisplatin or observation . All efficacy analyses were performed on an intention-to-treat basis . Results Median follow-up was 9.3 years ( range , 5.8 to 13.8 ; 33 lost to follow-up ) ; there were 271 deaths in 482 r and omly assigned patients . ACT continues to show a benefit ( hazard ratio [ HR ] , 0.78 ; 95 % CI , 0.61 to 0.99 ; P = .04 ) . There was a trend for interaction with disease stage ( P = .09 ; HR for stage II , 0.68 ; 95 % CI , 0.5 to 0.92 ; P = .01 ; stage IB , HR , 1.03 ; 95 % CI , 0.7 to 1.52 ; P = .87 ) . ACT result ed in significantly prolonged DSS ( HR , 0.73 ; 95 % CI , 0.55 to 0.97 ; P = .03 ) . Observation was associated with significantly higher risk of death from lung cancer ( P = .02 ) , with no difference in rates of death from other causes or second primary malignancies between the arms . CONCLUSION Prolonged follow-up of patients from the JBR.10 trial continues to show a benefit in survival for adjuvant chemotherapy . This benefit appears to be confined to N1 patients . There was no increase in death from other causes in the chemotherapy arm BACKGROUND Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer ( NSCLC ) is not known . We aim ed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC . METHODS 840 patients with stage IB-IIIA NSCLC from 101 centres in 14 countries were r and omly assigned to observation ( n=433 ) or to 30 mg/m(2 ) vinorelbine plus 100 mg/m(2 ) cisplatin ( n=407 ) . Postoperative radiotherapy was not m and atory and was undertaken according to every centre 's policy . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N95053737 . FINDINGS 367 patients in the chemotherapy group and 431 in the control group received their assigned treatment . 301 ( 36 % ) patients had stage IB disease , 203 ( 24 % ) had stage II disease , and 325 ( 39 % ) had stage IIIA disease . Tolerance to chemotherapy mainly included neutropenia in 335 ( 92 % ) patients and febrile neutropenia in 34 ( 9 % ) ; seven ( 2 % ) toxic deaths were also recorded . Compliance was greater with cisplatin than with vinorelbine ( median dose intensity 89 % [ range 17 - 108 ] vs 59 % [ 17 - 100 ] ) . After a median follow-up of 76 months ( range 43 - 116 ) , median survival was 65.7 months ( 95 % CI 47.9 - 88.5 ) in the chemotherapy group and 43.7 ( 35.7 - 52.3 ) months in the observation group . Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls ( hazard ratio 0.80 [ 95 % CI 0.66 - 0.96 ] ; p=0.017 ) . Overall survival at 5 years with chemotherapy improved by 8.6 % , which was maintained at 7 years ( 8.4 % ) . INTERPRETATION Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC , better defining indication of adjuvant chemotherapy BACKGROUND Results from phase II studies in patients with stage IIIA non-small-cell lung cancer with ipsilateral mediastinal nodal metastases ( N2 ) have shown the feasibility of resection after concurrent chemotherapy and radiotherapy with promising rates of survival . We therefore did this phase III trial to compare concurrent chemotherapy and radiotherapy followed by resection with st and ard concurrent chemotherapy and definitive radiotherapy without resection . METHODS Patients with stage T1 - 3pN2M0 non-small-cell lung cancer were r and omly assigned in a 1:1 ratio to concurrent induction chemotherapy ( two cycles of cisplatin [ 50 mg/m(2 ) on days 1 , 8 , 29 , and 36 ] and etoposide [ 50 mg/m(2 ) on days 1 - 5 and 29 - 33 ] ) plus radiotherapy ( 45 Gy ) in multiple academic and community hospitals . If no progression , patients in group 1 underwent resection and those in group 2 continued radiotherapy uninterrupted up to 61 Gy . Two additional cycles of cisplatin and etoposide were given in both groups . The primary endpoint was overall survival ( OS ) . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00002550 . FINDING OUTPUT:

RESULTS For patients who have undergone surgical resection , high-level evidence suggests that use of postoperative RT does not influence survival , but optimizes local control for patients with N2 involvement , and its use in the setting of positive margins or gross primary /nodal residual disease is recommended . No high-level evidence exists for the routine use of preoperative induction chemoradiation therapy ; however , modern surgical series and a post-hoc Intergroup 0139 clinical trial analysis suggest that a survival benefit may exist if patients are properly selected and surgical techniques/postoperative care is optimized .

MS2_dynamic_1_shot537

***TASK*** the task is to summarize an input biomedical literature 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 Forty patients suffering from a medial femoral neck fracture participated in a prospect i ve , r and omized study . In 20 patients , the femoral component was cemented using a contemporary technique . In the patient group operated on with the bone vacuum technique , the medullary cavity was drained during the insertion of the stem . The proximal draining hole was placed in the intertrochanteric region , along the prolongation of the linea aspera . The distal hole was placed 2 cm below the tip of the femoral component . Embolic phenomena were documented intraoperatively by continuous transesophageal echocardiographic imaging of the right atrium and ventricle . The clinical relevance of the emboli was noted simultaneously by recording hemodynamic and blood gas parameters . Patients of the control group showed severer and longer-lasting episodes of embolism than patients of the bone vacuum group . Ongoing emboli were first seen during the injection of the cement , and continued during stem insertion . Massive emboli of small particles could be verified in 19 patients ( 95 % ) of the control group and in 1 patient ( 5 % ) of the bone vacuum group ( P < 0.05 ) . During massive emboli , a distinct decrease in the arterial oxygen saturation and the end-expiratory carbon dioxide level was observed . The calculated average pulmonary shunt volume showed an increase after the insertion of the stem using the contemporary technique ( 36.5 % ; P < 0.05 ) . These distinct hemodynamic changes were not observed in the bone vacuum group . This study was able to show a clearly reduced risk of pulmonary emboli using the bone vacuum cementing technique . The presence of pre-existing disease greatly magnified the clinical relevance of fat embolism This prospect i ve r and omized trial compared the efficacy of unipolar versus bipolar hemiarthroplasty in elderly patients ( ≥ 65 years ) with displaced femoral neck fractures in terms of quality of life and functional outcomes . One hundred fifteen patients with a mean age of 82.1 years were enrolled in this study and r and omized to either unipolar or bipolar hemiarthroplasty . Quality of life and functional outcomes were assessed using the Musculoskeletal Functional Assessment instrument and Short Form-36 health survey . Seventy-eight patients completed 1 year of followup . There were no differences between the groups in estimated blood loss , length of hospital stay , mortality rate , number of dislocations , postoperative complications , or ambulatory status at 1 year . There also were no significant differences between the two groups at either point in postoperative Short Form-36 or Musculoskeletal Functional Assessment instrument scores . Results of this prospect i ve r and omized study suggest that the bipolar endoprosthesis provides no advantage in the treatment of displaced femoral neck fractures in elderly patients regarding quality of life and functional outcomes In a prospect i ve trial of 278 patients aged over 65 years , treatment of displaced subcapital fractures was r and omly allocated to closed reduction and internal fixation with a sliding compression screwplate , Moore hemiarthroplasty , or total hip treatment with a Howse semicaptive prosthesis . One year after operation there was little difference between the three groups in mortality ( 25 per cent ) or general complications . The revision rate within the first year was highest for internal fixation ( 25 per cent ) , but many of the replacements also required a further anaesthetic for reduction of a dislocation ( Moore , 11 per cent ; Howse 12.5 per cent ) . Total hip replacement result ed in the least pain and most mobility at 1 year , while hemiarthroplasty was worst in these respects . We conclude that internal fixation and particularly primary total hip replacement should be given serious consideration in the management of the elderly patient with a displaced subcapital fracture We report a r and omised prospect i ve trial of the early results of three types of treatment for displaced intracapsular hip fractures . We used a question naire sent to patients at about six months ( Nottingham Health Profile , NHP ) in addition to clinical assessment s. There was a 67.4 % usable response to the question naire , similar to that in other studies using the NHP . There were more responders from younger patients , those walking independently before injury and those with higher mental test scores on admission . In the younger group ( 65 to 79 years ) we found a trend for better scores in most NHP indices after the use of a bipolar prosthesis rather than a unipolar prosthesis or internal fixation , particularly for social function , pain and physical mobility . Postal assessment using the NHP gave a satisfactory response rate even in the elderly , and can provide an extra assessment to complement or replace hospital follow-up in some circumstances A prospect i ve clinical trial has been conducted comparing the use of a hydoxyapatite-coated bipolar hemiarthroplasty and an uncemented bipolar prosthesis in the treatment of displaced subcapital fractures of the femur . The trial was conducted over 1 year , 82 patients suffering displaced subcapital fractures of the femur were included . The patients were followed up for 1 year postoperatively . The functional result was significantly superior in the hydroxyapatite-coated group . Characteristic changes were found on radiographs both proximally and distally , indicating that distal stem fixation with proximal stress shielding had occurred We performed a r and omised prospect i ve trial to compare a cemented unipolar prosthesis ( Thompson ) with a cemented bipolar prosthesis ( Monk ) in the treatment of displaced intracapsular fractures of the hip in patients over 80 years of age . Patients with a mental test score of less than 5/13 were excluded but the mortality was still about 30 % at one year in both groups . We therefore feel that subjective criteria such as the level of pain and the return to the preinjury state are of paramount importance . Two years after operation there was no statistical difference between the rate of complications in the two groups . After adjusting OUTPUT: For this comparison , there were no significant differences in any other outcome . Comparison of unipolar hemiarthroplasty with bipolar hemiarthroplasty ( seven trials , 857 participants ) showed no significant differences between the two types of implant . REVIEW ERS ' CONCLUSIONS Cementing prostheses in place seems to reduce pain post-operatively and results in better mobility , but because of the under-reporting of outcomes and the small number of patients involved , no definite conclusions can be made . INPUT: Background and purpose Short femoral stems have been introduced in total hip arthroplasty in order to save proximal bone stock . We hypothesized that a short stem preserves periprosthetic bone mineral density ( BMD ) and provides good primary stability . Methods We carried out a prospect i ve cohort study of 30 patients receiving the collum femoris-preserving ( CFP ) stem . Preoperative total hip BMD and postoperative periprosthetic BMD in Gruen zones 1–7 were investigated by dual-energy x-ray absorptiometry ( DXA ) , stem migration was analyzed by radiostereometric analysis ( RSA ) , and the Harris hip score ( HHS ) was determined . Results 2 patients were excluded intraoperatively and 1 patient was revised due to a deep infection , leaving 27 patients for analysis . The mean HHS increased from 49 ( 24–79 ) preoperatively to 99 ( 92–100 ) after 2 years . DXA after 1 year showed substantial loss of BMD in Gruen zone 7 ( –31 % ) , zone 6 ( –19 % ) , and zone 2 ( –13 % , p < 0.001 ) compared to baseline BMD determined immediately postoperatively . The bone loss in these regions did not recover after 2 years , whereas the more moderate bone loss in Gruen zones 1 , 3 , and 5 partially recovered . There was a correlation between low preoperative total hip BMD and a higher amount of bone loss in Gruen zones 2 , 6 and 7 . RSA showed minor micromotion of the stem : mean subsidence was 0.13 ( 95 % CI : –0.28 to 0.01 ) mm and mean rotation around the longitudinal axis was 0.01º ( 95 % CI : –0.1 to 0.39 ) after 2 years . Interpretation We conclude that substantial loss in proximal periprosthetic BMD can not be prevented by the use of a novel type of short , curved stem , and forces appear to be transmitted distally . However , the stems showed very small migration — a characteristic of stable uncemented implants Bone stock-preserving short stem prostheses have gained importance in total hip arthroplasty ( THA ) with the use of minimally invasive surgical procedures . Because of their metaphyseal fixation and their dependency on the calcar radius , it is unknown whether the femoral offset can be reproduced with the same accuracy following short stem vs st and ard stem THA . This study clarifies whether it is possible to restore the femoral offset using a short stem prosthesis ( Fitmore ; Zimmer , Warsaw , Indiana ) compared with a conventional straight stem prosthesis ( CLS ; Zimmer ) following minimally invasive implantation using an anterolateral approach . In a prospect i ve , r and omized , double-blinded study , 80 patients underwent THA using a short stem ( SS group ; n=40 ) or CLS implant ( control group ; n=40 ) . Follow-up examinations were conducted 6 weeks postoperatively . Radiological and functional outcomes were measured . Subjective assessment of quality of life was evaluated using the Harris Hip Score ( HHS ) , the Short Form 36-item health survey ( SF-36 ) , and the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Pre- and postoperative comparison of the groups ' change in offset showed no significant differences ( SS group difference from pre- to postoperative , 6.1±6.5 mm ; control group difference from pre- to postoperative , 6.5±7.1 mm ; P=.93 ) . Group comparison after 6 weeks revealed no significant differences in HHS , SF-36 , or WOMAC . Based on these data , an equivalent reproducibility of the femoral offset was demonstrated following short stem and straight stem THA using a minimally invasive anterolateral approach . If the long-term results of short stems show a comparable survival , they represent a sensible alternative to st and ard stems Purpose On the basis of positive clinical results with mid- and long-term follow-up using the Mayo short stem , the Metha neck-preserving stem ( BBraun , Aesculap , Tuttlingen , Germany ) was introduced . The purpose of this study was to vali date the implant design by direct acquisition of bone remodelling data from total hip arthroplasty ( THA ) recipients using dual-energy X-ray absorptiometry ( DEXA ) . Methods After power analysis , 25 patients were included in this prospect i ve study . Patients were examined clinical ly and underwent DEXA examinations preoperatively and postoperatively at one week , six months and one and two years after THA . Gruen zones were adapted to the short stem design ( R1–R7 ) . Results The Harris Hip Score ( HHS ) increased significantly by 31 points . No stem had to be revised . Bone mineral density ( BMD ) in the greater trochanter decreased significantly from 0.78 g/cm2 postoperatively to 0.72 g/cm2 two years after surgery . Marginal changes were seen in the lateral distal regions ( R4–R5 ) . In the minor trochanter region , BMD increased significantly after two years by 12.9 % . In the calcar region , BMD exceeded the baseline value by 6.1 % two years after implantation . Conclusions Stress shielding seems to occur at the greater trochanter due to the vast cross-section of the implant . However , the aim of proximal load transfer of the Metha stem seems to be partially achieved . DEXA analysis revealed a concentrated load distribution on the medial portion of the femur , which is an important region to guarantee long-term implant survival Background Stress shielding of the proximal femur has been observed in a number of conventional cementless implants used in total hip arthroplasty . Short femoral-neck implants are cl aim ing less interference with the biomechanics of the proximal femur . The goal of this study was to investigate the changes of bone-mineral density in the proximal femur and the clinical outcome after impl OUTPUT:

Our results suggest that compared with CS , SS may provide superior bone remodelling and similar survival rates and clinical outcomes . However , the short-term follow-up of the included studies was inadequate to determine the long-term performance of SS

MS2_dynamic_1_shot538

***TASK*** the task is to summarize an input biomedical literature 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 heart failure are a growing population within cardiac rehabilitation . The purpose of this study was to compare , through a single-centre , parallel-group , r and omized controlled trial , the effects of Nordic walking and st and ard cardiac rehabilitation care on functional capacity and other outcomes in patients with moderate to severe heart failure . METHODS Between 2008 and 2009 , 54 patients ( aged 62.4 ± 11.4 years ) with heart failure ( mean ejection fraction = 26.9 % ± 5.0 % ) were r and omly assigned to st and ard cardiac rehabilitation care ( n = 27 ) or Nordic walking ( n = 27 ) ; both groups performed 200 to 400 minutes of exercise per week for 12 weeks . The primary outcome , measured after 12 weeks , was functional capacity assessed by a 6-minute walk test ( 6MWT ) . RESULTS Compared with st and ard care , Nordic walking led to higher functional capacity ( Δ 125.6 ± 59.4 m vs Δ 57.0 ± 71.3 m travelled during 6MWT ; P = 0.001 ) , greater self-reported physical activity ( Δ 158.5 ± 118.5 minutes vs Δ 155.5 ± 125.6 minutes ; P = 0.049 ) , increased right grip strength ( Δ 2.3 ± 3.5 kg vs Δ 0.3 ± 3.1 kg ; P = 0.026 ) , and fewer depressive symptoms ( Hospital Anxiety and Depression Scale score = Δ -1.7 ± 2.4 vs Δ -0.8 ± 3.1 ; P = 0.014 ) . No significant differences were found for peak aerobic capacity , left-h and grip strength , body weight , waist circumference , or symptoms of anxiety . CONCLUSIONS Nordic walking was superior to st and ard cardiac rehabilitation care in improving functional capacity and other important outcomes in patients with heart failure . This exercise modality is a promising alternative for this population Background Exercise training has now become established practice in patients with chronic heart failure . Women are often under-represented in intervention studies compared to men . For this reason it was our aim to conduct a combined endurance and muscle strength training program to evaluate its effect on clinical performance data and health-related psychosocial factors in women and men . Methods One hundred and sixteen women , mean age 69 ± 9 years , body mass index ( BMI ) 25.8 ± 4.9 , and 169 men , mean age 66 ± 9 years , BMI 26.6 ± 3.6 underwent combined endurance/resistance training . The training program lasted 29 ± 7 days and comprised bicycle ergometer training , a 6-min walk test as a training unit and muscle strength training for the lower and upper extremities . Results Differences between women and men were found in clinical parameters . In particular , statistically significant differences were revealed between the women and men with regard to cardiopulmonary performance . Quality of life was significantly improved on discharge with regard to both physical and mental health , whereas anxiety and depression showed no significant alteration . Conclusion A specialized in-hospital program for women and men combining endurance/resistance training and education is feasible . But our program revealed a very low level of cardiopulmonary performance in women . Women need to be encouraged and motivated to participate in such programs Exercise is now considered an important component of management in chronic heart failure ( CHF ) , but little is known about central hemodynamic changes that occur during different exercise modalities in these patients . Seventeen patients ( ejection fraction 25 + /- 2 % ) undertook brachial artery and right heart catheterization and oxygen consumption assessment at rest , during submaximal and peak cycling ( Cyc ) , and during submaximal upper and lower limb resistance exercise . Cardiac output ( CO ) increased relative to baseline during peak Cyc ( P < 0.05 ) but did not change during submaximal Cyc or upper or lower limb exercise . Heart rate ( HR ) was lowest during upper limb exercise and progressively increased during lower limb exercise , submaximal Cyc , and peak Cyc , with significant differences between each of these ( P < 0.01 ) . Conversely , stroke volume ( SV ) decreased during submaximal Cyc and lower limb exercise and was lower during peak and submaximal Cyc and lower limb exercise than during upper limb exercise ( P < 0.05 ) . CHF patients are dependent on increases in HR to increase CO during exercise when SV may decline . Resistance exercise , performed at appropriate intensity , induces a similar hemodynamic burden to aerobic exercise in patients with CHF Background : In chronic heart failure ( CHF ) , cardiac cachexia is often associated with the terminal stage of this disease . In animal studies it has been demonstrated that myostatin , a key regulator of skeletal muscle mass , is elevated in advanced stages of this syndrome . Design : The aim of the present study was to investigate the expression of myostatin in patients with late stage CHF ( NYHA IIIb ) in comparison to healthy subjects . Furthermore the effects of physical exercise on myostatin were analyzed . Methods : Twenty-four patients were either r and omized to a sedentary control group ( CHF-S ) or exercise training ( CHF-E ) . At baseline and after 12 weeks mRNA and myostatin protein in the peripheral skeletal muscle as well as myostatin serum concentration were measured . Furthermore 12 age-matched healthy men were compared to all patients at baseline ( HC ) . Results : CHF patients showed a two-fold increase of myostatin mRNA ( p = 0.05 ) and a 1.7-fold ( p = 0.01 ) augmentation of protein content in skeletal muscle compared to healthy subjects . In late-stage CHF , exercise training led to a 36 % reduction of the mRNA and OUTPUT: Subgroup analysis revealed that AE reduced LVEDV ( − 10.21 ml ; P = 0.007 , I2 = 0 % ) , while RT and combined RT and AE had no effect on LVEDV compared with control participants . RT results in a greater gain in V̇O2$$ \dot{\mathrm{V}}{\mathrm{O}}_2 $ $ peak , and induces no deleterious effects on cardiac function in HF patients INPUT: Objective To examine the reproducibility and responsiveness to change of a six minute walk test and a quality of life measure in elderly patients with heart failure . Design Longitudinal within patient study . Subjects 60 patients with heart failure ( mean age 82 years ) attending a geriatric outpatient clinic , 45 of whom underwent a repeat assessment three to eight weeks later . Main outcome measures Subjects underwent a st and ardised six minute walk test and completed the chronic heart failure question naire ( CHQ ) , a heart failure specific quality of life question naire . Intraclass correlation coefficients ( ICC ) were calculated using a r and om effects one way analysis of variance as a measure of reproducibility . Guyatt ’s responsiveness coefficient and effect sizes were calculated as measures of responsiveness to change . Results 24 patients reported no major change in cardiac status , while seven had deteriorated and 14 had improved between the two clinic visits . Reproducibility was satisfactory ( ICC > 0.75 ) for the six minute walk test , for the total CHQ score , and for the dyspnoea , fatigue , and emotion domains of the CHQ . Effect sizes for all measures were large ( > 0.8 ) , and responsiveness coefficients were very satisfactory ( > 0.7 ) . Effect sizes for detecting deterioration were greater than those for detecting improvement . Conclusions Quality of life assessment and a six minute walk test are reproducible and responsive measures of cardiac status in frail , very elderly patients with heart failure The assessment of functional capacity reflects the ability to perform activities of daily living that require sustained aerobic metabolism . The integrated efforts and health of the pulmonary , cardiovascular , and skeletal muscle systems dictate an individual ’s functional capacity . Numerous investigations have demonstrated that the assessment of functional capacity provides important diagnostic and prognostic information in a wide variety of clinical and research setting s. This scientific statement , an up date of the previously published American Heart Association ( AHA ) document,1 highlights the major clinical and research applications of functional capacity assessment . For a comprehensive review of exercise testing , the reader is referred to the American College of Cardiology (ACC)/AHA Guidelines for Exercise Testing.2,3 Functional capacity is the ability of an individual to perform aerobic work as defined by the maximal oxygen uptake ( Vo2max ) , that is , the product of cardiac output and arteriovenous oxygen ( a−Vo2 ) difference at physical exhaustion , as shown in the following equation : ! [Formula][1 ] Where HR indicates heart rate and SV indicates stroke volume . Because Vo2max typically is achieved by exercise that involves only about half of the total body musculature , it is generally believed that Vo2max is limited by maximal cardiac output rather than peripheral factors.4 Although Vo2max is measured in liters of oxygen per minute , it usually is expressed in milliliters of oxygen per kilogram of body weight per minute to facilitate intersubject comparisons . In addition , functional capacity , particularly when estimated from the work rate achieved rather than directly measured Vo , is frequently expressed in metabolic equivalents ( METs ) , with 1 MET representing the resting energy expenditure ( ≈3.5 mL O2 · kg−1 · min−1 ) . In this instance , functional capacity is commonly expressed clinical ly as a multiple of the resting metabolic rate . Vo2max … [ 1 ] : CONTEXT Heart failure is often preceded by isolated systolic hypertension , but the effectiveness of antihypertensive treatment in preventing heart failure is not known . OBJECTIVE To assess the effect of diuretic-based antihypertensive stepped-care treatment on the occurrence of heart failure in older persons with isolated systolic hypertension . DESIGN Analysis of data from a multicenter , r and omized , double-blind , placebo-controlled clinical trial . PARTICIPANTS A total of 4736 persons aged 60 years and older with systolic blood pressure between 160 and 219 mm Hg and diastolic blood pressure below 90 mm Hg who participated in the Systolic Hypertension in the Elderly Program ( SHEP ) . INTERVENTION Stepped-care antihypertensive drug therapy , in which the step 1 drug is chlorthalidone ( 12.5 - 25 mg ) or matching placebo , and the step 2 drug is atenolol ( 25 - 50 mg ) or matching placebo . MAIN OUTCOME MEASURES Fatal and nonfatal heart failure . RESULTS During an average of 4.5 years of follow-up , fatal or nonfatal heart failure occurred in 55 of 2365 patients r and omized to active therapy and 105 of the 2371 patients r and omized to placebo ( relative risk [ RR ] , 0.51 ; 95 % confidence interval [ CI ] , 0.37 - 0.71 ; P<.001 ; number needed to treat to prevent 1 event [ NNT ] , 48 ) . Among patients with a history of or electrocardiographic evidence of prior myocardial infa rct ion ( MI ) , the RR was 0.19 ( 95 % CI , 0.06 - 0.53 ; P=.002 ; NNT , 15 ) . Older patients , men , and those with higher systolic blood pressure or a history of or electrocardiographic evidence of MI at baseline had higher risk of developing heart failure . CONCLUSION In older persons with isolated systolic hypertension , stepped-care treatment based on low-dose chlorthalidone exerted a strong protective effect in preventing heart failure . Among patients with prior MI , an 80 % risk reduction was observed BACKGROUND We prospect ively evaluated the potential of the 6-minute walk test compared with peak VO2 in predicting outcome of patients with New York Heart Association ( NYHA ) class II or III heart failure . METHODS AND RESULTS Patients with a history of heart failure caused by systolic dysfunction were included . The combined final outcome ( death or hospitalization for heart failure ) was used as the judgment criterion . One hundred twenty-one OUTPUT:

Comparison of the studies investigating reliability shows that the 6MWT has good reproducibility . The 6MWT demonstrates moderate correlation with peak VO(2 ) levels , and ability to predict VO(2 ) ( functional capacity ) dependent on distance walked . Cut-off distances vary from 300 to 490 meters depending on the study ; if total distance walked remains equal or less than these values , the 6MWT retains its strong predictive value . The 6MWT has good reliability , moderate validity , and a significant ability to predict functional capacity in patients with CHF who do not walk greater than 490 meters

MS2_dynamic_1_shot539

***TASK*** the task is to summarize an input biomedical literature 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 investigate the risk of first-time acute coronary syndrome ( ACS ) , stroke and venous thromboembolism ( VTE ) in patients with ankylosing spondylitis ( AS ) , psoriatic arthritis ( PsA ) and undifferentiated spondyloarthritis ( uSpA ) , compared to each other and to the general population ( GP ) . Methods This is a prospect i ve nationwide cohort study . Cohorts with AS ( n = 6448 ) , PsA ( n = 16,063 ) and uSpA ( n = 5190 ) patients and a GP ( n = 266,435 ) cohort , were identified 2001–2009 in the Swedish National Patient and Population registers . The follow-up began 1 January 2006 , or 6 months after the first registered spondyloarthritis ( SpA ) diagnosis thereafter , and ended at ACS/stroke/VTE event , death , emigration or 31 December 2012 . Crude and age- and sex-st and ardized incidence rates ( SIRs ) and hazard ratios ( HRs ) were calculated for incident ACS , stroke or VTE , respectively . Results St and ardized to the GP cohort , SIRs for ACS were 4.3 , 5.4 and 4.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort , respectively , compared to 3.2 in the GP cohort . SIRs for stroke were 5.4 , 5.9 and 5.7 events per 1000 person-years at risk in the AS , PsA and uSpA cohort compared to 4.7 in the GP cohort . Corresponding SIRs for VTE were 3.6 , 3.2 and 3.5 events per 1000 person-years at risk compared to 2.2 in the GP cohort . Age- and sex-adjusted HRs ( 95 % CI ) for ACS events were significantly increased in AS ( 1.54 ( 1.31–1.82 ) ) , PsA ( 1.76 ( 1.59–1.95 ) ) and uSpA ( 1.36 ( 1.05–1.76 ) ) compared to GP . Age-adjusted HRs for ACS was significantly decreased in female AS patients ( 0.59 ( 0.37–0.97 ) ) compared to female PsA patients . Age- and sex-adjusted HRs for stroke events were significantly increased in AS ( 1.25 ( 1.06–1.48 ) ) and PsA ( 1.34 ( 1.22–1.48 ) ) , and nonsignificantly increased in uSpA ( 1.16 ( 0.91–1.47 ) ) compared to GP . For VTE the age- and sex-adjusted HRs for AS , PsA and uSpA were equally and significantly increased with about 50 % compared to GP . Conclusions Patients with AS , PsA and uSpA are at increased risk for ACS and stroke events , which emphasizes the importance of identification of and intervention against cardiovascular risk factors in SpA patients . Increased alertness for VTE is warranted in patients with STUDY OBJECTIVES To underst and reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee . DESIGN A qualitative study , nested within a r and omised controlled trial , examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis . In the intervention arm , participants undertook a series of simple exercises and repositioning of the kneecap using tape . In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions , guided by a topic schedule , to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy . Interviews were audiotaped , fully transcribed and analysed thematically according to the method of constant comparison . A model explaining factors influencing compliance was developed . SETTING Patients were interviewed at home . The study was nested within a pragmatic r and omised controlled trial . PARTICIPANTS Twenty participants in the intervention arm of the r and omised trial were interviewed three months after they had completed the physiotherapy programme . Eight were interviewed again one year later . MAIN RESULTS Initial compliance was high because of loyalty to the physiotherapist . Reasoning underpinning continued compliance was more complex , involving willingness and ability to accommo date exercises within everyday life , the perceived severity of symptoms , attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis . A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms . CONCLUSIONS Non-compliance with physiotherapy , as with drug therapies , is common . From the patient 's perspective , decisions about whether or not to comply are rational but often can not be predicted by therapists or research ers . Ultimately , this study suggests that health professionals need to underst and reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention Fernández-de-las-Peñas C , Alonso-Blanco C , Alguacil-Diego IM , Miangolarra-Page JC : One-year follow-up of two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2006;85:559–567 . Objective : To assess the long-term effects on functional and mobility outcomes of two exercise interventions for the management of patients with ankylosing spondylitis . Design : In an extended 12-mo follow-up of a r and omized controlled trial , 40 patients who were OUTPUT: Conflicting evidence was found as to whether supervision of exercise improved adherence . Adherence to prescribed exercise in SpA was poorly reported and predominately for people with AS . The levels of adherence and factors affecting prescribed exercise in SpA remain unclear . INPUT: Fernández-de-las-Peñas C , Alonso-Blanco C , Morales-Cabezas M , Miangolarra-Page JC : Two exercise interventions for the management of patients with ankylosing spondylitis : A r and omized controlled trial . Am J Phys Med Rehabil 2005;84:407–419 . Objective : The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis ( AS ) on functional and mobility outcomes . Design : R and omized controlled trial . Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a r and om numbers table . The control group was treated with a conventional protocol of physical therapy in AS , whereas the experimental group was treated with the protocol suggested by our research group . The conventional intervention consisted of 20 exercises : motion and flexibility exercises of the cervical , thoracic , and lumbar spine ; stretching of the shortened muscles ; and chest expansion exercises . The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation ( GPR ) method . This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened . The study lasted 4 mos . During this period , patients received a weekly group session managed by an experienced physiotherapist . Each session lasted an hour , and there were 15 total sessions . Changes in activity , mobility , and functional capacity were evaluated by an assessor blinded to the intervention , using the following previously vali date d scores from the Bath group : BASMI ( tragus to wall distance , modified Schöber test , cervical rotation , lumbar side flexion , and intermalleolar distance ) , BASDAI ( The Bath Ankylosing Spondylitis Disease Activity Index ) , and BASFI ( The Bath Ankylosing Spondylitis Functional Index ) . Results : Both groups showed an improvement ( prepost scores ) in all the outcome measures , mobility measures of the BASMI index , as well as in BASFI and BASDAI indexes . In the control group , the improvement in tragus to wall distance ( P = 0.009 ) and in lumbar side flexion ( P = 0.02 ) was statistically significant . Although the rest of the outcomes also improved , they did not reach a significant level ( P > 0.05 ) . In the experimental group , the improvement in all the clinical measures of the BASMI index ( P < 0.01 ) and in the BASFI index ( P = 0.003 ) was statistically significant . The intergroup comparison between the improvement ( prepost scores ) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index , except in tragus to wall distance , as well as in the BASFI index . Conclusions : The experimental protocol developed by our research group , based on the GPR method and specific strengthening and flexibility exercises of the muscle chains , offers promising results in the management of patients suffering from AS . Further trials on this topic are required We investigated the effects of home-based daily exercise on joint mobility , functional capacity , pain , and depression in patients with ankylosing spondylitis ( AS ) . The patients were r and omly assigned to a wait-list control group or to an exercise-therapy group . The exercise-therapy group performed a 20-min exercise program once per day for 8 consecutive weeks . After 8 weeks , compared with the control group , the exercise group showed improvements in joint mobility ( cervical flexion , extension , shoulder flexion , abduction , hip abduction , and knee flexion ) , finger – floor distance , and functional capacity . Pain and depression scores were significantly lower after the exercise program in the exercise group than in the control group . These findings indicate that exercise therapy increases joint mobility and functional capacity , and decreases pain and depression in patients with AS . Home-based exercise , which is easily accessible to patients , might be an effective intervention for AS Abstract . A cohort of 25 patients with spondylarthropathy ( SpA ) participated in a 3-year follow-up study of functional changes before and after an intensive 3-week inpatient course . They answered questions in the following functional status/disability indices : Bath ankylosing spondylitis functional index ( BASFI ) , Dougados functional index ( DFI ) , health assessment question naire for spondylarthropathy ( HAQ-S ) , Bath ankylosing spondylitis disease activity index ( BASDAI ) , Bath ankylosing spondylitis patient global assessment ( BAS-G ) , and horizontal visual analogue scale for stiffness ( stiffness VAS ) before and after the course and 3 years later by mail . A control group of 18 consecutive SpA patients from the waiting list for an inpatient course filled in the same question naires as study patients 3 months before entry and again 3 weeks later at home without rehabilitation . During the waiting time for the inpatient course , control group global assessment s ( BASDAI , BAS-G , and stiffness-VAS ) worsened slightly , and BASFI but not HAQ-S and DFI scores remained unchanged in the 3 weeks without treatment . The results of the 25 study patients showed small and not significant improvements in all functional index scores ( BASFI –0.5 points , DFI –1.1 , and HAQ-S –0.17 ) , whereas improvements were significant in BASDAI , BAS-G , and stiffness-VAS ( –13 mm , –13 mm , and –11 mm , respectively ) after the 3-week inpatient course . At 3-year follow-up , these small changes had disappeared and the changes were not significant . The global indices and BASFI worsened slightly ( 0.4 ) from baseline results , while DFI was slightly better ( –0.4 ) and HAQ-S remained at the post-treatment level after 3 years . Thus , BAS OUTPUT:

The results of this review suggest that an individual home-based or supervised exercise program is better than no intervention ; that supervised group physiotherapy is better than home exercises ; and that combined inpatient spa-exercise therapy followed by group physiotherapy is better than group physiotherapy alone

MS2_dynamic_1_shot540

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results BACKGROUND Reduction of alveolar height and width after tooth extraction may present problems for implant placement , especially in the anterior maxilla where bone volume is important for biologic and esthetic reasons . Different graft material s have been proposed to minimize the reduction in ridge volume . The aim of this study was to compare radiographic and histomorphometric results of magnesium-enriched hydroxyapatite ( MHA ) and calcium sulfate ( CS ) grafts in fresh sockets after tooth extraction s. METHODS Forty-five fresh extraction sockets with three bone walls were selected in 15 patients . A split-mouth design was used : 15 sockets on the right side of the jaw received MHA , 15 sockets on the left side received CS , and 15 r and om unfilled sockets were considered the control ( C ) group . Intraoral digital radiographs were taken at baseline and at 3 months after graft material placement . At 3 months , cylinder bone sample s were obtained for histology and histomorphometry analysis . RESULTS The difference in mean radiographic vertical bone level from baseline to 3 months was -2.48 + /- 0.65 mm in the CS group , -0.48 + /- 0.21 mm in the MHA group , and -3.75 + /- 0.63 mm in the unfilled C group . Statistically significant differences ( P < 0.05 ) were found between CS and MHA groups and between MHA and C groups . Histologic examination revealed bone formation in all treated sites ; trabecular bone assessment did not differ among apical , mesial , and coronal portions of the specimens . Mean vital bone measurements for CS , MHA , and C groups were 45.0 % + /- 6.5 % , 40.0 % + /- 2.7 % , and 32.8 % + /- 5.8 % , respectively . Statistically significant differences ( P < 0.05 ) were found among all groups . Connective tissue percentages averaged 41.5 % + /- 6.7 % for the CS group , 41.3 % + /- 1.3 % for the MHA group , and 64.6 % + /- 6.8 % for the C group . Statistically significant differences ( P < 0.05 ) were found between CS and C groups and between MHA and C groups . The CS-grafted sockets showed 13.9 % + /- 3.4 % residual implant material , whereas the MHA-treated sockets showed 20.2 % + /- 3.2 % residual material . The difference between the groups was statistically significant ( P < 0.05 ) . CONCLUSIONS Radiographs revealed a greater reduction of alveolar ridge in the CS group than in the MHA group . Histologic examination showed more bone formation and faster resorption in the CS group and more residual implant material in the MHA group Background and Purpose : The resorption of alveolar bone following tooth extraction results in a narrowing and shortening of the residual ridge , which leads to esthetic and restorative problems , and reduces the bone volume available for implant therapy . The aim of this study was to evaluate the prevention of alveolar collapse after tooth extraction , using titanium membrane ( Frios Boneshield ; DENTSPLY Friadent , Mannheim , Germany ) , associated ( or not ) with autologous bone graft . Material s and Methods : A total of 10 nonsmoking healthy subjects , ranging from 35 to 60 years old , were selected for this study . Each patient had a minimum of 2 uni-radicular periodontally hopeless teeth , which were scheduled for extraction . After the procedure , 2 titanium pins were fixed on the vestibular bone surfaces that were used as references for the initial measures ( depth , width , and height ) of the socket . Of the sockets,1 was r and omly chosen to be filled with autologous bone graft ( test ) removed from superior maxillary tuber , and the other one did not receive the graft ( control ) . A titanium membrane was adapted and fixed , covering the sockets , which remained for at least 10 weeks . After a 6-month healing , the final measures were performed . Results : There was exposure of the membrane in 5 of the 10 treated subjects . Average bone filling ( ±st and ard deviation ) among the 10 subjects was 8.80 ± 2.93 mm ( range 4 - 13 ) in the control group and 8.40 ± 3.35 mm ( range 4 - 13 ) in the test group . Average bone loss in width in both OUTPUT: During the post- extraction healing period , the weighted mean changes as based on the data derived from the individual selected studies show the clinical loss in width to be greater than the loss in height , assessed both clinical ly as well as radiographically INPUT: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Objective : The aim of this study was to evaluate the performance of a new glass ionomer filling material ( ChemFlex ™ ) using the atraumatic restorative treatment ( ART ) approach in class I cavities in the permanent dentition of Latvian schoolchildren . Methods : A total of 63 fillings ( 40 test and 23 control ) were placed using the ART technique in 41 schoolchildren in Riga at the Stomatology Institute of the Medical Academy of Latvia . These fillings were then blindly assessed after 2 years . Results : The complete success rate for both the test and the control material fillings were 92.5 and 94.9 % , respectively . Conclusion : The new glass ionomer filling has shown a good performance in terms of retention , marginal failure and fractures in class I cavities The present r and omised clinical trial was aim ed at comparing three minimally invasive restorative treatment approaches for managing dental caries in occlusal surfaces using a non-gamma-2 amalgam and a low-viscosity glass-ionomer as the restorative material . The treatment approaches tested in parallel groups were : conventional in a university setting , modified-conventional and ultraconservative ( Atraumatic Restorative Treatment , ART ) approaches in a field setting . A split-mouth design was used in which the two restorative material s were r and omly placed in 430 matched contralateral pairs of permanent molar teeth . A total of 152 children from five primary schools were recruited and treated by a dental therapist . The restorations were evaluated after 6 years by 2 calibrated independent examiners . The 6-year successes for all occlusal amalgam and glass-ionomer restorations were 72.6 and 72.3 % , respectively . There were no statistically significant differences observed between the successes for both amalgam and glass-ionomer restorations placed either by the ART ( 68.6 % , with 95 % CI = 61–76 % ) approach or by the conventional ( 74.5 % , with 95 % CI = 65–82 % ) and the modified-conventional ( 75.8 % , with 95 % CI = 67–83 % ) approaches after 6 years . There was also no statistically significant difference observed between the successes of occlusal ART restorations with glass-ionomer ( 67.1 % , with 95 % CI = 56–77 % ) and occlusal conventional restorations with amalgam ( 74 % , with 95 % CI = 61–85 % ) after 6 years . ‘ Restoration fracture/marginal defects ’ and ‘ loss of material ’ were the most common causes for failure . The former was more often recorded in amalgam restorations and the latter in glass-ionomer restorations . Secondary caries was observed for 2 % of glass-ionomer and for 10 % of amalgam restorations . This difference was statistically significant ( p = 0.001 ) . The ART approach using glass-ionomer performed equally well as conventional restorative approaches using electrically driven equipment and amalgam for treating dentinal lesions in occlusal surfaces after 6 years OBJECTIVE To compare the survival of glass ionomer cement ( GIC ) restorations placed in a dental clinic setting using both the atraumatic restorative treatment ( ART ) approach with h and instruments , and conventional cavity preparation with rotary instruments . METHOD AND MATERIAL S Two encapsulated high-strength conventional GICs ( Fuji IX GP , Ketac-Molar Aplicap ) were placed in 82 Class I and 53 Class II preparations and one encapsulated non-gamma 2 amalgam alloy ( GK-amalgam ) was placed in 32 Class I preparations , in the primary molars of 60 Chinese children with a mean age of 7.40 + /- 1.24 ( SD ) years . Thus , 9 treatment groups were formed . RESULTS After two years , there were no significant survival differences found among 7 of the 9 treatment groups ( p = 0.99 ) . However , two groups comprising Fuji IX GP and Ketac-Molar Aplicap placed in Class II cavities prepared using the ART approach showed significantly lower restoration survivals ( p < 0.001 ) . Only 3 of the 72 initially sealed fissures adjacent to the restorations appeared to retain any GIC material . CONCLUSIONS In a clinic setting , both the ART h and instrument and conventional rotary instrument methods were equally suitable for high Class I restoration survival , but not for Class II restoration survival where the conventional cavity preparation method was preferable AIM The aim of this study was to assess OUTPUT:

Studies investigating restorations placed in the primary dentition showed no significant differences between the groups after 12 and 24 months . In the permanent dentition , the longevity of ART restorations is equal to or greater than that of equivalent amalgam restorations for up to 6.3 years and is site-dependent . No difference was observed in primary teeth .

MS2_dynamic_1_shot541

***TASK*** the task is to summarize an input biomedical literature 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 : Two-port laparoscopic cholecystectomy has been reported to be safe and feasible . However , whether it offers any additional advantages remains controversial . This study reports a r and omized trial that compared the clinical outcomes of two-port laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy . Methods : One hundred and twenty consecutive patients who underwent elective laparoscopic cholecystectomy were r and omized to receive either the two-port or the four-port technique . All patients were blinded to the type of operation they underwent . Four surgical tapes were applied to st and ard four-port sites in both groups at the end of the operation . All dressings were kept intact until the first follow-up 1 week after surgery . Postoperative pain at the four sites was assessed on the first day after surgery using a 10-cm unscaled visual analog scale ( VAS ) . Other outcome measures included analgesia requirements , length and difficulty of the operation , postoperative stay , and patient satisfaction score on surgery and scars . Results : Demographic data were comparable for both groups . Patients in the two-port group had shorter mean operative time ( 54.6 ± 24.7 min vs 66.9 ± 33.1 min for the four-post group ; p = 0.03 ) and less pain at individual subcostal port sites [ mean score using 10-cm unscaled VAS : 1.5 vs 2.8 ( p = 0.01 ) at the midsubcostal port site and 1.3 vs 2.3 ( p = 0.02 ) at the lateral subcostal port site ] . Overall pain score , analgesia requirements , hospital stay , and patient satisfaction score on surgery and scars were similar between the two groups . Conclusion : Two-port laparoscopic cholecystectomy result ed in less individual port-site pain and similar clinical outcomes but fewer surgical scars compared to four-port laparoscopic cholecystectomy . Thus , it can be recommended as a routine procedure in elective laparoscopic cholecystectomy Advances in instrumentation have led to the development of 2-mm laparoscopic equipment . The purpose of our investigation was to vali date the safety and efficacy of laparoscopic cholecystectomy ( LC ) using one 10-mm and three 2-mm ports ( mini-LC ) . Mini-LC was performed using a 2-mm fiberoptic videolaparoscope inserted via a midepigastric port , 2-mm graspers inserted via right upper quadrant ports , and st and ard dissection , clipping , and cautery instruments inserted via the umbilical port . Data from 100 sequential patients were acquired between July 1996 and August 1997 and compared with those of 100 sequential patients who had undergone conventional LC ( C-LC ) . The operative time ranged from 30 to 256 minutes for the mini-LC group and 25 to 255 minutes for the C-LC group , with means of 89 and 82 minutes , respectively ( P > 0.05 ) . Postoperative length of stay ranged from 0 to 18 days for the mini-LC group and 0 to 21 days for the C-LC group , with means of 1.5 and 1.9 days , respectively ( P > 0.05 ) . There were no conversions to open cholecystectomy . These data suggest that a more minimalist approach to laparoscopic cholecystectomy can be accomplished safely and effectively The main objectives of minisite cholecystectomy ( MC ) are to have smaller incisions , better cosmetic results , less trauma , and a lower morbidity rate . This prospect i ve r and omized study compares MC with conventional laparoscopic cholecystectomy ( CLC ) in terms of surgical trauma and cosmetic results in 44 patients . Conversion from MC to CLC was required in five patients . No conversion to open surgery was needed in the CLC group . The average operating time was slightly longer in the MC group , but the difference was not statistically significant ( 81 minutes versus 72 minutes , p=0.22 ) . The population characteristics , postoperative respiratory function measurements , pain scores , and analgesic requirements were similar in the two groups . The average score for scar tissue was significantly lower in the MC group ( 0.73 versus 1.93 , p=0.0045 ) . Only the cosmetic results of MC were superior to CLC . This technique could be a feasible alternative procedure in patients seeking better cosmetic results . However , further studies with larger sample sizes are needed to evaluate the postoperative morbidity of MC.RésuméLes objectifs principaux de la cholécystectomie laparoscopique minime ( CM ) ( par mini-trocars ) sont de réaliser de plus petites incisions , d’obtenir un meilleur résultat esthétique , de provoquer moins de trauma et d’avoir un taux plus bas de morbidité que la cholécystectomie par laparoscopic classique . Cette étude prospect i ve r and omisée a comparé la CM à la cholécystectomie par laparoscopic ( CL ) traditionnelle en termes de traumatisme chirurgical et de résultat esthétique chez 44 patients . On a du convertir la CM en CL chez cinq patients . Aucune conversion vers la chirurgie ouverte n’a été nécessaire dans le groupe de CL traditionnelle . Le temps moyen d’intervention a été plus long dans le groupe CM mais cette différence n’était pas statistiquement significative ( 81 min vs. 72 min , p=0.22 ) . Les caractéristiques de la population , les fonctions respiratoires , les scores de la douleur et les besoins en analgésiques étaient similaires dans les deux groupes . Les scores moyens d’évaluation de la cicatrice ont été significativement plus bas dans le groupe CM ( 0.73 vs. 1.93 OUTPUT: Although minilaparoscopic surgeries were converted , more often there was not a trend toward increased conversion to an open technique . INPUT: Opinion is divided whether intra-operative cholangiography should be performed routinely or on a selective basis during laparoscopic cholecystectomy . We therefore performed the first prospect i ve r and omized trial of static cholangiography in patients who did not have indications for cholangiograms . Laparoscopic cholecystectomy was attempted on 164 consecutive patients , of whom 49 ( 30 % ) patients were excluded from the trial due to indications for or against cholangiography . In the remaining 115 ( 70 % ) patients , 56 were r and omized to the cholangiography group while 59 patients did not receive cholangiograms . Duration of postoperative hospitalization and interval to return to full activity were identical in the two groups . Static cholangiograms added 16 ± 1 min ( mean ± SEM ) to the procedures ( p<0.01 ) . Cholangiography increased the total charges for the operation by almost $ 700 ( p<0.01 ) . Cholangiograms were performed successfully in 94.6 % of the patients and changed the operative management in 4 ( 7.5 % ) patients . There was 1 ( 1.9 % ) false negative study . Intra-operative cholangiography did not reveal aberrant bile ducts at risk of injury from the operative dissection . There was no mortality or cholangiogram-related morbidity in either group . In follow-up ranging from 2–12 months , there has been no clinical evidence of bile duct injury or retained common bile duct stones . In summary , in patients without indications for cholangiography , the performance of static cholangiograms markedly increased the operative time and cost of laparoscopic cholecystectomy . The operative management of a minority of patients was changed by the information obtained , but laparoscopic cholecystectomy may be performed safely in the absence of cholangiograms with little risk of injury to the major ductal system or retained calculi . RésuméLes avis sont partagés quant à la pratique systématique , ou seulement élective , d'une cholangiographie lors de la cholécystectomie coelioscopique . Nous avons mené le premier essai r and omisé prospect if de cholangiographie peropératoire chez des patients n'ayant pas d'indication formelle de cholangiographie . Dans une série de 164 cholécystectomies coelioscopiques consécutives , 49 patients ( 30 % ) ont été éliminés de l'étude parce qu'il existait une indication ou une contreindication formelles à la cholangiographie peropératoire . Les 115 patients restants ( 70 % ) ont été r and omisés ; 56 ont eu une cholangiographie alors que 59 n'ont pas eu de cholangiographie peropératoire . La durée de l'hospitalisation postopératoire et le délai entre l'intervention et la reprise de travail étaient similaires dans les deux groupes . La cholangiographie a prolongé l'intervention de 16 ± 1 min ( moyenne ± écart type de la moyenne ) ( p<0.01 ) . Le coût supplémentaire d'une cholangiographie peropératoire a été estimé à environ 700 $ US ( p<0.01 ) . La cholangiographie a pu être effectuée chez 94.6 % des patients , et celle-ci a changé la tactique opératoire chez 4 ( 7.5 % ) patients . Il y a eu un résultat faussement négatif ( 1.9 % ) . La cholangiographie peropératoire n'a pas montré d'anomalie anatomique des voies biliares pouvant les compromettre lors de la dissection . La mortalité a été nulle dans chaque groupe . De même , il n'y a eu aucune morbidité en rapport direct avec la cholangiographie . Dans la période du suivi allant de 2 à 12 mois , il n'y a eu acune lésion biliaire ni de lithiase résiduelle de la voie biliaire cliniquement évidentes . En conclusion , chez un patients ans indication formelle de cholangiographie , la réalisation d'une cholangiographie peropératoire augmente considérablement la durée et le coût de l'intervention . La tactique opératoire a été très peu influencée très peu par les donées de la cholangiographie . La cholécystectomie coelioscopique peut être réalisée sans cholangiographie peropératoire systématique sans augmenter pour autant le risque de lésions des voies biliaires ou de calcul résiduel . ResumenLas opiniones se encuentran divididas respecto a si se debe realizar colangiografía intraoperatoria en forma rutinaria o en forma selectiva en el curso de una colecistectomía laparoscópica . Por ello hemos realizado el primer estudio aleatorizado de colangiografía estática en pacientes que no tenían indicaciones para colangiograma . Se intentó la colecistectomía laparoscópica en 164 pacientes consecutivos ; 49 ( 30 % ) fueron excluidos debido a indicaciones en favor o en contra de colangiografía . Los otros 115 pacientes ( 70 % ) se repartieron al azar 56 a colangiografía y 59 al grupo de no colangiografía . La duración de la hospitalización postoperatoria y del tiempo de retorno a actividad normal fueron idénticos en los dos grupos . Los colangiogramas estáticos añadieron 16 ± 1 min . al procedimiento ( p<0.01 ) y elevaron el costo de la operación en $ 700 ( p<0.01 ) . Los colangiogramas fueron exit OUTPUT:

N-OTC is associated with shorter operative time and fewer peri-operative complications , and it is comparable to R-OTC in terms of CBD injury risk during cholecystectomy . R-OTC is helpful for peri-operative CBD stone detection and there is therefore reduced readmission for retained CBD stones . The N-OTC approach may be adopted routinely for patients undergoing laparoscopic cholecystectomy providing there are no clinical , biochemical or radiological features suggestive of CBD stones .

MS2_dynamic_1_shot542

***TASK*** the task is to summarize an input biomedical literature 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 COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved BACKGROUND The Patient Assessment of Constipation- Quality of Life ( PAC-QOL ) is a self-reported question naire measuring health-related quality of life ( HRQL ) of constipated patients and was used as secondary endpoint in three identical double-blind , r and omized , placebo-controlled Phase III clinical trials . These 12-week trials in subjects with severe chronic constipation evaluated the effects of prucalopride , a selective 5-HT(4 ) agonist given orally once daily . METHODS To consoli date the main treatment effect results observed in the prucalopride trial population s , analyses were undertaken on the pooled data of the three trials to confirm the psychometric properties of the PAC-QOL and to provide guidance for the interpretation of the clinical significance of its scores . KEY RESULTS The evaluation of the psychometric properties confirmed the PAC-QOL reliability , validity and responsiveness to measure the impact of chronic constipation symptoms on HRQL in the prucalopride trials . The 1-point improvement in PAC-QOL scores used as target response level for the main treatment effect analyses was vali date d as a relevant definition of response for treatment group comparisons . Cumulative distribution curves , drawn for each treatment group to provide more complete information on treatment effects than single minimal important difference point estimates , demonstrated consistent superior effects of prucalopride over placebo on all PAC-QOL scores . CONCLUSIONS & INFERENCES The PAC-QOL question naire is a useful measurement tool to assess , from a patient perspective , the potential therapeutic value of chronic constipation treatments in clinical trials and , by directly reflecting the patient 's own perspective on constipation and its treatment , eventually also for informing daily medical practice The Memorial Symptom Assessment Scale ( MSAS ) is a new patient-rated instrument that was developed to provide multidimensional information about a diverse group of common symptoms . This study evaluated the reliability and validity of the MSAS in the cancer population . R and omly selected in patients and out patients ( n = 246 ) with prostate , colon , breast or ovarian cancer were assessed using the MSAS and a battery of measures that independently evaluate phenomena related to quality of life . Symptom prevalence in the 218 evaluable patients ranged from 73.9 % for lack of energy to 10.6 % for difficulty swallowing . Based on a content analysis , three symptoms were deleted and two were added ; the revised scale evaluates 32 physical and psychological symptoms . A factor analysis of variance yielded two factors that distinguished three major symptom groups and several subgroups . The major groups comprised psychological symptoms ( PSYCH ) , high prevalence physical symptoms ( PHYS H ) , and low prevalence physical symptoms ( PHYS L ) . Internal consistency was high in the PHYS H and PSYCH groups ( Cronback alpha coefficients of 0.88 and 0.83 , respectively ) , and moderate in the PHYS L group ( alpha = 0.58 ) . Although the severity , frequency and distress dimensions were highly intercorrelated , canonical correlations and other analyses demonstrated that multidimensional assessment ( frequency and distress ) augments information about the impact of symptoms . High correlations with clinical status and quality of life measures support the validity of the MSAS and indicate the utility of several subscale scores , including PSYCH , PHYS , and a brief Global Distress Index . The MSAS is a reliable and valid instrument for the assessment of symptom prevalence , characteristics and distress . It provides a method for comprehensive symptom assessment that may be useful when information about symptoms is desirable , such as clinical trials that incorporate quality of life measures or studies of symptom epidemiology Background / Aim : A large number of diseases are ascribed to Helicobacter pylori ( H. pylori ) , particularly chronic active gastritis , peptic ulcer disease and gastric cancer . Successful treatment of H. pylori infection with antimicrobial agents can lead to regression of H. pylori – associated disorders . Antibiotic resistance against H. pylori is increasing , and it is necessary to find new effective agents . Nigella sativa seed ( NS ) , a commonly used herb , possesses in vitro anti-helicobacter activity . The present study was undertaken to evaluate the efficacy of NS in eradication of H. pylori infection in non-ulcer dyspeptic patients . Material s and Methods : The study was conducted on 88 adult patients attending King Fahd Hospital of the University , Al-Khobar , Saudi Arabia OUTPUT: : GI PROs cover a wide range of biopsychosocial symptoms . Although plentiful , GI PROs are limited by low method ological quality . INPUT: Background The COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved The present study cross-vali date d self-report pain scales : Verbal Rating Scale ( VRS ) , Facial Expression Scale ( FACES ) , Color Analogue Scale ( CAS ) and Poker Chip Tool ( PCT ) in Thai children aged 5 - 12 years . The concordance with observational measure , Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) was also tested . Among 100 students , test-retest reliability of all self-report measures was moderate to good ( K = 0.501 - 0.712 ) and only FACES yielded acceptable face validity(IC > 0.5 ) . Validation in 87 patients , all scales showed construct and concurrent validity . FACES was the most preferred scale . Agreement of self-report measures and CHEOPS was better in the age group 5 - 8 years ( K = 0.417 - 0.826 ) than 9 - 12 years ( K = 0.231 - 0.529 ) . In conclusion , FACES is a valid , reliable and practical tool . Self-report measures are more in concordance with CHEOPS in the younger age group OBJECTIVE To determine the construct , content , and convergent validity of 2 self-report pain scales for use in the untrained child in the emergency department ( ED ) . METHODS A prospect i ve study was conducted of all children who presented to an urban ED between 5 and 16 years of age inclusive after written informed consent was obtained . Children were excluded if they were intoxicated , had altered sensorium , were clinical ly unstable , did not speak English , or had developmental delays . Children marked their current pain severity on a st and ardized Color Analog Scale ( CAS ) and a 7-point Faces Pain Scale ( FPS ) . They were then asked whether their pain was mild , moderate , or severe . Children were then administered an analgesic at the discretion of the attending physician and asked to repeat these measurements . For assessing content validity , the scales were also administered to age- and gender-matched children in the ED for nonpainful conditions . Convergent validity was assessed by determining the Spearman correlation coefficient between the 2 pain scales . RESULTS A total of 60 children were enrolled , 30 with pain and 30 without , with a mean age of 9.3 + /- 3.3 years . Boys accounted for 38 of the enrollees ( 63.3 % ) . The median score before analgesic administration was 6.0 cm ( interquartile range [ IQR ] : 4.0 - 8.0 ) on the CAS and 3.0 faces ( IQR : 2.0 - 5.0 ) on the FPS ; after analgesic administration , the median scores decreased to 3.1 cm ( IQR : 1.1 - 4.3 ) and 2.0 faces ( IQR : 1.0 - 3.0 ) , respectively . As the reported pain intensity increased , so did the scores on the 2 pain scales . The 30 children with no pain had a median score on the CAS of 0.0 ( IQR : 0.0 - 1.0 ) and on the FPS of 0.0 ( IQR : 0.0 - 1.0 ) , whereas the 13 children with severe pain had a median CAS of 7.0 ( IQR : 6.0 - 8.0 ) and a median FPS of 5.0 ( IQR : 4.0 - 6.0 ) . The Spearman correlation coefficient between the CAS and the FPS was positive and strong ( r = 0.894 ) . CONCLUSION The CAS and the FPS exhibit construct , content , and convergent validity in the measurement of acute pain in children in the ED Objective To evaluate the psychometric properties of 4 measures of acute pain in youth with sickle cell disease ( SCD ) during a medical procedure . Methods Heart rate , child self-report , parent proxy-report , and observable pain behaviors were examined in 48 youth with SCD ages 2 to 17 years . Criterion validity for acute pain was assessed by responsiveness to a st and ardized painful stimulus ( venipuncture ) in a prospect i ve pre-post design . Convergent validity was evaluated through the correlation across measures in reactivity to the stimulus . Results Child self-reported pain , parent proxy-report , and behavioral distress scores increased in response to venipuncture ( concurrent and convergent validity ) . OUTPUT:

Based on available evidence , the NRS-11 , FPS-R , and CAS were strongly recommended for self-report of acute pain . Only weak recommendations could be made for self-report measures for postoperative and chronic pain . No measures were recommended for children younger than 6 years , identifying a need for further measurement refinement in this age range .

MS2_dynamic_1_shot543

***TASK*** the task is to summarize an input biomedical literature 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 Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches Background — The long-term impact of chronic heart failure management programs over the typical life span of affected individuals is unknown . Methods and Results — The effects of a nurse-led , multidisciplinary , home-based intervention ( HBI ) in a typically elderly cohort of patients with chronic heart failure initially r and omized to either HBI ( n=149 ) or usual postdischarge care ( UC ) ( n=148 ) after a short-term hospitalization were studied for up to 10 years of follow-up ( minimum 7.5 years of follow-up ) . Study end points were all-cause mortality , event-free survival ( event was defined as death or unplanned hospitalization ) , recurrent hospital stay , and cost per life-year gained . Median survival in the HBI cohort was almost twice that of UC ( 40 versus 22 months ; P<0.001 ) , with fewer deaths overall ( HBI , 77 % versus 89 % ; adjusted relative risk , 0.74 ; 95 % CI , 0.53 to 0.80 ; P<0.001 ) . HBI was associated with prolonged event-free survival ( median , 7 versus 4 months ; P<0.01 ) . HBI patients had more unplanned readmissions ( 560 versus 550 ) but took 7 years to overtake UC ; the rates of readmission ( 2.04±3.23 versus 3.66±7.62 admissions ; P<0.05 ) and related hospital stay ( 14.8±23.0 versus 28.4±53.4 days per patient per year ; P<0.05 ) were significantly lower in the HBI group . HBI was associated with 120 more life-years per 100 patients treated compared with UC ( 405 versus 285 years ) at a cost of $ 1729 per additional life-year gained when we accounted for healthcare costs including the HBI . Conclusions — In altering the natural history of chronic heart failure relative to UC ( via prolonged survival and reduced frequency of recurrent hospitalization ) , HBI is a remarkably cost- and time-effective strategy over the longer term 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 AIMS To test the effect of education and support by a nurse on self-care and re source utilization in patients with heart failure . METHODS A total of 179 patients ( mean age 73 , 58 % male , NYHA III-IV ) hospitalized with heart failure were evaluated prospect ively . Patients were r and omized to the study intervention or to ' care as usual ' OUTPUT: No significant differences were observed in quality of life . In conclusion , TC improves transitions for older patients and should be included in the reorganization of healthcare services INPUT: BACKGROUND Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches Background — The long-term impact of chronic heart failure management programs over the typical life span of affected individuals is unknown . Methods and Results — The effects of a nurse-led , multidisciplinary , home-based intervention ( HBI ) in a typically elderly cohort of patients with chronic heart failure initially r and omized to either HBI ( n=149 ) or usual postdischarge care ( UC ) ( n=148 ) after a short-term hospitalization were studied for up to 10 years of follow-up ( minimum 7.5 years of follow-up ) . Study end points were all-cause mortality , event-free survival ( event was defined as death or unplanned hospitalization ) , recurrent hospital stay , and cost per life-year gained . Median survival in the HBI cohort was almost twice that of UC ( 40 versus 22 months ; P<0.001 ) , with fewer deaths overall ( HBI , 77 % versus 89 % ; adjusted relative risk , 0.74 ; 95 % CI , 0.53 to 0.80 ; P<0.001 ) . HBI was associated with prolonged event-free survival ( median , 7 versus 4 months ; P<0.01 ) . HBI patients had more unplanned readmissions ( 560 versus 550 ) but took 7 years to overtake UC ; the rates of readmission ( 2.04±3.23 versus 3.66±7.62 admissions ; P<0.05 ) and related hospital stay ( 14.8±23.0 versus 28.4±53.4 days per patient per year ; P<0.05 ) were significantly lower in the HBI group . HBI was associated with 120 more life-years per 100 patients treated compared with UC ( 405 versus 285 years ) at a cost of $ 1729 per additional life-year gained when we accounted for healthcare costs including the HBI . Conclusions — In altering the natural history of chronic heart failure relative to UC ( via prolonged survival and reduced frequency of recurrent hospitalization ) , HBI is a remarkably cost- and time-effective strategy over the longer term Abstract Objectives : To determine whether specialist nurse intervention improves outcome in patients with chronic heart failure . Design : R and omised controlled trial . Setting : Acute medical admissions unit in a teaching hospital . Participants : 165 patients admitted with heart failure due to left ventricular systolic dysfunction . The intervention started before discharge and continued thereafter with home visits for up to 1 year . Main outcome measures : Time to first event analysis of death from all causes or readmission to hospital with worsening heart failure . Results : 31 patients ( 37 % ) in the intervention group died or were readmitted with heart failure compared with 45 ( 53 % ) in the usual care group ( hazard ratio=0.61 , 95 % confidence interval 0.33 to 0.96).Compared with usual care , patients in the intervention group had fewer readmissions for any reason ( 86 v 114 , P=0.018 ) , fewer admissions for heart failure ( 19 v 45 , P<0.001 ) and spent fewer days in hospital for heart failure ( mean 3.43 v 7.46 days , P=0.0051 ) . Conclusions : Specially trained nurses can improve the outcome of patients admitted to hospital with heart failure . What is already known on this topic Studies have suggested that nurse intervention may reduce readmission in patients with heart failure What this study adds Home based intervention from nurses reduces readmissions for worsening heart failure Regular contact to review treatment and patient education are likely to contribute to this Cardiac pain arising from chronic stable angina ( CSA ) is a cardinal symptom of coronary artery disease and has a major negative impact on health-related quality of life ( HRQL ) , including pain , poor general health status , and inability to self-manage . Current secondary prevention approaches lack adequate scope to address CSA as a multidimensional ischemic and persistent pain problem . This trial evaluated the impact of a low-cost six-week angina psychoeducation program , entitled The Chronic Angina Self-Management Program ( CASMP ) , on HRQL , self-efficacy , and re source fulness to self-manage ang OUTPUT:

However , there were no consistent relationships observed between intervention characteristics and the effects of interventions . Most trials review ed demonstrated a beneficial impact of nursing interventions for secondary prevention in patients with CAD or heart failure .

MS2_dynamic_1_shot544

***TASK*** the task is to summarize an input biomedical literature 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: Several experimental studies have shown that melatonin has an oncostatic action , either by stimulating host antitumor immune defenses or by directly inhibiting the growth of some cancer histotypes , including melanoma . Our previous clinical studies demonstrated that melatonin may induce stabilization of the disease in untreatable metastatic solid tumor patients , and these results have been confirmed by others , at least in patients with metastatic melanoma . On the contrary , at present there are no data related to the possible efficacy of melatonin as an adjuvant endocrine therapy . This study was performed to investigate the impact of melatonin therapy on the disease-free survival ( DFS ) in melanoma patients surgically treated for regional node recurrence . The study included 30 node-relapsed melanoma patients , who were r and omized to receive no treatment or adjuvant therapy of melatonin ( 20 mg/day orally in the evening ) every day until disease progression . After a median follow up of 31 months , the percent of DFS was significantly higher in melatonin-treated individuals than in controls . The DFS curve was also significantly longer in melatonin group than in controls . No melatonin-related toxicity was observed . This preliminary study suggests that an adjuvant endocrine therapy with melatonin may be effective in preventing disease progression in node-relapsed melanoma patients Our previous experimental studies have shown that the best approach to increase the biological anti-tumour activity of interleukin 2 ( IL-2 ) is not co-administration of another cytokine , but the association with immunomodulating neurohormones , in an attempt to reproduce the physiological links between psychoendocrine and immune systems , which play a fundamental role in the regulation of the immune responses . In particular , the association with the pineal neurohormone melatonin ( MLT ) has been shown to cause tumour regressions in neoplasms that are generally non-responsive to IL-2 alone . To confirm these preliminary results , a clinical trial was performed in locally advanced or metastatic patients with solid tumours other than renal cell cancer and melanoma . The study included 80 consecutive patients , who were r and omised to be treated with IL-2 alone subcutaneously ( 3 million IU day-1 at 8.00 p.m. 6 days a week for 4 weeks ) or IL-2 plus MLT ( 40 mg day-1 orally at 8.00 p.m. every day starting 7 days before IL-2 ) . A complete response was obtained in 3/41 patients treated with IL-2 plus MLT and in none of the patients receiving IL-2 alone . A partial response was achieved in 8/41 patients treated with IL-2 plus MLT and in only 1/39 patients treated with IL-2 alone . Tumour objective regression rate was significantly higher in patients treated with IL-2 and MLT than in those receiving IL-2 alone ( 11/41 vs 1/39 , P < 0.001 ) . The survival at 1 year was significantly higher in patients treated with IL-2 and MLT than in the IL-2 group ( 19/41 vs 6/39 , P < 0.05 ) . Finally , the mean increase in lymphocyte and eosinophil number was significantly higher in the IL-2 plus MLT group than in patients treated with IL-2 alone ; on the contrary , the mean increase in the specific marker of macrophage activation neopterin was significantly higher in patients treated with IL-2 alone . The treatment was well tolerated in both groups of patients . This study shows that the concomitant administration of the pineal hormone MLT may increase the efficacy of low-dose IL-2 subcutaneous therapy BACKGROUND Exposure to light at night may increase the risk of breast cancer by suppressing the normal nocturnal production of melatonin by the pineal gl and , which , in turn , could increase the release of estrogen by the ovaries . This study investigated whether such exposure is associated with an increased risk of breast cancer in women . METHODS Case patients ( n = 813 ) , aged 20 - 74 years , were diagnosed from November 1992 through March 1995 ; control subjects ( n = 793 ) were identified by r and om-digit dialing and were frequency matched according to 5-year age groups . An in-person interview was used to gather information on sleep habits and bedroom lighting environment in the 10 years before diagnosis and lifetime occupational history . Odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) were estimated by use of conditional logistic regression , with adjustment for other potential risk factors . RESULTS Breast cancer risk was increased among subjects who frequently did not sleep during the period of the night when melatonin levels are typically at their highest ( OR = 1.14 for each night per week ; 95 % CI = 1.01 to 1.28 ) . Risk did not increase with interrupted sleep accompanied by turning on a light . There was an indication of increased risk among subjects with the brightest bedrooms . Graveyard shiftwork was associated with increased breast cancer risk ( OR = 1.6 ; 95 % CI = 1.0 to 2.5 ) , with a trend of increased risk with increasing years and with more hours per week of graveyard shiftwork ( P = .02 , Wald chi-squared test ) . CONCLUSION The results of this study provide evidence that indicators of exposure to light at night may be associated with the risk of developing breast cancer Hypotension is a frequent side-effect of cancer biotherapies with cytokines . Cytokine-induced hypotension would mainly depend on the stimulation of nitric oxide ( NO ) production , which represents the most effective endogenous vasodilator . Moreover , it has been proven that both biological activity and toxicity of cytokines are influenced by the psychoneuroendocrine system , in particular by the pineal hormone melatonin . To investigate the possible modulatory effect of melatonin on cytokine cardiovascular toxicity , we evaluated the influence of a concomitant melatonin administration on interleukin-2(IL-2)- OUTPUT: Conclusions Melatonin as an adjuvant therapy for cancer led to substantial improvements in tumor remission , 1-year survival , and alleviation of radiochemotherapy-related side effects INPUT: Obesity , the global epidemic health problem , results in chronic disorders . Melatonin supplementation may prevent the adverse health consequences of obesity . The aim of this study was to assess the effects of melatonin supplementation on inflammatory and oxidative stress parameters in obese women . In r and omized , double-blind , placebo-controlled trial , 44 obese women were r and omly assigned to melatonin ( n=22 ) and placebo ( n=22 ) groups . Subjects were supplemented with a daily dose of 6 mg melatonin or placebo with low calorie diet for 40 days . Serum TNF-α , IL-6 , hsCRP , TAC , and MDA levels were assessed before and after intervention . In the melatonin group , mean serum TNF-α , IL-6 , hsCRP , and MDA levels decreased significantly ( p<0.05 ) from 3.52±0.72 pg/ml , 27.12±6.32 pg/ml , 2.54±0.49 mg/l , and 3.81±0.29 nmol/l to 1.73±0.07 , 16.34±6.32 , 1.67±0.27 , and 2.79±0.29 , respectively . Whilst in the placebo group the decrease in values were not statistically significant . Mean TAC level increased slightly ( from 1.11±0.30 to 1.14±0.45 mmol/l ) in the melatonin group whereas it decreased slightly ( from 1.13±0.15 to 1.08±0.21 nmol/l ) in the placebo group . Significant differences were observed only for TNF-α ( p=0.02 ) and IL-6 ( p=0.03 ) between the 2 study groups . Considering the improvements in inflammatory and oxidative stress factors in obese women , it seems that melatonin supplementation may provide beneficial effects in obesity treatment by ameliorating some of its complications . However , further studies are needed to make concise conclusions The objective of the present study was to assess the toxicology of melatonin ( 10 mg ) , administered for 28 days to 40 volunteers r and omly assigned to groups receiving either melatonin ( N = 30 ) or placebo ( N = 10 ) in a double-blind fashion . The following measurements were performed : polysomnography ( PSG ) , laboratory examinations , including complete blood count , urinalysis , sodium , potassium and calcium levels , total protein levels , albumin , blood glucose , triglycerides , total cholesterol , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and very low-density lipoprotein ( VLDL ) , urea , creatinine , uric acid , glutamic-oxalacetic transaminase ( GOT ) , glutamic-pyruvate transaminase ( GPT ) , bilirubin , alkaline phosphatase , gama-glutamic transaminase ( GGT ) , T3 , T4 , TSH , LH/FSH , cortisol , and melatonin serum concentrations . In addition , the Epworth Somnolence Scale ( ESS ) and a sleep diary ( SD ) were also applied to the volunteers 1 wk before each PSG . In addition , the volunteers were asked about possible side effects ( SE ) that appeared during the treatment . The study was carried out according to the following timetable : Visit 0 , filling out the term of consent and inclusion criteria ; Visit 1 , PSG , laboratory examinations , ESS , SD , melatonin serum concentrations ; Visit 2 , SD , melatonin serum concentrations , SE ; Visit 3 , melatonin serum concentrations , PSG , ESS , SE ; Visit 4 , laboratory examinations , SE , melatonin serum concentrations , SD ; and Visit 5 , PSG , ESS , SE . Analysis of the PSG showed a statistically significant reduction of stage 1 of sleep in the melatonin group . No other differences between the placebo and melatonin groups were obtained . In the present study we did not observe , according to the parameters analyzed , any toxicological effect that might compromise the use of melatonin at a dose of 10 mg for the period of time utilized in this study Nonalcoholic fatty liver disease is the most common chronic liver disease and nonalcocholic steatohepatitis ( NASH ) is its advanced form . Oxidative stress and hepatocyte apoptosis may be involved in pathogenesis of NASH and particularly in progress of NASH to liver fibrosis and cirrhosis , which are initiated by the inflammation and which promote the progress of the disease . The aim of this study was to evaluate the effects of melatonin and L-tryptophan on selected biochemical parameters of blood in patients with NASH . Forty five patients with NASH , confirmed by histopathological examination of liver biopsy sample s , were admitted to the study . They were divided into three groups ( I , II and III ) . The first group ( group I , n=15 ) received preparation Essentiale forte 3 times a day and tryptophan 500 mg twice daily for 4 weeks . In the second group ( group II , n=15 ) , Essentiale forte three times a day was administered with melatonin 5 mg applied twice a day for 4 weeks . The third group ( group III , n=15 ) received only Essentiale forte with placebo three times a day for 4 weeks . After four-week treatment we found statistically significant reduction in GGTP , triglycerides and proinflammatory cytokine levels in the melatonin-treated ( group I ) and the L-tryptophan-treated patients ( group II ) . Plasma level of melatonin was significantly elevated in groups treated with tryptophan ( group I ) and melatonin ( group II ) OUTPUT:

The results of the present meta- analysis support that melatonin supplementation could be effective on ameliorating of inflammatory mediators

MS2_dynamic_1_shot545

***TASK*** the task is to summarize an input biomedical literature 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 preliminary trial of oral delta-9-tetrahydrocannabinol ( THC ) demonstrated an analgesic effect of the drug in patients experiencing cancer pain . Placebo and 5 , 10 , 15 , and 20 mg THC were administered double blind to ten patients . Pain relief significantly superior to placebo was demonstrated at high dose levels ( 15 and 20 mg ) . At these levels , substantial sedation and mental clouding were reported Context Because the same systems metabolize cannabinoids and protease inhibitors , cannabinoids might alter viral loads in HIV-infected patients taking protease inhibitors . Contribution In this r and omized trial , 62 HIV-infected patients taking indinavir or nelfinavir received a marijuana cigarette , dronabinol capsule , or placebo capsule three times daily for 21 days . Half of the patients in all three groups had undetectable viral loads during the study , and average changes in viral load with marijuana and dronabinol , relative to placebo , were small . Caution s The findings of no large harmful effects on viral loads with either smoked or oral cannabinoids need to be confirmed in larger and longer trials . The Editors Marijuana has been smoked for medicinal purpose s for centuries ( 1 ) . Introduced into western medicine in 1842 , marijuana was used to treat various illnesses on the basis of its purported analgesic , anticonvulsant , sedative , hypnotic , and antispasmodic properties . With the passage of the Marihuana Tax Act in 1937 , use of marijuana as a therapeutic agent in the United States waned until the substance was removed from the U.S. Pharmacopoeia in 1942 . The Controlled Substances Act of 1970 placed marijuana in the Schedule I category along with other substances deemed to have no medicinal value and high potential for abuse . In 1986 , the U.S. Food and Drug Administration approved a synthetic , oral form of marijuana 's main psychoactive component , delta-9-tetrahydrocannabinol ( dronabinol , Marinol , Roxane Laboratories , Columbus , Ohio ) , for treating chemotherapy-induced nausea and vomiting ( 2 - 5 ) . A r and omized , controlled trial demonstrated that dronabinol increased self-reported appetite but not weight in patients with AIDS-related wasting syndrome ; these findings led to an expansion of the labeling indication for this use in 1992 ( 6 , 7 ) . Before the advent of highly active antiretroviral therapy in the 1990s , many patients infected with HIV-1 experienced wasting as a preterminal manifestation of the disease ( 8) . Patients with AIDS-related wasting syndrome often reported that they preferred smoked marijuana to dronabinol because it was easier to titrate the dose to achieve the desired effect ; smoked marijuana delivers cannabinoids to the bloodstream much more rapidly than dronabinol ( 9 ) . By the mid-1990s , cannabis buyers ' clubs in the San Francisco Bay area were reportedly selling marijuana to 11 000 patients with HIV infection ( 10 - 12 ) . With the increased availability of protease inhibitorcontaining antiretroviral regimens in the mid-1990s , the incidence of AIDS-related wasting syndrome decreased markedly , as did most of the other late-stage opportunistic manifestations of advanced HIV disease ( 13 - 15 ) . Protease inhibitors , which can inhibit or stimulate the hepatic cytochrome P-450 enzyme system , are subject to many significant drugdrug interactions with other agents used in treating HIV infection and its complications ( 16 , 17 ) . The potential for a drugdrug interaction between protease inhibitors and marijuana is worrisome since many HIV-infected patients continue to smoke marijuana as an appetite stimulant or to decrease nausea associated with their antiretroviral therapy ( 18 , 19 ) . The likelihood of such an interaction is supported by the facts that cannabinoids are metabolized by some of the same cytochrome P-450 enzyme isoforms that metabolize the more widely prescribed protease inhibitors and that tetrahydrocannabinol has been shown to inhibit the metabolism of other drugs ( 20 - 23 ) . Although few recent clinical trials have evaluated the potential therapeutic effects of smoked marijuana , significant progress has been made in underst and ing the pharmacology of cannabinoids in humans . Of the two cannabinoid receptors identified , CB1 ( found mainly in cells of the central nervous system ) is thought to be responsible for the neurologic and behavioral effects of marijuana ( 24 , 25 ) . The identification of a CB2 receptor , found predominantly on B lymphocytes and natural killer cells , suggests that cannabinoids may also affect the immune response . Some studies suggest that marijuana can impair the immune system through B-lymphocyte modulation , tumor necrosis factor inhibition , or changes in the phenotype and function of circulating lymphocytes ( 26 - 29 ) . The hallmark of successful antiretroviral therapy is sustained suppression of HIV RNA levels associated with increasing CD4 + cell counts ( 30 - 32 ) . Considering the potential for both a protease inhibitorcannabinoid interaction and an effect of smoked marijuana on the immune system , we design ed a study to determine the safety or toxicity profile of cannabinoids ( smoked and oral ) in persons with HIV infection . We chose HIV RNA levels as our primary outcome because an intervention that interacted unfavorably with either the antiretroviral agent pharm OUTPUT: INTERPRETATION Short-term use of existing medical cannabinoids appeared to increase the risk of nonserious adverse events . INPUT: BACKGROUND The Cannabinoid Use in Progressive Inflammatory brain Disease ( CUPID ) trial aim ed to determine whether or not oral Δ(9)-tetrahydrocannabinol ( Δ(9)-THC ) slowed the course of progressive multiple sclerosis ( MS ) ; evaluate safety of cannabinoid administration ; and , improve methods for testing treatments in progressive MS . OBJECTIVES There were three objectives in the CUPID study : ( 1 ) to evaluate whether or not Δ(9)-THC could slow the course of progressive MS ; ( 2 ) to assess the long-term safety of Δ(9)-THC ; and ( 3 ) to explore newer ways of conducting clinical trials in progressive MS . DESIGN The CUPID trial was a r and omised , double-blind , placebo-controlled , parallel-group , multicentre trial . Patients were r and omised in a 2 : 1 ratio to Δ(9)-THC or placebo . R and omisation was balanced according to Exp and ed Disability Status Scale ( EDSS ) score , study site and disease type . Analyses were by intention to treat , following a pre-specified statistical analysis plan . A cranial magnetic resonance imaging ( MRI ) sub study , Rasch measurement theory ( RMT ) analyses and an economic evaluation were undertaken . SETTING Twenty-seven UK sites . PARTICIPANTS Adults aged 18 - 65 years with primary or secondary progressive MS , 1-year evidence of disease progression and baseline EDSS 4.0 - 6.5 . INTERVENTIONS Oral Δ(9)-THC ( maximum 28 mg/day ) or matching placebo . ASSESSMENT VISITS Three and 6 months , and then 6-monthly up to 36 or 42 months . MAIN OUTCOME MEASURES Primary outcomes were time to EDSS progression , and change in Multiple Sclerosis Impact Scale-29 version 2 ( MSIS-29v2 ) 20-point physical subscale ( MSIS-29phys ) score . Various secondary patient- and clinician-reported outcomes and MRI outcomes were assessed . RMT analyses examined performance of MS-specific rating scales as measurement instruments and tested for a symptomatic or disease-modifying treatment effect . Economic evaluation estimated mean incremental costs and quality -adjusted life-years ( QALYs ) . RESULTS Effectiveness - recruitment targets were achieved . Of the 498 r and omised patients ( 332 to active and 166 to placebo ) , 493 ( 329 active and 164 placebo ) were analysed . PRIMARY OUTCOMES no significant treatment effect ; hazard ratio EDSS score progression ( active : placebo ) 0.92 [ 95 % confidence interval ( CI ) 0.68 to 1.23 ] ; and estimated between-group difference in MSIS-29phys score ( active-placebo ) -0.9 points ( 95 % CI -2.0 to 0.2 points ) . Secondary clinical and MRI outcomes : no significant treatment effects . Safety - at least one serious adverse event : 35 % and 28 % of active and placebo patients , respectively . RMT analyses - scale evaluation : MSIS-29 version 2 , MS Walking Scale-12 version 2 and MS Spasticity Scale-88 were robust measurement instruments . There was no clear symptomatic or disease-modifying treatment effect . Economic evaluation - estimated mean incremental cost to NHS over usual care , over 3 years £ 27,443.20 per patient . No between-group difference in QALYs . CONCLUSIONS The CUPID trial failed to demonstrate a significant treatment effect in primary or secondary outcomes . There were no major safety concerns , but unwanted side effects seemed to affect compliance . Participants were more disabled than in previous studies and deteriorated less than expected , possibly reducing our ability to detect treatment effects . RMT analyses supported performance of MS-specific rating scales as measures , enabled group- and individual person-level examination of treatment effects , but did not influence study inferences . The intervention had significant additional costs with no improvement in health outcomes ; therefore , it was dominated by usual care and not cost-effective . Future work should focus on determining further factors to predict clinical deterioration , to inform the development of new studies , and modifying treatments in order to minimise side effects and improve study compliance . The absence of disease-modifying treatments in progressive MS warrants further studies of the cannabinoid pathway in potential neuroprotection . TRIAL REGISTRATION Current Controlled Trials IS RCT N62942668 . FUNDING The National Institute for Health Research Health Technology Assessment programme , the Medical Research Council Efficacy and Mechanism Evaluation programme , Multiple Sclerosis Society and Multiple Sclerosis Trust . The report will be published in full in Health Technology Assessment ; Vol . 19 , No. 12 . See the NIHR Journals Library website for further project information Abstract Objective To evaluate the effect of the oral synthetic δ-9-tetrahydrocannabinol dronabinol on central neuropathic pain in patients with multiple sclerosis . Design R and omised double blind placebo controlled crossovertrial . Setting Outpatient clinic , University Hospital of Aarhus , Denmark . Participants 24 patients aged between 23 and 55 years with multiple sclerosis and central pain . Intervention Orally administered dronabinol at a maximum doseof 10 mg daily or corresponding placebo for three weeks ( 15 - 21days ) , separated by a three week washout period . Main outcome measure Median spontaneous pain intensity ( numericalrating scale ) in the last week of treatment . Results Median spontaneous pain intensity was significantlylower during dronabinol treatment than during placebo treatment(4.0 ( 25th to 75th centiles 2.3 to 6.0 ) v 5.0 ( 4.0 to 6.4),P = 0.02 ) , and median pain relief score OUTPUT:

There was an increased risk of non-serious AEs with cannabinoids compared with placebo . Conclusions There was moderate evidence to support cannabinoids in treating chronic , non-cancer pain at 2 weeks . Similar results were observed at later time points , but the confidence in effect is low . There is little evidence that cannabinoids increase the risk of experiencing serious AEs , although non-serious AEs may be common in the short-term period following use

MS2_dynamic_1_shot546

***TASK*** the task is to summarize an input biomedical literature 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 examine the proportion of time spent in three levels of mobility ( lying , sitting , and st and ing or walking ) by a cohort of hospitalized older veterans as measured by vali date d wireless accelerometers . DESIGN A prospect i ve , observational cohort study . SETTING One hundred fifty-bed Department of Veterans Affairs hospital . PARTICIPANTS Forty-five hospitalized medical patients , aged 65 and older who were not delirious , did not have dementia , and were able to walk in the 2 weeks before admission were eligible . MEASUREMENTS Wireless accelerometers were attached to the thigh and ankle of patients for the first 7 days after admission or until hospital discharge , whichever came first . The mean proportion of time spent lying , sitting , and st and ing or walking was determined for each hour after hospital admission using a previously vali date d algorithm . RESULTS Forty-five male patients ( mean age 74.2 ) with a mean length of stay of 5.1 days generated 2,592 one-hour periods of data . A baseline functional assessment indicated that 35 ( 77.8 % ) study patients were willing and able to walk a short distance independently . No patient remained in bed the entire measured hospital stay , but on average , 83 % of the measured hospital stay was spent lying in bed . The average amount of time that any one individual spent st and ing or walking ranged from a low of 0.2 % to a high of 21 % , with a median of 3 % , or 43 minutes per day . CONCLUSION This is the first study to continuously monitor mobility levels early during a hospital stay . On average , older hospitalized patients spent most of their time lying in bed , despite an ability to walk independently Background The Hospital Elder Life Program ( HELP ) has been shown to be highly efficient and (cost-)effective in reducing delirium incidence in the USA . HELP provides multicomponent protocol s targeted at specific risk factors for delirium and introduces a different view on care organization , with trained volunteers playing a pivotal role . The primary aim of this study is the quantification of the (cost-)effectiveness of HELP in the Dutch health care system . The second aim is to investigate the experiences of patients , families , professionals and trained volunteers participating in HELP . Methods / Design A multiple baseline approach ( also known as a stepped-wedge design ) will be used to evaluate the ( cost- ) effectiveness of HELP in a cluster r and omized controlled study . All patients aged 70 years and older who are at risk for delirium and are admitted to cardiology , internal medicine , geriatrics , orthopedics and surgery at two participating community hospitals will be included . These eight units are implementing the intervention in a successive order that will be determined at r and om . The incidence of delirium , the primary outcome , will be measured with the Confusion Assessment Method ( CAM ) . Secondary outcomes include the duration and severity of delirium , quality of life , length of stay and the use of care services up to three months after hospital discharge . The experiences of patients , families , professionals and volunteers will be investigated using a qualitative design based on the grounded theory approach . Professionals and volunteers will be invited to participate in focus group interviews . Additionally , a r and om sample of ten patients and their families from each hospital unit will be interviewed at home after discharge . Discussion We hypothesize that HELP will reduce delirium incidence during hospital admission and decrease the duration and severity of delirium and length of hospital stays among these older patients , which will lead to reduced health care costs . The results of this study may fundamentally change our views on care organization for older patients at risk for delirium . The stepped-wedge design was chosen for ethical , practical and statistical reasons . The study results will be generalizable to the Dutch hospital care system , and the proven cost-effectiveness of HELP will encourage the spread and implementation of this program . Trial Registration Netherl and s Trial register : 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 OBJECTIV OUTPUT: They were not formally evaluated but report positive effects of the volunteers on patient and staff satisfaction . INPUT: BACKGROUND A major obstacle to screening for early mobility disability ( ie , mobility difficulty ) , a major public health concern , is the lack of a method that identifies those who are at high risk . The goal of this study was to develop easy-to-use clinical nomograms for estimation of the probability of incident mobility difficulty . METHODS We conducted a population -based prospect i ve study using data from 266 high physically and cognitively functioning older women , aged 70 to 80 years , who were free of mobility disability at the baseline evaluation of the Women 's Health and Aging Study II . The outcome measure was incident mobility disability within 18 months , defined as self-reported difficulty walking 0.8 km , climbing 10 steps , or transferring from or into a car or bus . Logistic regression and receiver operating characteristic curve analyses were used for evaluation of the optimal combination of self-reported and performance-based mobility measures . Bootstrap sampling and estimation was used for validation . RESULTS Predictive nomograms were developed based on a final model that included 3 simple-to-obtain measures of pre clinical disability : self-report of modification in mobility tasks without having difficulty with them , one-leg stance balance , and time to walk 1 m at a usual pace . Final model accuracy ( as estimated by the area under the receiver operating characteristic curve ) was 73 % ( SE = 0.04 ) . Validation analysis confirmed the high accuracy of these nomograms . CONCLUSIONS An original tool was developed for assessment of the risk of mobility difficulty in older women that can be used to assist physicians and research ers in deciding which women to target for preventive interventions OBJECTIVES To evaluate the effectiveness of an enhanced balance training program in improving mobility and well-being of elderly people with balance problems . DESIGN Prospect i ve , single-blind , r and omized , controlled trial . SETTING District general hospital . PARTICIPANTS One hundred ninety-nine patients aged 60 and older with a Berg Balance Scale ( BBS ) score of less than 45 . INTERVENTIONS Six weeks enhanced balance training consisting of a series of repetitive tasks of increasing difficulty specific to functional balance . The control group received physiotherapy conforming to existing practice in elderly patients with mobility problems . MEASUREMENTS Ten-meter timed walk test ( TWT ) , BBS , Frenchay Activities Index ( FAI ) , Falls H and icap Inventory ( FHI ) , and European Quality of Life question naire ( Euroqol ) measured at 6 , 12 , and 24 weeks after intervention . RESULTS The mean age + /- st and ard deviation of subjects was 82.7 + /- 5.6 , and baseline characteristics were comparable between the groups . Both groups showed improvements in TWT ( intervention : 22.5 - 16.5 seconds , P = .001 ; control : 20.5 - 15.8 seconds , P = .054 ) , BBS ( intervention : 33.3 - 42.7 , P = .001 ; control : 33.4 - 42.0 , P < .0001 ) , FAI ( 18 - 21 , P = .02 in both groups ) , FHI score ( intervention : 31 - 17 , P = .0001 ; control : 33 - 17 , P = .0001 ) and Euroqol score ( intervention : 58 - 65 , P = .04 ; control : 60 - 65 , P = .07 ) . There were no intergroup differences at any time . More patients reported increased confidence in walking indoors ( 36 % vs 28 % ; P = .04 ) and outdoors ( 27 % vs 18 % ; P = .02 ) in the enhanced balance-training group . CONCLUSION Exercise programs significantly improve balance and mobility in patients with balance problems , independent of strategy . Enhanced balance training may , in addition , improve confidence and quality of life but needs further investigation The purpose of this study was to determine whether a walking program supplemented by tasks design ed to challenge balance and mobility ( WALK+ ) could improve physical function more than a traditional walking program ( WALK ) in older adults at risk for mobility disability . 31 community-dwelling older adults ( M + /- SD age = 76 + /- 5 yr ; Short Physical Performance Battery [ SPPB ] score = 8.4 + /- 1.7 ) were r and omized to treatment . Both interventions were 18 sessions ( 1 hr , 3x/wk ) and progressive in intensity and duration . Physical function was assessed using the SPPB and the 400-m-walk time . A subset of participants in the WALK group who had relatively lower baseline function showed only small improvement in their SPPB scores after the intervention ( 0.3 + /- 0.5 ) , whereas a subset of participants in the WALK+ group with low baseline function showed substantial improvement in their SPPB scores ( 2.2 + /- 0.7 ) . These preliminary data underscore the potential importance of tailoring interventions for older adults based on baseline levels of physical function Abstract Objective : To evaluate the effect of intensive geriatric rehabilitation on demented patients with hip fracture . Design : Preplanned sub analysis of r and omised intervention study . Settting : Jyväskylä Central Hospital , Finl and . Participants : 243 independently living patients aged 65 years or older admitted to hospital with hip fracture . Intervention : After surgery patients in the intervention group ( n=120 ) were referred to the geriatric ward whereas those in the control group were discharged to local hospitals . Main outcome measures : Length of hospital stay , mortality , and place of residence three months and one year after surgery for hip fracture . Results : The median length of hospital stay of hip fracture patients with moderate dementia ( mini mental state examination score 12 - 17 ) was 47 days in the intervention group ( n=24 ) and 147 days in the control group ( n OUTPUT:

Several tools are available to assess mobility in the ambulatory setting . Relatively few studies support therapeutic exercise to improve mobility limitation . Strong evidence supports resistance and balance exercises for improving mobility-limiting physical weakness and balance disorders . Addressing functional deficits and environmental barriers with exercise and mobility devices can lead to improved function , safety , and quality of life for patients with mobility limitations

MS2_dynamic_1_shot547

***TASK*** the task is to summarize an input biomedical literature 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 transition to college has been identified as a critical period for increases in overweight status . Overweight college students are at-risk of becoming obese adults , and , thus prevention efforts targeting college age individuals are key to reducing adult obesity rates . The current study evaluated an Internet intervention with first year college students ( N=170 ) r and omly assigned to one of four treatment conditions : 1 ) no treatment , 2 ) 6-week online intervention 3 ) 6-week weight and caloric feedback only ( via email ) , and 4 ) 6-week combined feedback and online intervention . The combined intervention group had lower BMI s at post-testing than the other three groups . This study demonstrated the effectiveness and feasibility of an online intervention to prevent weight gain among college students Background Epidemiologic data indicate most adolescents and adults experience multiple , simultaneous risk behaviors . Purpose The purpose of this study is to examine the efficacy of a brief image-based multiple-behavior intervention ( MBI ) for college students . Methods A total of 303 college students were r and omly assigned to : ( 1 ) a brief MBI or ( 2 ) a st and ard care control , with a 3-month postintervention follow-up . Results Omnibus treatment by time multivariate analysis of variance interactions were significant for three of six behavior groupings , with improvements for college students receiving the brief MBI on alcohol consumption behaviors , F(6 , 261 ) = 2.73 , p = 0.01 , marijuana-use behaviors , F(4 , 278 ) = 3.18 , p = 0.01 , and health-related quality of life , F(5 , 277 ) = 2.80 , p = 0.02 , but not cigarette use , exercise , and nutrition behaviors . Participants receiving the brief MBI also got more sleep , F(1 , 281 ) = 9.49 , p = 0.00 , than those in the st and ard care control . Conclusions A brief image-based multiple-behavior intervention may be useful in influencing a number of critical health habits and health-related quality -of-life indicators of college students Objective : The authors ' purpose in this study was to compare the effects of macronutrient intake on systemic glucose levels in previously sedentary participants who followed 1 of 4 diets that were either higher protein or high carbohydrate , while initiating an exercise program . Participants and Methods : The authors r and omly assigned 94 sedentary participants to 1 of 4 diet groups consisting of Diet 1 ( 55 % carbohydrate , 30 % fat , 15 % protein ) , Diet 2 ( 55 % carbohydrate , 30 % fat , 15 % protein and caloric restriction ) , Diet 3 ( 40 % carbohydrate , 30 % fat , 25 % protein ) , and Diet 4 ( 40 % carbohydrate , 30 % fat , 25 % protein and caloric restriction ) and followed recommended aerobic exercise prescriptions . Results : Repeated measures analyses of variance ( ANOVA ) revealed a significant time factor ( p = .021 ) but no significant differences between diet groups ( p = .207 ) . A trend was evident in the higher protein groups , with a 5.2 % decrease in glucose levels with Diet 3 and 5.0 % with Diet 4 . Although glucose levels changed over time with the greatest changes in the 2 higher protein diets , levels were not significantly different within participants . Conclusions : The results of the study indicate that systemic glucose availability was affected by higher protein consumption in Diet 3 participants , with the same trend in Diet 4 participants , although nonsignificant . These findings demonstrate that consuming a lower carbohydrate diet for 12 weeks can possibly change systemic glucose levels PURPOSE This study examined the effects of brief image-based interventions , including a multiple behavior health contract , a one-on-one tailored consultation , and a combined consultation plus contract intervention , for impacting multiple health behaviors of students in a university health clinic . METHODS A total of 155 college students attending a major southern university were recruited to participate in a study evaluating a health promotion program titled Project Fitness during the fall 2005 and spring 2006 . Participants were r and omly assigned to one of three treatments as they presented at the clinic : 1 ) a multiple behavior health contract , 2 ) a one-on-one tailored consultation , or 3 ) a combined consultation plus contract intervention . Baseline and 1-month post-intervention data were collected using computer-assisted question naires in a quiet office within the student health clinic . RESULTS Omnibus repeated- measures analyses of variance were significant for drinking driving behaviors , F(2,136 ) = 4.43 , p = .01 , exercise behaviors , F(5,140 ) = 6.12 , p = .00 , nutrition habits , F(3,143 ) = 5.37 , p = .00 , sleep habits , F(2,144 ) = 5.03 , p = .01 , and health quality of life , F(5,140 ) = 3.09 , p = .01 , with improvements on each behavior across time . Analysis of group-by-time interaction effects showed an increase in the use of techniques to manage stress , F(2,144 ) = 5.48 , p = .01 , and the number of health behavior goals set in the last 30 days , F(2,143 ) = 5.35 , p = .01 , but only among adolescents receiving the consultation , or consultation plus contract . Effect sizes were consistently larger across health behaviors , and medium in size , when both consult and contract were used together . CONCLUSIONS Brief interventions using a positive goal image of fitness , and addressing a number of health habits using a contract and consultation strategy alone , or in combination , have the potential to influence positive changes in multiple health behaviors of college students OUTPUT: This appears to be the first systematic review of physical activity , diet and weight loss interventions targeting university and college students . INPUT: OBJECTIVE To examine the viability of monetary incentives to increase fitness-center use and maintain/improve the Body Mass Indexes ( BMI s ) of first-year students over the fall semester . METHOD R and omized-controlled trial with no-treatment and incentive conditions involving 117 first-year students . For 12 weeks , students in the incentive condition received monetary payments ranging from $ 10 to $ 38.75 for meeting research er-set fitness-center use goals that were identical across conditions . Fitness-center use was monitored through electronic ID-card check-in and check-out records at the campus fitness center . RESULTS 63 % of incentive-condition participants met the weekly fitness-center use goals on average compared to only 13 % of control-condition participants , a significant difference , p<0.001 . Goal achievement significantly decreased over time , p<0.01 and at roughly the same rate in the control and incentive conditions , p=0.23 . Average BMI increases over the fall semester in the control ( 24.2 ( 0.6 ) to 24.6 (0.6)kg/m(2 ) ) versus incentive condition ( 23.1 ( 0.4 ) to 23.5 (0.4)kg/m(2 ) ) were not significantly different ( p=0.70 ) . CONCLUSION Weekly monetary incentives result ed in significantly more first-year students meeting weekly fitness-center use goals . However , the increased fitness-center use by the incentive condition did not prevent an increase in BMI during fall semester Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs Behavioral treatments for obesity seek to modify eating and exercise behaviors by a change in their antecedents and consequences . More direct modification of antecedents and consequences by ( a ) the provision of food to patients and ( b ) the provision of financial rewards for weight loss was hypothesized to improve treatment outcomes . Two hundred two men and women were r and omly assigned to no treatment , st and ard behavioral treatment ( SBT ) , SBT plus food provision , SBT plus incentives , or SBT plus food provision and incentives . The major finding was that food provision significantly enhanced weight loss . Weight losses with SBT averaged 7.7 , 4.5 , and 4.1 kg at 6 , 12 , and 18 months , respectively , compared with 10.1 , 9.1 , and 6.4 kg , respectively , at the same intervals with the addition of food . Food provision also enhanced attendance , completion of food records , quality of diet , and nutrition knowledge . We conclude that the provision of food to weight-loss patients is a promising methodology that deserves further exploration Two behavioral techniques were assessed to determine their effects on subjects ' adherence to unsupervised exercise . The subjects were 35 moderately fit persons who had just completed an adult fitness program ( AF group ) and 42 sedentary individuals who were recruited through the campus newspaper ( NEWS group ) . Participants were r and omly assigned to one of three conditions : ( a ) self-monitoring , ( b ) reinforcement supplied by another person , or ( c ) control . All subjects were given instructions on how to exercise and asked to exercise on their own for 18 weeks . Self-monitoring subjects kept written records of their exercise behavior , while reinforcement subjects verbally reported their exercise behavior to another person who periodically administered rewards . Pre- and posttreatment tests on the NEWS group revealed no significant treatment or interaction effects . However , the reinforcement group had an 11 % improvement in predicted max VO2 and a 9 bpm improvement in exercise heart rate compared to 7.8 % , 5 bpm for the self-monitoring ( SM ) group and 5.3 % , 6 bpm for the control group . T-tests indicated that reward and SM groups improved significantly on these variables , whereas the control group did not . SM ( M = 2.07 ) and reinforcement ( M = 2.29 ) groups reported a significantly higher frequency of exercise per week than the control ( M = 1.36 ) group . The AF subjects were able to maintain their fitness level ( with the exception of a small increase in body fat ) over the 18-week period . The behavioral interventions had little differential effect on adherence by AF subjects who were already regular exercisers Exercise is important for long-term weight loss , but few studies have examined ways to improve exercise adherence in overweight subjects participating in a behavioral weight loss program . This paper presents two studies , one conducted at the University of Pittsburgh and one at the University of Minnesota , that sought to improve exercise adherence by exerting more direct control over the environmental antecedents and consequences controlling exercise . Study 1 investigated the use of a personal trainer who called participants regularly and met them at their home or office at scheduled times for a walk . Study 2 investigated the effect of a lottery incentive for exercise adherence . In both studies , the effect of these manipulations was examined in the context of a 24-week st and ard behavioral weight control program with three supervised exercise sessions per week . Neither intervention achieved statistically OUTPUT:

Assured , or " sure thing , " incentives and objective behavioral assessment in particular appear to moderate incentive effectiveness . The effect estimate from the meta- analysis suggests that financial incentives increase exercise session attendance for interventions up to 6 months in duration .

MS2_dynamic_1_shot548

***TASK*** the task is to summarize an input biomedical literature 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 short-term efficacy and side effects associated with two methylpheni date hydrochloride ( MPH ) dosing patterns . METHODS Twenty-five boys with attention deficit hyperactivity disorder ( ADHD ) participated in a 5-week , triple-blind , placebo-controlled , crossover evaluation of MPH administered twice ( b.i.d . ) versus thrice ( t.i.d . ) per day ( mean dose = 8.8 + /- 5 mg , .30 + /- .1 mg/kg/dose ) . Four dosing conditions ( placebo , titration [ gradual increase to target dose ] , b.i.d . , and t.i.d . ) were used . Dependent measures obtained on a weekly basis included : parent and teacher ratings of child behavior , parent-child conflicts , parent report of stimulant side effects , child self-report of mood symptoms , a sleep log , laboratory measures of attention , and actigraphic recording of sleep activity . RESULTS All dosing conditions result ed in significant effects on ADHD symptoms when compared with baseline . Relative to placebo , t.i.d . dosing was characterized by improvement on the greatest number of behavioral measures , and both b.i.d . and t.i.d . were generally more effective than titration . Direct comparisons of b.i.d . and t.i.d . dosing revealed that t.i.d . was associated with greater improvement on the Conners Parent Rating Scale Impulsivity/Hyperactivity factor , with a similar marginally significant effect for the ADD-H Teacher Rating Scale Hyperactivity factor . The analysis of clinical ly significant change favored a three-times-a-day dosing schedule over placebo on both parent and teacher ratings of impulsivity/hyperactivity and attention . Compared with placebo , appetite suppression was rated , on average , as more severe in the t.i.d . and titration conditions , but not in the b.i.d . condition . However , the number of subjects who exhibited any or severe appetite suppression did not differ significantly between the b.i.d . and t.i.d . schedules . Although there was no difference in sleep duration for children on b.i.d . and t.i.d . schedules , total sleep time appeared to decrease slightly on t.i.d . relative to placebo according to both parent ratings and actigraphic assessment . There were no significant differences between b.i.d . and t.i.d . on any other side effects or sleep variables . CONCLUSIONS For many children with ADHD , t.i.d . dosing may be optimal . There are few differences in acute side effects between b.i.d . and t.i.d . MPH dosing . The dosing schedule should be selected according to the severity and time course of ADHD symptoms rather than in anticipation of dosing schedule-related side effects Background This study examined augmenting atomoxetine with extended-release methylpheni date in children whose attention-deficit/hyperactivity disorder ( ADHD ) previously failed to respond adequately to stimulant medication . Methods Children with ADHD and prior stimulant treatment ( N = 25 ) received atomoxetine ( 1.2 mg/kg/day ) plus placebo . After 4 weeks , patients who were responders ( n = 4 ) were continued on atomoxetine/placebo while remaining patients were r and omly assigned to either methylpheni date ( ATX/MPH ) ( 1.1 mg/kg/day ) or placebo augmentation ( ATX/PB ) for another 6 weeks . Patients and sites were blind to timing of active augmentation . Safety measures included vital signs , weight , and adverse events . Efficacy was assessed by ADHD rating scales . Results Categorical increases in vital signs occurred for 5 patients ( 3 patients in ATX/MPH , 2 patients in ATX/PBO ) . Sixteen percent discontinued the study due to AE , but no difference between augmentation groups . Atomoxetine treatment was efficacious on outcome measures ( P ≤ .001 ) , but methylpheni date did not enhance response . Conclusion Methylpheni date appears to be safely combined with atomoxetine , but conclusions limited by small sample . With atomoxetine treatment , 43 % of patients achieved normalization on ADHD ratings Abstract Hypotheses concerning unexpected , psychostimulant-related effects reported in previous studies were examined by separating behavioral/physical complaints highly specific to methylpheni date ( MPH ) from those that ( a ) may mimic core/ secondary symptoms of the disorder , or ( b ) are commonly reported by unmedicated children in the general population . Sixty-five children with attention-deficit/hyperactivity disorder ( ADHD ) participated in a double-blind , placebo-controlled , within-subject ( crossover ) experimental design and received a placebo and four MPH doses in counterbalanced order following baseline assessment . Behavioral and physical complaints were significantly higher under baseline relative to placebo and the four immediate-release MPH conditions ( 5 mg , 10 mg , 15 mg , and 20 mg ) across three symptom categories : ADHD core/ secondary symptoms ; symptoms commonly reported in the general population , including unmedicated children with ADHD ; and symptoms highly specific to MPH . No significant differences were found among active drug conditions . Past unexpected findings of psychostimulant effects in ADHD may be due to the inclusion of scale items that reflect core/ secondary features of ADHD and normally occurring behavioral/physical complaints in children OBJECTIVE To evaluate the efficacy and safety of osmotic-release methylpheni date ( OROS-MPH ) compared with placebo for attention-deficit/hyperactivity disorder ( ADHD ) , and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy ( CBT ) for substance use disorders ( SUD ) . METHOD This was a 16-week , r and omized , controlled , multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents ( aged 13 through OUTPUT: Methylpheni date increases the risks of decreased appetite , weight loss , and abdominal pain in children and adolescents with attention deficit hyperactivity disorder . No differences in the risks of gastrointestinal adverse events according to type , dose , or duration of administration were found INPUT: Background This study examined augmenting atomoxetine with extended-release methylpheni date in children whose attention-deficit/hyperactivity disorder ( ADHD ) previously failed to respond adequately to stimulant medication . Methods Children with ADHD and prior stimulant treatment ( N = 25 ) received atomoxetine ( 1.2 mg/kg/day ) plus placebo . After 4 weeks , patients who were responders ( n = 4 ) were continued on atomoxetine/placebo while remaining patients were r and omly assigned to either methylpheni date ( ATX/MPH ) ( 1.1 mg/kg/day ) or placebo augmentation ( ATX/PB ) for another 6 weeks . Patients and sites were blind to timing of active augmentation . Safety measures included vital signs , weight , and adverse events . Efficacy was assessed by ADHD rating scales . Results Categorical increases in vital signs occurred for 5 patients ( 3 patients in ATX/MPH , 2 patients in ATX/PBO ) . Sixteen percent discontinued the study due to AE , but no difference between augmentation groups . Atomoxetine treatment was efficacious on outcome measures ( P ≤ .001 ) , but methylpheni date did not enhance response . Conclusion Methylpheni date appears to be safely combined with atomoxetine , but conclusions limited by small sample . With atomoxetine treatment , 43 % of patients achieved normalization on ADHD ratings Research participants were 46 adolescents ( mean age = 13.8 years ) who completed an intensive summer treatment program including a placebo-controlled , double-blind , crossover trial of 3 doses of methylpheni date ( MPH ) totaling 25 , 50 , or 75 mg per day . Dependent measures focused on social behavior and included observed behavior frequencies and ratings completed by counselors and parents , including side effects . Multiple data analytic methods were used with the goal of ( a ) describing the shape of the dose-response curves across multiple measures of social functioning , ( b ) determining the percentage of adolescents whose social behavior improved in response to MPH , and ( c ) assessing the incremental gains that result from increases in dose . The results show that ( a ) the shape of the dose-response curve is influenced by the measurement method , ( b ) the majority of adolescents exhibited improved social behavior when treated with MPH , ( c ) the bulk of the positive effects of MPH were achieved at the lowest dose , and ( d ) there appear to be diminishing positive effects and an increased risk of negative effects with successively higher doses OBJECTIVE Response to atomoxetine , a nonstimulant norepinephrine-specific reuptake inhibitor , was compared with the effect of osmotic-release oral methylpheni date , a long-acting methylpheni date preparation , in patients with attention deficit hyperactivity disorder ( ADHD ) . METHOD In a large placebo-controlled , double-blind study , patients ages 6 - 16 with ADHD , any subtype , were r and omly assigned to receive 0.8 - 1.8 mg/kg per day of atomoxetine ( N=222 ) , 18 - 54 mg/day of osmotically released methylpheni date ( N=220 ) , or placebo ( N=74 ) for 6 weeks . The a priori specified primary analysis compared response ( at least 40 % decrease in ADHD Rating Scale total score ) to osmotically released methylpheni date with response to atomoxetine and placebo . After 6 weeks , patients treated with methylpheni date were switched to atomoxetine under double-blind conditions . RESULTS The response rates for both atomoxetine ( 45 % ) and methylpheni date ( 56 % ) were markedly superior to that for placebo ( 24 % ) , but the response to osmotically released methylpheni date was superior to that for atomoxetine . Each medication was well tolerated , with completion rates and discontinuations for adverse events not significantly different from those for placebo . Of the 70 subjects who did not respond to methylpheni date , 30 ( 43 % ) subsequently responded to atomoxetine . Likewise , 29 ( 42 % ) of the 69 patients who did not respond to atomoxetine had previously responded to osmotically released methylpheni date . CONCLUSION Response was significantly greater with osmotically released methylpheni date than with atomoxetine . One-third of patients who received methylpheni date followed by atomoxetine responded better to one or the other , suggesting that there may be preferential responders Our objective was to evaluate the effectiveness of a long-acting formulation of methylpheni date ( MPH-SODAS ) on attention-deficit/hyperactivity disorder ( ADHD ) symptoms in an outpatient sample of adolescents with ADHD and substance use disorders ( SUD ) . Secondary goals were to evaluate the tolerability and impact on drug use of MPH-SODAS . This was a 6-week , single-blind , placebo-controlled crossover study assessing efficacy of escalated doses of MPH-SODAS on ADHD symptoms in 16 adolescents with ADHD/SUD . Participants were r and omly allocated to either group A ( weeks 1 - 3 on MPH-SODAS , weeks 4 - 6 on placebo ) or group B ( reverse order ) . The primary outcome measures were the Swanson , Nolan and Pelham Scale , version IV ( SNAP-IV ) and the Clinical Global Impression Scale ( CGI ) . We also evaluated the adverse effects of MPH-SODAS using the Barkley Side Effect Rating Scale and subject reports of drug use during the study . The sample consisted of marijuana ( N = 16 ; 100 % ) and cocaine users ( N = 7 ; 43.8 % ) . Subjects had a significantly greater reduction in SNAP-IV and CGI scores ( P < 0.001 for all analyses ) during MPH- OUTPUT:

What this study adds The results suggest that among children and adolescents with a diagnosis of ADHD , methylpheni date may improve teacher reported symptoms of ADHD and general behaviour and parent reported quality of life . Methylpheni date is associated with an increased risk of non-serious but not serious adverse events .

MS2_dynamic_1_shot549

***TASK*** the task is to summarize an input biomedical literature 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: 1 . The objective of this study was to investigate the efficacy of home-medicated non-steroidal anti-inflammatory ( NSAID ) analgesics , using an electronic patient diary . Single doses of ketoprofen 25 mg and ketoprofen 50 mg were compared with ibuprofen 200 mg and placebo in the treatment of a single occasion of episodic tension-type headache , using a double-blind , r and omized , parallel group design . 2 . A total of 166 patients with headache compatible with episodic tension-type headache and no refractory headaches or contraindications to NSAIDs were contacted by advertisements and selected by question naires . Patients performed the study at home , using an electronic diary for headache assessment , with a form to allow comments and corrections . Visual analogue scales ( VAS 10 cm ) of headache severity , five-item headache relief rating ( HRR ) scales , and time of intake of ' escape ' analgesics were scored regularly , for 4 h following intake of trial medication . 3 . VAS-scores ( n = 1407 ) and HRRs ( n = 452 ) were returned by 159 patients . Of these scores , 1.5 % were inadvertently omitted from the electronic diary or modified on the comment forms . 4 . Headache ( VAS and HRR ) improved more with all three NSAIDs than with placebo , although the effect of ibuprofen was significant for HRR only . After 2 and 4 h respectively , the reduction in VAS-ratios was 17 and 19 % with placebo , 18 and 53 % with ibuprofen 200 mg , 41 and 61 % with ketoprofen 25 mg , and 47 and 59 % with ketoprofen 50 mg . After 4 h , headache improved strongly ( highest HRR ) in 18 % of patients on placebo , 39 % on ibuprofen 200 mg , 62 % on ketoprofen 25 mg , and 55 % on ketoprofen 50 mg . Headache disappeared completely ( VAS-score = 0 ) in one patient ( 3 % ) with placebo ( after 180 min ) , 10 % with ibuprofen 200 mg ( average 211 min ) , 18 % with ketoprofen 25 mg ( 159 min ) , and 28 % with ketoprofen 50 mg ( 146 min ) . 5 . The effects of ketoprofen 50 mg were more pronounced than those of ibuprofen 200 mg , which seemed to start later . Ketoprofen 25 mg and 50 mg were very similar , suggesting a maximal effect of the lower dose . Mild to moderate adverse events were reported by 9 % of the patients , half of which occurred with ketoprofen 50 mg . Treatment of headache with ketoprofen can start with 25 mg , and possibly less . 6 . Although a direct comparative study would be necessary to determine the relative benefits of the novel electronic patient diaries over traditional paper- and -pencil methods , this study has shown the usefulness of this newer technique to detect differences in efficacy between low doses of analgesics under ambulant conditions , with very limited loss of data . Electronic patient diaries appear to be an important new attribute for the efficacy assessment of self-medicated drugs Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size BACKGROUND Aspirin is a widely used NSAID that has been extensively studied in numerous conditions . Nonprescription analgesics , such as aspirin , are frequently used for a wide variety of common ailments , including conditions such as dental pain and tension-type headache . OBJECTIVE We sought to compare the efficacy and safety profiles of aspirin , acetaminophen with codeine , and placebo in the treatment of post-operative dental pain and tension-type headache . OUTPUT: Ibuprofen 400 mg provides an important benefit in terms of being pain free at 2 hours for a small number of people with frequent episodic tension-type headache who have an acute headache with moderate or severe initial pain . There is no information about the lesser benefit of no worse than mild pain at 2 hours INPUT: 1 . The objective of this study was to investigate the efficacy of home-medicated non-steroidal anti-inflammatory ( NSAID ) analgesics , using an electronic patient diary . Single doses of ketoprofen 25 mg and ketoprofen 50 mg were compared with ibuprofen 200 mg and placebo in the treatment of a single occasion of episodic tension-type headache , using a double-blind , r and omized , parallel group design . 2 . A total of 166 patients with headache compatible with episodic tension-type headache and no refractory headaches or contraindications to NSAIDs were contacted by advertisements and selected by question naires . Patients performed the study at home , using an electronic diary for headache assessment , with a form to allow comments and corrections . Visual analogue scales ( VAS 10 cm ) of headache severity , five-item headache relief rating ( HRR ) scales , and time of intake of ' escape ' analgesics were scored regularly , for 4 h following intake of trial medication . 3 . VAS-scores ( n = 1407 ) and HRRs ( n = 452 ) were returned by 159 patients . Of these scores , 1.5 % were inadvertently omitted from the electronic diary or modified on the comment forms . 4 . Headache ( VAS and HRR ) improved more with all three NSAIDs than with placebo , although the effect of ibuprofen was significant for HRR only . After 2 and 4 h respectively , the reduction in VAS-ratios was 17 and 19 % with placebo , 18 and 53 % with ibuprofen 200 mg , 41 and 61 % with ketoprofen 25 mg , and 47 and 59 % with ketoprofen 50 mg . After 4 h , headache improved strongly ( highest HRR ) in 18 % of patients on placebo , 39 % on ibuprofen 200 mg , 62 % on ketoprofen 25 mg , and 55 % on ketoprofen 50 mg . Headache disappeared completely ( VAS-score = 0 ) in one patient ( 3 % ) with placebo ( after 180 min ) , 10 % with ibuprofen 200 mg ( average 211 min ) , 18 % with ketoprofen 25 mg ( 159 min ) , and 28 % with ketoprofen 50 mg ( 146 min ) . 5 . The effects of ketoprofen 50 mg were more pronounced than those of ibuprofen 200 mg , which seemed to start later . Ketoprofen 25 mg and 50 mg were very similar , suggesting a maximal effect of the lower dose . Mild to moderate adverse events were reported by 9 % of the patients , half of which occurred with ketoprofen 50 mg . Treatment of headache with ketoprofen can start with 25 mg , and possibly less . 6 . Although a direct comparative study would be necessary to determine the relative benefits of the novel electronic patient diaries over traditional paper- and -pencil methods , this study has shown the usefulness of this newer technique to detect differences in efficacy between low doses of analgesics under ambulant conditions , with very limited loss of data . Electronic patient diaries appear to be an important new attribute for the efficacy assessment of self-medicated drugs UNLABELLED Reactive measures ( measures that change the phenomenon assessed ) cause problems in interpreting any changes observed . This study examined whether electronic daily diary measures of pain , activity interference , mood , and pain beliefs were reactive in terms of both observable data and patient-reported effects . Patients with chronic temporom and ibular disorder pain ( N = 71 , 86 % female ) completed electronic diaries 3 times daily for approximately 2 weeks and subsequently reported perceived effects on symptom-related variables . Seventy-three percent of patients reported that the assessment affected their pain , whereas 51 % , 45 % , and 39 % thought that it affected their daily activities , mood , and beliefs , respectively . In contrast , there was little objective evidence of reactivity as observed in the electronic diary ratings ; changes over 14 days were small ( eg , predicted changes on 0 to 10 scales : positive mood , .1 ; pain , -.3 ; perceived control , -.5 ) and not statistically significant . Subjective reactivity was generally not significantly related to objective reactivity . The data suggest that patients view daily assessment as having positive and negative effects on pain-related variables , but pain-related measures do not show reactive effects . PERSPECTIVE Electronic daily diary assessment methods hold the potential to increase knowledge concerning patients ' experiences with pain and sequential relations between pain-related variables , but only if the measurement process is nonreactive . This study provides evidence that electronic diary assessment of pain-related variables is nonreactive Objective : This study was design ed to compare 3 commonly used method ologies for assessing clinical pain during trials involving patients diagnosed with fibromyalgia syndrome . Baseline characteristics , characteristics over time , and compliance were evaluated for each of the methods . Methods : Fourteen patients diagnosed with fibromyalgia syndrome were asked to monitor their symptoms of pain using 3 different strategies over a 12-week period : 1 ) real-time pain reports were collected on an electronic diary using r and omly-scheduled audible prompts ; 2 ) end-of-week reports asked patients to rate their mean pain over the past week on the electronic diary ; and 3 ) monthly in-clinic reports asked patients to rate their mean pain for the week using a traditional paper and pencil diary . Results : Significantly different baseline values were obtained for the 3 methods . Paper and pencil produced the highest values , and real-time pain reports produced the lowest baseline values . Pain ratings were more likely to reflect decreases in the 2 methods relying on recall than the real-time strategy . The average adherence with pain monitoring using the electronic diary was 85 % , which was superior to the OUTPUT:

Compliance was generally high , and positively associated with shorter diaries , age , having a user 's manual , financial compensation and using an alarm .

MS2_dynamic_1_shot550

***TASK*** the task is to summarize an input biomedical literature 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 have examined the independent and combined effects on blood pressure and blood lipids of alcohol restriction and weight loss in overweight male drinkers with a view to assessing overall effects on cardiovascular risk of two widely promoted nonpharmacological approaches for hypertension . Eighty-six men with a mean age of 44.3 years , a mean regular alcohol intake of 440 ml/wk ( five or six st and ard drinks per day ) , a mean blood pressure of 137.4 mm Hg systolic and 84.8 mm Hg diastolic , and a mean body mass of 92.5 kg entered a controlled two-way factorial study . The subjects were r and omly assigned to four groups for an 18-week intervention in which members of two groups drank only low-alcohol beer , thereby reducing their alcohol intake by 374 ml/wk , while those of the other two groups continued their normal alcohol intake . Within the low and normal alcohol intake groups subjects either continued their usual diet or reduced their caloric intake by 4,200 - 6,300 kJ/day ( 1,000 - 1,500 kcal/day ) ( with protein , fat , and carbohydrate provided as 15 % , 30 % , and 55 % of total calories , respectively ) . Calorie reduction and alcohol restriction caused weight losses of 7.5 ( p less than 0.001 ) and 2.1 ( p less than 0.01 ) kg , respectively . Calorie reduction and alcohol restriction were associated with decreases in systolic blood pressure of 5.4 ( p less than 0.001 ) and 4.8 ( p less than 0.01 ) mm Hg , respectively , and in diastolic blood pressure of 4.2 ( p less than 0.001 ) and 3.3 ( p less than 0.01 ) mm Hg , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS The aim of this study was to determine whether moderate restriction of dietary salt intake leads to an additional fall in blood pressure in treated hypertensive men who are asked to simultaneously reduce their usual alcohol intake . Sixty-three subjects entered an initial 2-week familiarization period during which they continued their usual alcohol intake and commenced a " low sodium " diet ( less than 60 mmol/day ) supplemented with 100 mmol sodium chloride per day as enteric-coated tablets . Subjects were then r and omly assigned to either drink a low alcohol beer alone for a 4-week period ( reducing their self-reported alcohol consumption from 537 to 57 ml/week ) or to continue their usual alcohol intake ( 543 versus 557 ml/week ) . Within the low and normal alcohol intake groups , subjects were assigned to either a low or normal sodium intake . The low sodium groups continued the sodium-restricted diet but were switched to placebo sodium chloride tablets for the 4 weeks . This result ed in a fall in the 24-hour urinary sodium excretion from 144 to 69 mmol/day . The normal sodium groups continued the low sodium diet but kept taking 100 mmol/day of the sodium chloride tablets , and their urinary sodium excretion remained unchanged ( 125 versus 142 mmol/day ) . Regular antihypertensive therapy was continued throughout . Fifty-nine subjects completed the trial . In those who reduced their alcohol intake there was a fall in both systolic blood pressure ( -5.4 mm Hg supine , p less than 0.01 ) and diastolic blood pressure ( -3.2 mm Hg supine , p less than 0.01 ) . ( ABSTRACT TRUNCATED AT 250 WORDS A direct pressor effect of alcohol is proposed as the basis for the association between regular alcohol consumption and an increase in blood pressure found in population studies . To examine this further , a r and omized controlled crossover trial of the effects of varying alcohol intake on blood pressure in 46 healthy male drinkers was conducted . From an average of 336 ml of ethanol per week , alcohol consumption was reduced by 80 % for 6 weeks by drinking a low alcohol content beer alone . This reduction was associated with a significant reduction in systolic and diastolic blood pressure ( p less than 0.001 and p less than 0.05 respectively ) . The mean difference in supine systolic blood pressure during the last 2 weeks of normal or low alcohol intake was 3.8 mm Hg , which correlated significantly with change in alcohol consumption ( r = 0.53 , p less than 0.001 ) . Reduction of alcohol intake also caused a significant decrease in weight ( p less than 0.001 ) . After adjustment for weight change , an independent effect of alcohol on systolic but not diastolic blood pressure was still evident , with a 3.1 mm Hg fall predicted for a decrease in consumption from 350 ml of ethanol equivalent per week to 70 ml per week ( p less than 0.01 ) . Systolic blood pressure rose again when normal drinking habits were resumed . These results provide clear evidence for a direct and reversible pressor effect of regular moderate alcohol consumption in normotensive men and suggest that alcohol may play a major role in the genesis of early stages of blood pressure elevation UNLABELLED Introduction Recent pharmacotherapy findings from new alcohol reduction programmes could change the paradigm of alcohol-dependence treatment . MATERIAL AND METHOD This study review s the neurobiological background and pharmacotherapy of alcohol-dependence disorder , focusing on opioid receptor antagonists , abstinence-oriented treatment and moderation-oriented treatment . RESULTS 1 . Alcohol-dependence treatment programs show only low to moderate efficacy . 2 . Patients usually show low motivation to sustain abstinence but high motivation to reduce OUTPUT: Major benefits were observed for reducing alcohol-associated injuries , recovery of ventricular heart function in alcoholic cardiomyopathy , blood pressure lowering , normalization of biochemical parameter , body weight reduction , histological improvement in pre-cirrhotic alcohol-related liver disease and slowed progression of an already existing alcohol-attributable liver fibrosis . Furthermore , reduced withdrawal symptoms , prevalence of psychiatric episodes and duration of in-patient hospital days , improvement of anxiety and depression symptoms , self-confidence , physical and mental quality of life , fewer alcohol-related adverse consequences as well as lower psychosocial stress levels and better social functioning can result from reduced alcohol intake . The review ed literature demonstrated remarkable socioeconomic cost benefits in areas such as the medical health-care system or workforce productivity . Individuals with heightened vulnerability further benefit significantly from alcohol reduction ( e.g. hypertension , hepatitis C , psychiatric co-morbidities , pregnancy , but also among adolescents and young adults ) . INPUT: Weight reduction was compared with metoprolol ( 200 mg daily ) in a r and omised placebo-controlled trial of first-line treatment of mild hypertension ( diastolic blood pressure 90 - 109 mm Hg ) in 56 overweight patients aged under 55 years . After 21 weeks of follow up the weight-reduction group had lost an average of 7.4 kg . The fall in their systolic pressure of 13 mm Hg was significantly greater than that in the placebo group ( 7 mm Hg ) but not different from that in the metoprolol group ( 10 mm Hg ) . Their fall in diastolic pressure ( 10 mm Hg ) was greater than that in both the metoprolol ( 6 mm Hg ) and placebo ( 3 mm Hg ) groups . At the end of the follow-up period 50 % of patients in the weight-reduction group had a diastolic pressure of less than 90 mm Hg . In the metoprolol group there was a decrease in high density lipoprotein (HDL)-cholesterol and an increase in the ratio of total to HDL-cholesterol ; in the weight-reduction group there was a decrease both in total cholesterol and in the ratio of total to HDL-cholesterol . Thus in this study population weight reduction produced significant and clinical ly important reductions in blood pressure but not the adverse effects on plasma lipids commonly associated with antihypertensive drug therapy We have examined the independent and combined effects on blood pressure and blood lipids of alcohol restriction and weight loss in overweight male drinkers with a view to assessing overall effects on cardiovascular risk of two widely promoted nonpharmacological approaches for hypertension . Eighty-six men with a mean age of 44.3 years , a mean regular alcohol intake of 440 ml/wk ( five or six st and ard drinks per day ) , a mean blood pressure of 137.4 mm Hg systolic and 84.8 mm Hg diastolic , and a mean body mass of 92.5 kg entered a controlled two-way factorial study . The subjects were r and omly assigned to four groups for an 18-week intervention in which members of two groups drank only low-alcohol beer , thereby reducing their alcohol intake by 374 ml/wk , while those of the other two groups continued their normal alcohol intake . Within the low and normal alcohol intake groups subjects either continued their usual diet or reduced their caloric intake by 4,200 - 6,300 kJ/day ( 1,000 - 1,500 kcal/day ) ( with protein , fat , and carbohydrate provided as 15 % , 30 % , and 55 % of total calories , respectively ) . Calorie reduction and alcohol restriction caused weight losses of 7.5 ( p less than 0.001 ) and 2.1 ( p less than 0.01 ) kg , respectively . Calorie reduction and alcohol restriction were associated with decreases in systolic blood pressure of 5.4 ( p less than 0.001 ) and 4.8 ( p less than 0.01 ) mm Hg , respectively , and in diastolic blood pressure of 4.2 ( p less than 0.001 ) and 3.3 ( p less than 0.01 ) mm Hg , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS The blood pressure responses of 19 mildly hypertensive ( diastolic blood pressure 90–104 mmHg ) individuals to treatment with either 1200 mg of elemental calcium supplementation or placebo were assessed weekly in a 6-month r and omized , double-blind , placebo-controlled crossover study . Both groups showed a decrease in blood pressure ( calcium treated : 6 ± 12 mmHg systolic , 7 ± 7 mmHg diastolic ; and placebo controlled : 9 ± 14 mmHg systolic , 9 ± 8 mmHg diastolic ) . Differences between the two groups were not significant ( P > 0.1 ) . There were no adverse effects to either treatment . This study does not support the hypothesis that dietary calcium supplementation is more effective than placebo in reducing blood pressure in mildly hypertensive individuals BACKGROUND Several nonpharmacological interventions , including exercise , are recommended in primary prevention of hypertension and other cardiovascular diseases in which the pathogenetic role of endothelial dysfunction has been suggested . We studied the effects of long-term aerobic exercise on endothelial function in patients with essential hypertension . METHODS AND RESULTS The forearm blood flow was measured by strain-gauge plethysmography . The responses of forearm vasculature to acetylcholine were smaller in the hypertensive patients than in the normotensive subjects . There was no significant difference in forearm vascular responses to isosorbide dinitrate in the normotensive and hypertensive subjects . We evaluated the effects of physical exercise for 12 weeks on forearm hemodynamics in untreated patients with mild essential hypertension who were divided r and omly into an exercise group ( n=10 ) and a control group ( n=7 ) . After 12 weeks , the forearm blood flow response to acetylcholine increased significantly , from 25.8+/-9.8 to 32.3+/-11.2 mL. min(-1 ) . 100 mL tissue(-1 ) ( P<0.05 ) , in the exercise group but not in the control group . The increase in the forearm blood flow after isosorbide dinitrate was similar before and after 12 weeks of follow-up in both groups . The infusion of N(G)-monomethyl-L-arginine abolished the exercise-induced enhancement of forearm vasorelaxation evoked by acetylcholine in the exercising group . In normotensive subjects also , long-term aer OUTPUT:

Robust statistically significant effects were found for improved diet , aerobic exercise , alcohol and sodium restriction , and fish oil supplements : mean reductions in systolic blood pressure of 5.0 mmHg [ 95 % confidence interval ( CI ) : 3.1 - 7.0 ] , 4.6 mmHg ( 95 % CI : 2.0 - 7.1 ) , 3.8 mmHg ( 95 % CI : 1.4 - 6.1 ) , 3.6 mmHg ( 95 % CI : 2.5 - 4.6 ) and 2.3 mmHg ( 95 % CI : 0.2 - 4.3 ) , respectively , with corresponding reductions in diastolic blood pressure . Relaxation significantly reduced blood pressure only when compared with non-intervention controls . We found no robust evidence of any important effect on blood pressure of potassium , magnesium or calcium supplements . Available evidence does not support relaxation therapies , calcium , magnesium or potassium supplements to reduce blood pressure

MS2_dynamic_1_shot551

***TASK*** the task is to summarize an input biomedical literature 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 program The combined DAK therapy for obesity in children and adolescents ’ funded and conducted by the Deutsche Angestellten-Krankenkasse ( DAK ) , a German health insurance company , commenced in 2003 . The treatment program lasts for 1 year and comprises of 2 phases : an initial inpatient therapy for 6 weeks followed by a home-based outpatient treatment of the overweight children , adolescents , and their families for 10.5 months . The therapy complies with the guidelines of the German Working Group of Obesity in Childhood and Adolescence ( AGA ) . Participants and Methods : In this study , 162 obese children and adolescents were compared with a control group of 75 obese subjects recruited from the waiting list for the program . The aim was to analyze whether the changes in weight , eating behavior , and physical fitness during the therapy period are a result of the therapy itself or whether they are attributable to external effects . Body weight , height , and physical fitness were assessed through direct measurements while behavior and quality of life were assessed using self-report question naires . The development of body weight was evaluated using the BMI -SDS which is a measure of how many st and ard deviations an individual BMI is above or below the age- and gender-specific mean . Results : Within the observation period the BMI SDS decreased significantly by 0.36 ± 0.34 in the intervention group , whereas no changes of BMI -SDS were observed in the control group ( 0.04 ± 0.17 ) . The study revealed significant , positive treatment effects in exploratory analyses with regard to weight loss , behavior changes , physical fitness , and development of quality of life as a result of the therapy . These effects were not seen in the control group . Conclusion : We conclude that these positive developments are a result of the treatment program The present study compared the relative effectiveness of a therapist-supported maintenance condition with a minimal contact maintenance condition in preventing relapse following an obesity treatment program . Thirty-two subjects who completed an initial 12-week cognitive/behavioral plus aerobic exercise treatment program were matched on absolute weight loss and r and omly assigned to one of two maintenance conditions . Subjects were assessed at pretreatment , posttreatment , and 3 , 6 , and 12 months following posttreatment using measures of weight , blood pressure , and depression . Three- and six-month follow-up results indicated that subjects who participated in the therapist-supported maintenance group continued to lose weight and /or maintained therapy-induced weight loss to a greater degree than control subjects . At the 12-month follow-up assessment therapist-supported subjects maintained therapy-induced weight loss better than the control subjects . These findings suggest that maintenance programs which provide continued contact emphasizing relapse prevention training may be an important adjunct in the maintenance of therapy-induced weight loss A report of a r and omized , controlled trial ( RCT ) should convey to the reader , in a transparent manner , why the study was undertaken and how it was conducted and analyzed . For example , a lack of adequately reported r and omization has been associated with bias in estimating the effectiveness of interventions ( 1 , 2 ) . To assess the strengths and limitations of an RCT , readers need and deserve to know the quality of its methods . Despite several decades of educational efforts , RCTs still are not being reported adequately ( 3 - 6 ) . For example , a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin-reuptake inhibitors as first-line management strategy for depression found that only 1 ( 0.8 % ) paper described r and omization adequately ( 5 ) . Inadequate reporting makes the interpretation of RCT results difficult if not impossible . Moreover , inadequate reporting borders on unethical practice when biased results receive false credibility . History of CONSORT In the mid-1990s , two independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement ( 7 ) , which was developed by an international group of clinical trialists , statisticians , epidemiologists , and biomedical editors . CONSORT has been supported by a growing number of medical and health care journals ( 8 - 11 ) and editorial groups , including the International Committee of Medical Journal Editors ( ICMJE , also known as the Vancouver Group ) ( 12 ) , the Council of Science Editors ( CSE ) , and the World Association of Medical Editors ( WAME ) . CONSORT is also published in Dutch , English , French , German , Japanese , and Spanish . It can be accessed on the Internet , along with other information about the CONSORT group ( 13 ) . The CONSORT statement comprises a checklist and flow diagram for reporting an RCT . For convenience , the checklist and diagram together are called simply CONSORT . They are primarily intended for use in writing , review ing , or evaluating reports of simple two-group , parallel RCTs . Preliminary data indicate that the use of CONSORT does indeed help to improve the quality of reports of RCTs ( 14 , 15 ) . In an evaluation ( 14 ) of 71 RCTs published in three journals in 1994 , allocation concealment was not clearly reported in 43 ( 61 % ) of the RCTs . Four years later , after these three journals required that authors reporting an RCT use CONSORT , the proportion of papers in which allocation concealment was not clearly reported had dropped to 39 % ( 30 of 77 ; mean difference , 22 % [ 95 % CI of the difference , 38 % to 6 % ] ) . The usefulness of CONSORT is enhanced by continuous monitoring of the biomedical literature ; this monitoring allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items . For example , when Meinert ( 16 ) observed that the flow diagram did not provide important information about the number of participants who entered each phase of an RCT ( enrollment , treatment allocation , follow-up , and data analysis ) , the diagram could be modified to accommo date the information . The check OUTPUT: Furthermore , mean attrition rates were much lower when compared with st and ard out-patient treatment . Explanations for the potentially greater impact of immersion relative to out-patient treatments are presented , including possibly differential effects on self-efficacy for both children and their parents INPUT: Background : The program The combined DAK therapy for obesity in children and adolescents ’ funded and conducted by the Deutsche Angestellten-Krankenkasse ( DAK ) , a German health insurance company , commenced in 2003 . The treatment program lasts for 1 year and comprises of 2 phases : an initial inpatient therapy for 6 weeks followed by a home-based outpatient treatment of the overweight children , adolescents , and their families for 10.5 months . The therapy complies with the guidelines of the German Working Group of Obesity in Childhood and Adolescence ( AGA ) . Participants and Methods : In this study , 162 obese children and adolescents were compared with a control group of 75 obese subjects recruited from the waiting list for the program . The aim was to analyze whether the changes in weight , eating behavior , and physical fitness during the therapy period are a result of the therapy itself or whether they are attributable to external effects . Body weight , height , and physical fitness were assessed through direct measurements while behavior and quality of life were assessed using self-report question naires . The development of body weight was evaluated using the BMI -SDS which is a measure of how many st and ard deviations an individual BMI is above or below the age- and gender-specific mean . Results : Within the observation period the BMI SDS decreased significantly by 0.36 ± 0.34 in the intervention group , whereas no changes of BMI -SDS were observed in the control group ( 0.04 ± 0.17 ) . The study revealed significant , positive treatment effects in exploratory analyses with regard to weight loss , behavior changes , physical fitness , and development of quality of life as a result of the therapy . These effects were not seen in the control group . Conclusion : We conclude that these positive developments are a result of the treatment program BACKGROUND Little is known about how the intensity of exercise influences cardiovascular fitness and body composition , especially in obese adolescents . OBJECTIVE Our goal was to determine the effects of physical training intensity on the cardiovascular fitness , percentage of body fat ( % BF ) , and visceral adipose tissue ( VAT ) of obese adolescents . DESIGN Obese 13 - 16-y-olds ( n = 80 ) were assigned to 1 ) biweekly lifestyle education ( LSE ) , 2 ) LSE + moderate-intensity physical training , or 3 ) LSE + high-intensity physical training . The intervention lasted 8 mo . Physical training was offered 5 d/wk , and the target energy expenditure for all subjects in physical training groups was 1047 kJ ( 250 kcal)/session . Cardiovascular fitness was measured with a multistage treadmill test , % BF with dual-energy X-ray absorptiometry , and VAT with magnetic resonance imaging . RESULTS The increase in cardiovascular fitness in the high-intensity physical training group , but not in the moderate-intensity group , was significantly greater than that in the LSE alone group ( P = 0.009 ) ; no other comparisons of the 3 groups were significant . Compared with the LSE alone group , a group composed of subjects in both physical training groups combined who attended training sessions > or=2 d/wk showed favorable changes in cardiovascular fitness ( P < 0.001 ) , % BF ( P = 0.001 ) , and VAT ( P = 0.029 ) . We found no evidence that the high-intensity physical training was more effective than the moderate-intensity physical training in enhancing body composition . CONCLUSIONS The cardiovascular fitness of obese adolescents was significantly improved by physical training , especially high-intensity physical training . The physical training also reduced both visceral and total-body adiposity , but there was no clear effect of the intensity of physical training INTRODUCTION The purpose of this study was to test the hypothesis that physical training ( PT ) , especially high-intensity PT , would have a favorable effect on components of the insulin resistance syndrome ( IRS ) in obese adolescents . METHODS Obese 13- to 16-yr-olds ( N = 80 ) were r and omly assigned to one of the following 8-month interventions ; 1 ) lifestyle education (LSE)-alone every 2 wk , 2 ) LSE+moderate-intensity PT , and 3 ) LSE+high-intensity PT . PT was offered 5 d x wk(-1 ) . Plasma triacylglycerol ( TAG ) , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDLC ) , very low-density lipoprotein cholesterol ( VLDLC ) , low-density lipoprotein cholesterol ( LDLC ) , low-density lipoprotein ( low density lipoprotein ( LDL ) ) particle size , apolipoproteins AI and B , glucose , insulin , and blood pressure were measured with st and ardized methods . RESULTS The intent-to-treat analyses for all subjects who completed pre- and post-tests regardless of their adherence to the interventions showed that the LSE+high-intensity PT group had more favorable changes than the LSE-alone group in TAG level ( P = 0.012 ) , TC/HDLC ( P = 0.013 ) , and diastolic blood pressure ( P = 0.031 ) . For efficacy analyses , all PT subjects who attended at least 2 d x wk(-1 ) ( 40 % ) were combined into one group ( LSE+PT ) and compared with the LSE-alone group . These two-group analyses showed significant interactions ( P < 0.001 ) between baseline values and group membership for deltaTAG , deltaVLDLC , and deltaTC/HDLC , such that subjects who had the least favorable baseline values showed the most beneficial impact of the PT . OUTPUT:

In conclusion , overweight and obese youth can improve physical fitness across a variety of test measures . When fitness improves , beneficial health effects are observed in some , but not all chronic disease risk factors

MS2_dynamic_1_shot552

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The aim of the present study was to compare the effect of increased aerobic capacity versus muscle strength rehabilitation of female hospital staff with long-lasting musculoskeletal back pain . Seventy-nine women agreed to participate in the intervention study . After a medical examination , 65 individuals were assigned to one of three balanced groups : Endurance training ( aerobic capacity promoting training : ET : n = 22 ) , strength promotion exercise ( SP : n = 24 ) or a control group ( CON : n = 19 ) . The active groups met twice a week for 60 minutes of exercise over 15 weeks . Aerobic capacity ( VO2max ) and musculoskeletal pain were measured immediately before ( T1 ) and after the intervention period ( T2 ) . Aerobic capacity significantly increased in the ET group , whereas no change was observed in the SP group , and a significant reduction was found in the CON group from T1 to T2 . Musculoskeletal pain was significantly reduced in both intervention groups , whereas minor changes were observed in the control group . Results from a 7-month follow-up ( T3 ) survey confirmed the beneficial effects of interventions on musculoskeletal pain . In conclusion , improved aerobic capacity appeared not to be a necessary mechanism in musculoskeletal back pain reduction BACKGROUND High rates of work-related injuries are seen among health care workers involved in lifting and transferring patients . We studied the effects of a participatory worker-management ergonomics team among hospital orderlies . METHODS This prospect i ve intervention trial examined work injuries and other outcomes before and after the intervention , with other hospital employees used as a concurrent control . All orderlies in a 1,200-bed urban hospital were studied using passively collected data ( mean employment during study period 100 - 110 orderlies ) ; 67 orderlies ( preintervention ) and 88 orderlies ( postintervention ) also completed a question naire . The intervention was the formation of a participatory ergonomics team with three orderlies , one supervisor , and technical advisors . This team design ed and implemented changes in training and work practice s. RESULTS The 2-year postintervention period was marked by decreased risks of work injury ( RR = 0.50 , 95 % CI 0.35 - 0.72 ) , lost time injury ( RR = 0.26 , 95 % CI 0.14 - 0.48 ) , and injury with three or more days of time loss ( RR = 0.19 , 95 % CI 0.07 - 0.53 ) . Total lost days declined from 136.2 to 23.0 annually per 100 full-time worker equivalents ( FTE ) . Annual workers ' compensation costs declined from $ 237/FTE to $ 139/FTE . The proportion of workers with musculoskeletal symptoms declined and there were statistically significant improvements in job satisfaction , perceived psychosocial stressors , and social support among the orderlies . CONCLUSION Substantial improvements in health and safety were seen following implementation of a participatory ergonomics program The aim of this Intervention was to evaluate the effect of training on patient-h and ling skills and prospect ively to assess the effect of skill on subsequent back pain and back injuries in nursing . Of a total of 255 nurses , 199 were assessed for their skill in patient-h and ling . One-half ( control group ) received traditional training in patient-h and ling , and the other half ( trained group ) received a curriculum of instruction totaling 40 hours . The skills of both groups were assessed on graduation . The control group was rated as less competent in patient-h and ling . Nurses in both groups were question ed about the prevalence of back pain and incidence of back injuries in the first year after graduation . In multiple regression analysis , the major risk Indicators for back injuries were poor patient-h and ling skill , low numbers of repetitions in the sit-up test , and high work-load scores . High score on the hysteria scale of Middlesex Hospital Question naire was a risk Indicator for all kinds of back pain . Though back pain was Independent of patient-h and ling skill , those rated as “ bad ” or “ poor ” had more back injuries ( 24 % ) than those who had been rated as “ good ” or “ excellent ” ( 2 % ) ( P < 0.001 ) , but the difference between the trained and control groups was not statistically significant . It was concluded that back Injuries may be prevented by the teaching of patient-h and ling skills A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL sessions . Further research is needed to answer the question of “ intensity versus type of exercise ” by comparing different intervention programs , with similar intensity Back injuries are a serious problem for nursing personnel who perform frequent patient-h and ling activities . Common prevention strategies include body mechanics education , technique training , and ergonomic interventions such as the introduction of assistive equipment . This investigation assessed and compared the effectiveness of two patient-h and ling approaches to reducing injury risk . One strategy involved using improved patient-h and ling technique with existing equipment , and the other approach aim ed at eliminating manual patient h and OUTPUT: Conclusions The findings here echo previous systematic review s supporting exercise as providing positive health benefits and training alone as not being effective . INPUT: OBJECTIVE Numerous studies has shown that regular physical exercise can reduce musculoskeletal pain , but the optimal setting to achieve high adherence and effectiveness remains unknown . This study investigated the effect of workplace versus home-based physical exercise on musculoskeletal pain among healthcare workers . METHODS The r and omized controlled trial ( RCT ) comprised 200 female healthcare workers from 18 departments at 3 hospitals . Participants were r and omly allocated at the cluster level to ten weeks of : ( i ) workplace physical exercise ( WORK ) performed during working hours for 5 × 10 minutes per week and up to 5 group-based coaching sessions on motivation for regular physical exercise , or ( ii ) home-based physical exercise ( HOME ) performed during leisure time for 5 × 10 minutes per week . Both groups received ergonomic counseling on patient h and ling and use of lifting aides . Average pain intensity ( 0 - 10 scale ) in the low back and neck/shoulder was the primary outcome . RESULTS Per week , 2.2 ( SD 1.1 ) and 1.0 ( SD 1.2 ) training sessions were performed in WORK and HOME groups , respectively . Pain intensity , back muscle strength and use of analgesics improved more following WORK than HOME ( P<0.05 ) . Between-group differences at follow-up ( WORK versus HOME ) was -0.7 points for pain intensity [ 95 % confidence interval ( 95 % CI ) -1.0- -0.3 ] , 5.5 Nm for back muscle strength ( 95 % CI 2.0 - 9.0 ) , and -0.4 days per week for use of analgesics ( 95 % CI -0.7- -0.2 ) . The effect size for between-group differences in pain intensity was small ( Cohen 's d=0.31 ) . CONCLUSIONS Workplace physical exercise is more effective than home-based exercise in reducing musculoskeletal pain , increasing muscle strength and reducing the use of analgesics among healthcare workers The aim of the present study was to compare the effect of increased aerobic capacity versus muscle strength rehabilitation of female hospital staff with long-lasting musculoskeletal back pain . Seventy-nine women agreed to participate in the intervention study . After a medical examination , 65 individuals were assigned to one of three balanced groups : Endurance training ( aerobic capacity promoting training : ET : n = 22 ) , strength promotion exercise ( SP : n = 24 ) or a control group ( CON : n = 19 ) . The active groups met twice a week for 60 minutes of exercise over 15 weeks . Aerobic capacity ( VO2max ) and musculoskeletal pain were measured immediately before ( T1 ) and after the intervention period ( T2 ) . Aerobic capacity significantly increased in the ET group , whereas no change was observed in the SP group , and a significant reduction was found in the CON group from T1 to T2 . Musculoskeletal pain was significantly reduced in both intervention groups , whereas minor changes were observed in the control group . Results from a 7-month follow-up ( T3 ) survey confirmed the beneficial effects of interventions on musculoskeletal pain . In conclusion , improved aerobic capacity appeared not to be a necessary mechanism in musculoskeletal back pain reduction Objective : To examine the effects of a new wearable type of lumbosacral support on low back pain . Methods : A total of 121 healthcare workers participated in this study . They were r and omly allocated into the experimental and control groups and the former wore the support with signals of compression on the back by poor posture for the first 3 months . The control group remained on a waiting list for the first 3 months . Medical history , musculoskeletal symptoms , feeling in good posture , sleep habits , psychological distress , Rol and -Morris Disability Question naire , and Somatosensory Amplification Scale ( SSAS ) were evaluated . The range of motion ( ROM ) in the shoulder and hip joints as well as spinal alignment were evaluated . Our primary concern was the difference in the change of low back pain measured by visual analog scale ( VAS ) between the two groups . Results : A total of 54 participants in the experimental and 53 participants in the control groups were analyzed . VAS and SSAS scores as well as lumbar spinal ROM in the experimental group significantly decreased . Low back pain ( OR=0.401 , 95 % CI=0.168 - 0.954 ) and neck pain in the experimental group ( OR=0.198 , 95 % CI=0.052 - 0.748 ) significantly decreased . Conclusions : The new lumbar support reduced VAS and SSAS scores , lumbar spinal ROM , low back pain , and neck pain . This new type of lumbar support reduced low back pain among healthcare workers AIMS AND OBJECTIVES ( i ) To examine patient lifting techniques used by nurses , and ( ii ) to evaluate an effectiveness of the Spine Care for Nurses programme in chronic nonspecific low back pain syndrome reduction and the execution of proper patient lifting techniques . BACKGROUND Millions of nurses around the world suffer from occupational-related chronic nonspecific low back pain ( chronic nonspecific low back pain syndrome ) . Generally , low back pain in nurses is a result of increased pressure on the spine and can be associated with improperly conducted patient lifting techniques . METHODS A r and omised controlled trial was conducted among 137 nurses with chronic nonspecific low back pain syndrome . Participants were r and omised into an experimental and control group ( experimental group n = 67 , control group n = 70 ) . Nurses in the experimental group attended the Spine Care for Nurses programme for 3 months . The programme consisted of didactic education , spine-strengthening exercises and education on safe patient h and ling techniques . The control group only received a brief written lifestyle guidance . The Zebris WinSpine Triple Lumbar examination was used to analyse nurses ' patient lifting techniques ( horizontal and vertical lifting ) . The lumbar pain intensity was OUTPUT:

Results Level of evidence from 54 high and medium quality studies showed moderate evidence of a positive effect of physical exercise . Within this domain , there was strong evidence of a positive effect of workplace strength training . There was limited evidence for ergonomics and strong evidence for no benefit of participatory ergonomics , multifaceted interventions , and stress management . No intervention domains were associated with “ negative effects ” . Conclusions The evidence synthesis recommends that implementing strength training at the workplace can reduce MSD among workers with physically dem and ing work . In regard to workplace ergonomics , there was not enough evidence from the scientific literature to guide current practice s. Based on the scientific literature , participatory ergonomics and multifaceted workplace interventions seem to have no beneficial effect on reducing MSD among this group of workers .

MS2_dynamic_1_shot553

***TASK*** the task is to summarize an input biomedical literature 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 telephone and mail are often used to promote physical activity adoption , their ability to produce long-term maintenance is unclear . In this study , 140 men and women aged 50 - 65 years received 1 year of telephone counseling to adopt higher ( i.e. , more vigorous ) versus lower intensity ( i.e. , moderate ) exercise . After 1 year , participants were rer and omized to a 2nd year of contact via ( a ) telephone and mail or ( b ) predominantly mail . Participants who were prescribed higher intensity exercise and received predominantly mail had better exercise adherence during the maintenance year than those who received telephone and mail . Both strategies were similarly effective in promoting maintenance in the lower intensity condition . Results suggest that after successful adoption of physical activity with the help of telephone counseling , less intensive interventions are successful for physical activity maintenance in older adults Two studies were undertaken to compare strategies for the adoption and maintenance of moderate-intensity , home-based exercise training . In the study of adoption , 52 men and women who had served for 6 months as controls for a study of moderate-intensity , home-based exercise training received 30 minutes of baseline instruction . They were then r and omized to receive continuing instruction and support through 10 staff-initiated telephone contacts of 5 minutes each every 2 weeks , or to receive no telephone contacts . In subjects receiving telephone contacts , peak oxygen uptake increased significantly after 6 months , whereas no increase was observed in subjects receiving no staff support ( p less than 0.05 ) . In the maintenance study , 51 men and women who had significantly increased their peak oxygen uptake by 6 months of moderate-intensity , home-based exercise training were r and omized to undergo daily self-monitoring and receive adherence instructions , or undergo weekly self-monitoring only , during a second 6-month period of training . Subjects performing daily self-monitoring reported completing significantly more exercise training sessions during the 6 months of training than subjects performing weekly self-monitoring ; functional capacity in both groups remained higher than before training ( p less than 0.05 ) . Taken together , these studies suggest that brief baseline instruction followed by continuing telephone contact with staff can be used to help people adopt a moderate-intensity , home-based exercise training program that can be maintained by simple self-monitoring strategies The purpose of this study was to determine how an exercise adherence intervention affects the physiological , functional , and quality of life outcomes of patients with heart failure ( HF ) . Sixteen HF patients were r and omly assigned to an exercise-only group ( n = 8) or to an exercise-with-adherence group ( n = 8) . Two of the 16 people died from nonexercise related causes during the study and were not included in the analysis . The intervention was tested over a 24-week period in which patients participated in a 12-week supervised exercise program ( Phase 1 ) followed by 12 weeks of unsupervised home exercise ( Phase 2 ) . The intervention format was one of individualized graphic feedback on exercise goals and participation and problem-solving support by nurses . Results indicate that patients who received the intervention exercised more frequently and experienced improved outcomes during both phases . The adherence intervention may encourage HF patients to continue to exercise and thereby maintain the health benefits gained in both phases of an exercise program 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 Two behavioral techniques were assessed to determine their effects on subjects ' adherence to unsupervised exercise . The subjects were 35 moderately fit persons who had just completed an adult fitness program ( AF group ) and 42 sedentary individuals who were recruited through the campus newspaper ( NEWS group ) . Participants were r and omly assigned to one of three conditions : ( a ) self-monitoring , ( b ) reinforcement supplied by another person , or ( c ) control . All subjects were given instructions on how to exercise and asked to exercise on their own for 18 weeks . Self-monitoring subjects kept written records of their exercise behavior , while reinforcement subjects verbally reported their exercise behavior to another person who periodically administered rewards . Pre- and posttreatment tests on the NEWS group revealed no significant treatment or interaction effects . However , the reinforcement group had an 11 % improvement in predicted max VO2 and a 9 bpm improvement in exercise heart rate compared to 7.8 % , 5 bpm for the self-monitoring ( SM ) group and 5.3 % , 6 bpm for the control group . T-tests indicated that reward and SM groups improved significantly on these variables , whereas the control group did not . SM ( M = 2.07 ) and reinforcement ( M = 2.29 ) groups reported a significantly higher frequency of exercise per week than the control ( M = 1.36 ) group . The AF subjects were able to maintain their fitness level ( with the exception of a small increase in body fat ) over the 18-week period . The behavioral interventions had little differential effect on adherence by AF subjects who were already regular exercisers OBJECTIVES To determine the efficacy of community water-based therapy for the management of lower limb osteoarth OUTPUT: Strong evidence was found for no long-term effectiveness on pain and self-reported physical function , moderate evidence for long-term effectiveness on patient global assessment of effectiveness , and conflicting evidence for observed physical function . For exercise programs with additional booster sessions , moderate evidence was found for long-term effectiveness on pain , self-reported physical function , and observed physical function . CONCLUSION The positive posttreatment effects of exercise therapy on pain and physical function in patients with OA of the hip and /or knee are not sustained in the long term . Long-term effectiveness was only found for patient global assessment of effectiveness . However , additional booster sessions after the treatment period positively influenced maintenance of beneficial posttreatment effects on pain and physical function in the long term INPUT: Examines types of social support that best predicts adherence at different time points during a 1-year endurance exercise program in 269 women and men ages 50 to 65 years . Results indicate that social support had similar effects on exercise participation for women and men , and support specific to exercise was a better predictor of exercise adherence than general social support . A preference for receiving a lesser amount of initial support from exercise staff was the strongest social support-related predictor of exercise adherence during the initial 6 months of the program . Support currently received from family and friends and exercise staff at Month 6 was found to be the strongest predictor of adherence during Months 7 to 12 . Format of exercise was also a strong predictor of exercise adherence with home-based programs related to greater adherence . Additionally , divorced nonsmokers appear to be at increased risk for poor early exercise adherence and should be targeted in interventions to promote exercise participation BACKGROUND Project ACTIVE was a r and omized clinical trial comparing two physical activity interventions , lifestyle and traditional structured exercise . The two interventions were evaluated and compared in terms of cost effectiveness and ability to enhance physical activity among sedentary adults . DESIGN This was a r and omized clinical trial . SETTING / PARTICIPANTS The study included 235 sedentary but healthy community-dwelling adults . INTERVENTION A center-based lifestyle intervention that consisted of behavioral skills training was compared to a structured exercise intervention that included supervised , center-based exercise . MAIN OUTCOME MEASURES The main outcome measures of interest included cost , cardiorespiratory fitness , and physical activity . RESULTS Both interventions were effective in increasing physical activity and fitness . At 6 months , the costs of the lifestyle and structured interventions were , respectively , $ 46.53 and $ 190.24 per participant per month . At 24 months these costs were $ 17.15 and $ 49.31 per participant per month . At both 6 months and 24 months , the lifestyle intervention was more cost-effective than the structured intervention for most outcomes measures . CONCLUSIONS A behaviorally-based lifestyle intervention approach in which participants are taught behavioral skills to increase their physical activity by integrating moderate-intensity physical activity into their daily lives is more cost-effective than a structured exercise program in improving physical activity and cardiorespiratory health . This study represents one of the first attempts to compare the efficiency of intervention alternatives for improving physical activity among healthy , sedentary adults Follow-up evaluation was conducted of 101 older men and women ( mean age = 67 + /- 5 years ) who had participated in a r and omized study of physiological and psychological effects of aerobic exercise . Eighty-five subjects completed the follow-up evaluation , and almost all of them ( 94 % ) reported continuing with physical activity , as assessed by a self-report measure . Total energy expenditure was calculated as an indicator of exercise maintenance , and energy expenditure at follow-up was predicted from measures of physiological functioning , psychological well-being , and cognitive functioning obtained at the conclusion of the structured exercise program . Greater cardiorespiratory endurance , faster psychomotor speed , and lower anxiety predicted exercise behavior at follow-up , accounting for 13 % of the variance in exercise behavior . Gender was not a significant predictor of exercise behavior Little is known about the predictors of maintenance in organized exercise programmes . The aim of this study was to investigate the behavioral predictors of maintenance of exercise participation in older adults , using an integrated social psychological model . To this end , we carried out a prospect i ve cohort study ( n = 1,725 ; age 50 years or older ) involving 10 different types of exercise programmes , with measurements at baseline and after 6 months . Predictors of intention to continue participating and the actual maintenance of exercise participation in the exercise programme were assessed using a step-wise logistic regression model . Significant odds ratios ( ORs ) predicting the intention to continue with the exercise programme were found for female sex , younger age , being married , being a non-smoker , being in paid employment , having a positive attitude towards exercise and having a high self-efficacy at baseline . Significant ORs predicting actual maintenance of exercise participation were short lapses , absence of lapses , high intention at baseline , high perceived quality of the programme , positive attitude at baseline and few risk situations at baseline . In order to promote maintenance of exercise participation for older adults , effort should be taken to prevent lapses , to help people cope with risk situations for lapses , to improve the attitude towards exercise participation and to improve the quality of the programme Signal detection methodology was used to identify the best combination of predictors of long-term exercise adherence in 269 healthy , initially sedentary adults ages 50 - 65 years . Less educated individuals who were assigned to supervised home-based exercise of either higher or lower intensity and who were less stressed and less fit at baseline than other individuals had the greatest probability of successful adherence by the 2nd year . Overweight individuals assigned to a group-based exercise program were the least likely to be successful 2 years later . Predictors of short-term ( 1-year ) adherence were generally similar to predictors of 2-year adherence . Signal detection analysis may be useful for identifying subgroups of people at risk for underadherence who subsequently might be targeted for intervention Background . Counseling sedentary primary care patients can increase physical activity , but whether this approach will increase exercise and fitness in elderly adults with chronic diseases remains to be determined . Methods . After receiving individualized nurse counseling to begin a program of walking for health , 60- to 80-year-old primary care patients were r and omized to one of three levels of telephone contacts over 10 months : ( i ) 20 nurse-initiated calls , ( ii ) 10 nurse-initiated calls plus 10 motivational calls programmed through an automated phone calling system , or ( iii ) no program-initiated phone contacts . Self-reported ( diary ) walking adherence was the primary outcome ; other OUTPUT:

Due to lack of high quality studies and often only one manuscript reporting on a particular determinant , we concluded " insufficient evidence " for most associations between determinants and physical activity or exercise .

MS2_dynamic_1_shot554

***TASK*** the task is to summarize an input biomedical literature 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 : HIV-associated wasting is defined as ≥10 % involuntary weight loss and includes declines in both lean and fat mass . This large ( 757 subjects ) , r and omized , double-blind , placebo-controlled trial investigated the efficacy , safety , and tolerability of recombinant human growth hormone ( rhGH ) in 2 doses—0.1 mg/kg up to a maximum of 6 mg daily ( DD ) or alternate days (AD)—in the treatment of wasting and weight loss in highly active antiretroviral therapy (HAART)-treated HIV-infected subjects . The evaluable population for ergometry comprised 555 subjects , 87.6 % of whom were receiving HAART . At 12 weeks , median maximum work output increased by 2.4 and 2.6 kJ in the AD and DD groups , respectively . The median treatment difference was 2.9 kJ for DD vs. placebo ( P < 0.0001 ) . Body weight increased by 2.2 and 2.9 kg in the AD and DD groups , respectively . Corresponding median treatment differences vs. placebo were 1.5 and 2.2 kg ( P < 0.0001 ) . Lean body mass ( LBM ) , by bioelectric impedance spectroscopy , increased by 3.3 and 5.2 kg , respectively ( P < 0.0001 vs. placebo ; P = 0.0173 DD vs. AD ) , and fat mass , predominately truncal , decreased . Quality of life ( QoL ) improved significantly in both rhGH groups . Fluid-retention adverse effects and hyperglycemia were more common in the DD than in the AD group . No significant changes in HIV viral load or CD4 cell count occurred . In conclusion , over the 12-week course of therapy , rhGH , 0.1 mg/kg DD , was superior to placebo in improving physical function , body weight , body composition , and QoL and was superior to AD dosing in restoring LBM Patients with acquired immunodeficiency syndrome ( AIDS ) often suffer from weight loss manifested by a loss of body cell mass ( BCM ) . The causes of human immunodeficiency virus (HIV)-associated wasting may include anorexia , malabsorption , and a variety of altered metabolic states . Malabsorption and diarrhea may result from gastrointestinal tract opportunistic infections or from direct effects of HIV on the gastrointestinal tract . Infection with HIV may produce metabolic derangements that alter nutrient utilization , result ing in loss of BCM . Nutritional assessment of the patient with AIDS should include an evaluation of BCM and physical and psychosocial functioning . Antiretroviral therapy and eradication of opportunistic infections do not always reverse wasting . Treatment should include nutritional counseling . Total parenteral nutrition is sometimes of benefit , particularly in patients with damaged gastrointestinal tracts . Dronabinol and megestrol acetate may promote weight gain ; however , dronabinol may have adverse effects , and most of the gain with megestrol acetate is in fat rather than BCM . If gonadal dysfunction is present , testosterone replacement therapy should be included in the treatment plan . Some studies suggest that oral anabolic steroids may improve muscle strength and body composition . In r and omized , placebo-controlled trials , mammalian-derived human growth hormone ( rhGH[m ] ) has produced sustained weight and BCM gains in AIDS patients . If a patient continues to lose BCM after the above factors have been addressed and corrected , a 12-week course of rhGH[m ] is indicated . Halting the progression of HIV-associated wasting may improve survival , enhance physical and social functioning , and enrich quality of life Hypogonadism is prevalent among human immunodeficiency virus-infected men , in whom significantly reduced quality of life and mood disturbances have been reported . Previous studies have not investigated the relationship between depression score and gonadal function among such patients . We first compared depression scores in hypogonadal ( n = 52 ) and eugonadal ( n = 10 ) patients with acquired immunodeficiency syndrome ( AIDS ) wasting , matched for weight and disease status , and then investigated the effects of testosterone administration on depression score in a r and omized , double-blind , placebo-controlled study among the group of hypogonadal men with AIDS wasting . The primary end point in all comparisons was the Beck Depression Inventory . Hypogonadal patients demonstrated significantly increased scores on the Beck inventory compared with eugonadal- , age- , weight- , and disease status-matched subjects ( 15.5+/-1.1 vs. 10.6+/-1.4 mean + /- SEM , P = 0.02 ) . Among the combined hypogonadal and eugonadal subjects , a significant inverse correlation was seen between the Beck score and both free ( r = 0.41 , P<0.01 ) and total serum testosterone levels ( r = -0.43 , P<0.001 ) . The relationship between the Beck score and testosterone levels remained highly significant , controlling for weight , viral load , CD4 count , and antidepressant use ( P<0.01 for free testosterone , P<0.001 for total testosterone ) . Furthermore , when subjects were divided into two groups , based on a Beck score greater than 18 or less than or equal to 18 , serum total and free testosterone levels were significantly lower in the subjects with a Beck score greater than 18 , whereas there were no differences in weight , viral load , CD4 count , or Karnofsky status . End of study data were available in 39 patients who completed the r and omized , placebo-controlled study . Beck score decreased significantly only in the subjects receiving testosterone ( -5.8+/-1.3 , P < 0.001 ) , but not in subjects r and omized to OUTPUT: The 3 treatments for HIV wasting assessed -- rhGH , testosterone , and anabolic steroids -- all demonstrated significant efficacy in increasing LBM as compared with placebo . Although meta- analysis did not indicate any statistically significant differences between these agents in the degree of efficacy in this outcome , the Food and Drug Administration-approved dose of rhGH may have advantages over the other 2 therapies in terms of improvements in functional capacity and INPUT: Twelve children with documented Prader-Labhart-Willi syndrome were treated with human growth hormone ( 24 U/m2/week ) during 1 year . The children were divided into three groups : group 1 : overweight and prepubertal ( n = 6 , age 3.8–7.0 years ) ; group 2 : underweight and prepubertal ( n = 3 , age 0.6–4.1 years ) ; group 3 : pubertal ( n = 3 , age 9.2–14.6 years ) . In group 1 , height increased from -1.7 SD to -0.6 SD , while weight decreased from 1.1 SD to 0.4 SD , with a dramatic drop in weight for height from 3.8 SD to 1.2 SD . H and length increased from -1.5 SD to -0.4 SD and foot length from -2.5 SD to -1.4 SD . Body fat , measured by dual X-ray energy absorptiometry , dropped by a third , whereas muscle mass increased by a fourth . Physical capability ( Wingate test ) improved considerably . The children were reported to be much more active and capable . In group 2 , similar changes were seen , but weight for height increased , probably because muscle mass increase exceeded fat mass decrease . Changes in group 3 were similar as in group 1 , even though far less distinct . Conclusion Growth hormone treatment in Prader-Labhart-Willi syndrome led to dramatic changes : distinct increase in growth velocity , height and muscle mass , as well as an improvement in physical performance . Fat mass and weight for height decreased in the initially overweight children , and weight for height increased in underweight children CONTEXT Symptoms of fluid retention in GH-deficient patients during GH replacement are greater in men than in women , suggesting that testosterone may augment or estradiol may attenuate the antinatriuretic actions of GH . The mechanisms underlying the sodium-retaining effects of GH are poorly understood . AIM The aim of this study was to investigate the effects of GH and testosterone , alone and in combination , on extracellular water ( ECW ) and the hormonal mechanisms involved . DESIGN Two separate , open-label , r and omized , two-period , crossover studies were performed ; the first compared the effects of GH alone with those of GH and testosterone , and the second compared the effects of testosterone alone with those of GH and testosterone . PARTICIPANTS Twelve hypopituitary men with GH deficiency and hypogonadism were studied . INTERVENTION During the weeks of intervention , GH ( 0.5 mg/d ) and testosterone enanthate ( 250 mg ) were administered by i m injection . OUTCOME MEASURES The outcome measures were ECW , IGF-I , plasma renin activity ( PRA ) , aldosterone ( Aldo ) , and atrial natriuretic peptide ( ANP ) . RESULTS GH treatment significantly increased ( P < 0.05 ) both IGF-I and ECW , and these changes were enhanced by cotreatment with testosterone ( P = 0.07 for both ) . PRA , Aldo , and ANP levels did not change . Testosterone treatment alone did not change the IGF-I concentration , whereas cotreatment with GH induced a marked increase . Testosterone alone increased ( P < 0.05 ) ECW , and the effect was augmented ( P < 0.01 ) by cotreatment with GH . Although PRA and ANP did not change , plasma Aldo decreased after single and combined treatments . CONCLUSION GH and testosterone exerted independent and additive effects on ECW . The mechanisms of fluid retention for both hormones are likely to be exerted on the renal tubules . This is the first direct evidence that testosterone increases ECW The purpose of this study was to determine whether growth hormone ( GH ) administration enhances the muscle anabolism associated with heavy-resistance exercise . Sixteen men ( 21 - 34 yr ) were assigned r and omly to a resistance training plus GH group ( n = 7 ) or to a resistance training plus placebo group ( n = 9 ) . For 12 wk , both groups trained all major muscle groups in an identical fashion while receiving 40 micrograms recombinant human GH.kg-1.day-1 or placebo . Fat-free mass ( FFM ) and total body water increased ( P less than 0.05 ) in both groups but more ( P less than 0.01 ) in the GH recipients . Whole body protein synthesis rate increased more ( P less than 0.03 ) , and whole body protein balance was greater ( P = 0.01 ) in the GH-treated group , but quadriceps muscle protein synthesis rate , torso and limb circumferences , and muscle strength did not increase more in the GH-treated group . In the young men studied , resistance exercise with or without GH result ed in similar increments in muscle size , strength , and muscle protein synthesis , indicating that 1 ) the larger increase in FFM with GH treatment was probably due to an increase in lean tissue other than skeletal muscle and 2 ) resistance training supplemented with GH did not further enhance muscle anabolism and function We studied the acute effects of a single , sc GH dose on exercise performance and metabolism during bicycling . Seven highly trained men [ age , 26 + /- 1 yr ( mean + /- SEM ) ; weight , 77 + /- 3 kg ; maximal oxygen uptake , 65 + /- 1 ml O(2).min(-1).kg(-1 ) ] performed 90 min of bicycling 4 h after receiving 7.5 IU ( 2.5 mg ) GH or placebo in a r and omized , double-blinded , cross-over design trial . A st and ardized pre-exercise meal was given 2 h before exercise . Blood was sample d at rest and during exercise and analyzed for GH , IGF-I , glucose , lactate , insulin , glycerol OUTPUT:

RESULTS Body cell mass was correlated with all measures of performance at baseline . Growth hormone significantly reduced fat mass , increased lean body mass through an increase in extracellular water , and increased body cell mass in men when coadministered with testosterone . Growth hormone supplementation influenced body composition and increased sprint capacity when administered alone and in combination with testosterone .

MS2_dynamic_1_shot555

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND No studies have examined whether increased consumption of oat cereal , rich in soluble fiber , favorably alters lipoprotein particle size and number . OBJECTIVE We examined the effects of large servings of either oat or wheat cereal on plasma lipids , lipoprotein subclasses , lipoprotein particle diameters , and LDL particle number . DESIGN Thirty-six overweight men aged 50 - 75 y were r and omly assigned to consume daily for 12 wk either oat or wheat cereal providing 14 g dietary fiber/d . Before and after the intervention , plasma lipid and lipoprotein subclasses were measured with proton nuclear magnetic resonance spectroscopy , and whole-body insulin sensitivity was estimated with the frequently sample d intravenous-glucose-tolerance test . RESULTS Time-by-treatment interactions ( P < 0.05 ) for LDL cholesterol ( oat : -2.5 % ; wheat : 8.0 % ) , small LDL cholesterol ( oat : -17.3 % ; wheat : 60.4 % ) , LDL particle number ( oat : -5.0 % ; wheat : 14.2 % ) , and LDL : HDL cholesterol ( oat : -6.3 % ; wheat : 14.2 % ) were observed . Time-by-treatment interactions were nearly significant for total cholesterol ( oat : -2.5 % ; wheat : 6.3 % ; P = 0.08 ) , triacylglycerol ( oat : -6.6 % ; wheat : 22.0 % ; P = 0.07 ) , and VLDL triacylglycerol ( oat : -7.6 % ; wheat : 2.7 % ; P = 0.08 ) . No significant time-by-treatment interactions were observed for HDL cholesterol , HDL-cholesterol subclasses , or LDL , HDL , and VLDL particle diameters . Insulin sensitivity did not change significantly with either intervention . CONCLUSIONS The oat compared with the wheat cereal produced lower concentrations of small , dense LDL cholesterol and LDL particle number without producing adverse changes in blood triacylglycerol or HDL-cholesterol concentrations . These beneficial alterations may contribute to the cardioprotective effect of oat fiber BACKGROUND The US Food and Drug Administration ( FDA ) approved health cl aims for 2 dietary fibers , beta-glucan ( 0.75 g/serving ) and psyllium ( 1.78 g/serving ) , on the assumption that 4 servings/d would reduce cardiovascular disease risk . OBJECTIVE We assessed the efficacy of this dose of fibers in reducing serum lipid risk factors for cardiovascular disease . DESIGN Sixty-eight hyperlipidemic adults consumed a test ( high-fiber ) and a control low-fat ( 25 % of energy ) , low-cholesterol ( < 150 mg/d ) diet for 1 mo each in a r and omized crossover study . The high-fiber diet included 4 servings/d of foods containing beta-glucan or psyllium that delivered 8 g/d more soluble fiber than did similar , unsupplemented foods in the control diet . Fasting blood sample s and blood pressure readings were obtained at baseline and weeks 2 and 4 , and the subjects ' weight was monitored weekly . RESULTS Compared with the control diet , the high-fiber diet reduced total cholesterol ( 2.1 + /- 0.7 % ; P = 0.003 ) , total : HDL cholesterol ( 2.9 + /- 0.8 % ; P = 0.001 ) , LDL : HDL cholesterol ( 2.4 + /- 1.0 % ; P = 0.015 ) , and apolipoprotein B : A-I ( 1.4 + /- 0.8 % ; P = 0.076 ) . Applying the Framingham cardiovascular disease risk equation to the data confirmed a reduction in risk of 4.2 + /- 1.4 % ( P = 0.003 ) . Small reductions in blood pressure were found after both diets . The subjects reported no significant differences in palatability or gastrointestinal symptoms between the diets . CONCLUSIONS The reduction in serum lipid risk factors for cardiovascular disease supports the FDA 's approval of a health cl aim for a dietary fiber intake of 4 servings/d . Although relatively small in terms of patient treatment , the reduction in cardiovascular disease risk is likely to be significant on a population basis BACKGROUND Dietary fiber intake remains low despite increasing evidence for its health benefits , including laxation . OBJECTIVE We aim ed to assess the effects of increasing fiber intake on bowel habits and gastrointestinal tolerance in healthy persons consuming a typical Canadian or US diet . DESIGN Under a r and omized crossover design , 23 free-living participants consumed a typical Canadian or US diet ( 35 % fat , 12 g fiber/d ) and received 25.0 - 28.7 g fiber/d from each of 5 breakfast cereals : All-Bran ( AB ) , Bran Buds with Corn ( BBC ) , Bran Buds with Psyllium ( BBP ) , BBC with viscous fiber blend ( VFB ) , or a low-fiber control for 3 wk , with each study arm separated by a washout of > /=1 wk . Seven-day stool collection s and a symptom diary were obtained during the last week of each study arm . RESULTS All study cereals induced significant ( P < 0.05 ) increases in fecal bulk from the control diet at 128 + /- 38 g to 199 + /- 5 OUTPUT: There was a wide variety of fibre sources used , with little similarity between groups in the choice of intervention . Adverse events , where reported , appeared to mostly reflect mild to moderate gastrointestinal side-effects and these were generally reported more in the fibre intervention groups than the control groups . The pooled analyses for CVD risk factors suggest reductions in total cholesterol and LDL cholesterol with increased fibre intake , and reductions in diastolic blood pressure . INPUT: BACKGROUND In 1997 , the US Food and Drug Administration passed a unique ruling that allowed oat bran to be registered as the first cholesterol-reducing food at a dosage of 3 g beta-glucan/d . OBJECTIVE The effects of a low dose of oat bran in the background diet only were investigated in volunteers with mild-to-moderate hyperlipidemia . DESIGN The study was a double-blind , placebo-controlled , r and omized , parallel study . Sixty-two healthy men ( n = 31 ) and women ( n = 31 ) were r and omly allocated to consume either 20 g oat bran concentrate ( OBC ; containing 3 g beta-glucan ) or 20 g wheat bran ( control ) daily for 8 wk . Fasting blood sample s were collected at weeks -1 , 0 , 4 , 8 , and 12 . A subgroup ( n = 17 ) was studied postpr and ially after consumption of 2 meals ( containing no OBC or wheat bran ) at baseline and after supplementation . Fasting plasma sample s were analyzed for total cholesterol , HDL cholesterol , triacylglycerol , glucose , and insulin . LDL cholesterol was measured by using the Friedewald formula . The postpr and ial sample s were anlayzed for triacylglycerol , glucose , and insulin . RESULTS No significant difference was observed in fasting plasma cholesterol , LDL cholesterol , glucose , or insulin between the OBC and wheat-bran groups . HDL-cholesterol concentrations fell significantly from weeks 0 to 8 in the OBC group ( P = 0.05 ) . There was a significant increase in fasting glucose concentrations after both OBC ( P = 0.03 ) and wheat-bran ( P = 0.02 ) consumption . No significant difference was found between the OBC and wheat-bran groups in any of the postpr and ial variables measured . CONCLUSIONS A low dosage of beta-glucan ( 3 g/d ) did not significantly reduce total cholesterol or LDL cholesterol in volunteers with plasma cholesterol concentrations representative of a middle-aged UK population This study was design ed as a test of the serum lipid response and dietary adaptation to recommended daily inclusion of instant oats in an otherwise regular diet . Hypercholesterolemic adults were r and omly assigned to a control or intervention group . Participants in the intervention group were given packages of instant oats and requested to eat two servings per day ( approximately two ounces dry weight ) , substituting the oats for other carbohydrate foods in order to maintain baseline calorie intake and keep weight stable . Serum lipids were measured in blood collected by venipuncture at baseline , four weeks , and eight weeks . Baseline mean total cholesterol ( TC ) levels were 6.56 mmol/L and 6.39 mmol/L for intervention and control groups , respectively . After eight weeks , mean serum total cholesterol of the intervention group was lower by -0.40 mmol/L , and mean net difference in TC between the two groups was 0.32 mmol/L ( 95 % CI : 0.09 , 0.54 ) . Low-density lipoprotein-cholesterol was similarly reduced with mean net difference of 0.25 mmol/L ( 95 % CI : 0.02 , 0.48 ) between the two groups . Mean soluble fiber intake increased along with slight self-imposed reductions in mean total fat , saturated fat , and dietary cholesterol intake in the intervention group . Neither group changed mean body weight . Daily inclusion of two ounces of oats appeared to facilitate reduction of serum total cholesterol and LDL-C in these hyperlipidemic individuals BACKGROUND No studies have examined whether increased consumption of oat cereal , rich in soluble fiber , favorably alters lipoprotein particle size and number . OBJECTIVE We examined the effects of large servings of either oat or wheat cereal on plasma lipids , lipoprotein subclasses , lipoprotein particle diameters , and LDL particle number . DESIGN Thirty-six overweight men aged 50 - 75 y were r and omly assigned to consume daily for 12 wk either oat or wheat cereal providing 14 g dietary fiber/d . Before and after the intervention , plasma lipid and lipoprotein subclasses were measured with proton nuclear magnetic resonance spectroscopy , and whole-body insulin sensitivity was estimated with the frequently sample d intravenous-glucose-tolerance test . RESULTS Time-by-treatment interactions ( P < 0.05 ) for LDL cholesterol ( oat : -2.5 % ; wheat : 8.0 % ) , small LDL cholesterol ( oat : -17.3 % ; wheat : 60.4 % ) , LDL particle number ( oat : -5.0 % ; wheat : 14.2 % ) , and LDL : HDL cholesterol ( oat : -6.3 % ; wheat : 14.2 % ) were observed . Time-by-treatment interactions were nearly significant for total cholesterol ( oat : -2.5 % ; wheat : 6.3 % ; P = 0.08 ) , triacylglycerol ( oat : -6.6 % ; wheat : 22.0 % ; P = 0.07 ) , and VLDL triacylglycerol ( oat : -7.6 % ; wheat : 2.7 % ; P = 0.08 ) . No significant time-by-treatment interactions were observed for HDL cholesterol , HDL-cholesterol subclasses , or LDL , HDL , and VLDL particle diameters . Insulin sensitivity did not change significantly with either intervention . CONCLUSIONS The oat compared with OUTPUT:

Pooled analyses showed that oat β-glucan has a lowering effect on LDL-cholesterol , non-HDL-cholesterol and apoB. Inclusion of oat-containing foods may be a strategy for achieving targets in CVD reduction

MS2_dynamic_1_shot556

***TASK*** the task is to summarize an input biomedical literature 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: Auricular acupuncture can be an effective treatment for acute anxiety , but there is a lack of direct comparisons of acupuncture to proven st and ard drug treatments . In this study we compared the efficacy of auricular acupuncture with intranasal midazolam , placebo acupuncture , and no treatment for reducing dental anxiety . Patients having dental extraction s ( n = 67 ) were r and omized to ( i ) auricular acupuncture , ( ii ) placebo acupuncture , and ( iii ) intranasal midazolam and compared with a no treatment group . Anxiety was assessed before the interventions , at 30 min , and after the dental extraction . Physiological variables were assessed continuously . With the no treatment group as control , the auricular acupuncture group , and the midazolam group were significantly less anxious at 30 min as compared with patients in the placebo acupuncture group ( Spielberger Stait-Trait Anxiety Inventory X1 , P = 0.012 and < 0.001 , respectively ) . In addition , patient compliance assessed by the dentist was significantly improved if auricular acupuncture or application of intranasal midazolam had been performed ( P = 0.032 and 0.049 , respectively ) . In conclusion , both , auricular acupuncture and intranasal midazolam were similarly effective for the treatment of dental anxiety Acupuncture is one of the most widely used and broadly research ed of the complementary and alternative therapies , but high- quality trials generally show no benefit over sham acupuncture . Many would view this result as evidence of ineffectiveness for this intervention . This discussion article focuses on the report of a large multicenter r and omized controlled trial of acupuncture for chronic low-back pain ( CLBP ) in the lay and academic press , the ensuing discussion , and its impact on both clinical practice and service provision . The authors suggest that interpretive bias has affected reporting , leading to question able conclusions and advocacy in favor of this form of care that may exceed the evidence . They also suggest that a lack of underst and ing of research into the placebo effect may have contributed to confusion in the interpretation of these trials Background : Auricular acupuncture is a promising method for postoperative pain relief . However , there is no evidence for its use after ambulatory surgery . Our aim was to test whether auricular acupuncture is better than invasive needle control for complementary analgesia after ambulatory knee surgery . Methods : One hundred and twenty patients undergoing ambulatory arthroscopic knee surgery under st and ardized general anesthesia were r and omly assigned to receive auricular acupuncture or a control procedure . Fixed indwelling acupuncture needles were inserted before surgery and retained in situ until the following morning . Postoperative rescue analgesia was directed to achieve pain intensity less than 40 mm on a 100-mm visual analogue scale . The primary outcome measure was the postoperative requirement for ibuprofen between surgery and examination the following morning . Results : Intention-to-treat analysis showed that patients from the control group ( n = 59 ) required more ibuprofen than patients from the auricular acupuncture group ( n = 61 ) : median ( interquartile range ) 600 ( 200–800 ) v. 200 ( 0–600 ) mg ( p = 0.012 ) . Pain intensity on a visual analogue scale was similar in both groups at all time points registered . The majority of patients in both groups believed that they had received true acupuncture and wanted to repeat it in future . Interpretation : Auricular acupuncture reduced the requirement for ibuprofen after ambulatory knee surgery relative to an invasive needle control procedure In alternative health care iridology is used as a diagnostic aid . The diagnosis of gall bladder disease was used to study its validity and interperformer consistency . The presence of an inflamed gall bladder containing gall stones is said to be easily recognised by certain signs in the lower lateral part of the iris of the right eye . Stereo colour slides were made of the right eye . Stereo colour slides were made of the right eye of 39 patients with this disease and 39 control subjects of the same sex and age . The slides were presented in a r and om order to five leading iridologists without supplementary information . The prevalence of the disease was estimated at 56 % . The median validity was 51 % with 54 % sensitivity and 52 % specificity . These results were close to chance validity ( iota = 0.03 ) . None of the iridologists reached a high validity . The median interperformer consistency was 60 % . This was only slightly higher than chance consistency ( kappa = 0.18 ) . This study showed that iridology is not a useful diagnostic aid OBJECTIVES Reflexology is an increasingly popular complementary therapy in which parts of the body are deemed to be represented on the soles of the feet . The aim of this study was to investigate whether this representation can be used as a valid method of diagnosis . METHODS Three experienced reflexologists took part in this study . Eighteen adults with one or more of six specified conditions were identified from primary care records . Two reflexologists , who were blinded to the patients ' conditions and monitored , then examined each patient 's feet and rated the probability that each of the six conditions was present . RESULTS There is little evidence that the distribution of ratings vary with the status of the condition . Receiver operating curves suggest that this diagnostic method is very poor at distinguishing between the presence and absence of conditions . Inter-rater reliability ( kappa ) scores were very low , providing no evidence of agreement between the examiners . CONCLUSION Despite certain limitations to the data provided by this study , the results do not suggest that reflexology techniques are a valid method of diagnosis Iridology is an analysis of health based on examination of the iris of the eye . One hundred forty-three patients had photographs taken of both eyes . Nine-five patients were free of kidney disease , defined as a creatinine level of less than 1.2 mg/dL ( mean OUTPUT: Where this is the case , it is suggested that subjecting these therapies to empirical evaluation may be tantamount to evaluating the absurd INPUT: Background : The indications for resurfacing of the glenoid in patients who have osteoarthritis of the shoulder are not clearly defined ; some investigators routinely perform hemiarthroplasty whereas others perform total shoulder arthroplasty . Methods : Forty-seven patients ( fifty-one shoulders ) who were scheduled to have a shoulder arthroplasty for the treatment of degenerative osteoarthritis were r and omly assigned , according to a r and om-numbers table , to one of two groups : replacement of the humeral head with resurfacing of the glenoid with a polyethylene component with cement ( total shoulder arthroplasty [ twenty-seven shoulders ] ) or replacement of the humeral head without resurfacing of the glenoid ( hemiarthroplasty [ twenty-four shoulders ] ) . All patients received the same type of humeral component , and all operations were performed by or under the direct supervision of the same surgeon . The patients were followed for a mean of thirty-five months ( range , twenty-four to seventy-two months ) postoperatively . Evaluation was performed with use of the scoring systems of the University of California at Los Angeles and the American Shoulder and Elbow Surgeons . Results : No difference was observed between the preoperative scores for the two groups of patients . Postoperatively , the mean scores with use of the University of California at Los Angeles system and the American Shoulder and Elbow Surgeons system were 23.2 points ( range , 10 to 31 points ) and 65.2 points ( range , 15 to 94 points ) , respectively , after hemiarthroplasty and 27.4 points ( range , 9 to 34 points ) and 77.3 points ( range , 3 to 100 points ) , respectively , after total shoulder arthroplasty . With the numbers available for study , no significant difference was found between the two operative groups with respect to the postoperative score . ( Thirty-five subjects per group would be needed , assuming an effect size of 0.60 and a power of 0.80 . ) Total shoulder arthroplasty provided significantly greater pain relief ( p = 0.002 ) and internal rotation ( p = 0.003 ) than hemiarthroplasty did . Total shoulder arthroplasty also provided superior results in the specific areas of patient satisfaction , function , and strength , although none of these differences were found to be significant , with the numbers available . Total shoulder arthroplasty was associated with increased cost ( $ 1177 ) , operative time ( thirty-five minutes ) , and blood loss ( 150 milliliters ) per patient compared with hemiarthroplasty . To date , none of the total shoulder arthroplasties in the study group have been revised . Hemiarthroplasty yielded equivalent results for elevation and external rotation . Three of the twenty-five patients who had had a hemiarthroplasty needed a subsequent operation for resurfacing of the glenoid . The mean cost for the revision operations was $ 15,998 . Conclusions : Total shoulder arthroplasty provided superior pain relief compared with hemiarthroplasty in patients who had glenohumeral osteoarthritis , but it was associated with an increased cost of $ 1177 per patient BACKGROUND We compared hemiarthroplasty ( HA ) and total shoulder replacement ( TSR ) for the treatment of osteoarthritis at minimum of 10 years from primary arthroplasty . METHODS Thirty-three patients ( 13 HA and 20 TSR ) were intraoperatively r and omized to HA or TSR after glenoid exposure and were assessed to a minimum of 10 years postoperatively . Apart from those who died , no patients were lost to follow-up . RESULTS At 6 months and 1 year , the TSR patients had less pain than the HA patients ( P < .05 ) , and this became more apparent at 2 years postoperatively ( P < .02 ) . There were no statistically significant differences between the groups at 10 years with respect to pain , function , and daily activities . No patients in the HA group rated their shoulders as pain-free at 10 years ; however , 42 % of the surviving TSR patients rated their shoulders as pain-free at 10 years . Four HA patients were revised to TSR due to severe pain secondary to glenoid erosion . Two shoulders in the TSR group have been revised . Nine of the 13 HA patients ( 69 % ) and 18 of the 20 TSR patients ( 90 % ) remained in situ at death or at the 10-year review . CONCLUSION TSR has advantages over HA with respect to pain and function at 2 years , and there has not been a reversal of the outcomes on longer follow-up . This longer-term review does not support the contention that HA will avoid later TSR complications , and in particular , an unacceptable rate of glenoid component failure Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument Background Glenohumeral osteoarthritis has been a well-described complication of open procedures to correct shoulder instability . What remains unknown is whether chondral injuries sustained during instability episodes contribute to osteoarthritis or whether the cause is primarily the stabilization procedure itself . Purpose To determine the prevalence of osteoarthrosis in a large data base of patients with acute and chronic shoulder instability before primary stabilization surgery . Study Design Retrospective review of prospect ively collected data . Methods Surgical and demographic data were collected on 422 patients with a diagnosis of shoulder instability who underwent arthroscopic examination and shoulder stabilization . Results There was a significant association between the grade of osteoarthrosis and the presence of osteoarthritis ( grade III or IV chond OUTPUT:

Complication and reoperation rates are higher compared to shoulder arthroplasty for primary glenohumeral joint arthritis ; however , the difference is not statistically significant . When reverse shoulder arthroplasties ( RSA ) were considered as a subgroup and compared to anatomic shoulder replacements ( total shoulders and hemiarthroplasties ) , they showed a lower revision rate

MS2_dynamic_1_shot557

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives To evaluate the efficacy and safety of ultrasound-guided percutaneous catheter drainage ( PCD ) treatment for severe acute pancreatitis compared to conservative and conventional surgical treatments . Methods Eighty-one patients with severe acute pancreatitis ( SAP ) were admitted and divided into three groups : forty-nine cases in the conservative therapy group ; nineteen cases in the surgery group ; and thirteen cases in the PCD therapy group . Forty-five patients with a CT severity index ( CTSI ) ≤ 8.0 received conservative treatment . One patient with CTSI = 7.0 underwent surgery . Thirty-five patients with a CTSI > 8.0 were r and omly selected for surgery or PCD treatment . After r and omization , six patients ( four patients in the surgery group and two patients in the PCD group ) were dropped from the study . The total number of patients included in the surgery and PCD groups was sixteen and thirteen , respectively . Results Four patients ( 8.2 % ) in the conservative therapy group died , five patients ( 31.3 % ) in surgery group with a CTSI > 8.0 died , and all patients in the PCD group survived . The mortality rate was lower in the PCD group than in the surgery group ( P = 0.048 ) . The serum C-reactive protein ( CRP ) level recovered more quickly in patients in the PCD group compared to those in the surgery group ( P < 0.001 ) . Conclusions Patients with SAP and a CTSI ≤ 8.0 could be treated with conservative therapy , while patients with a CTSI > 8.0 should be treated with surgery or PCD therapy if the life-threatening complications of extensive fluid collection or necrosis are a factor . However , PCD therapy used in a timely manner for drainage may decrease mortality in patients with SAP , decrease inflammatory mediator release , and avoid incidence of severe sepsis or acute respiratory distress syndrome ( ARDS ) and emergency surgery BACKGROUND Necrotizing pancreatitis with infected necrotic tissue is associated with a high rate of complications and death . St and ard treatment is open necrosectomy . The outcome may be improved by a minimally invasive step-up approach . METHODS In this multicenter study , we r and omly assigned 88 patients with necrotizing pancreatitis and suspected or confirmed infected necrotic tissue to undergo primary open necrosectomy or a step-up approach to treatment . The step-up approach consisted of percutaneous drainage followed , if necessary , by minimally invasive retroperitoneal necrosectomy . The primary end point was a composite of major complications ( new-onset multiple-organ failure or multiple systemic complications , perforation of a visceral organ or enterocutaneous fistula , or bleeding ) or death . RESULTS The primary end point occurred in 31 of 45 patients ( 69 % ) assigned to open necrosectomy and in 17 of 43 patients ( 40 % ) assigned to the step-up approach ( risk ratio with the step-up approach , 0.57 ; 95 % confidence interval , 0.38 to 0.87 ; P=0.006 ) . Of the patients assigned to the step-up approach , 35 % were treated with percutaneous drainage only . New-onset multiple-organ failure occurred less often in patients assigned to the step-up approach than in those assigned to open necrosectomy ( 12 % vs. 40 % , P=0.002 ) . The rate of death did not differ significantly between groups ( 19 % vs. 16 % , P=0.70 ) . Patients assigned to the step-up approach had a lower rate of incisional hernias ( 7 % vs. 24 % , P=0.03 ) and new-onset diabetes ( 16 % vs. 38 % , P=0.02 ) . CONCLUSIONS A minimally invasive step-up approach , as compared with open necrosectomy , reduced the rate of the composite end point of major complications or death among patients with necrotizing pancreatitis and infected necrotic tissue . ( Current Controlled Trials number , IS RCT N13975868 . BACKGROUND & AIMS Treatment of patients with necrotizing pancreatitis has become more conservative and less invasive , but there are few data from prospect i ve studies to support the efficacy of this change . We performed a prospect i ve multicenter study of treatment outcomes among patients with necrotizing pancreatitis . METHODS We collected data from 639 consecutive patients with necrotizing pancreatitis , from 2004 to 2008 , treated at 21 Dutch hospitals . Data were analyzed for disease severity , interventions ( radiologic , endoscopic , surgical ) , and outcome . RESULTS Overall mortality was 15 % ( n=93 ) . Organ failure occurred in 240 patients ( 38 % ) , with 35 % mortality . Treatment was conservative in 397 patients ( 62 % ) , with 7 % mortality . An intervention was performed in 242 patients ( 38 % ) , with 27 % mortality ; this included early emergency laparotomy in 32 patients ( 5 % ) , with 78 % mortality . Patients with longer times between admission and intervention had lower mortality : 0 to 14 days , 56 % ; 14 to 29 days , 26 % ; and > 29 days , 15 % ( P<.001 ) . A total of 208 patients ( 33 % ) received interventions for infected necrosis , with 19 % mortality . Catheter drainage was most often performed as the first intervention ( 63 % of cases ) , without additional necrosectomy in 35 % of patients . Primary catheter drainage had fewer complications than primary necro OUTPUT: AUTHORS ' CONCLUSIONS Low to very low quality evidence suggested that the minimally invasive step-up approach result ed in fewer adverse events , serious adverse events , less organ failure , and lower costs compared to open necrosectomy . Very low quality evidence suggested that the endoscopic minimally invasive step-up approach result ed in fewer adverse events than the video-assisted minimally invasive step-up approach but increased the number of procedures required for treatment . There is currently no evidence to suggest that early open necrosectomy is superior or inferior to peritoneal lavage or delayed open necrosectomy . INPUT: Recent sonographic monitoring of patients treated for amoebic liver abscess has shown the healing or resolution time varying between 10 and 300 days . The effect of percutaneous needle aspiration under or resolution time was studied in 36 patients . Nineteen patients had drugs and needle aspiration under ultrasound guide whilst the 17 patients had drugs -- metronidazole , diloxanide , and chloroquine -- alone . Both groups were monitored clinical ly and sonographically . Results showed that the abscess cavities of 18 out of 19 patients ( 94.7 % ) of the aspirated group and 10 of 17 patients ( 58.8 % ) of the non-aspirated group had resolved at the end of three weeks . The difference in response to treatment was significant ( P less than 0.02 ) more so for lesion size more than 6 cm ( P less than 0.01 ) . There was also a more rapid clinical response in the aspirated group than in the non-aspirated group , particularly for patients whose lesion size was more than 6 cm ( P less than 0.01 ) . In conclusion , percutaneous needle aspiration is safe , enhances clinical recovery , and accelerates resolution particularly in patients with large abscess cavities This prospect i ve study was carried out on 200 patients with clinical ly , ultrasonographically and serologically confirmed amoebic liver abscess . The role of ultrasound-guided needle aspiration in addition to medications was evaluated compared to drug treatment alone . Both the groups were monitored clinical ly and sonographically for up to 6 months after diagnosis . The initial response ( after 15 days ) was better in the aspirated group ( P < 0.05 ) but resolution of abscess after 6 months were similar . There was a more rapid clinical response in the aspirated group , particularly in those with larger ( > 6 cm ) abscesses and there were no complications . Percutaneous ultrasound-guided needle aspiration is a safe diagnostic and therapeutic approach which enhances clinical recovery , accelerates resolution , especially in large abscesses , and prevents complications This prospect i ve study was carried out on 33 patients with clinical ly , serologically and ultrasonographically confirmed amoebic liver abscess . All patients were r and omly treated with metronidazole and chlorochin or a combination of medicamentous therapy and percutaneous drainage . Ultrasonographic characteristics of amoebic liver abscesses were rotound or oval shape , usually hypoechogenic content with specific dorsal sonic enhancement , and in the majority of cases , location near liver capsule . Shorter duration of amoebic liver abscess resolution time in the group of patients treated with the combined therapy was observed particularly in the first four weeks of the treatment . The authors concluded that percutaneous drainage in combination with medicamentous therapy represents a successful therapeutic approach in the treatment of amoebic liver abscesses OBJECTIVE --To determine the value of needle aspiration in uncomplicated amoebic liver abscess . DESIGN --R and omised case-control study with a minimum follow up of one year , comparing patients treated with drugs alone with those treated with additional needle aspiration . SETTING --Referral based gastroenterology clinic . PATIENTS --39 Consecutive patients with amoebic liver abscess in the right lobe , of whom 37 completed the study . INTERVENTION -- Metronidazole 2.4 g/day was given to all patients for 10 days . Needle aspiration of the abscess was performed in 19 patients on the day of admission to hospital . MAIN OUTCOME MEASURES --Abdominal pain , fever , anorexia , and hepatomegaly were measured . Erythrocyte sedimentation rate , serum aspartate , and alanine aminotransferase activities , and alkaline phosphatase activity were also measured . RESULTS -- Clinical improvement was similar in both groups of patients . Improvement in haematological and biochemical variables and rates of healing of cavities were also similar . CONCLUSIONS --Chemotherapy with potent tissue amoebicidal drugs such as metronidazole is optimally effective in treating amoebic liver abscess , and in uncomplicated cases routine aspiration is not required OBJECTIVE The purpose of this study was to determine the effectiveness of percutaneous catheter drainage ( PCD ) and to compare PCD with percutaneous needle aspiration in the management of liver abscess . SUBJECTS AND METHODS Sixty patients with pyogenic liver abscess were r and omly assigned to two groups in a prospect i ve study . Antibiotics were administered for 10 days , starting the day of the beginning of percutaneous treatment . One group was treated with sonographically guided PCD and the other group with repeated percutaneous needle aspiration . Percutaneous needle aspiration was attempted a maximum of three times . Lack of response to the third aspiration was considered failure of treatment ; these patients were treated with PCD but were not included in the PCD group for analysis . Patient demographics , duration of hospital stay , treatment outcome , and complications were analyzed . RESULTS Percutaneous needle aspiration was successful in 20 ( 67 % ) of the 30 patients after one ( n = 12 ) , two ( n = 7 ) , or three ( n = 1 ) aspirations . PCD was curative in all 30 patients after one ( n = 24 ) or two ( n = 6 ) procedures . All abscesses 50 mm or less in longest diameter were successfully managed , 10 by percutaneous needle aspiration and 12 by PCD . None of patients in the percutaneous needle aspiration group with multiloculated abscesses ( n = 5 ) was successfully treated . Hospital stay did not differ significantly between the groups . There were no complications related to the procedure . CONCLUSION PCD is more effective than percutaneous needle aspiration in the management of liver abscess . Percutaneous needle aspiration can be used as a valid alternative for simple abscesses OUTPUT:

There was no significant difference in relation to the resolution of fever , abscess size , and hospital stay . The beneficial effects of PA were seen with medium-to-large ( > 5 cm ) ALA and not with small ( < 5 cm ) ALA . Percutaneous aspiration as compared with metronidazole alone results in the early resolution of pain and tenderness in patients with medium-to-large ALA . Percutaneous catheter drainage is better for larger ALA .

MS2_dynamic_1_shot558

***TASK*** the task is to summarize an input biomedical literature 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 identify the determinants of improvement in walking capacity following therapeutic exercise in chronic stroke survivors . DESIGN A secondary analysis of data obtained from a prospect i ve , single-blind , r and omized controlled intervention trial . SUBJECTS Sixty-three community-dwelling individuals ( mean age = 65 years , age range = 50 - 87 years ) with a chronic stroke ( post-stroke duration : mean = 5.5 years , range = 1 - 28 years ) . METHODS Subjects were r and omized into a leg exercise group ( n = 32 ) or an arm exercise group ( n = 31 ) . Subjects in each group underwent 3 1-hour exercise sessions per week for 19 weeks . Walking capacity , cardiorespiratory fitness , isometric knee extensor muscle strength , balance ability , and balance confidence were evaluated before and after the interventions . Multiple regression analysis was performed to identify the determinants of improvement in walking capacity . RESULTS After controlling for age , gender , post-stroke duration , and baseline walking capacity , gain in paretic leg muscle strength and peak oxygen consumption remained independently associated with gain in walking capacity ( R2 = 0.229 ) . CONCLUSION Enhancement of cardiorespiratory fitness and paretic leg muscle strength are both significant determinants in improving walking capacity among chronic stroke survivors . However , the rather weak relationship ( R2 = 0.229 ) indicates that other factors not measured in this study may also contribute to the improvement in walking capacity This study evaluated the feasibility , safety , and findings from a protocol for exercise-bicycle ergometry in subacute-stroke survivors . Of 117 eligible c and i date s , 14 could not perform the test and 3 discontinued because of cardiac safety criteria . In the 100 completed tests , peak heart rate was 116 + /- 19.1 beats/min ; peak VO(2 ) was 11.4 + /- 3.7 ml x kg x min(-1 ) , peak METs were 3.3 + /- 0.91 , exercise duration was 5.1 + /- 2.84 min , and Borg score was 14 + /- 2.6 . Among 71 tests , anaerobic threshold was achieved in 3.0 + /- 1.7 min with a VO(2 ) of 8.6 + /- 1.7 ml x kg x min(-1 ) . After screening , this protocol is feasible and safe in subacute-stroke survivors with mild to moderate deficits . These stroke survivors have severely limited functional exercise capacity . Research and clinical practice in stroke rehabilitation should incorporate more comprehensive evaluation and treatment of endurance limitations Background and Purpose — Stroke often impairs gait thereby reducing mobility and fitness and promoting chronic disability . Gait is a complex sensorimotor function controlled by integrated cortical , subcortical , and spinal networks . The mechanisms of gait recovery after stroke are not well understood . This study examines the hypothesis that progressive task-repetitive treadmill exercise ( T-EX ) improves fitness and gait function in subjects with chronic hemiparetic stroke by inducing adaptations in the brain ( plasticity ) . Methods — A r and omized controlled trial determined the effects of 6-month T-EX ( n=37 ) versus comparable duration stretching ( CON , n=34 ) on walking , aerobic fitness and in a subset ( n=15/17 ) on brain activation measured by functional MRI . Results — T-EX significantly improved treadmill-walking velocity by 51 % and cardiovascular fitness by 18 % ( 11 % and −3 % for CON , respectively ; P<0.05 ) . T-EX but not CON affected brain activation during paretic , but not during nonparetic limb movement , showing 72 % increased activation in posterior cerebellar lobe and 18 % in midbrain ( P<0.005 ) . Exercise-mediated improvements in walking velocity correlated with increased activation in cerebellum and midbrain . Conclusions — T-EX improves walking , fitness and recruits cerebellum-midbrain circuits , likely reflecting neural network plasticity . This neural recruitment is associated with better walking . These findings demonstrate the effectiveness of T-EX rehabilitation in promoting gait recovery of stroke survivors with long-term mobility impairment and provide evidence of neuroplastic mechanisms that could lead to further refinements in these paradigms to improve functional outcomes BACKGROUND AND PURPOSE Rehabilitation care after stroke is highly variable and increasingly shorter in duration . The effect of therapeutic exercise on impairments and functional limitations after stroke is not clear . The objective of this study was to determine whether a structured , progressive , physiologically based exercise program for subacute stroke produces gains greater than those attributable to spontaneous recovery and usual care . METHODS This r and omized , controlled , single-blind clinical trial was conducted in a metropolitan area and 17 participating healthcare institutions . We included persons with stroke who were living in the community . One hundred patients ( mean age , 70 years ; mean Orpington score , 3.4 ) consented and were r and omized from a screened sample of 582 . Ninety-two subjects completed the trial . Intervention was a structured , progressive , physiologically based , therapist-supervised , in-home program of thirty-six 90-minute sessions over 12 weeks targeting flexibility , strength , balance , endurance , and upper-extremity function . Main outcome measures were postintervention strength ( ankle and knee isometric peak torque , grip strength ) , upper- and lower-extremity motor control ( Fugl Meyer ) , balance ( Berg and functional reach ) , endurance ( peak aerobic capacity and exercise duration ) , upper-extremity function ( Wolf Motor Function Test ) , and mobility ( timed 10-m walk and 6-minute walk distance ) . RESULTS In the intention-to-treat multivariate analysis of variance OUTPUT: Most studies recruited participants with mild stroke , and it is possible that cardiorespiratory fitness is even more impaired after severe stroke . Maximal oxygen uptake might have been overestimated , as less healthy and older stroke survivors may not tolerate maximal exercise testing . INPUT: PURPOSE To determine whether isokinetic training can improve the strength of the hemiparetic knee musculature , functional mobility , and physical activity and to evaluate its effect on spasticity in long-term stroke survivors . DESIGN Nonr and omized self-controlled trial . SUBJECTS A volunteer sample of 15 community-dwelling stroke survivors of at least 6 months . INTERVENTION A 6-week ( 3 days/week , 40 minutes/day ) program consisting of warm-up , stretches , reciprocal knee extension and flexion isokinetic strengthening , and cool-down for the paretic limb . MAIN OUTCOME MEASURES Peak isokinetic hamstring and quadriceps torque , quadriceps spasticity , gait velocity , timed Up and Go , timed stair climb , and the Human Activity Profile ( HAP ) scores were recorded at baseline , after training , and 4 weeks after training cessation ( follow-up ) . RESULTS Paretic muscle strength improved after training ( p < .05 ) while tone remained consistent ( p > .87 ) . Gait velocity increased after training ( p < .05 ) and at follow-up ( p < .05 ) . Changes in stair climbing and timed Up and Go were not significant ( p > .37 ; p > .91 ) , although subjects perceived gains in their physical abilities at follow-up ( p < .01 ) . CONCLUSIONS Gains in strength and gait velocity without concomitant increases in muscle tone are possible after a short-term strengthening program for stroke survivors . The psychological benefit associated with physical activity is significant OBJECTIVE To test the effects of a high intensity home-based progressive strength training program on the clinical signs and symptoms of osteoarthritis ( OA ) of the knee . METHODS Forty-six community dwelling patients , aged 55 years or older with knee pain and radiographic evidence of knee OA , were r and omized to a 4 month home based progressive strength training program or a nutrition education program ( attention control ) . Thirty-eight patients completed the trial with an adherence of 84 % to the intervention and 65 % to the attention control . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index pain and physical function subscales . Secondary outcomes included clinical knee examination , muscle strength , physical performance measures , and question naires to measure quality of life variables . RESULTS Patients in the strength training group who completed the trial had a 71 % improvement in knee extension strength in the leg reported as most painful versus a 3 % improvement in the control group ( p < 0.01 ) . In a modified intent to treat analysis , self-reported pain improved by 36 % and physical function by 38 % in the strength training group versus 11 and 21 % , respectively , in the control group ( p = 0.01 for between group comparison ) . In addition , those patients in the strength training group who completed the trial had a 43 % mean reduction in pain ( p = 0.01 vs controls ) , a 44 % mean improvement in self-reported physical function ( p < 0.01 vs controls ) , and improvements in physical performance , quality of life , and self-efficacy when compared to the control group . CONCLUSION High intensity , home based strength training can produce substantial improvements in strength , pain , physical function and quality of life in patients with knee OA BACKGROUND AND PURPOSE Many stroke survivors have minimal to moderate neurological deficits but are physically deconditioned and have a high prevalence of cardiovascular problems ; all of these are potentially modifiable with exercise . The purpose s of this r and omized , controlled pilot study were ( 1 ) to develop a home-based balance , strength , and endurance program ; ( 2 ) to evaluate the ability to recruit and retain stroke subjects ; and ( 3 ) to assess the effects of the interventions used . METHODS Twenty minimally and moderately impaired stroke patients who had completed inpatient rehabilitation and who were 30 to 90 days after stroke onset were r and omized to a control group or to an experimental group that received a therapist-supervised , 8-week , 3-times-per-week , home-based exercise program . The control group received usual care as prescribed by the patients ' physicians . Baseline and postintervention assessment s included the Fugl-Meyer Motor Assessment , the Barthel Index of Activities of Daily Living ( ADL ) , the Lawton Scale of Instrumental ADL , and the Medical Outcomes Study -36 Health Status Measurement . Functional assessment s of balance and gait included a 10-m walk , 6-Minute Walk , and the Berg Balance Scale . Upper extremity function was evaluated by the Jebsen Test of H and Function . RESULTS Of 22 patients who met study criteria , 20 completed the study and 2 refused to participate . The experimental group tended to improve more than the control group in motor function ( Fugl-Meyer Upper Extremity : mean change in score , 8 . 4 versus 2.2 ; Fugl-Meyer Lower Extremity : 4.7 versus -0.9 ; gait velocity : median change , 0.25 versus .09 m/s ; 6-Minute Walk : 195 versus 114 ft ; Berg Balance Score : 7.8 versus 5 ; and Medical Outcomes Study -36 Health Status Measurement of Physical Function : 15 . 5 versus 9 ) . There were no trends in differences in change scores by the Jebsen Test of H and Function , Barthel Index , and Lawton Instrumental ADL Scale . CONCLUSIONS This study demonstrated that a r and omized , controlled clinical trial of a poststroke exercise program is feasible . Measures of neurological impairments and lower extremity function showed the most benefit . Effects of the intervention on upper extremity dexterity and functional health status were equivocal . The lasting effects of the intervention were not assessed Bourbonnais D , Bilodeau S , Lepage Y OUTPUT:

Conclusions : There is preliminary evidence that progressive resistance strength training programmes reduce musculoskeletal impairment after stroke . Whether strengthening enhances the performance of functional activities or participation in societal roles remains unknown

MS2_dynamic_1_shot559

***TASK*** the task is to summarize an input biomedical literature 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 investigate the associations of metformin , serum vitamin B12 , calcium supplements , and cognitive impairment in patients with diabetes . RESEARCH DESIGN AND METHODS Participants were recruited from the Primary Research in Memory ( PRIME ) clinics study , the Australian Imaging , Biomarkers and Lifestyle ( AIBL ) study of aging , and the Barwon region of southeastern Australia . Patients with Alzheimer disease ( AD ) ( n = 480 ) or mild cognitive impairment ( n = 187 ) and those who were cognitively intact ( n = 687 ) were included ; patients with stroke or with neurodegenerative diseases other than AD were excluded . Subgroup analyses were performed for participants who had either type 2 diabetes ( n = 104 ) or impaired glucose tolerance ( n = 22 ) . RESULTS Participants with diabetes ( n = 126 ) had worse cognitive performance than participants who did not have diabetes ( n = 1,228 ; adjusted odds ratio 1.51 [ 95 % CI 1.03–2.21 ] ) . Among participants with diabetes , worse cognitive performance was associated with metformin use ( 2.23 [ 1.05–4.75 ] ) . After adjusting for age , sex , level of education , history of depression , serum vitamin B12 , and metformin use , participants with diabetes who were taking calcium supplements had better cognitive performance ( 0.41 [ 0.19–0.92 ] ) . CONCLUSIONS Metformin use was associated with impaired cognitive performance . Vitamin B12 and calcium supplements may alleviate metformin-induced vitamin B12 deficiency and were associated with better cognitive outcomes . Prospect i ve trials are warranted to assess the beneficial effects of vitamin B12 and calcium use on cognition in older people with diabetes who are taking metformin Epidemiological studies have identified a robust association between type II diabetes mellitus and Alzheimer disease ( AD ) , and neurobiological studies have suggested the presence of central nervous system insulin resistance in individuals with AD . Given this association , we hypothesized that the central nervous system – penetrant insulin-sensitizing medication metformin would be beneficial as a disease-modifying and /or symptomatic therapy for AD , and conducted a placebo-controlled crossover study of its effects on cerebrospinal fluid ( CSF ) , neuroimaging , and cognitive biomarkers . Twenty nondiabetic subjects with mild cognitive impairment or mild dementia due to AD were r and omized to receive metformin then placebo for 8 weeks each or vice versa . CSF and neuroimaging ( Arterial Spin Label MRI ) data were collected for biomarker analyses , and cognitive testing was performed . Metformin was found to be safe , well-tolerated , and measureable in CSF at an average steady-state concentration of 95.6 ng/mL. Metformin was associated with improved executive functioning , and trends suggested improvement in learning/memory and attention . No significant changes in cerebral blood flow were observed , though post hoc completer analyses suggested an increase in orbitofrontal cerebral blood flow with metformin exposure . Further study of these findings is warranted INTRODUCTION Type 2 diabetes ( DM-2 ) increases the risk of developing Alzheimer´s disease ( AD ) , and patients with AD are more likely to develop DM-2 . DM-2 and AD share some pathophysiological features . In AD , amyloid-β ( Aβ ) is accumulated as extracellular plaques in the gray matter of the brain , while in DM-2 islet amyloid polypeptide ( IAPP ) is accumulated in the pancreas . Premature cellular degeneration is seen in both diseases . Glucagon-like peptide-1 ( GLP-1 ) reduces the amount of Aβ and improves cognition in animal studies . The present study tests the hypothesis that treatment with the long-acting GLP-1 receptor agonist liraglutide affects the accumulation of Aβ in patients with AD . MATERIAL AND METHODS This is a r and omized , controlled , double-blinded intervention study with AD patients treated for six months with liraglutide ( n = 20 ) or placebo ( n = 20 ) . The primary outcome is change in deposition of Aβ in the central nervous system ( CNS ) by Pittsburgh compound B positron emission tomography ( PET ) . The secondary outcome is evaluation of cognition using a neuro-psychological test battery , and examination of changes in glucose uptake in the CNS by 18F-fluoro-deoxy-glucose PET . Finally , a perfusion-weighted magnetic resonance imaging with contrast will be performed to evaluate blood flow . CONCLUSION No registered drug affects the deposition of Aβ in the brain of AD patients . Our goal is to find a new therapeutic agent that alters the pathophysiology in AD patients by decreasing the formation of Aβ plaques and thereby presumably improves the cognitive function . FUNDING The trial is investigator-initiated and investigator-driven and is supported by Novo Nordisk Sc and inavia . TRIAL REGISTRATION Clinical Trials.gov : NCT01469351 OBJECTIVE To examine the effects of intranasal insulin administration on cognition , function , cerebral glucose metabolism , and cerebrospinal fluid biomarkers in adults with amnestic mild cognitive impairment or Alzheimer disease ( AD ) . DESIGN R and omized , double-blind , placebo-controlled trial . SETTING Clinical research unit of a Veterans Affairs medical center . PARTICIPANTS The intent-to-treat sample consisted of 104 adults with amnestic mild cognitive impairment ( n = 6 OUTPUT: The results of 29 pairwise comparisons indicated that cognition was significantly improved in subjects treated with antidiabetic agents compared with placebo . Pioglitazone 15 to 30 mg demonstrated the greatest efficacy compared to placebo in network meta- analysis . No significant differences in acceptability were identified when comparing agents with each other and with placebo . The current findings indicate a pro-cognitive class effect of antidiabetic agents in AD/MCI . INPUT: Objectives To study the effects of metformin on the incidence of vitamin B-12 deficiency ( < 150 pmol/l ) , low concentrations of vitamin B-12 ( 150 - 220 pmol/l ) , and folate and homocysteine concentrations in patients with type 2 diabetes receiving treatment with insulin . Design Multicentre r and omised placebo controlled trial . Setting Outpatient clinics of three non-academic hospitals in the Netherl and s. Participants 390 patients with type 2 diabetes receiving treatment with insulin . Intervention 850 mg metformin or placebo three times a day for 4.3 years . Main outcome measures Percentage change in vitamin B-12 , folate , and homocysteine concentrations from baseline at4 , 17 , 30 , 43 , and 52 months . Results Compared with placebo , metformin treatment was associated with a mean decrease in vitamin B-12 concentration of −19 % ( 95 % confidence interval −24 % to −14 % ; P<0.001 ) and in folate concentration of −5 % ( 95 % CI −10 % to −0.4 % ; P=0.033 ) , and an increase in homocysteine concentration of 5 % ( 95 % CI −1 % to 11 % ; P=0.091 ) . After adjustment for body mass index and smoking , no significant effect of metformin on folate concentrations was found . The absolute risk of vitamin B-12 deficiency ( < 150 pmol/l ) at study end was 7.2 percentage points higher in the metformin group than in the placebo group ( 95 % CI 2.3 to 12.1 ; P=0.004 ) , with a number needed to harm of 13.8 per 4.3 years ( 95 % CI 43.5 to 8.3 ) . The absolute risk of low vitamin B-12 concentration ( 150 - 220 pmol/l ) at study end was 11.2 percentage points higher in the metformin group ( 95 % CI 4.6 to 17.9 ; P=0.001 ) , with a number needed to harm of 8.9 per 4.3 years ( 95 % CI 21.7 to 5.6 ) . Patients with vitamin B-12 deficiency at study end had a mean homocysteine level of 23.7 µmol/l ( 95 % CI 18.8 to 30.0 µmol/l ) , compared with a mean homocysteine level of 18.1 µmol/l ( 95 % CI 16.7 to 19.6 µmol/l ; P=0.003 ) for patients with a low vitamin B-12 concentration and 14.9 µmol/l ( 95 % CI 14.3 to 15.5 µmol/l ; P<0.001 compared with vitamin B-12 deficiency ; P=0.005 compared with low vitamin B-12 ) for patients with a normal vitamin B-12 concentration ( > 220 pmol/l ) . Conclusions Long term treatment with metformin increases the risk of vitamin B-12 deficiency , which results in raised homocysteine concentrations . Vitamin B-12 deficiency is preventable ; therefore , our findings suggest that regular measurement of vitamin B-12 concentrations during long term metformin treatment should be strongly considered . Trial registration Clinical trials.gov NCT00375388 Background . Women with polycystic ovary syndrome have elevated homocysteine levels . Elevated homocysteine levels associate with pregnancy complications . Women with polycystic ovary syndrome are often treated with metformin , a drug that may increase homocysteine levels . Hence , we investigated the effect of metformin treatment on homocysteine levels in nonpregnant and pregnant women with polycystic ovary syndrome . Methods . Two prospect i ve r and omized placebo‐controlled studies included women with polycystic ovary syndrome in a university hospital setting . Sixty‐three infertile women were treated with metformin 1,000 mg bid or placebo for 16 weeks and 38 pregnant women with metformin 850 mg bid or placebo from the first trimester and throughout pregnancy . All the women had polycystic ovary syndrome and all participants received diet and lifestyle advice , and oral folate and vitamin B12 substitution , and a daily oral multivitamin tablet . The main outcome measures were serum levels of homocysteine , folate , and vitamin B12 . Results . Serum homocysteine levels were unaffected by metformin treatment both in nonpregnant and pregnant women with polycystic ovary syndrome . However , in nonpregnant women both serum folate and vitamin B12 levels decreased with treatment . At inclusion in nonpregnant women , serum homocysteine levels associated negatively with serum levels of folate and methyl malonic acid and positively with free testosterone index . No such associations were seen in pregnant women . Conclusions . Metformin treatment in women with polycystic ovary does not increase serum homocysteine levels in the nonpregnant or the pregnant state Background Women with polycystic ovary syndrome ( PCOS ) are at increased risk for cardiovascular ( CV ) and metabolic disorders . There is a close relationship between elevated and rogen plasma levels and the ultrasound findings of stromal hypertrophy . In r and omized trials , the administration of metformin has been shown to be followed by an improvement in insulin sensitivity and decrease in and rogen levels in most women . In the present study , we investigate the association between reduced ovarian volume in PCOS patients after administration of metformin with improvement OUTPUT:

Therefore , although the overall effect of metformin on the concentration of serum Hcy was neutral , our results suggested that metformin could increase the concentration of Hcy when exogenous B-group vitamins or folic acid supplementation was not given

MS2_dynamic_1_shot560

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = BACKGROUND Obesity exacerbates the age-related decline in physical function and causes frailty in older adults ; however , the appropriate treatment for obese older adults is controversial . METHODS In this 1-year , r and omized , controlled trial , we evaluated the independent and combined effects of weight loss and exercise in 107 adults who were 65 years of age or older and obese . Participants were r and omly assigned to a control group , a weight-management ( diet ) group , an exercise group , or a weight-management-plus-exercise ( diet-exercise ) group . The primary outcome was the change in score on the modified Physical Performance Test . Secondary outcomes included other measures of frailty , body composition , bone mineral density , specific physical functions , and quality of life . RESULTS A total of 93 participants ( 87 % ) completed the study . In the intention-to-treat analysis , the score on the Physical Performance Test , in which higher scores indicate better physical status , increased more in the diet-exercise group than in the diet group or the exercise group ( increases from baseline of 21 % vs. 12 % and 15 % , respectively ) ; the scores in all three of those groups increased more than the scores in the control group ( in which the score increased by 1 % ) ( P<0.001 for the between-group differences ) . Moreover , the peak oxygen consumption improved more in the diet-exercise group than in the diet group or the exercise group ( increases of 17 % vs. 10 % and 8 % , respectively ; P<0.001 ) ; the score on the Functional Status Question naire , in which higher scores indicate better physical function , increased more in the diet-exercise group than in the diet group ( increase of 10 % vs. 4 % , P<0.001 ) . Body weight decreased by 10 % in the diet group and by 9 % in the diet-exercise group , but did not decrease in the exercise group or the control group ( P<0.001 ) . Lean body mass and bone mineral density at the hip decreased less in the diet-exercise group than in the diet group ( reductions of 3 % and 1 % , respectively , in the diet-exercise group vs. reductions of 5 % and 3 % , respectively , in the diet group ; P<0.05 for both comparisons ) . Strength , balance , and gait improved consistently in the diet-exercise group ( P<0.05 for all comparisons ) . Adverse events included a small number of exercise-associated musculoskeletal injuries . CONCLUSIONS These findings suggest that a combination of weight loss and exercise provides greater improvement in physical function than either intervention alone . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT00146107 . ) OBJECTIVE To study the overall effect of the Active Prevention in High-Risk Individuals of Diabetes Type 2 in and Around Eindhoven ( APHRODITE ) lifestyle intervention on type 2 diabetes risk reduction in Dutch primary care after 0.5 and 1.5 years and to evaluate the variability between general practice s. RESEARCH DESIGN AND METHODS Individuals at high risk for type 2 diabetes ( Finnish Diabetes Risk Score ≥13 ) were r and omly assigned into an intervention group ( n = 479 ) or a usual-care group ( n = 446 ) . Comparisons were made between study groups and between general practice s regarding changes in clinical and lifestyle OUTPUT: There was no evidence that other programme characteristics were associated with programme effectiveness . Most but not all behavioural weight management programmes are effective . INPUT: Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values < 0.01 . CONCLUSIONS A diabetes prevention program administered through an existing community-based system and delivered by community health workers is effective at inducing significant long-term reductions in metabolic indicators and adiposity OBJECTIVE To study the overall effect of the Active Prevention in High-Risk Individuals of Diabetes Type 2 in and Around Eindhoven ( APHRODITE ) lifestyle intervention on type 2 diabetes risk reduction in Dutch primary care after 0.5 and 1.5 years and to evaluate the variability between general practice s. RESEARCH DESIGN AND METHODS Individuals at high risk for type 2 diabetes ( Finnish Diabetes Risk Score ≥13 ) were r and omly assigned into an intervention group ( n = 479 ) or a usual-care group ( n = 446 ) . Comparisons were made between study groups and between general practice s regarding changes in clinical and lifestyle measures over 1.5 years . Participant , general practitioner , and nurse practitioner characteristics were compared between individuals who lost weight or maintained a stable weight and individuals who gained weight . RESULTS Both groups showed modest changes in glucose values , weight measures , physical activity , energy intake , and fiber intake . Differences OUTPUT:

Intervention-only programmes were in general more cost effective than programmes that also included a screening component . The longer the period evaluated , the more cost-effective interventions appeared . There was insufficient evidence to answer the question of ( 1 ) whether lifestyle programmes are more cost effective than metformin or ( 2 ) whether low-intensity lifestyle interventions are more cost effective than the more intensive lifestyle programmes that were tested in trials .

MS2_dynamic_1_shot561

***TASK*** the task is to summarize an input biomedical literature 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: Two types of schizophrenic patients , 27 with a high and 21 with a low energetic level , were treated for 3 weeks under double blind conditions with 16 ( 24 patients ) or 80 mg ( 24 patients ) haloperidol orally per day . The patients were rated by the ward psychiatrist as markedly or not markedly improved . Evaluation made by odds ratio comparison showed that ( 1 ) patients with a high energetic level ( plus-type patients ) improved with low doses whereas ( 2 ) patients with a low energetic level ( minus-type patients ) improved with high doses of haloperidol OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate CONTEXT Although olanzapine has been widely adopted as a treatment of choice for schizophrenia , its long-term effectiveness and costs have not been evaluated in a controlled trial in comparison with a st and ard antipsychotic drug . OBJECTIVE To evaluate the effectiveness and cost impact of olanzapine compared with haloperidol in the treatment of schizophrenia . DESIGN AND SETTING Double-blind , r and omized controlled trial with r and omization conducted between June 1998 and June 2000 at 17 US Department of Veterans Affairs medical centers . PARTICIPANTS Three hundred nine patients with a Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnosis of schizophrenia or schizoaffective disorder , serious symptoms , and serious dysfunction for the previous 2 years . Fifty-nine percent fully completed and 36 % partially completed follow-up assessment s. INTERVENTIONS Patients were r and omly assigned to receive flexibly dosed olanzapine , 5 to 20 mg/d , with prophylactic benztropine , 1 to 4 mg/d ( n = 159 ) ; or haloperidol , 5 to 20 mg/d ( n = 150 ) , for 12 months . MAIN OUTCOME MEASURES St and ardized measures of symptoms , quality of life , neurocognitive status , and adverse effects of medication . Veterans Affairs administrative data and interviews concerning non-VA service use were used to estimate costs from the perspective of the VA health care system and society as a whole ( ie , consumption of all re sources on behalf of these patients ) . RESULTS There were no significant differences between groups in study retention ; positive , negative , or total symptoms of schizophrenia ; quality of life ; or extrapyramidal symptoms . Olanzapine was associated with reduced akathisia in the intention-to-treat analysis ( P<.001 ) and with lower symptoms of tardive dyskinesia in a secondary analysis including only observations during blinded treatment with study drug . Small but significant advantages were also observed on measures of memory and motor function . Olanzapine was also associated with more frequent reports of weight gain and significantly greater VA costs , ranging from 3000 dollars to 9000 dollars annually . Differences in societal costs were somewhat smaller and were not significant . CONCLUSION Olanzapine does not demonstrate advantages compared with haloperidol ( in combination with prophylactic benztropine ) in compliance , symptoms , extrapyramidal symptoms , or overall quality of life , and its benefits in reducing akathisia and improving cognition must be balanced with the problems of weight gain and higher cost In a 12-weeks double-blind study high dosage versus st and ard dosage haloperidol therapy was evaluated in 23 male , chronic schizophrenic in patients . The patients were relatively treatment-resistant and , in spite of traditional neuroleptic medication , were characterized by a moderate to severe degree of illness . At the end of the trial the dose of haloperidol in the st and ard dosage group was 12–36 mg/day ( mean 15 ) , in the high dosage group 10–240 mg/day ( mean 103 ) . No significant difference in therapeutic effect was found between the two groups as measured by the Brief Psychiatric Rating Scale and global assessment . About half the patients in both groups improved during the trial . A greater incidence of side effects was noticed in the high dosage OUTPUT: However , it would be underst and able if clinicians were cautious in prescribing doses in excess of 7.5 mg/day of haloperidol to a person with uncomplicated acute schizophrenia , and if people with schizophrenia were equally reticent to take greater doses . INPUT: OBJECTIVES Schizophrenia causes significant impairments of quality of life . As treatment approaches have advanced , more attention has been given to re-integrating patients into their psychosocial environments , rather than simply monitoring psychotic symptoms . The development of the second-generation antipsychotics raised hope that these medications would provide better quality of life improvement than conventional antipsychotics . This improvement is particularly relevant early in the course of schizophrenia . METHODS To address these considerations , improvements in measures of general health and social function ( determined using the SF-36 ) were assessed in 195 patients with first-episode schizophrenia for up to one year following r and omization to either olanzapine or haloperidol in a double blind clinical trial . We hypothesized that olanzapine would demonstrate better improvement on these measures than haloperidol . In order to test this hypothesis , we used a repeated measure model with SF-36 scores as the outcome , and treatment group , time , time2 , time-by-treatment group interaction , and time2-by-treatment group interaction as fixed effects . RESULTS Both treatments demonstrated similar changes on the SF-36 . Independent of treatment , patients demonstrated significant improvements in most of the SF-36 subscales , which approached normative scores by the end of one year of treatment . Forty-six of 100 olanzapine-treated patients and 37 of 95 haloperidol-treated patients completed the one year of this study ( p<.4 ) . CONCLUSIONS These results suggest an important initial treatment goal for patients with new onset schizophrenic disorders , namely that they can expect to recover significant quality of life and social function at least initially in treatment Background Most tools for estimating utilities use clinical trial data from general health status models , such as the 36-Item Short-Form Health Survey ( SF-36 ) . A disease-specific model may be more appropriate . The objective of this study was to apply a disease-specific utility mapping function for schizophrenia to data from a large , 1-year , open-label study of long-acting risperidone and to compare its performance with an SF-36-based utility mapping function . Methods Patients with schizophrenia or schizoaffective disorder by DSM-IV criteria received 25 , 50 , or 75 mg long-acting risperidone every 2 weeks for 12 months . The Positive and Negative Syndrome Scale ( PANSS ) and SF-36 were used to assess efficacy and health-related quality of life . Movement disorder severity was measured using the Extrapyramidal Symptom Rating Scale ( ESRS ) ; data concerning other common adverse effects ( orthostatic hypotension , weight gain ) were collected . Transforms were applied to estimate utilities . Results A total of 474 patients completed the study . Long-acting risperidone treatment was associated with a utility gain of 0.051 using the disease-specific function . The estimated gain using an SF-36-based mapping function was smaller : 0.0285 . Estimates of gains were only weakly correlated ( r = 0.2 ) . Because of differences in scaling and variance , the requisite sample size for a r and omized trial to confirm observed effects is much smaller for the disease-specific mapping function ( 156 versus 672 total subjects ) . Conclusion Application of a disease-specific mapping function was feasible . Differences in scaling and precision suggest the clinical ly based mapping function has greater power than the SF-36-based measure to detect differences in utility BACKGROUND We investigated the impact of treatment with long-acting , injectable risperidone versus placebo on health-related quality of life ( HRQoL ) in patients with schizophrenia . Results are discussed in the context of HRQoL in the general U.S. population . METHOD Patients with DSM-IV schizophrenia entered a r and omized , double-blind , placebo-controlled trial . After screening , previous antipsychotics were discontinued , and oral risperidone was titrated up to a dose of 4 mg/day over 1 week . Patients were then r and omly assigned to receive placebo [ N = 92 ] or long-acting risperidone ( 25 [ N = 93 ] , 50 [ N = 97 ] , or 75 mg [ N = 87 ] every 2 weeks ) for 12 weeks . HRQoL was measured using the Medical Outcomes Study Short-Form 36-item question naire ( SF-36 ) . RESULTS At week 12 , patients receiving long-acting risperidone had improved significantly ( p < .05 ) in 5 domains of the SF-36 ( bodily pain , general health , social functioning , role-emotional , and mental health ) compared with patients receiving placebo . The effect was greatest for the 25-mg group , with significant improvement versus placebo in 6 domains ( p < .05 ) . At baseline , all SF-36 domain scores except bodily pain were significantly lower ( p < .05 ) than normal values in all groups . With placebo , scores in all 8 domains remained below normal values after 12 weeks , while patients receiving long-acting risperidone showed improvement in HRQoL toward normal levels , with clinical ly meaningful improvements in all mental-health domains . In the 25-mg group , scores in 7 domains were not statistically different from normal values after 12 weeks . CONCLUSIONS Long-acting , injectable risperidone improved HRQoL toward normal levels . After 12 weeks , HRQoL of patients receiving 25 mg was not significantly different from normal Background : Little information is available on the impact of the atypical antipsychotic olanzapine on quality of life ( QOL ) . A 6-week , double-blind r and omized multicenter trial , with a long-term extension , was conducted to evaluate the clinical efficacy and QOL of olanzapine and haloperidol in treating schizophrenia and other psychotic disorders . Methods : A total of 828 out patients provided QOL data . Study patients were aged OUTPUT:

Most of the evidence concerns the SF-36 and EQ-5D , and for these instruments there was evidence for known group validity . Although the evidence base is limited in a number of important respects , including problems with the measures used to develop constructs in the validation studies , it is sufficient to raise doubts about the use of generic measures of health like the EQ-5D and SF-36 in patients with schizophrenia

MS2_dynamic_1_shot562

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Local treatment of burn injuries with conventional anti-infective preparations does not provide the moist environment that promotes fast wound healing . In a r and omized controlled trial the effects of liposome polyvinyl-pyrrolidone-iodine ( PVP-I ) hydrogel , a novel formulation of PVP-I in a liposome hydrogel with high water-binding capacity , were investigated in 43 patients with partial-thickness burn wounds in an intraindividual comparison with a conventional silver-sulfadiazine cream . Treatment with liposome PVP-I hydrogel result ed in significantly faster complete healing of the burn wounds compared with silver-sulfadiazine cream ( 9.9 ± 4.5 days versus 11.3 ± 4.9 ; P < 0.015 ) . The cosmetic result ( smoothness , elasticity , appearance ) was rated as excellent for 37.0 % of study wounds with liposome PVP-I hydrogel compared with 13.0 % of wounds treated with silver-sulfadiazine cream . Local tolerability was good ; h and ling and change of dressing were rated as easy . Local treatment with liposome PVP-I hydrogel thus provides fast wound healing with a favorable cosmetic result St and ard treatment for extensive partial-thickness burns in the United States and in much of the world involves the application of topical antimicrobial agents and repetitive wound débridements and dressing changes . We evaluated a new biologic wound covering , TransCyte ( Advanced Tissue Sciences , La Jolla , Calif , formerly marketed as Dermagraft-Transitional Covering ) , for the treatment of partial-thickness burns . This material is composed of human newborn fibroblasts which are then cultured on the nylon mesh of Biobrane ( Dow B. Hickam , Inc , Sugarl and , Tex ) ; the thin silicone membrane bonded to the mesh provides a moisture vapor barrier for the wound . A prospect i ve , r and omized , comparison study of silver sulfadiazine and TransCyte was performed with the use of paired wound sites on 14 patients . Wounds treated with TransCyte healed more quickly ( mean 11.14 days to 90 % epithelialization vs 18.14 days , P = .002 ) . A noncomparison evaluation was then done for an additional 18 patients , and it confirmed excellent wound healing and an absence of infections . There were no infections in the 32 wound sites treated with TransCyte . In the first study group , late wound evaluations ( 3 , 6 , and 12 months postburn ) were performed with use of the Vancouver Scar Scale . The results indicated that wound sites treated with TransCyte healed with less hypertrophic scarring than sites treated with silver sulfadiazine ( P < .001 at 3 and 6 months , P = .006 at 12 months ) Histological and clinical studies of wound healing have been made on comparable fresh partial thickness burns with honey dressing or silver sulfadiazine ( SSD ) in two groups of 25 r and omly allocated patients . Of the wounds treated with honey 84 per cent showed satisfactory epithelialization by the 7th day , and in 100 per cent of the patients by the 21st day . In wounds treated with silver sulfadiazine , epithelialization occurred by the 7th day in 72 per cent of the patients and in 84 per cent of patients by 21 days . Histological evidence of reparative activity was seen in 80 per cent of wounds treated with the honey dressing by the 7th day with minimal inflammation . Fifty two per cent of the silver sulfadiazine treated wounds showed reparative activity with inflammatory changes by the 7th day . Reparative activity reached 100 per cent by 21 days with the honey dressing and 84 per cent with SSD . Thus in honey dressed wounds , early subsidence of acute inflammatory changes , better control of infection and quicker wound healing was observed while in the SSD treated wounds sustained inflammatory reaction was noted even on epithelialization To compare the effect of honey dressing and silver-sulfadiazene ( SSD ) dressing on wound healing in burn patients . Patients ( n=78 ) of both sexes , with age group between 10 and 50 years and with first and second degree of burn of less than 50 % of TBSA ( Total body surface area ) were included in the study , over a period of 2 years ( 2006 - 08 ) . After stabilization , patients were r and omly attributed into two groups : ‘ honey group ’ and ‘ SSD group ’ . Time elapsed since burn was recorded . After washing with normal saline , undiluted pure honey was applied over the wounds of patients in the honey group ( n=37 ) and SSD cream over the wounds of patients in SSD group ( n=41 ) , everyday . Wound was dressed with sterile gauze , cotton pads and b and aged . Status of the wound was assessed every third and seventh day and on the day of completion of study . Patients were followed up every fortnight till epithelialization . The bacteriological examination of the wound was done every seventh day . The mean age for case ( honey group ) and control ( SSD group ) was 34.5 years and 28.5 years , respectively . Wound swab culture was positive in 29 out of 36 patients who came within 8 hours of burn and in all patients who came after 24 hours . The average duration of healing in patients treated with honey and SSD dressing at any time of admission was 18.16 and 32.68 days , respectively . Wound of all those patients ( 100 % ) who reported within 1 hour became sterile with honey dressing in less than 7 days while none with SSD . All of the wounds became sterile in less than 21 days with honey , OUTPUT: Our review suggests that silver-containing dressings and topical silver were either no better or worse than control dressings in preventing wound infection and promoting healing of burn wounds INPUT: BACKGROUND Ointments ( e.g. , petrolatum ) are thought to be occlusive , thereby blocking transcutaneous water loss and trapping water under the skin 's surface . If this premise is correct , then petrolatum should delay barrier recovery after barrier perturbation , as shown previously in occluded murine skin . OBJECTIVE We reexamined the assumption that Vaseline Petroleum Jelly ( VPJ ) is occlusive , ascertaining both its site and mechanism of action . METHODS Barrier recovery was measured in VPJ-treated versus untreated sites after acetone-induced barrier disruption in human volunteers . Moreover , VPJ was localized within the stratum corneum ( SC ) with tracers and ruthenium tetroxide staining , which allowed visualization of the depth of VPJ penetration and its relation to intercellular membrane structures . RESULTS VPJ accelerated , rather than impeded , barrier recovery . Moreover , VPJ was present within the interstices at all levels of the SC , where it replaced intercellular bilayers . CONCLUSION VPJ neither forms nor acts like an epicutaneous impermeable membrane ; instead , it permeates throughout the SC interstices , allowing normal barrier recovery despite its occlusive properties PURPOSE To evaluate and characterize the wound healing process profile induced by allantoin incorporated in soft lotion oil/water emulsion using the planimetric and histological methods . METHODS Female Wistar rats ( n=60 ) were r and omly assigned to 3 experimental groups : ( C ) control group-without treatment ; ( E ) group treated with soft lotion O/W emulsion excipients ; ( EA ) group treated with soft lotion O/W emulsion containing allantoin 5 % . The emulsions either containing or not allantoin were topically administered for 14 days and the wound area was evaluated by planimetry and by qualitative and quantitative histological analysis of open wound model . RESULTS The data which were obtained and analyzed innovate by demonstrating , qualitatively and quantitatively , by histological analysis , the profile of healing process induced by allantoin . The results suggest that the wound healing mechanism induced by allantoin occurs via the regulation of inflammatory response and stimulus to fibroblastic proliferation and extracellular matrix synthesis . CONCLUSION This work show , for the first time , the histological wound healing profile induced by allantoin in rats and demonstrated that it is able to ameliorate and fasten the reestablishment of the normal skin During a ten year observation period it was found that scar formation after thoracic surgery is influenced by various factors : metabolism , operative technique and factors of a general nature . On the basis of these findings , a study was carried out to investigate the effect of the scar-specific Contractubex gel ( Merz+Co . , D-Frankfurt/Main ) , containing 10 % onion extract , 50 U sodium heparin per g of gel and 1 % allantoin , in the treatment of children who underwent thoracic surgery and to evaluate its effect on scar development . Before and during the six-month treatment period , both macromorphology and scar colour were assessed ; furthermore , a global evaluation of the therapeutic result was made . Additionally , the scars were characterized after a six-month treatment-free follow-up period . The results of 38 Contractubex-treated and 27 untreated patients were compared . In the treated scars , the global evaluation of the therapeutic result was better than in the untreated scars . In the Contractubex group , the rating was " good " and " very good " in 84 % of cases , as compared to 59 % of the untreated cases . In the treated group , the increase in scar size was markedly lower than in the untreated patients . The treated scars showed a tendency towards quicker paling than the untreated scars . In the treated group , the conversion of primary physiological scars to unphysiological scars ( hypertrophic or keloidal scars ) was less frequent than in the untreated group . The tolerability of the product was very good in 37 of the 38 treated patients , and good in one patient . All scar-specific effects of Contractubex continued to persist after the end of treatment BACKGROUND Onion extract gel ( OE ) and 0.5 % hydrocortisone , silicone and vitamin E lotion ( HSE ) are two over-the-counter preparations used to enhance the cosmesis of keloids and hypertrophic scars . OBJECTIVE To determine the tolerability and efficacy of OE versus HSE versus placebo in subjects with keloids and hypertrophic scars . METHODS Thirty subjects ( > or = 18 years ) with keloids or hypertrophic scars were r and omly assigned to one of three study preparations for 16 weeks . Scar volume was measured at baseline and weeks 4 , 8 , 12 and 16 . Subjects and blinded investigators assessed scar parameters ( in duration , erythema , pigmentation alteration , pain , itching , tenderness and cosmetic appearance ) and patient satisfaction at each visit using a visual analog scale ( VAS ) . Data analysis included : mean percentage change ( MPC ) for subjects completing the study ( n = 15 ) ; the mixed model test to determine differences between the groups over time ; and the Kruskal-Wallis test for the analysis of differences in subjects ' satisfaction within the three groups over 16 weeks for subjects who completed at least one follow-up visit ( n = 21 ) . RESULTS All three preparations were well tolerated with the exception of a mild acneiform-like eruption in one OE patient . Significant improvements were obtained with OE in volume , length , width and in duration and with HSE in volume , length , in duration , erythema and pigmentation alteration . There was a trend showing that a higher percentage of subjects were satisfied with OE than with HSE or placebo . The Mix Model Analysis ( MMA ) showed significant improvements with OE over placebo in investigator cosmetic assessment , lesion in duration , p OUTPUT:

Contractubex showed best results in the prevention of pathological scars .

MS2_dynamic_1_shot563

***TASK*** the task is to summarize an input biomedical literature 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 responsiveness ( sensitivity to change ) of 6 shoulder outcome instruments . METHODS In a prospect i ve cohort study of 153 total shoulder arthroplasties , outcome was measured by the Short Form 36 ( SF-36 ) ; Disabilities of the Arm , Shoulder , and H and question naire ( DASH ) ; Shoulder Pain and Disability Index ( SPADI ) ; American Shoulder and Elbow Surgeons question naire for the shoulder ( ASES ) ; and the Constant ( Murley ) Score ( CS ) . Responsiveness was mainly quantified by effect sizes before and 6 months after operation . Sensitivity analysis of the effects by receiver operating characteristic ( ROC ) curves was performed to determine the instruments ' ability to classify effects into global health change assessment categories . RESULTS Effect sizes of the self- assessment total scores were 0.71 , 1.19 , 2.10 , and 2.13 for the SF-36 , DASH , SPADI , and ASES , respectively . The clinical ASES and the CS had effect sizes of 1.87 and 2.23 , respectively . The SPADI ( effect size 2.12 ) and the CS ( effect size 2.72 ) were most responsive for pain . For functioning , the patient ASES ( effect size 2.10 ) , the CS ( effect size 1.82 ) , and the clinical ASES ( effect size 1.85 ) were almost equal . The SF-36 bodily pain scale and most scores of the condition-specific instruments showed a significant area under the ROC of up to 0.77 . CONCLUSION The SPADI and /or the CS are the most suitable for short , responsive , shoulder-specific assessment . The more expensive patient ASES can be used for most responsive shoulder-function assessment . For a comprehensive measurement of health and quality of life , the DASH and /or the SF-36 should be added to the set Objective To compare the sensitivity to change of two HIV-health-related quality of life ( HRQoL ) question naires – the Medical Outcomes Study ( MOS-HIV ) and Multidimensional Quality of Life ( MQOL-HIV ) for use in clinical research . Methods A sample of 296 HIV-infected patients starting or switching antiretroviral treatment were r and omly assigned either the MOS-HIV or MQOL-HIV question naires at baseline and after 3 months of treatment . Ceiling and floor effects were evaluated . Sensitivity to change was assessed by comparing the percentage of dimensions with statistically significant pre – post-treatment changes and the effect sizes in those groups of patients who reported improvement and no change in self-report questions ( overall , physical , mental and social health status ) and clinical characteristics ( number of opportunistic infections , number of symptoms , viral load level and CD4 + count ) . Results Ceiling effects were found in HRQoL scores at baseline and after 3 months of treatment in Pain ( 42.3 - 41.6 % ) , Role Function ( 73.1–77.6 % ) and Social Function ( 60.9–63 % ) on MOS-HIV subscales , and in Social Support ( 38.2–37.6 % ) and Partner Intimacy ( 38.2–33.7 % ) on MQOL-HIV . For patients who improved in self-reported and objective clinical indicators of health status , mean percentage of dimensions with statistically significant pre – post-treatment changes was 86.4 % on MOS-HIV and 50 % on MQOL-HIV , where mean st and ardized effect size was 0.45 on MOS-HIV and 0.33 on MQOL-HIV for the total of dimensions . Conclusions Based on sensitivity to change the results suggest that for 3 months both question naires can be used , but the MOS-HIV is more sensitive than the MQOL-HIV for use in clinical research Objectives : To underst and the treatment goals of Alzheimer ’s disease ( AD ) patients , carers , and physicians ; to estimate whether clinical ly important goals are met during treatment with donepezil ; and to compare a measure of goal attainment with st and ard measures used to evaluate AD treatment . Methods : In a 12 month phase IV trial , 108 patients with mild to moderate AD , their primary carers , and treating physicians set goals assigned to five domains , using Goal Attainment Scaling ( GAS ) as the primary outcome . Goal attainment was assessed quarterly . GAS scores were correlated with st and ard outcomes , including the Alzheimer ’s Disease Assessment Scale-Cognitive ( ADAS-cog ) , and the Clinician ’s Interview-Based Impression of Change-Plus ( CIBIC-plus ) . Results : Physicians set fewer goals ( 342 , mean ( SD ) per patient=3 ( 1 ) ) than patients /carers ( 855 , mean=9 ( 3 ) ) , particularly in leisure ( 20 % by physicians compared with 76 % by patients /carers ) , and social interaction ( 24 % versus 49 % ) . Physicians observed statistically significant improvement in global goal attainment for six months , and patients /carers for nine months . Patients /carers described consistent goal attainment , whereas physicians observed variable effects , such as decline in cognition but improved social interaction and behaviour . Physician global GAS scores correlated highly with the CIBIC-plus at weeks 12 ( r= −0.82 ) and 52 ( r=−0.80 ) , but not with the ADAS-cog ( r=0.12 and r=−0.45 , respectively ) . Patient/carer global GAS scores correlated moderately with the physician ’s CIBIC-plus ( week 12 r=−0.51 ; week 52 r=−0.56 ) , and nominally with the ADAS-cog . Conclusions : Patients /carers and physicians differ in their expectations and impressions of treatment effects . Clinical OUTPUT: The involvement of patient and /or caregiver in the goal - setting procedure is possible and multiple domains can be implemented . The possibility to set at least 3 realistic goals per patient in less than 30 min is unclear and the need for involvement of a blinded assessor is not well established . Conclusion : GAS proved to be useful on important aspects of an outcome measure for psychogeriatric patients with cognitive disorders . Since other relevant aspects showed mixed results and the number of studies investigating the use of GAS in psychogeriatric patients with cognitive disorders is small , the evidence is not strong enough yet to state that GAS is an applicable outcome measure in this population INPUT: Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields OBJECTIVES The aggregated locomotor function ( ALF ) score , a simple measure of observed locomotor function , using timed walking , stairs and transfers , was developed and evaluated for intra-tester reliability , criterion-related validity and responsiveness in a sample of patients with knee osteoarthritis . METHODS Patients with knee osteoarthritis ( n = 214 ) were recruited for inclusion in a r and omized controlled trial investigating two methods of exercise provision . Before treatment , patients completed the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and Short Form 36 health survey ( SF-36 ) question naires and were timed whilst performing an 8 m walk , ascending and descending a set of gymnasium stairs and completing a test of transferring in and out of a chair . A group of 15 patients also undertook a replicate test-retest reliability study of the above outcome measures . St and ardized response means were calculated for the ALF , WOMAC and SF-36 from data from the clinical trial . RESULTS The ALF takes 10 min to administer and demonstrated excellent intra-tester reliability , with excellent intra-class correlation coefficient ( ICC ) statistics ( ICC(2,k ) 0.99 ; 95 % CI 0.98 - 0.99 ) , and low st and ard error of measurement ( 0.86 s ) and smallest detectable difference ( 9.5 % ) values . Criterion-related validity with the physical function dimensions of the WOMAC and SF-36 was good , with correlation coefficients of 0.59 and - 0.53 respectively . St and ardized response means were higher for the ALF ( 0.49 ) than for both the WOMAC ( 0.39 ) and the SF-36 ( 0.12 ) . CONCLUSIONS This work has demonstrated that the ALF can be used as a measure of physical function status and as a means of quantifying treatment response . The measure offers a simple and convenient outcome in the assessment and treatment of locomotor dysfunction . The ALF score is a reliable , valid and responsive outcome measure over 12 months and can be recommended for use in the evaluation of patients with knee osteoarthritis Objective : To compare responsiveness of the Harris Hip Score with generic measures ( that is , the Short Form-36 ( SF-36 ) , and a test of walking speed and pain during walking ) in patients with osteoarthritis ( OA ) of the hip . Method : The first 75 cases within the population of a r and omised clinical trial on manual therapy and exercise therapy were selected for secondary analysis . Experienced ( self reported ) recovery by the patients after treatment ( five weeks ) was used as an external criterion for clinical ly relevant improvement . Responsiveness was evaluated by comparing responsiveness ratios and receiver operating characteristic curves . Results : The responsiveness ratio for the Harris Hip Score was high ( 1.70 ) compared with walking speed ( 0.45 ) , pain during walking ( 0.66 ) , and the subscales of the SF-36—“bodily pain ” ( 0.42 ) and “ physical functioning ” ( 0.36 ) . The area under the curve also was highest for the Harris Hip Score ( 0.92 ) compared with walking speed ( 0.71 ) , pain during walking ( 0.73 ) , and the SF-36 subscales — bodily pain and physical functioning ( both 0.66 ) . Conclusion : The Harris Hip Score is more responsive than the test of walking speed , pain , and subscales for function of the SF-36 in patients with OA of the hip . The Harris Hip Score seems to be a suitable instrument to evaluate change in hip function in patients with OA of the hip BACKGROUND The OARSI St and ing Committee for Clinical Trials Response Criteria Initiative had developed two sets of responder criteria to present the results of changes after treatment in three symptomatic domains ( pain , function , and patient 's global assessment ) as a single variable for clinical trials ( 1 ) . For each domain , a response was defined by both a relative and an absolute change , with different cut-offs with regard to the drug , the route of administration and the OA localization . OBJECTIVE To propose a simplified set of responder criteria with a similar cut-off , whatever the drug , the route or the OA localization . METHODS Data driven approach : ( 1 ) Two data bases were considered : the " elaboration " data base with which the formal OARSI sets of responder criteria were elaborated , and the " revisit " data base . ( 2 ) Six different scenarios were evaluated : The two formal OARSI sets of OUTPUT:

On balance of the limited evidence , the 40 m self-paced test was the best rated walk test , the 30 s-chair st and test and timed up and go test were the best rated sit to st and tests , and the Stratford battery , Physical Activity Restrictions and Functional Assessment System were the best rated multi-activity measures .

MS2_dynamic_1_shot564

***TASK*** the task is to summarize an input biomedical literature 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 Regular physical exercise may improve a variety of physiological and psychological factors in depressive persons . However , there is little experimental evidence to support this assumption for adolescent population s. We conducted a r and omized controlled trial to investigate the effect of physical exercise on depressive state , the excretions of stress hormones and physiological fitness variables in adolescent females with depressive symptoms . METHODS Forty-nine female volunteers ( aged 18 - 20 years ; mean 18.8 + /- 0.7 years ) with mild-to-moderate depressive symptoms , as measured by the Centre for Epidemiologic Studies Depression ( CES-D ) scale , were r and omly assigned to either an exercise regimen or usual daily activities for 8 weeks . The subjects were then crossed over to the alternate regimen for an additional 8-week period . The exercise program consisted of five 50-min sessions per week of a group jogging training at a mild intensity . The variables measured were CES-D rating scale , urinary cortisol and epinephrine levels , and cardiorespiratory factors at rest and during exercise endurance test . RESULTS After the sessions of exercise the CES-D total depressive score showed a significant decrease , whereas no effect was observed after the period of usual daily activities ( ANOVA ) . Twenty-four hour excretions of cortisol and epinephrine in urine were reduced due to the exercise regimen . The training group had a significantly reduced resting heart rate and increased peak oxygen uptake and lung capacity . CONCLUSIONS The findings of this study suggest that a group jogging exercise may be effective in improving depressive state , hormonal response to stress and physiological fitness of adolescent females with depressive symptoms BACKGROUND Depression is common and tends to be recurrent . Alternative treatments are needed that are non-stigmatising , accessible and can be prescribed by general medical practitioners . AIMS To compare the effectiveness of three interventions for depression : physical exercise , internet-based cognitive-behavioural therapy ( ICBT ) and treatment as usual ( TAU ) . A secondary aim was to assess changes in self-rated work capacity . METHOD A total of 946 patients diagnosed with mild to moderate depression were recruited through primary healthcare centres across Sweden and r and omly assigned to one of three 12-week interventions ( trail registry : KCTR study ID : KT20110063 ) . Patients were reassessed at 3 months ( response rate 78 % ) . RESULTS Patients in the exercise and ICBT groups reported larger improvements in depressive symptoms compared with TAU . Work capacity improved over time in all three groups ( no significant differences ) . CONCLUSIONS Exercise and ICBT were more effective than TAU by a general medical practitioner , and both represent promising non-stigmatising treatment alternatives for patients with mild to moderate depression BACKGROUND Depression is a major health problem for community-dwelling elderly adults . Since limited re sources are available to decrease the high prevalence of depressive symptoms among the elderly adults , improved support for them can be provided if we can determine which intervention is superior in ridding depressive symptoms . OBJECTIVE To compare the effectiveness of the physical fitness exercise program and the cognitive behavior therapy program on primary ( depressive symptoms ) and secondary outcomes ( 6-min walk distance , quality of life , and social support ) for community-dwelling elderly adults with depressive symptoms . DESIGN AND SETTING S A prospect i ve r and omized control trial was conducted in three communities in northern Taiwan . PARTICIPANTS The elderly adults in the three communities were invited to participate by mail , phone calls , and posters . There were a total of 57 participants who had depressive symptoms and all without impaired cognition that participated in this trial . None of the participants withdrew during the 9 months of follow-up for this study . METHODS Fifty-seven participants were r and omly assigned to one of the three groups : the physical fitness exercise program group , the cognitive behavior therapy ( CBT ) group , or the control group . The primary ( Geriatric Depression Scale-15 , GDS-15 ) , and secondary outcomes ( 6-min walk distance , SF-36 , and Inventory of Socially Supportive Behaviors scales , ISSB ) were collected immediately ( T2 ) , at 3 months ( T3 ) , and at 6 months after the interventions ( T4 ) . RESULTS After the interventions , the CBT group participants demonstrated significantly lower symptoms of depression ( p=0.009 ) at T2 and perceived more social support from those around them ( p<0.001 , < 0.001 and = 0.004 , respectively ) at three time-point comparisons than the control group . Moreover , after intervention , participants in the physical fitness exercise program group had decreased GDS-15 scores at three time-point comparisons ( p=0.003 , 0.012 and 0.037 , respectively ) , had a substantially greater 6-min walk distance ( p=0.023 ) , a better quality of life ( p<0.001 ) , and a better perceived social support at T2 ( p<0.001 ) . CONCLUSIONS Immediately after a 12-week intervention , there were significant decreases in depressive symptoms and more perceived social support amongst those in the CBT group . When considering the effectiveness in the decrease of depressive symptoms longer term , the increase in the 6-min walk distance and raising the patients ' quality of life , physical fitness exercise program may be a better intervention for elderly adults with depressive symptoms BACKGROUND Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression . However , the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder ( MDD ) has not been systematic ally evaluated . OBJECTIVE To assess the effectiveness of an aerobic exercise program compared with st and ard medication OUTPUT: DiskussionDieser Übersichtssartikel zeigt , dass körperliche Aktivität zu einer Verminderung der Symptomatik und einer Steigerung der affektiven Befindlichkeit bei Patienten mit depressiven Erkrankungen führt . INPUT: BACKGROUND Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression . However , the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder ( MDD ) has not been systematic ally evaluated . OBJECTIVE To assess the effectiveness of an aerobic exercise program compared with st and ard medication ( ie , antidepressants ) for treatment of MDD in older patients , we conducted a 16-week r and omized controlled trial . METHODS One hundred fifty-six men and women with MDD ( age , > or = 50 years ) were assigned r and omly to a program of aerobic exercise , antidepressants ( sertraline hydrochloride ) , or combined exercise and medication . Subjects underwent comprehensive evaluations of depression , including the presence and severity of MDD using Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and Hamilton Rating Scale for Depression ( HAM-D ) and Beck Depression Inventory ( BDI ) scores before and after treatment . Secondary outcome measures included aerobic capacity , life satisfaction , self-esteem , anxiety , and dysfunctional cognitions . RESULTS After 16 weeks of treatment , the groups did not differ statistically on HAM-D or BDI scores ( P = .67 ) ; adjustment for baseline levels of depression yielded an essentially identical result . Growth curve models revealed that all groups exhibited statistically and clinical ly significant reductions on HAM-D and BDI scores . However , patients receiving medication alone exhibited the fastest initial response ; among patients receiving combination therapy , those with less severe depressive symptoms initially showed a more rapid response than those with initially more severe depressive symptoms . CONCLUSIONS An exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons . Although antidepressants may facilitate a more rapid initial therapeutic response than exercise , after 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD Background This prospect i ve longitudinal study investigates whether suspected motor problems and low preference for active play in childhood are associated with physical inactivity and low cardiorespiratory fitness in adolescence . Methodology /Principal Findings The study sample consisted of the Northern Finl and Birth Cohort 1986 ( NFBC 1986 ) composed of 5,767 children whose parents responded to a postal inquiry concerning their children 's motor skills at age 8 years and who themselves reported their physical activity at age 16 years . Cardiorespiratory fitness was measured with a cycle ergometer test at age 16 years . Odds ratios ( OR ) and their 95 % confidence intervals ( 95 % CI ) for the level of physical activity and fitness were obtained from multinomial logistic regression and adjusted for socio-economic position and body mass index . Low preference for active play in childhood was associated with physical inactivity ( boys : OR 3.31 , 95 % CI 2.42–4.53 ; girls : OR 1.79 , 95 % CI 1.36–2.36 ) and low cardiorespiratory fitness ( boys : OR 1.87 , 95 % CI 1.27–2.74 ; girls : OR 1.52 , 95 % CI 1.09–2.11 ) in adolescence . Suspected gross ( OR 2.16 , 95 % CI 1.33–3.49 ) and fine ( OR 1.88 , 95 % CI 1.35–2.60 ) motor problems were associated with physical inactivity among boys . Children with suspected motor problems and low preference for active play tended to have an even higher risk of physical inactivity in adolescence . Conclusions / Significance Low preference for active play in childhood was associated with physical inactivity and low cardiorespiratory fitness in adolescence . Furthermore , children with suspected motor problems and low preference for active play tended to have an even higher risk of physical inactivity in adolescence . Identification of children who do not prefer active play and who have motor problems may allow targeted interventions to support their motor learning and participation in active play and thereby promote their physical activity and fitness in later life BACKGROUND This study examined associations of fitness and fatness with cognitive processes , academic achievement , and behavior , independent of demographic factors , at the baseline of an exercise trial . METHODS Overweight , sedentary but otherwise healthy 7 - 11 year olds ( N=170 ) participated in a study of health , cognition and achievement in the Augusta , GA area from 2003 - 2006 . Children underwent evaluations of fatness and fitness , psychological assessment s of cognition and academic achievement , and behavior ratings by parents and teachers . Partial correlations examined associations of fitness and fatness with cognitive and achievement scores and behavior ratings , controlling for demographic factors . RESULTS Fitness was associated with better cognition , achievement and behavior , and fatness with worse scores . Specifically , executive function , mathematics and reading achievement , and parent ratings of child behavior were related to fitness and fatness . Teacher ratings were related to fitness . CONCLUSION These results extend prior studies by providing reliable , st and ardized measures of cognitive processes , achievement , and behavior in relation to detailed measures of fitness and fatness . However , cross-sectional associations do not necessarily indicate that improving one factor , such as fatness or fitness , will result in improvements in factors that were associated with it . Thus , r and omized clinical trials are necessary to determine the effects of interventions Background Obesity , sedentary lifestyle and poor cardiorespiratory fitness in childhood may increase the risk of health problems later in life . Purpose The authors studied the association of early childhood weight status with cardiorespiratory fitness and leisure-time physical activity ( LTPA ) in adolescence . The stability and associations of LTPA and fitness from childhood through adolescence were also studied . Methods Body mass index ( BMI ) was assessed annually since birth in a prospect i ve , longitud OUTPUT:

There is strong evidence for a positive association between CRF and cluster of PF with AP in cross-sectional studies ; and evidence from longitudinal studies for a positive association between cluster of PF and AP ; the relationship between muscular strength and flexibility with AP remains uncertain

MS2_dynamic_1_shot565

***TASK*** the task is to summarize an input biomedical literature 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 efficacy of individualized classical homeopathy in the treatment of fibromyalgia . METHODS This study was a double-blind , r and omized , parallel-group , placebo-controlled trial of homeopathy . Community-recruited persons ( N = 62 ) with physician-confirmed fibromyalgia ( mean age 49 yr , s.d . 10 yr , 94 % women ) were treated in a homeopathic private practice setting . Participants were r and omized to receive oral daily liquid LM ( 1/50,000 ) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo . Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths , at baseline , 2 months and 4 months ( prior to a subsequent optional crossover phase of the study which is reported elsewhere ) . Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care , self-rating scales on fibromyalgia-related quality of life , pain , mood and global health at baseline and 3 months , were the primary clinical outcome measures for this report . RESULTS Fifty-three people completed the treatment protocol . Participants on active treatment showed significantly greater improvements in tender point count and tender point pain , quality of life , global health and a trend toward less depression compared with those on placebo . CONCLUSIONS This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy . Using a broad selection of remedies and the flexible LM dose ( 1/50,000 dilution factor ) series , the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia OBJECTIVES To study the effect of a combination of thalassotherapy , exercise and patient education in people with fibromyalgia . METHODS Patients with fibromyalgia , selected from a rheumatology out-patient department and from members of the Dutch fibromyalgia patient association , were pre-r and omized to receive either 2(1/2 ) weeks of treatment in a Tunisian spa resort , including thalassotherapy , supervised exercise and group education ( active treatment ) or treatment as usual ( control treatment ) . Primary outcome measure was health-related quality of life , measured with the R AND -36 question naire . Secondary measures included the Fibromyalgia Impact Question naire , the McGill Pain Question naire , the Beck Depression Inventory , tender point score and a 6-min treadmill walk test . RESULTS Fifty-eight participants receiving the active treatment reported significant improvement on R AND -36 physical and mental component summary scales . For physical health , differences from the 76 controls were statistically significant after 3 months , but not after 6 and 12 months . A similar pattern of temporary improvement was seen in the self-reported secondary measures . Tender point scores and treadmill walk tests improved more after active treatment , but did not reach significant between-group differences , except for walk tests after 12 months . CONCLUSIONS A combination of thalassotherapy , exercise and patient education may temporarily improve fibromyalgia symptoms and health-related quality of life Background Alterations in the intestinal bacterial flora are believed to be contributing factors to many chronic inflammatory and degenerative diseases including rheumatic diseases . While microbiological fecal culture analysis is now increasingly used , little is known about the relationship of changes in intestinal flora , dietary patterns and clinical outcome in specific diseases . To clarify the role of microbiological culture analysis we aim ed to evaluate whether in patients with rheumatoid arthritis ( RA ) or fibromyalgia ( FM ) a Mediterranean diet or an 8-day fasting period are associated with changes in fecal flora and whether changes in fecal flora are associated with clinical outcome . Methods During a two-months-period 51 consecutive patients from an Integrative Medicine hospital department with an established diagnosis of RA ( n = 16 ) or FM ( n = 35 ) were included in the study . According to predefined clinical criteria and the subjects ' choice the patients received a mostly vegetarian Mediterranean diet ( n = 21 ; mean age 50.9 + /-13.3 y ) or participated in an intermittent modified 8-day fasting therapy ( n = 30 ; mean age 53.7 + /- 9.4 y ) . Quantitative aerob and anaerob bacterial flora , stool pH and concentrations of secretory immunoglobulin A ( sIgA ) were analysed from stool sample s at the beginning , at the end of the 2-week hospital stay and at a 3-months follow-up . Clinical outcome was assessed with the DAS 28 for RA patients and with a disease severity rating scale in FM patients . Results We found no significant changes in the fecal bacterial counts following the two dietary interventions within and between groups , nor were significant differences found in the analysis of sIgA and stool ph . Clinical improvement at the end of the hospital stay tended to be greater in fasting vs. non-fasting patients with RA ( p = 0.09 ) . Clinical outcome was not related to alterations in the intestinal flora . Conclusion Neither Mediterranean diet nor fasting treatments affect the microbiologically assessed intestinal flora and sIgA levels in patients with RA and FM . The impact of dietary interventions on the human intestinal flora and the role of the fecal flora in rheumatic diseases have to be clarified with newer molecular analysis techniques . The potential benefit of fasting treatment in RA and FM should be further tested in r and omised trials This article describes an ongoing , long-term clinical exercise program for women with fibromyalgia syndrome ( FMS ) , some of whom also have chronic fatigue and immune dysfunction syndrome ( CFIDS ) . The recorded outcomes from the most recent year of the program also are reported . Particip OUTPUT: Review of these articles result ed in the following recommendations regarding nonpharmaceutical treatments of FMS . Strong evidence supports aerobic exercise and cognitive behavioral therapy . Moderate evidence supports massage , muscle strength training , acupuncture , and spa therapy ( balneotherapy ) . Limited evidence supports spinal manipulation , movement/body awareness , vitamins , herbs , and dietary modification . CONCLUSIONS Several nonpharmacologic treatments and manual-type therapies have acceptable evidentiary support in the treatment of FMS INPUT: OBJECTIVE To assess the efficacy of individualized classical homeopathy in the treatment of fibromyalgia . METHODS This study was a double-blind , r and omized , parallel-group , placebo-controlled trial of homeopathy . Community-recruited persons ( N = 62 ) with physician-confirmed fibromyalgia ( mean age 49 yr , s.d . 10 yr , 94 % women ) were treated in a homeopathic private practice setting . Participants were r and omized to receive oral daily liquid LM ( 1/50,000 ) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo . Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths , at baseline , 2 months and 4 months ( prior to a subsequent optional crossover phase of the study which is reported elsewhere ) . Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care , self-rating scales on fibromyalgia-related quality of life , pain , mood and global health at baseline and 3 months , were the primary clinical outcome measures for this report . RESULTS Fifty-three people completed the treatment protocol . Participants on active treatment showed significantly greater improvements in tender point count and tender point pain , quality of life , global health and a trend toward less depression compared with those on placebo . CONCLUSIONS This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy . Using a broad selection of remedies and the flexible LM dose ( 1/50,000 dilution factor ) series , the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia OBJECTIVES To assess the feasibility of a R and omised Controlled Trial ( RCT ) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome ( FMS ) . METHODS In a pragmatic parallel group RCT design , adults with a diagnosis of FMS ( ACR criteria ) were r and omly allocated to usual care or usual care plus adjunctive care by a homeopath . Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines . The primary outcome measure was the difference in Fibromyalgia Impact Question naire ( FIQ ) total score at 22 weeks . RESULTS 47 patients were recruited . Drop out rate in the usual care group was higher than the homeopath care group ( 8/24 vs 3/23 ) . Adjusted for baseline , there was a significantly greater mean reduction in the FIQ total score ( function ) in the homeopath care group than the usual care group ( -7.62 vs 3.63 ) . There were significantly greater reductions in the homeopath care group in the McGill pain score , FIQ fatigue and tiredness upon waking scores . We found a small effect on pain score ( 0.21 , 95 % CI -1.42 to 1.84 ) ; but a large effect on function ( 0.81 , 95 % CI -8.17 to 9.79 ) . There were no reported adverse events . CONCLUSIONS Given the acceptability of the treatment and the clinical ly relevant effect on function , there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS INTRODUCTION Chronic primary insomnia is defined as difficulty in initiating or maintaining sleep or of non-restorative sleep that lasts for at least 1 month and causes significant distress or impairment in social , occupational or other important areas of functioning . The homeopathic simillimum is that remedy which most closely corresponds to the totality of symptoms ; remedy selection is based on a full evaluation of the patient 's physical , emotional and mental characteristics . AIM / PURPOSE The purpose of this r and omised , double-blind , placebo-controlled study was to evaluate the efficacy of homeopathic simillimum in the treatment of chronic primary insomnia . METHOD 30 participants were selected in accordance with DSM-IV TR (2000)(1 ) criterion 307.42 Primary Insomnia and then r and omly divided between treatment and placebo groups . The measurement tools used were a Sleep Diary ( SD ) and the Sleep Impairment Index (SII).(2 ) After an initial consultation , 2 follow-up consultations at 2-week intervals took place . Homeopathic medication was prescribed at the first and second consultations . The SII was completed at each consultation and participants were instructed at the first consultation to start the SD . RESULTS SD data revealed that verum treatment result ed in a significant increase in duration of sleep throughout the study , compared to the placebo treatment which result ed in no significant increase in duration of sleep . A significant improvement in SII summary scores and number of improved individual questions were found in the verum group , responses to all 11 questions having improved significantly upon completion of the study . An initial improvement occurred in the placebo group , but was not sustained . Comparison of results between the groups revealed a statistically significant difference . CONCLUSION The homeopathic simillimum treatment of primary insomnia was effective , compared to placebo . Homeopathy is a viable treatment modality for this condition and further research is justified OBJECTIVES ( 1 ) To replicate a study of the efficacy of Argentum nitricum 12X in the reduction of test anxiety as demonstrated previously . ( 2 ) To investigate the correlation between individuals identified to match the A. nitricum profile and the reduction of test anxiety . To compare traditionally prepared homeopathic A. nitricum 12X with radionically-prepared A. nitricum 12X and placebo . DESIGN A double blind , placebo-controlled , r and omised clinical trial with three arms . SETTING The study was conducted at Southern Cross University , Lismore , Australia . SUBJECTS OUTPUT:

Efficacy was found for the functional somatic syndromes group ( fibromyalgia and chronic fatigue syndrome ) , but not for anxiety or stress . For other disorders , homeopathy produced mixed effects . Meaningful safety data were lacking in the reports , but the superficial findings suggested good tolerability of homeopathy .

MS2_dynamic_1_shot566

***TASK*** the task is to summarize an input biomedical literature 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: Migraine is a painful condition in which patients suffer from recurrent episodes of disabling pain , which could be very severe and can lead to grave psychological disturbances . There is no curative treatment for migraine , but there are various treatment modalities , though , with conflicting reports on their efficacy . This study was conducted to compare the effectiveness of electro acupuncture therapy and the conventional drug therapy on the psychological profile of migraneurs based on the assessment of quality of life and disability parameters . Migraneurs ( n = 60 ) were recruited from the Psychiatry and Neurology OPD , Guru Tegh Bahadur Hospital , Delhi . Following a written consent , migraneurs were r and omly allocated into 2 study groups -- Group A received 10 sittings of electro acupuncture on selected acupuncture points over a period of 30 days , while for the same duration the Group D received a conventional drug therapy in the form of oral flunarizine 20 mg OD along with paracetamol 500 mg SOS . The patients were assessed twice , before and after completion of the treatment programme ( 30 days ) . The quality of life was assessed with WHOQOL BREF ( WHO Quality of Life Biomedical Research and Education Foundation ) question naire and the disability was assessed with MIDAS ( Migraine Disability Assessment ) question naire . Statistical analysis was performed using repeated measure 's ANOVA with Tukey 's test . Migraneurs were found to have lower quality of life and higher disability scores but following the treatment regimes , the 2 study groups showed a significant improvement in both the parameters studied . It was however observed , that the acupuncture group showed a better response and was thus found to be more effective as compared to the drug group ( P = 0.005 to 0.000 ) . We thus conclude that acupuncture is a better treatment option than the conventional drug therapy in not only relieving the pain of migraine but in also improving the psychological profile in migraneurs . Hence its use should be encouraged as an alternative/adjunct treatment for migraine The effects of flunarizine administration ( 10 mg/day , at bed time ) were studied in 120 common migraine patients who were followed for 24 months with quarterly controls . Besides headache index ( HI ) and analgesic use , other variables were monitored , such as arousal ( Tolouse Pieron test ) , mood ( Hamilton rating scale for depression ) , sleep/wake ( hrs ) and body weight . The study was open-type and after the 6th month control some responder ( R ) cases ( HI reduction ≥ 60 % ) presenting HI scores ≤ 4 could continue the survey off-treatment . The percentage of R cases was 54.5 % at the 3rd month , a figure that further increased up to 72 % by the 9th month ; relapses on treatment were not observed and rebound-headache occurred in 1/4 of R cases let off-treatment . Lower ( p < 0.05 ) baseline HI values characterized non-responders . Side-effects not requiring withdrawal were drowsiness ( 42 % within the 1st month ) and weight gain ( mean 7.9 ± 6.9 kg ) in 54 % of the cases , while a retarded type depression was the most frequent cause of drop-out from trial ( 7.5 % ) . The results , while confirming the high prophylactic activity of flunarizine in common migraine , stress the importance of clinical long-term survey of side-effects using antimigraine drugs and suggest the need for further investigations about flunarizine effects on CNS The calcium-entry blocker flunarizine ( Sibelium ; Janssen ) was compared with the beta-adrenoreceptor-blocking agent propranolol in the prophylaxis of migraine . Fifty-eight patients were entered into a double-blind 4-month treatment trial . Patients in whom beta-blockers were contraindicated were excluded from the trial . At the end of the trial 28 patients had received 10 mg flunarizine at night during the study , 29 patients had received 60 mg propranolol 3 times a day and 1 patient was withdrawn . Both groups responded well ; and there was a 4-fold drop in frequency of attacks . There was no significant difference between the two groups in terms of patient profile , onset of response to therapy , final response to therapy , incidence of dropout from the trial or incidence of side-effects . Side-effects for flunarizine were weight gain ( 9 patients ) and tiredness ( 6 ) , and for propranolol sleep disturbances including nightmares ( 6 ) , tiredness ( 8) , mental changes ( e.g. irritability ) ( 3 ) and weight gain ( 4 ) . Both flunarizine and propranolol are useful drugs for migraine prophylaxis and can be used effectively as first-line drugs . The low incidence of generally mild side-effects with flunarizine may make it preferable to many of the agents at present in use for migraine prophylaxis The clinical efficacy of flunarizine and of propranolol for the prevention of migraine attacks was assessed in a multicenter double-blind study lasting four months which was preceded by a single-blind placebo period of one month . For both drugs , more than half of the patients judged the effect to be good or very good . When considering the patients ' daily logs , both drugs produced a significant reduction of the number of attacks . Propranolol furthermore significantly reduced the severity of attacks and the number of analgesics used during the attacks . In both groups no severe side effects were observed The initiation of a prophylactic treatment in a migraine sufferer depends upon the stratification of the patient ’s frequency of attacks and the disability they cause , as well as the patient ’s acute consumption and comorbid diseases . We report on 14 patients who were among a group of 618 migraine sufferers who received a new preventative treatment . These 14 patients developed an increase in the frequency of their migraine attacks that was possibly induced by this OUTPUT: Flunarizine also seems to be effective in children . The most frequent AEs were sedation and weight increase . INPUT: Current treatment of migraine either abortive or prophylactic is often unsatisfactory . Prophylactic treatment of severe migraine may reduce attack frequency , and current therapy centers on beta-blockers , serotonin ( 5-HT ) reuptake blockers and 5-HT2 receptor antagonists . The author compared the efficacy and safety of amitriptyline and fluvoxamine among migraine patients ( 24F , 8 M vs. 23F , 9 M ) in a double blind study . The efficacy of amitriptyline has already been established by earlier clinical studies . The other investigated drug , fluvoxamine , has a more selective 5-HT reuptake blocking property than amitriptyline . In this study , amitriptyline significantly reduced the number of headache attacks , but it caused severe drowsiness in many migraineurs . The fluvoxamine also favorably influenced on the number of headache attacks and caused only slight side effects . These findings suggest , that fluvoxamine may be an alternative drug in migraine prophylaxis , however , further studies should be performed with more subjects UNLABELLED Selective serotonin reuptake inhibitors have recently been used in the treatment of migraine . OBJECTIVE We studied the safety and efficacy of fluoxetine in the prevention of migraine . PATIENTS Between February 1997 and December 1997 , we examined 52 patients ( 33 women ) at the Headache Diagnosis and Therapy Service of the Second University of Naples . Ages ranged from 18 to 65 years , and all patients suffered from migraine without aura according to IHS 1988 criteria . The sample was divided into two groups : group A included 32 patients ( 19 women ; mean age , 36.8 years [ SD 12.4 ] ) who received fluoxetine at a dosage of 20 mg per day ; group B included 20 patients ( 14 women ; mean age , 38.8 years [ SD 15.6 ] ) who received placebo . METHODS Our study was a single-center , r and omized , double-blind , parallel study of fluoxetine for the prophylactic control of migraine and consisted of two phases : 30 days of pharmacological wash out and 6 months of therapy with monthly follow-up . Patients were r and omly assigned to two groups : A , fluoxetine or B , placebo . At the first visit , patients provided a detailed history and underwent neurological evaluation and a Zung test for depression . No pathological values were revealed . In order to monitor symptomatology , all patients received a form for the calculation of the total pain index at monthly follow-up . RESULTS A comparison of the total pain index between basal values ( calculated during the period of wash out ) and monthly follow-up ( calculated monthly during the period of 6 months of the therapy ) showed significant reduction ( P < .05 ) beginning from the third month of treatment in the fluoxetine group and no significant reduction in the placebo group . CONCLUSION Even if preliminary and to be confirmed , these data seem to support the use of fluoxetine in the treatment of migraine Abstract Patients with chronic tension- type headache ( CTTH ) are the most difficult to treat . Tricyclic antidepressants are the first-line therapeutic agents , but their anticholinergic side effects limit their usage . Selective serotonin reuptake inhibitors ( SSRI ) with fewer side effects than tricyclic antidepressants have also been used in treatment of CTTH , but the results are conflicting . In this study , prophylactic action of sertraline in treatment of nondepressed patients with CTTH was investigated and compared with amitriptyline in a prospect i ve , r and omized , open label , parallel-group study . A 4-week baseline period was followed by a 12-week treatment period with either 50 mg sertraline ( n=41 patients ) or 25 mg amitriptyline ( n=44 patients ) . Efficacies of treatments were determined by using a headache diary , in which patients recorded the occurrence , number , intensity and duration of headaches in days , analgesic drug consumption and any adverse events . Both drugs reduced headache symptoms and analgesic drug consumption at the first , second and third months of treatment compared to baseline values . There was significant superiority of amitriptyline in the headache symptoms and drug consumption reductions versus sertraline at the second and third months of treatment . Side effects were more favorable in the sertraline-treated patients , but dropouts were similar in both groups . These results suggest that both drugs were effective in the treatment of non-depressed patients with CTTH , but in comparison between groups , amitriptyline was more effective than sertraline Amitriptyline , which is a noradrenaline reuptake and 5-HT reuptake inhibitor , has an established role in the management of chronic tension-type headaches . In a single-blind study , patients with chronic tension-type headache were r and omized to either fluoxetine 20 mg ( a selective 5-HT reuptake inhibitor ) or desipramine 75 mg ( a selective noradrenaline reuptake inhibitor ) and followed for 12 weeks to compare the effectiveness of the two drugs in improving headache , and to assess whether pain control is related to changes in depression . Patients were evaluated at weekly intervals on an analog pain-rating scale and at 4-weekly intervals on the Montgomery and Asberg Depression Rating Scale ( MADRS ) , the MOS general health status question naire ( SF36 ) , the Hospital Anxiety and Depression Scale ( HADS ) , and a side effects checklist . Eighteen patients were r and omized to take fluoxetine and 19 to take desipramine . Of the 25 patients who completed the trial , 12 were on fluoxetine and 13 were on desipramine . There was no significant difference between the two groups at baseline nor in change of pain ; reduction in use of analgesic OUTPUT:

Over 2 months of treatment , SSRIs are no more efficacious than placebo in patients with migraine . In patients with chronic TTH , SSRIs are less efficacious than tricyclic antidepressants . In comparison with SSRIs , the burden of adverse events in patients receiving tricyclics was greater .

MS2_dynamic_1_shot567

***TASK*** the task is to summarize an input biomedical literature 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 American men with hypertension in low socioeconomic urban population s achieve poor rates of hypertension control and suffer early from its complications . METHODS In a r and omized clinical trial with 309 hypertensive urban African American men aged 21 to 54 years , we evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician ( NP/CHW/MD ) team and a less intensive education and referral intervention in controlling blood pressure ( BP ) and minimizing progression of left ventricular hypertrophy ( LVH ) and renal insufficiency . Changes in BP , left ventricular mass ( LVM ) , and serum creatinine from baseline to 36 months were compared between groups . RESULTS At 36 months , the mean systolic BP/diastolic BP change from baseline was -7.5/-10.1 mm Hg for the more intensive group and + 3.4/-3.7 mm Hg for the less intensive group ( P = .001 and .005 for between-group differences in systolic BP and diastolic BP , respectively ) . The proportion of men with controlled BP ( < 140/90 mm Hg ) was 44 % in the more intensive group and 31 % in the less intensive group ( P = .045 ) . The LVM was significantly lower in the more intensive group than in the less intensive group ( more intensive , 274 g ; less intensive , 311 g ; P = .004 ) . There was a trend toward slowing of the progression of renal insufficiency ( incidence of 50 % increase in serum creatinine ) in the more intensive group compared to the less intensive group ( more intensive , 5.2 % ; less intensive , 8.0 % ; P = .08 ) . CONCLUSIONS During 36 months , the more intensive intervention led to a lower BP and decreased progression of LVH in a sample of hypertensive young African American men Coronary atherosclerotic disease remains the leading cause of death in the United States despite a considerable decrease in mortality rates since the 1980s ( 1 ) . This decrease in the rate of death from ischemic heart disease is attributable in part to the now-established technologies of invasive cardiac procedures : cardiac catheterization , percutaneous transluminal coronary angioplasty , and coronary artery bypass grafting ( 2 ) . Unfortunately , as with many health indicators and health services , improvements in both the mortality rate from coronary disease and rates of invasive cardiac procedures among black persons have lagged behind those of white persons ( 1 , 3 - 10 ) . Although previous work documented ethnic differences in use of cardiac procedures , the studies were limited by cross-sectional design , examination of a few selected practice setting s , or exclusion of potentially confounding clinical and socioeconomic variables ( 11 - 24 ) . Furthermore , previous research has not addressed whether or which factors can alter trends in use of cardiac procedures and thus narrow disparity among ethnic groups . We hypothesized that the large variation in use of cardiac procedures between black persons and white persons would decrease with acquisition of adequate health insurance when this occurs in conjunction with development of a serious illness . Increased use of cardiac procedures among black persons may follow attainment of health insurance or establishment of a regular source of medical care . Once serious illness occurs , avoidance of discretionary procedures because of increased risk for complications may lead to a relative decrease in use of procedures among white persons , especially if procedures were previously overused . End-stage renal disease ( ESRD ) is a significant illness in which patients are at high risk for cardiovascular disease ; patients with ESRD almost always acquire Medicare health insurance and enter a comprehensive system of care . Cross-sectional research suggests that access to dialysis and physician visits improved after enactment of the Medicare program ( 25 , 26 ) . We used the progression of patients from chronic renal failure to ESRD as a natural experiment to examine whether ethnic differences in use of cardiovascular procedures narrow with initiation of long-term dialysis and coincident acquisition of insurance . Methods Study Design and Patients We performed a national longitudinal cohort study in patients with chronic renal failure and ascertained use of cardiovascular procedures before ( baseline ) and after ( follow-up ) development of ESRD . To be eligible for inclusion in the study , patients had to have new-onset ESRD in 1986 or 1987 , be either black or white , and be at least 18 years of age . We followed patients for up to 7 years : until death , renal transplantation , or the end of the study on 31 December 1992 . Data Collection We used data from the Case Mix Severity Study of the United States Renal Data System ( USRDS ) . The USRDS is a national research organization created and funded by the National Institutes of Health to assemble information on ESRD incidence , prevalence , treatment , morbidity , and mortality . The primary purpose of the Case Mix Severity Study , conducted from 1989 to 1991 , was to provide prevalence data on the frequency of various comorbid conditions that commonly occur in ESRD . The Case Mix Severity Study used a two-stage r and om sampling method of patients and dialysis units to obtain a 5 % national r and om sample of patients with incident ESRD in 1986 to 1987 ( 27 ) . Abstract ers review ed medical charts in dialysis units to identify patients ' clinical and socioeconomic status by using a st and ardized instrument that recorded information obtained shortly before development of ESRD and initiation of dialysis . Variables included information about health insurance , education , marital status , employment status , type of employment , medical history of coronary disease , coronary risk factors , comorbid conditions , and physical examination and laboratory data . Data on medical evidence of ESRD , as part of the USRDS , provided baseline sociode OUTPUT: On average , these health care interventions improved the quality of care for racial/ethnic minorities , improved health outcomes ( such as diabetes control and reduced diabetes complications ) , and possibly reduced health disparities in quality of care . There is evidence supporting the use of interventions that target patients ( primarily through culturally tailored programs ) , providers ( especially through one-on-one feedback and education ) , and health systems ( particularly with nurse case managers and nurse clinicians ) . INPUT: Background Countries in sub-Saharan Africa ( SSA ) are experiencing an epidemic of cardiovascular disease ( CVD ) propelled by rapidly increasing rates of hypertension . Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs . Although SSA bears 24 % of the global disease burden , it has only 3 % of the global health workforce . Given such limited re sources , cost-effective strategies , such as task shifting , are needed to mitigate the rising CVD epidemic in SSA . Ghana , a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization ( WHO ) task-shifting strategy . This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage , on blood pressure ( BP ) reduction . Methods Using a cluster r and omized design , 32 community health centers ( CHCs ) and district hospitals in Ghana will be r and omized to either the intervention group ( 16 CHCs ) or the control group ( 16 CHCs ) . A total of 640 patients with uncomplicated hypertension ( BP 140–179/90–99 mm Hg and absence of target organ damage ) will be enrolled in this study ( 20 patients per CHC ) . The intervention consists of WHO Package of CV risk assessment , patient education , initiation and titration of antihypertensive medications , behavioral counseling on lifestyle behaviors , and medication adherence every three months for 12 months . The primary outcome is the mean change in systolic BP from baseline to 12 months . The secondary outcomes are rates of BP control at 12 months ; levels of physical activity , percent change in weight , and dietary intake of fruits and vegetables at 12 months ; and sustainability of intervention effects at 24 months . All outcomes will be assessed at baseline , six months and 12 months . Trained community health nurses will deliver the intervention as part of Ghana ’s community-based health planning and services ( CHPS ) program . Discussion Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in re source -poor setting s . Trial registration NCT01802372 Background The high burden of undetected and undertreated hypertension and diabetes mellitus is a major health challenge worldwide . The mPower Heart Project aim ed to develop and test a feasible and scalable intervention for hypertension and diabetes mellitus by task‐sharing with the use of a mobile phone – based clinical decision support system at Community Health Centers in Himachal Pradesh , India . Methods and Results The development of the intervention and mobile phone – based clinical decision support system was carried out using mixed methods in five Community Health Centers . The intervention was subsequently evaluated using pre – post evaluation design . During intervention , a nurse care coordinator screened , examined , and entered patient parameters into mobile phone – based clinical decision support system to generate a prescription , which was vetted by a physician . The change in systolic blood pressure , diastolic blood pressure , and fasting plasma glucose ( FPG ) over 18 months of intervention was quantified using generalized estimating equations models . During intervention , 6797 participants were enrolled . Six thous and sixteen participants had hypertension ( mean systolic blood pressure : 146.1 mm Hg , 95 % CI : 145.7 , 146.5 ; diastolic blood pressure : 89.52 mm Hg , 95 % CI : 89.33 , 89.72 ) , of which 3152 ( 52 % ) subjects were newly detected . Similarly , 1516 participants had diabetes mellitus ( mean FPG : 177.9 mg/dL , 95 % CI : 175.8 , 180.0 ) , of which 450 ( 30 % ) subjects were newly detected . The changes in systolic blood pressure , diastolic blood pressure , and FPG observed at 18 months of follow‐up were −14.6 mm Hg ( 95 % CI : −15.3 , −13.8 ) , −7.6 mm Hg ( CI : −8.0 , −7.2 ) , and −50.0 mg/dL ( 95 % CI : −54.6 , −45.5 ) , respectively , and were statistically significant even after adjusting for age , sex , and Community Health Center . Conclusions A nurse‐facilitated , mobile phone – based clinical decision support system‐enabled intervention in primary care was associated with improvements in blood pressure and blood glucose control and has the potential to scale‐up in re source poor setting s. Clinical Trial Registration URL : https://www . clinical trials.gov . Unique identifiers : NCT01794052 . Clinical Trial Registry — India : CTRI/2013/02/003412 OBJECTIVE To evaluate a simple cardiovascular risk management package for assessing and managing cardiovascular risk using hypertension as an entry point in primary care facilities in low-re source setting s. METHODS Two geographically distant regions in two countries ( China and Nigeria ) were selected and 10 pairs of primary care facilities in each region were r and omly selected and matched . Regions were then r and omly assigned to a control group , which received usual care , or to an intervention group , which applied the cardiovascular risk management package . Each facility enrolled 60 consecutive patients with hypertension . Intervention sites educated patients about risk factors at baseline and initiated treatment with hydrochlorothiazide at 4 months in patients at medium risk of a cardiovascular event , according to a st and ardized treatment algorithm . Systolic blood pressure change from baseline to 12 months was the primary outcome measure . F OUTPUT:

The overall quality of evidence based on GRADE criteria was moderate for systolic blood pressure , but low for diastolic blood pressure . INTERPRETATION Task-sharing interventions are effective in reducing blood pressure .

MS2_dynamic_1_shot568

***TASK*** the task is to summarize an input biomedical literature 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 Neutrophil oxygen radical production is increased in end-stage renal disease ( ESRD ) patients and it is further enhanced during dialysis with low-flux cellulosic membranes . This increased oxygen radical production may contribute to the protein and lipid oxidation observed in ESRD patients . We tested the hypothesis that high-flux hemodialysis does not increase oxygen radical production and that it is not associated with protein oxidation . METHODS Neutrophil oxygen radical production was measured during dialysis with high-flux dialyzers containing polysulfone and cellulose triacetate membranes . Free sulfhydryl and carbonyl groups and advanced oxidation protein products were measured to assess plasma protein oxidation . RESULTS Pre-dialysis , neutrophil oxygen radical production was significantly greater than normal and increased significantly as blood passed through the dialyzer in the first 30 minutes of dialysis . Post-dialysis , however , neutrophil oxygen radical production had decreased and was not different from normal . Pre-dialysis , significant plasma protein oxidation was evident from reduced free sulfhydryl groups , increased carbonyl groups , and increased advanced oxidation protein products . Post-dialysis , plasma protein free sulfhydryl groups had increased to normal levels , while plasma protein carbonyl groups increased slightly , and advanced oxidation protein products remained unchanged . CONCLUSIONS The results of this study show that neutrophil oxygen radical production normalizes during high-flux dialysis , despite a transient increase early in dialysis . This decrease in oxygen radical production is associated with an improvement in some , but not all , measures of protein oxidation Red blood cells and plasma reduced and oxidized glutathione levels , glutathione peroxidase ( GSH-Px ) activity , thiobarbituric acid reactants ( TBAR ) of both chronic ambulatory peritoneal dialysis ( CAPD ) patients and a matched control group were investigated in this study . Oxidized and reduced pyridinic nucleotides in red blood cells ( RBC ) , in which NADPH is a direct expression of hexose monophosphate shunt function , were also studied . The results obtained indicate that RBC and plasma are exposed to oxidative stress in CAPD . This condition is characterized by a decreased GSH/GSSG ratio , particularly evident in RBC as a consequence of the GSSG accumulation . Lipid peroxidation is increased , as indicated by raised TBAR levels , and reduced pyridinic nucleotides are decreased . Increased GSH-Px levels and unmodified or slightly increased GSH content were observed in the RBC but not in plasma , which showed decreased GSH and unmodified peroxidase activity . Peroxidase correlated positively with TBAR levels in the RBC lysates . In a subgroup of patients treated with erythropoietin ( vs. untreated patients and controls ) no differences were observed in the glutathione-related parameters studied . These data suggest that a mechanism for adaptation to oxidative conditions may be present in CAPD and its effects on RBC integrity are discussed in comparison with the hemodialysis conditions previously studied Increased markers of oxidative stress and acute-phase inflammation are prevalent in patients undergoing maintenance hemodialysis therapy ( MHD ) , and are associated with increased mortality and hospitalization rates and decreased erythropoietin responsiveness . No adequately powered studies have examined the efficacy of antioxidant therapies on markers of inflammation and oxidative stress . We tested the hypothesis that oral antioxidant therapy over 6 months would decrease selected biomarkers of acute-phase inflammation and oxidative stress and improve erythropoietic response in prevalent MHD patients . In total , 353 patients were enrolled in a prospect i ve , placebo-controlled , double-blind clinical trial and r and omly assigned to receive a combination of mixed tocopherols ( 666 IU/d ) plus α-lipoic acid ( ALA ; 600 mg/d ) or matching placebos for 6 months ( NCT00237718 ) ; 238 patients completed the study . High-sensitivity C-reactive protein ( hsCRP ) and IL-6 concentration were measured as biomarkers of systemic inflammation , and F2 isoprostanes and isofurans were measured as biomarkers of oxidative stress . The groups did not significantly differ at baseline . At 3 and 6 months , the treatment had no significant effect on plasma hsCRP , IL-6 , F2 isoprostane , or isofuran concentrations and did not improve the erythropoietic response . No major adverse events were related to the study drug , and both groups had similar mortality and hospitalization rates during the study . In conclusion , the administration of mixed tocopherols and ALA was generally safe and well tolerated , but did not influence biomarkers of inflammation and oxidative stress or the erythropoietic response BACKGROUND Erythrocytes represent an important component of the antioxidant capacity of blood , comprising , in particular , intracellular enzymes , including platelet-activating factor acetylhydrolase ( PAF-AH ) and glutathione peroxidase ( Gpx ) . We evaluated the erythrocyte PAF-AH and Gpx activities in various stages of chronic kidney disease ( CKD ) , and further investigated whether erythropoietin ( EPO ) administration in these patients has any influence on the enzyme activities . METHODS Thirty-six patients ( 19 men and 17 women ) with CKD ( stages 1 to 5 ) participated in the study . Thirteen of them presented with CKD stage 1 to 2 ( group I ) , whereas 23 patients presented with CKD stage 3 to 5 and r and omized into two groups ( i.e. , groups II and III ) . Patients of group II ( N= 11 ) were administered EPO subcutaneously , 50 units per kg once per week . In group III ( N= 12 ) , E OUTPUT: Even from an early stage , imbalance in redox status is evident and as the kidney function worsens it becomes more profound . Hemodialysis therapy per se seems to negatively influence the redox status by the elevation of lipid peroxidation markers , protein carbonylation , and impairing erythrocyte antioxidant defense . However , other dialysis modalities do not so far appear to confer advantages . Supplementation with antioxidants might assist and should be considered as an early intervention to halt premature atherogenesis development at an early stage of CKD INPUT: Red blood cells and plasma reduced and oxidized glutathione levels , glutathione peroxidase ( GSH-Px ) activity , thiobarbituric acid reactants ( TBAR ) of both chronic ambulatory peritoneal dialysis ( CAPD ) patients and a matched control group were investigated in this study . Oxidized and reduced pyridinic nucleotides in red blood cells ( RBC ) , in which NADPH is a direct expression of hexose monophosphate shunt function , were also studied . The results obtained indicate that RBC and plasma are exposed to oxidative stress in CAPD . This condition is characterized by a decreased GSH/GSSG ratio , particularly evident in RBC as a consequence of the GSSG accumulation . Lipid peroxidation is increased , as indicated by raised TBAR levels , and reduced pyridinic nucleotides are decreased . Increased GSH-Px levels and unmodified or slightly increased GSH content were observed in the RBC but not in plasma , which showed decreased GSH and unmodified peroxidase activity . Peroxidase correlated positively with TBAR levels in the RBC lysates . In a subgroup of patients treated with erythropoietin ( vs. untreated patients and controls ) no differences were observed in the glutathione-related parameters studied . These data suggest that a mechanism for adaptation to oxidative conditions may be present in CAPD and its effects on RBC integrity are discussed in comparison with the hemodialysis conditions previously studied In hemodialysis patients , oxidative stress results from an imbalance between the production of reactive oxygen species and antioxidant defense mechanisms . Recently , a new dialysis multi‐‐layer membrane has been developed , by modifying the inner surface of regenerated cellulose to support a vitamin E coating . The aim of our study was to investigate the effects of hemodialysis treatment with vitamin E‐‐modified membrane on anemia and erythropoietin requirement in a group of chronic uremic patients . Ten uremic , non diabetic , patients on st and ard bicarbonate dialysis were treated with vitamin E‐‐bonded dialysis membrane for 12 months . Hematological parameters , erythropoietin requirement , serum vitamin E and serum malonyldialdehyde ( ( MDA ) ) were evaluated before starting the study and monthly . No significant changes in hemoglobin level , RBC count , hematocrit and EPO requirement were observed . Basal vitamin E levels were in the normal range ( ( 13.0±2.88 mg//L vs. 14.79±3.12 mg//L ; NS ) ) . On the contrary , basal MDA levels were higher than those observed in the control group ( ( 1.87±0.36 vs. 1.13±0.18 mmol//mL ; p < 0.01 ) ) and a significant decrease of MDA levels was found after 1 month of Excebrane ® treatment ( ( 1.39±0.25 nmol//mL ; p < 0.02 ) ) . In conclusion , the role of the “ oxidative hemolysis ” in the pathogenesis of anemia in CHD patients is still not clearly defined , but it could be of minor clinical relevance . Although the effectiveness of vitamin E‐‐coated membranes as a scavenger of ROS allows a better control of intradialytic oxidative stress , it does n't seem to contribute to clinical management of anemia in these patients BACKGROUND Asymmetric dimethylarginine ( ADMA ) is an endogenous inhibitor of nitric oxide synthase and an independent predictor of overall mortality and cardiovascular outcome in haemodialysis ( HD ) patients . In the present study , we compared the effects of a vitamin E-coated polysulfone membrane ( PSE ) and a non-vitamin E-coated polysulfone membrane ( PS ) on oxidative stress markers such as ADMA . METHODS Thirty-one HD patients were enrolled to this investigation . They were allocated into two groups : in the PSE group ( n = 16 ) , PSE was used for 6 months , followed by PS for an additional 12 months ; in the PS group ( n = 15 ) , PS was used for the entire observation period . Plasma ADMA , oxidized low density lipoprotein ( Ox-LDL ) and malondialdehyde LDL ( MDA-LDL ) levels were measured at baseline , 3 , 6 , 12 and 18 months . Plasma ADMA in peritoneal dialysis ( PD ) patients and in healthy individuals was also measured . RESULTS Predialysis concentrations of ADMA ( 0.72+/- 0.13 nmol/ml ) were significantly higher in the HD group than in both PD patients ( 0.63+/-0.10 nmol/ml , P<0.01 ) and healthy individuals ( 0.44+/-0.01 nmol/ml , P<0.0001 ) . Treatment with PSE for 6 months significantly reduced predialysis levels of ADMA ( 0.54+/-0.09 nmol/ml ) compared with baseline ( 0.74+/-0.12 nmol/ml ; P<0.01 ) . Predialysis levels of Ox-LDL and MDA-LDL after 6 months therapy with PSE were also significantly lower than baseline values . Treatment with PS subsequent to treatment with PSE again increased ADMA , Ox-LDL and MDA-LDL back to baseline levels . In the PS group , ADMA , Ox-LDL and MDA-LDL levels remained unchanged during the entire treatment period of 18 months . CONCLUSIONS We confirmed that use of PSE reduced ADMA that had accumulated in HD patients . This finding indicates that PSE exerts anti-oxidant activity . A r and omized controlled study will be required to determine whether PSE prevents cardiovascular diseases and other dialysis-related complications by reducing oxidative stress Hemodialysis deteriorates oxidative stress . Vit OUTPUT:

The conversion of dialysis patients to a vitamin E-coated dialyser is associated with an improvement in circulating biomarkers of lipid peroxidation , which is of potential clinical benefit

MS2_dynamic_1_shot569

***TASK*** the task is to summarize an input biomedical literature 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 effect of antihypertensive drugs on cardiovascular events in patients with coronary artery disease ( CAD ) and normal blood pressure remains uncertain . OBJECTIVE To compare the effects of amlodipine or enalapril vs placebo on cardiovascular events in patients with CAD . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized , multicenter , 24-month trial ( enrollment April 1999-April 2002 ) comparing amlodipine or enalapril with placebo in 1991 patients with angiographically documented CAD ( > 20 % stenosis by coronary angiography ) and diastolic blood pressure < 100 mm Hg . A sub study of 274 patients measured atherosclerosis progression by intravascular ultrasound ( IVUS ) . INTERVENTIONS Patients were r and omized to receive amlodipine , 10 mg ; enalapril , 20 mg ; or placebo . IVUS was performed at baseline and study completion . MAIN OUTCOME MEASURES The primary efficacy parameter was incidence of cardiovascular events for amlodipine vs placebo . Other outcomes included comparisons of amlodipine vs enalapril and enalapril vs placebo . Events included cardiovascular death , nonfatal myocardial infa rct ion , resuscitated cardiac arrest , coronary revascularization , hospitalization for angina pectoris , hospitalization for congestive heart failure , fatal or nonfatal stroke or transient ischemic attack , and new diagnosis of peripheral vascular disease . The IVUS end point was change in percent atheroma volume . RESULTS Baseline blood pressure averaged 129/78 mm Hg for all patients ; it increased by 0.7/0.6 mm Hg in the placebo group and decreased by 4.8/2.5 mm Hg and 4.9/2.4 mm Hg in the amlodipine and enalapril groups , respectively ( P<.001 for both vs placebo ) . Cardiovascular events occurred in 151 ( 23.1 % ) placebo-treated patients , in 110 ( 16.6 % ) amlodipine-treated patients ( hazard ratio [ HR ] , 0.69 ; 95 % CI , 0.54 - 0.88 [ P = .003 ] ) , and in 136 ( 20.2 % ) enalapril-treated patients ( HR , 0.85 ; 95 % CI , 0.67 - 1.07 [ P = .16 ] . Primary end point comparison for enalapril vs amlodipine was not significant ( HR , 0.81 ; 95 % CI , 0.63 - 1.04 [ P = .10 ] ) . The IVUS sub study showed a trend toward less progression of atherosclerosis in the amlodipine group vs placebo ( P = .12 ) , with significantly less progression in the subgroup with systolic blood pressures greater than the mean ( P = .02 ) . Compared with baseline , IVUS showed progression in the placebo group ( P<.001 ) , a trend toward progression in the enalapril group ( P = .08 ) , and no progression in the amlodipine group ( P = .31 ) . For the amlodipine group , correlation between blood pressure reduction and progression was r = 0.19 , P = .07 . CONCLUSIONS Administration of amlodipine to patients with CAD and normal blood pressure result ed in reduced adverse cardiovascular events . Directionally similar , but smaller and nonsignificant , treatment effects were observed with enalapril . For amlodipine , IVUS showed evidence of slowing of atherosclerosis progression The West of Scotl and Coronary Prevention Study ( WOSCOPS ) showed that pravastatin reduced the risk of coronary heart disease ( CHD ) events in 6,595 middle-aged hypercholesterolaemic men aged 45 - 64 years without prior myocardial infa rct ion followed for an average of 4.9 years . We hypothesised prospect ively ( a ) that baseline levels of haemorheological variables were related to baseline and incident CHD and to mortality ; and ( b ) that reduction in lipoproteins by pravastatin would lower plasma and blood viscosity , a potential contributory mechanism to CHD events . We therefore studied plasma and blood viscosity , fibrinogen , haematocrit , and blood cell counts at baseline and 1 year . At baseline , plasma and blood viscosity were related to risk factors , CHD measures , and claudication . On univariate analysis , baseline levels of all rheological variables ( except platelet count ) were related to incident CHD ; CHD mortality ; and total mortality . On multivariate analysis including baseline CHD and risk factors , plasma and blood viscosity , haematocrit and white cell count each remained significantly associated with incident CHD ; while fibrinogen remained an independent predictor of mortality ( all p < 0.03 ) . After one year , lipoprotein reduction by pravastatin was associated with significant reductions ( about one quarter of a st and ard deviation ) in plasma viscosity ( mean difference 0.02 mPa.s , p < 0.001 ) and in blood viscosity ( mean difference 0.06 mPa.s , p<0.001 ) , but was not associated with significant changes in other rheological variables . We therefore suggest that pravastatin therapy , which reduces elevated lipoproteins in hypercholesterolaemic men , may lower risks of CHD and mortality partly by lowering plasma and blood viscosity . Further studies are required to test this hypothesis To determine the effect of atorvastatin on blood rheology in patients with familial hypercholesterolemia ( FH ) on regular LDL apheresis , we prospect OUTPUT: Regarding the repolarization changes on the ECG NSTEMI shows similarities with other clinical symptoms where increased intramyocardial microvascular resistance can be supposed without coronary artery disease : false positive exercise stress test , supraventricular tachycardia , left ventricular strain and conduction disturbances . CONCLUSION The acute treatment of NSTEMI should aim to improve the blood inflow to the stiff myocardium and /or impaired microvascular system and decrease the high microvascular resistance INPUT: Background The results of angiographic studies have suggested that calcium channel – blocking agents may prevent new coronary lesion formation , the progression of minimal lesions , or both . Methods and Results The Prospect i ve R and omized Evaluation of the Vascular Effects of Norvasc Trial ( PREVENT ) was a multicenter , r and omized , placebo-controlled , double-masked clinical trial design ed to test whether amlodipine would slow the progression of early coronary atherosclerosis in 825 patients with angiographically documented coronary artery disease . The primary outcome was the average 36-month angiographic change in mean minimal diameters of segments with a baseline diameter stenosis of 30 % . A secondary hypothesis was whether amlodipine would reduce the rate of atherosclerosis in the carotid arteries as assessed with B-mode ultrasonography , which measured intimal-medial thicknesses ( IMT ) . The rates of clinical events were also monitored . The placebo and amlodipine groups had nearly identical average 36-month reductions in the minimal diameter : 0.084 versus 0.095 mm , respectively ( P = 0.38 ) . In contrast , amlodipine had a significant effect in slowing the 36-month progression of carotid artery atherosclerosis : the placebo group experienced a 0.033-mm increase in IMT , whereas there was a 0.0126-mm decrease in the amlodipine group ( P = 0.007 ) . There was no treatment difference in the rates of all-cause mortality or major cardiovascular events , although amlodipine use was associated with fewer cases of unstable angina and coronary revascularization . Conclusions Amlodipine has no demonstrable effect on angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but is associated with fewer hospitalizations for unstable angina and revascularization The aim of our study was to assess the effects of lacidipine , a long-acting calcium antagonist , on 24-hour average blood pressure , blood pressure variability , and baroreflex sensitivity . In 10 mildly to moderately hypertensive patients with type II diabetes mellitus ( aged 18 to 65 years ) , 24-hour ambulatory blood pressure was continuously monitored noninvasively ( Portapres device ) after a 3-week pretreatment with placebo and a subsequent 4-week once daily lacidipine ( 4 mg ) or placebo treatment ( double-blind crossover design ) . Systolic blood pressure , diastolic blood pressure , and heart rate means were computed each hour for 24 hours ( day and night ) at the end of each treatment period . Similar assessment s were also made for blood pressure and heart rate variability ( st and ard deviation and variation coefficient ) and for 24-hour baroreflex sensitivity , which was quantified ( 1 ) in the time domain by the slope of the spontaneous sequences characterized by progressive increases or reductions of systolic blood pressure and RR interval and ( 2 ) in the frequency domain by the squared ratio of RR interval and systolic blood pressure spectral power ≈0.1 and 0.3 Hz over the 24 hours . Compared with placebo , lacidipine reduced the 24-hour , daytime , and nighttime systolic and diastolic blood pressure ( P < 0.05 ) with no significant change in heart rate . It also reduced 24-hour , daytime , and nighttime st and ard deviation ( −19.6 % , −14.4 % , and −24.0 % , respectively;P < 0.05 ) and their variation coefficient . The 24-hour average slope of all sequences ( 7.7±1.7 ms/mm Hg ) seen during placebo was significantly increased by lacidipine ( 8.7±1.8 ms/mm Hg , P < 0.01 ) , with a significant increase being obtained also for the 24-hour average & agr ; coefficient at 0.1 Hz ( from 5.7±1.5 to 6.4±1.3 ms/mm Hg , P < 0.01 ) . Thus , in diabetic hypertensive patients , lacidipine reduced not only 24-hour blood pressure means but also blood pressure variability . This reduction was accompanied by an improvement of baroreflex sensitivity . Computer analysis of beat-to-beat 24-hour noninvasive blood pressure monitoring may offer valuable information about the effects of antihypertensive drugs on hemodynamic and autonomic parameters in daily life The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) , sponsored by the National Heart , Lung , and Blood Institute ( NHLBI ) , is the largest outcome trial of antihypertensive treatment ever carried out and the only large blood pressure ( BP ) trial to be carried out in a US population in the past decade.1 The rationale for ALLHAT , which was design ed in the early 1990s , was the urgent need to determine which of the several classes of antihypertensive drugs that had been developed and released for clinical use was most effective in preventing coronary heart disease ( CHD ) , defined as fatal CHD and nonfatal myocardial infa rct ion.2 The only r and omized trials that had previously compared representatives of the antihypertensive drug classes , the Department of Veterans Affairs Cooperative Study Group on Antihypertensive Agents3 and the Treatment of Mild Hypertension Study (TOMHS),4 showed BP reductions with all classes but were not powered to evaluate CHD outcomes . Further , prior outcome trials had shown that the reduction in CHD event rates with antihypertensive treatment was less than expected based on epidemiologic data .5 Adverse effects of study drugs , particularly diuretics , including hypokalemia , hypomagnesemia , hyperuricemia , hyperlipidemia , insulin resistance , and ventricular ectopic activity , had been adduced to account for the disappointing out OUTPUT:

INTERPRETATION Drug-class effects on interindividual variation in blood pressure can account for differences in effects of antihypertensive drugs on risk of stroke independently of effects on mean SBP .

MS2_dynamic_1_shot570

***TASK*** the task is to summarize an input biomedical literature 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 effect of a neuromuscular training program on the incidence of anterior cruciate ligament injuries in female team h and ball players . Design Prospect i ve intervention study . Setting Female team h and ball : Division I – III in Norway . Participants Players from the three top divisions : control season ( 1998–1999 ) , 60 teams ( 942 players ) ; first intervention season ( 1999–2000 ) , 58 teams ( 855 players ) ; second intervention season ( 2000–2001 ) , 52 teams ( 850 players ) . InterventionA five-phase program ( duration , 15 min ) with three different balance exercises focusing on neuromuscular control and planting/l and ing skills was developed and introduced to the players in the autumn of 1999 and revised before the start of the season in 2000 . The teams were instructed in the program and supplied with an instructional video , poster , six balance mats , and six wobble boards . Additionally , a physical therapist was attached to each team to follow up with the intervention program during the second intervention period . Main Outcome Measures The number of anterior cruciate ligament injuries during the three seasons and compliance with the program . Results There were 29 anterior cruciate ligament injuries during the control season , 23 injuries during the first intervention season ( OR , 0.87 ; CI , 0.50–1.52 ; p = 0.62 ) , and 17 injuries during the second intervention season ( OR , 0.64 ; CI , 0.35–1.18 ; p = 0.15 ) . In the elite division , there were 13 injuries during the control season , six injuries during the first intervention season ( OR , 0.51 ; CI , 0.19–1.35 ; p = 0.17 ) , and five injuries in the second intervention season ( OR , 0.37 ; CI , 0.13–1.05 ; p = 0.06 ) . For the entire cohort , there was no difference in injury rates during the second intervention season between those who complied and those who did not comply ( OR , 0.52 ; CI , 0.15–1.82 ; p = 0.31 ) . In the elite division , the risk of injury was reduced among those who completed the anterior cruciate ligament injury prevention program ( OR , 0.06 ; CI , 0.01–0.54 ; p = 0.01 ) compared with those who did not . Conclusions This study shows that it is possible to prevent anterior cruciate ligament injuries with specific neuromuscular training Abstract . This prospect i ve r and omized intervention investigated whether training on a balance board could reduce the amount of traumatic injuries of the lower extremities in female soccer players . A total of 221 female soccer players from 13 different teams playing in the second and third Swedish divisions volunteered to participate in the study . Seven teams ( n=121 ) were r and omized to an intervention group and six teams ( n=100 ) to a control group and were followed during one outdoor season ( April – October ) . Before and after the season muscle flexibility and balance/postural sway of the lower extremities were measured in the players . There were no significant differences in age , height , weight , muscle flexibility and balance/postural sway of the lower extremities between the intervention and the control group . During the season the players in the intervention group performed a special training program consisting of 10–15 min of balance board training in addition to their st and ard soccer practice and games . After a 37 % drop-out the intervention group consisted of 62 players and the control group of 78 players . The results showed no significant differences between the groups with respect either to the number , incidence , or type of traumatic injuries of the lower extremities . The incidence rate of " major " injuries was higher in the intervention group than in the control group . Four of five anterior cruciate ligament injuries occurred in the intervention group , which means that we could not prevent severe knee injuries in female soccer players with balance board training . However , among the players who had been injured during the 3-month period prior to this investigation there were significantly more players from the control group than from the intervention group who sustained new injuries during the study period STUDY DESIGN Controlled single-group pretest/posttest design . OBJECTIVE The purpose of this study was to determine if a 6-week neuromuscular training program design ed to decrease the incidence of anterior cruciate ligament ( ACL ) injuries would improve single-limb postural stability in young female athletes . We hypothesized neuromuscular training would result in an improvement in postural stability , with the greatest improvement taking place in the medial-lateral direction . BACKGROUND Balance training has become a common component of programs design ed to prevent ACL injury . Rehabilitation programs can improve postural stability following ACL injury and reconstruction ; however , there is limited information available which quantifies improvement of postural stability following neuromuscular training design ed to prevent ACL injuries in a healthy population . METHODS AND MEASURES Forty-one healthy female high school athletes ( mean age , 15.3 years ; age range , 13 - 17 years ) participated in this study . Single-limb postural stability for both lower extremities was assessed with a Biodex Stability System . The neuromuscular training program consisted of three 90-minute training sessions per week for 6 weeks . Following the completion of the training program , each subject was re-evaluated to determine change in total , anterior-posterior , and medial-lateral single-limb stability . Two-way analysis of variance models were used to determine differences between pretraining and posttraining and between limbs . RESULTS The subjects showed a significant improvement in single-limb total stability ( P = .004 ) and anterior-posterior stability ( P = .001 ) , but not medial-lateral stability ( P = .650 ) for both the right and left lower extremity following training . In addition , the subjects demonstrated OUTPUT: Examination of the similarities and differences between the training regimens gives insight into the development of more effective and efficient interventions . INPUT: Objective To assess the effect of a neuromuscular training program on the incidence of anterior cruciate ligament injuries in female team h and ball players . Design Prospect i ve intervention study . Setting Female team h and ball : Division I – III in Norway . Participants Players from the three top divisions : control season ( 1998–1999 ) , 60 teams ( 942 players ) ; first intervention season ( 1999–2000 ) , 58 teams ( 855 players ) ; second intervention season ( 2000–2001 ) , 52 teams ( 850 players ) . InterventionA five-phase program ( duration , 15 min ) with three different balance exercises focusing on neuromuscular control and planting/l and ing skills was developed and introduced to the players in the autumn of 1999 and revised before the start of the season in 2000 . The teams were instructed in the program and supplied with an instructional video , poster , six balance mats , and six wobble boards . Additionally , a physical therapist was attached to each team to follow up with the intervention program during the second intervention period . Main Outcome Measures The number of anterior cruciate ligament injuries during the three seasons and compliance with the program . Results There were 29 anterior cruciate ligament injuries during the control season , 23 injuries during the first intervention season ( OR , 0.87 ; CI , 0.50–1.52 ; p = 0.62 ) , and 17 injuries during the second intervention season ( OR , 0.64 ; CI , 0.35–1.18 ; p = 0.15 ) . In the elite division , there were 13 injuries during the control season , six injuries during the first intervention season ( OR , 0.51 ; CI , 0.19–1.35 ; p = 0.17 ) , and five injuries in the second intervention season ( OR , 0.37 ; CI , 0.13–1.05 ; p = 0.06 ) . For the entire cohort , there was no difference in injury rates during the second intervention season between those who complied and those who did not comply ( OR , 0.52 ; CI , 0.15–1.82 ; p = 0.31 ) . In the elite division , the risk of injury was reduced among those who completed the anterior cruciate ligament injury prevention program ( OR , 0.06 ; CI , 0.01–0.54 ; p = 0.01 ) compared with those who did not . Conclusions This study shows that it is possible to prevent anterior cruciate ligament injuries with specific neuromuscular training OBJECTIVE : To determine if anterior cruciate ligament ( ACL ) injuries in female athletes occur r and omly or correlate with a specific phase of the menstrual cycle . DESIGN AND SETTING : Female athletes who sustained ACL injuries reported the days of their menstrual cycles and provided saliva sample s for sex-hormone determination . Salivary sex-hormone profiles were assessed to confirm the self-reported menstrual histories . SUBJECTS : A total of 38 female athletes ( 20 college , 15 high school , 1 middle school , 2 recreational ) with recent ACL injuries participated in the study over a 3-year period . MEASUREMENTS : Athletes with recent ACL injuries completed a question naire defining the injury , the last menstrual cycle , prior knee injury , school , and type of birth control used ( if any ) . Each subject provided a 30-cc saliva sample within 72 hours of injury . Saliva sample s were placed into sealed containers and frozen at -20 degrees C. We obtained 13 additional control sample s from uninjured females to test the correlation between saliva and serum sex-hormone levels . Progesterone and estrogen were assayed by radioimmunoassay . Physical examination , magnetic resonance imaging , or surgery confirmed the injury in all subjects . RESULTS : The correlations between saliva and serum estrogen and progesterone were 0.73 ( alpha = .01 ) and 0.72 ( alpha = .01 ) , respectively . Ten of 27 athletes who reported their cycle day at time of injury sustained an ACL injury immediately before or 1 to 2 days after the onset of menses . We rejected the null hypothesis that such high frequency was due to r and om chance . CONCLUSIONS : A significantly greater number of ACL injuries occurred on days 1 and 2 of the menstrual cycle . Salivary sex-hormone levels correlated with the reported cycle day An increased incidence of sports related injuries in the premenstrual phase as well as in the menstrual phase of the menstrual cycle has been described . This may be explained by alterations in proprioception and neuromuscular coordination due to hormonal variations . Prospect i ve , within women analysis of knee joint kinesthesia and neuromuscular coordination were performed by repeated measures analysis of variance in three hormonally verified phases of three consecutive menstrual cycles . Thirty-two healthy , moderately active female subjects volunteered to participate in the study . Twenty-five of the subjects performed at least one hormonally verified menstrual cycle . A specially design ed device was used to investigate knee joint kinaesthesia and neuromuscular coordination was measured with the square hop test . These tests were carried out in the menstrual phase , ovulation phase and premenstrual phase determined by hormone analyses in three consecutive menstrual cycles . An impaired knee joint kinaesthesia was detected in the premenstrual phase and the performance of square hop test was significantly improved in the ovulation phase compared to the other two phases . The results of this study indicate that the variation of sex hormones in the menstrual cycle has an effect on performance of knee joint kinaesthesia and neuromuscular coordination The purpose of this study was to examine gender differences in the incidence of anterior cruciate ligament ( ACL ) injuries in a population of high-level team h and ball players . We also wanted to OUTPUT:

The clinical relevance of this finding is that female athletes may be more predisposed to anterior cruciate ligament injuries during the preovulatory phase of the menstrual cycle . These findings may lead to potential interventions targeted toward this phase of the menstrual cycle to reduce the incidence of anterior cruciate ligament injury

MS2_dynamic_1_shot571

***TASK*** the task is to summarize an input biomedical literature 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 describe the vision-targeted , health-related quality of life , measured with the National Eye Institute Visual Function Question naire ( NEI-VFQ ) , in patients with age-related macular degeneration , cataract , or reduced visual acuity ; to determine the relationship between the NEI-VFQ subscale scores and clinical measures of visual function ; and to assess the internal consistency and reliability of the NEI-VFQ subscales . DESIGN The 39-item NEI-VFQ was administered at the 5-year clinic visit to 4077 Age-Related Eye Disease Study participants . RESULTS The subscales of the NEI-VFQ had moderate to high internal consistency ( Cronbach 's alpha = 0.58 - 0.91 ) . The NEI-VFQ scores for participants with advanced age-related macular degeneration in 1 or both eyes , severe nuclear opacity , reduced visual acuity , or cataract surgery generally were lower than scores for disease-free participants ( P<.001 ) . CONCLUSION These findings support the use of the NEI-VFQ as a measure of vision-targeted , health-related quality of life among patients with age-related macular degeneration , cataract , or reduced visual acuity OBJECTIVE To develop and test the psychometric properties of a 25-item version of the National Eye Institute Visual Function Question naire ( NEI VFQ-25 ) . DESIGN Prospect i ve observational cohort study of persons with 1 of 5 chronic eye diseases or low vision who were scheduled for nonurgent visits in ophthalmology practice s and a reference sample of persons without eye disease . SETTING Eleven university-based ophthalmology practice s and the NEI Clinical Center . PATIENTS Eligible participants had to have 1 of the following eye conditions : age-related cataracts , age-related macular degeneration , diabetic retinopathy , primary open-angle glaucoma , cytomegalovirus retinitis , or low vision from any cause . Seven of the 12 sites also enrolled persons in a reference sample . Reference sample participants had no evidence of underlying eye disease but were scheduled for either screening eye examinations or correction of refractive error . All eligible persons had to be 21 years or older , English speaking , and cognitively able to give informed consent and participate in a health status interview . MEASUREMENTS AND MAIN RESULTS To provide the data needed to create the NEI VFQ-25 , all subjects completed an interview that included the 51-item NEI VFQ . Estimates of internal consistency indicate that the subscales of the NEI VFQ-25 are reliable . The validity of the NEI VFQ-25 is supported by high correlations between the short- and long-form versions of the measure , observed between-group differences in scores for persons with different eye diseases of varying severity , and the moderate-to-high correlations between the NEI VFQ-25 subscales that have the most to do with central vision and measured visual acuity . CONCLUSIONS The reliability and validity of the NEI VFQ-25 are comparable to those of the 51-item NEI VFQ field test version of the survey . This shorter version will be more feasible in setting s such as clinical trials where interview length is a critical consideration . In addition , preliminary analyses indicate that the psychometric properties of the NEI VFQ-25 are robust for the eye conditions studied ; this suggests that the measure will provide reproducible and valid data when used across multiple conditions of varying severity OBJECTIVE To assess the impact of best-eye and worst-eye visual acuity ( BEVA and WEVA , respectively ) on health-related quality of life and utility in patients with wet age-related macular degeneration . DESIGN This cross-sectional , prospect i ve , observational , multicenter study was performed in France , Germany , and Italy . Patients were stratified into 4 severity groups ( BEVA , 20/40 ; WEVA , 20/200 ) . Patients completed the National Eye Institute 25-Item Visual Function Question naire , the Macular Disease Quality of Life Scale , and the Health Utility Index 3 . Analysis of variance was used to adjust for age , sex , and country . RESULTS Patients ( N = 360 ) were mainly female ( 59.6 % ) , with a mean age of 77 years and mean time since age-related macular degeneration diagnosis of 2.3 years . Health Utility Index 3 scores decreased with VA severity from 0.62 to 0.39 . The National Eye Institute 25-Item Visual Function Question naire global score decreased with VA severity from 67.0 to 40.7 and was related to the BEVA ( P < .001 ) and WEVA ( P = .03 ) . Corresponding changes were observed on the general vision , distance vision , driving , and mental health dimensions . The average weighted impact score on the Macular Disease Quality of Life varied from -4.6 to -2.6 , decreasing with VA severity . Both eyes contributed to the average weighted impact score . CONCLUSION The BEVA and WEVAs influenced vision-related quality of life independently , as measured by the National Eye Institute 25-Item Visual Function Question naire and Macular Disease Quality of Life Scale BACKGROUND The National Eye Institute Visual Function Question naire ( NEI-VFQ ) measures vision-targeted quality of life , but it is unclear whether it is sensitive to changes within individuals over time . OBJECTIVE To determine the responsiveness of the NEI-VFQ to " within-individual " changes in visual acuity in patients who had subfoveal choroidal neovascularization in at least one eye secondary to age-related macular degeneration , ocular histoplasmosis syndrome , or idiopathic causes , and who participated in r and omized trials of submacular surgery . METHODS Trained telephone interviewers administered the NEI-VFQ as part of annual follow-up data collection for pilot trials and larger clin OUTPUT: Visual loss was associated with a marked impact on health utilities . However , the relationship was not comparable between conditions or by measure of HSUVs . Key results included the finding that overall , self-rated time-trade off estimates were more likely to discriminate between different VA levels than EQ-5D values . Additionally , a stronger correlation was observed between HSUVs and better-seeing eye VA compared to worse-seeing eye VA . Conclusions Visual acuity has a significant impact on HSUVs . INPUT: Objective To evaluate the psychometric properties of the National Eye Institute Visual Function Question naire-25 ( NEI VFQ-25 ) and Visual Function Question naire Utility Index ( VFQ-UI ) in patients with non-infectious intermediate and posterior uveitis . Methods Secondary analysis of pooled data from a 26-week , multicenter , masked , r and omized , sham-controlled Phase 3 clinical trial . Health-related quality of life was assessed using the NEI VFQ-25 , the EQ-5D , and SF-36 . Internal consistency reliability , reproducibility , convergent validity , and known groups of BCVA and vitreous haze severity were assessed . Clinical ly significant difference was assessed using anchor-based and distribution-based methods . Results The study included 224 subjects with non-infectious intermediate ( 80.4 % ) or posterior uveitis ( 19.6 % ) . The NEI VFQ-25 and the VFQ-UI demonstrated good internal consistency ( Cronbach ’s alpha 0.87–0.94 ) and test – retest reliability ( ICCs 0.58–0.88 ) . Spearman ’s product – moment rank correlations between the NEI VFQ-25 and VFQ-UI scores and the SF-6D , EQ-5D , and BCVA ranged from small to moderate . There was a significant association between visual functioning and known groups of visual acuity ( p < 0.05 ) . Clinical significance , using the anchor-based method ( difference between visual acuity groups ≥10–<15 letter better and no change ) , was 10.2 for change from baseline to week 26 for the NEI VFQ-25 composite score and 0.05 for the VFQ-UI . Using the distribution-based method , the clinical significance was 3.86 for the composite score and 0.04 for the VFQ-UI . Conclusion The NEI VFQ-25 and the VFQ-UI are reliable and valid measures of vision-related functioning and preference-based status in patients with non-infectious intermediate and posterior uveitis BACKGROUND Cost-effectiveness/cost-utility analyses are increasingly needed to inform decisions about care . Algorithms have been developed using the Functional Assessment of Cancer Therapy ( FACT ) quality of life instrument to estimate utility weights for cost analyses . This study was design ed to compare these algorithms in the setting of ovarian cancer . METHODS GOG-0152 was a 550-patient r and omized phase III trial of interval cytoreduction , and GOG-0172 was a 415-patient r and omized phase III trial comparing intravenous versus intraperitoneal therapy among women with advanced ovarian cancer . QOL data were collected via the FACT at four time points in each study . Two published mapping algorithms ( Cheung and Dobrez ) and a linear transformation method were applied to these data . The agreement between measures was assessed by the concordance correlation coefficient ( r(CCC ) ) , and paired t-tests were used to compare means . RESULTS While agreement between the estimation algorithms was good ( ranged from 0.72 to 0.81 ) , there were statistically significant ( p<0.001 ) and clinical ly meaningful differences between the scores : mean scores were higher with Dobrez than with Cheung or the linear transformation method . Scores were also statistically significantly different ( p<0.001 ) between studies . CONCLUSIONS In the absence of prospect ively collected utility data , the use of mapping algorithms is feasible , however , the optimal algorithm is not clear . There were significant differences between studies , which highlight the need for validation of these algorithms in specific setting s. If cost analyses incorporate mapping algorithms to obtain utility estimates , investigators should take the variability into account Background . Currently there are no reported cancer-specific health state valuations in low- and middle-income countries using a vali date d preference-based measure . The EORTC-8D , a cancer-specific preference-based measure , has 81,920 health states and is useful for economic evaluations in cancer care . The aim of this study was to develop a utility algorithm to value EORTC-8D health states using preferences derived from a representative population sample in Sri Lanka . Methods . The time-tradeoff method was used to elicit preferences from a general population sample of 780 in Sri Lanka . A block design of 85 health states , with a time horizon of 10 years , was used for the direct valuation . Data were analyzed using generalized least squares with r and om effects . All respondents with at least one logical inconsistency were excluded from the analysis . Results . After logical inconsistencies were excluded , 4520 observations were available from 717 respondents for the analysis . The preferred model specified main effects with an interaction term for any level 4 or worse descriptor within a health state . Worsening of physical functioning had a substantially greater utility decrement than any other dimension in this population . Limitations are that the data collection could not include the whole country and that females formed a large part of the sample . Conclusions . Preference weights for EORTC-8D health states for Sri Lanka have been derived : These will be very useful in economic evaluations of cancer-related interventions in a range of low- and middle-income countries Background The aim of the study was to develop a menopause-specific , preference-based health-related quality -of-life ( HRQoL ) index reflecting both menopausal symptoms and potential side-effects of Hormone Replacement Therapy ( HRT ) . Methods The study had three phases : the development of a health state classification , a prospect i ve valuation survey and the estimation of a model to interpolate HRQoL indices for all remaining health states as defined by the classification . A menopausal health state classification was developed with seven dimensions : hot flushes , aching joints/muscles , anxious/frightened feelings , breast tenderness , bleeding , vaginal dryness and undesirable and rogenic signs . Each dimension contains between three and five levels and defines a total of 6,075 health states . A sample of OUTPUT:

Conclusion Various methods have been used at all stages of CSPBM development . The choice between developing a classification system de novo or from an existing instrument may depend on the availability of a suitable existing measure , while the choice between a decomposed or composite approach appears to be determined primarily by the purpose for which the instrument is design ed .

MS2_dynamic_1_shot572

***TASK*** the task is to summarize an input biomedical literature 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 previous study of 225 patients with sick-sinus syndrome r and omised to either single-chamber atrial pacing ( n=110 ) or single-chamber ventricular pacing ( n=115 ) , we found that after a mean follow-up of 3.3 years , atrial pacing was associated with significantly less atrial fibrillation and thromboembolism whereas there was no significant difference in mortality and heart failure between the two groups . We aim ed to find out whether this beneficial effect of atrial pacing is maintained during extended follow-up of up to 8 years . METHODS Follow-up visits for all patients were at 3 months , 12 months , then once a year at which patients had a physical examination , ECG recording , and pacemaker check-up . Endpoints were mortality , cardiovascular death , atrial fibrillation , thromboembolic events , heart failure , and atrioventricular block . Data was analysed on Dec 31 , 1996 . FINDINGS At long-term follow-up , 39 patients from the atrial group had died versus 57 from the ventricular group ( relative risk 0.66 [ 95 % CI 0.44 - 0.99 ] ; p=0.045 ) . 19 patients from the atrial group and 39 patients from the ventricular group died from a cardiovascular cause ( 0.47 [ 0.27 - 0.82 ] ; p=0.0065 ) . The cumulative incidences of atrial fibrillation and chronic atrial fibrillation were also significantly lower in the atrial group than in the ventricular group ( 0.54 [ 0.33 - 0.89 ] , p=0.012 and 0.35 [ 0.16 - 0.76 ] , p=0.004 , respectively ) . Thromboembolic events occurred in 13 patients in the atrial group and 26 in the ventricular group ( 0.47 [ 0.24 - 0.92 ] , p=0.023 ) . Heart failure was less severe in the atrial group than in the ventricular group ( p<0.05 ) . In multivariate analysis , atrial pacing was significantly associated with freedom from thromboembolic events ( 0.47 [ 0.24 - 0.92 ] , p=0.028 ) and survival from cardiovascular death ( 0.52 [ 0.30 - 0.91 ] , p=0.022 ) , but no longer with overall survival ( 0.71 [ 0.46 - 1.08 ] , p=0.11 ) or chronic atrial fibrillation ( 0.45 [ 0.20 - 1.05 ] , p=0.063 ) . Atrioventricular block occurred in four patients in the atrial group ( 0.6 % annual risk ) . INTERPRETATION The beneficial effect of atrial pacing found in our previous study is enhanced substantially over time . Patients with sick-sinus syndrome should be treated with an atrial rather than ventricular-pacing system because after long-term follow-up , atrial pacing is associated with a significantly higher survival , less atrial fibrillation , fewer thromboembolic complications , less heart failure , and a low-risk of atrioventricular block OBJECTIVES To evaluate the long-term functional and hemodynamic effects of right ventricular outflow tract ( RVOT ) pacing by comparison with right ventricular apical ( RVA ) pacing . BACKGROUND Acute studies have suggested that RVOT pacing could significantly improve cardiac performance in comparison with RVA pacing but no data are available in chronically implanted patients . METHODS Sixteen patients with chronic atrial tachyarrhythmia and complete AV block were included . Left ventricular ejection fraction ( LVEF ) was > or = 40 % in ten and < 40 % in six . Patients were implanted with a st and ard DDDR pacemaker connected to two ventricular leads . A screw-in lead was placed at the RVOT and connected to the atrial port . A second lead was positioned at the RVA and connected to the ventricular port . Right ventricular outflow tract and RVA pacing was achieved by programming either the AAIR or the VVIR mode respectively . Four months later patients were r and omized so as to undergo either RVOT or RVA pacing for three months according to a blind crossover protocol . Apart from the pacing mode , programming remained unchanged throughout the study . At the end of each period , NYHA class , LVEF , exercise time and maximal oxygen uptake were assessed . RESULTS No significant difference was observed between the two modes for all the parameters analyzed . These identical results were observed in all patients globally , in patients with LVEF > or = 40 % as in those with LVEF < 40 % . CONCLUSIONS Within the limits of this study , no symptomatic improvement or hemodynamic benefit was noted after three months of RVOT pacing , by comparison with RVA pacing Background Dual‐chamber ( DDDR ) pacing preserves AV synchrony and may reduce heart failure ( HF ) and atrial fibrillation ( AF ) compared with ventricular ( VVIR ) pacing in sinus node dysfunction ( SND ) . However , DDDR pacing often results in prolonged QRS duration s ( QRSd ) as the result of right ventricular stimulation , and ventricular desynchronization may result . The effect of pacing‐induced ventricular desynchronization in patients with normal baseline QRSd is unknown . Methods and Results Baseline QRSd was obtained from 12‐lead ECGs before pacemaker implantation in MOST , a 2010‐patient , 6‐year , r and omized trial of DDDR versus VVIR pacing in SND . Cumulative percent ventricular paced ( Cum%VP ) was determined OUTPUT: R and omized-controlled trials provided inconclusive results with respect to exercise capacity , functional class , quality of life , and survival . INPUT: Background —Atrioventricular nodal radiofrequency ablation ( AVNA ) with permanent ventricular pacing can be used to control rate in patients with atrial fibrillation ( AF ) . However , long-term outcomes after AVNA are uncertain , especially in light of irreversible pacemaker dependence . Methods and Results —We examined 9122 consecutive patients with AF . The outcomes in 453 patients with AVNA ( 26 % of whom underwent an implantable cardiac defibrillator implant and 37 % underwent cardiac resynchronization therapy implant ) were compared with AF patients without AVNA after propensity score 1:1 matching . During follow-up in the propensity-matched cohort ( 2.41±3.23 years , median 1.23 , quartiles 0.33–3.12 ) , 100 patients died ( yearly rate of death 6.6 % ) . Mode of death was available in 86 % of patients , which was cardiovascular in 67 % of the patients ( related to heart failure in 38 % , sudden death in 5 % , and other cardiovascular reason in 24 % ) and noncardiovascular in 33 % . AVNA in patients with AF was associated with a lower risk of mortality ( odds ratio 0.47 , 95 % confidence interval , 0.29–0.77 ; P=0.003 ) , a lower risk of cardiovascular mortality ( odds ratio = 0.41 , 95 % confidence interval 0.23–0.73 ; P=0.003 ) , and nonsignificant lower risk of stroke and thromboembolic events ( odds ratio = 0.61 , 95 % confidence interval 0.36–1.06 ; P=0.08 ) . Conclusions —In sick AF patients with multiple comorbidities , AVNA with permanent ventricular pacing for rate control seems safe during follow-up and may be associated with lower mortality Background —Cardiac resynchronization ( CRT ) prolongs survival in patients with systolic heart failure and QRS prolongation . However , most trials excluded patients with permanent atrial fibrillation . Methods and Results —The Resynchronization for Ambulatory Heart Failure Trial ( RAFT ) r and omized patients to an implantable cardioverter defibrillator ( ICD ) or ICD+CRT , stratified by the presence of permanent atrial fibrillation . Patients with permanent atrial fibrillation were r and omized to CRT-ICD ( n=114 ) or ICD ( n=115 ) . Patients receiving a CRT-ICD were similar to those receiving an ICD : age ( 71.6±7.3 versus 70.4±7.7 years ) , left ventricular ejection fraction ( 22.9±5.3 % versus 22.3±5.1 % ) , and QRS duration ( 151.0±23.6 versus 153.4±24.7 ms ) . There was no difference in the primary outcome of death or heart failure hospitalization between those assigned to CRT-ICD versus ICD ( hazard ratio , 0.96 ; 95 % CI , 0.65–1.41 ; P=0.82 ) . Cardiovascular death was similar between treatment arms ( hazard ratio , 0.97 ; 95 % CI , 0.55–1.71 ; P=0.91 ) ; however , there was a trend for fewer heart failure hospitalizations with CRT-ICD ( hazard ratio , 0.58 ; 95 % CI , 0.38–1.01 ; P=0.052 ) . The change in 6-minute hall walk duration between baseline and 12 months was not different between treatment arms ( CRT-ICD : 19±84 m versus ICD : 16±76 m ; P=0.88 ) . Patients treated with CRT-ICD showed a trend for a greater improvement in Minnesota Living with Heart Failure score between baseline and 6 months ( CRT-ICD : 41±21 to 31±21 ; ICD : 33±20 to 28±20 ; P=0.057 ) . Conclusions — Patients with permanent atrial fibrillation who are otherwise CRT c and i date s appear to gain minimal benefit from CRT-ICD compared with a st and ard ICD . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00251251 BACKGROUND Controlled clinical trial data are lacking for cardiac resynchronization therapy ( CRT ) outcomes in patients with advanced heart failure ( HF ) from reduced left ventricular ejection fraction ( HFrEF ) and intermittent atrial fibrillation or flutter ( IAF/AFL ) . OBJECTIVE The purpose of this study was to describe CRT outcomes in patients with IAF/AFL and advanced HF . METHODS HF outcomes in patients in the COMPANION ( Comparison of Medical Therapy , Pacing , and Defibrillation in Heart Failure ) trial with New York Heart Association class III or IV HFrEF , left ventricular ejection fraction ≤0.35 , sinus rhythm at r and omization , and no history of baseline arrhythmia were compared with those with a history of IAF/AFL . RESULTS In those with no history of baseline arrhythmia ( n = 887 ) , compared with optimal pharmacological therapy ( OPT ) with no CRT , the CRT + OPT arms exhibited a significant reduction in the end points of death or any hospitalization ( hazard ratio [ HR ] 0.73 [ 95 % Confidence Interval ( CI ) : 0.60 to 0.89 ] ; P = .002 ) and death or HF hospitalization ( HR 0.53 [ 95 % CI : 0.41 to 0.68 ] ; P < .0 OUTPUT:

Conclusion The results of our meta- analysis suggest that AF was associated with decreased CRT benefits in patients with HF . CRT , however , benefits patients with AF with AVJ ablation

MS2_dynamic_1_shot573

***TASK*** the task is to summarize an input biomedical literature 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 Physical inactivity and sedentary lifestyles are known to predispose to overweight and obesity . These lifestyles are also known to track from childhood into adulthood with consequent cardiovascular and metabolic problems . This study aim ed to describe the frequency of physical activity and the relationship between physical activity and body mass index of urban Nigerian school children and adolescents . Methods Children from seven schools in Abeokuta , southwest Nigeria were selected using a multi-staged r and om sampling technique . Results Of 570 children , 411 ( 72.1 % ) were involved in moderate to vigorous physical activities . Involvement in physical activity was higher in older children ( P<0.001 ) , males ( P<0.001 ) , and children of mothers with a higher educational level ( P=0.03 ) . Eleven ( 1.9 % ) children were overweight or obese whereas 163 ( 28.6 % ) were underweight . There were more children with underweight than overweight among the subject population with a high level of physical activity ( 35.6 % vs. 4.4 % , P=0.499 ) . Conclusions A large proportion of the children in urban Nigeria participate in physical activity . The prevalence of overweight and obesity is low but undernutrition is a major nutritional problem among these children The present study examines the effect of animal- source -food ( ASF ) intake on arm muscle area growth as part of a larger study examining causal links between ASF intake , growth rate , physical activity , cognitive function and micronutrient status in Kenyan schoolchildren . This r and omised , controlled feeding intervention study was design ed with three isoenergetic feeding interventions of meat , milk , and plain traditional vegetable stew ( githeri ) , and a control group receiving no snack . A total of twelve elementary schools were r and omly assigned to interventions , with three schools per group , and two cohorts of 518 and 392 schoolchildren were enrolled 1 year apart . Children in each cohort were given feedings at school and studied for three school terms per year over 2 years , a total of 9 months per year : cohort I from 1998 to 2000 and cohort II from 1999 to 2001 . Food intake was assessed by 24 h recall every 1 - 2 months and biochemical analysis for micronutrient status conducted annually ( in cohort I only ) . Anthropometric measurements included height , weight , triceps skinfold ( TSF ) and mid-upper-arm circumference ( MUAC ) . Mid-upper-arm muscle area ( MAMA ) and mid-upper-arm fat area ( MAFA ) were calculated . The two cohorts were combined for analyses . The meat group showed the steepest rates of gain in MUAC and MAMA over time , and the milk group showed the next largest significant MUAC and MAMA gain compared with the plain githeri and control groups ( P < 0.05 ) . The meat group showed the least increase in TSF and MAFA of all groups . These findings have implication s for increasing micronutrient intake and lean body mass in primary schoolchildren consuming vegetarian diets AIM To investigate the determinants of overweight and obesity among 10- to 15-year-old schoolchildren in a population in the transitional phase in the North West Province of South Africa . METHODS A cross-sectional survey was used to investigate weight status ( anthropometric indicators ) and determinants of overweight/obesity including dietary intake , physical activity and socio-economic status . A single , r and om sample ( n=1257 ) , stratified for gender , type of school and ethnic group , was used . Data were collected on demographics , family circumstances , habitual physical activity , dietary intake and anthropometry to evaluate weight status and body fat content . One-way analysis of variance , the generalised linear models procedure of SAS and the Tukey post hoc honest significant difference test were used to analyse the data . RESULTS Few children were overweight or obese ( 7.8 % ) according to International Obesity Task Force ( IOTF ) st and ards ( body mass index ( BMI ) -for-age ) . These st and ards were compared with other accepted st and ard values . Both Cole 's IOTF/ BMI -for-age st and ard and the sum of skinfold thicknesses st and ard classified normal-weight status similarly at a level of 92 % ( P<0.01 ) and were found to be useful in determining overweight/obesity . The prevalence rate was higher in females and white children , and was more apparent in urban areas , smaller households and children of parents with low- or high-income occupations . Boys and pre-menarcheal girls had mean body fat percentage in the normal/optimal range , whereas that of post-menarcheal girls was moderately high . Few variables showed a significant association with high body fat percentage : in boys , only the number of members in the household and physical activity levels over the weekend ; in girls , only age . The overweight/obese boys mostly lived in smaller households , and the overweight/obese post-menarcheal girls were most inactive on both weekdays and weekends , and more overweight with increasing age . CONCLUSION Smaller households , inactivity and increasing age for girls were found to be determinants that influence the development of overweight/obesity , while female gender and age post-menarche were identified as determinants of higher body fat content . For overweight/obesity prevention , the focus should be on pre-menarcheal girls , aged 10 - 13 years , using these determinants to identify overweight/obesity risk . Preventive programmes should aim to increase the physical activity of children to improve their current and future weight status An epidemiological assessment of blood pressure determinants in a r and om sample of 254 Nigerian adolescents aged 6 - 17 years in Benin City , Nigeria , was conducted . None of the adolescents reported cigarette smoking . Only 2.6 % of the males and 0 % of the females were alcohol users . Socio- OUTPUT: Quantitative synthesis revealed a trend towards increasing proportions of overweight/obesity over time in school-aged children in this region , as well as a persistent problem of underweight . Body composition measures were found to be higher in girls than boys , and higher in urban living and higher socioeconomic status children compared to rural population s or those of lower socioeconomic status . This review provides evidence for an overweight/obesity transition in school-aged children in Sub Saharan Africa . INPUT: INTRODUCTION We aim ed to determine the risk factors associated with abdominal obesity ( AO ) in suburban adolescents . METHODS This cross-sectional study included adolescents aged 15 - 17 years from five r and omly selected secondary schools in the Hulu Langat district of Selangor state , Malaysia . Waist circumference ( WC ) was measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest . Information on sociodemographic data , dietary habits , physical activity levels and duration of sleep was obtained via interviewer-administered question naires . Participants ' habitual food intake was determined using a 73-item Food Frequency Question naire . RESULTS Among 832 participants , 56.0 % were girls ; 48.4 % were Malay , 40.5 % Chinese , 10.2 % Indian and 0.8 % of other ethnic groups . Median age and WC were 16 ( interquartile range [ IQR ] 15 - 16 ) years and 67.9 ( IQR 63.0 - 74.6 ) cm , respectively . Overall prevalence of AO ( > 90th percentile on the WC chart ) was 11.3 % . A higher proportion ( 22.4 % ) of Indian adolescents were found to have AO compared with Malay and Chinese adolescents . Logistic regression analysis showed that female gender ( adjusted odds ratio [ OR ] 7.064 , 95 % confidence interval [ CI ] 2.087 - 23.913 ; p = 0.002 ) , Indian ethnicity ( adjusted OR 10.164 , 95 % CI 2.182 - 47.346 ; p = 0.003 ) , irregular meals ( adjusted OR 3.193 , 95 % CI 1.043 - 9.774 ; p = 0.042 ) and increasing body mass index ( BMI ) ( adjusted OR 2.867 , 95 % CI 2.216 - 3.710 ; p < 0.001 ) were significantly associated with AO . CONCLUSION AO was common among Malaysian adolescents . Female gender , Indian ethnicity , irregular meals and increasing BMI were significant risk factors The relationship between dietary intake and obesity is complex , and dietary pattern analysis may offer new insight . We examined associations between dietary patterns identified in a diverse cohort of adolescents and weight status cross-sectionally and over a 5-year period . Project EAT ( Eating Among Teens ) ( Time 1 ) collected data on 4746 middle ( younger cohort ) and high school ( older cohort ) students in 1998 - 9 . EAT-II ( Time 2 ) resurveyed 2516 of the original cohort in 2003 - 4 . All analyses were run separately by age cohort and sex . The relationship between dietary patterns identified previously ( vegetable , fruit , vegetable & fruit , starchy food , sweet & salty snack food , and fast food ) and weight status was examined using logistic regression . All analyses were adjusted for socioeconomic status , race/ethnicity and activity level ( longitudinal analyses were also adjusted for baseline weight status ) . In cross-sectional analyses , higher adherence to dietary patterns loading heavily on vegetables was associated with lower risk of overweight/obese weight status in older and younger girls , whereas higher adherence to a ' sweet & salty snack food ' pattern was associated with lower risk in older and younger boys . These associations were found prospect ively in older boys and girls , but were no longer significant in analyses adjusting for baseline weight status . We did not find consistent or intuitive associations between dietary patterns and weight status . Identified patterns may not capture the elements of diet that are truly important in determining adolescent weight , or diet may not be the primary driver in determining weight status at this age . Method ological difficulties in assessing diet must also be taken into consideration Unhealthy dietary pattern increases the risk of obesity and metabolic disorders in growing children and adolescents . However , the way the habitual pattern of breakfast consumption influences body composition and risk of obesity in adolescents is not well defined . Thus , the aim of the present study was to assess any associations between breakfast consumption practice s and body composition profiles in 236 apparently healthy adolescents aged 12 to 19 years . A self-administered question naire on dietary behaviour and lifestyle practice s and a dietary food frequency question naire were used . Body composition and adiposity indices were determined using st and ard anthropometric measurement protocol s and dual energy χ-ray absorptiometry ( DXA ) . Mean age of the participants was 15.3±1.9 years . The majority of participants ( 71.2 % ) fell in the normal body mass index ( BMI ) ranges . Breakfast consumption patterns showed that only half of the participants ( 50 % ) were consuming breakfast daily . Gender-specific multivariate analyses ( ANCOVA ) showed that in both boys and girls , those eating breakfast at least 5 times a week had significantly lower body weight , body mass index ( BMI ) , BMI z-scores , waist circumference , body fat mass and percent body fat ( % BF ) compared to infrequent breakfast eaters , after adjustment for age , household income , pubertal status , eating-out and snacking practice s , daily energy intakes , and daily physical activity levels . The present findings indicate that infrequent breakfast consumption is associated with higher body adiposity and abdominal obesity . Therefore , daily breakfast consumption with healthy food choices should be encouraged in growing children and adolescents to prevent adiposity during these critical years of growth INTRODUCTION Paediatric obesity is a public health concern worldwide as it can track into adulthood and increase the risk of adult morbidity and mortality . While the aetiology of obesity is multi-factorial , OUTPUT:

The studies showed that obese and overweight adolescents consume significantly more energy and macronutrients . They are also more likely to skip their daily meals compared to their normal weight peers . In most studies , the direction of the PA effect on body weight was unclear . Some studies found that higher PA is associated with a lower risk of overweight and obesity . Conclusions This review identified a lack of evidence and well-conducted prospect i ve studies on the effect of diet and PA on cardio-metabolic health of Malaysian adolescents

MS2_dynamic_1_shot574

***TASK*** the task is to summarize an input biomedical literature 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: Obesity and type 2 diabetes ( T2D ) are associated with abnormal cardiovascular autonomic function and increased risk for cardiac complications , especially after exercise . Since improvements at rest are not always observed after training , we investigated changes in resting and post-exercise autonomic function in obese women with and without T2D after16-week of walking training . Heart rate ( HR ) variability ( HRV ) and baroreflex sensitivity ( BRS ) were measured at rest and 20 min after a 20 min bout of treadmill exercise at 65 % VO2 peak in obese women with ( n = 8) and without T2D ( n = 12 ) before and after training . HRV was analyzed by frequency-domain [ high- ( HF ) power and low-frequency ( LF ) ] and BRS by the sequence method . Exercise training induced similar significant changes in VO2 peak , resting systolic blood pressure ( SBP ) and post-exercise autonomic function in both groups . Training increased VO2 peak ( 6 % ; P < 0.01 ) and decreased resting SBP ( 8 % ; P < 0.001 ) . Increased post-exercise HR recovery ( 5 % ; P < 0.001 ) , HF power ( 14 % ; P < 0.05 ) , LF power ( 14 % ; P < 0.05 ) and BRS ( 86 % ; P < 0.001 ) were also observed . Resting autonomic function and post-exercise SBP were not altered after training . In conclusion , endurance training reduced blood pressure without changes in HRV and BRS at rest , but training increased HRV and BRS during the recovery of acute endurance exercise indicating an improved post-exercise autonomic modulation of HR , which was similar in obese women with and without T2D Aims /hypothesisGait characteristics and balance are altered in diabetic patients . Little is known about possible treatment strategies . This study evaluates the effect of a specific training programme on gait and balance of diabetic patients . Methods This was a r and omised controlled trial ( n = 71 ) with an intervention ( n = 35 ) and control group ( n = 36 ) . The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening ( twice weekly over 12 weeks ) . Controls received no treatment . Individuals were allocated to the groups in a central office . Gait , balance , fear of falls , muscle strength and joint mobility were measured at baseline , after intervention and at 6-month follow-up . Results The trial is closed to recruitment and follow-up . After training , the intervention group increased habitual walking speed by 0.149 m/s ( p < 0.001 ) compared with the control group . Patients in the intervention group also significantly improved their balance ( time to walk over a beam , balance index recorded on Biodex balance system ) , their performance-oriented mobility , their degree of concern about falling , their hip and ankle plantar flexor strength , and their hip flexion mobility compared with the control group . After 6 months , all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength . Two patients developed pain in their Achilles tendon : the progression for two related exercises was slowed down . Conclusions /interpretationSpecific training can improve gait speed , balance , muscle strength and joint mobility in diabetic patients . Further studies are needed to explore the influence of these improvements on the number of reported falls , patients ’ physical activity levels and quality of life . Trial registration : Clinical Trials.gov NCT00637546 Funding : This work was supported by the Swiss National Foundation ( SNF ) : Objective : The objective of this study was to eluci date whether the degree of autonomic modulation is associated with the degree of microvascular complications in patients with type 1 diabetes . Methods : A total of 290 type 1 individuals with diabetes were r and omly recruited during normal visits to outpatient clinics at 4 Danish hospitals . The degree of autonomic modulations was quantified by measuring heart rate variability ( HRV ) during passive spectral analysis and active tests ( valsalva ratio [ VT ] , response to st and ing [ RT ] , and deep breathing [ E : I ] ) . To describe possible associations between severity of microvascular complications and measures of autonomic modulation , multivariate analysis was performed . Results : After adjusting for diabetes duration , sex , age , pulse pressure , heart rate , and smoking , autonomic dysfunction remained significantly correlated with severity of retinopathy , nephropathy , and peripheral neuropathy in individuals with type 1 diabetes patients . Conclusions : Autonomic dysfunction is present in early stages of retinopathy , nephropathy , and peripheral neuropathy in patients with type 1 diabetes BACKGROUND Diabetes is the most important cause of peripheral neuropathy ( DPN ) . No definitive treatment for DPN has been established , and very few data on the role of exercise training on DPN have been reported . AIM OF THE STUDY We sought to examine the effects of long-term exercise training on the development of DPN in both Types 1 and 2 diabetic patients . PARTICIPANTS AND METHODS Seventy-eight diabetic patients without signs and symptoms of peripheral DPN were enrolled , r and omized , and subdivided in two groups : 31 diabetic participants [ 15 f , 16 m ; 49+/-15.5 years old ; body mass index ( BMI ) = 27.9+/-4.7 ] , who performed a prescribed and supervised 4 h/week brisk walking on a treadmill at 50 % to 85 % of the heart rate reserve ( exercise group : EXE ) , and a control group of 47 diabetic participants ( CON ; 24 f , 23 m ; 52.9+/-13.4 years old ; BMI = OUTPUT: Physical exercise has become a therapy for T2DM , because it improves physical fitness and functional capacity , enhances metabolic control and insulin sensitivity , reduces inflammatory markers and neuropathy symptoms and can increase the regenerative capacity of cutaneous axons , slowing or preventing neuropathy progression . However , it is not clear to what extent physical exercise can improve HRV in this population . Weekly frequency might be the most important factor to improve HRV . These aspects could help to design better programs based in scientific evidence , incorporating HRV as an important variable associated with diabetic neuropathy and mortality INPUT: Background : This study aim ed to determine whether morbidly obese women have an alteration of heart rate ( HR ) kinetics and HR variability ( HRV ) during the 6-min walk test ( 6MWT ) and if an aerobic exercise training can modify these indexes after gastric bypass surgery ( GBS ) . Design and methods : Nineteen morbidly obese women were r and omized to a trained ( TG ) or control group and 12 women of eutrophic group ( EG ) were also evaluated . The obese women were tested on two occasions : 1 week before and 4 months after GBS through record of HR and R-R intervals during 6MWT for analysis HR kinetics . The TG underwent an aerobic exercise training program on a treadmill ( 1-h session , totaling 36 sessions over 12-week ) . Results : Both obese groups demonstrated a significant reduction of rMSSD and slower HR kinetics during the 6MWT when compared to the EG . In addition , only the TG demonstrated a significant improvement in HRV indexes , walking distance , faster time constant and mean response time of HR during 6MWT after training ( p < 0.05 ) . Conclusion : Morbidly obese women have slower HR kinetics and altered cardiac modulation during submaximal exercise . However , aerobic exercise training can produce beneficial adaptations in HRV and faster HR kinetics following GBS . Implication s for Rehabilitation The obesity is one of the most important threats to health in developed countries and bariatric surgery is an option for treatment of morbid obesity . Exercise is an effective means of improving health after this procedure due alterations of autonomic nervous system in this population . This study showed that a program of aerobic physical training after bariatric surgery was able to improve the kinetics of heart rate and the cardiac autonomic modulation , both evaluated during submaximal exercise Background Patients undergoing bariatric surgery do not seem to increase objective ly measured physical activity ( PA ) after surgery , despite substantial weight loss . The aims of the present study were ( i ) to objective ly characterize 3 months pre-surgery to 9 months postsurgery PA and sedentary behavior changes in women undergoing Roux-en-Y gastric bypass ( RYGB ) using tri-axial accelerometers and ( ii ) to examine associations between pre-surgery versus postsurgery PA and sedentary behavior with anthropometric measures taken in home environment . Methods Fifty-six women , with an average pre-surgery body mass index ( BMI ) of 37.6 ( SD 2.6 ) and of age 39.5 years ( SD 5.7 ) , were recruited at five Swedish hospitals . PA was measured for 1 week by the Actigraph GT3X+ accelerometer , and anthropometric measures were taken at home visits 3 months pre-surgery and 9 months postsurgery , thus limiting seasonal effects . Results Average BMI loss , 9 months postsurgery , was 11.7 ( SD 2.7 ) BMI units . There were no significant pre- to postsurgery differences in PA or sedentary behavior . However , pre-surgery PA showed negative association with PA change and positive association with postsurgery PA . Adjustments for pre-surgery BMI had no impact on these associations . Conclusions No significant differences were observed in objective ly measured changes in PA or time spent sedentary from 3 months pre-surgery to 9 months postsurgery among women undergoing RYGB . However , women with higher pre-surgery PA decreased their PA postsurgery while women with lower pre-surgery PA increased their PA OBJECTIVES To estimate the magnitude of small meaningful and substantial individual change in physical performance measures and evaluate their responsiveness . DESIGN Secondary data analyses using distribution- and anchor-based methods to determine meaningful change . SETTING Secondary analysis of data from an observational study and clinical trials of community-dwelling older people and subacute stroke survivors . PARTICIPANTS Older adults with mobility disabilities in a strength training trial ( n=100 ) , subacute stroke survivors in an intervention trial ( n=100 ) , and a prospect i ve cohort of community-dwelling older people ( n=492 ) . MEASUREMENTS Gait speed , Short Physical Performance Battery ( SPPB ) , 6-minute-walk distance ( 6MWD ) , and self-reported mobility . RESULTS Most small meaningful change estimates ranged from 0.04 to 0.06 m/s for gait speed , 0.27 to 0.55 points for SPPB , and 19 to 22 m for 6MWD . Most substantial change estimates ranged from 0.08 to 0.14 m/s for gait speed , 0.99 to 1.34 points for SPPB , and 47 to 49 m for 6MWD . Based on responsiveness indices , per-group sample sizes for clinical trials ranged from 13 to 42 for substantial change and 71 to 161 for small meaningful change . CONCLUSION Best initial estimates of small meaningful change are near 0.05 m/s for gait speed , 0.5 points for SPPB , and 20 m for 6MWD and of substantial change are near 0.10 m/s for gait speed , 1.0 point for SPPB , and 50 m for 6MWD . For clinical use , substantial change in these measures and small change in gait speed and 6MWD , but not SPPB , are detectable . For research use , these measures yield feasible sample sizes for detecting meaningful change The purpose of this study was to determine whether pre- to postoperative increases in physical activity ( PA ) are associated with weight loss and health-related quality of life ( HRQoL ) following bariatric surgery . Participants were 199 Roux-en-Y gastric bypass ( RYGB ) surgery patients . The International Physical Activity Question naire ( IPAQ ) was used to categorize participants into three groups according to their OUTPUT:

No relationship was identified between changes in weight and walking performance post-surgery .

MS2_dynamic_1_shot575

***TASK*** the task is to summarize an input biomedical literature 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 functional differences between persons with amputation who are classified as Medicare Functional Classification Level (MFCL)-2 and -3 include the abilities to walk at various cadences and to negotiate environmental barriers outside the home . This study compared the effect of active microprocessor control and passive mechanical control of the prosthetic knee on function and safety in 17 subjects with transfemoral amputation ( 8 MFCL-2 and 9 MFCL-3 ) . Assessed functional tasks included hill and stair descent , an attentional dem and task , and an obstacle course . Self-reported measures included concentration , multitasking ability , and numbers of stumbles and falls . Active knee control was associated with significant improvements ( p < 0.05 ) in hill and stair gait , speed ( hills , obstacle course , and attentional dem and task ) , and ability to multitask while walking for both cohorts . MFCL-2 subjects also reported a significant reduction ( p < 0.01 ) in uncontrolled falls . Over the study , 50 % of MFCL-2 subjects and 33 % of MFCL-3 subjects transitioned to a higher MFCL . Results suggest that active knee control improves function and reduces the frequency of adverse events in a population that is at risk for falls . Use of active knee control may allow persons with amputation to exp and their functional domain , transition to a higher MFCL , and access additional prosthetic options Microprocessor-controlled prosthetic knees are cl aim ed to improve gait efficiency in transfemoral ( TF ) amputees . This hypothesis was tested in a prospect i ve r and omized crossover trial that compared the Mauch SNS knee and the C-Leg microprocessor-controlled knee in eight TF amputees . The subjects were given a 3-month acclimation period in each knee . Then , their net oxygen cost ( mL/kg/m ) was measured while they walked overground at four speeds in r and om order : 0.8 m/s , 1.0 m/s , 1.3 m/s , and self-selected walking speed ( SSWS ) . The C-Leg caused small reductions in net oxygen cost that were not statistically significant compared with the Mauch SNS at any of the walking speeds ( p > 0.190 ) . Subjects chose higher SSWSs with the C-Leg compared with the Mauch SNS ( mean + /- st and ard deviation = 1.31 + /- 0.12 m/s vs 1.21 + /- 0.10 m/s , respectively , p = 0.046 ) but did not incur higher oxygen costs ( p = 0.270 ) , which suggests greater efficiency only at their SSWS OBJECTIVE To evaluate the gait of transfemoral amputee patients using a prosthesis with a 4-bar linkage knee joint with either a mechanical swing phase control ( Otto Bock 3R20 ) or a pneumatic swing phase control ( Tehlin knee ) . DESIGN R and omized cross-over trial . SETTING Rehabilitation Department of a university hospital in The Netherl and s. PATIENTS Twenty-eight subjects with unilateral transfemoral amputation for reasons other than chronic vascular disease ; ages between 16 and 65 years and familiar with the use of the Otto Bock 3R20 knee . SELECTION PROCEDURE a consecutive sample . INTERVENTION The Otto Bock 3R20 was used by the subjects before they entered the study . The patients changed to the Tehlin knee at r and om either after 1 or 2 assessment s with the Otto Bock 3R20 . MAIN OUTCOME MEASURES Temporal and kinematic variables in gait analysis ( speed recordings were taken before and after the equipment for the measurements of the other parameters was placed on the patients ) . Subjective scores for comfortable and fast ambulation were obtained by means of 2 question naires . Question naire A consisted of multiple choice questions ( maximum score : 5 ) and questions using an 8-point rating scale ( maximum score : 7 ) . In question naire B , the patient was asked to compare the present prosthesis with the previous one . RESULTS Fast walking speed in gait analysis was higher with the Tehlin knee than with the 3R20 ( without equipment 95 % confidence interval ( CI ) .02-.09 m/sec , with equipment CI .04-.11 ) , while comfortable walking speed was not higher with the Tehlin knee ( without equipment CI -.20-.20 m/sec , with equipment CI .00-.05 ) . Symmetry of walking as regards swing phase duration was closer to 100 % with the Tehlin knee than with the 3R20 ( comf . walking CI 4 % to 19 % , fast walking CI 7 % to 17 % ) . Knee joint range of motion during swing phase was smaller with the Tehlin knee than with the 3R20 ( comf . walking CI 1.8 degrees-8.7 degrees , fast walking CI 2.0 degrees-9.5 degrees ) . Knee flexion duration during swing phase was shorter for the Tehlin knee than for the 3R20 at fast walking speed ( CI 6 - 46msec ) , while knee flexion duration from and to 10 degrees flexion was shorter for the Tehlin knee at comfortable speed ( CI 18 - 67msec ) and fast speed ( CI 20 - 64msec ) . In question naire A the amputees reported the Tehlin knee to be better for fast walking ( part A1 CI .01-.52 , part A2 CI .13-.98 ) and in question naire B for both comfortable and fast walking The C-Leg ( Otto Bock , Duderstadt , Germany ) is a microprocessor-controlled prosthetic knee that may enhance amputee gait . This intrasubject r and omized study compared the gait biomechanics of transfemoral amputees wearing the C-Leg with those wearing a common noncomputerized prosthesis , the Mauch SNS ( Ossur , Reykjavik , Icel and ) . After subjects had a 3-month acclimation OUTPUT: Fluid knee benefits and indications : Knees with hydraulic or pneumatic swing resistance are indicated for active walkers , permitting increased walking comfort , speed , and symmetry . Microprocessor knee benefits : Compared with nonmicroprocessor knees : a ) With respect to self-report indices and measures , microprocessor knees are indicated to reduce stumbles , falls , and associated frustrations as well as the cognitive dem and s of ambulation . b ) With respect to self-report indices and measures , microprocessor knees are indicated to increase confidence while walking , self-reported mobility , satisfaction , well-being , and quality of life . c ) With respect to physical performance indices and measures , microprocessor knees are indicated to increase self-selected walking speed , walking speed on uneven terrain , and metabolic efficiency during gait . Microprocessor knees for limited community ambulators : Among limited community ambulators , microprocessor knees are indicated to enable increases in level ground walking speed and walking speed on uneven terrain while substantially reducing uncontrolled falls and increasing both measured and perceived balance . INPUT: Objective : To determine whether there are changes in level walking performance for people using a powered ankle prosthesis that was tuned by an independent , manufacturer-certified prosthetist in accordance with device recommendations . Design : Intervention study with cross-over design . Setting : Laboratory . Participants : Convenience sample of 10 individuals with unilateral , transtibial amputation , and 10 age- and gender-matched control participants . Interventions : Powered ankle prosthesis ( BiOM T2 Ankle System ) . Main outcome metrics : Metabolic costs of walking , preferred walking speed . Results : There were no significant differences in oxygen consumption ( 2.9 % difference ; P = 0.606 , d = 0.26 ) , cost of transport ( ~1 % difference ; P = 0.652 , d = 0.23 ) , or preferred walking speed ( ~1 % difference ; P = 0.147 , d = 0.76 ) when using the powered ankle compared to unpowered prostheses . Secondary analyses of user characteristics revealed that participants who were classified as having the highest function ( K4 on Medicare ’s 5-point scale from K0 to K4 ) were significantly more likely to exhibit energy cost savings than those classified as having lower function ( K3 ; P = 0.014 , d = 2.36 ) . Conclusions : Participants did not demonstrate significant improvements in energetics or preferred speed when wearing a clinical ly tuned powered ankle prosthesis compared to their non-powered prostheses . Prescribers of powered devices should underst and that not all users will show an immediate reduction in energy expenditure Twenty unilateral trans-femoral amputees fitted with either the Contoured Adducted Trochanteric-Controlled Alignment Method ( CAT-CAM ) socket ( n=10 ) or the quadrilateral ( QUAD ) socket ( n=10 ) , and a “ non-amputee ” control group ( n=10 ) participated in the study . Subjects meeting the following criteria were studied : healthy males between the ages of 18 and 55 years , amputation due to non-vascular pathology , an unaffected sound limb , at least six months use of the test prosthesis , and a minimal stump length of 15 cm . Subjects ambulated in two r and omized trials separated by 20 minutes of rest at 2 assigned speeds : a pace reflecting normal walking speed ( 97 m/min=2.5 mph ) or a slower speed ( 48.5 m/min=1.25 mph ) . Heart rate ( HR ) and Oxygen uptake ( VO2 ) measured during steady state walking were analyzed via two-way ANOVA . Differences among means were further analyzed using Tukey post hoc and simple effects tests . Significant differences were observed between the control group and CAT-CAM subjects with respect to VO2 ( p < 0.05 ) and HR ( p < 0.01 ) at the slower speed . The control group and subjects using the QUAD socket also differed with respect to VO2 ( p < 0.01 ) and HR ( p < 0.01 ) at the slower pace . Faster pace required more energy expenditure ( p < 0.01 ) and produced higher HR ( p < 0.01 ) than slower speeds . At faster pace , a significantly higher energy expenditure in the QUAD than the CAT-CAM group was observed ( p<0.01 ) . It is concluded that ambulating at normal pace using the CAT-CAM socket design uses less energy than when using a QUAD socket design Abstract Purpose : The purpose of this study was to clinical ly evaluate the automatic stance-phase lock ( ASPL ) knee mechanism against participants ’ existing weight-activated braking ( WAB ) prosthetic knee joint . Method : This prospect i ve crossover study involved 10 young adults with an above-knee amputation . Primary measurements consisted of tests of walking speeds and capacity . Heart rate was measured during the six-minute walk test and the Physiological Cost Index ( PCI ) which was calculated from heart rate estimated energy expenditure . Activity was measured with a pedometer . User function and quality of life were assessed using the Lower Limb Function Question naire ( LLFQ ) and Prosthetic Evaluation Question naire ( PEQ ) . Long-term follow-up over 12 months were completed . Results : Walking speeds were the same for WAB and APSL knees . Energy expenditure ( PCI ) was lower for the ASPL knees ( p = 0.007 ) . Step counts were the same for both knees , and question naires indicated ASPL knee preference attributed primarily to knee stability and improved walking , while limitations included terminal impact noise . Nine of 10 participants chose to keep using the ASPL knee as part of the long-term follow-up . Conclusions : Potential benefits of the ASPL knee were identified in this study by functional measures , question naires and user feedback , but not changes in activity or the PEQ . Keywords : Amputee ; artificial knee joint ; energy expenditure ; prosthesis ; stance-phase control ; transfemoral amputation , stance-phase BACKGROUND Energy expenditure and walking speed are generally recommended for use as measures of status and outcome for walking . The objective of this study was to measure the physiological cost index ( PCI ) and comfort walking speed ( CWS ) at three levels of lower limb amputation : transfemoral , transtibial and Syme level , and the relationship of these physiological variables to prosthetic ambulation supported with walking aids and stump length . MATERIAL AND METHODS This study was a prospect i ve cross-sectional study .Eighty-nine individuals with lower limb amputation for reasons other than peripheral vascular disease ( PVD ) were recruited among patients at the Department of Prosthetics and Orthotics in University Clinical Center of Kosovo . PCI was assessed by five minutes of continuous indoor walking at CWS . RESULTS Significant differences were found in PCI ( F=29.87 , P < 0.001 OUTPUT:

During walking , oxygen consumption ( ml O2/kg/min ) and heart rate ( beats/min ) increased with a higher walking speed and a more proximal amputation . During walking , oxygen consumption ( ml O2/kg/min ) and heart rate ( beats/min ) increased with a higher walking speed and a more proximal amputation .

MS2_dynamic_1_shot576

***TASK*** the task is to summarize an input biomedical literature 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 split-mouth design is a popular design in oral health research . In the most common split-mouth study , each of two treatments are r and omly assigned to either the right or left halves of the dentition . The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect . However , already about 20 years ago the pitfalls of the design have been reported in the oral health literature . Yet , many clinicians are not aware of the potential problems with the split-mouth design . Further , it is our experience that most statisticians are not even aware of the existence of this design . Since most of the critical remarks appeared in the oral health literature , we argue that it is necessary to introduce the split-mouth design to a statistical audience , so that both clinicians and statisticians clearly underst and the advantages , limitations , statistical considerations , and implication s of its use in clinical trials and advise them on its use in practice Two formulations of posterior composite resin ( P-30 and Bisfil-P ) were evaluated and compared to a high-copper , dispersed-phase amalgam ( Dispersalloy ) . One hundred twenty-eight restorations were placed in 27 patients so that each patient received at least one of each material . After 3 years of clinical service , all three restorative material s produced clinical ly acceptable restorations , according to US Public Health Service and Leinfelder criteria . The amalgam restorations , however , underwent less wear ( 44 microns ) than did the posterior composite resin restorations ( 60 to 74 microns ) . Stratification of data by type of tooth , class of restoration , and size of restoration produced the same ranking of wear from lowest to highest : Dispersalloy , Bisfil-P , and P-30 . Resin restorations showed 45 % more wear in molars than in premolars , and more wear was associated with moderately sized restorations than with conservative restorations . The surface texture of restorations of composite resin with porous strontium glass filler was nearly as smooth as that of enamel and was significantly smoother than that of the restorations of composite resin with zinc glass filler or of unpolished amalgam Previous studies noted specific changes in urinary porphyrin excretion patterns associated with exposure to mercury ( Hg ) in animals and humans . In our study , urinary porphyrin concentrations were examined in normal children 8–18 years-old from a re analysis of data provided from a r and omized , prospect i ve clinical trial that was design ed to evaluate the potential health consequences of prolonged exposure to Hg from dental amalgam fillings ( the parent study ) . Our analysis examined dose-dependent correlations between increasing Hg exposure from dental amalgams and urinary porphyrins utilizing statistical models with adjustments for the baseline level ( i.e. study year 1 ) of the following variables : urinary Hg , each urinary porphyrin measure , gender , race , and the level of lead ( Pb ) in each subject ’s blood . Significant dose-dependent correlations between cumulative exposure to Hg from dental amalgams and urinary porphyrins associated with Hg body-burden ( pentacarboxyporphyrin , precoproporphyrin , and coproporphyrin ) were observed . Overall , 5–10 % increases in Hg-associated porphyrins for subjects receiving an average number of dental amalgam fillings in comparison to subjects receiving only composite fillings were observed over the 8-year course of the study . In contrast , no significant correlations were observed between cumulative exposure to Hg from dental amalgams and urinary porphyrins not associated with Hg body-burden ( uroporphyrin , heptacarboxyporphyrin , and hexacarboxyporphyrin ) . In conclusion , our study , in contrast to the no-effect results published from the parent study , further establishes the sensitivity and specificity of specific urinary porphyrins as a biomarker for low-level Hg body-burden , and also reveals that dental amalgams are a significant chronic contributor to Hg body-burden In 41 patients class 11 cavities each of the lower jaw were filled with the material s Adaptic , Concise cap , Epoxydent or amalgam . The models made from impressions were systemically measured by a coordinate measuring machine according to a procedure determined by us ( measuring error of this method about 15 micron ) . After one year the following abrasions were found : amalgam 18 micron + /- 58 micron , Adaptic 92 micron + /- 97 micron , Concise Cap 146 micron + /- 75 micron , Epoxydent 38 micron + /- 50 micron . Evaluation of the clinical examination showed that the material s Concise and Epoxydent were significantly inferior as regards border closure than amalgam and Adaptic . We determined further that a large percentage of composite filling showed visible discoloration of the borders ( Adaptic 42 % , Concise 55 % , Epoxydent 80 % ) . Many of the fillings were discolored after a year . Adaptic was highly significantly different with 31.6 % discolored fillings to both other material s ( Concise 79 % , Epoxydent 78.4 % ) Dental amalgams are a commonly used dental restorative material , and amalgams are about 50 % mercury ( Hg ) . In our study , urinary Hg levels was examined in children of age 8–18 years , with and without dental amalgam fillings , from a completed clinical trial ( parent study ) that was design ed to evaluate the potential health consequences of prolonged exposure to Hg from dental amalgam fillings . Our study was design ed to determine whether there was a significant dose-dependent correlation between increasing Hg exposure from dental amalgams and urinary Hg levels . Hg exposure depends on the size and number of teeth with dental amalgams . Overall , consistent with the results observed in the parent study , there was a statistically significant dose-dependent correlation between cumulative exposure to Hg from dental amalgams and urinary Hg OUTPUT: The investigators found no difference in adverse effects between composite and amalgam restorations . There is low- quality evidence to suggest that resin composites lead to higher failure rates and risk of secondary caries than amalgam restorations . This review reinforces the benefit of amalgam restorations and the results are particularly useful in parts of the world where amalgam is still the material of choice to restore posterior teeth with proximal caries . INPUT: The split-mouth design is a popular design in oral health research . In the most common split-mouth study , each of two treatments are r and omly assigned to either the right or left halves of the dentition . The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect . However , already about 20 years ago the pitfalls of the design have been reported in the oral health literature . Yet , many clinicians are not aware of the potential problems with the split-mouth design . Further , it is our experience that most statisticians are not even aware of the existence of this design . Since most of the critical remarks appeared in the oral health literature , we argue that it is necessary to introduce the split-mouth design to a statistical audience , so that both clinicians and statisticians clearly underst and the advantages , limitations , statistical considerations , and implication s of its use in clinical trials and advise them on its use in practice This paper examines the evidence demonstrating the effectiveness of sealants in high-caries-risk children and discusses the Research Triangle Institute/University of North Carolina 's ( RTI/UNC ) systematic review . The strict RTI/UNC protocol limited the number of sealant studies that could be included . This analysis exp and ed their criteria to permit additional methods of determining caries risk ( for example , past caries experience , less than two pairs of sound first permanent molars available/child in half-mouth design s ) and outcome measures in addition to DMFS ( that is , percent sealant retention , survival rates , cost-effectiveness , changes in salivary S. mutans levels ) . Nine clinical studies with a r and omized , half-mouth , clinical trial design and seven studies with observational study design s were included . There is good evidence that sealants can be used efficaciously and effectively in high-risk children as long as the sealant is retained . Sealants are more effective in preventing further caries and providing cost savings in a shorter time span if placed in children who have high rather than low caries risk This study aim ed to assess the in vitro efficacy of the lasers Er : YAG , Nd : YAG , and CO(2 ) operating in the low energy mode for caries prevention in pits and fissures . Forty-five caries-free enamel occlusal sections were r and omly divided into three groups : G1 - Er : YAG ( 80 mJ/2 Hz ) ; G2 - Nd : YAG Laser ( 1 W and 10 Hz ) ; and G3 - CO(2 ) Laser ( 0.4 W and 20 Hz ) . After surface treatment , the sample s were su bmi tted to challenge with acid consisting of a 10-day immersion in demineralizing ( 6 h ) and remineralizing solution ( 18 h ) . Next , enamel demineralization was quantitatively evaluated by subsurface microhardness test and polarized-light microscopy ( PLM , mm(2 ) ) and qualitatively assessed by scanning electron microscopy . The Wilcoxon test was used for comparison of each group with its own control . ANOVA ( α = 5 % ) was employed for comparison among groups , and Fisher 's LSD multiple comparison test was applied , to check the difference in means . Concerning the microhardness analyses , statistical difference between control , and experimental areas was only detected for the CO(2 ) group . Experimental values were higher than the controls . As for PLM analyses , smaller demineralized areas were measured for G2 ( Nd : YAG ) and G3 ( CO(2 ) ) compared with the control areas . In conclusion , the present findings suggest that the CO(2 ) laser should be selected in order to increase the enamel resistance to acid in pits and fissures Objective : This study was performed to assess the resin tag length penetration in enamel surface after bonding of brackets to identify which system was most efficient . Methodology : Our study was based on a more robust confocal microscopy for visualizing the resin tags in enamel . Totally , 100 extracted human first and second premolars have been selected for this study and were r and omly divided into ten groups of 10 teeth each . In Group 1 , the buccal enamel surface was etched with 37 % phosphoric acid ( 3 M ESPE ) , Group 2 with 37 % phosphoric ( Ultradent ) . In Groups 5 , 6 , and 7 , erbium , chromium-doped : Yttrium sc and ium-gallium-garnet ( Er , Cr : YSGG ) laser ( Biolase ) was used for etching the using following specifications : Group 5 ( 1.5 W/20 Hz , 15 s ) , Group 6 ( 2 W/10 Hz , 15 s ) , and Group 7 ( 2 W/20 Hz , 15 s ) . In Groups 8 , 9 , and 10 , Er , Cr : YSGG laser ( Biolase ) using same specifications and additional to this step , conventional etching on the buccal enamel surface was etched with 37 % ( 3 M ESPE ) after laser etching . In Groups 1 , 5 , 6 , 7 , 8 , 9 , and 10 3 M Unitek Transbond XT primer was mixed with Rhodamine B dye ( Sigma-Aldrich , Germany ) to etched surface and then cured for 20 s. In Group 2 , Ultradents bonding agent was mixed with Rhodamine B. In Group 3 , 3 M Unitek Transbond PLUS , Monrovia , USA , which was mixed with Rhodamine B dye ( Sigma-Aldrich , Germany ) . Group 4 , with self-etching primer ( Ultradent-Peak SE , USA ) was mixed with Rhodamine B dye ( Sigma-Aldrich , Germany ) . Later ( 3 M Unitek , Transbond XT , Monrovia USA ) [ Figure 1 ] was used to bond the modified Begg brackets ( T. P. Orthodontics ) in Groups 1 , 3 , 5 , 6 , 7 , 8 , 9 , and OUTPUT:

One study reported that laser preparation as an adjunct to acid-etching enhanced the retention rate . No significant difference in the incidence of caries was reported . And no significant differences were found in heart rates , oxygen saturation or degree of the patient dental anxiety between acid-etching and laser preparation . Conclusion The present limited evidence suggests that lasers could be an effective pretreatment method . The retention rate was similar to that of conventional acid etching .

MS2_dynamic_1_shot577

***TASK*** the task is to summarize an input biomedical literature 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: Antibiotics given perioperatively are thought to decrease the occurrence of postoperative wound infection . The duration of treatment for hip fracture surgery is empirical . This r and omized , double-blind , single-hospital clinical study was carried out to assess the effect of both antibiotic use and duration of use on wound infections in hip fracture surgery . Wound infection rates in three groups of patients were compared : those who received four doses of cefazolin ( 108 patients ) , those who received one dose of cefazolin and three doses of placebo ( 83 patients ) and those who received four placebo doses ( 121 patients ) . Results showed an infection rate of 1.6 % for the four-dose group , 2.4 % for the one-dose group and 3.7 % for the placebo group . These differences were not statistically significant , even when both treatment groups were combined and compared with the placebo group . The authors conclude that until more patients are added , empirical use of antibiotics should be continued in patients who undergo hip fracture surgery 22 patients with fractures of the femoral shaft were divided into 2 groups . One group ( 12 patients ) were given the st and ard postoperative physiotherapy and the remainder ( 10 patients ) received intensive physiotherapy . Clinical examination of the knee joint was performed 2 , 4 and 9 weeks postoperatively . The patients ' mean age was 31 years ; 15 of them were men . The fractures in 18 patients were treated with intramedullary nailing , 2 with a long-shanked Jewett nail and 2 with AO-nailing . Mobilisation and quadriceps atrophy of the injured limb of the patients given intensive physiotherapy appeared to improve faster than in the patients of the routine physiotherapy group . Nine weeks after the operation the range of knee movement had normalised in the cases given intensive physiotherapy . The flexion strength of the knee in the operated limb was close to the values for the normal limb after nine weeks , but the extension strength was still 40 - 66 % below the values for the healthy limb . The greatest increase in muscle power occurred during the first four postoperative weeks . Intensive physiotherapy seems to hasten the recovery of quadriceps strength of the patients with fractures of the femoral shaft , and to shorten the duration of sick leave of the patients operated on by closed intramedullary nailing A prospect i ve , r and omized , double-blind study was performed to evaluate the effects of antibiotic prophylaxis on the development of a wound infection in 239 patients who had immediate stabilization of a fracture of the proximal part of the femur with a dynamic hip screw . The effects of two perioperative doses of cefotiam , given twelve hours apart , were compared with those of two doses of a placebo . Sixteen perioperative risk factors were evaluated to determine whether it was possible to identify patients who were at risk for a wound infection . All patients were followed for a minimum of six weeks . Antibiotic prophylaxis significantly reduced the prevalence of wound infection ( p < 0.05 ) : the rate of major wound infection decreased from 5 to 1 per cent and the rate of minor wound infection , from 11 to 4 per cent . The most powerful predictors of major wound infection were the duration of the operation , the interval between the accident and admission to the hospital , and the duration of postoperative urinary catheterization . The preoperative level of serum albumin and the absolute lymphocyte count were significant predictors ( p < 0.05 ) of minor wound infection and systemic infection , respectively We conducted a r and omized study of 100 patients to examine the efficacy and risks of two methods of urinary-bladder management after total joint-replacement surgery . Patients who had hip or knee replacement were r and omly assigned either to Group I , in which indwelling catheters were placed during the operation and removed the next morning , or Group II , in which urinary retention was treated by intermittent catheterization as needed . After the removal of the indwelling catheter , the patients in Group I had a lower incidence of urinary retention than those in Group II ( 27 vs. 52 percent ; P less than 0.01 ) . Bladder distention ( volume above 700 ml ) was more common in Group II ( 45 percent as compared with 7 percent in Group I ; P less than 0.01 ) and was associated with an increased need for subsequent long-term catheterization . There was no significant difference between the groups in the rates of urinary tract infection ( 11 vs. 15 percent ) . We could not identify patients at high risk for retention or infection on the basis of preoperative urinary symptoms , previous urinary tract surgery , previous urinary tract infection or urinary retention , high-risk medical conditions , sex , type of anesthesia , or age ( in the absence of prophylactic treatment ) . We conclude that the short-term use of an indwelling catheter after extended surgery , such as joint replacement , reduces the incidence of urinary retention and bladder overdistention , without increasing the rate of urinary tract infection 59 elderly patients ( mean age 82 ) with femoral neck fractures were r and omised into two groups . 27 patients received daily an oral nutrition supplement ( 250 ml , 20 g protein , 254 kcal ) for a mean of 32 days ; 32 patients acted as controls . On admission most patients had nutritional deficiencies . Despite being offered adequate quantities , nutritional requirements were not met during the hospital stay . Clinical outcome was significantly better in the supplemented group ( 56 % favourable course vs 13 % in controls ) during the stay in the convalescent hospital . The rates of complications and deaths were also significantly lower in supplemented patients ( 44 % vs 87 % ) . 6 months after the fracture the rates of complications and mortality were significantly lower in supplemented patients OUTPUT: The results of these 11 studies suggest that early surgical repair ( within 24 to 48 hours ) is associated with a reduction in 1-year mortality . Evidence from cohort studies indicates that for medically stable patients who do not have active comorbid illness ( such as unstable angina ) , surgical repair of hip fracture within the first 24 to 48 hours of admission is associated with a decrease in 1-year mortality . Patients who would benefit from delay and further medical evaluation have not been well characterized . In this study , wound infection rates were lowest when antibiotics were administered 0 to 2 hours before surgery . Antibiotics seem to reduce the risk for deep-wound infections by approximately 44 % , and therapy should probably be continued for 24 hours ( that is , about 3 doses should be given ) . Published data suggest that antibiotics should be administered 0 to 2 hours before surgery . Efficacy of Thromboembolic Prophylaxis on Prevention of Deep Venous Thrombosis * The studies review ed strongly support the use of thromboembolic prophylaxis , but which agent is optimal is less clear . INPUT: The necessary duration of antibiotic administration after open fracture has not been established . In a double-blind prospect i ve trial we r and omized 248 patients with open fractures to receive one or five days of cefonicid sodium therapy or five days of cefam and ole nafate therapy as part of the initial treatment . Rates of fracture-associated infections in the three groups were ten ( 13 % ) of 79 , ten ( 12 % ) of 85 , and 11 ( 13 % ) of 84 , respectively . The 95 % confidence limit for the difference in infection rates between the one-day group and the combined five-day groups was 0 % to 8.3 % . The actual difference was 0.2 % . A brief course of antibiotic administration is not inferior to a prolonged course of antibiotics for prevention of postoperative fracture-site infections Background The optimal antibiotic regimen is still controversial in open fractures . The purpose of this study was to evaluate the efficacy of two different antibiotic regimens in management of type III-A open fractures . Methods From January 2001 to January 2008 , patients with type IIIA open fractures admitted in Shahid Beheshti Hospital Affiliated to Babol University of Medical Sciences were enrolled . Patients r and omly received cefazolin plus gentamicin ( group I ) or cefazolin plus ciprofloxacin ( group II ) . Both regimens were administered for 3 days . All patients were followed for 3 months . The efficacy of both regimens was compared . Results One hundred-forty eight and 153 patients were treated in group I and II , respectively . The mean age of the patients treated in group I was 36.96±14.4 and in group II was 36.93±13.51 years . The rate of deep infection in group I was 5.4 % and in group II was 6.5 % . The efficacy of regimen I was 94.6 % and regimen II was 93.5 % . Conclusion Cefazolin plus gentamicin , or cefazolin plus ciprofloxacin both can be successfully used for prevention of infection in type IIIA open fractures 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 OBJECTIVE The purpose of this study was to compare the efficacy of a single agent , ciprofloxacin , with that of combination antibiotic therapy consisting of cefam and ole and gentamicin in all types of open fracture wounds . STUDY DESIGN A prospect i ve double-blind r and omized clinical trial . SETTING A Level 1 trauma center . PATIENTS One hundred ninety-five consecutive patients with 203 open fractures were enrolled over a twenty-month period . Twenty-nine fractures from low-velocity gunshot wounds were excluded , and three other patients were excluded because of protocol violations . Our final number of patients were 163 , with 171 open fractures . MAIN OUTCOME MEASUREMENT The infection rates for Type I and Type II open fractures for both antibiotic groups were calculated . The infection rate of Type III open fractures for both antibiotic groups was also calculated . Chi-square analysis with Yates correction was used to assess statistical significance of two treatment groups . RESULTS The infection rate for Types I and II open fractures in the ciprofloxacin group was 5.8 percent and 6 percent for the cefam and ole/gentamicin group ( p = 1.000 ) . The infection rate for Type III open fractures for the ciprofloxacin group was 31 percent ( 8 of 26 ) versus 7.7 percent ( 2 of 26 ) for the cefam and ole/gentamicin group ( p = 0.079 ) . There were no statistically significant differences in infection rate between the group treated with ciprofloxacin and that treated with cefam and ole/gentamicin for Types I and II open fracture wounds . However , there appeared to be a high failure rate for the ciprofloxacin Type III open fracture group , with patients being 5.33 times more likely to become infected than those in the combination therapy group . Although this difference was not statistically significant , possibly because of the small sample size , there was a definite trend toward statistical significance . CONCLUSION Single-agent antibiotic therapy with ciprofloxacin is effective in treatment of Type I and Type II open fracture wounds . However , on the basis of our results , we can not recommend ciprofloxacin alone for Type III wounds . Possibly one can use fluoroquinolones in combination therapy , specifically as an alternate to an aminoglycoside 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 OUTPUT:

Results of r and omized controlled trials performed to date provide evidence that antibiotic prophylaxis reduces subsequent infection and that courses as short as one day are as effective as courses of three to five days , although the evidence warrants only low to moderate confidence .

MS2_dynamic_1_shot578

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To address the epidemic of hypertension in blacks born and living in sub-Saharan Africa , we compared in a r and omised clinical trial ( NCT01030458 ) single-pill combinations of old and new antihypertensive drugs in patients ( 30–69 years ) with uncomplicated hypertension ( 140–179/90–109 mm Hg ) . After ⩾4 weeks off treatment , 183 of 294 screened patients were assigned to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg ( n=89 ; R ) or amlodipine/valsartan 5/160 mg ( n=94 ; E ) and followed up for 6 months . To control blood pressure ( < 140/<90 mm Hg ) , bisoprolol and amlodipine could be doubled ( 10 mg per day ) and α-methyldopa ( 0.5–2 g per day ) added . Sitting blood pressure fell by 19.5/12.0 mm Hg in R patients and by 24.8/13.2 mm Hg in E patients and heart rate decreased by 9.7 beats per minute in R patients with no change in E patients ( –0.2 beats per minute ) . The between-group differences ( R minus E ) were 5.2 mm Hg ( P<0.0001 ) systolic , 1.3 mm Hg ( P=0.12 ) diastolic , and 9.6 beats per minute ( P<0.0001 ) . In 57 R and 67 E patients with data available at all visits , these estimates were 5.5 mm Hg ( P<0.0001 ) systolic , 1.8 mm Hg ( P=0.07 ) diastolic and 9.8 beats per minute ( P<0.0001 ) . In R compared with E patients , 45 vs 37 % ( P=0.13 ) proceeded to the higher dose of r and omised treatment and 33 vs 9 % ( P<0.0001 ) had α-methyldopa added . There were no between-group differences in symptoms except for ankle oedema in E patients ( P=0.012 ) . In conclusion , new compared with old drugs lowered systolic blood pressure more and therefore controlled hypertension better in native African black patients Background The efficacy of angiotensin-converting enzyme ( ACE ) inhibitors in decreasing blood pressure in African patients is controversial . Objective We examined the ambulatory blood pressure ( ABP ) response to a diuretic and an ACE inhibitor in hypertensive patients of East African descent and evaluated the individual characteristics that determined treatment efficacy . Design A single-blind r and omized AB/BA crossover design . Setting Hypertensive families of East African descent from the general population in the Seychelles . Participants Fifty-two ( 29 men and 23 women ) out of 62 eligible hypertensive patients were included . Main outcome measures ABP response to 20 mg lisinopril ( LIS ) daily and 25 mg hydrochlorothiazide ( HCT ) daily given for a 4-week period . Results The daytime systolic/diastolic ABP response to HCT was 4.9 [ 95 % confidence interval ( CI ) 1.2–8.6]/3.6 ( 1.0–6.2 ) mmHg for men and 12.9 (9.2–16.6)/6.3 ( 3.7–8.8 ) mmHg for women . With LIS the response was 18.8 (15.0–22.5)/14.6 ( 12.0–17.1 ) mmHg for men and 12.4 (8.7–16.2)/7.7 ( 5.1–10.2 ) mmHg for women . The night-time systolic/diastolic response to HCT was 5.0 (0.6–9.4)/2.7 [ (−0.4)–5.7 ] mmHg for men and 11.5 (7.1–16.0)/5.7 ( 2.6–8.8 ) mmHg for women , and to LIS was 18.7 (14.2–22.1)/15.4 ( 12.4–18.5 ) mmHg for men and 3.5 [(−1.0)–7.9]/2.3 [ (−0.8)–5.4 ] mmHg for women . Linear regression analyses showed that gender is an independent predictor of the ABP responses to HCT and to LIS . Conclusions Hypertensive patients of African descent responded better to LIS than to HCT . Men responded better to LIS than to HCT and women responded similarly to both drugs Objective : To investigate HIV , its treatment , and hypertension as stroke risk factors in Malawian adults . Methods : We performed a case-control study of 222 adults with acute stroke , confirmed by MRI in 86 % , and 503 population controls , frequency-matched for age , sex , and place of residence , using Global Positioning System for r and om selection . Multivariate logistic regression models were used for case-control comparisons . Results : HIV infection ( population attributable fraction [ PAF ] 15 % ) and hypertension ( PAF 46 % ) were strongly linked to stroke . HIV was the predominant risk factor for young stroke ( ≤45 years ) , with a prevalence of 67 % and an adjusted odds ratio ( aOR ) ( 95 % confidence interval ) of 5.57 ( 2.43–12.8 ) ( PAF 42 % ) . There was an increased risk of a stroke in patients with untreated HIV infection ( aOR 4.48 [ 2.44–8.24 ] , p < 0. OUTPUT: Fewer studies assessing combination therapy were available , but there was a trend towards superiority for CCBs plus ACE inhibitors or diuretics compared to other combinations . Evidence broadly supports current guidelines and provides a clear rationale for promoting CCBs as first-line agents and early initiation of combination therapy . INPUT: Fifty patients ( 25 Blacks and 25 Indians ) suffering from mild-to-moderate hypertension ( supine diastolic blood pressure 100 - 105 mmHg ) were studied in order to compare the antihypertensive effect of a combination of a beta-blocker ( sotalol hydrochloride 160 mg/d ) plus a thiazide derivative ( hydrochlorothiazide 25 mg/d ) ( Sotazide ; B-M ) with that of a combination of reserpine 0,1 mg/d ( Serpasil ; Ciba ) plus hydrochlorothiazide 25 mg/d ( Dichlotride ; Frosst MSD ) . The combination of reserpine plus hydrochlorothiazide was found to be as effective as that of sotalol plus hydrochlorothiazide in lowering the blood pressure in both the Black and the Indian patients . Two patients taking the combination containing reserpine developed side-effects , but this did not occur in any of those taking the combination containing sotalol . We feel that in developing countries , where the cost of therapy is important , reserpine in a dosage of less than 0,1 mg/d plus a thiazide derivative in low dosage is preferable to a beta-blocker plus a thiazide derivative in the treatment of hypertension In a double-blind study to investigate the antihypertensive effect of a fixed triple combination with 0.05 mg reserpine , 2.5 mg clopamide and 0.4 mg dihydroergocristine in comparison to a fixed double combination with 0.05 mg reserpine and 2.5 mg clopamide , a patient subgroup of 34 patients followed a unicenter ( central unit , ' institute ' ) as well as a multicenter ( established physicians ) study design . The patients visited both investigation units on the day of admission to the study ( week 0 ) , after four weeks and after eight weeks of therapy ( after the morning intake of the drugs ) . The paper in h and looks at the results of this subgroup with respect to the conformity of blood pressure values in the two investigative units . The analyses confirm the already published results of the entire study : Both combinations proved to be highly effective antihypertensive drugs . The triple combination showed therapeutical advantages for systolic blood pressure after four weeks , for diastolic pressure after eight weeks of therapy at the ' institute ' as well as , although less distinct , in the medical offices . A comparison of the individual values did not show a convincing coherence of the measurements between institute and offices . All investigated possible systematic sources of error ( different methods of measurement , days or times of measurement ) could be excluded by correlation statistics as a reason for the divergences . The results show the necessity -- particularly in multicenter studies --of a careful documentation of all accompanying data ( e.g. method or time of measurement ) as well as a greatest possible st and ardization of investigation ( e.g. identical measuring apparatus and investigator . In a double-blind , parallel , 12-week trial , antihypertensive effects of diltiazem and reserpine were compared in 107 patients with essential hypertension . Diltiazem reduced blood pressure from 176/100 mmHg to 154/86 mmHg after 12 weeks , and reserpine reduced blood pressure from 171/96 mmHg to 155/85 mmHg . The difference between diltiazem and reserpine was not statistically significant . However , among a subset of patients given 180 mg/day of diltiazem , a significantly better antihypertensive effect was achieved than among a subset given 0.3 mg of reserpine . The incidence of side effects and complications in the diltiazem group was about one half that in the reserpine group ( 12.3 % and 27.1 % , respectively ) . Side effects of diltiazem were mild , and the drug was extremely well tolerated . These results show that diltiazem is an effective antihypertensive drug for the treatment of mild to moderate essential hypertension Low-dose combination therapy has been proposed as a rational first-line approach to hypertension treatment . We compared the efficacy and tolerability of the fixed combination of reserpine ( 0.1 mg ) plus the thiazide clopamid ( 5 mg ) with its single components and the calcium-antagonist nitrendipine ( 20 mg ) in a r and omized , double-blind , parallel study of 273 hypertensive patients with diastolic blood pressure ( BP ) between 100 and 114 mm Hg . The four groups did not differ regarding baseline characteristics ( mean age , 58 years ; 51 % men ; mean BP after a 2-week placebo period , 158 to 160/103 to 104 mm Hg ) . After 6 weeks of treatment with one capsule daily , mean reductions in sitting BP from baseline at 24 hours after dosing in the reserpine-clopamid combination , reserpine , clopamid , and nitrendipine groups were -23.0/-17.1 , -14.0/-11.7 , -13.6/-11.9 , and -11.6/-12.3 mm Hg , respectively ( 2P < .01 ) . The corresponding normalization rates ( diastolic BP < 90 mm Hg ) were 55 % , 40 % , 36 % , and 33 % ( 2P = .11 ) . All patients whose BP had not been normalized at this point received two capsules of the respective medication once daily from weeks 7 to 12 . At week 12 , mean BP reductions were -25.7/-18.1 , -14.6/-12.2 , -17.7/-13.4 , and -14.9/-15.3 mm Hg in the four groups , respectively ( 2P < .01 ) . The respective normalization rates were 69 % , 35 % , 39 % , and 45 % ( OUTPUT:

Due to significant heterogeneity across trials , a significant effect in diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , and heart rate ( HR ) could not be found . The SBP effects were achieved with 0.5 mg/day or greater . AUTHORS ' CONCLUSIONS Reserpine is effective in reducing SBP roughly to the same degree as other first-line antihypertensive drugs .

MS2_dynamic_1_shot579

***TASK*** the task is to summarize an input biomedical literature 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 Fall-related injuries in older people are a leading cause of morbidity and mortality . Self-reported fall events in the last year is often used to estimate fall risk in older people . However , it remains to be investigated if the fall frequency and the consequences of the falls have an impact on the risk for subsequent injurious falls in the long term . The objective of this study was to investigate if a history of one single non-injurious fall , at least two non-injurious falls , or at least one injurious fall within 12 months increases the risk of sustaining future injurious falls . Methods Community-dwelling individuals 75–93 years of age ( n = 230 ) were initially followed prospect ively with monthly calendars reporting falls over a period of 12 months . The participants were classified into four groups based on the number and type of falls ( 0 , 1 , ≥2 non-injurious falls , and ≥1 injurious fall severe enough to cause a visit to a hospital emergency department ) . The participants were then followed for several years ( mean time 5.0 years ±1.1 ) regarding injurious falls requiring a visit to the emergency department . The And ersen – Gill method of Cox regression for multiple events was used to estimate the risk of injurious falls . Results During the long-term follow-up period , thirty per cent of the participants suffered from at least one injurious fall . Those with a self-reported history of at least one injurious fall during the initial 12 months follow-up period showed a significantly higher risk for sustaining subsequent injurious falls in the long term ( hazard ratio 2.78 ; 95 % CI , 1.40–5.50 ) compared to those with no falls . No other group showed an increased risk . Conclusions In community-dwelling people over 75 years of age , a history of at least one self-reported injurious fall severe enough to cause a visit to the emergency department within a period of 12 months implies an increased risk of sustaining future injurious falls . Our results support the recommendations to offer a multifactorial fall-risk assessment coupled with adequate interventions to community-dwelling people over 75 years who present to the ED due to an injurious fall Background Medication use is a potentially modifiable risk factor for falling ; psychotropic and cardiovascular drugs have been indicated as main drug groups that increase fall risk . However , evidence is mainly based on studies that recorded falls retrospectively and /or did not determine medication use at the time of the fall . Therefore , we investigated the associations indicated in the literature between medication use and falls , using prospect ively recorded falls and medication use determined at the time of the fall . Methods Data from the B-PROOF ( B-vitamins for the prevention of osteoporotic fractures ) study were used , concerning community-dwelling elderly aged ≥65 years . We included 2,407 participants with pharmacy dispensing records . During the 2- to 3-year follow-up , participants recorded falls using a fall calendar . Cox proportional hazard models were applied , adjusting for potential confounders including age , sex , health status variables and concomitant medication use . Results During follow-up , 1,147 participants experienced at least one fall . Users of anti-arrhythmic medication had an increased fall risk ( hazard ratio [ HR ] 1.61 ; 95 % confidence interval [ CI ] 1.12–2.32 ) compared with non-users . Similarly , non-selective beta-blocker use was associated with an increased fall risk ( HR 1.41 [ 95 % CI 1.12–1.78 ] ) , while statin use was associated with a lower risk ( HR 0.81 [ 95 % CI 0.71–0.94 ] ) . Benzodiazepine use ( HR 1.32 [ 95 % CI 1.02–1.71 ] ) , and antidepressant use ( HR 1.40 [ 95 % CI 1.07–1.82 ] ) were associated with an increased fall risk . Use of other cardiovascular and psychotropic medication was not associated with fall risk . Conclusion Our results strengthen the evidence for an increased fall risk in community-dwelling elderly during the use of anti-arrhythmics , non-selective beta-blockers , benzodiazepines , and antidepressant medication . Clinicians should prescribe these drugs cautiously and if possible choose safer alternatives for older patients OBJECTIVES To determine whether benzodiazepine use in older women increased the risk of decline in physical function . DESIGN A four-year prospect i ve cohort study . SETTING The communities of Iowa and Washington counties , Iowa . PARTICIPANTS Eight hundred eighty-five women aged 70 and older who had completed physical performance tests in 1988 and 1992 . MEASUREMENTS Benzodiazepine use was determined during in-home interviews and classified by dose , duration , indication for use , and half-life . Physical performance tests included an assessment of st and ing balance , walking speed ( 8-foot distance ) , and repeated chair raises . RESULTS Ninety ( 10.2 % ) reported benzodiazepine use at baseline . After adjustment for baseline physical performance score and potential confounders , benzodiazepine use was associated with a greater decline in physical performance over 4 years than nonuse ( beta=-1.16 ; st and ard error (SE)=0.25 ; P<.001 ) . The use of higher-than-recommended dose was related to decline ( beta=-2.26 ; SE=0.47 ; P<.001 ) , and use of lower doses was not ( beta=-0.53 ; SE=0.46 ; P=.246 ) . Long-term use ( > or=3 years ) was related to decline ( beta=-1.65 ; SE=0.34 ; P<.001 ) , whereas recent and past use were not . Similar results were obtained when restricting the sample to those without disability at baseline . CONCLUSION This study provides evidence that older women who used OUTPUT: Exposure to BZDs was associated with a higher risk of falls in older adults , which is consistent with the results reported in the literature and previous review s and meta-analyses . BZDs increase the risk of falling when used either as monotherapy or in combined therapies . It is preferable to use short-acting BZDs , to avoid cumulative effects over time predisposing to falls . A high proportion of falls in older adults are related to the use of BZDs . INPUT: A population -based sample ( N = 787 ) was followed for 8 years and assessed three times on measures of well-being ( depressive symptoms , morale , and control ) and fall history . Marginal models assessed the association between baseline well-being measures and falling . R and om effects models assessed change in well-being indicators as well as change in fall rate over 8 years . After adjustment for sociodemographics , psychotropic medication , health , and sensorimotor function , our results showed that depressive symptoms , control , and morale were risk factors for subsequent falling , and an increase in depressive symptoms or a reduction in morale was associated with an increasing fall rate . We conclude that the three well-being measures are independently associated with falling and need to be considered in fall-risk assessment s and population -based prevention and intervention strategies AIM To determine the prevalence of potentially suboptimal medication use and association with adverse outcomes . METHODS A prospect i ve , observational cohort study of 4260 community-dwelling older men from Perth , Western Australia ( mean age of 77 ± 3.6 years ) was conducted . Follow-up was for 4.5 years ( or until death , if sooner ) . Cox proportional hazard models were used to explore associations between suboptimal medication use and prospect i ve clinical outcomes . Logistic regression analyses were used to explore predictors of a fall in the previous 12 months . RESULTS Use of potentially inappropriate medicines ( 48.7 % ) , polypharmacy ( ≥5 medications , 35.8 % ) and potential under-utilization ( 56.7 % ) were highly prevalent , and overall 82.3 % of participants reported some form of potentially suboptimal medication use . A self-reported history of falls in the previous 12 months was independently associated with the number of medicines taken ( odds ratio [OR]= 1.06 , 95 % confidence interval [ CI ] 1.02 , 1.09 ) and use of one or more potentially inappropriate medicines ( OR = 1.23 , 95 % CI 1.04 , 1.45 ) . After adjusting for age , co-morbidity , smoking status , body mass index , hypertension and educational attainment , the number of medicines reported was associated with admission to hospital ( hazard ratio [HR]= 1.04 , 95 % CI 1.03 , 1.06 ) , cardiovascular events ( HR = 1.09 , 95 % CI 1.06 , 1.12 ) and all cause mortality ( HR = 1.04 , 95 % CI 1.00 , 1.07 ) . Use of one or more potentially inappropriate medicines was associated with admission to hospital ( HR = 1.16 , 95 % CI 1.08 , 1.24 ) . Potential under-utilization was associated with cardiovascular events ( HR = 1.20 , 95 % CI 1.03 , 1.40 ) . CONCLUSIONS These data suggest that both medication over-use and under-use occur frequently among older men and may be harmful PURPOSE To develop a simple screen based on easily collectable measures to identify older people living in residential care facilities at high risk of falls . METHODS This prospect i ve study was conducted in seven residential care facilities in the U.K. Residents aged>60 years who were not bedbound or terminally ill participated . Demographics , medical history , medication use , cognition ( mini mental state examination ( MMSE ) ) , function ( Barthel , balance and sit-to-st and ability ) and behavior ( neuro-psychiatric inventory ( NPI ) and impulsivity ) were recorded at baseline . Falls and injuries were prospect ively recorded over 6 months . Data were analyzed for differences between fallers and non-fallers and significant variables entered into logistic regression analysis . RESULTS Two hundred and forty residents completed the study . In the follow-up period , 50 % fell ≥1 times . Fallers had worse function , cognition , behavior and balance and took more medications . Falling in the past year , walking frame and hypnotic/anxiolytic and anti-depressant medication use were also associated with increased likelihood of falling . Logistic regression identified MMSE<17 , impulsivity score ≥ 2 , st and ing balance score<6 , requiring a walking frame , falling in the previous year and use of antidepressants and hypnotics/anxiolytics as independent and significant predictors of falls . The area under the receiver operating curve ( ROC ) for this model was 0.79 ( 95 % CI 0.73 - 0.84 ) . CONCLUSIONS This tool comprising multi-factorial measures provides a simple way of quantifying the probability with which a care home resident will fall over a 6-month period . The tool may also assist in guiding the development and targeting of interventions to prevent falls in this group Context Underst and ing and improving the quality of medication management is particularly important in the context of the Medicare prescription drug benefit that took effect last January 2006 . Objective To determine the prevalence of physician – patient dialogue about medication cost and medication adherence among elderly adults nationwide . Design Cross-sectional survey . Participants National stratified r and om sample of community-dwelling Medicare beneficiaries aged 65 and older . Main Outcome Measures Rates of physician – patient dialogue about nonadherence and cost-related medication switching . Results Forty-one percent of seniors reported taking five or more prescription medications , and more than half has 2 or more prescribing physicians . Thirty-two percent overall and 24 % of those with 3 or more chronic conditions reported not having talked with their doctor about all their different medicines in the last 12 months . Of seniors reporting skipping doses or stopping a medication because of side effects or perceived nonefficacy , 27 % had not talked with a physician about it . Of those reporting cost-related nonadherence , 39 % had not talked with a OUTPUT:

Conclusions The use of sedatives and hypnotics and antidepressants including tricyclic antidepressants , selective serotonin reuptake inhibitors , and serotonin norepinephrine reuptake inhibitors appears to be related with an increased risk of falls . It is not clear if the use of antihypertensive medications is associated with the risk of falls in older people

MS2_dynamic_1_shot580

***TASK*** the task is to summarize an input biomedical literature 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 effect of aquatic exercise and education on fall risk factors in older adults with hip osteoarthritis ( OA ) . METHOD Seventy-nine adults , 65 years of age or older with hip OA and at least 1 fall risk factor , were r and omly assigned to 1 of 3 groups : aquatics and education ( AE ; aquatic exercise twice a wk with once-a-wk group education ) , aquatics only ( A ; 2 wk aquatic exercise ) and control ( C ; usual activity ) . Balance , falls efficacy , dual-task function , functional performance ( chair st and s ) , and walking performance were measured pre- and postintervention or control period . RESULTS There was a significant improvement in fall risk factors ( full-factorial MANCOVA , baseline values as covariates ; p = .038 ) ; AE improved in falls efficacy compared with C and in functional performance compared with A and C. CONCLUSION The combination of aquatic exercise and education was effective in improving fall risk factors in older adults with arthritis OBJECTIVE To examine effects of activity strategy training ( AST ) , a structured rehabilitation program taught by occupational therapists and design ed to teach adaptive strategies for symptom control and engagement in physical activity ( PA ) . METHODS A r and omized controlled pilot trial was conducted at 4 sites ( 3 senior housing facilities and 1 senior center ) in southeastern , lower Michigan . Fifty-four older adults with hip or knee osteoarthritis ( mean + /- SD age 75.3+/-7.1 years ) participated . At each site , older adults were r and omly assigned to 1 of 2 programs : exercise plus AST ( Ex + AST ) or exercise plus health education ( Ex + Ed ) . The programs involved 8 sessions over 4 weeks with 2 followup sessions over a 6-month period , and were conducted concurrently within each site . Pain , total PA and PA intensity ( measured objective ly by actigraphy and subjectively by the Community Healthy Activities Model Program for Seniors question naire ) , arthritis self-efficacy , and physical function were assessed at baseline and posttest . RESULTS At posttest , participants who received Ex + AST had significantly higher levels of objective peak PA ( P=0.02 ) compared with participants who received Ex + Ed . Although not statistically significant , participants in Ex + AST tended to have larger pain decreases , increased total objective and subjective PA , and increased physical function . No effects were found for arthritis self-efficacy . CONCLUSION Although participants were involved in identical exercise programs , participants who received AST tended to have larger increases in PA at posttest compared with participants who received health education . Future studies will be needed to examine larger sample s and long-term effects of AST OBJECTIVE The Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) was a r and omized , single-blind clinical trial lasting 18 months that was design ed to determine whether long-term exercise and dietary weight loss are more effective , either separately or in combination , than usual care in improving physical function , pain , and mobility in older overweight and obese adults with knee osteoarthritis ( OA ) . METHODS Three hundred sixteen community-dwelling overweight and obese adults ages 60 years and older , with a body mass index of > or = 28 kg/m(2 ) , knee pain , radiographic evidence of knee OA , and self-reported physical disability , were r and omized into healthy lifestyle ( control ) , diet only , exercise only , and diet plus exercise groups . The primary outcome was self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Secondary outcomes included weight loss , 6-minute walk distance , stair-climb time , WOMAC pain and stiffness scores , and joint space width . RESULTS Of the 316 r and omized participants , 252 ( 80 % ) completed the study . Adherence was as follows : for healthy lifestyle , 73 % ; for diet only , 72 % ; for exercise only , 60 % ; and for diet plus exercise , 64 % . In the diet plus exercise group , significant improvements in self-reported physical function ( P < 0.05 ) , 6-minute walk distance ( P < 0.05 ) , stair-climb time ( P < 0.05 ) , and knee pain ( P < 0.05 ) relative to the healthy lifestyle group were observed . In the exercise group , a significant improvement in the 6-minute walk distance ( P < 0.05 ) was observed . The diet-only group was not significantly different from the healthy lifestyle group for any of the functional or mobility measures . The weight-loss groups lost significantly ( P < 0.05 ) more body weight ( for diet , 4.9 % ; for diet plus exercise , 5.7 % ) than did the healthy lifestyle group ( 1.2 % ) . Finally , changes in joint space width were not different between the groups . CONCLUSION The combination of modest weight loss plus moderate exercise provides better overall improvements in self-reported measures of function and pain and in performance measures of mobility in older overweight and obese adults with knee OA compared with either intervention alone OBJECTIVE To evaluate the effects of st and ardized western acupuncture and physiotherapy on pain and functional ability in patients with severe osteoarthritic knee pain awaiting knee arthroplasty . METHODS Three-arm , assessor-blind , r and omized controlled trial . PARTICIPANTS 181 patients awaiting knee arthroplasty . INTERVENTIONS acupuncture for 6 weeks ; physiotherapy for 6 weeks ; st and ardized advice . MAIN OUTCOME MEASURES Oxford Knee Score question naire ( OKS ) ( primary ) ; 50 m timed walk , and duration of hospital stay following knee arthroplasty . RESULTS There was no baseline difference between groups . At OUTPUT: Our systematic review confirms that international recommendations on exercise for knee osteoarthritis also apply to subjects aged 70 - 80 years . INPUT: OBJECTIVE Physical activity improves function in adults with arthritis , but it is unknown if there is a grade d relationship between physical activity and functional benefit . This study was undertaken to examine the cross-sectional and longitudinal relationship between self-reported physical activity and observed functional performance in adults with knee osteoarthritis ( OA ) . METHODS The Osteoarthritis Initiative cohort included 2,589 patients with knee OA ( 2,301 with longitudinal followup data ) who were ages 45 - 79 years at baseline . Prospect i ve annual functional performance was assessed for 2 years using timed 20-meter walk tests . We used linear regression to estimate differences across physical activity quartiles in subsequent function ( baseline and 1-year activity predicts 1-year and 2-year function , respectively ) adjusted for demographic factors ( age , sex , race/ethnicity , education level , and marital status ) and health factors ( OA severity , knee symptoms , knee pain , knee injury , body mass index , comorbidity , depression , smoking , alcohol use , and other joint pain ) . RESULTS Increasing physical activity levels had a significant grade d relationship to functional performance . Adults in physical activity quartile groups from least active to most active had an average gait speed of 4.0 , 4.2 , 4.3 , and 4.5 feet/second , respectively , at baseline ( P for trend<0.001 ) and 4.0 , 4.2 , 4.3 , and 4.5 feet/second , respectively , after 1 year ( P for trend<0.001 ) ; increasing trends remained significant after adjusting for covariates . Findings were similar within sex and age groups . CONCLUSION These prospect i ve data indicate a consistent grade d relationship between physical activity level and better performance in adults with knee OA . These findings support guidelines that encourage patients with arthritis who can not attain minimum recommended physical activity to be as active as possible Background Evidence exists demonstrating the benefits of exercise for people with osteoarthritis , but little is known about whether exercise programs are effective , that is , whether the benefits of exercise can be seen in “ real life ” programs for “ normal ” people under nonlaboratory conditions . Objective To identify characteristics of and outcomes for participants who adhere to a community-based aquatic exercise program . Method Two hundred and forty-nine adults with osteoarthritis were recruited from Washington State for r and omization to a 20-week Arthritis Foundation aquatic exercise program ( n = 125 ) or a wait-list control group ( n = 124 ) . Adherers were defined as those attending at least two classes per week for 16 of 20 weeks . Measures included : Quality of Well Being Scale , Health Assessment Question naire , Center for Epidemiological Studies -Depression Scale , and a single arthritis quality of life rating-item . Results Baseline to postintervention change scores revealed that treatment-group adherers ( N = 35 ) reported improved quality of well-being , physical function , and change in arthritis quality of life compared to controls ( N = 124 ) . When comparing treatment-group adherers ( N = 35 ) to treatment-group nonadherers ( N = 67 ) , quality of well-being and depressed mood improved for adherers , but not for nonadherers . Conclusion When analyzed for level of participation , exercise benefits adults with osteoarthritis . Consistent participation in exercise programs results in better outcomes . Improved methods are needed to enhance adherence , with increased attention to the role of intrinsic factors such as self-efficacy and belief systems BACKGROUND : Earlier observational studies of the relation between physical activity and obesity are inconsistent and ambiguous , showing a clear cross-sectional inverse relation , and a prospect i ve association only when physical activity at the time of follow-up is included . OBJECTIVE : To examine the long-term effect of leisure time physical activity ( LTPA ) on subsequent development of obesity and the effect of body weight on later physical inactivity in a population -based longitudinal setting taking into account the effects of historical changes on future changes as well as pertinent confounders . DESIGN : The study included 3653 women and 2626 men aged 20–78 y selected at r and om within sex – age strata from the general population of Copenhagen . At two surveys , 5 y apart , LTPA , body mass index ( BMI ) ( weight/height2 , kg/m2 ) , several possible confounders and modifying factors were assessed . Obesity ( defined as BMI ≥30 kg/m2 ) and LTPA was assessed at the 3rd survey 10 y later . Odds ratios ( with 95 % confidence limits ) for developing obesity between the last two surveys were estimated by logistic regression analysis , taking into account baseline and preceding changes in BMI and LTPA . A similar analysis of odds ratios for physical inactivity as outcome at the 3rd survey was conducted . RESULTS : Compared to physical inactivity , the odds ratios of development of obesity among women with medium and high level of activity were 0.81 ( 0.53 , 1.25 ) and 1.16 ( 0.73 , 1.84 ) , respectively , and among men , the odds ratios were 1.28 ( 0.71 , 2.33 ) and 1.65 ( 0.91 , 2.99 ) , respectively . Compared to median BMI , the odds ratio of later physical inactivity among women with high BMI was 1.91 ( 1.39 , 2.61 ) , and among men the odds ratio was 1.50 ( 1.01 , 2.22 ) . The associations were not confounded or modified by age , pre-existing diseases , smoking , alcohol intake , educational level , occupational physical activity or by familial predisposition to obesity . CONCLUSION : This study did not support that physical inactivity as reported in the freely living adult population in OUTPUT:

For patients with knee OA there is limited evidence that a lower level of physical function is associated with a lower level of physical activity . There is also limited evidence that depression is not associated with the level of physical activity . For patients with hip OA there is limited evidence that higher age , higher body mass index ( BMI ) and a low level of physical function is associated with a low level of physical activity . CONCLUSION A high age ( hip OA ) , a high BMI ( hip OA ) and a low level of physical function ( both hip and knee OA ) are related to a low level of physical activity .

MS2_dynamic_1_shot581

***TASK*** the task is to summarize an input biomedical literature 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 patients with atrial fibrillation ( AF ) undergoing radiofrequency ( RF ) electrical disconnection of multiple pulmonary veins ( PVs ) , the incidence of late conduction recurrences has not been systematic ally determined . Methods and Results —Using a prospect ively design ed , multistep approach , we aim ed at assessing the correlation between acute achievement and chronic maintenance of electrical conduction block across RF lesions disconnecting the distal tract of the PV in 43 patients ( 52.3±8.2 years ) with AF . Forty-one left superior ( LS ) , 42 right superior ( RS ) , 25 left inferior ( LI ) , and 9 right inferior ( RI ) PVs were targeted during 108 EP procedures ( 2.6±0.5 per patient ) . Seventeen patients underwent 2 procedures , 23 patients underwent 3 procedures , and 3 patients underwent 4 procedures . During the first attempt , electrical disconnection was achieved in 112 PVs ( 95.7 % ) . During a next procedure ( time interval , 4.6±1.9 months ) , conduction recurrence was observed in 32 of 39 LSPVs ( 82.1 % ) , 29 of 40 RSPVs ( 72.5 % ) , 20 of 24 LIPVs ( 83.3 % ) , and 7 of 9 RIPV ( 77.8 % ) . After reablation at gap sites , a later procedure ( time interval , 5.1±2.4 months ) revealed a second recurrence in 13 of 22 LSPVs ( 59.1 % ) and 14 of 19 RSPVs ( 73.7 % ) . Conclusions —Conduction recurrence across disconnecting RF lesions can be observed in ≈80 % of cases 4 months after ablation . After reablation , similar recurrence rates are observed 5 months later . This high rate of late conduction recurrence may contribute significantly to AF recurrence in patients undergoing catheter ablation aim ing at disconnection of multiple PVs BACKGROUND Atrial fibrillation ( AF ) recurrence after pulmonary vein isolation ( PVI ) is associated with PV to left atrium reconduction . Effective lesion creation necessitates adequate contact force between the ablation catheter and myocardium . OBJECTIVE The purpose of this study was to study the utility of contact force-guided ablation on immediate and long-term outcomes . METHODS Seventy-five patients with highly symptomatic paroxysmal AF underwent wide circumferential PVI using an irrigated-tip radiofrequency catheter . In 25 patients , ablation was guided by real-time contact force measurements ( CF group ; SmartTouch , Biosense Webster ) . A control group of 50 patients underwent PVI using a st and ard nonforce sensing catheter ( st and ard group ; ThermoCool , Biosense Webster ) . After PVI , all patients underwent adenosine testing to unmask dormant conduction . Patients were followed up at 3 , 6 , and 12 months and by transtelephonic monitoring as well . RESULTS Dormant conduction was unmasked and subsequently eliminated in 4 PV pairs ( 8 % ; 16 % of patients ) in the CF group and 35 PV pairs ( 35 % ; 52 % of patients ) in the st and ard group ( P = .0004 per PV pair ; P = .0029 per patient ) . The single-procedure , off-antiarrhythmic drug freedom from recurrent atrial arrhythmias at 1 year was 88 % in the CF group vs 66 % in the st and ard group ( P = .047 ) . Procedure duration and fluoroscopy time were significantly longer in the CF group ( P = .0038 and P = .0001 , respectively ) . CONCLUSION The use of real-time contact force guidance results in a significant reduction in the prevalence of dormant conduction with improved long-term freedom from recurrent arrhythmias . The utility of a contact force-guided approach requires evaluation in a long-term prospect i ve r and omized study BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range OUTPUT: Conclusion : CF‐guided RF catheter ablation was associated with a significant AF/atrial tachycardia‐free survival benefit compared with non‐CF‐guided ablation in patients with paroxysmal AF rather than persistent AF . In addition , CF‐guided ablation strategy also reduced the procedure time , fluoroscopy time , as well as RF time despite no distinct effect on the alleviation of procedure‐related complications INPUT: Background — Data regarding the long-term efficacy of atrial fibrillation ( AF ) ablation are still lacking . Methods and Results —Two hundred four consecutive patients symptomatic for paroxysmal or persistent/permanent AF were r and omly assigned to 2 different ablation schemes : pulmonary vein isolation ( PVI ) and PVI plus left linear lesions ( LL ) . Primary end point was to assess the maintenance of sinus rhythm ( SR ) after procedures 1 and 2 in the absence of antiarrhythmic drugs in a long-term follow-up of at least 3 years . Paroxysmal AF — With a single procedure at 12-month follow-up , 46 % of patients treated with PVI maintained SR , whereas at 3-year follow-up , 29 % were in SR ; using the “ PVI plus LL ” at the 12-month follow-up , 57 % of patients were in SR , whereas at the 3-year follow-up , 53 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 62 % with PVI and 85 % with PVI plus LL . Persistent/Permanent AF — With a single procedure at the 12-month follow-up , 27 % of patients treated with PVI were in SR , whereas at the 3-year follow-up , 19 % maintained SR ; using the PVI plus LL with a single procedure at the 12-month follow-up 45 % of patients were in SR , whereas at the 3-year follow-up , 41 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 39 % with PVI and 75 % with PVI plus LL . Conclusions —A long-term follow-up of AF ablation shows that short-term results can not be considered permanent because AF recurrences are still present after the first year especially in patients who have had “ PVI ” strategy . PVI isolation plus LL is superior to the PVI strategy in maintaining SR without antiarrhythmic drugs after procedures 1 and 2 both in paroxysmal and persistent AF BACKGROUND Recent data have shown that the septum and anterior left atrial ( LA ) wall may contain " rotor " sites required for AF maintenance . However , whether adding ablation of such sites to st and ard ICE-guided PVAI improves outcome is not well known . OBJECTIVE To determine if adjuvant anterior LA ablation during PVAI improves the cure rate of paroxysmal and permanent AF . METHODS One hundred AF patients ( 60 paroxysmal , 40 persistent/permanent ) undergoing first-time PVAI were enrolled over three months to receive adjuvant anterior LA ablation ( Group I ) . These patients were compared with 100 r and omly selected , matched first-time PVAI controls from the preceding three months who did not receive adjuvant ablation ( Group II ) . All 200 patients underwent ICE-guided PVAI during which all four PV antra and SVC were isolated . In group I , a decapolar lasso catheter was used to map the septum and anterior LA wall during AF ( induced or spontaneous ) for continuous high-frequency , fractionated electrograms ( CFAE ) . Sites where CFAE were identified were ablated until the local EGM was eliminated . A complete anterior line of block was not a requisite endpoint . Patients were followed up for 12 months . Recurrence was assessed post-PVAI by symptoms , clinic visits , and Holter at 3 , 6 , and 12 months . Patients also wore rhythm transmitters for the first 3 months . Recurrence was any AF/AFL > 1 min occurring > 2 months post-PVAI . RESULTS Patients ( age 56 + /- 11 years , 37 % female , EF 53%+/- 11 % ) did not differ in baseline characteristics between group I and II by design . Group I patients had longer procedure time ( 188 + /- 45 min vs 162 + /- 37 min ) and RF duration ( 57 + /- 12 min vs 44 + /- 20 min ) than group II ( P < 0.05 for both ) . Overall recurrence occurred in 15/100 ( 15 % ) in group I and 20/100 ( 20 % ) in group II ( P = 0.054 ) . Success rates did not differ for paroxysmal patients between group I and II ( 87 % vs 85 % , respectively ) . However , for persistent/permanent patients , group I had a higher success rate compared with group II ( 82 % vs 72 % , P = 0.047 ) . CONCLUSIONS Adjuvant anterior LA ablation does not appear to impact procedural outcome in patients with paroxysmal AF but may offer benefit to patients with persistent/permanent AF AIMS To investigate the effectiveness of additional substrate modification ( SM ) by left atrial ( LA ) linear lesions as compared with pulmonary vein isolation ( PVI ) alone in patients with persistent atrial fibrillation ( AF ) in a prospect i ve r and omized study . Percutaneous PVI has evolved as an accepted treatment for paroxysmal AF but seemed to be less effective in patients with persistent AF . The benefit of PVI alone and additional linear lesions has not been vali date d in a r and omized study so far . METHODS AND RESULTS Sixty-two patients with persistent AF ( median duration 7 , range 1 - 18 months ) were r and omly assigned to either PVI alone ( n = 30 ) or additional SM ( n = 32 ) consisting of a roof line connecting both left superior and right superior PV and LA isthmus ablation between left inferior PV and mitral annulus . Procedures including SM were performed using a three-dimensional mapping system ( EnSite NavX , St Jude Medical , St Paul , MN , USA ) . Anti-arrhythmic drugs were discontinued within 8 weeks after ablation in both groups . Follow-up included daily trans-telephonic ECG transmitted irrespective of the OUTPUT:

Where data were available , the relative benefits seen held true both after a single or multiple procedure(s ) . For patients with persistent atrial fibrillation , CA achieves significantly greater freedom from recurrent atrial fibrillation compared with medical therapy .

MS2_dynamic_1_shot582

***TASK*** the task is to summarize an input biomedical literature 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 The aim of this study was to examine physical , physiological , and motor responses and perceived exertion during different soccer drills . In small-sided games , the individual playing area ( ∼275 m2 , ∼175 m2 , and ∼75 m2 ) was varied while the number of players per team was kept constant : 5 vs. 5 plus goal keepers . Participants were ten male youth soccer players . Each session comprised three small-sided game formats , which lasted 8 min each with a 5-min passive rest period between them . A range of variables was recorded and analysed for the three drills performed over three training sessions : ( a ) physiological , measured using Polar Team devices ; ( b ) physical , using GPS SPI elite devices ; ( c ) perceived exertion , rated using the CR-10 scale ; and ( d ) motor response , evaluated using an observational tool that was specially design ed for this study . Significant differences were observed for most of the variables studied . When the individual playing area was larger , the effective playing time , the physical ( total distance covered ; distances covered in low-intensity running , medium-intensity running , and high-intensity running ; distance covered per minute ; maximum speed ; work-to-rest ratio ; sprint frequency ) and physiological workload ( percent maximum heart rate ; percent mean heart rate ; time spent above 90 % maximum heart rate ) , and the rating of perceived exertion were all higher , while certain motor behaviours were observed less frequently ( interception , control and dribble , control and shoot , clearance , and putting the ball in play ) . The results show that the size of the pitch should be taken into account when planning training drills , as it influences the intensity of the task and the motor response of players A Comparison Of Physiological Responses To Various Intermittent And Continuous Small-Sided Games In Young Soccer Players The purpose of this study was to investigate physiological responses to various intermittent and continuous small-sided games ( SSGs ) - including 2-a-side , 3-a-side , and 4-a-side games - in young soccer players . Twenty soccer players ( average age 16.6±0.5 years ; mean body height 176.2±4.6 cm ; mean body mass 65.9±5.6 kg ) voluntarily participated in this study . The subjects underwent anthropometric measurements followed by the YoYo intermittent recovery test . Then , they played intermittent ( SSGint ) and continuous ( SSGcon ) 2-a-side , 3-a-side , and 4-a-side soccer-specific SSGs in r and om order at 2-day intervals . Paired t-tests were used to assess differences between the training regimens ( intermittent and continuous ) in terms of heart rate ( HR ) , percentage of maximum HR ( % HRmax ) , and blood lactate concentration ( LA ) . The differences in LA , HR and % HRmax between the 2-a-side , 3-a-side and 4-a-side SSGint or the 2-a-side , 3-a-side and 4-a-side SSGcon were identified using a one-way analysis of variance with repeated measures . The results demonstrated that the 3-a-side SSGint and SSGcon measurements were significantly higher than the 2-a-side and 4-a-side games in terms of HR and % HRmax , whereas the 2-a-side SSGint and SSGcon result ed in higher LA responses compared to other SSG types . The study results also demonstrated that SSGint and SSGcon are similar in terms of physiological responses except for 2-a-side game LA responses . The results of this study suggest that both SSGint and SSGcon could be used for the physiological adaptations required for soccer specific aerobic endurance Abstract Sanchez-Sanchez , J , Hernández , D , Casamichana , D , Martínez-Salazar , C , Ramirez-Campillo , R , and Sampaio , J. Heart rate , technical performance , and session-RPE in elite youth soccer small-sided games played with wildcard players . J Strength Cond Res 31(10 ) : 2678–2685 , 2017—The aim of this study was to compare heart rate ( HR ) , rating of perceived exertion ( RPE ) , and technical-tactical actions during small-sided games ( SSGs ) played without ( CTR ) , with internal ( IW ) , and with IW and external ( IEW ) wildcard players . A total of 22 young male soccer players ( age 17.2 ± 0.9 years ) r and omly completed six 4vs4 SSG situations . The control conditions occurred with goals scored without goal keeper ( 4vs4-NO ) and with goal keeper ( 4vs4-GK ) . During the experimental conditions , the situations incorporated 2 IW ( 4vs4 + 2IW-NO , 4vs4 + 2IW-GK ) and 2 IEW ( 4vs4 + 2IW+2IEW-NO , 4vs4 + 2IW+2IEW-GK ) . Processed results did not include data from goal keepers , IW , and IEW players . The HR was divided in intensity-zones ( Z1 , Z2 , and Z3 , for < 80 % , 80–90 % , and > 90 % of maximal HR , respectively ) and the analyzed technical-tactical actions were the pass , dribbling , collective success , and pause . The effects of IW and IEW were analyzed through repeated measures analysis of variance . During 4vs4 + 2IW+2IEW-NO , greater time was recorded in Z1 ( p ⩽ 0.05 ) compared with 4vs4-NO and 4s4 + 2IW-NO . During 4vs4 + 2IW+2IEW-GK , greater time was recorded in Z1 and less in Z3 ( p ⩽ 0.05 ) compared with 4vs4-GK . Greater RPE was reported in 4vs4-NO ( OUTPUT: SSG-based football plans ( 2 to 4 SSG sessions per week ) show athletic performance improvements in football players by improving sprint , repeated sprint ability ( RSA ) and change of direction ( COD ) along with muscular and physiological adaptation INPUT: Brink , MS , Nederhof , E , Visscher , C , Schmikli , SL , and Lemmink , KAPM . Monitoring load , recovery , and performance in young elite soccer players . J Strength Cond Res 24(3 ) : 597 - 603 , 2010-The purpose of this study was to investigate the relation between training load , recovery , and monthly field test performance in young elite soccer players to develop training guidelines to enhance performance . In a prospect i ve , nonexperimental cohort design , 18 young elite soccer players registered training and match duration for a full competitive season by means of daily training logs . Furthermore , session rating of perceived exertion ( RPE ) and total quality of recovery ( TQR ) scores were recorded . Weekly duration ( TLd ) , load ( duration × session RPE = TLrpe ) , and TQR scores were calculated for 1 and 2 weeks before a monthly submaximal interval shuttle run tests to determine interval endurance capacity . Participants spent on average 394.4 ± 134.9 minutes per week on training and game play with an average session RPE of 14.4 ± 1.2 ( somewhat hard ) and TQR of 14.7 ± 1.3 ( good recovery ) . R and om intercept models showed that every extra hour training or game play result ed in enhanced field test performance ( p < 0.05 ) . Session RPE and TQR scores did not contribute to the prediction of performance . The duration of training and game play in the week before field test performance is most strongly related to interval endurance capacity . Therefore , coaches should focus on training duration to improve interval endurance capacity in elite soccer players . To evaluate the group and individual training response , field tests should be frequently executed and be incorporated in the training program The purpose of the present study was to examine the influence of direct supervision on muscular strength , power , and running speed during 12 weeks of resistance training in young rugby league players . Two matched groups of young ( 16.7 ± 1.1 years [ mean ± SD ] ) , talented rugby league players completed the same periodized resistance-training program in either a supervised ( SUP ) ( N = 21 ) or an unsupervised ( UNSUP ) ( N = 21 ) environment . Measures of 3 repetition maximum ( 3RM ) bench press , 3RM squat , maximal chin-ups , vertical jump , 10– and 20-m sprints , and body mass were completed pretest ( week 0 ) , midtest ( week 6 ) , and posttest ( week 12 ) training program . Results show that 12 weeks of periodized resistance training result ed in an increased body mass , 3RM bench press , 3RM squat , maximum number of chin-ups , vertical jump height , and 10– and 20-m sprint performance in both groups ( p < 0.05 ) . The SUP group completed significantly more training sessions , which were significantly correlated to strength increases for 3RM bench press and squat ( p < 0.05 ) . Furthermore , the SUP group significantly increased 3RM squat strength ( at 6 and 12 weeks ) and 3RM bench press strength ( 12 weeks ) when compared to the UNSUP group ( p < 0.05 ) . Finally , the percent increase in the 3RM bench press , 3RM squat , and chin-upmax was also significantly greater in the SUP group than in the UNSUP group ( p < 0.05 ) . These findings show that the direct supervision of resistance training in young athletes results in greater training adherence and increased strength gains than does unsupervised training To examine the effects of aerobic interval training on the decline in short-passing ability caused by a short bout of high-intensity intermittent activities . For this r and omized controlled trial , 26 junior soccer players ( mean age , 17.8 + /- 0.6 years ; mean height , 178 + /- 5 cm ; mean body mass , 74.5 + /- 6.9 kg ) were recruited . After baseline measurements , subjects were r and omly allocated to 1 of 2 groups : the control group ( CG ) or the aerobic interval training group ( ITG ) . The ITG completed 4 weeks of high-intensity aerobic training , consisting of 4 bouts of running for 4 min at 90%-95 % of maximal heart rate , with 3 min of active recovery between sets , in addition to normal training . Maximum oxygen uptake , Yo-Yo Intermittent Recovery Test level 1 ( YYIRT ) , and short-passing ability ( measured using the Loughborough Soccer Passing Test ( LSPT ) ) were measured before and after a 5 min high-intensity simulation ( HIS ) , reproducing the most intense phase of a match . The ITG ( n = 11 ) , but not the CG ( n = 10 ) , showed a significant 12 % and 4 % increase in YYIRT and maximal oxygen consumption after training , respectively , and reduced the worsening in LSPT penalty time after the HIS ( p < 0.05 ) . The relative exercise intensity during HIS decreased in the ITG only ( p < 0.01 ) . Our results demonstrated that junior soccer players may benefit from aerobic training to attenuate the decline in short-passing ability caused by a short bout of intermittent activities completed at the same pretraining workload Objective In this study , the injury incidence and association with type and volume of training in international rowers were described . Design A prospect i ve cohort design was used over a 12-month period . Patients 20 international rowers who were competing as part of the Irish Amateur Rowing Union squad system . Methods The rowers were interviewed monthly , and data were collected regarding their training and competition exposure as well as their injury experience . Results A mean injury rate of 3.67 per 1000 exposure hours was reported with a total of 44 injuries reported in a 12-month period . The mean number of injuries sustained per athlete was 2.2 ( 1.24 ) over the 12 OUTPUT:

Of the few studies examining negative consequences associated with workloads , increases in training load led to increases in injury rates , while longer training duration was associated with a greater incidence of illness . Conclusion The combined capacity for adolescent males to grow , train and improve physical performance highlights and underscores an exciting responsiveness to training in the football environment . However , the capacity to train has some established barriers for adolescents experiencing high workloads , which could also result in negative consequences .

MS2_dynamic_1_shot583

***TASK*** the task is to summarize an input biomedical literature 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 Cognitive impairment after critical illness is common and debilitating . We developed a cognitive therapy program for critically ill patients and assessed the feasibility and safety of administering combined cognitive and physical therapy early during a critical illness . Methods We r and omized 87 medical and surgical ICU patients with respiratory failure and /or shock in a 1:1:2 manner to three groups : usual care , early once-daily physical therapy , or early once-daily physical therapy plus a novel , progressive , twice-daily cognitive therapy protocol . Cognitive therapy included orientation , memory , attention , and problem-solving exercises , and other activities . We assessed feasibility outcomes of the early cognitive plus physical therapy intervention . At 3 months , we also assessed cognitive , functional , and health-related quality of life outcomes . Data are presented as median ( interquartile range ) or frequency ( % ) . Results Early cognitive therapy was a delivered to 41/43 ( 95 % ) of cognitive plus physical therapy patients on 100 % ( 92–100 % ) of study days beginning 1.0 ( 1.0–1.0 ) day following enrollment . Physical therapy was received by 17/22 ( 77 % ) of usual care patients , by 21/22 ( 95 % ) of physical therapy only patients , and 42/43 ( 98 % ) of cognitive plus physical therapy patients on 17 % ( 10–26 % ) , 67 % ( 46–87 % ) , and 75 % ( 59–88 % ) of study days , respectively . Cognitive , functional , and health-related quality of life outcomes did not differ between groups at 3-month follow-up . Conclusions This pilot study demonstrates that early rehabilitation can be extended beyond physical therapy to include cognitive therapy . Future work to determine optimal patient selection , intensity of treatment , and benefits of cognitive therapy in the critically ill is needed Purpose : The purpose of this review is to evaluate the literature related to mobilization of the critically ill patient with an emphasis on functional outcomes and patient safety . Methods : We search ed the electronic data bases of PubMed , CINAHL , Medline ( Ovid ) , and The Cochrane Library for a period spanning 2000‐2011 . Articles used in this review included r and omized and nonr and omized clinical trials , prospect i ve and retrospective analyses , and case series in peer review ed journals . Sackett 's Levels of Evidence were used to classify the current literature to evaluate the strength of the outcomes reported . Results : Fifteen studies met inclusion criteria and were review ed . According to Sackett 's Levels of Evidence , 9 studies were level 4 evidence , one study was level 3 , 4 studies were level 2 , and one study was level one evidence . Ten studies pertained to patient safety/feasibility and 10 studies pertained to functional outcomes with 5 fitting into both categories . Conclusion : A search of the scientific literature revealed a limited number of studies that examined the mobilization of critically ill patients in the intensive care unit . However , literature that does exist supports early mobilization and physical therapy as a safe and effective intervention that can have a significant impact on functional outcomes Objectives : To investigate whether a daily exercise session , using a bedside cycle ergometer , is a safe and effective intervention in preventing or attenuating the decrease in functional exercise capacity , functional status , and quadriceps force that is associated with prolonged intensive care unit stay . A prolonged stay in the intensive care unit is associated with muscle dysfunction , which may contribute to an impaired functional status up to 1 yr after hospital discharge . No evidence is available concerning the effectiveness of an early exercise training intervention to prevent these detrimental complications . Design : R and omized controlled trial . Setting : Medical and surgical intensive care unit at University Hospital Gasthuisberg . Patients : Ninety critically ill patients were included as soon as their cardiorespiratory condition allowed bedside cycling exercise ( starting from day 5 ) , given they still had an expected prolonged intensive care unit stay of at least 7 more days . Interventions : Both groups received respiratory physiotherapy and a daily st and ardized passive or active motion session of upper and lower limbs . In addition , the treatment group performed a passive or active exercise training session for 20 mins/day , using a bedside ergometer . Measurements and Main Results : All outcome data are reflective for survivors . Quadriceps force and functional status were assessed at intensive care unit discharge and hospital discharge . Six-minute walking distance was measured at hospital discharge . No adverse events were identified during and immediately after the exercise training . At intensive care unit discharge , quadriceps force and functional status were not different between groups . At hospital discharge , 6-min walking distance , isometric quadriceps force , and the subjective feeling of functional well-being ( as measured with “ Physical Functioning ” item of the Short Form 36 Health Survey question naire ) were significantly higher in the treatment group ( p < .05 ) . Conclusions : Early exercise training in critically ill intensive care unit survivors enhanced recovery of functional exercise capacity , self-perceived functional status , and muscle force at hospital discharge Introduction The purpose of this trial was to investigate the effectiveness of an exercise rehabilitation program commencing during ICU admission and continuing into the outpatient setting compared with usual care on physical function and health-related quality of life in ICU survivors . Methods We conducted a single-center , assessor-blinded , r and omized controlled trial . One hundred and fifty participants were stratified and r and omized to receive usual care or intervention if they were in the ICU for 5 days or more and had no permanent neurological insult . The intervention group received intensive exercises in the ICU and the ward and as out patients . Participants were assessed at recruitment , ICU admission , hospital discharge and at 3- , 6- and 12-month follow-up . Physical function was evaluated using the Six-Minute Walk Test ( 6MWT ) ( primary outcome ) , the Timed Up and Go Test and OUTPUT: Early mobilization appears to decrease the incidence of ICU-AW , improve the functional capacity , and increase the number of ventilator-free days and the discharged-to-home rate for patients with a critical illness in the ICU setting INPUT: Purpose : The purpose of this review is to evaluate the literature related to mobilization of the critically ill patient with an emphasis on functional outcomes and patient safety . Methods : We search ed the electronic data bases of PubMed , CINAHL , Medline ( Ovid ) , and The Cochrane Library for a period spanning 2000‐2011 . Articles used in this review included r and omized and nonr and omized clinical trials , prospect i ve and retrospective analyses , and case series in peer review ed journals . Sackett 's Levels of Evidence were used to classify the current literature to evaluate the strength of the outcomes reported . Results : Fifteen studies met inclusion criteria and were review ed . According to Sackett 's Levels of Evidence , 9 studies were level 4 evidence , one study was level 3 , 4 studies were level 2 , and one study was level one evidence . Ten studies pertained to patient safety/feasibility and 10 studies pertained to functional outcomes with 5 fitting into both categories . Conclusion : A search of the scientific literature revealed a limited number of studies that examined the mobilization of critically ill patients in the intensive care unit . However , literature that does exist supports early mobilization and physical therapy as a safe and effective intervention that can have a significant impact on functional outcomes Introduction The purpose of this trial was to investigate the effectiveness of an exercise rehabilitation program commencing during ICU admission and continuing into the outpatient setting compared with usual care on physical function and health-related quality of life in ICU survivors . Methods We conducted a single-center , assessor-blinded , r and omized controlled trial . One hundred and fifty participants were stratified and r and omized to receive usual care or intervention if they were in the ICU for 5 days or more and had no permanent neurological insult . The intervention group received intensive exercises in the ICU and the ward and as out patients . Participants were assessed at recruitment , ICU admission , hospital discharge and at 3- , 6- and 12-month follow-up . Physical function was evaluated using the Six-Minute Walk Test ( 6MWT ) ( primary outcome ) , the Timed Up and Go Test and the Physical Function in ICU Test . Patient-reported outcomes were measured using the Short Form 36 Health Survey , version 2 ( SF-36v2 ) and Assessment of Quality of Life ( AQoL ) Instrument . Data were analyzed using mixed models . Results The a priori enrollment goal was not reached . There were no between-group differences in demographic and hospital data , including acuity and length of acute hospital stay ( LOS ) ( Acute Physiology and Chronic Health Evaluation II score : 21 vs 19 ; hospital LOS : 20 vs 24 days ) . No significant differences were found for the primary outcome of 6MWT or any other outcomes at 12 months after ICU discharge . However , exploratory analyses showed the rate of change over time and mean between-group differences in 6MWT from first assessment were greater in the intervention group . Conclusions Further research examining the trajectory of improvement with rehabilitation is warranted in this population .Trial registration The trial was registered with the Australian New Zeal and Clinical Trials Registry ACTRN12605000776606 Background The purpose of this study was to identify predictors of 3-month mortality in critically ill older persons under medical care and to assess the clinical impact of an ICU stay on physical and cognitive dependence and subjective health status in survivors . Methods We conducted a prospect i ve observational cohort study including all older persons 75 years and older consecutively admitted into ICU during a one-year period , except those admitted after cardiac arrest , All patients were followed for 3 months or until death . Comorbidities were assessed using the Charlson index and physical dependence was evaluated using the Katz index of Activity of Daily Living ( ADL ) . Cognitive dependence was determined by a score based on the individual components of the Lawton index of Daily Living and subjective health status was evaluated using the Nottingham Health Profile ( NHP ) score . Results One hundred patients were included in the analysis . The mean age was 79.3 ± 3.4 years . The median Charlson index was 6 [ IQR , 4 to 7 ] and the mean ADL and cognitive scores were 5.4 ± 1.1 and 1.2 ± 1.4 , respectively , corresponding to a population with a high level of comorbidities but low physical and cognitive dependence . Mortality was 61/100 ( 61 % ) at 3 months . In multivariate analysis only comorbidities assessed by the Charlson index [ Adjusted Odds Ratio , 1.6 ; 95 % CI , 1.2 - 2.2 ; p < 0.003 ] and the number of organ failures assessed by the SOFA score [ Adjusted Odds Ratio , 2.5 ; 95 % CI , 1.1 - 5.2 ; p < 0.02 ] were independently associated with 3-month mortality . All 22 patients needing renal support after Day 3 died . Compared with pre-admission , physical ( p = 0.04 ) , and cognitive ( p = 0.62 ) dependence in survivors had changed very little at 3 months . In addition , the mean NHP score was 213.1 ± 132.8 at 3 months , suggesting an acceptable perception of their quality of life . Conclusions In a selected population of non surgical patients 75 years and older , admission into the ICU is associated with a 3-month survival rate of 38 % with little impact on physical and cognitive dependence and subjective health status . Nevertheless , a high comorbidity level ( ie , Charlson index ) , multi-organ failure , and the need for extra-renal support at the early phase of intensive care could be considered as predictors of death Multiple organ failure ( MOF ) is accompanied by muscle wasting , but changes in body composition are frequently obscured by fluid retention ( edema ) , mainly in superficial and visceral tissue . There is OUTPUT:

Conclusions There is considerable variability in the type of measures utilized to measure physical impairments and limitations in survivors of critical illness .

MS2_dynamic_1_shot584

***TASK*** the task is to summarize an input biomedical literature 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 use two different exercise programs over a 2-year period to reduce falls and their sequelae among residents of two long-term care facilities . DESIGN R and omized , controlled trial . SETTING The study took place at two long-term care facilities with services ranging from independent living to skilled nursing . PARTICIPANTS One hundred and ten participants whose average age was 84 and who were capable of ambulating with or without assistive devices and could follow simple directions . INTERVENTION Participants were r and omized to one of two exercise groups ( resistance/endurance plus basic enhanced programming or tai chi plus basic enhanced programming ) or to a control group ( basic enhanced programming only ) . Exercise classes were held three times per week throughout the study . MEASUREMENTS Participants were evaluated for cognitive and physical functioning at baseline and 6 , 12 , and 24 months . Falls were determined from incident reports filed by the nursing staffs at the facilities . RESULTS Time to first fall , time to death , number of days hospitalized , and incidence of falls did not differ among the treatment and control groups ( P>.05 ) . Among all participants , those who fell had significantly lower baseline Folstein Mini-Mental State Examination and instrumental activities of daily living scores and experienced significantly greater declines in these measures over the 2-year program . CONCLUSION There were no significant differences in falls among the two exercise groups and the control group . Lack of treatment differences and low adherence rates suggest that residents of long-term care facilities may require individualized exercise interventions that can be adapted to their changing needs Multimodal exercise programs incorporating traditional progressive resistance training ( PRT ) , weight-bearing impact training and /or balance training are recommended to reduce risk factors for falls and fracture . However , muscle power , or the ability to produce force rapidly , has emerged as a more crucial variable to functional decline than muscle strength or mass . The aim of this 12-month community-based r and omized controlled trial , termed Osteo-cise : Strong Bones for Life , was to evaluate the effectiveness and feasibility of a multimodal exercise program incorporating high-velocity (HV)-PRT , combined with an osteoporosis education and behavioral change program , on bone mineral density ( BMD ) , body composition , muscle strength and functional muscle performance in older adults . Falls incidence was evaluated as a secondary outcome . A total of 162 older adults ( mean ± SD ; 67 ± 6 years ) with risk factors for falls and /or low BMD were r and omized to the Osteo-cise program ( n = 81 ) or a control group ( n = 81 ) . Exercise consisted of fitness center-based HV-PRT , weight-bearing impact and challenging balance/mobility activities performed three times weekly . After 12 months , the Osteo-cise program led to modest but significant net gains in femoral neck and lumbar spine BMD ( 1.0 % to 1.1 % , p < 0.05 ) , muscle strength ( 10 % to 13 % , p < 0.05 ) , functional muscle power ( Timed Stair Climb , 5 % , p < 0.05 ) and dynamic balance ( Four Square Step Test 6 % , p < 0.01 ; Sit-to-St and , 16 % , p < 0.001 ) relative to controls . There was no effect on total body lean mass or mobility ( timed-up- and -go ) , and no difference in falls rate ( incidence rate ratio [ IRR ] , 1.22 ; 95 % confidence interval [ CI ] , 0.72 - 2.04 ) . In conclusion , this study demonstrates that the Osteo-cise : Strong Bones for Life community-based , multimodal exercise program represents an effective approach to improve multiple musculoskeletal and functional performance measures in older adults with risk factors for falls and /or low BMD . Although this did not translate into a reduction in the rate of falls , further large-scale trials are needed to evaluate the efficacy of this multimodal approach on reducing falls and fracture BACKGROUND Obesity exacerbates the age-related decline in physical function and causes frailty in older adults ; however , the appropriate treatment for obese older adults is controversial . METHODS In this 1-year , r and omized , controlled trial , we evaluated the independent and combined effects of weight loss and exercise in 107 adults who were 65 years of age or older and obese . Participants were r and omly assigned to a control group , a weight-management ( diet ) group , an exercise group , or a weight-management-plus-exercise ( diet-exercise ) group . The primary outcome was the change in score on the modified Physical Performance Test . Secondary outcomes included other measures of frailty , body composition , bone mineral density , specific physical functions , and quality of life . RESULTS A total of 93 participants ( 87 % ) completed the study . In the intention-to-treat analysis , the score on the Physical Performance Test , in which higher scores indicate better physical status , increased more in the diet-exercise group than in the diet group or the exercise group ( increases from baseline of 21 % vs. 12 % and 15 % , respectively ) ; the scores in all three of those groups increased more than the scores in the control group ( in which the score increased by 1 % ) ( P<0.001 for the between-group differences ) . Moreover , the peak oxygen consumption improved more in the diet-exercise group than in the diet group or the exercise group ( increases of 17 % vs. 10 % and 8 % , respectively ; P<0.001 ) ; the score on the Functional Status Question naire , in which higher scores indicate better physical function , increased more in the diet-exercise group than in the diet group ( increase of 10 % vs. 4 % , P<0.001 ) . Body weight decreased by 10 % in the diet group and by 9 % in the diet-exercise group , but did not decrease in the exercise group or the control group ( P< OUTPUT: Exercise significantly reduced the number of falls and fall-associated injuries , and improved physical function and cognition . These results seemed independent of participants ’ baseline characteristics ( age , physical function , and cognitive status ) and exercise frequency . Long-term exercise training does not overall influence the risk of dropouts due to health issues or mortality in older adults , and results in a reduced mortality risk in clinical population s. Moreover , exercise reduces the number of falls and fall-associated injuries , and improves physical function and cognition in this population INPUT: Multimodal exercise programs incorporating traditional progressive resistance training ( PRT ) , weight-bearing impact training and /or balance training are recommended to reduce risk factors for falls and fracture . However , muscle power , or the ability to produce force rapidly , has emerged as a more crucial variable to functional decline than muscle strength or mass . The aim of this 12-month community-based r and omized controlled trial , termed Osteo-cise : Strong Bones for Life , was to evaluate the effectiveness and feasibility of a multimodal exercise program incorporating high-velocity (HV)-PRT , combined with an osteoporosis education and behavioral change program , on bone mineral density ( BMD ) , body composition , muscle strength and functional muscle performance in older adults . Falls incidence was evaluated as a secondary outcome . A total of 162 older adults ( mean ± SD ; 67 ± 6 years ) with risk factors for falls and /or low BMD were r and omized to the Osteo-cise program ( n = 81 ) or a control group ( n = 81 ) . Exercise consisted of fitness center-based HV-PRT , weight-bearing impact and challenging balance/mobility activities performed three times weekly . After 12 months , the Osteo-cise program led to modest but significant net gains in femoral neck and lumbar spine BMD ( 1.0 % to 1.1 % , p < 0.05 ) , muscle strength ( 10 % to 13 % , p < 0.05 ) , functional muscle power ( Timed Stair Climb , 5 % , p < 0.05 ) and dynamic balance ( Four Square Step Test 6 % , p < 0.01 ; Sit-to-St and , 16 % , p < 0.001 ) relative to controls . There was no effect on total body lean mass or mobility ( timed-up- and -go ) , and no difference in falls rate ( incidence rate ratio [ IRR ] , 1.22 ; 95 % confidence interval [ CI ] , 0.72 - 2.04 ) . In conclusion , this study demonstrates that the Osteo-cise : Strong Bones for Life community-based , multimodal exercise program represents an effective approach to improve multiple musculoskeletal and functional performance measures in older adults with risk factors for falls and /or low BMD . Although this did not translate into a reduction in the rate of falls , further large-scale trials are needed to evaluate the efficacy of this multimodal approach on reducing falls and fracture Background Gait and balance impairments may increase the risk of falls , the leading cause of accidental death in the elderly population . Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering . A rapid step is the most important protective postural strategy , acting to recover equilibrium and prevent a fall from initiating . It can arise from large perturbations , but also frequently as a consequence of volitional movements . We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling . We describe the water-based balance training program and a study protocol to evaluate its efficacy ( Trial registration number # NCT00708136 ) . Methods / Design The proposed water-based training program involves use of unpredictable , multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses . Perturbations are made by pushing slightly the subjects and by water turbulence , in 24 training sessions conducted over 12 weeks . Concurrent cognitive tasks during movement tasks are included . Principles of physical training and exercise including awareness , continuity , motivation , overload , periodicity , progression and specificity were used in the development of this novel program . Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning . A prospect i ve , r and omized , cross-over trial with concealed allocation , assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program . A total of 36 community-dwelling adults ( age 65–88 ) with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group ( no training ) . Voluntary step reaction times and postural stability using stabiliogram diffusion analysis will be tested before and after the 12 weeks of training . Discussion This study will determine whether a water-based balance training program that includes perturbation exercises , in a group setting , can improve speed of voluntary stepping responses and improve balance control . Results will help guide the development of more cost-effective interventions that can prevent the occurrence of falls in the elderly BACKGROUND Water-based resistance training ( WRT ) has been indicated to promote strength gains in elderly population . However , no study has compared different training strategies to identify the most efficient one . The aim of this study was to compare the effects of 3 WRT strategies on the strength and functional capacity of older women . METHODS In total , 36 women were r and omly allocated to training groups : simple set of 30 seconds [ 1 × 30s ; 66.41 ( 1.36 ) y ; n = 12 ] , multiple sets of 10 seconds [ 3 × 10s ; 66.50 ( 1.43 ) y ; n = 11 ] , and simple set of 10 seconds [ 1 × 10s ; 65.23 ( 1.09 ) y ; n = 13 ] . Training lasted for 12 weeks . The maximal dynamic strength ( in kilograms ) and muscular endurance ( number of repetitions ) of knee extension , knee flexion , elbow flexion , and bench press , as well as functional capacity ( number of repetitions ) , were evaluated . RESULTS All types of training promoted similar gains in maximal dynamic strength of knee extension and flexion as well as elbow flexion . Only the 1 × 30s and 1 × 10s groups presented increments in bench press maximal strength . All 3 groups showed increases in muscular endurance in all exercises and functional capacity . CON OUTPUT:

However , aquatic exercise improved key predisposing physical fitness components that are modifiable and internal risk factors for falling . Conclusions There is limited , low- quality evidence to support the use of aquatic exercise for improving physiological components that are risk factors for falling .

MS2_dynamic_1_shot585

***TASK*** the task is to summarize an input biomedical literature 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 an experimental study of weight reduction , 62 obese men and women were administered a pretreatment question naire and r and omly assigned to three experimental treatment groups : ( a ) an external control group with a nonrefundable contingency ; ( 6 ) a self-control group with a refundable contingency ; and ( c ) a self-control group with a nonrefundable contingency . The results indicated that the self-control and external-control treatments were equally effective in producing reduction in weight . However , both self-control interventions were more effective than the external-control intervention in promoting maintenance of weight loss We developed a computer-stored medical record system containing a limited set of the total clinical data base -- primarily diagnostic studies and treatments . This system responds to its own content according to physician-authored reminder rules . To determine the effect of the reminder messages generated by 1490 rules on physician behavior , we r and omly assigned practitioners in a general medicine clinic to study or control groups . The computer found indications for six different actions per patient in 12 467 patients during a 2-year study : 61 study group residents who received computer reminders responded to 49 % of these indications ; 54 control group residents , to only 29 % ( p less than 0.0001 ) . Preventive care ( occult blood testing , mammographic screening , weight reduction diets , influenza and pneumococcal vaccines ) was affected . The intentions of the study group to use a given action for an indication predicted their response to the indications ( p less than 0.03 , r2 = 0.33 ) . The intentions of the control residents did not Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs To examine the relative cost-effectiveness of single versus multiple patient education strategies to reduce hypertension , we assigned patients to seven intervention groups and to a usual-care control group using a r and omized factorial design . We compared cost-effectiveness measures for single , double , and triple combinations of ( a ) a clinic exit interview with patients to clarify their medical regimens , ( b ) an educational meeting with a member of the patient 's family to aid in management at home , and ( c ) a series of small group sessions to help patients overcome personal barriers to management . We observed consistent results for six different effectiveness measures under a variety of decision-making rules . Our results suggest that in the absence of targeting of multiple interventions to systematic ally selected high-risk patients , multiple intervention combinations are not more cost-effective than single interventions Forty smokers and 47 overweight individuals were recruited for a home correspondence program for either smoking cessation or weight loss . Participants were assigned to one of four programs for changing their respective health behaviors : ( 1 ) a home correspondence program conducted entirely by mail , ( 2 ) the mail program with supplemental financial contigency contracts tied to completion of written homework , ( 3 ) the correspondence programs supplemented both by homework contracts and by regular calls to a telephone answering system , and ( 4 ) a st and ard behavioral group program which acted as a comparison condition . Results showed that all three correspondence approaches produced significant changes in health behaviors equal to the changes experienced by participants in the st and ard group program . The implication of these findings for development of low cost programs for disease prevention are discussed Objective To evaluate whether nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound . Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevent OUTPUT: Interventions aim ed at improving health professionals ' management or the delivery of health care for overweight/obese patients are more effective than usual care . 2 . Interventions aim ed at redressing negative attitudes and related practice s towards overweight/obese patients are more effective than usual care . 3 . Organisational interventions design ed to change the structure of services for overweight/obese people are more effective than educational or behavioural interventions for health professionals . 4 . INPUT: Employers commonly use adjustments to health insurance premiums as incentives to encourage healthy behavior , but the effectiveness of those adjustments is controversial . We gave 197 obese participants in a workplace wellness program a weight loss goal equivalent to 5 percent of their baseline weight . They were r and omly assigned to a control arm , with no financial incentive for achieving the goal , or to one of three intervention arms offering an incentive valued at $ 550 . Two intervention arms used health insurance premium adjustments , beginning the following year ( delayed ) or in the first pay period after achieving the goal ( immediate ) . A third arm used a daily lottery incentive separate from premiums . At twelve months there were no statistically significant differences in mean weight change either between the control group ( whose members had a mean gain of 0.1 pound ) and any of the incentive groups ( delayed premium adjustment , -1.2 pound ; immediate premium adjustment , -1.4 pound ; daily lottery incentive , -1.0 pound ) or among the intervention groups . The apparent failure of the incentives to promote weight loss suggests that employers that encourage weight reduction through workplace wellness programs should test alternatives to the conventional premium adjustment approach by using alternative incentive design s , larger incentives , or both OBJECTIVE To examine the viability of monetary incentives to increase fitness-center use and maintain/improve the Body Mass Indexes ( BMI s ) of first-year students over the fall semester . METHOD R and omized-controlled trial with no-treatment and incentive conditions involving 117 first-year students . For 12 weeks , students in the incentive condition received monetary payments ranging from $ 10 to $ 38.75 for meeting research er-set fitness-center use goals that were identical across conditions . Fitness-center use was monitored through electronic ID-card check-in and check-out records at the campus fitness center . RESULTS 63 % of incentive-condition participants met the weekly fitness-center use goals on average compared to only 13 % of control-condition participants , a significant difference , p<0.001 . Goal achievement significantly decreased over time , p<0.01 and at roughly the same rate in the control and incentive conditions , p=0.23 . Average BMI increases over the fall semester in the control ( 24.2 ( 0.6 ) to 24.6 (0.6)kg/m(2 ) ) versus incentive condition ( 23.1 ( 0.4 ) to 23.5 (0.4)kg/m(2 ) ) were not significantly different ( p=0.70 ) . CONCLUSION Weekly monetary incentives result ed in significantly more first-year students meeting weekly fitness-center use goals . However , the increased fitness-center use by the incentive condition did not prevent an increase in BMI during fall semester Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs Objective To examine whether adding either small , variable financial incentives or optional group sessions improves weight losses in a community-based , Internet behavioral program . Design and methods Participants ( N=268 ) from Shape Up Rhode Isl and 2012 , a 3 month Web-based community wellness initiative , were r and omized to : Shape Up+Internet behavioral program ( SI ) , Shape Up+Internet program+Incentives ( SII ) , or Shape Up+Internet program+Group sessions ( SIG ) . Results At the end of the 3 month program , SII achieved significantly greater weight losses than SI ( SII:6.4 % [ 5.1 - 7.7 ] ; SI:4.2 % [ 3.0 - 5.6 ] ; P=.03 ) ; weight losses in SIG were not significantly different from the other two conditions ( SIG : 5.8 % [ 4.5 - 7.1 ] , P’s≥.10 ) . However , at the 12 month no treatment follow-up visit , both SII and SIG had greater weight losses than SI ( SII : 3.1 % [ 1.8 - 4.4 ] ; SIG : 4.5 % [ 3.2 - 5.8 ] ; SI : 1.2 % [ -0.1 - 2.6 ] ; P’s≤.05 ) . SII was the most cost-effective approach at both 3 ( SII : $ 34/kg ; SI : $ 34/kg ; SIG : $ 87/kg ) and 12 months ( SII : $ 64/kg ; SI : $ 140/kg ; SIG : $ 113/kg ) . Conclusions Modest financial incentives enhance weight losses during a community campaign and both incentives and optional group meetings improved overall weight loss outcomes during the follow-up period . However , the use of the financial incentives is the most cost-effective approach Background This research evaluated the effects of financial incentives and purchase restrictions on food purchasing in a food benefit program for low income people . Methods Participants ( n=279 ) were r and omized to groups : 1 ) Incentive- 30 % OUTPUT:

Our primary conclusion is that there is a lack of compelling evidence that incentives of any form represent a compelling NCD reduction strategy .

MS2_dynamic_1_shot586

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To address the epidemic of hypertension in blacks born and living in sub-Saharan Africa , we compared in a r and omised clinical trial ( NCT01030458 ) single-pill combinations of old and new antihypertensive drugs in patients ( 30–69 years ) with uncomplicated hypertension ( 140–179/90–109 mm Hg ) . After ⩾4 weeks off treatment , 183 of 294 screened patients were assigned to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg ( n=89 ; R ) or amlodipine/valsartan 5/160 mg ( n=94 ; E ) and followed up for 6 months . To control blood pressure ( < 140/<90 mm Hg ) , bisoprolol and amlodipine could be doubled ( 10 mg per day ) and α-methyldopa ( 0.5–2 g per day ) added . Sitting blood pressure fell by 19.5/12.0 mm Hg in R patients and by 24.8/13.2 mm Hg in E patients and heart rate decreased by 9.7 beats per minute in R patients with no change in E patients ( –0.2 beats per minute ) . The between-group differences ( R minus E ) were 5.2 mm Hg ( P<0.0001 ) systolic , 1.3 mm Hg ( P=0.12 ) diastolic , and 9.6 beats per minute ( P<0.0001 ) . In 57 R and 67 E patients with data available at all visits , these estimates were 5.5 mm Hg ( P<0.0001 ) systolic , 1.8 mm Hg ( P=0.07 ) diastolic and 9.8 beats per minute ( P<0.0001 ) . In R compared with E patients , 45 vs 37 % ( P=0.13 ) proceeded to the higher dose of r and omised treatment and 33 vs 9 % ( P<0.0001 ) had α-methyldopa added . There were no between-group differences in symptoms except for ankle oedema in E patients ( P=0.012 ) . In conclusion , new compared with old drugs lowered systolic blood pressure more and therefore controlled hypertension better in native African black patients Background The efficacy of angiotensin-converting enzyme ( ACE ) inhibitors in decreasing blood pressure in African patients is controversial . Objective We examined the ambulatory blood pressure ( ABP ) response to a diuretic and an ACE inhibitor in hypertensive patients of East African descent and evaluated the individual characteristics that determined treatment efficacy . Design A single-blind r and omized AB/BA crossover design . Setting Hypertensive families of East African descent from the general population in the Seychelles . Participants Fifty-two ( 29 men and 23 women ) out of 62 eligible hypertensive patients were included . Main outcome measures ABP response to 20 mg lisinopril ( LIS ) daily and 25 mg hydrochlorothiazide ( HCT ) daily given for a 4-week period . Results The daytime systolic/diastolic ABP response to HCT was 4.9 [ 95 % confidence interval ( CI ) 1.2–8.6]/3.6 ( 1.0–6.2 ) mmHg for men and 12.9 (9.2–16.6)/6.3 ( 3.7–8.8 ) mmHg for women . With LIS the response was 18.8 (15.0–22.5)/14.6 ( 12.0–17.1 ) mmHg for men and 12.4 (8.7–16.2)/7.7 ( 5.1–10.2 ) mmHg for women . The night-time systolic/diastolic response to HCT was 5.0 (0.6–9.4)/2.7 [ (−0.4)–5.7 ] mmHg for men and 11.5 (7.1–16.0)/5.7 ( 2.6–8.8 ) mmHg for women , and to LIS was 18.7 (14.2–22.1)/15.4 ( 12.4–18.5 ) mmHg for men and 3.5 [(−1.0)–7.9]/2.3 [ (−0.8)–5.4 ] mmHg for women . Linear regression analyses showed that gender is an independent predictor of the ABP responses to HCT and to LIS . Conclusions Hypertensive patients of African descent responded better to LIS than to HCT . Men responded better to LIS than to HCT and women responded similarly to both drugs Objective : To investigate HIV , its treatment , and hypertension as stroke risk factors in Malawian adults . Methods : We performed a case-control study of 222 adults with acute stroke , confirmed by MRI in 86 % , and 503 population controls , frequency-matched for age , sex , and place of residence , using Global Positioning System for r and om selection . Multivariate logistic regression models were used for case-control comparisons . Results : HIV infection ( population attributable fraction [ PAF ] 15 % ) and hypertension ( PAF 46 % ) were strongly linked to stroke . HIV was the predominant risk factor for young stroke ( ≤45 years ) , with a prevalence of 67 % and an adjusted odds ratio ( aOR ) ( 95 % confidence interval ) of 5.57 ( 2.43–12.8 ) ( PAF 42 % ) . There was an increased risk of a stroke in patients with untreated HIV infection ( aOR 4.48 [ 2.44–8.24 ] , p < 0. OUTPUT: Fewer studies assessing combination therapy were available , but there was a trend towards superiority for CCBs plus ACE inhibitors or diuretics compared to other combinations . Evidence broadly supports current guidelines and provides a clear rationale for promoting CCBs as first-line agents and early initiation of combination therapy . INPUT: In a prospect i ve cohort study , associations of resting heart rate with risk of coronary , cardiovascular disease , cancer , and all-cause mortality in age-specific cohorts of black and white men and women were examined over 22 years of follow-up . Participants were employees from 84 companies and organizations in the Chicago , Illinois , area who volunteered for a screening examination . Participants included 9,706 men aged 18 - 39 years , 7,760 men aged 40 - 59 years , 1,321 men aged 60 - 74 years , 6,928 women aged 18 - 39 years , 6,915 women aged 40 - 59 years , and 1,151 women aged 60 - 74 years at the baseline examination in 1967 - 1973 . Vital status was ascertained through 1992 . For fatal coronary disease , multivariate-adjusted relative risks associated with a 12 beats per minute higher heart rate ( one st and ard deviation ) were as follows : for men aged 18 - 39 years , relative risk ( RR ) = 1.27 ( 95 % confidence interval ( CI ) 1.08 - 1.48 ) ; for men aged 40 - 59 years , RR = 1.13 ( 95 % CI 1.05 - 1.21 ) ; for men aged 60 - 74 years , RR = 1.00 ( 95 % CI 0.89 - 1.12 ) ; for women aged 40 - 59 years , RR = 1.21 ( 95 % CI 1.07 - 1.36 ) ; and for women aged 60 - 74 years , RR = 1.16 ( 95 % CI 0.99 - 1.37 ) . Corresponding risks for all fatal cardiovascular diseases were similar to those for coronary death alone . Deaths from cancer were significantly associated with heart rate in men and women aged 40 - 59 years . All-cause mortality was associated with higher heart rate in men aged 18 - 39 years ( RR = 1.11 , 95 % CI 1.01 - 1.20 ) , men aged 40 - 59 years ( RR = 1.16 , 95 % CI 1.11 - 1.21 ) , and women aged 40 - 59 years ( RR = 1.20 , 95 % CI 1.13 - 1.27 ) . Heart rate was not associated with mortality in women aged 18 - 39 years . In summary , heart rate was a risk factor for mortality from coronary disease , all cardiovascular diseases , and all causes in younger men and in middle-aged men and women , and for cancer mortality in middle-aged men and women Summary In a multicentre , double-blind , between-patient study the hypotensive effect of oxprenolol was investigated in 329 patients with mild to moderate hypertension . A factorial experimental design with three factors was chosen : oxprenolol — none or daily doses of 20 , 40 , 60 and 80 mg ; dihydralazine and hydrochlorothiazide , respectively , none or 30 mg daily . Each treatment was given for 4 weeks after an adequate period of withdrawal from any other possible hypotensive therapy and one week of placebo wash-out . Irrespective of the association with dihydralazine and /or hydrochlorothiazide , oxprenolol had a hypotensive effect linearly related to dose for st and ing systolic ( P<0.05 ) and diastolic ( P<0.01 ) pressure , and for lying diastolic ( P<0.05 ) pressure . The addition of dihydralazine enhanced the time-course of the hypotensive effect of oxprenolol , particularly the 80 mg dose level . In general , the combination of oxprenolol with dihydralazine and hydrochlorothiazide caused larger reductions in blood pressure , particularly with oxprenolol 80 mg . In the latter group , the eventual falls in blood pressure were 30.5 and 14.4 mmHg for lying systolic and diastolic , respectively ; and 32.1 and 20.0 mmHg for the st and ing systolic and diastolic pressures . The drug was well tolerated ; major side effects ( heart failure and bronchospasm ) occurred in three patients The effect of atenolol , a new beta-1-adrenergic receptor blocking agent , was studied in a double-blind cross-over trial in 24 carefully selected hypertensive out patients . After a four-week run-in period on matching placebo each patient received atenolol 200 mg/day , atenolol 400 mg/day , a combination of atenolol 200/mg day with bendrofluazide 5 mg/day , and bendrofluazide 5 mg/day alone , according to a r and om sequence . Atenolol at either dose produced a significantly greater reduction in all blood pressure levels except st and ing systolic pressure than bendrofluazide alone . There was no statistically significant difference between the effects of the two atenolol doses on either blood pressure or pulse rate . The addition of bendrofluazide to atenolol result ed in a further significant lowering of the blood pressure . A significant effect of thiazide on weight was noted . The study shows that atenolol , a cardioselective beta-blocker of similar potency to propranolol in animals but without membrane-stabilizing or partial agonist acitivity , is an effective and well-tolerated hypotensive agent This r and omised , double-blind study was design ed to investigate the efficacy of a once-daily ( OD ) combination of the AT1 receptor blocker , epro OUTPUT:

When the blood pressure lowering effect of beta-blockers from this review was compared to that of thiazide diuretics from our previous review ( Chen 2009 ) , second-line beta-blockers reduce systolic BP to the same extent as second-line thiazide diuretics , but reduce diastolic BP to a greater degree . The different effect on diastolic BP means that beta-blockers have little or no effect on pulse pressure whereas thiazides cause a significant dose-related decrease in pulse pressure . This difference in the pattern of BP lowering with beta-blockers as compared to thiazides might be the explanation for the fact that beta-blockers appear to be less effective at reducing adverse cardiovascular outcomes than thiazide diuretics , particularly in older individuals

MS2_dynamic_1_shot587

***TASK*** the task is to summarize an input biomedical literature 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 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 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 PURPOSE To evaluate the efficacy and safety of high-dose , hypofractionated proton beam therapy for hepatocellular carcinoma ( HCC ) and intrahepatic cholangiocarcinoma ( ICC ) . MATERIAL S AND METHODS In this single-arm , phase II , multi-institutional study , 92 patients with biopsy-confirmed HCC or ICC , determined to be unresectable by multidisciplinary review , with a Child-Turcotte-Pugh score ( CTP ) of A or B , ECOG performance status of 0 to 2 , no extrahepatic disease , and no prior radiation received 15 fractions of proton therapy to a maximum total dose of 67.5 Gy equivalent . Sample size was calculated to demonstrate > 80 % local control ( LC ) defined by Response Evaluation Criteria in Solid Tumors ( RECIST ) 1.0 criteria at 2 years for HCC patients , with the parallel goal of obtaining acceptable precision for estimating outcomes for ICC . RESULTS Eighty-three patients were evaluable : 44 with HCC , 37 with ICC , and two with mixed HCC/ICC . The CTP score was A for 79.5 % of patients and B for 15.7 % ; 4.8 % of patients had no cirrhosis . Prior treatment had been given to 31.8 % of HCC patients and 61.5 % of ICC patients . The median maximum dimension was 5.0 cm ( range , 1.9 to 12.0 cm ) for HCC patients and 6.0 cm ( range , 2.2 to 10.9 cm ) for ICC patients . Multiple tumors were present in 27.3 % of HCC patients and in 12.8 % of ICC patients . Tumor vascular thrombosis was present in 29.5 % of HCC patients and in 28.2 % of ICC patients . The median dose delivered to both HCC and ICC patients was 58.0 Gy . With a median follow-up among survivors of 19.5 months , the LC rate at 2 years was 94.8 % for HCC and 94.1 % for ICC . The overall survival rate at 2 years was 63.2 % for HCC and 46.5 % ICC . CONCLUSION High-dose hypofractionated proton therapy demonstrated high LC rates for HCC and ICC safely , supporting ongoing phase III trials of radiation in HCC and ICC 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 . PURPOSE To describe results of a planned interim analysis of a prospect i ve , OUTPUT: For the comparison of radiotherapy plus chemoembolisation versus chemoembolisation alone , the risk ratio for one-year all-cause mortality was 0.51 ( 95 % confidence interval ( CI ) 0.41 to 0.62 ; P < 0.001 ; 9 trials ; low- quality evidence ) ; for complete response rate was 2.14 ( 95 % CI 1.47 to 3.13 ; P < 0.001 ; 7 trials ; low- quality evidence ) ; and for overall response rate defined as complete response plus partial response was 1.58 ( 95 % CI 1.40 to 1.78 ; P < 0.001 ; 7 trials ; low- quality evidence ) , all in favour of combined treatment with external beam radiotherapy plus transarterial chemoembolisation and seemingly supported by our Trial Sequential Analysis . Additionally , the combined treatment was associated with a higher risk of elevated total bilirubin and elevated alanine aminotransferase . AUTHORS ' CONCLUSIONS We found very low- and low- quality evidence suggesting that combined external beam radiotherapy and chemoembolisation may be associated with lower mortality and increased complete and overall response rates , despite an increased toxicity as expressed by a higher rise of bilirubin and alanine aminotransferase . 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 & NA ; The double‐blinded r and omized controlled trial showed that daily repetitive transcranial magnetic stimulation of primary motor cortex provided short‐term positive effect on neuropathic pain without serious adverse events . & NA ; There is little evidence for multisession repetitive transcranial magnetic stimulation ( rTMS ) on pain relief in patients with neuropathic pain ( NP ) , although single‐session rTMS was suggested to provide transient pain relief in NP patients . We aim ed to assess the efficacy and safety of 10 daily rTMS in NP patients . We conducted a r and omized , double‐blind , sham‐controlled , crossover study at 7 centers . Seventy NP patients were r and omly assigned to 2 groups . A series of 10 daily 5‐Hz rTMS ( 500 pulses/session ) of primary motor cortex ( M1 ) or sham stimulation was applied to each patient with a follow‐up of 17 days . The primary outcome was short‐term pain relief assessed using a visual analogue scale ( VAS ) . The secondary outcomes were short‐term change in the short form of the McGill pain question naire ( SF‐MPQ ) , cumulative changes in the following scores ( VAS , SF‐MPQ , the Patient Global Impression of Change scale [ PGIC ] , and the Beck Depression Inventory [ BDI ] ) , and the incidence of adverse events . Analysis was by intention to treat . This trial is registered with the University hospital Medical Information Network Clinical Trials Registry . Sixty‐four NP patients were included in the intention‐to‐treat analysis . The real rTMS , compared with the sham , showed significant short‐term improvements in VAS and SF‐MPQ scores without a carry‐over effect . PGIC scores were significantly better in real rTMS compared with sham during the period with daily rTMS . There were no significant cumulative improvements in VAS , SF‐MPQ , and BDI . No serious adverse events were observed . Our findings demonstrate that daily high‐frequency rTMS of M1 is tolerable and transiently provides modest pain relief in NP patients Introduction Systematic review er authors intending to include all r and omized participants in their meta-analyses need to make assumptions about the outcomes of participants with missing data . Objective The objective of this paper is to provide systematic review er authors with a relatively simple guidance for addressing dichotomous data for participants excluded from analyses of r and omized trials . Methods This guide is based on a review of the Cochrane h and book and published method ological research . The guide deals with participants excluded from the analysis who were considered ‘ non-adherent to the protocol ’ but for whom data are available , and participants with missing data . Results Systematic review er authors should include data from ‘ non-adherent ’ participants excluded from the primary study authors ' analysis but for whom data are available . For missing , unavailable participant data , authors may conduct a complete case analysis ( excluding those with missing data ) as the primary analysis . Alternatively , they may conduct a primary analysis that makes plausible assumptions about the outcomes of participants with missing data . When the primary analysis suggests important benefit , sensitivity meta-analyses using relatively extreme assumptions that may vary in plausibility can inform the extent to which risk of bias impacts the confidence in the results of the primary analysis . The more plausible assumptions draw on the outcome event rates within the trial or in all trials included in the meta- analysis . The proposed guide does not take into account the uncertainty associated with assumed events . Conclusions This guide proposes methods for h and ling participants excluded from analyses of r and omized trials . These methods can help in establishing the extent to which risk of bias impacts meta- analysis results Objective . Pain is a patient-important outcome , but current reporting in r and omized controlled trials and systematic review s is often suboptimal , impeding clinical interpretation and decision making . Methods . A working group at the 2014 Outcome Measures in Rheumatology ( OMERACT 12 ) was convened to provide guidance for reporting treatment effects regarding pain for individual studies and systematic review s. Results For individual trials , authors should report , in addition to mean change , the proportion of patients achieving 1 or more thresholds of improvement from baseline pain ( e.g. , ≥ 20 % , ≥ 30 % , ≥ 50 % ) , achievement of a desirable pain state ( e.g. , no worse than mild pain ) , and /or a combination of change and state . Effects on pain should be accompanied by other patient-important outcomes to facilitate interpretation . When pooling data for meta analysis , authors should consider converting all continuous measures for pain to a 100 mm visual analog scale ( VAS ) for pain and use the established , minimally important difference ( MID ) of 10 mm , and the conventionally used , appreciably important differences of 20 mm , 30 mm , and 50 mm , to facilitate interpretation . Effects ≤ 0.5 units suggest a small or very small effect . To further increase interpretability , the pooled estimate on the VAS should also be transformed to a binary outcome and expressed as a relative risk and risk difference OUTPUT:

Results suggested that all therapies had little to no effect on pain and other patient-important outcomes . Our findings are inconsistent with major clinical practice guidelines ; the available evidence suggests no beneficial effects of any therapies that research ers have evaluated in r and omized controlled trials

MS2_dynamic_1_shot588

***TASK*** the task is to summarize an input biomedical literature 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 evaluated overactive bladder ( OAB ) symptoms and sexual and emotional health in sexually active women with OAB/urgency urinary incontinence ( UUI ) treated with tolterodine extended release ( ER ) . Sexually active women with OAB symptoms were r and omized to placebo or tolterodine ER . Five-day bladder diaries , Sexual Quality of Life Question naire — Female ( SQOL-F ) , Pelvic Organ Prolapse/Urinary Incontinence Sexual Question naire ( PISQ ) , and Hospital Anxiety and Depression Scale ( HAD ) were completed at baseline and week 12 . Tolterodine ER ( n = 201 ; mean ± SD age , 49 ± 12 years ) reduced UUI episodes ( P = 0.0029 ) , total ( P = 0.0006 ) and OAB ( P < 0.0001 ) micturitions , and pad use per 24 h ( P = 0.0024 ) , and was associated with improvements in SQOL-F ( P = 0.004 ) , PISQ total ( P = 0.009 ) , and HAD Anxiety ( P = 0.03 ) scores versus placebo ( n = 210 ; mean ± SD age , 47 ± 12 years ) . OAB symptoms improved with tolterodine ER as did the scores of sexual health and anxiety measures in sexually active women with OAB The Authors carried out a r and om double-blind trial on 30 patients affected by idiopathic urge incontinence with oxybutynin chloride ( 15 mg/die ) and placebo for two 20 day therapeutical cycles . The 24 patients who completed the trial oxybutynin chloride induced statistically significant effects -- compared to placebo too -- both on the subjective symptoms ( reduction or disappearance of the urgency in 14 cases - 60.8 % - and of urge incontinence in 16 cases - 76.1 % ) and on the objective symptoms showed by cystomanometry ( increased bladder capacity at the FD and VSD in 14 and 15 cases , respectively ; absence of involuntary contraction in 9 cases and normal or reduced detrusor pressure at the VSD in 13 out of 16 cases ) . Improvements , though less significant , were also obtained with the placebo BACKGROUND Solifenacin succinate is an antimuscarinic drug with reported efficacy and tolerability at a recommended starting dose of 5 mg QD in patients with overactive bladder ( OAB ) . OBJECTIVE The objective of this trial was to investigate the efficacy , safety , and tolerability of solifenacin 10 mg QD in patients with OAB . METHODS In this multicenter , Phase III , double-blind , placebo-controlled , parallel-group trial , patients aged ≥18 years with OAB were r and omized at a 1:1 ratio to receive solifenacin 10 mg or placebo QD for 12 weeks . The patients were instructed to complete a micturition diary for the 3 days preceding each scheduled visit ( weeks 4 , 8 , and 12 ) . The primary end point was the change from baseline in the mean number of micturitions per 24 hours ; secondary end points included the mean change from baseline in the number of episodes per 24 hours of urgency , incontinence , nocturnal voiding , and nocturia and the mean volume voided per micturition . Tolerability was monitored through adverse events ( AEs ) , vital sign measurements , ECGs , laboratory assessment s , and physical examination . RESULTS A total of 672 patients were r and omized and received ≥1 dose of study drug ( solifenacin , n = 340 ; placebo , n = 332 ) . The mean ( SE ) decrease from baseline to study end in the number of micturitions per 24 hours was significantly greater in the solifenacin group compared with the placebo group ( -3.0 [ 0.2 ] vs -1.5 [ 0.2 ] , respectively ; P < 0.001 ) . The mean decrease in the number of episodes of incontinence was significantly greater in the solifenacin group compared with the placebo group ( -2.0 [ 0.2 ] vs -1.1 [ 0.2 ] ; P < 0.001 ) , as was the mean decrease in the number of episodes of urgency ( -4.1 [ 0.2 ] vs -2.1 [ 0.2 ] ; P < 0.001 ) . Of the patients with ≥1 incontinence episode per 24 hours at baseline , significantly more patients in the solifenacin group achieved complete continence at study end than did patients in the placebo group ( 119/225 [ 52.9 % ] vs 80/237 [ 33.8 % ] ; P < 0.001 ) . The change from baseline to study end in the mean volume voided per micturition increased significantly in the solifenacin group compared with the placebo group ( 47.2 vs 2.7 mL ; P < 0.001 ) . Most AEs were mild or moderate in intensity . The AEs that were most commonly reported in the solifenacin-treated group were anticholinergic in nature : dry mouth ( 91 [ 26.8 % ] vs 13 patients [ 3.9 % ] in the placebo group ; P < 0.001 ) ; constipation ( 58 [ 17.1 % ] vs 11 [ 3.3 % ] ; P < 0.001 ) ; and blurred vision ( 12 [ 3.5 % ] vs 4 [ 1.2 % ] ; P < 0.05 ) . Serious AEs ( SAEs ) were reported for 5 patients in the solifenacin group and 3 patients in the placebo group . In the solifenacin group , OUTPUT: This is the first study allowing trade-offs between efficacy and adverse events of various drugs and dosages in the treatment of patients with OAB . INPUT: PURPOSE VICTOR was a 12-week , double-blind , placebo controlled trial assessing the safety and tolerability of solifenacin plus tamsulosin in men with residual overactive bladder symptoms after tamsulosin monotherapy . Efficacy of solifenacin plus tamsulosin vs placebo plus tamsulosin was also evaluated . MATERIAL S AND METHODS A total of 398 men 45 years old or older were r and omized to 12 weeks of solifenacin plus tamsulosin or placebo plus tamsulosin once daily . The study population had 8 or more micturitions per 24 hours and 1 or more urgency episode per 24 hours after taking tamsulosin for 4 or more weeks , a total International Prostate Symptom Score of 13 or greater , a Patient Perception of Bladder Condition score of 3 or greater , a post-void residual of 200 ml or less and a peak flow rate of 5 ml per second or greater . Adverse events were monitored throughout the study . The primary efficacy end point was mean change from baseline to week 12 in micturitions per 24 hours . Secondary measures included mean change in urgency episodes per 24 hours , and changes in Patient Perception of Bladder Condition , Urgency Perception Scale and total International Prostate Symptom Scores . RESULTS The most frequent adverse events in the solifenacin plus tamsulosin and placebo plus tamsulosin groups were dry mouth ( 7 % and 3 % , respectively ) and dizziness ( 3 % and 2 % , respectively ) . Of the patients on solifenacin plus tamsulosin 7 ( 3 % ) reported retention and 3 required catheterization . No patients on placebo plus tamsulosin reported retention . Patients on solifenacin plus tamsulosin vs placebo plus tamsulosin showed larger reductions in frequency but not of statistical significance ( -1.05 vs -0.67 , p = 0.135 ) . However , patients on solifenacin plus tamsulosin vs placebo plus tamsulosin did show statistically significant reductions in urgency ( -2.18 vs -1.10 , p < 0.001 ) . Patient reported outcome measures showed no significant between group differences . CONCLUSIONS Solifenacin plus tamsulosin was well tolerated . There was a low incidence of urinary retention requiring catheterization . At week 12 solifenacin plus tamsulosin decreased daily micturitions and urgency episodes . Only urgency reached statistical significance vs placebo plus tamsulosin PURPOSE In this open label , prospect i ve study we determined the efficacy and tolerability of tolterodine extended release ( ER ) in men with benign prostatic hyperplasia ( BPH ) and lower urinary tract symptoms ( LUTS ) in whom previous alpha-blocker therapy had failed . MATERIAL S AND METHODS A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events ( 11 ) or a lack of efficacy ( 32 ) received tolterodine ER ( 4 mg daily ) for 6 months . Primary efficacy end points were American Urological Association symptom score , and mean daytime and nighttime micturition frequency . Secondary end points were the peak urinary flow rate , post-void residual volume , the incidence of urinary retention , total score on the erectile function domain of the International Index of Erectile Function and adverse events . RESULTS A total of 39 men ( 91 % ) with a mean age of 61 years completed the 6-month trial . Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly . Significant changes in mean American Urological Association symptom scores ( -6.1 ) , the peak urinary flow rate ( 1.9 ml per second ) and post-void residual volume ( -22 ml ) were also observed . Of the men 27 ( 63 % ) were potent at baseline and 29 ( 67 % ) were potent after 6 months of tolterodine ER treatment . Mean International Index of Erectile Function erectile function domain scores increased ( 6.9 ) . Four men ( 9 % ) discontinued therapy because of intolerable dry mouth . There were no reports of urinary retention . CONCLUSIONS Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers PURPOSE We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder ( OAB ) and benign prostatic obstruction . MATERIAL S AND METHODS Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction ( Abrams-Griffith score greater than 20 ) were r and omized ( 1:2 ) into 2 groups , namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation ( 4 mg once daily ) only and group 2-propiverine hydrochloride ( 20 mg once daily ) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen . RESULTS A total of 211 men , including 69 in group 1 and 142 in group 2 , were treated and 198 ( 93.8 % ) completed the 8 weeks of treatment . Significant improvements were noted in each group after treatment in urinary frequency , maximum flow rate , average micturition volume and International Prostate Symptom Score . Compared with group 1 improvement rates with regard to urinary frequency ( 23.5 % vs 14.3 % , p = 0.004 ) , average mictur OUTPUT:

Data from 12-week , r and omised , double-blind , placebo-controlled trials of tolterodine extended release ( ER ) , oxybutynin and solifenacin show that combined antimuscarinic+α-blocker treatment is generally more effective than monotherapy or placebo in men with OAB symptoms . The efficacy and safety of tolterodine ER+α-blocker treatment was not affected by prostate size or prostate-specific antigen ( PSA ) level . In men meeting entry criteria for OAB and benign prostatic obstruction trials , tolterodine ER alone was effective selectively in men with prostate size or PSA level below study medians . Post hoc analyses from double-blind , placebo-controlled trials and prospect i ve studies of fesoterodine , oxybutynin , propiverine , solifenacin and tolterodine also suggest that antimuscarinics are generally safe and efficacious in men . A retrospective data base study found that risk of AUR in men was the highest in the first month of treatment and decreased considerably thereafter . Antimuscarinics , alone or with an α-blocker , appear to be efficacious and safe in many men with predominant OAB symptoms or persistent OAB symptoms despite α-blocker or 5-α-reductase inhibitor treatment .

MS2_dynamic_1_shot589

***TASK*** the task is to summarize an input biomedical literature 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 This study aim ed to evaluate the associations of selected demographic , individual , social , and environmental factors with moderate-to-vigorous physical activity ( MVPA ) in a sample of children and adolescents . Methods MVPA was assessed among youth ( n = 294 ) 10 - 17-years-old using the ActiGraph accelerometer . Youth completed measures of demographic and individual variables related to physical activity ( PA ) , perceived social support by parents and peers , and perceived neighborhood characteristics . Parents completed the long-form of the International Physical Activity Question naire . The Physical Activity and Media Inventory was used to measure the home environment and Geographical Information Systems software was used to measure the physical neighborhood environment . Bivariate correlations and hierarchical multiple regression were conducted stratified by gender . Results Boys participated in significantly more MVPA than girls . In hierarchical analyses , peer support , home PA equipment , and temperature were significantly associated with MVPA among boys whereas distance to the school they attended was associated with MVPA among girls . The final models accounted for 25 % and 15 % of the variance in MVPA among boys and girls , respectively . Conclusions Important differences exist among the individual , social , and environmental factors related to MVPA between boys and girls . Boys ' levels of activity appear to be influenced by factors closely linked to unstructured and social types of activities whereas girls ' activities relate to internal and external barriers as well as their proximity to their schools . The prospect i ve contribution of these important individual , social , and environmental factors to changes in MVPA among children and adolescents remains to be determined PURPOSE The objectives of this study were to describe longitudinal trends in adolescent physical activity in a sample of U.S. adolescents and to assess the effect of multiple individual , parental , and environmental factors on initial level and rates of change in adolescent physical activity . METHODS Study subjects were 12,812 boys and girls 10 to 18 years of age who were participating in the Growing Up Today Study and their mothers . We used accelerated longitudinal analysis to describe trajectories of physical activity from 1997 - 1999 , and r and om effects linear mixed models to determine which factors were independently associated with baseline physical activity and changes in physical activity over time . RESULTS Mean hours of physical activity ranged from 7.3 - 11.6 hours per week in boys and from 8.0 - 11.2 hours per week in girls . Physical activity was best modeled as a quadratic function of age , increasing until early adolescence and declining after age 13 in boys and girls . Multivariable modeling demonstrated that variables associated with physical activity level at baseline in boys and girls were age , body mass index , psychosocial variables , personal attitudes about body shape , perceived peer attitudes about body shape/fitness , parental attitudes about physical activity , parental physical activity , and environmental barriers to physical activity . Age was the only factor that predicted change in physical activity over time . CONCLUSIONS Interventions to increase physical activity in adolescents should begin before adolescence . Interventions may be more effective if they are multimodal and focus on modifiable individual , parental , and environmental factors OBJECTIVE To test whether self-efficacy for overcoming barriers to physical activity has direct , indirect ( i.e. , mediated ) , or moderating relations with naturally occurring change in perceived social support and declines in physical activity during high school . METHODS Latent growth modeling was used with measures completed in the 8th , 9th , and 12th grade s by a cohort of 195 Black and White girls . RESULTS Self-efficacy was stable and moderated the relation between changes in physical activity and perceived social support . Girls who maintained a perception of strong social support had less of a decline in physical activity if they also had high self-efficacy . However , girls having high self-efficacy had a greater decline in physical activity if they perceived declines in social support . CONCLUSIONS R and omized controlled trials of physical activity interventions based on social cognitive theory should consider that the influence of girls ' perceptions of social support on their physical activity may differ according to their efficacy beliefs about barriers to physical activity Background Few studies have examined the mediators of behavior change in successful school-based physical activity interventions . The aim of this study was to explore potential mediators of physical activity in the Fit-4-Fun program for primary school children . Design Group r and omized controlled trial . Methods Four primary schools were recruited in April , 2011 and r and omized by school into intervention or control conditions . Participants included 213 children ( mean age = 10.7 years ± 0.6 ; 52.2 % female ) with the treatment group ( n = 118 ) completing the 8-week multi-component Fit-4-Fun program . Participants were assessed at baseline , 3- and 6-months . Physical activity was measured using Yamax SW700 pedometers ( mean steps/day ) and question naires were used to assess constructs from Social Cognitive Theory and Competence Motivation Theory . Hypothesized mediators measured included social support from peers , parents and teachers ; physical activity self-efficacy ( barrier and task ) ; enjoyment ; and perceived school physical environment . Mediation was assessed using Preacher and Hayes ’ multiple mediation regression SPSS macro . Action theory ( A ) , conceptual theory ( B ) and the significance of the product of coefficients ( AB ) are reported . Results The intervention had a significant effect on physical activity ( p<0.001 ) . The action theory test results revealed significant treatment effects at 3-months for perceived school environment ( A=0.28 , p<0.001 ) ; and at 6-month follow-up for perceived school environment ( A=0.058 , p<0.001 ) , teacher social support ( A=0.54 , p<0.05 ) and enjoyment ( A=-0.23 , p<0.05 ) . The conceptual theory test revealed a significant relationship between changes in teacher social support and changes in physical activity at 6-month follow-up ( B=828 , P<0.05 ) . Teacher social support was shown to have a significant mediating effect OUTPUT: Longitudinal research supported the cross-sectional analyses . INPUT: Background This study aim ed to evaluate the associations of selected demographic , individual , social , and environmental factors with moderate-to-vigorous physical activity ( MVPA ) in a sample of children and adolescents . Methods MVPA was assessed among youth ( n = 294 ) 10 - 17-years-old using the ActiGraph accelerometer . Youth completed measures of demographic and individual variables related to physical activity ( PA ) , perceived social support by parents and peers , and perceived neighborhood characteristics . Parents completed the long-form of the International Physical Activity Question naire . The Physical Activity and Media Inventory was used to measure the home environment and Geographical Information Systems software was used to measure the physical neighborhood environment . Bivariate correlations and hierarchical multiple regression were conducted stratified by gender . Results Boys participated in significantly more MVPA than girls . In hierarchical analyses , peer support , home PA equipment , and temperature were significantly associated with MVPA among boys whereas distance to the school they attended was associated with MVPA among girls . The final models accounted for 25 % and 15 % of the variance in MVPA among boys and girls , respectively . Conclusions Important differences exist among the individual , social , and environmental factors related to MVPA between boys and girls . Boys ' levels of activity appear to be influenced by factors closely linked to unstructured and social types of activities whereas girls ' activities relate to internal and external barriers as well as their proximity to their schools . The prospect i ve contribution of these important individual , social , and environmental factors to changes in MVPA among children and adolescents remains to be determined 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 Background and aims : Home-based exercise is a viable solution for frail elderly individuals with difficulties in reaching exercise facilities outside home . The aim of this study was to determine the effects of a home-based video exercise program on physiological performance , functional capacity and health-related quality of life . Methods : Community-dwelling frail women ≥75 yrs , receiving public home care , were r and omized into a training group ( n=30 ) and a control group ( n=31 ) . Participants exercised for 26 minutes , three times per week for five months . Both groups received a bi-weekly telephone call . The effect of intervention was evaluated by the physical performance test , mobility-tiredness score , maximal isometric h and grip and biceps strength , lower limb explosive power , repeated chair rise ( 5 times ) , 10-m maximal walking-speed , semi-t and em balance , and health-related quality of life , as measured by EQ-5D and self-rated health . Results : Twenty-five participants ( 83 % ) in the training group and 28 ( 90 % ) in the control group completed the project . Adherence to the training protocol was on average 89.2 % . At follow-up , between-group analysis revealed a significant difference only in EQ-5D ( valued by time-trade-off tariffs ) , result ing from a significant decrease observed in the control group and a trend towards an increase in the training group ( p=0.082 ) . Significant within-group improvements , ranging from 8–35 % , were also observed for the physical performance test , mobility-tiredness score , h and grip , biceps strength , chair rise , and 10-m maximal walking-speed in the training group , and for walking-speed and self-rated health in the control group . Conclusions : These results suggest that home-based training for frail older women using an exercise video induces lasting health-related quality -of-life ( EQ-5D ) . In addition , a tendency towards improvements in physiological performance and functional capacity was observed Background The family food environment is an important influence in the development OUTPUT:

Interventions that reduced sedentary time by using TV limiting devices were shown to be effective for children but the results were limited for adults . Overall , large exercise equipment ( ie . treadmills ) , and prominent exergaming material s ( exergaming bike , dance mats ) were found to be more effective than smaller devices . Observational studies revealed that location and quantity of televisions correlated with SD behavior with the latter having a greater effect on girls . This was similarly found for the quantity of PA equipment which also correlated with behavior in females .

MS2_dynamic_1_shot590

***TASK*** the task is to summarize an input biomedical literature 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 : Regular aerobic exercise in patients with cystic fibrosis ( CF ) improves aerobic conditioning and delays disease progression , result ing in better quality of life . The purpose of this study was to evaluate the effect of an aerobic exercise program based on verbal and written guidelines on maximum exercise capacity using a cardiopulmonary exercise test , quality of life , and the self-reported aerobic exercise practice of children and adolescents with CF . METHODS : This r and omized controlled trial followed guidelines for physical exercise in a CF center . Subjects were assigned to 2 groups : intervention ( group 1 ) , with 17 subjects ; and control ( group 2 ) , also with 17 subjects . Data were collected from October 2010 to October 2011 , and the study population comprised 7–20-y-old children and adolescents with CF . The intervention consisted of h and ing out a manual with guidelines for aerobic physical exercises and reinforcing recommendations in telephone calls every 2 weeks . RESULTS : Thirty-four subjects were included in the study , 20 of whom were boys ( 58.5 % ) . The groups were similar at baseline . In group 1 , 6 subjects ( 35.2 % ) reported practicing physical exercises regularly . The mean age was 13.4 ± 2.8 y , the mean percent-of-predicted FEV1 was 95.5 ± 17.9 % , and the mean peak oxygen uptake ( V̇O2 ) relative to body mass was 34.9 ± 9.0 mL/kg/min . In group 2 , 4 subjects ( 23.5 % ) reported practicing physical exercises regularly . The mean age was 12.7 ± 3.3 y , the mean percent-of-predicted FEV1 was 100.1 ± 21.2 % , and the mean peak V̇O2 was 33.2 ± 8.2 mL/kg/min . In group 1 , there was a significant increase in physical exercise practice as reported by subjects after 3 months of intervention compared with group 2 ( P = .01 ) . No statistically significant differences were found for the other variables . CONCLUSIONS : Verbal and written guidelines for aerobic exercise , together with supervision over the telephone , had a positive impact on the self-reported regular physical exercise practice of children and adolescents . However , no improvement was found in lung function and maximum exercise capacity or domains of the quality of life question naire STUDY OBJECTIVE Exercise has the potential to improve the ability of a patient with cystic fibrosis ( CF ) to cope with the physical dem and s of everyday life , and may improve prognosis . The purpose of this study was to compare the effects of a home-based , semi-supervised , upper-body strength-training regimen with a similarly structured aerobic training regimen . DESIGN Data were collected during a 1-year r and omized clinical trial . SETTING Counselors conducted in-home visits with the participants once per week for the first 8 weeks followed by monthly visits for the remainder of the study . PATIENTS Sixty-seven patients with CF , aged 8 to 18 years , participated in the trial . INTERVENTION Participants in both exercise conditions were encouraged to exercise at least three times per week for 1 year . Each child in the aerobic group was given a stair-stepping machine , and each child in the upper-body strength training group was given an upper-body-only weight-resistance machine . MEASURES AND RESULTS Aerobic fitness , pulmonary function , quality of life , and strength were measured at baseline , at 6 months , and at 12 months . Strength training increased the maximum weight lifted for biceps curls significantly more than aerobic training ( p < 0.02 ) . However , this differential did not remain significant after control for increase in height . Both training procedures were associated with increased strength ( p < 0.002 ) and physical work capacity ( PWC ) [ p < 0.033 ] . CONCLUSIONS We concluded that strength and aerobic training may increase upper-body strength , and that both types of training may increase PWC for children with CF . Future trials should be conducted with no-training control subjects and larger sample s to increase statistical power QUESTION Does exercise using a gaming console result in similar cardiovascular dem and and energy expenditure as formally prescribed exercise in adults with cystic fibrosis ? How do these patients perceive gaming console exercise ? DESIGN R and omised cross-over trial with concealed allocation and intention-to-treat analysis . PARTICIPANTS 19 adults with cystic fibrosis admitted to hospital for treatment of a pulmonary exacerbation . INTERVENTION Participants underwent two 15-minute exercise interventions on separate days ; one involving a gaming console and one a treadmill or cycle ergometer . OUTCOME MEASURES Cardiovascular dem and was measured using heart rate and rating of perceived exertion ( RPE ) . Energy expenditure was estimated using a portable activity monitor . Perception ( enjoyment , fatigue , workload , effectiveness , feasibility ) was rated using a horizontal 10-cm visual analogue scale . RESULTS There was no significant difference in average heart rate ( mean difference 3 beats/min , 95 % CI -3 to 9 ) or energy expenditure ( 0.1 MET , 95 % CI -0.3 to 0.5 ) between the two interventions . Both interventions provided a ' hard ' workout ( RPE ∼15 ) . Gaming console exercise was rated as more enjoyable ( mean difference 2.6 cm , 95 % CI 1.6 to 3.6 ) than formal exercise but they did n't differ significantly in fatigue ( -1.0 cm , 95 % CI -2.4 to 0.3 ) , perceived effectiveness ( -0.4 cm , 95 % CI -1.2 to 0.3 ) , or perceived feasibility for inclusion in routine management ( 0.2 cm , OUTPUT: There was also wide variation in the quality of the included studies .This systematic review shows very low- to low- quality evidence from both short- and long-term studies that in people with cystic fibrosis aerobic or anaerobic physical exercise training ( or a combination of both ) has a positive effect on aerobic exercise capacity , pulmonary function and health-related quality of life . Exercise training is already part of regular outpatient care offered to most people with cystic fibrosis , and since there is some evidence for beneficial effects on aerobic fitness and no negative side effects exist , there is no reason to actively discourage this . The benefits from including physical exercise training in an individual 's regular care may be influenced by the type and duration of the training programme . INPUT: BACKGROUND Aerobic training has a number of well known beneficial effects in both normal and asthmatic children . However , the impact of training on the clinical management of the underlying bronchial asthma remains controversial , particularly in the most severe patients . METHODS Clinical evaluation , spirometric tests , symptom limited maximum exercise testing , and exercise challenge tests were performed in a group of children with stable moderate to severe asthma . Forty two patients ( 24 boys ) aged 8–16 were evaluated twice : before and after supervised aerobic training ( group 1 , n = 26 ) and two months apart ( untrained group 2 , n = 16 ) . RESULTS Spirometric and maximal exercise variables in the initial evaluation were significantly reduced in group 1 ( p<0.05 ) but medication and clinical scores and the occurrence of exercise induced bronchospasm ( EIB ) did not differ between the two groups . Aerobic improvement with training ( maximal oxygen uptake and /or anaerobic threshold increment > 10 % and 100 ml ) was inversely related to the baseline level of fitness and was independent of disease severity . Although the clinical score and the occurrence of EIB did not change after training , aerobic improvement was associated with a significant reduction in the medication score and the daily use of both inhaled and oral steroids ( p<0.05 ) . CONCLUSIONS Aerobic improvement with training in less fit asthmatic children is related to a short term decrease in the daily use of inhaled and oral steroids , independent of the severity of the disease The optimal exercise modality for reductions of abdominal obesity and risk factors for type 2 diabetes in youth is unknown . We examined the effects of aerobic exercise ( AE ) versus resistance exercise ( RE ) without caloric restriction on abdominal adiposity , ectopic fat , and insulin sensitivity and secretion in youth . Forty-five obese adolescent boys were r and omly assigned to one of three 3-month interventions : AE , RE , or a nonexercising control . Abdominal fat was assessed by magnetic resonance imaging , and intrahepatic lipid and intramyocellular lipid were assessed by proton magnetic resonance spectroscopy . Insulin sensitivity and secretion were evaluated by a 3-h hyperinsulinemic-euglycemic clamp and a 2-h hyperglycemic clamp . Both AE and RE prevented the significant weight gain that was observed in controls . Compared with controls , significant reductions in total and visceral fat and intrahepatic lipid were observed in both exercise groups . Compared with controls , a significant improvement in insulin sensitivity ( 27 % ) was observed in the RE group . Collapsed across groups , changes in visceral fat were associated with changes in intrahepatic lipid ( r = 0.72 ) and insulin sensitivity ( r = −0.47 ) . Both AE and RE alone are effective for reducing abdominal fat and intrahepatic lipid in obese adolescent boys . RE but not AE is also associated with significant improvements in insulin sensitivity STUDY OBJECTIVE Exercise has the potential to improve the ability of a patient with cystic fibrosis ( CF ) to cope with the physical dem and s of everyday life , and may improve prognosis . The purpose of this study was to compare the effects of a home-based , semi-supervised , upper-body strength-training regimen with a similarly structured aerobic training regimen . DESIGN Data were collected during a 1-year r and omized clinical trial . SETTING Counselors conducted in-home visits with the participants once per week for the first 8 weeks followed by monthly visits for the remainder of the study . PATIENTS Sixty-seven patients with CF , aged 8 to 18 years , participated in the trial . INTERVENTION Participants in both exercise conditions were encouraged to exercise at least three times per week for 1 year . Each child in the aerobic group was given a stair-stepping machine , and each child in the upper-body strength training group was given an upper-body-only weight-resistance machine . MEASURES AND RESULTS Aerobic fitness , pulmonary function , quality of life , and strength were measured at baseline , at 6 months , and at 12 months . Strength training increased the maximum weight lifted for biceps curls significantly more than aerobic training ( p < 0.02 ) . However , this differential did not remain significant after control for increase in height . Both training procedures were associated with increased strength ( p < 0.002 ) and physical work capacity ( PWC ) [ p < 0.033 ] . CONCLUSIONS We concluded that strength and aerobic training may increase upper-body strength , and that both types of training may increase PWC for children with CF . Future trials should be conducted with no-training control subjects and larger sample s to increase statistical power This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer Although exercise may be beneficial in cystic fibrosis ( CF ) , patients ' low tolerance to climatic heat stress means that physical exertion can increase morbidity and mortality . We postulated that the high salt content of CF patients ' sweat and the consequent absence of body-fluid hyperosmolality during a long episode of swe OUTPUT:

Results Overall , exercise intolerance is prevalent in pediatric chronic disease .

MS2_dynamic_1_shot591

***TASK*** the task is to summarize an input biomedical literature 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: There is limited information on the effects of vitamin D on serum 25 hydroxyvitamin D ( 25OHD ) in young people and none on African Americans . The main objective of this trial was to measure the effect of different doses of vitamin D3 on serum 25OHD and serum parathyroid hormone ( PTH ) in young women with vitamin D insufficiency ( serum 25OHD ≤ 20 ng/mL ( 50 nmol/L ) . A r and omized double-blind placebo-controlled trial of vitamin D3 was conducted in young white and African American women , age 25 to 45 years . A total of 198 healthy white ( 60 % ) and African American ( 40 % ) women were r and omly assigned to placebo , or to 400 , 800 , 1600 , or 2400 IU of vitamin D3 daily . Calcium supplements were added to maintain a total calcium intake of 1000 to 1200 mg daily . The primary outcomes of the study were the final serum 25OHD and PTH levels at 12 months . The absolute increase in serum 25OHD with 400 , 800 , 1600 , and 2400 IU of vitamin D daily was slightly greater in African American women than in white women . On the highest dose of 2400 IU/d , the mixed model predicted that mean 25OHD increased from baseline 12.4 ng/mL ( 95 % confidence interval [ CI ] , 9.2 - 15.7 ) to 43.2 ng/mL ( 95 % CI , 38.2 - 48.1 ) in African American women and from 15.0 ng/mL ( 95 % CI , 12.3 - 17.6 ) to 39.1 ng/mL ( 95 % CI , 36.2 - 42.0 ) in white women . There was no significant effect of vitamin D dose on serum PTH in either race but there was a significant inverse relationship between final serum PTH and serum 25OHD . Serum 25OHD exceeded 20 ng/mL in 97.5 % of whites on the 400 IU/d dose and between 800 and 1600 IU/d for African Americans . The recommended dietary allowance ( RDA ) suggested by the Institute of Medicine for young people is 600 IU daily . The increase in serum 25OHD after vitamin D supplementation was similar in young and old , and in white and African American women OBJECTIVE In observational studies , low serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations have been associated with insulin resistance and other risk factors for cardiovascular disease . RESEARCH DESIGN AND METHODS We present 1-year data from an ongoing 5-year trial in 511 individuals with impaired fasting glucose ( IFG ) and /or impaired glucose tolerance ( IGT ) r and omly assigned to 20,000 IU/week vitamin D3 or placebo . An oral glucose tolerance test was performed at baseline and after 1 year . RESULTS Mean baseline serum 25(OH)D was 59.9 nmol/L and 61.1 nmol/L in the vitamin D and placebo groups , respectively , and increased by 45.8 nmol/L and 3.4 nmol/L , respectively . With adjustment for baseline concentrations , no differences in measures of glucose metabolism , insulin secretion or sensitivity , blood pressure , or hs-CRP were found after 1 year . There was a slight , but significant decrease in total and LDL cholesterol in the vitamin D group compared with the placebo group , but as there was also a decrease in HDL cholesterol , the change in the total/HDL cholesterol ratio did not differ significantly . Only analyzing subjects with 25(OH)D < 50 nmol/L did not change the results . CONCLUSIONS This study shows that vitamin D supplementation does not improve glycemic indices , blood pressure , or lipid status in subjects with IFG and /or IGT CONTEXT Observational studies show an association between low vitamin D status assessed by circulating 25-hydroxyvitamin D and cardiovascular events and mortality . Data from r and omized controlled trials are limited . OBJECTIVE The aim of this study was to test whether daily doses of vitamin D(3 ) at 400 or 1000 IU/d for 1 yr affected conventional markers of cardiovascular disease ( CVD ) risk . DESIGN We conducted a parallel-group , double-blind , placebo-controlled r and omized controlled trial . R and omization was computer generated . Participants and study investigators were blinded to intervention groupings throughout the trial . SETTING The study was conducted at the Clinical Research Facility , University of Aberdeen , United Kingdom . PARTICIPANTS A total of 305 healthy postmenopausal women aged 60 - 70 yr were recruited for the study . INTERVENTION Each woman received a daily capsule of 400 or 1000 IU vitamin D(3 ) or placebo r and omly allocated . MAIN OUTCOME MEASURES Primary outcomes were serum lipid profile [ total , high-density lipoprotein , and low-density lipoprotein cholesterol ; triglycerides ; and apolipoproteins A-1 and B100 ] , insulin resistance ( homeostatic model assessment ) , inflammatory biomarkers ( high-sensitivity C-reactive protein , IL-6 , soluble intracellular adhesion molecule-1 ) , and blood pressure . RESULTS A total of 265 ( 87 % ) participants completed all study visits . Small differences between groups for serum apol OUTPUT: In subgroup analyses , it was shown that the effect of vitamin D supplementation on risk of hypercalcemia , hypercalciuria , or kidney stones was not modified by baseline 25-hydroxyvitamin D , vitamin D dose and duration , or calcium co-supplementation . CONCLUSIONS Long-term vitamin D supplementation result ed in increased risks of hypercalcemia and hypercalciuria , which were not dose related . However , vitamin D supplementation did not increase risk of kidney stones . INPUT: BACKGROUND Different dosing protocol s have been used for vitamin D supplementation , but there has been a lack of comparative data among them . OBJECTIVE Our objective was to determine whether the same cumulative dose of vitamin D3 produces different effects if it is given daily , weekly , or monthly . DESIGN Women , age 81 + /- 8 yr ( + /- sd , n = 48 ) , who had undergone surgery to repair hip fracture were r and omized to vitamin D3-supplementation protocol s at 1,500 IU daily , or 10,500 IU once weekly , or 45,000 IU once every 28 d. The primary outcome measure was the serum 25-hydroxyvitamin D [ 25(OH)D ] concentration attained . RESULTS Initially , serum 25(OH)D concentrations for daily , weekly , and monthly groups were , respectively , 15.13 + /- 6.9 , 15.7 + /- 10.1 , and 16.2 + /- 10.1 ng/ml . By d 7 , these had increased significantly in all the groups ( P < 0.001 ) . On the first day after the monthly dose , both serum 25(OH)D and serum 1,25-dihydroxyvitamin D had increased significantly ( P < 0.012 each ) , whereas these did not change significantly on the day after daily or weekly doses . After 2 months , serum 25(OH)D with daily , weekly , and monthly dosing were , respectively , 33.2 + /- 8.5 , 29.2 + /- 8.9 , and 37.1 + /- 10.3 ng/ml ; there were no significant differences among these values . CONCLUSIONS Supplementation with vitamin D can be achieved equally well with daily , weekly , or monthly dosing frequencies . Therefore , the choice of dose frequency can be based on whichever approach will optimize an individual 's adherence with long-term vitamin D supplementation The Cohort Consortium Vitamin D Pooling Project of Rarer Cancers ( VDPP ) brought together 10 cohorts to conduct a prospect i ve study of the association between vitamin D status , measured as serum concentrations of 25-hydroxyvitamin D ( 25(OH)D ) , and the development of 7 rarer cancer sites : endometrial , esophageal , gastric , kidney , non-Hodgkin lymphoma , ovarian , and pancreatic cancers . The cohorts come from 3 continents , with participants from a wide range of latitude who are racially diverse . Across each cancer site , there was no evidence of a protective association between higher concentrations of 25-hydroxyvitamin D ( > 75 nmol/L ) and cancer outcome . An increased risk at very high levels ( ≥100 nmol/L ) was noted for pancreatic cancer , confirming previous reports . The articles included in this issue detail the overall design and governance of the project , correlates of vitamin D status , and results from the cancer site-specific investigations . The Vitamin D Pooling Project realizes a major goal of consortium efforts , namely , to rigorously test hypotheses for rarer cancer outcomes that may not be adequately addressed in any one prospect i ve cohort study . The results of this study have application for the planning and conduct of intervention trials , especially in determining potential risks Objective : Assessment of the effectiveness and safety of high daily 125 μg ( 5000 IU ) or 250 μg ( 10 000IU ) doses of vitamin D2 during 3 months , in rapidly obtaining adequate 25 hydroxyvitamin D ( 25OHD ) levels . Design : Longitudinal study .Subjects : Postmenopausal osteopenic/osteoporotic women ( n=38 ) were studied during winter and spring . Median age ( 25–75th percentile ) was 61.5 ( 57.00–66.25 ) years , and mean bone mineral density ( BMD ) was 0.902 (0.800–1.042)g/cm2 . Subjects were r and omly divided into three groups : control group ( n=13 ) : no vitamin D2 , 125 μg/day ( n=13 ) and 250 μg/day ( n=12 ) of vitamin D2 groups , all receiving 500 mg calcium/day . Serum calcium , phosphate , bone alkaline phosphatase ( BAP ) , C-telopeptide ( CTX ) , 25OHD , mid-molecule parathyroid hormone ( mmPTH ) , daily urinary calcium and creatinine excretion were determined at baseline and monthly . Results : For all subjects ( n=38 ) , the median baseline 25 hydroxyvitamin D ( 25OHD ) level was 36.25 ( 27.5–48.12 ) nmol/l . After 3 months , 8 % of the patients in the control group , 50 % in the 125 μg/day group and 75 % in the 250 μg/day group had 25OHD values above 85 nmol/l ( 34 ng/ml ) . Considering both vitamin D2 groups together , mmPTH and BAP levels diminished significantly after 3 months ( P<0.02 ) , unlike those of CTX . Serum calcium remained within normal range during the follow-up . Conclusions : The oral dose of vitamin D2 required to rapidly achieve adequate levels of 25OHD is seemingly much higher than the usual recommended vitamin D3 dose ( 20 μg/day ) . During 3 months , 250 μg/day of vitamin D2 most effectively raised 25OHD levels to 85 OUTPUT:

Dietary recommendations and r and omized trials on vitamin D supplementation should evaluate whether increases in circulating 25-hydroxyvitamin D levels match expectations -- for instance , the average increases obtained by trials on vitamin D3 without concomitant calcium supplements

MS2_dynamic_1_shot592

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND There has been limited study of yoga training as a complementary exercise strategy to manage the symptom of dyspnea in patients with chronic obstructive pulmonary disease ( COPD ) . PURPOSE The primary purpose of this pilot study was to evaluate a yoga program for its safety , feasibility , and efficacy for decreasing dyspnea intensity ( DI ) and dyspnea-related distress ( DD ) in older adults with COPD . METHODS Clinical ly stable patients with COPD ( n = 29 ; age 69.9 + /- 9.5 ; forced expiratory volume in 1 second ( FEV(1 ) ) 47.7 + /- 15.6 % predicted ; female = 21 ) were r and omized to a 12-week yoga program specifically design ed for people with COPD or usual-care control ( UC ) . The twice-weekly yoga program included asanas ( yoga postures ) and visama vritti pranayama ( timed breathing ) . Safety measure outcomes included heart rate , oxygen saturation , dyspnea , and pain . Feasibility was measured by patient-reported enjoyment , difficulty , and adherence to yoga sessions . At baseline and at 12 weeks , DI and DD were measured during incremental cycle ergometry and a 6-minute walk ( 6MW ) test . Secondary efficacy outcomes included physical performance , psychologic well-being , and health-related quality of life ( HRQoL ) . RESULTS Yoga training was safe and feasible for patients with COPD . While yoga training had only small effects on DI after the 6MW test ( effect size [ ES ] , 0.20 ; p = 0.60 ) , there were greater reductions in DD in the yoga group compared to UC ( ES , 0.67 ; p = 0.08 ) . Yoga training also improved 6MW distance ( + 71.7 + /- 21.8 feet versus -27.6 + /- 36.2 feet ; ES = 0.78 , p = 0.04 ) and self-reported functional performance ( ES = 0.79 , p = 0.04 ) compared to UC . There were small positive changes in muscle strength and HRQoL. CONCLUSIONS Elderly patients with COPD participated safely in a 12-week yoga program especially design ed for patients with this chronic illness . After the program , the subjects tolerated more activity with less DD and improved their functional performance . These findings need to be confirmed in a larger , more sufficiently powered efficacy study BACKGROUND Despite recent advances in pharmacologic and device therapy , morbidity and mortality from heart failure ( HF ) remain high . Yoga combines physical and breathing exercises that may benefit patients with HF . We hypothesized that an 8-week regimen of yoga in addition to st and ard medical therapy would improve exercise capacity , inflammatory markers , and quality of life ( QoL ) in patients with HF . METHODS AND RESULTS New York Heart Association Class I-III HF patients were r and omized to yoga treatment ( YT ) or st and ard medical therapy ( MT ) . Measurements included a grade d exercise test ( GXT ) to V O(2Peak ) and the following serum biomarkers : interleukin-6 ( IL-6 ) , high-sensitivity C-reactive protein ( hsCRP ) , and extracellular superoxide dismutase ( EC-SOD ) . The Minnesota Living with Heart Failure Question naire ( MLHFQ ) was administered to assess changes in QoL. A total of 19 patients were enrolled after the initial screening . Of the 19 patients , 9 were r and omized to YT and 10 to MT . Patients had a mean EF of 25 % . GXT time and V O(2Peak ) were significantly improved in the YT versus MT groups ( + 18 % in the YT and -7.5 % in MT ; P = .03 vs. control and + 17 in YT and -7.1 in MT ; P = .02 , respectively ) . There were statistically significant reductions in serum levels of IL-6 and hsCRP and an increase in EC-SOD in the YT group ( all P < .005 vs. MT ) . MLHFQ scores improved by 25.7 % in the YT group and by 2.9 % in the MT group . CONCLUSIONS Yoga improved exercise tolerance and positively affected levels of inflammatory markers in patients with HF , and there was also a trend toward improvements in Background and Purpose — Balance impairment is common after stroke ; modified yoga may be able to improve balance and other important poststroke variables . Scientific- evidence is needed to support such treatment interventions . The purpose of this study was to assess the impact of a yoga-based rehabilitation intervention on balance , balance self-efficacy , fear of falling ( FoF ) , and quality of life after stroke . Methods — This was a prospect i ve , r and omized , pilot study of yoga-based rehabilitation for people with chronic stroke . All yoga sessions were taught by a registered yoga therapist , occurred twice per week for 8 weeks and included seated , st and ing , and floor postures with relaxation and meditation . Balance was assessed with the Berg Balance Scale , balance self-efficacy with the Activities-specific Balance Confidence Scale , FoF with a dichotomous yes/no question , and quality of life with the Stroke Specific Quality of Life scale . Results — There were no significant differences between wait-list control ( n=10 ) and yoga ( n=37 ) groups in baseline or follow-up scores . However , using within-group comparisons , yoga group data demonstrated significant improvement in balance ( Berg Balance Scale , 41.3±11.7 vs 46.3±9.1 ; P<0.001 ) and FoF ( 51 % vs 46 % with FoF ; P<0.001 ) . Conclusions OUTPUT: Symptoms of anxiety were reduced after yoga in individuals with stroke , although this was not observed in individuals with COPD . The effect of yoga on symptoms of depression varied across studies with no significant effects compared with usual care . Conclusions : Yoga programs have similar design s and components across chronic disease population s. Compared with usual care , yoga result ed in significant improvements in exercise capacity and a mean improvement in HRQL . INPUT: BACKGROUND There has been limited study of yoga training as a complementary exercise strategy to manage the symptom of dyspnea in patients with chronic obstructive pulmonary disease ( COPD ) . PURPOSE The primary purpose of this pilot study was to evaluate a yoga program for its safety , feasibility , and efficacy for decreasing dyspnea intensity ( DI ) and dyspnea-related distress ( DD ) in older adults with COPD . METHODS Clinical ly stable patients with COPD ( n = 29 ; age 69.9 + /- 9.5 ; forced expiratory volume in 1 second ( FEV(1 ) ) 47.7 + /- 15.6 % predicted ; female = 21 ) were r and omized to a 12-week yoga program specifically design ed for people with COPD or usual-care control ( UC ) . The twice-weekly yoga program included asanas ( yoga postures ) and visama vritti pranayama ( timed breathing ) . Safety measure outcomes included heart rate , oxygen saturation , dyspnea , and pain . Feasibility was measured by patient-reported enjoyment , difficulty , and adherence to yoga sessions . At baseline and at 12 weeks , DI and DD were measured during incremental cycle ergometry and a 6-minute walk ( 6MW ) test . Secondary efficacy outcomes included physical performance , psychologic well-being , and health-related quality of life ( HRQoL ) . RESULTS Yoga training was safe and feasible for patients with COPD . While yoga training had only small effects on DI after the 6MW test ( effect size [ ES ] , 0.20 ; p = 0.60 ) , there were greater reductions in DD in the yoga group compared to UC ( ES , 0.67 ; p = 0.08 ) . Yoga training also improved 6MW distance ( + 71.7 + /- 21.8 feet versus -27.6 + /- 36.2 feet ; ES = 0.78 , p = 0.04 ) and self-reported functional performance ( ES = 0.79 , p = 0.04 ) compared to UC . There were small positive changes in muscle strength and HRQoL. CONCLUSIONS Elderly patients with COPD participated safely in a 12-week yoga program especially design ed for patients with this chronic illness . After the program , the subjects tolerated more activity with less DD and improved their functional performance . These findings need to be confirmed in a larger , more sufficiently powered efficacy study OBJECTIVE health-related quality of life ( HRQOL ) and mental well-being are associated with healthy ageing . Physical activity positively impacts both HRQOL and mental well-being . Yoga is a physical activity that can be modified to suits the needs of older people and is growing in popularity . We conducted a systematic review with meta- analysis to determine the impact of yoga-based exercise on HRQOL and mental well-being in people aged 60 + . METHODS search es were conducted for relevant trials in the following electronic data bases ; MEDLINE , EMBASE , Cochrane Central Register of Controlled Trials , CINAHL , Allied and Complementary Medicine Data base , PsycINFO and the Physiotherapy Evidence Data base ( PEDro ) from inception to January 2017 . Trials that evaluated the effect of physical yoga on HRQOL and /or on mental well-being in people aged 60 + years were included . Data on HRQOL and mental well-being were extracted . St and ardised mean differences and 95 % confidence intervals ( CI ) were calculated using r and om effects models . Method ological quality of trials was assessed using the PEDro scale . RESULTS twelve trials of high method ological quality ( mean PEDro score 6.1 ) , totalling 752 participants , were identified and provided data for the meta- analysis . Yoga produced a medium effect on HRQOL ( Hedges ' g = 0.51 , 95 % CI 0.25 - 0.76 , 12 trials ) and a small effect on mental well-being ( Hedges ' g = 0.38 , 95 % CI 0.15 - 0.62 , 12 trials ) . CONCLUSION yoga interventions result ed in small to moderate improvements in both HRQOL and mental well-being in people aged 60 + years . Further , research is needed to determine the optimal dose of yoga to maximise health impact . PROSPERO REGISTRATION NUMBER ( CRD42016052458 ) BACKGROUND Despite yoga 's popularity , few clinical trials have employed rigorous methodology to systematic ally explore its functional benefits compared with more established forms of exercise . The objective of this study was to compare the functional benefits of yoga with the conventional stretching-strengthening exercises recommended for adults . METHODS Sedentary healthy adults ( N = 118 ; M age = 62.0 ) participated in an 8-week ( three times a week for 1 hour ) r and omized controlled trial , which consisted of a Hatha yoga group ( n = 61 ) and a stretching-strengthening exercise group ( n = 57 ) . St and ardized functional fitness tests assessing balance , strength , flexibility , and mobility were administered at baseline and postintervention . RESULTS A repeated measures multivariate analysis of variance showed a significant time effect for measures of balance [ F(3,18 ) = 4.88 , p < .01 , partial η(2 ) = .45 ] , strength [ F(2,19 ) = 15.37 , p < .001 , partial η(2 ) = .62 ] , flexibility [ F(4,17 ) = 8.86 , p < .001 , partial η(2 ) = .68 ] , and mobility [ F(2,19 ) = 8.54 , p < . OUTPUT:

Conclusion This review is the first to compare the effects of yoga with active and inactive controls in older adults not characterised by a specific clinical condition . Results indicate that yoga interventions improve multiple physical function and HRQoL outcomes in this population compared to both control conditions . This study provides robust evidence for promoting yoga in physical activity guidelines for older adults as a multimodal activity that improves aspects of fitness like strength , balance and flexibility , as well as mental wellbeing .

MS2_dynamic_1_shot593

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction < or = 35 % were r and omized to receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the AlereNet system and 142 received st and ard care . Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes . No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P < .003 ) for patients r and omized to the AlereNet group . CONCLUSIONS This is the largest multicenter , r and omized trial of a technology-based daily weight and symptom-monitoring system for patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups CONTEXT Comprehensive discharge planning by advanced practice nurses has demonstrated short-term reductions in readmissions of elderly patients , but the benefits of more intensive follow-up of hospitalized elders at risk for poor outcomes after discharge has not been studied . OBJECTIVE To examine the effectiveness of an advanced practice nurse-centered discharge planning and home follow-up intervention for elders at risk for hospital readmissions . DESIGN R and omized clinical trial with follow-up at 2 , 6 , 12 , and 24 weeks after index hospital discharge . SETTING Two urban , academically affiliated hospitals in Philadelphia , Pa. PARTICIPANTS Eligible patients were 65 years or older , hospitalized between August 1992 and March 1996 , and had 1 of several medical and surgical reasons for admission . INTERVENTION Intervention group patients received a comprehensive discharge planning and home follow-up protocol design ed specifically for elders at risk for poor outcomes after discharge and implemented by advanced practice nurses . MAIN OUTCOME MEASURES Readmissions , time to first readmission , acute care visits after discharge , costs , functional status , depression , and patient satisfaction . RESULTS A total of 363 patients ( 186 in the control group and 177 in the intervention group ) were enrolled in the study ; 70 % of intervention and 74 % of control subjects completed the trial . Mean age of sample was 75 years ; 50 % were men and 45 % were black . By week 24 after the index hospital discharge , control group patients were more likely than intervention group patients to be readmitted at least once ( 37.1 % vs 20.3 % ; P<.001 ) . Fewer intervention group patients had multiple readmissions ( 6.2 % vs 14.5 % ; P = .01 ) and the intervention group had fewer hospital days per patient ( 1.53 vs 4.09 days ; P<.001 ) . Time to first readmission was increased in the intervention group ( P<.001 ) . At 24 weeks after discharge , total Medicare reimbursements for health services were about $ 1.2 million in the control group vs about $ 0.6 million in the intervention group ( P<.001 ) . There were no significant group differences in post-discharge acute care visits , functional status , depression , or patient satisfaction . CONCLUSIONS An advanced practice nurse-centered discharge planning and home care intervention for at-risk hospitalized elders reduced readmissions , lengthened the time between discharge and readmission , and decreased the costs of providing health care . Thus , the intervention demonstrated great potential in promoting positive outcomes for hospitalized elders at high risk for rehospitalization while reducing costs BACKGROUND Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no OUTPUT: Conclusions Interventions with components that influenced learning and self-organization were associated with a significant improvement in hospital readmissions-related outcomes . Learning alone might be necessary but not be sufficient for improving transitions . However , building self-organization into the intervention might help people effectively respond to problems and adapt in uncertain situations to reduce the likelihood of readmission INPUT: BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction < or = 35 % were r and omized to receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the AlereNet system and 142 received st and ard care . Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes . No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P < .003 ) for patients r and omized to the AlereNet group . CONCLUSIONS This is the largest multicenter , r and omized trial of a technology-based daily weight and symptom-monitoring system for patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups Heart failure ( HF ) is the leading cause of rehospitalization in older adults . The purpose of this pilot study was to examine whether telemonitoring by an advanced practice nurse reduced subsequent hospital readmissions , emergency department visits , costs , and risk of hospital readmission for patients with HF . One hundred two patient/caregiver dyads were r and omized into 2 groups postdischarge ; 84 dyads completed the study . Hospital readmissions , emergency department visits , costs , and days to readmission were abstract ed from medical records . Participants were interviewed soon after discharge and 3 months later about effects of telemonitoring on depressive symptoms , quality of life , and caregiver mastery . There were no significant differences due to telemonitoring for any outcomes . Caregiver mastery , informal social support , and electronic home monitoring were not significant predictors for risk of hospital readmission . Further studies should address the interaction between the advanced practice nurse and follow-up intervention with telemonitoring of patients with HF to better target those who are most likely to benefit Background .The high cost of caring for patients with congestive heart failure ( CHF ) results primarily from frequent hospital readmissions for exacerbations . Home nurse visits after discharge can reduce readmissions , but the intervention costs are high . Objectives .To compare the effectiveness of three hospital discharge care models for reducing CHF-related readmission charges : 1 ) home telecare delivered via a 2-way video-conference device with an integrated electronic stethoscope ; 2 ) nurse telephone calls ; and 3 ) usual outpatient care . Research Design . One-year r and omized trial . Subjects . English-speaking patients 40 years of age and older with a primary hospital admission diagnosis of CHF . Measures .Our primary outcome was CHF-related readmission charges during a 6-month period after r and omization . Secondary outcomes included all-cause readmissions , emergency department ( ED ) visits , and associated charges . Results .Thirty-seven subjects were r and omized : 13 to home telecare , 12 each telephone care and 12 to usual care . Mean CHF-related readmission charges were 86 % lower in the telecare group ( $ 5850 , SD $ 21,094 ) and 84 % lower in the telephone group ( $ 7320 , SD $ 24,440 ) than in the usual care group ( $ 44,479 , SD $ 121,214 ) . However , the between-group difference was not statistically significant . Both intervention groups had significantly fewer CHF-related ED visits ( P = 0.0342 ) and charges ( P = 0.0487 ) than the usual care group . Trends favoring both interventions were noted for all other utilization outcomes . Conclusions .Substantial reductions in hospital readmissions , emergency visits , and cost of care for patients with CHF might be achieved by widespread deployment of distance technologies to provide posthospitalization monitoring . Home telecare may not offer incremental benefit beyond telephone follow-up and is more expensive OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) < 40 % were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r OUTPUT:

Patient quality of life and satisfaction with home telemonitoring were similar or better than with usual care .

MS2_dynamic_1_shot594

***TASK*** the task is to summarize an input biomedical literature 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 resveratrol has widely been studied for its potential health benefits , little is known about its metabolic effects in humans . Our aims were to determine whether the polyphenol resveratrol improves insulin sensitivity in type 2 diabetic patients and to gain some insight into the mechanism of its action . After an initial general examination ( including blood chemistry ) , nineteen patients enrolled in the 4-week-long double-blind study were r and omly assigned into two groups : a resveratrol group receiving oral 2 × 5 mg resveratrol and a control group receiving placebo . Before and after the second and fourth weeks of the trial , insulin resistance/sensitivity , creatinine-normalised ortho-tyrosine level in urine sample s ( as a measure of oxidative stress ) , incretin levels and phosphorylated protein kinase B (pAkt):protein kinase B ( Akt ) ratio in platelets were assessed and statistically analysed . After the fourth week , resveratrol significantly decreased insulin resistance ( homeostasis model of assessment for insulin resistance ) and urinary ortho-tyrosine excretion , while it increased the pAkt : Akt ratio in platelets . On the other h and , it had no effect on parameters that relate to β-cell function ( i.e. homeostasis model of assessment of β-cell function ) . The present study shows for the first time that resveratrol improves insulin sensitivity in humans , which might be due to a resveratrol-induced decrease in oxidative stress that leads to a more efficient insulin signalling via the Akt pathway The red grape constituent resveratrol possesses cancer chemopreventive properties in rodents . The hypothesis was tested that , in healthy humans , p.o . administration of resveratrol is safe and results in measurable plasma levels of resveratrol . A phase I study of oral resveratrol ( single doses of 0.5 , 1 , 2.5 , or 5 g ) was conducted in 10 healthy volunteers per dose level . Resveratrol and its metabolites were identified in plasma and urine by high-performance liquid chromatography-t and em mass spectrometry and quantitated by high-performance liquid chromatography-UV . Consumption of resveratrol did not cause serious adverse events . Resveratrol and six metabolites were recovered from plasma and urine . Peak plasma levels of resveratrol at the highest dose were 539 ± 384 ng/mL ( 2.4 μmol/L , mean ± SD ; n = 10 ) , which occurred 1.5 h post-dose . Peak levels of two monoglucuronides and resveratrol-3-sulfate were 3- to 8-fold higher . The area under the plasma concentration curve ( AUC ) values for resveratrol-3-sulfate and resveratrol monoglucuronides were up to 23 times greater than those of resveratrol . Urinary excretion of resveratrol and its metabolites was rapid , with 77 % of all urinary agent-derived species excreted within 4 h after the lowest dose . Cancer chemopreventive effects of resveratrol in cells in vitro require levels of at least 5 μmol/L. The results presented here intimate that consumption of high-dose resveratrol might be insufficient to elicit systemic levels commensurate with cancer chemopreventive efficacy . However , the high systemic levels of resveratrol conjugate metabolites suggest that their cancer chemopreventive properties warrant investigation . ( Cancer Epidemiol Biomarkers Prev 2007;16(6):1246–52 BACKGROUND The many putative beneficial effects of the polyphenol resveratrol include an ability to bolster endogenous antioxidant defenses , modulate nitric oxide synthesis , and promote vasodilation , which thereby improves blood flow . Resveratrol may therefore modulate aspects of brain function in humans . OBJECTIVE The current study assessed the effects of oral resveratrol on cognitive performance and localized cerebral blood flow variables in healthy human adults . DESIGN In this r and omized , double-blind , placebo-controlled , crossover study , 22 healthy adults received placebo and 2 doses ( 250 and 500 mg ) of trans-resveratrol in counterbalanced order on separate days . After a 45-min resting absorption period , the participants performed a selection of cognitive tasks that activate the frontal cortex for an additional 36 min . Cerebral blood flow and hemodynamics , as indexed by concentration changes in oxygenated and deoxygenated hemoglobin , were assessed in the frontal cortex throughout the posttreatment period with the use of near-infrared spectroscopy . The presence of resveratrol and its conjugates in plasma was confirmed by HPLC after the same doses in a separate cohort ( n = 9 ) . RESULTS Resveratrol administration result ed in dose-dependent increases in cerebral blood flow during task performance , as indexed by total concentrations of hemoglobin . There was also an increase in deoxyhemoglobin after both doses of resveratrol , which suggested enhanced oxygen extraction , that became apparent toward the end of the 45-min absorption phase and was sustained throughout task performance . Cognitive function was not affected . Resveratrol metabolites were present in plasma throughout the cognitive task period . CONCLUSION These results showed that single doses of orally administered resveratrol can modulate cerebral blood flow variables Background —The Diabetes Atherosclerosis Intervention Study showed that treatment with fenofibrate decreases progression of coronary atherosclerosis in subjects with type 2 diabetes . We determined whether on-treatment plasma lipid concentrations and LDL particle size contribute to the favorable effect of fenofibrate on the progression of coronary artery disease ( CAD ) . Methods and Results —A total of OUTPUT: Statistically significant ( p < 0.05 ) positive effects , indicating that resveratrol supplementation was more effective than placebo/control , were identified for systolic blood pressure , hemoglobin A1c , and creatinine , but not for fasting glucose , homeostatic model assessment of insulin resistance , diastolic blood pressure , insulin , triglycerides , LDL , or HDL cholesterol . No major adverse events were reported and side effects of resveratrol were not different than placebo/control . Though limitations in sample size and treatment duration preclude definitive changes in clinical practice , significant improvements in multiple cardiometabolic biomarkers and an excellent safety profile support resveratrol as a leading c and i date as an adjunct to pharmacological management of T2DM INPUT: ABSTRACT Objective “ The obesity epidemic ” has led to an increase in obesity-related conditions including non-alcoholic fatty liver disease ( NAFLD ) , for which effective treatments are in dem and . The polyphenol resveratrol prevents the development of experimental NAFLD through modulation of cellular pathways involved in calorie restriction . We aim ed to test the hypothesis that resveratrol alleviates NAFLD in a r and omised , clinical trial . Material s and methods A total of 28 overweight patients with transaminasemia and histological NAFLD were r and omised 1:1 to placebo or resveratrol 1.5 g daily for 6 months . Twenty-six participants completed the trial and underwent repeated clinical investigation , blood work , MR spectroscopy ; and 19 participants agreed to a repeat liver biopsy . Results Resveratrol treatment was generally not superior to placebo in improving plasma markers of liver injury ( primary outcome : alanine transaminase , p = 0.51 ) . Resveratrol-treated patients showed a 3.8 % decrease in liver lipid content ( p = 0.03 ) , with no difference between the two treatment arms ( p = 0.38 ) and no improvement of histological features . Resveratrol treatment was not associated with improvements in insulin sensitivity or markers of the metabolic syndrome , except for a transient decrease in systolic BP . Microarray analysis and qRT-PCR revealed no major changes in expression profile . Also , we report a serious adverse event in a patient who developed fever and bicytopenia . Conclusions In this placebo-controlled , high-dose and long-term study , resveratrol treatment had no consistent therapeutic effect in alleviating clinical or histological NAFLD , though there may be a small ameliorating effect on liver function tests and liver fat accumulation Ageing is thought to be associated with decreased vascular function partly due to oxidative stress . Resveratrol is a polyphenol , which in animal studies has been shown to decrease atherosclerosis , and improve cardiovascular health and physical capacity , in part through its effects on Sirtuin 1 signalling and through an improved antioxidant capacity . We tested the hypothesis that resveratrol supplementation enhances training-induced improvements in cardiovascular health parameters in aged men . Twenty-seven healthy physically inactive aged men ( age : 65 ± 1 years ; body mass index : 25.4 ± 0.7 kg m(-2 ) ; mean arterial pressure ( MAP ) : 95.8 ± 2.2 mmHg ; maximal oxygen uptake : 2488 ± 72 ml O2 min(-1 ) ) were r and omized into 8 weeks of either daily intake of either 250 mg trans-resveratrol ( n = 14 ) or of placebo ( n = 13 ) concomitant with high-intensity exercise training . Exercise training led to a 45 % greater ( P < 0.05 ) increase in maximal oxygen uptake in the placebo group than in the resveratrol group and to a decrease in MAP in the placebo group only ( -4.8 ± 1.7 mmHg ; P < 0.05 ) . The interstitial level of vasodilator prostacyclin was lower in the resveratrol than in the placebo group after training ( 980 ± 90 vs. 1174 ± 121 pg ml(-1 ) ; P < 0.02 ) and muscle thromboxane synthase was higher in the resveratrol group after training ( P < 0.05 ) . Resveratrol administration also abolished the positive effects of exercise on low-density lipoprotein , total cholesterol/high-density lipoprotein ratio and triglyceride concentrations in blood ( P < 0.05 ) . Resveratrol did not alter the effect of exercise training on the atherosclerosis marker vascular cell adhesion molecule 1 ( VCAM-1 ) . Sirtuin 1 protein levels were not affected by resveratrol supplementation . These findings indicate that , whereas exercise training effectively improves several cardiovascular health parameters in aged men , concomitant resveratrol supplementation can blunt these effects Resveratrol is a naturally occurring polyphenolic compound . Numerous animal studies have been reported on its wide-ranging beneficial effects in the biological system including diabetes mellitus ( DM ) . We hypothesized , therefore , that oral supplementation of resveratrol would improve the glycemic control and the associated risk factors in patients with type 2 diabetes mellitus ( T2DM ) . The present clinical study was therefore carried out to test the hypothesis . Sixty-two patients with T2DM were enrolled from Government Headquarters Hospital , Ootacamund , India , in a prospect i ve , open-label , r and omized , controlled trial . Patients were r and omized into control and intervention groups . The control group received only oral hypoglycemic agents , whereas the intervention group received resveratrol ( 250 mg/d ) along with their oral hypoglycemic agents for a period of 3 months . Hemoglobin A(1c ) , lipid profile , urea nitrogen , creatinine , and protein were measured at the baseline and at the end of 3 months . The results reveal that supplementation of resveratrol for 3 months significantly improves the mean hemoglobin A(1c ) ( means ± SD , 9.99 ± 1.50 vs 9.65 ± 1.54 ; P < .05 ) , systolic blood pressure ( mean ± SD , 139.71 ± 16.10 vs 127.92 ± 15.37 ; P < .05 ) , total cholesterol ( mean ± SD , 4.70 ± 0.90 vs 4.33 ± 0.76 ; OUTPUT:

We conclude that resveratrol does not change lipid profile concentration .

MS2_dynamic_1_shot595

***TASK*** the task is to summarize an input biomedical literature 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 A main reason for investigating the clinical effects and possible merits of post-operative corticosteroid administration was its practical implication s in traumatology . It was also hoped to obtain information relevant to the analgesic activity of steroid . A crossover study has been done in 12 healthy subjects , each of whom had two separate , but identical operations for removal of non-erupted 3rd molar teeth on each side of the jaw . 3 h after surgery , either betamethasone 9 mg ( Celeston Chronodose ® ) or placebo was injected intramuscularly in a r and omized fashion . A paired comparison was made of the post-operative courses . All but 1 patient experienced less pain after the steroid injection . Surprisingly , some patients reported pronounced relief within min after the injection , whereas in others there was a time-lag . Swelling , measured on the 3rd day , was reduced by 47 % after the steroid as compared to placebo . There was poor agreement between the steroid-induced reductions in pain and swelling . This exemplifies the dissociation between pain and other inflammatory events , and indicates that the analgesic and anti-inflammatory properties of a steroid may depend on discrete mechanisms , which may show considerable individual variation . From overall assessment , all 12 patients favoured the post-operative course when the steroid was administered . Almost the same levels of pain relief , reduction in swelling , and preference were reached in the present patients , who received the steroid 3 h post-operatively , as had previously been found in a similar trial in which the drug was injected prior to surgery . The results suggest that short term corticosteroid administration may be a valuable means of reducing pain and excessive inflammatory response after surgical or accidental soft tissue/bone injury OBJECTIVE To determine the effect of preoperative dexamethasone sodium phosphate administration on posttonsillectomy morbidity for electrocautery ( " hot " ) and sharp ( " cold " ) dissection techniques . DESIGN Prospect i ve , r and omized , double-blind study . SETTING University pediatric hospital and county teaching hospital . Subjects A total of 219 children , aged 9 months to 12 years , undergoing tonsillectomy . Intervention Participants who underwent tonsillectomy were r and omly assigned to receive either intravenous dexamethasone sodium phosphate ( 1 mg/kg ) or placebo . OUTCOME MEASURES Pain scores , oral intake , and emesis on postoperative day ( POD ) 1 . RESULTS A total of 106 subjects ( 62 undergoing hot and 44 cold tonsillectomies ) received preoperative steroids , and 113 ( 56 hot and 57 cold tonsillectomies ) received placebo . On POD 1 , pain scores reported by patients ( P = .02 ) , parents ( P = .002 ) , and physicians ( P<.001 ) were significantly lower in subjects receiving steroids than in those receiving placebo . Emesis was reduced from a mean of 2.1 ( placebo group ) to 1.2 episodes ( steroid group ) ( P = .02 ) . Oral intake improved from 24.5 % of normal diet ( placebo ) to 31.7 % ( steroid group ) ( P = .004 ) . When all 4 groups were compared ( cold placebo , cold steroid , hot placebo , and hot steroid ) , pain scores reported by physicians and parents were significantly lower in the cold steroid group than in the other groups . CONCLUSIONS Perioperative dexamethasone use reduces posttonsillectomy morbidity in pediatric patients in the early postoperative period after hot or cold tonsillectomy . The combination of steroid and cold dissection technique provided the greatest advantage in reducing posttonsillectomy subjective pain levels Edema contributes substantially to the postoperative discomfort and morbidity of adenotonsillectomy . In a double-blind study , 58 children undergoing adenotonsillectomy were given a single intraoperative dose of either dexamethasone or saline . The steroid markedly affected the postoperative course in the first day after surgery . According to parental reports , the percentage of patients vomiting was reduced from 48 to 4 % . Severe throat pain was reported in 57 % of controls and only 20 % of dexamethasone patients . Twice as many steroid patients as controls tolerated some soft food on the first postoperative day . It appears that dexamethasone can greatly improve patient diet and comfort after adenotonsillectomy A prospect i ve , r and omized , double-blind study to determine the postoperative efficacy of steroids in tonsillectomy was performed in 49 children . A single dose of intravenous dexamethasone or placebo was administered after each child was anesthetized . Postoperatively each child was examined for objective signs of trismus ( measured by interincisor distance ) , temperature elevation , and weight loss , as well as for subjective signs of mouth odor , oral intake , pain , level of activity , and analgesic usage . There were no statistical differences noted in any of the variables compared in the two groups and the complication rates were also A prospect i ve , r and omized , double-blinded , placebo-controlled clinical trial was conducted in 41 patients evaluating the effect of a single preoperative dose of intravenous dexamethasone on postoperative vomiting and pain in children undergoing elective tonsillectomy . Dexamethasone was found to significantly reduce the incidence of vomiting in the first 24 hours postoperatively ( P=0.02 ) , the time to first intake of solids ( P=0.001 ) , the need to administer a rescue antiemetic ( P=0.005 ) and intravenous fluid therapy requirements ( P=0.006 ) in the postoperative period . No significant difference was found between the dexamethasone and placebo groups in the time to first intake of fluids , pain scores OUTPUT: : A single , intraoperative dose of dexamethasone may reduce post-tonsillectomy pain on postoperative day 1 , by a factor of 1 on a 10-point pain scale . INPUT: BACKGROUND High-dose glucocorticoid may reduce postsurgical pain and improve recovery . We hypothesized that 125 mg methylprednisolone ( MP ) would reduce time to meet functional discharge criteria after total hip arthroplasty ( THA ) . METHODS Forty-eight patients undergoing unilateral THA under spinal anaesthesia were consecutively included in this r and omized , double-blind , placebo-controlled trial receiving preoperative i.v . MP or saline . All patients received a st and ardized , multimodal analgesic regime with paracetamol , celecoxib , and gabapentin . The primary outcome was time to meet well-defined functional discharge criteria . Secondary outcomes were h and grip strength and endurance , pain , nausea , vomiting , fatigue , sleep quality , and rescue analgesic- , antiemetic- , and hypnotic medicine requirements . The inflammatory response measured by C-reactive protein ( CRP ) and actual length of stay were also registered . Discharge criteria were assessed twice daily ( at 09:00 and 14:00 h ) until discharge . Other outcomes were assessed at 2 , 4 , 6 , 8 , and 24 h after operation , and also in a question naire from postoperative day ( POD ) 1 - 4 . RESULTS Time to meet discharge criteria was [ median ( IQR ) ( 95 % CI ) , MP vs placebo ] : 23.5 ( 23.3 - 23.7 ) ( 17.8 - 43.8 ) vs 23.5 ( 23.0 - 23.8 ) ( 20.0 - 46.8 ) h , the mean difference ( 95 % CI ) being -1.3 ( -4.7 to 2.2 ) h , P=0.65 . Overall pain for the first 24 h after surgery was significantly reduced in the MP vs the placebo group ( P<0.01 ) , as was CRP at 24 h ( P<0.0001 ) . No other between-group differences were observed . No drug-related complications were observed at follow-up on POD30 . CONCLUSIONS MP 125 mg i.v . before surgery added to a multimodal oral analgesic regime did not reduce time to meet functional discharge criteria after THA , but improved analgesia for the first 24 Abstract Current trends in orthopaedic surgery have explored different forms of adjuvant treatments to minimize postoperative pain and the risk of nausea and vomiting . A small single preoperative dose of dexamethasone , as part of a comprehensive multimodal analgesic regimen in low-risk patients undergoing total hip arthroplasty ( THA ) , provides antiemetic and opioid-sparing effects but the longer-term effects on pain , complications , or function are not known . We therefore asked whether such a routine would affect longer-term pain , complications , or function . Fifty patients undergoing elective primary THA using spinal anesthesia were initially r and omized to receive either dexamethasone ( 40 mg intravenous ) or saline placebo . The patients , anesthesiologists , nurses , and research coordinators were blinded to the study arms . The functional outcome was measured using the Harris hip score . Outcomes were assessed 6 weeks and 1 year postoperatively . We observed no difference in resting pain between the two groups at either time period . Both groups had similar functional outcome scores for the total Harris hip score and individual scoring items at each followup interval . There were no wound complications , deep infections , or osteonecrosis in the contralateral hip at 1-year followup . We recommend the addition of a small single preoperative dose of dexamethasone to a comprehensive multimodal analgesic regimen in low-risk patients given its immediate antiemetic and opioid-sparing effects , and absence of subsequent effects . Level of Evidence : Level II , therapeutic study ( prospect i ve comparative study ) . See the Guidelines for Authors for a complete description of levels of evidence Background Dexamethasone is a potent analgesic and antiemetic . However , the benefit of dexamethasone after TKA is unclear , as is the efficacy in a current multimodal regime . Questions / purpose sWe determined ( 1 ) whether the addition of dexamethasone to a protocol including ramosetron further reduces postoperative emesis compared with ramosetron alone ; ( 2 ) whether it reduces postoperative pain ; and ( 3 ) whether it increases the risk for wound complications in a current multimodal regime after TKA . Methods We r and omized 269 patients undergoing TKAs to receive dexamethasone ( 10 mg ) 1 hour before surgery and ramosetron immediately after surgery ( Dexa-Ra group , n = 135 ) , or ramosetron alone ( Ra group , n = 134 ) . We recorded the incidence of postoperative nausea and vomiting ( PONV ) , severity of nausea , incidence of antiemetic requirement , complete response , pain level , and opioid consumption . Patients were assessed 0 to 6 , 6 to 24 , 24 to 48 , and 48 to 72 hours postoperatively . In addition , patients were evaluated for wound complications and periprosthetic joint infections at a minimum of 1 year after surgery . Results The Dexa-Ra group had a lower incidence of PONV during the entire 72-hour evaluation period and experienced less severe nausea for the first 6 hours after TKA , although not between 6 to 72 hours . Overall use of a rescue antiemetic was less frequent , and complete response was more frequent in the Dexa-Ra group . Patients in the Dexa-Ra group experienced lower pain and consumed less opioids during the 6- to 24-hour period and during the overall study period OUTPUT:

Meta- analysis showed that high-dose systemic steroid ( dexamethasone > 0.1 mg/kg ) rather than low dose is effective to reduce postoperative nausea and vomiting and postoperative acute pain ( within 24 h ) . In addition , systemic steroid is associated within faster functional rehabilitation and greater inflammation control . On the other h and , systemic steroid is associated with a higher level of postoperative serum glucose on the operation day . Conclusions Our study suggests that by providing lower incidence of postoperative nausea and vomiting and less postoperative acute pain , high-dose systemic steroid plays a critical role in rapid recovery to TKA and THA . The preliminary results also show the superior possibility of systemic steroid in functional rehabilitation and inflammation control .

MS2_dynamic_1_shot596

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Aims /hypothesisLow 25-hydroxyvitamin D levels predict future cardiovascular events and are common in patients with type 2 diabetes . We compared the effect of 100,000 and 200,000 IU doses of vitamin D3 on endothelial function , blood pressure and markers of glycaemic control in patients with type 2 diabetes . Methods This was a r and omised , parallel group , placebo-controlled trial . Patients with type 2 diabetes and baseline 25-hydroxyvitamin D levels < 100 nmol/l were enrolled from community and hospital-based diabetes clinics . Participants were assessed in a university department of clinical pharmacology and received a single oral dose of placebo or vitamin D3 ( 100,000 IU or 200,000 IU ) at baseline , r and omly allocated via numbered bottles prepared offsite ; participants and investigators were both blinded to treatment allocation . Endothelial function , office blood pressure , B-type natriuretic peptide , insulin resistance and glycosylated haemoglobin were measured at baseline , and at 8 and 16 weeks . Results We r and omised 61 participants to the three groups ( placebo 22 , 100,000 IU vitamin D3 19 , 200,000 IU vitamin D3 20 ) . There was no significant difference in the primary outcome of endothelial function at 8 weeks ( placebo 5.2 % , n = 22 ; 100,000 IU 4.3 % , n = 19 ; 200,000 IU 4.9 % , n = 17 ) or at 16 weeks . Insulin resistance and glycosylated haemoglobin did not improve with either dose of vitamin D3 . On covariate analysis , systolic blood pressure was significantly lower in both treatment arms than in the placebo group at 8 weeks ( placebo 146.4 mmHg , 100,000 IU 141.4 mmHg [ p = 0.04 vs placebo ] , 200,000 IU 136.8 mmHg [ p = 0.03 vs placebo ] ) . B-type natriuretic peptide levels were significantly lower in the 200,000 IU group by 16 weeks ( placebo 34 pg/ml , 200,000 IU 21 pg/ml , p = 0.02 ) . No significant excess of adverse effects was noted in the treatment arms . Conclusions /interpretationHigh-dose vitamin D3 improved systolic blood pressure and B-type natriuretic peptide levels , but not endothelial function , insulin resistance or glycosylated haemoglobin in patients with type 2 diabetes . Trial registration IS RCT N50587697 ( www.controlled-trials.com ) Funding Diabetes UK , grant number 06/0003429 . M. D. Witham is funded by a Scottish Government NES/CSO Clinician Scientist Award BACKGROUND Adequate calcium intake can have a favorable effect on some metabolic variables . OBJECTIVE The objective of the study was to determine the effects of daily calcium intake and of supplementation with calcium and vitamin D ( calcium+D ) during a weight-loss intervention on blood pressures , plasma lipid and lipoprotein concentrations , and glucose and insulin concentrations in low calcium consumers . DESIGN Healthy , overweight or obese women ( n = 63 ) with a daily calcium intake of < 800 mg/d were r and omly assigned in a double-blind manner to 1 of 2 groups : the group consuming 2 tablets/d of a calcium + vitamin D supplement ( 600 mg elemental calcium and 200 IU vitamin D/tablet ) or the group consuming placebo ; both groups observed a 700 kcal/d energy restriction . These 63 women then completed a 15-wk weight-loss intervention . RESULTS Initial daily calcium intake was significantly correlated with plasma HDL cholesterol ( r = 0.41 , P < 0.001 ) and with 2-h postload glycemia ( r = -0.29 , P < 0.05 ) during an oral-glucose-tolerance test , independent of fat mass and waist circumference . After the 15-wk intervention , significantly greater decreases in total : LDL and LDL : HDL ( P < 0.01 for both ) and of LDL cholesterol ( P < 0.05 ) were observed in the calcium+D group than in the placebo group . The differences in total : HDL and LDL : HDL were independent of changes in fat mass and in waist circumference . A tendency for more beneficial changes in HDL cholesterol , triacylglycerol , and total cholesterol was also observed in the calcium+D group ( P = 0.08 ) . CONCLUSION Consumption of calcium+D during a weight-loss intervention enhanced the beneficial effect of body weight loss on the lipid and lipoprotein profile in overweight or obese women with usual low daily calcium intake BACKGROUND Indirect evidence suggests that optimal vitamin D status is achieved with a serum 25-hydroxyvitamin D [ 25(OH)D ] concentration > 75 nmol/L. OBJECTIVE We aim ed to determine the intake of vitamin D(3 ) needed to raise serum 25(OH)D to > 75 nmol/L. DESIGN The design was a 6-mo , prospect i ve , r and omized , double-blinded , double-dummy , placebo-controlled study of vitamin D(3 ) supplementation . Serum 25(OH OUTPUT: Combining all studies , no significant improvement was seen in fasting glucose , HbA(1c ) or insulin resistance in those treated with vitamin D compared with placebo . No effect was seen on glycated haemoglobin in patients with diabetes and no differences were seen for any outcome in patients with normal fasting glucose . Insufficient data were available to draw conclusions regarding micro- or macrovascular events ; two trials failed to show a reduction in new cases of diabetes in patients treated with vitamin D. CONCLUSIONS There is currently insufficient evidence of beneficial effect to recommend vitamin D supplementation as a means of improving glycaemia or insulin resistance in patients with diabetes , normal fasting glucose or impaired glucose tolerance INPUT: Introduction Vitamin D has potential benefits for extraskeletal health . These could include an anti-inflammatory effect as well as a reduction in endothelial dysfunction . We aim to provide quality evidence for the hypothesis that supplementation with vitamin D will improve endothelial function ( EF ) , possibly through the abrogation of systemic inflammation . Methods and analysis We will conduct a systematic review of all r and omised controlled trials on vitamin D supplementation and EF lasting 12 weeks or more . The search will cover the period 2000–2015 and include studies that describe direct measures of EF , markers of endothelial cell ( EC ) activation and if concurrently reported , indicators of systemic inflammation . Study selection will follow the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines and study quality will be assessed by the Jadad score in addition to an evaluation of allocation concealment and data analysis . If sufficient data are available , a meta- analysis will be conducted . The effect sizes will be generated using Hedges ’ g score , for both fixed and r and om effect models . I2 statistics and Galbraith plots will be used to assess heterogeneity and identify their potential sources . Potential publication and small sample size bias will be assessed by visual inspections of funnel plots and also Egger 's test . Meta-regression analysis ( if feasible ) will be conducted with restricted maximum likelihood ( REML ) estimation method , controlling for potential confounders ( demographics , study methods , location , etc ) . A backward elimination process will be applied in the regression modelling procedure . Subgroup analysis , conditional on number of studies retrieved and their sample size , will be stratified on participant disease category , total dose administered , degree of 25(OH)D change and type of supplement used . Ethics and dissemination Formal ethical approval is not required as primary data will not be collected . The results will be disseminated through a peer- review ed publication , conference presentation and the popular press . Trial registration number International Prospect i ve Register for Systematic Review s ( PROSPERO ) number CRD42014013523 Low serum 25-hydroxyvitamin D ( 25(OH)D ) has been shown to correlate with increased risk of type 2 diabetes . Small , observational studies suggest an action for vitamin D in improving insulin sensitivity and /or insulin secretion . The objective of the present study was to investigate the effect of improved vitamin D status on insulin resistance ( IR ) , utilising r and omised , controlled , double-blind intervention administering 100 microg ( 4000 IU ) vitamin D(3 ) ( n 42 ) or placebo ( n 39 ) daily for 6 months to South Asian women , aged 23 - 68 years , living in Auckl and , New Zeal and . Subjects were insulin resistant - homeostasis model assessment 1 (HOMA1)>1.93 and had serum 25(OH)D concentration < 50 nmol/l . Exclusion criteria included diabetes medication and vitamin D supplementation > 25 microg ( 1000 IU)/d . The HOMA2 computer model was used to calculate outcomes . Median ( 25th , 75th percentiles ) serum 25(OH)D(3 ) increased significantly from 21 ( 11 , 40 ) to 75 ( 55 , 84 ) nmol/l with supplementation . Significant improvements were seen in insulin sensitivity and IR ( P = 0.003 and 0.02 , respectively ) , and fasting insulin decreased ( P = 0.02 ) with supplementation compared with placebo . There was no change in C-peptide with supplementation . IR was most improved when endpoint serum 25(OH)D reached > or = 80 nmol/l . Secondary outcome variables ( lipid profile and high sensitivity C-reactive protein ) were not affected by supplementation . In conclusion , improving vitamin D status in insulin resistant women result ed in improved IR and sensitivity , but no change in insulin secretion . Optimal vitamin D concentrations for reducing IR were shown to be 80 - 119 nmol/l , providing further evidence for an increase in the recommended adequate levels . Registered Trial No. ACTRN12607000642482 Vitamin D ( VitD ) supplementation has been advocated for cardiovascular risk reduction ; however , supporting data are sparse . The objective of this study was to determine whether VitD supplementation reduces cardiovascular risk . Subjects in this prospect i ve , r and omized , double-blind , placebo-controlled trial of post-menopausal women with serum 25-hydroxyvitamin D concentrations > 10 and < 60 ng/mL were r and omized to Vitamin D3 2500 IU or placebo , daily for 4 months . Primary endpoints were changes in brachial artery flow-mediated vasodilation ( FMD ) , carotid-femoral pulse wave velocity ( PWV ) , and aortic augmentation index ( AIx ) . The 114 subjects were mean ( st and ard deviation ) 63.9 ( 3.0 ) years old with a 25-hydroxyvitamin D level of 31.3 ( 10.6 ) ng/mL. Low VitD ( < 30 ng/mL ) was present in 47 % and was associated with higher body-mass index , systolic blood pressure , glucose , CRP , and lower FMD ( all p<0.05 ) . After 4 months , 25-hydroxyvitamin D levels increased by 15.7 ( 9.3 ) ng/mL on vitamin D3 vs. −0.2 ( 6.1 ) ng/mL on placebo ( p<0.001 ) . There were no significant differences between groups in changes in FMD ( 0.3 [ 3.4 ] vs. 0.3 [ 2 OUTPUT:

Available high- quality RCTs did not support a beneficial effect of cholecalciferol on systemic IL-6 and CRP .

MS2_dynamic_1_shot597

***TASK*** the task is to summarize an input biomedical literature 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 . We performed a r and omised controlled study regarding the effects of and rogen replacement therapy ( ART ) on lower urinary tract symptoms ( LUTS ) in hypogonadal men with benign prostate hypertrophy ( BPH ) . Methods . Fifty-two patients with hypogonadism and BPH were r and omly assigned to receive testosterone ( ART group ) as 250 mg of testosterone enanthate every 4 weeks or to the untreated control group . We compared International Prostate Symptom Score ( IPSS ) , uroflowmetry data , post-voiding residual volume ( PVR ) and systemic muscle volume at baseline and 12 months after treatment . Results . Forty-six patients ( ART group , n = 23 ; control , n = 23 ) were included in the analysis . At the 12-month visit , IPSS showed a significant decrease compared with baseline in the ART group ( 15.7 ± 8.7 vs. 12.5 ± 9.5 ; p < 0.05 ) . No significant changes were observed in the control group . The ART group also showed improvement in maximum flow rate and voided volume ( p < 0.05 ) , whereas no significant improvements were observed in the controls . PVR showed no significant changes in either group . In addition , the ART group showed significant enhancement of mean muscle volume ( p < 0.05 ) , whereas no significant changes were seen in the controls . Conclusion . ART improved LUTS in hypogonadal men with mild BPH Although weight loss associated with human immunodeficiency virus ( HIV ) infection is multifactorial in its pathogenesis , it has been speculated that hypogonadism , a common occurrence in HIV disease , contributes to depletion of lean tissue and muscle dysfunction . We , therefore , examined the effects of testosterone replacement by means of And roderm , a permeation-enhanced , nongenital transdermal system , on lean body mass , body weight , muscle strength , health-related quality of life , and HIV-disease markers . We r and omly assigned 41 HIV-infected , ambulatory men , 18 - 60 yr of age , with serum testosterone levels below 400 ng/dL , to 1 of 2 treatment groups : group I , two placebo patches ( n = 21 ) ; or group II , two testosterone patches design ed to release 5 mg testosterone over 24 h. Eighteen men in the placebo group and 14 men in the testosterone group completed the 12-week treatment . Serum total and free testosterone and dihydrotestosterone levels increased , and LH and FSH levels decreased in the testosterone-treated , but not in the placebo-treated , men . Lean body mass and fat-free mass , measured by dual energy x-ray absorptiometry , increased significantly in men receiving testosterone patches [ change in lean body mass , + 1.345 + /- 0.533 kg ( P = 0.02 compared to no change ) ; change in fat-free mass , + 1.364 + /- 0.525 kg ( P = 0.02 compared to no change ) ] , but did not change in the placebo group [ change in lean body mass , 0.189 + /- 0.470 kg ( P = NS compared to no change ) ; change in fat-free mass , 0.186 + /- 0.470 kg ( P = NS compared to no change ) ] . However , there was no significant difference between the 2 treatment groups in the change in lean body mass . The change in lean body mass during treatment was moderately correlated with the increment in serum testosterone levels ( r = 0.41 ; P = 0.02 ) . The testosterone-treated men experienced a greater decrease in fat mass than those receiving placebo patches ( P = 0.04 ) . There was no significant change in body weight in either treatment group . Changes in overall quality of life scores did not correlate with testosterone treatment ; however , in the subcategory of role limitation due to emotional problems , the men in the testosterone group improved an average of 43 points of a 0 - 100 possible score , whereas those in the placebo group did not change . Red cell count increased in the testosterone group ( change in red cell count , + 0.1 + /- 0.1 10(12)/L ) but decreased in the placebo group ( change in red cell count , -0.2 + /- 0.1 10(12)/L ) . CD4 + and CD8 + T cell counts and plasma HIV copy number did not significantly change during treatment . Serum prostate-specific antigen and plasma lipid levels did not change in either treatment group . Testosterone replacement in HIV-infected men with low testosterone levels is safe and is associated with a 1.35-kg gain in lean body mass , a significantly greater reduction in fat mass than that achieved with placebo treatment , an increased red cell count , and an improvement in role limitation due to emotional problems . Further studies are needed to assess whether testosterone supplementation can produce clinical ly meaningful changes in muscle function and disease outcome in HIV-infected men The male aging process brings about declines in hormonal function including a gradual decline in bioavailable testosterone levels . Animal studies suggest that testosterone modulates cognitive function through enhancing acetylcholine release and up-modulation of nicotinic receptors . Tau protein deposition is also affected by and rogen supplementation in animals . We hypothesize that testosterone replacement in elderly hypogonadal males may improve cognition , in particular the visual-spatial domain . Thirty-six male patients with a new diagnosis of Alzheimer 's disease had their total and bioavailable testosterone levels measured . None of the patients had been on acetylcholinesterase inhibitors . Ten of the 36 patients ( 28 % ) were deemed biochemically hypogonadal ( total testosterone < 240 ng/dl or 7 nmol/l ) . Five of the hypogonadal OUTPUT: Testosterone replacement therapy does not increase PSA levels in men being treated for hypogonadism , except when it is given IM and even the increase with IM administration is minimal INPUT: CONTEXT Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation . Trial 's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm . The changes in muscle performance and physical function were evaluated in relation to participant 's perception of change . METHODS Men aged 65 years and older , with mobility limitation , total testosterone 100 - 350 ng/dL , or free testosterone less than 50 pg/mL , were r and omized to placebo or 10 g testosterone gel daily for 6 months . Primary outcome was leg-press strength . Secondary outcomes included chest-press strength , stair-climb , 40-m walk , muscle mass , physical activity , self-reported function , and fatigue . Proportions of participants exceeding minimally important difference in study arms were compared . RESULTS Of 209 r and omized participants , 165 had follow-up efficacy measures . Mean ( SD ) age was 74 ( 5.4 ) years and short physical performance battery score 7.7 ( 1.4 ) . Testosterone arm exhibited greater improvements in leg-press strength , chest-press strength and power , and loaded stair-climb than placebo . Compared with placebo , significantly greater proportion of men receiving testosterone improved their leg-press and chest-press strengths ( 43 % vs 18 % , p = .01 ) and stair-climbing power ( 28 % vs 10 % , p = .03 ) more than minimally important difference . Increases in leg-press strength and stair-climbing power were associated with changes in testosterone levels and muscle mass . Physical activity , walking speed , self-reported function , and fatigue did not change . CONCLUSIONS Testosterone administration in older men with mobility limitation was associated with patient-important improvements in muscle strength and stair-climbing power . Improvements in muscle strength and only some physical function measures should be weighed against the risk of adverse events in this population Serum and rogen levels decline with aging in normal males , such that a significant number of men over 60 yr of age will have a mean serum total testosterone ( T ) level near the low end of the normal adult range . It is not known whether lower T levels in older men have an effect on and rogen-responsive organ systems , such as muscle , bone , bone marrow , and prostate , nor are there data to evaluate the relative benefits and risks of T supplementation in older men . We assessed the physiological and biochemical effects of T therapy in 13 healthy men , 57 - 76 yr old , who had low or borderline low serum T levels ( < or = 13.9 nmol/L ) . Intramuscular testosterone enanthate ( TE ; 100 mg weekly ) and placebo injections were given for 3 months each . Before treatment and at the end of both 3-month treatment regimens , lean body mass , body fat , biochemical parameters of bone turnover , hematological parameters , lipoprotein profiles , and prostate parameters [ such as prostate-specific antigen ( PSA ) ] were evaluated . Serum T levels rose in all subjects with TE treatment , such that the lowest level of T during a week 's period was 19.7 + /- 0.7 nmol/L ( mean + /- SE ) . After 3 months of TE treatment , lean body mass was significantly increased , and urinary hydroxyproline excretion was significantly depressed . With TE treatment , there was a significant increase in hematocrit , a decline in total cholesterol and low density lipoprotein cholesterol , and a sustained increase in serum PSA levels . Placebo treatment led to no significant changes in any of these parameters . We conclude that short term ( 3 months ) TE supplementation to healthy older men who have serum T levels near or below the lower limit of normal for young adult men results in an increase in lean body mass and possibly a decline in bone resorption , as assessed by urinary hydroxyproline excretion , with some effect on serum lipoproteins , hematological parameters , and PSA . The sustained stimulation of PSA and the increase in hematocrit that occur with physiological TE supplementation suggest that older men should be screened carefully and followed periodically throughout T therapy CONTEXT Steroid 5α-reductase inhibitors are used to treat benign prostatic hyperplasia and and rogenic alopecia , but the role of 5α-dihydrotestosterone ( DHT ) in mediating testosterone 's effects on muscle , sexual function , erythropoiesis , and other and rogen-dependent processes remains poorly understood . OBJECTIVE To determine whether testosterone 's effects on muscle mass , strength , sexual function , hematocrit level , prostate volume , sebum production , and lipid levels are attenuated when its conversion to DHT is blocked by dutasteride ( an inhibitor of 5α-reductase type 1 and 2 ) . DESIGN , SETTING , AND PATIENTS The 5α-Reductase Trial was a r and omized controlled trial of healthy men aged 18 to 50 years comparing placebo plus testosterone enthanate with dutasteride plus testosterone enanthate from May 2005 through June 2010 . INTERVENTIONS Eight treatment groups received 50 , 125 , 300 , or 600 mg/wk of testosterone enanthate for 20 weeks plus placebo ( 4 groups ) or 2.5 mg/d of dutasteride ( 4 groups ) . MAIN OUTCOME MEASURES The primary outcome was change in fat-free mass ; secondary outcomes : changes in fat mass , muscle strength , sexual function , prostate volume , sebum production , and hematocrit and lipid levels . RESULTS A total of 139 men were r and omized ; 102 completed the 20-week intervention . Men assigned to dutasteride OUTPUT:

Intramuscular TRT is more effective than transdermal formulations at increasing LBM and improving muscle strength in middle-aged and older men , particularly in the lower extremities

MS2_dynamic_1_shot598

***TASK*** the task is to summarize an input biomedical literature 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 impact of Hatha yoga as add-on treatment to quetiapine fumarate extended release ( QXR ) or escitalopram ( ESC ) in depressed patients on hypothalamic-pituitary-adrenal ( HPA ) axis activity was assessed . METHODS 60 in patients suffering from major depressive disorder ( MDD ) according to DSM-IV were r and omized for a 5 week treatment with Yoga or not ( control group ) and with either QXR ( 300 mg/day ) or ESC ( 10 mg/day ) . Serial dexamethasone/corticotropin releasing hormone ( DEX/CRH ) tests were performed to assess HPA axis function . The Hamilton Depression Rating Scale ( 21-HAMD ) was used weekly . RESULTS A more pronounced down regulation of the HPA axis activity due to yoga could not be detected . The stepwise long term cortisol reduction was seen in both medication groups , irrespectively of yoga add-on treatment . In addition , cortisol improvers in week 1 of therapy ( reduction in cortisol peak value within the DEX/CRH test ) reached significant greater amelioration of depressive symptoms after 5 weeks . CONCLUSIONS Our results suggest that antidepressant agents down regulate HPA axis function to a greater extent than additional Hatha yoga treatment . Moreover , an early reduction of HPA system hyperactivity after one week of pharmacological treatment seems to raise the possibility of a favorable treatment response Background : The dem and for clinical ly efficacious , safe , patient acceptable , and cost-effective forms of treatment for mental illness is growing . Several studies have demonstrated benefit from yoga in specific psychiatric symptoms and a general sense of well-being . Objective : To systematic ally examine the evidence for efficacy of yoga in the treatment of selected major psychiatric disorders . Methods : Electronic search es of The Cochrane Central Register of Controlled Trials and the st and ard bibliographic data bases , MEDLINE , EMBASE , and PsycINFO , were performed through April 2011 and an up date d in June 2011 using the keywords yoga AND psychiatry OR depression OR anxiety OR schizophrenia OR cognition OR memory OR attention AND r and omized controlled trial ( RCT ) . Studies with yoga as the independent variable and one of the above mentioned terms as the dependent variable were included and exclusion criteria were applied . Results : The search yielded a total of 124 trials , of which 16 met rigorous criteria for the final review . Grade B evidence supporting a potential acute benefit for yoga exists in depression ( four RCTs ) , as an adjunct to pharmacotherapy in schizophrenia ( three RCTs ) , in children with ADHD ( two RCTs ) , and Grade C evidence in sleep complaints ( three RCTs ) . RCTs in cognitive disorders and eating disorders yielded conflicting results . No studies looked at primary prevention , relapse prevention , or comparative effectiveness versus pharmacotherapy . Conclusion : There is emerging evidence from r and omized trials to support popular beliefs about yoga for depression , sleep disorders , and as an augmentation therapy . Limitations of literature include inability to do double-blind studies , multiplicity of comparisons within small studies , and lack of replication . Biomarker and neuroimaging studies , those comparing yoga with st and ard pharmaco- and psychotherapies , and studies of long-term efficacy are needed to fully translate the promise of yoga for enhancing mental health CONTEXT Yoga is increasing in popularity , with an estimated 15 million practitioners in the United States , yet there is a dearth of empirical data addressing the holistic benefits of yoga . OBJECTIVE To compare the physical and mental benefits of an exercise-based yoga practice to that of a more comprehensive yoga practice ( one with an ethical/spiritual component ) . DESIGN Students with mild to moderate depression , anxiety , or stress and who agreed to participate were assigned to one of three groups : integrated yoga , yoga as exercise , control . PARTICIPANTS A total of 81 undergraduate students 18 years and older at a university in the southeastern United States participated in the study . MAIN OUTCOME MEASURES Depression , anxiety , stress , hope , and salivary cortisol . RESULTS Over time , participants in both the integrated and exercise yoga groups experienced decreased depression and stress , an increased sense of hopefulness , and increased flexibility compared to the control group . However , only the integrated yoga group experienced decreased anxiety-related symptoms and decreased salivary cortisol from the beginning to the end of the study . CONCLUSIONS Yoga , practice d in a more integrated form , ie , with an ethical and spiritual component , may provide additional benefits over yoga practice d as an exercise regimen Major depressive disorder ( MDD ) is a common , debilitating chronic condition in the United States and worldwide . Particularly in women , depressive symptoms are often accompanied by high levels of stress and ruminations , or repetitive self-critical negative thinking . There is a research and clinical imperative to evaluate complementary therapies that are acceptable and feasible for women with depression and that target specific aspects of depression in women , such as ruminations . To begin to address this need , we conducted a r and omized , controlled , mixed- methods community-based study comparing an 8-week yoga intervention with an attention-control activity in 27 women with MDD . After controlling for baseline stress , there was a decrease in depression over time in both the yoga group and the attention-control group , with the yoga group having a unique trend in decreased ruminations . Participants in the yoga group reported experiencing increased connectedness and gaining a coping strategy through yoga . The findings provide support for future large scale research to explore the effects of yoga for depressed women and the unique role of yoga in decreasing rumination We had previously reported decreased serum brain-derived neurotrophic factor ( BDNF ) levels in depressed patients . In the present study , we tested the hypothesis that antidepressant treatment would normalize serum BDNF OUTPUT: In addition , preliminary studies suggest that alterations in cortisol , BDNF , and HRV may play a role in how yoga exerts its clinical effect . DISCUSSION The results suggest that body-oriented yoga could work through some of the theoretically predicted mechanisms . INPUT: Sahaj Yoga is a meditative technique that has been found to have beneficial effects in some psycho-somatic illnesses . The study was carried out on 30 cases ( 19 Males , 11 females , age 18 - 45 years ) of major depression diagnosed on the basis of DSM IV criteria . The patients were then r and omly divided into two groups : Group 1 : ( 10 Males & 5 Females ) Patients who were practising Sahaj Yoga and also received conventional anti-depressants . Group 2 : ( 9 Males & 6 Females ) Patients who were only receiving conventional anti-depressants . Training in Sahaj yoga was conducted under the supervision of a trained Sahaj Yogi for 8 weeks . At start of the study , all the patients were subjected to Hamilton Rating Scale for Depression ( HAM-D ) and Hamilton Rating Scale for Anxiety ( HAM-A ) . Above scales were again assessed after two months of treatment . There was significant improvement in HAM-D as well as HAM-A scores in both Group 1 and Group 2 patients ( P<0.001 ) . However , percentage improvement in HAM-D scores and HAM-A scores in patients receiving Sahaj Yoga was significantly higher than in Group 2 patients . The number of patients who went into remission after two months of intervention were also significantly higher in Group 1 patients ( P=0.02 ) . The present study demonstrates that Sahaj Yoga has got a potential role as a component in the management of depressive disorders OBJECTIVE To evaluate feasibility , efficacy , and tolerability of Sudarshan Kriya yoga ( SKY ) as an adjunctive intervention in patients with major depressive disorder ( MDD ) with inadequate response to antidepressant treatment . METHODS Patients with MDD ( defined by DSM-IV-TR ) who were depressed despite ≥ 8 weeks of antidepressant treatment were r and omized to SKY or a waitlist control ( delayed yoga ) arm for 8 weeks . The primary efficacy end point was change in 17-item Hamilton Depression Rating Scale ( HDRS-17 ) total score from baseline to 2 months . The key secondary efficacy end points were change in Beck Depression Inventory ( BDI ) and Beck Anxiety Inventory ( BAI ) total scores . Analyses of the intent-to-treat ( ITT ) and completer sample were performed . The study was conducted at the University of Pennsylvania between October 2014 and December 2015 . RESULTS In the ITT sample ( n = 25 ) , the SKY arm ( n = 13 ) showed a greater improvement in HDRS-17 total score compared to waitlist control ( n = 12 ) ( -9.77 vs 0.50 , P = .0032 ) . SKY also showed greater reduction in BDI total score versus waitlist control ( -17.23 vs -1.75 , P = .0101 ) . Mean changes in BAI total score from baseline were significantly greater for SKY than waitlist ( ITT mean difference : -5.19 ; 95 % CI , -0.93 to -9.34 ; P = .0097 ; completer mean difference : -6.23 ; 95 % CI , -1.39 to -11.07 ; P = .0005 ) . No adverse events were reported . CONCLUSIONS Results of this r and omized , waitlist-controlled pilot study suggest the feasibility and promise of an adjunctive SKY-based intervention for patients with MDD who have not responded to antidepressants . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT02616549 We conducted a pilot r and omized controlled trial ( RCT ) comparing a prenatal yoga intervention to perinatal-focused health education in pregnant women with depression . Findings document acceptability and feasibility of the yoga intervention : no yoga-related injuries were observed , instructors showed fidelity to the yoga manual , and women rated interventions as acceptable . Although improvements in depression were not statistically different between groups , they favored yoga . This study provides support for a larger scale RCT examining prenatal yoga to improve mood during pregnancy BACKGROUND This study examined the effects of brief daily yogic meditation on mental health , cognitive functioning , and immune cell telomerase activity in family dementia caregivers with mild depressive symptoms . METHODS Thirty-nine family dementia caregivers ( mean age 60.3 years old ( SD = 10.2 ) ) were r and omized to practicing Kirtan Kriya or listening to relaxation music for 12 min per day for 8 weeks . The severity of depressive symptoms , mental and cognitive functioning were assessed at baseline and follow-up . Telomerase activity in peripheral blood mononuclear cells ( PMBC ) was examined in peripheral P BMC pre-intervention and post-intervention . RESULTS The meditation group showed significantly lower levels of depressive symptoms and greater improvement in mental health and cognitive functioning compared with the relaxation group . In the meditation group , 65.2 % showed 50 % improvement on the Hamilton Depression Rating scale and 52 % of the participants showed 50 % improvement on the Mental Health Composite Summary score of the Short Form-36 scale compared with 31.2 % and 19 % , respectively , in the relaxation group ( p < 0.05 ) . The meditation group showed 43 % improvement in telomerase activity compared with 3.7 % in the relaxation group ( p = 0.05 ) . CONCLUSION This pilot study found that brief daily meditation practice s by family dementia caregivers can lead to improved mental and cognitive functioning and lower levels of depressive symptoms . This improvement is accompanied by an increase in telomerase activity suggesting improvement in stress-induced cellular aging . These results need to be confirmed in a larger sample OBJECTIVES The impact of Hatha yoga as add-on treatment to quetiapine fumarate extended release ( OUTPUT:

Compared to aerobic exercise , no short- or medium-term group differences in depression severity was found . Higher short-term depression severity was found for yoga compared to electro-convulsive therapy ; remission rates did not differ between groups . No short-term group differences occurred when yoga was compared to antidepressant medication . Conflicting evidence was found when yoga was compared to attention-control interventions , or when yoga as an add-on to antidepressant medication was compared to medication alone . This review found some evidence for positive effects beyond placebo and comparable effects compared to evidence -based interventions .

MS2_dynamic_1_shot599

***TASK*** the task is to summarize an input biomedical literature 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 controlled trial comparing family therapy with individual supportive therapy in anorexia nervosa and bulimia nervosa was undertaken . Eighty patients ( 57 with anorexia nervosa ; 23 with bulimia nervosa ) were first admitted to a specialized unit to restore their weight to normal . Before discharge , they were r and omly allocated to family therapy or the control treatment ( individual supportive therapy ) . After one year of psychological treatment , they were reassessed , using body weight , menstrual function , and ratings on the Morgan and Russell scales . Family therapy was found to be more effective than individual therapy in patients whose illness was not chronic and had begun before the age of 19 years . A more tentative finding was the greater value of individual supportive therapy in older patients . To our knowledge , this is the first controlled trial of family therapy in anorexia nervosa and clarifies the specific indications for this treatment BACKGROUND Very limited evidence is available on how to treat adults with anorexia nervosa and treatment outcomes are poor . Novel treatment approaches are urgently needed . AIMS To evaluate the efficacy and acceptability of a novel psychological therapy for anorexia nervosa ( Maudsley Model of Anorexia Nervosa Treatment for Adults , MANTRA ) compared with specialist supportive clinical management ( SSCM ) in a r and omised controlled trial . METHOD Seventy-two adult out- patients with anorexia nervosa or eating disorder not otherwise specified were recruited from a specialist eating disorder service in the UK . Participants were r and omly allocated to 20 once weekly sessions of MANTRA or SSCM and optional additional sessions depending on severity and clinical need ( trial registration : IS RCT N62920529 ) . The primary outcomes were body mass index , weight and global score on the Eating Disorders Examination at end of treatment ( 6 months ) and follow-up ( 12 months ) . Secondary outcomes included : depression , anxiety and clinical impairment ; neuropsychological outcomes ; recovery rates ; and additional service utilisation . RESULTS At baseline , patients r and omised to MANTRA were significantly less likely to be in a partner relationship than those receiving SSCM ( 3/34 v. 10/36 ; P<0.05 ) . Patients in both treatments improved significantly in terms of eating disorder and other outcomes , with no differences between groups . Strictly defined recovery rates were low . However , MANTRA patients were significantly more likely to require additional in-patient or day-care treatment than those receiving SSCM ( 7/34 v. 0/37 ; P = 0.004 ) . CONCLUSIONS Adults with anorexia nervosa are a difficult to treat group . The imbalance between groups in partner relationships may explain differences in service utilisation favouring SSCM . This study confirms SSCM as a useful treatment for out- patients with anorexia nervosa . The novel treatment , MANTRA , design ed for this patient group may need adaptations to fully exploit its potential OBJECTIVE Adoption of effective treatments for recurrent binge-eating disorders depends on the balance of costs and benefits . Using data from a recent r and omized controlled trial , we conducted an incremental cost-effectiveness analysis ( CEA ) of a cognitive-behavioral therapy guided self-help intervention ( CBT-GSH ) to treat recurrent binge eating compared to treatment as usual ( TAU ) . METHOD Participants were 123 adult members of an HMO ( mean age = 37.2 years , 91.9 % female , 96.7 % non-Hispanic White ) who met criteria for eating disorders involving binge eating as measured by the Eating Disorder Examination ( C. G. Fairburn & Z. Cooper , 1993 ) . Participants were r and omized either to treatment as usual ( TAU ) or to TAU plus CBT-GSH . The clinical outcomes were binge-free days and quality -adjusted life years ( QALYs ) ; total societal cost was estimated using costs to patients and the health plan and related costs . RESULTS Compared to those receiving TAU only , those who received TAU plus CBT-GSH experienced 25.2 more binge-free days and had lower total societal costs of $ 427 over 12 months following the intervention ( incremental CEA ratio of -$20.23 per binge-free day or -$26,847 per QALY ) . Lower costs in the TAU plus CBT-GSH group were due to reduced use of TAU services in that group , result ing in lower net costs for the TAU plus CBT group despite the additional cost of CBT-GSH . CONCLUSIONS Findings support CBT-GSH dissemination for recurrent binge-eating treatment BACKGROUND Currently , without systematic evidence , psychotherapy for anorexia nervosa in adults draws on psychodynamic , cognitive and systemic theories . AIMS To assess effectiveness of specific psychotherapies in out-patient management of adult patients with anorexia nervosa . METHOD Eighty-four patients were r and omised to four treatments : three specific psychotherapies - ( a ) a year of focal psychoanalytic psychotherapy ; ( b ) 7 months of cognitive-analytic therapy ( CAT ) ; ( c ) family therapy for 1 year - and ( d ) low contact , ' routine ' treatment for 1 year ( control ) . RESULTS At 1 year , there was symptomatic improvement in the whole group of patients . This improvement was modest , several patients being significantly undernourished at follow-up . Psychoanalytic psychotherapy and family therapy were significantly superior to the control treatment ; CAT tended to show benefits . CONCLUSIONS Psychoanalytic and family therapy are of specific value in the out-patient treatment of adult patients with anorexia OBJECTIVE Research suggests that family treatment for adolescents with anorexia nervosa may be effective . This study was design ed to determine the optimal length of such family therapy . METHOD Eighty-six OUTPUT: The cognitive behavioral approach was the most effective treatment , especially for bulimia nervosa , binge eating disorder and the night eating syndrome . For anorexia nervosa , the family approach showed greater effectiveness . Other effective approaches were interpersonal psychotherapy , dialectic behavioral therapy , support therapy and self-help manuals . Moreover , there was an increasing number of preventive and promotional approaches that addressed individual , family and social risk factors , being promising for the development of positive self-image and self-efficacy . A abordagem cognitivo-comportamental foi o tratamento mais efetivo , principalmente para bulimia nervosa , transtorno da compulsão alimentar periódica e síndrome do comer noturno . Para anorexia nervosa , a abordagem familiar demonstrou maior efetividade . INPUT: A controlled trial comparing family therapy with individual supportive therapy in anorexia nervosa and bulimia nervosa was undertaken . Eighty patients ( 57 with anorexia nervosa ; 23 with bulimia nervosa ) were first admitted to a specialized unit to restore their weight to normal . Before discharge , they were r and omly allocated to family therapy or the control treatment ( individual supportive therapy ) . After one year of psychological treatment , they were reassessed , using body weight , menstrual function , and ratings on the Morgan and Russell scales . Family therapy was found to be more effective than individual therapy in patients whose illness was not chronic and had begun before the age of 19 years . A more tentative finding was the greater value of individual supportive therapy in older patients . To our knowledge , this is the first controlled trial of family therapy in anorexia nervosa and clarifies the specific indications for this treatment OBJECTIVE Selective serotonin reuptake inhibitor ( SSRI ) medication does not appear to be effective in ill , malnourished anorexia nervosa ( AN ) patients . However , it may be effective in preventing relapse after weight restoration . The purpose of this study was to determine whether nutritional supplements could potentiate the effects of fluoxetine in underweight AN subjects . METHOD Twenty-six subjects with AN participated in a trial of fluoxetine . In a double-blind , placebo-controlled manner , subjects received either nutritional supplements or a nutritional placebo . The nutritional supplement included tryptophan ( the precursor of serotonin ) , vitamins , minerals , and essential fatty acids believed to influence serotonin pathway function . RESULTS There was no significant difference in weight gain between subjects treated with fluoxetine plus nutritional supplements versus fluoxetine plus a nutritional placebo . Moreover , there were no significant differences between groups on mean changes in anxiety or obsessive and compulsive symptoms . DISCUSSION The results of this study suggest that supplement strategies are not a substitute for adequate nutrition and are ineffective in increasing the efficacy of fluoxetine in underweight AN subjects Fifteen women with bulimia nervosa were treated with a 4-month course of combined cognitive-behavioral , nutritional and antidepressant therapy ( 5 with amineptine and 10 with fluvoxamine ) . Patients were monitored before and after 1 , 2 and 4 months of therapy for body mass index ( BMI ) , for eating disorder symptoms by the Eating Disorder Inventory ( EDI ) and the Bulimic Investigation Test ( BITE ) , and for depression and anxiety by the Hamilton Rating Scale for Depression and for Anxiety ( HRS-D and -A ) . BITE symptoms and gravity improved significantly and equally in the two groups during the 4 months of therapy . Global EDI scores , depression and anxiety decreased but not significantly . BMI was normal before therapy and did not change during treatment BACKGROUND Currently , without systematic evidence , psychotherapy for anorexia nervosa in adults draws on psychodynamic , cognitive and systemic theories . AIMS To assess effectiveness of specific psychotherapies in out-patient management of adult patients with anorexia nervosa . METHOD Eighty-four patients were r and omised to four treatments : three specific psychotherapies - ( a ) a year of focal psychoanalytic psychotherapy ; ( b ) 7 months of cognitive-analytic therapy ( CAT ) ; ( c ) family therapy for 1 year - and ( d ) low contact , ' routine ' treatment for 1 year ( control ) . RESULTS At 1 year , there was symptomatic improvement in the whole group of patients . This improvement was modest , several patients being significantly undernourished at follow-up . Psychoanalytic psychotherapy and family therapy were significantly superior to the control treatment ; CAT tended to show benefits . CONCLUSIONS Psychoanalytic and family therapy are of specific value in the out-patient treatment of adult patients with anorexia OBJECTIVE To determine whether a grade d exercise program used in the treatment of anorexia nervosa improves quality of life and does not decrease the rate of gain of body fat . METHODS A r and omized controlled trial with outcome measures : change in percent body fat , body mass index ( BMI ) , and Medical Outcomes Survey Short Form 36-item Quality of Life question naire . RESULTS Fifteen females and one male meeting the DSM-IV criteria for the diagnosis of anorexia nervosa were r and omized . There was no difference in change in BMI or percent body fat at 3 months . Quality of life outcomes improved from baseline in the experimental group compared with the control group . However , this difference was not statistically significant . DISCUSSION Incorporation of a grade d exercise program may increase compliance with treatment , but it did not reduce the short-term rate of gain of body fat or BMI . Longer studies with more subjects are necessary to determine the usefulness of a grade d exercise program in anorexia nervosa OBJECTIVE Research suggests that family treatment for adolescents with anorexia nervosa may be effective . This study was design ed to determine the optimal length of such family therapy . METHOD Eighty-six adolescents ( 12 - 18 years of age ) diagnosed with anorexia nervosa were allocated at r and om to either a short-term ( 10 sessions over 6 months ) or long-term treatment ( 20 sessions over 12 months ) and evaluated at the end of 1 year using the Eating Disorder Examination ( EDE ) between 1999 and 2002 . RESULTS Although adequately powered to detect differences between treatment groups , an intent-to-treat analysis found no significant differences between the short-term and long-term treatment groups . Although a nonsignificant finding does not prove the null hypothesis , in no instance does the confidence interval on the effect size on the difference between the groups approach a moderate .5 level . However , post hoc analyses suggest that subjects with severe eating-related obsessive-compulsive features or who come from nonintact families respond OUTPUT:

Cognitive behavioral therapy may reduce relapse risk for adults with AN after weight restoration , although its efficacy in the underweight state remains unknown . Variants of family therapy are efficacious in adolescents , but not in adults . Evidence for AN treatment is weak ; evidence for treatment-related harms and factors associated with efficacy of treatment are weak ; and evidence for differential outcome by sociodemographic factors is nonexistent .